Tegretol medicine. Tegretol (Carbamazepine): Uses, Side Effects, and Interactions – Comprehensive Guide

03.12.197626.10.2021 by alexxlab

What are the primary uses of Tegretol. How does Carbamazepine work in the body. What are the most common side effects of Tegretol. How does Tegretol interact with other medications. What precautions should be taken when using Carbamazepine. How is Tegretol administered and dosed. What are the potential risks and warnings associated with Tegretol use.

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Understanding Tegretol: An Overview of Carbamazepine

Tegretol, known generically as Carbamazepine, is a widely prescribed medication used primarily in the treatment of epilepsy and certain types of nerve pain. This anticonvulsant drug has been a staple in neurological treatment for decades, offering relief to millions of patients worldwide. But what exactly is Tegretol, and how does it work in the body?

Carbamazepine functions by stabilizing the electrical activity in the brain and nerves. It achieves this by reducing the excessive firing of neurons, which is often responsible for seizures and neuropathic pain. By modulating sodium channels in neurons, Tegretol helps to calm overactive neural circuits, providing relief from various neurological conditions.

Key Characteristics of Tegretol

Anticonvulsant properties
Mood-stabilizing effects
Pain-relieving capabilities
Available in various formulations (tablets, extended-release capsules, oral suspension)

Primary Uses and Therapeutic Applications of Carbamazepine

Tegretol’s versatility makes it a valuable tool in treating several medical conditions. While its primary use is in epilepsy management, healthcare providers also prescribe it for other purposes. What are the main therapeutic applications of Carbamazepine?

Epilepsy and Seizure Disorders

Carbamazepine is highly effective in controlling various types of seizures, including:

Partial seizures
Tonic-clonic seizures
Mixed seizure patterns

Neuropathic Pain Management

Tegretol has shown significant efficacy in treating certain types of nerve pain, such as:

Trigeminal neuralgia
Diabetic neuropathy
Post-herpetic neuralgia

Bipolar Disorder

In some cases, Carbamazepine is used as a mood stabilizer for patients with bipolar disorder, particularly in managing manic episodes.

Side Effects and Adverse Reactions Associated with Tegretol

While Tegretol can be highly effective, it’s crucial to be aware of potential side effects. What are the most common adverse reactions patients might experience when taking Carbamazepine?

Common Side Effects

Dizziness
Drowsiness
Nausea and vomiting
Blurred vision
Headache
Dry mouth

Serious Side Effects

In rare cases, Tegretol may cause more severe side effects that require immediate medical attention:

Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis)
Blood disorders (agranulocytosis, aplastic anemia)
Liver dysfunction
Hyponatremia (low sodium levels)

It’s important to note that the benefits of Tegretol often outweigh the risks for many patients. However, close monitoring by a healthcare provider is essential to manage any potential adverse effects.

Drug Interactions: Navigating Tegretol’s Impact on Other Medications

Carbamazepine can interact with a wide range of medications, potentially altering their effectiveness or increasing the risk of side effects. How does Tegretol interact with other drugs, and what precautions should patients and healthcare providers take?

Enzyme Induction and Its Consequences

Tegretol is known to be a potent inducer of liver enzymes, particularly the cytochrome P450 system. This can lead to:

Increased metabolism of other drugs
Reduced effectiveness of certain medications
Potential need for dosage adjustments of concurrent medications

Specific Drug Interactions

Some notable interactions include:

Oral contraceptives: Tegretol may reduce their effectiveness
Warfarin and other anticoagulants: Carbamazepine can decrease their anticoagulant effect
Certain antidepressants: Interactions may lead to increased side effects or reduced efficacy
Antifungal medications: Some azole antifungals can increase Tegretol levels in the blood

Given the complex nature of these interactions, it’s crucial for patients to inform all their healthcare providers about their use of Tegretol and any other medications they’re taking.

Dosage and Administration: Optimizing Tegretol Treatment

Proper dosing of Tegretol is critical for achieving optimal therapeutic effects while minimizing side effects. How is Carbamazepine typically administered, and what factors influence dosage decisions?

Dosage Forms

Tegretol is available in several formulations:

Immediate-release tablets
Extended-release tablets and capsules
Oral suspension
Chewable tablets

Dosing Considerations

The appropriate dose of Tegretol varies depending on several factors:

The condition being treated
Patient age and weight
Liver and kidney function
Concurrent medications

Typically, treatment begins with a low dose that is gradually increased to achieve the desired therapeutic effect. Regular blood tests to monitor Tegretol levels and liver function are often necessary to ensure safe and effective treatment.

Special Populations and Precautions: Tailoring Tegretol Use

Certain groups of patients may require special consideration when using Tegretol. What precautions should be taken for specific populations?

Pregnancy and Breastfeeding

Carbamazepine use during pregnancy carries potential risks, including:

Increased risk of birth defects
Potential for neonatal withdrawal symptoms

Women who are pregnant or planning to become pregnant should discuss the risks and benefits of Tegretol use with their healthcare provider. For breastfeeding mothers, careful consideration is needed as Carbamazepine can pass into breast milk.

Elderly Patients

Older adults may be more sensitive to the side effects of Tegretol and may require lower doses or more careful monitoring. Factors to consider include:

Increased risk of hyponatremia
Potential for drug interactions due to polypharmacy
Changes in liver and kidney function affecting drug metabolism

Patients with Liver or Kidney Disease

Tegretol metabolism and excretion can be affected in patients with liver or kidney impairment. These patients may require:

Dose adjustments
More frequent monitoring of drug levels and organ function
Consideration of alternative treatments in severe cases

Long-term Use and Monitoring: Ensuring Continued Safety and Efficacy

For many patients, Tegretol is a long-term treatment option. How can healthcare providers and patients ensure the continued safety and effectiveness of Carbamazepine over extended periods?

Regular Monitoring

Long-term use of Tegretol typically involves:

Periodic blood tests to check Carbamazepine levels
Liver function tests
Complete blood counts to monitor for potential blood disorders
Electrolyte panels, particularly to check sodium levels

Managing Side Effects

Over time, some patients may develop tolerance to certain side effects, while others may experience new issues. Strategies for managing long-term side effects include:

Dose adjustments
Switching to extended-release formulations
Adding supportive treatments to manage specific side effects

Assessing Ongoing Need

Periodic evaluation of the continued need for Tegretol is important, especially in epilepsy patients who may have been seizure-free for extended periods. Any changes to treatment should be made gradually and under close medical supervision.

Tegretol in Combination Therapy: Enhancing Treatment Outcomes

In some cases, Carbamazepine may be used in combination with other medications to enhance treatment outcomes. When and why might combination therapy with Tegretol be considered?

Epilepsy Management

For patients with difficult-to-control seizures, Tegretol may be combined with other anticonvulsants such as:

Valproic acid
Levetiracetam
Lamotrigine

The goal of combination therapy in epilepsy is to achieve better seizure control with potentially lower doses of individual medications, thereby reducing side effects.

Bipolar Disorder Treatment

In bipolar disorder, Carbamazepine might be used alongside:

Lithium
Antipsychotics
Other mood stabilizers

This approach can help manage both manic and depressive episodes more effectively in some patients.

Neuropathic Pain Management

For complex pain conditions, Tegretol may be part of a multimodal pain management strategy, potentially combined with:

Gabapentin or pregabalin
Tricyclic antidepressants
Topical treatments

When considering combination therapy, it’s crucial to account for potential drug interactions and cumulative side effects. Close monitoring and careful dose adjustments are essential to optimize treatment outcomes while minimizing risks.

In conclusion, Tegretol (Carbamazepine) remains a valuable medication in the treatment of various neurological and psychiatric conditions. Its effectiveness in managing epilepsy, neuropathic pain, and bipolar disorder has made it a mainstay in clinical practice. However, the complex pharmacology of Carbamazepine, including its potential for drug interactions and side effects, necessitates careful management and ongoing monitoring. By understanding the nuances of Tegretol use, including proper dosing, potential adverse effects, and special considerations for different patient populations, healthcare providers can optimize treatment outcomes and improve patient quality of life. As with any medication, the decision to use Tegretol should be made on an individual basis, weighing the potential benefits against the risks and considering alternative treatment options when appropriate.

Tegretol Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Side Effects of Tegretol (Carbamazepine), Warnings, Uses

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Tegretol XR 400 mg

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Carbamazepine: medicine to treat epilepsy and nerve pain

Carbamazepine is a prescription medicine. It’s important to take it as instructed by your doctor.

Dosage

How much you take will depend on what you are taking it for.

You’ll usually start on a low dose of 100mg to 200mg, taken once or twice a day. This will be increased over several weeks to the usual dose.

The usual dose for:

epilepsy – 800mg to 1200mg, taken as 1 or 2 doses
nerve pain – 600mg to 800mg, taken as 1 or 2 doses
bipolar disorder – 400mg to 600mg, taken as 1 or 2 doses

In children, the dose of carbamazepine will depend on the weight of your child. Your doctor will be able to prescribe the right dose for your child.

How to take it

If you take carbamazepine twice a day, try to space your doses evenly through the day. For example, first thing in the morning, and in the evening. You can take it with or without food.

Tablets – you can take tablets with or without food. Swallow the tablets whole with a drink of water. The tablets have a score line to help you break the tablet in half if you have difficulties swallowing the tablet whole.

Liquid – to take carbamezapine liquid shake the bottle before you measure out your dose. The medicine will come with a plastic syringe or spoon to help you measure out the right dose. If you don’t have one, ask your pharmacist for one. Do not use a kitchen teaspoon as it will not give the right amount.

Suppositories – take the wrapping off and push a suppository gently into your anus. Read the instructions in the leaflet inside the package. They will explain how to use the suppository.

Will my dose go up or down?

To prevent the chance of side effects, your doctor will start you off on a low dose of carbamazepine. They will increase it gradually over a few days or weeks.

Once you find a dose that suits you, it will usually stay the same – unless your condition changes, or your doctor starts you on a new medicine that may affect carbamazepine.

What if I forget to take it?

If you take carbamazepine and miss a dose:

once a day – take the missed dose as soon as you remember. If it’s less than 12 hours before the next dose is due, it’s better to leave out the missed dose and take your next dose as normal.
twice a day – take the missed dose as soon as you remember. If it’s less than 8 hours before the next dose is due, it’s better to leave out the missed dose and take your next dose as normal.

Do not take 2 doses at the same time to make up for a forgotten dose.

If you have epilepsy, it’s important to take this medicine regularly. Missing doses may trigger a seizure.

If you forget doses often, it may help to set an alarm to remind you. You could also ask your pharmacist for advice on other ways to help you remember to take your medicine.

What if I take too much?

Ask your doctor for advice straight away. Taking too much carbamazepine can lead to serious side effects.

Carbamazepine: MedlinePlus Drug Information

Carbamazepine may cause life-threatening allergic reactions called Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN). These allergic reactions may cause severe damage to the skin and internal organs. The risk of SJS or TEN is highest in people of Asian ancestry who have a genetic (inherited) risk factor. If you are Asian, your doctor will usually order a test to see if you have the genetic risk factor before prescribing carbamazepine. If you do not have this genetic risk factor, your doctor may prescribe carbamazepine, but there is still a slight risk that you will develop SJS or TEN. Call your doctor immediately if you develop a painful rash, hives, blistering or peeling of skin, easy bruising, mouth sores, or a fever during your treatment with carbamazepine. Stevens-Johnson syndrome or toxic epidermal necrolysis usually occurs during the first few months of treatment with carbamazepine.

Carbamazepine may decrease the number of blood cells produced by your body. In rare cases, the number of blood cells may decrease enough to cause serious or life-threatening health problems. Tell your doctor if you have ever had bone marrow depression (decreased number of blood cells) or any other blood disorders, especially if it was caused by another medication. If you experience any of the following symptoms, call your doctor immediately: sore throat, fever, chills, or other signs of infection that come and go or do not go away; shortness of breath; fatigue; unusual bleeding or bruising such as heavy menstrual bleeding, nose bleeds, or bleeding gums; tiny red or purple dots or spots on the skin; or mouth sores..

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body’s response to carbamazepine.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with carbamazepine and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs) or the manufacturer’s website to obtain the Medication Guide.

Tegretol (carbamazepine) Drug / Medicine Information

carbamazepine

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Tegretol.

It does not contain all the available information. It does not take the place of talking
to your doctor or pharmacist.

The information in this leaflet was last updated on the date listed on the final page.
More recent information on the medicine may be available.

You should ensure that you speak to your pharmacist or doctor to obtain the most up
to date information on the medicine. You can also download the most up to date leaflet
from www.novartis.com.au.

Those updates may contain important information about the medicine and its use of
which you should be aware.

All medicines have risks and benefits. Your doctor has weighed the risks of you or
your child taking this medicine against the benefits they expect it will have.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Tegretol is used for

Tegretol has several uses:

to control epilepsy, a condition in which there are repeated seizures (fits). There
are many different

types of seizures, ranging from mild to severe.

to control sudden, repeated attacks of facial pain, known as trigeminal neuralgia

to control mania, a mental condition with episodes of overactivity, elation or irritability

to control bipolar mood disorder where periods of mania alternate with periods of
depression.

Tegretol belongs to a group of medicines called anticonvulsants.

These medicines are thought to work by regulating the way messages in the brain are
passed on by nerves so that seizures do not happen. Tegretol also regulates other
nerve functions in the body.

Tegretol may be used alone or in combination with other medicines to treat your condition.

Ask your doctor if you have any questions about why this medicine has been prescribed
for you.

Your doctor may have prescribed it for another purpose.

Tegretol is only available with a doctor’s prescription. There is no evidence that
this medicine is addictive.

Before you take Tegretol

When you must not take it

Do not take Tegretol if you have an allergy to:

carbamazepine (the active ingredient of Tegretol) or any of the other ingredients
of Tegretol listed at the end of this leaflet

any other medicine containing carbamazepine

tricyclic antidepressants, which are medicines use to treat depression

Tell your doctor if you are allergic to oxcarbazepine, the active ingredient in Trileptal,
or to phenytoin. These two medicines are also used to treat epilepsy.

Some people who are allergic to oxcarbazepine or phenytoin are also allergic to Tegretol.

Some of the symptoms of an allergic reaction may include shortness of breath, wheezing
or difficulty breathing; swelling of the face, lips, tongue or other parts of the
body; rash, itching or hives on the skin.

Do not take Tegretol if you are taking a medicine called a monoamine oxidase inhibitor
(MAOI) or have been taking it within the past 14 days.

Taking this medicine with a MAOI, or within 14 days of taking a MAOI, may cause a
serious reaction with a sudden increase in body temperature, extremely high blood
pressure and severe convulsions.

Do not take Tegretol if you have, or have had, any of the following conditions:

severe liver or heart disease

a disease of the blood

an irregular heartbeat caused by a condition called A-V block

systemic lupus erythematosus, also called SLE

hepatic porphyria, a disturbance in the production of porphyrin, a pigment important
for liver function and blood formation

If you are not sure whether any of the above conditions apply to you, ask your doctor.

Do not take Tegretol after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.

In that case, return it to your pharmacist.

If you are not sure whether you should start taking Tegretol, talk to your doctor
or pharmacist.

Before you start to take it

Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.

Your doctor will want to know if you are prone to allergies.

Tell your doctor if you have, or have had, any medical conditions, especially the
following:

heart problems

glaucoma

prostate problems or if you cannot retain your urine

liver or kidney problems

problems with your blood in the past that were caused by medicines you were taking

a mental disorder such as depression or schizophrenia

Tell your doctor if you have an intolerance to fructose. In that case, you should
not take Tegretol liquid but you can take Tegretol tablets.

Each mL of Tegretol liquid contains 175 mg of sorbitol. Sorbitol is converted by the
liver to fructose. If people with intolerance to fructose take sorbitol, it can lead
to stomach upset and diarrhoea.

Tegretol liquid contains parahydroxybenzoates which may cause allergic reactions.

Tell your doctor if you are of Asian descent, particularly if you are Chinese or Thai.

Your doctor may want to do a genetic test before you take Tegretol for the first time.

The risk of serious skin reactions in patients of Han Chinese or Thai origin associated
with carbamazepine or chemically-related compounds may be predicted by testing a blood
sample of these patients.

Your doctor should be able to advise if a blood test is necessary before taking Tegretol.

Tell your doctor if you are pregnant or intend to become pregnant.

Your doctor will discuss with you the potential risk of taking Tegretol during pregnancy
since it may cause harm or abnormalities in your baby during pregnancy and soon after
birth. But, if you have epilepsy, it is very important to control your fits while
you are pregnant. Your doctor can help you decide whether or not you should take Tegretol
in this case.

Tell your doctor if you are breast-feeding or plan to breast-feed.

Tegretol passes into breast milk but it is unlikely to affect your baby. With the
advice of your doctor, you may breast-feed provided that you watch your baby for any
signs of an unwanted side effect. If your baby develops a skin rash, becomes very
sleepy or has other unusual symptoms, do not breast-feed again until you speak to
your doctor.

If you have not told your doctor about any of these things, tell him/her before you
take Tegretol.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you
buy without a prescription from a pharmacy, supermarket or health food shop.

Many medicines and Tegretol may interfere with each other. These include:

MAOI medicines. Tegretol must not be taken together with a MAOI or within 14 days
of taking a MAOI

other medicines used to treat depression such as fluvoxamine, nefazodone, paroxetine,
bupropion, citalopram, tricyclic antidepressants and trazodone

other medicines used to treat seizures including phenytoin, levetiracetam and oxcarbazepine

some medicines used to treat mental disorders such as clozapine, haloperidol, thioridazine,
lithium, olanzapine, quetiapine, risperidone and ziprasidone

some medicines used to treat heart problems or high cholesterol

some medicines used to help you sleep or calm you down

some pain relievers such as paracetamol, dextro-propoxyphene, tramadol and ibuprofen

warfarin, a medicine used to prevent blood clots

some diuretics (fluid tablets), which are medicines used to reduce water retention
and high blood pressure

some antibiotics and antifungal medicines used to treat infections, such as erythromycin,
clarithromycin, doxycycline, itraconazole, ketoconazole, fluconazole, voriconazole
and rifampicin

corticosteroids such as prednisolone and dexamethasone

St John’s wort, an ingredient in many medicines that you can buy without a prescription
from a pharmacy, health food shop or supermarket.

antihistamines such as loratadine and terfenadine, which are medicines used to prevent
or relieve the symptoms of allergies such as hay fever

isoniazid, a medicine used to prevent and treat tuberculosis

acetazolamide, a medicine used to reduce fluid retention and to treat glaucoma and
some types of seizures

medicines used to treat stomach or duodenal ulcers, such as cimetidine and omeprazole

muscle relaxants such as dantrolene and oxybutynin

ticlopidine, a medicine used to prevent blood clotting

some medicines used to treat asthma, such as theophylline and aminophylline

some medicines used to prevent rejection of organ transplants and to treat severe
rheumatoid arthritis and some skin diseases, such as cyclosporin and everolimus

some medicines used to treat cancer, such as cisplatin, doxorubicin and imatinib

methadone, a medicine used to control severe pain and to treat heroin addiction

metoclopramide, a medicine used to treat nausea and vomiting

isotretinoin, a medicine used to treat acne

danazol, a medicine used to treat endometriosis

a vitamin called nicotinamide

muscle relaxants, which are medicines used during surgery

medicines used to treat HIV such as indinavir, ritonavir and saquinavir

levothyroxine, a medicine used to treat underactive thyroids

praziquantel, a medicine used to treat worm infections of the blood

medicines containing oestrogen and progesterone, including hormone replacement therapy
and contraceptives

The above medicines may be affected by Tegretol or they may affect how well it works.
You may need to take different amounts of your medicines or you may need to take different
medicines.

Tell your doctor if you are using hormonal contraceptives (e.g.birth control pills
or injections).

If you are a female of childbearing age you should use an effective method of contraception
throughout your treatment and for 2 weeks after your last dose. If you begin taking
Tegretol while you are using hormonal contraceptives, they may not work as well as
they should. Unplanned pregnancies can happen. Your doctor can suggest another form
of birth control (non-hormonal) while you are taking Tegretol.

Tell your doctor immediately if you notice irregular vaginal bleeding or spotting.

Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking Tegretol.

How to take Tegretol

Follow all directions given to you by your doctor and pharmacist carefully.

These directions may differ from the information contained in this leaflet.

If you do not understand the instructions on the label, ask your doctor or pharmacist
for help.

How much to take

Your doctor will tell you how much Tegretol you need to take each day. This may depend
on your age, your medical condition and whether or not you are taking other medicines.

Your doctor will usually start your treatment with a low dose and then slowly increase
it to the lowest amount needed to control your condition. Some people will need higher
doses than other people will.

How to take it

Tegretol is available in conventional tablets, controlled release (CR) tablets and
in liquid form. The liquid is usually used for children or adults who have trouble
swallowing tablets.

If you are taking Tegretol tablets, swallow them with a full glass of water.

If you are taking Tegretol CR tablets, do not crush or chew them.

The CR tablets have a special coating that would be destroyed by crushing or chewing
the tablet.

If the dose is one-half tablet, you can buy a tablet cutter from your pharmacist to
make sure the dose is accurate.

If you are taking Tegretol liquid, shake the bottle well before each dose is measured.

Shaking the bottle and using a medicine measure will make sure that you take the correct
dose. You can get a medicine measure from your pharmacist.

When to take it

Take your dose of Tegretol during or after a meal.

This helps to prevent stomach upset.

Tegretol is usually taken in 2 or 3 doses during the day. But your doctor may tell
you to take it more or less often, depending on your situation.

If you forget to take it

If your next dose is not due for more than 2 or 3 hours, take the missed dose as soon
as you remember. Then take your next dose at the usual time and continue on with your
normal schedule.

If your next dose is due within 2 or 3 hours, skip the missed dose. Take your next
dose at the usual time and continue on with your normal schedule.

Do not take a double dose to make up for the one that you missed.

This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering when to take your medicine, ask your pharmacist for
some hints.

How long to take it

Continue taking your medicine for as long as your doctor tells you.

Tegretol helps to control your condition but does not cure it. You must take it every
day, even if you feel well.

Do not stop taking Tegretol or lower the dose without first checking with your doctor.
Do not let yourself run out of medicine over the weekend or on holidays.

Stopping your medicine suddenly or lowering the dose may cause unwanted side effects
or make your condition worse. If you are taking this medicine to treat epilepsy, you
could develop seizures (fits). Your doctor will usually reduce the dose slowly before
you can stop taking it completely.

If you take too much (Overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26)
for advice, or go to Accident and Emergency at your nearest hospital if you think
that you or anyone else may have taken too much Tegretol. Do this even if there are
no signs of discomfort or poisoning.

Keep the telephone numbers for these places handy.

Some of the symptoms of an overdose may include agitation, disorientation, fainting,
vomiting, difficulty breathing, fast and irregular heartbeat, blurred vision, shakiness
and slurred speech. If you are taking the controlled release (CR) tablets, it may
take longer for you to notice these effects.

While you are taking Tegretol

Things you must do

If you become pregnant while taking Tegretol, tell your doctor immediately.

Your doctor can discuss with you the risks of taking it while you are pregnant.

Be sure to keep all of your doctor’s appointments so that your progress can be checked.

To help prevent unwanted side effects from happening, your doctor may want to do some
tests before you start taking Tegretol and from time to time during the course of
your treatment.

Contact your doctor immediately if at any time you have thoughts of harming or killing
yourself.

A number of people being treated with antiepileptics have had such thoughts or behaviour.

Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.

Otherwise your doctor may think that it was not effective and change your treatment
unnecessarily.

Before having any surgery or emergency treatment, tell the doctor or dentist in charge
that you are taking Tegretol.

This medicine may interfere with some of the medicines used during surgery.

If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking Tegretol.

Tell any other doctor, dentist or pharmacist who treats you that you are taking Tegretol.

Things you must not do

Do not stop taking Tegretol or lower the dose without first checking with your doctor.

Do not use Tegretol to treat any other complaints unless your doctor tells you to.

Do not give this medicine to anyone else, even if their symptoms seem similar to yours
or they have the same condition as you do.

Things to be careful of

Avoid drinking grapefruit juice while you are being treated with Tegretol.

Grapefruit juice may interact with Tegretol and affect how your body uses this medicine.

Be careful driving, operating machinery or doing jobs that require you to be alert
until you know how Tegretol affects you. Children should avoid doing things like riding
bicycles or climbing trees.

This medicine may cause dizziness, drowsiness, blurred vision, double vision or lack
of muscle coordination in some people, especially when you first start to use it or
when the dose is increased.

Be careful when drinking alcohol while you are taking Tegretol.

The combination could make you more sleepy, dizzy or light headed than usual. Your
doctor may suggest you avoid alcohol while you are being treated with Tegretol.

When outdoors, wear protective clothing and use at least a 15+ sunscreen. Do not use
a sunlamp or tanning bed or booth.

This medicine may cause your skin to be much more sensitive to sunlight than it normally
is. Exposure to sunlight may cause a skin rash, itching, redness or severe sunburn.
If your skin does appear to be burning, tell your doctor.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking Tegretol.

All medicines can have side effects. Sometimes they are serious, most of the time
they are not. You may need medical treatment if you get some of the side effects.
If you are over 65 years old, you may have an increased risk of getting side effects.

Do not be alarmed by the following lists of possible side effects. You may not experience
any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following side effects and they worry you:

dizziness or light headedness

tiredness or drowsiness

eye pain

weakness, unsteadiness when walking

headache

restlessness, agitation or confusion

difficulty in speaking or slurred speech

numbness or tingling in hands or feet

muscle pain or cramps

nausea (feeling sick) or vomiting, loss of appetite

weight gain

stomach pain or discomfort

diarrhoea

constipation

dry mouth

swollen, red, sore tongue

mouth ulcers or cold sores

change in sense of taste

blurred or double vision, swollen runny eyes, difficulty seeing

ringing or buzzing in the ears or other changes in hearing

frequent need to urinate (pass water)

sweating

hair loss

acne

change in skin colour

excessive hairiness, especially in women

sexual disturbances such as impotence

breast enlargement in men

unusual secretion of breast milk

loss of muscle coordination

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital
if you notice any of the following:

signs of allergy such as swelling of the face, lips, tongue or other parts of the
body; wheezing or troubled breathing, difficulty swallowing, itching, hives, chest
discomfort or tightness, loss of consciousness

skin rash, redness, blisters or peeling skin, accompanied by fever, chills, headache,
cough, body aches

sudden increase in body temperature, accompanied by sweating, fast heart beat and
muscle stiffness, altered consciousness, high blood pressure, excessive salivation

constant “flu-like” symptoms (chills, fever, sore throat, swollen glands, aching joints,
lack of energy)

unusual bleeding or bruising under the skin, nosebleeds

shortness of breath and dizziness when exercising

frequent infections or fever

severe chills, sore throat, swollen glands or mouth ulcers

persistent nausea or vomiting, loss of appetite and feeling generally unwell, which
may be accompanied by pain in the abdomen, fever, itching, a yellow colour to skin
or eyes, dark coloured urine or light coloured bowel motions

diarrhoea, abdominal pain and fever

severe upper stomach pain, often with loss of appetite and vomiting

more frequent or more severe seizures (fits)

sudden onset of uncontrollable muscle spasms affecting the eyes, head, neck and body

trembling, uncontrolled body movements

lethargy, confusion

depression, aggressive behaviour, recurrence of a previous mental illness, hallucinations
(seeing or hearing things that aren’t there)

swelling of the feet and legs or weight increase due to fluid build-up

changes in behaviour, weakness

change in heartbeat (fast, slow, irregular), sometimes with fainting or chest pain

passing less urine than normal which may be accompanied by lack of energy, vomiting,
headache and confusion

blood in the urine

symptoms of sunburn such as redness, itching, swelling or blistering that may happen
more quickly than normal

red blotchy rash mainly on the face which may be accompanied by fatigue, fever, nausea,
loss of appetite

swelling and redness along a vein or nerve, which is extremely tender when touched

signs that blood clots may have formed, such as sudden severe headache, sudden loss
of coordination or vision, pain in the calves, thighs or chest

severe headache accompanied by stiff neck, muscle spasms and extreme sensitivity to
bright light

a fall due to dizziness, drowsiness, decrease in blood pressure or confusion.

Tell your doctor if you notice anything else that is making you feel unwell.

Other side effects not listed above may happen in some people. Some of these side
effects (for example, changes in sodium levels, thyroid function, structure of bones,
cholesterol level or blood pressure) can only be found when your doctor does tests
from time to time to check your progress.

After taking Tegretol

Storage

Keep your medicine in the original container until it is time to take it.

Store the medicine in a cool dry place.

Do not store Tegretol or any other medicine in the bathroom or near a sink.

Do not leave it in the car or on window sills.

Heat and dampness can destroy some medicines. Tegretol will keep well if it is cool
and dry.

Keep Tegretol where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.

Disposal

If your doctor tells you to stop taking Tegretol or you find that it has passed the
expiry date, ask your pharmacist what to do with any medicine you have left over.

Product description

What it looks like

Tegretol tablets:

Tegretol 100 mg: white tablets marked with a break line and BW on one side, GEIGY
on the other side; packs of 100 tablets.

Tegretol 200 mg: white tablets marked with a break line and GK on one side, CG on
the other side; packs of 100 tablets.

Tegretol CR tablets:

Tegretol CR 200 mg: beige-orange capsule shaped tablets with a break line on both
sides, marked H/C on one side and C/G on the other; in PVC/PE/PVDC/Al blister packs
of 200 tablets.

Tegretol CR 400 mg: brown – orange capsule shaped tablets with a break line on both
sides, marked ENE/ENE on one side and CG/CG on the other; in PVC/PE/PVDC/Al blister
packs of 200 tablets.

Tegretol liquid:

a thick, white, caramel flavoured liquid, packed in 300 mL brown glass bottles with
a child-resistant cap.

Ingredients

Tegretol tablets contain 100 mg or 200 mg of carbamazepine as the active ingredient.
They also contain:

cellulose-microcrystalline

carmellose sodium

silica-colloidal anhydrous

magnesium stearate

Tegretol CR tablets contain 200 mg or 400 mg of carbamazepine as the active ingredient.
They also contain:

cellulose-microcrystalline

silica-colloidal anhydrous

magnesium stearate

talc

Aquacoat ECD-30

acrylates copolymer

carmellose sodium

hypromellose

polyoxyl 40 hydrogenated castor oil

iron oxide red CI 77491

iron oxide yellow CI 77492

titanium dioxide

Tegretol liquid contains 100 mg of carbamazepine per 5 mL of liquid. It also contains:

methyl hydroxybenzoate

propyl hydroxybenzoate

caramel flavour

propylene glycol

PEG-8 stearate

saccharin sodium

sorbic acid

sorbitol solution (70%)

cellulose-dispersible

hyetellose

purified water

Diabetic patients can take Tegretol liquid. It contains sorbitol solution (875 mg/
5 mL) which is slowly converted into glucose, providing 14 kJ per 5 mL of liquid.
Tegretol liquid contains traces of benzoates.

Sponsor

Tegretol is supplied in Australia by:

NOVARTIS Pharmaceuticals Australia Pty Limited

ABN 18 004 244 160

54 Waterloo Road

Macquarie Park NSW 2113

Telephone 1-800-671-203

® = Registered Trademark

This leaflet was prepared in

October 2020

Australian Registration Number.

Tegretol 100 mg AUST R 41846

Tegretol 200 mg AUST R 41848

Tegretol CR 200 mg AUST R 42974

Tegretol CR 400 mg AUST R 42944

Tegretol Liquid AUST R 59160

(tgr261020c) based on PI (tgr261020i)

carbamazepine (oral) | Michigan Medicine

What is the most important information I should know about carbamazepine?

You should not take carbamazepine if you have a history of bone marrow suppression, or if you are allergic to carbamazepine or to certain antidepressant medications.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

Carbamazepine may cause serious blood problems or a life-threatening skin rash or allergic reaction. Call your doctor if you have a fever, unusual weakness, bleeding, bruising, or a skin rash that causes blistering and peeling.

Some people have thoughts about suicide while taking seizure medicine. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Do not stop taking carbamazepine without asking your doctor first, even if you feel fine.

What is carbamazepine?

Carbamazepine is an anticonvulsant that is used to treat seizures and nerve pain such as trigeminal neuralgia and diabetic neuropathy. Carbamazepine is also used to treat bipolar disorder.

Carbamazepine may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking carbamazepine?

You should not take carbamazepine if you have a history of bone marrow suppression, or if you are allergic to carbamazepine or to an antidepressant such as amitriptyline, desipramine, doxepin, imipramine, or nortriptyline.

Do not use carbamazepine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include furazolidone, isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Carbamazepine may cause severe or life-threatening skin rash, and especially in people of Asian ancestry. Your doctor may recommend a blood test before you start the medication to determine your risk.

Tell your doctor if you have ever had:

heart problems;
liver or kidney disease;
glaucoma;
porphyria;
depression, mood disorder; or
suicidal thoughts or actions.

You may have thoughts about suicide while taking carbamazepine. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Do not start or stop taking seizure medication during pregnancy without your doctor’s advice. Carbamazepine may harm an unborn baby, but having a seizure during pregnancy could harm both mother and baby. The benefit of preventing seizures may outweigh any risk. Tell your doctor right away if you become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of carbamazepine on the baby.

Carbamazepine can make birth control pills or implants less effective. Use a barrier form of birth control (such as a condom or diaphragm with spermicide) to prevent pregnancy.

You should not breastfeed while you are using carbamazepine.

How should I take carbamazepine?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Swallow the extended-release tablet or capsule whole and do not crush, chew, or break it. Tell your doctor if you cannot swallow a pill whole.

The chewable tablet must be chewed before you swallow it.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

It may take up to 4 weeks before your symptoms improve. Keep using the medication as directed and call your doctor promptly if this medicine seems to stop working as well in preventing your seizures.

You will need frequent medical tests.

Store at room temperature away from moisture, heat, and light.

Do not stop using carbamazepine suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Follow your doctor’s instructions about tapering your dose.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe drowsiness, weak or shallow breathing, and loss of consciousness.

What should I avoid while taking carbamazepine?

Drinking alcohol with this medicine can cause side effects, and can also increase your risk of seizures.

Grapefruit may interact with carbamazepine and lead to unwanted side effects. Avoid the use of grapefruit products.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Carbamazepine could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

What are the possible side effects of carbamazepine?

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Report any new or worsening symptoms to your doctor, such as: sudden mood or behavior changes, depression, anxiety, insomnia, or if you feel agitated, hostile, restless, irritable, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

a skin rash, no matter how mild;
loss of appetite, right-sided upper stomach pain, dark urine;
slow, fast, or pounding heartbeats;
anemia or other blood problems –fever, chills, sore throat, mouth sores, bleeding gums, nosebleeds, pale skin, easy bruising, unusual tiredness, feeling light-headed or short of breath; or
low levels of sodium in the body –headache, confusion, severe weakness, feeling unsteady, increased seizures.

Common side effects may include:

dizziness, loss of coordination, problems with walking;
nausea, vomiting; or
drowsiness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect carbamazepine?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Using carbamazepine with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Many drugs can affect carbamazepine, and some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about carbamazepine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2021 Cerner Multum, Inc. Version: 14.01. Revision date: 12/30/2019.

Tegretol – Uses, Side Effects, Interactions

How does this medication work? What will it do for me?

Carbamazepine is used to manage certain types of seizures, alone or in combination with other medications. It is also used to treat the nerve pain of trigeminal neuralgia and to treat acute mania and prevention of bipolar (manic-depressive) disorders.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Liquid
Each 5 mL of orange suspension contains 100 mg of carbamazepine. Nonmedicinal ingredients: citric acid, citrus-vanilla flavour, FD&C Yellow No. 6, pluronic polyol, potassium sorbate, propylene glycol, sucrose, sorbitol, water, and xanthan gum. Alcohol-, bisulfite-, gluten-, lactose-, parabens- and tartrazine-free.

Tablets

200 mg
Each white, round, flat-faced and bevelled-edged tablet, imprinted “CG” on one side and “G/K” on the other and a score, contains 200 mg of carbamazepine. Nonmedicinal ingredients: cellulose compounds, magnesium stearate, and silicon dioxide. Alcohol-, bisulfite-, gluten-, lactose-, parabens- and tartrazine-free.

Chewable tablets

100 mg
Each white with red specks, round, flat-faced, bevelled-edged tablet, engraved “GEIGY” on one side and “M/R” with bisect on the other, contains 100 mg of carbamazepine. Nonmedicinal ingredients: cherry-mint flavour, cornstarch, erythrosine, gelatin, glycerin, magnesium stearate, silicon dioxide, sodium starch glycolate, stearic acid, and sugar. Alcohol-, bisulfite-, gluten-, lactose-, parabens- and tartrazine-free.

200 mg
Each white with red specks, oval, biconvex tablet, engraved “GEIGY” on one side and “P/U” with bisect on the other, contains 200 mg of carbamazepine. Nonmedicinal ingredients: cherry-mint flavour, cornstarch, erythrosine, gelatin, glycerin, magnesium stearate, silicon dioxide, sodium starch glycolate, stearic acid, and sugar. Alcohol-, bisulfite-, gluten-, lactose-, parabens- and tartrazine-free.

Controlled-release tablets

200 mg
Each beige-orange, oval, slightly biconvex, controlled-release tablet, “C/G” engraved on one side and “H/C” engraved on the other, fully bisected on both sides, contains 200 mg of carbamazepine. Nonmedicinal ingredients: acrylic esters, castor oil derivative, cellulose compounds, iron oxides, magnesium stearate, silicon dioxide, talc, and titanium dioxide. Alcohol-, bisulfite-, gluten-, lactose-, parabens- and tartrazine-free.

400 mg
Each brown-orange, oval, slightly biconvex, controlled-release tablet, “CG/CG” engraved on one side and “ENE/ENE” engraved on the other, fully bisected on both sides, contains 400 mg of carbamazepine. Nonmedicinal ingredients: acrylic esters, castor oil derivative, cellulose compounds, iron oxides, magnesium stearate, silicon dioxide, talc, and titanium dioxide. Alcohol-, bisulfite-, gluten-, lactose-, parabens- and tartrazine-free.

How should I use this medication?

Recommended doses of carbamazepine vary greatly, depending on the condition being treated and the age and circumstances of the person being treated.

Seizure disorder: The starting dose for adults and children over 12 years of age is 100 mg to 200 mg once or twice daily. Depending on the effectiveness of the medication, the doctor may increase the dose gradually up to 1,600 mg daily in divided doses. Most people achieve the best response at daily doses between 800 mg and 1,200 mg.

The starting dose for children between 6 and 12 years of age is 100 mg daily in divided doses and increased by 100 mg daily until the best response is achieved. The daily maximum dose for children is 1,000 mg daily in divided doses.

If carbamazepine is being added to medications that are already being taken for seizures, the starting doses may be lower.

Trigeminal neuralgia pain: The starting dose of carbamazepine for treating the pain of trigeminal neuralgia is 100 mg taken twice daily. The dose is increased to a maximum of 1,200 mg daily, depending on the effectiveness of the medication.

Mania and bipolar disorders: The usual starting dose for the treatment of mania and bipolar disorders is 200 mg to 400 mg daily, taken in divided doses. The daily dose is then increased as instructed by the doctor to a maximum of 1,600 mg daily. If other medications, such as lithium, are being taken, the starting dose will be lower.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Carbamazepine should be taken with meals whenever possible.

The controlled release tablets should be swallowed whole with some liquid during or after a meal. They should not be crushed or chewed.

When taking carbamazepine suspension, shake the medication bottle well before measuring the dose of medication. An oral syringe should be used to measure each dose of the liquid, as it provides a more accurate measurement than household teaspoons.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store all forms of this medication at room temperature, away from humidity, and out of reach of children. The chewable tablets and liquid should be protected from light.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take carbamazepine if you:

are allergic to carbamazepine or any ingredients of the medication
are allergic to tricyclic compounds such as amitriptyline, trimipramine, or imipramine
have a history of acute intermittent porphyria
have a history of bone marrow depression
have a serious blood disorder
have severe heart disease (heart block)
have liver disease
have taken an MAO inhibitor (e.g., phenelzine, tranylcypromine) within the past 14 days or will take one within the next 14 days (If you have taken an MAO inhibitor recently but more than 14 days ago, your dosage of carbamazepine should be low initially, and increased very gradually.)
are taking the antifungal medication itraconazole or voriconazole

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

abdominal pain
acne
clumsiness or unsteadiness
constipation
dizziness
drowsiness
dryness of mouth or throat
hair or nail changes
headache
increased sensitivity of skin to sunlight (skin rash, itching, redness, or severe sunburn)
increased sweating
loss of appetite
memory loss
nausea
red eyes
ringing in the ears
sexual problems (males)
taste changes
vomiting
weight gain

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

behavioural changes (e.g., confusion, agitation, or hostility)
blood pressure changes
blurred vision
breast enlargement
continuous “back-and-forth” eye movements
decreased coordination
difficulty speaking or slurred speech
double vision
fainting
glaucoma (increased pressure in the eye, eye pain)
hallucinations (seeing or hearing things that are not there)
increase in seizures
irregular, pounding heartbeat
muscle or stomach cramps
numbness, tingling, pain, or weakness in hands and feet
painful swelling and redness along a vein
reddish-purple bumps on skin (may be itchy)
severe headache
severe nausea and vomiting
signs of allergic skin reaction (e.g., skin rash, hives, or itching)
signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
signs of bleeding (e.g., black, tarry stools, blood in urine or stools, pinpoint-sized red spots on skin, unusual bruising, bleeding that does not stop easily)
signs of a blood clot in the arm or leg (tenderness, pain, swelling, warmth, or redness in the arm or leg) or lungs (difficulty breathing, sharp chest pain that is worst when breathing in, coughing, coughing up blood, sweating, or passing out)
signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
signs of infection (e.g., cough or hoarseness, sore throat, chills, fever, swollen or painful glands, unusual tiredness or weakness)
signs of inflammation of the colon (e.g., abdominal pain, diarrhea, fever)
signs of liver damage (e.g., darkening of urine, pale stools, yellow eyes or skin)
signs of low sodium in the blood (e.g., muscle twitching, confusion, increased seizures, unusual drowsiness)
signs of meningitis not caused by infection (e.g., headache [severe], throbbing, or with stiff neck or back)
signs of pancreatitis (inflammation of the pancreas; e.g., severe upper abdominal pain, loss of appetite, vomiting)
signs of porphyria (e.g., darkening of urine, severe abdominal pain, excessive sweating)
signs of urinary problems (e.g., sudden decrease in amount of urine, blood in the urine, pain on urination)
swelling of face, hands, feet, or lower legs
symptoms of lupus (e.g., fever, general feeling of being unwell, joint pain, confusion, muscle aches, skin rash)
trembling or loss of muscle coordination
weakness

Check with your doctor immediately if any of the following side effects occur:

rapid development of signs of anemia or bleeding, sometimes combined with fever
rapid development of signs of liver or other organ damage
signs of an allergic reaction (e.g., wheezing, tightness in chest, troubled breathing, shortness of breath, or cough)
signs of neuroleptic malignant syndrome (e.g., high fever, muscle stiffness, sweating, racing or irregular heartbeat, altered consciousness)
signs of severe skin reactions (e.g., blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort)
sores, ulcers, or white spots on lips or in the mouth

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take this medication.

Anemia: Carbamazepine may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia), such as shortness of breath, feeling unusually tired or pale skin, contact your doctor as soon as possible.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.

Birth control: Carbamazepine, like other anticonvulsants, may reduce the effectiveness of birth control pills. Women taking carbamazepine should use an alternative, non-hormonal birth control method such as condoms. If you become pregnant while taking this medication, contact your doctor immediately.

Bleeding: Carbamazepine may cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early.

Bone strength: Long term use of antiepileptics has been associated with a risk of weakened or brittle bones. If you have osteoporosis, are at risk for developing osteoporosis, or have a history of disease affecting your bones, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Cancer: Some studies indicate a possible risk of developing cancer with long term use of carbamazepine. Discuss the potential benefits and possible risks of taking this medication with your doctor.

Depression: Carbamazepine has been known to cause mood swings and symptoms of depression. If you have depression or a history of depression, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking this medication, contact your doctor as soon as possible.

Drowsiness/reduced alertness: Carbamazepine may cause dizziness and drowsiness. People taking carbamazepine should avoid operating hazardous machinery (including cars) until they are certain that the medication does not affect their mental alertness, judgment, or physical coordination.

Heart disease: If you have coronary artery disease, organic heart disease, or congestive heart failure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Hypersensitivity syndrome: A severe allergic reaction called hypersensitivity syndrome has occurred for some people with the use of carbamazepine. This reaction involves a number of organs in the body and may be fatal if not treated quickly. Stop taking the medication and get immediate medical attention if you have symptoms of a severe allergic reaction, including fever, swollen glands, yellowing of the skin or eyes, or flu-like symptoms with skin rash or blistering.

Glaucoma: Carbamazepine may cause the symptoms of glaucoma (increased pressure in the eye) to become worse. If you have glaucoma, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Report any changes in vision to your doctor as soon as possible while you are taking this medication.

Periodic eye examinations are recommended for people who take this medication.

Infection: Carbamazepine can reduce the number of cells that fight infection in the body (white blood cells). If you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness, contact your doctor. Let your doctor know if you are experiencing more frequent infections than normal. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Kidney function: If you have kidney disease or decreased kidney function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: Carbamazepine can cause decreased liver function and may cause liver failure. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Lupus: In rare cases, carbamazepine can cause lupus. If you experience symptoms such as fever, facial rash or joint pain, or your lupus symptoms worsen while taking this medication, contact your doctor.

Neuroleptic malignant syndrome (NMS): Carbamazepine, like other medications used to treat some psychiatric illnesses, can cause a potentially fatal syndrome known as neuroleptic malignant syndrome (NMS). If you notice the symptoms of NMS such as high fever, muscle stiffness, confusion or loss of consciousness, sweating, racing or irregular heartbeat, or fainting, get immediate medical attention.

Psychiatric issues: Carbamazepine may activate certain mental disorders or cause confusion and agitation for seniors. When used to treat bipolar disorder, some people have experienced worsening of their symptoms of depression, feeling unlike themselves, or they may want to hurt themselves or others. People should be closely monitored by their doctor for emotional and behavioural changes.

Skin reactions: Although uncommon, carbamazepine has been linked to serious skin reactions. If you experience symptoms of a serious skin reaction (such as skin rash; redness of the skin; skin peeling; or blisters on the lips, eyes, or mouth) with fever, chills, headache, cough, or body aches, contact your physician immediately.

Stopping the medication: Suddenly stopping carbamazepine can cause seizures. Before stopping this medication, discuss with your doctor how you should gradually reduce the dose.

Suicidal thoughts and behaviour: Some people taking anti-seizure medications may have suicidal thoughts or behaviour. If this happens to you or you notice this in a family member who is taking this medication, contact your doctor immediately. You should be closely monitored by your doctor for emotional and behaviour changes while taking this medication.

Low thyroid hormones: Carbamazepine can cause thyroid hormones to be removed from the body more quickly than usual. This is most noticeable if you take thyroid replacement therapy. If you have an underactive thyroid, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your thyroid function with blood tests when you first start taking carbamazepine.

Pregnancy: Women with epilepsy who are pregnant or intend to become pregnant need special care. The potential benefits of carbamazepine must be weighed against its risks, particularly during the first 3 months of pregnancy. If needed to prevent major seizures, do not stop taking the medication. Usually, women with epilepsy who are pregnant should be treated with only one medication to prevent seizures.

Additional folic acid supplementation may be advisable for women taking carbamazepine, as this medication may contribute to a lack of folic acid in the body. Talk to your doctor about the benefits and risks of using carbamazepine during pregnancy.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking carbamazepine, it may affect your baby. If a mother taking carbamazepine breast-feeds her infant, the infant must be observed for possible side effects (e.g., drowsiness or skin rash). The benefits of breast-feeding should be weighed against the possible risks to the infant. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using carbamazepine to treat trigeminal neuralgia or psychiatric disorders in children have not been established. The use of this medication for these conditions in this age group is not recommended.

Seniors: People over the age of 65 years may require lower doses of this medication.

What other drugs could interact with this medication?

There may be an interaction between carbamazepine and any of the following:

abiraterone
acetaminophen
acetazolamide
alcohol
allopurinol
alpha blockers (e.g., alfuzosin, doxazosin, silodosin, tamsulosin)
antiarrythmics (e.g., amiodarone, disopyramide, dronedarone, propafenone, quinidine)
anti-cancer medications (e.g., cabazitaxel, docetaxel; doxorubicin; etoposide, ifosfamide, irinotecan, vincristine)
antihistamines (e.g., cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
antipsychotic medications (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
antiseizure medications (e.g., clobazam, levetiracetam, phenobarbital, phenytoin, primidone, topiramate, valproic acid, zonisamide)
apixaban
aprepitant
azelastine
“azole” antifungals (e.g., fluconazole, itraconazole, ketoconazole, voriconazole)
barbiturates (e.g., butalbital, pentobarbital phenobarbital)
BCG
benzodiazepines (e.g., alprazolam, clonazepam, midazolam)
birth control pills (oral contraceptives)
bisoprolol
bosentan
brimonidine
buprenorphine
bupropion
buspirone
calcitriol
calcium channel blockers (e.g., amlodipine, diltiazem, felodipine, verapamil)
cannabis
celecoxib
cimetidine
ciprofloxacin
chloral hydrate
chloroquine
clindamycin
cobicistat
conivaptan
corticosteroids (e.g., dexamethasone, methylprednisolone)
cyclosporine
dabigatran
danazol
dantrolene
dapsone
darifenacin
deferasirox
desmopressin
dexmethylphenidate
diclofenac
enzalutamide
estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
everolimus
exemestane
fingolimod
“flozin” diabetes medications (SGLT2 inhibitors; e.g., canagliflozin, dapagliflozin, enpagliflozin)
flunarizine
flutamide
“gliptin” diabetes medications (e.g., linagliptin, saxagliptin, sitagliptin)
grapefruit juice
guanfacine
hepatitis C antivirals (e.g., daclatasvir, dasabuvir, ledipasvir, paritaprevir, ombitasvir, sofosbuvir)
HIV integrase inhibitors (e.g., dolutegravir, elvitegravir)
HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz)
HIV protease inhibitors (e.g., darunavir, indinavir, ritonavir, saquinavir)
ivabradine
ivacaftor
lidocaine
lithium
losartan
macitentan
macrolide antibiotics (e.g., azithromycin, clarithromycin, erythromycin)
maraviroc
mebendazole
mefloquine
melatonin
methadone
methylphenidate
mifepristone
mirtazapine
modafinil
monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
muscle relaxants (e.g., baclofen, cyclobenzaprine, methocarbamol, orphenadrine)
nabilone
narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone)
naloxegol
nefazodone
nitrates (e.g., isosorbide dinitrate, isosorbide mononitrate)
olopatadine
ondansetron
orlistat
phosphodiesterase 5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)
pramipexole
praziquantel
primaquine
progestins (e.g., dienogest, levonorgestrel, medroxyprogesterone, norethindrone)
propranolol
proton pump inhibitors (PPIs; e.g., esomeprazole, omeprazole, pantoprazole)
quinine
repaglinide
retinoic acid medications (e.g., etretinate, isotretinoin)
rifabutin
rifampin
rilpivirine
rivaroxaban
roflumilast
romidepsin
ropinirole
St. John’s wort
selective serotonin reuptake inhibitors (SSRIs; e.g., fluoxetine, fluvoxamine, sertraline)
serotonin/norepinephrine reuptake inhibitors (e.g., desvenlafaxine, duloxetine, venlafaxine)
sirolimus
solifenacin
“statin” anticholesterol medications (e.g., atorvastatin, lovastatin, simvastatin)
sulfonamide antibiotics (e.g., sulfamethoxazole, sulfisoxazole)
sulfonylureas (e.g., chlorpropamide, glipizide, glyburide)
tacrolimus
tapentadol
tetracyclines (doxycycline, minocycline, tetracycline)
thalidomide
theophyllines (e.g., aminophylline, oxtriphylline, theophylline)
thiazide diuretics (certain water pills; e.g., hydrochlorothiazide, indapamide)
thiazolidinediones (e.g., pioglitazone, rosiglitazone)
thyroid replacements (e.g., dessicated thyroid, levothyroxine)
ticagrelor
ticlopidine
tocilizumab
tofacitinib
tolterodine
tolvaptan
tramadol
trazodone
tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, imipramine)
trimethoprim
tyrosine kinase inhibitors (e.g., dasatinib, imatinib, nilotinib, sunitinib)
ulipristal
warfarin
zafirlukast
zolpidem
zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

stop taking one of the medications,
change one of the medications to another,
change how you are taking one or both of the medications, or
leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2021. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Tegretol

Carbamazepine

Carbamazepine is an antiepileptic and psychotropic drug, the concentration of which in the blood requires regular monitoring and maintenance within the therapeutic dose in order to achieve a therapeutic effect and prevent side effects.

Russian synonyms

Aktinerval, Zagretol, Zeptol, Karbadak, Karbapin, Karbalepsin, Karzepin, Mazepin, Stazepin, Storilat, Timonil, Finzepin, Finlepsin “,” Epial “.

Synonyms English

Carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Tegretol-XR).

Research method

Immunoassay.

Units

μg / ml (micrograms per milliliter).

What biomaterial can be used for research?

Venous blood.

How to properly prepare for the study?

Do not eat for 2-3 hours before the examination, you can drink clean non-carbonated water.
Do not smoke for 30 minutes prior to examination.

General information about the study

Carbamazepine belongs to anticonvulsant, antiepileptic, antipsychotic, antidepressant, normotimic, analgesic drugs. It is used in the treatment of epilepsy, bipolar disorders, and certain types of neuralgias (eg, trigeminal neuralgia, pain in diabetic neuropathy).

Carbamazepine blocks sodium channels of membranes of hyperactive nerve cells, reduces the effect of excitatory neurotransmitter amino acids (glutamate, aspartate), enhances inhibitory (GABAergic) processes and interaction with central adenosine receptors.Antimanic properties are due to inhibition of dopamine and norepinephrine metabolism. The anticonvulsant effect is manifested in partial and generalized seizures. Effective (especially in children and adolescents) for relieving symptoms of anxiety and depression, as well as reducing irritability and aggression. Prevents attacks of trigeminal neuralgia, reduces the severity of clinical manifestations of alcohol withdrawal (including agitation, tremors, gait disturbances) and reduces seizure activity.With diabetes insipidus, it reduces urine output and thirst.

It is absorbed slowly in the digestive tract, but almost completely, and food does not affect the rate and degree of its absorption. The maximum concentration in the blood with a single dose of a regular tablet is reached after 12 hours. The blood protein binding is 70-80%. Penetrates into saliva, cerebrospinal fluid, breast milk (25-60% of the plasma level) and through the placental barrier. It is metabolized in the liver to form several metabolites.The half-life of carbamazepine in an adult’s body is 14-65 hours (with prolonged use – 8-29 hours), and in children 8-19 hours. 70% of the drug is excreted by the kidneys and 30% through the intestines. In children, the excretion of carbamazepine is accelerated. The onset of anticonvulsant action varies from several hours to several days (sometimes up to 1 month). The anti-neuralgic effect develops in 8-72 hours, the anti-manic effect – after 7-10 days. The drug is prescribed as monotherapy or in combination with other medicines.

While taking carbamazepine, various side effects may occur: dizziness, agitation, hallucinations, depression, aggressive behavior, activation of psychosis, headache, double vision, accommodation disorders, lens opacity, nystagmus, conjunctivitis, tinnitus, change in taste, speech disorders (dysarthria, slurred speech), abnormal involuntary movements, peripheral neuritis, paresthesias, muscle weakness and symptoms of paresis, atrioventricular block, congestive heart failure, hyper- or hypotension, thromboembolism, renal dysfunction, interstitial nephritis, nausea, vomiting increased levels of liver enzymes, jaundice, hepatitis, osteomalacia, sexual dysfunction, moderate leukopenia, thrombocytopenia, hematopoietic disorders, hyponatremia, delayed-type hypersensitivity multiorgan reactions, exfoliative dermatitis, lupus-like syndrome (skin rash, urticaria, hyperthermia, sl abost), Stevens-Johnson syndrome, Lyell, anaphylactic reactions.

The level of carbamazepine in the blood requires regular monitoring, since its concentration must be maintained in a fairly narrow therapeutic window. With an insufficient concentration of the drug, the patient may resume seizures, manic episodes, pain disorders, and with an increase in the dose, the toxicity of the drug and the risk of side effects increase.

In case of an overdose of the drug, disorientation, drowsiness, agitation appears, in severe cases hallucinations and coma, blurred vision, dysarthria, nystagmus, ataxia, dyskinesia, hyper- / hyporeflexia, convulsions, myoclonus, hypothermia, respiratory depression, pulmonary edema, hypochycardia – / hypertension, cardiac arrest, vomiting, decreased colon motility, fluid retention, oliguria or anuria.

Difficulties in maintaining a certain concentration of carbamazepine are associated with individual characteristics – the level of absorption of the drug in the digestive tract, the functional state of the liver in which the drug is metabolized, the content of the protein in the blood with which the drug binds, as well as interactions with other medications. Doses of carbamazepine and the regimen of its administration are prescribed and adjusted by the attending physician individually for each patient.

Thanks to laboratory monitoring of the drug content in the blood, it is possible to maintain the drug concentration within the therapeutic window, which allows you to get maximum efficiency from its use and prevent overdose and side effects.

What is the research used for?

Determination of the concentration of carbamazepine in the blood in order to maintain an adequate therapeutic dose;
selection and adjustment of the drug dose;
identification of an insufficient or excessive dose of the drug.

When is the study scheduled?

Every 2-3 weeks from the beginning of the appointment of carbamazepine and the selection of the dose, then every 2-3 months;
when correcting therapy and prescribing other drugs, taking into account interactions with them;
for relapses of the disease while taking carbamazepine;
in the event of undesirable side effects.

What do the results mean?

Reference values: 4 – 12 μg / ml.

The generally accepted therapeutic range for carbamazepine concentrations in adults and children is 4-12 μg / ml. The toxic effect develops at concentrations above 15 μg / ml.

What can influence the result?

The level of carbamazepine in the blood is affected by the intake of fluoxetine, acetaminophen, warfarin, isoniazid, theophylline, erythromycin, ethosuximide, benzodiazepine, phenobarbital, primidone, phenytoin.

Carbamazepine for the treatment of schizophrenia | Cochrane

People with schizophrenia often hear voices or see things (hallucinations) and have strange beliefs (perception deceptions). They may also experience lethargy, fatigue, loss of energy, and disorganized thoughts and behavior. These symptoms make schizophrenia a serious illness that affects many people throughout their lives.

The main treatment for schizophrenia is the use of antipsychotics. However, despite the fact that they are successful in helping most patients, 5 to 15% will continue to suffer from debilitating symptoms.Several treatment options are available for these people: changing the dose of the medication, switching to another antipsychotic drug, or taking additional medications that are not antipsychotics. Carbamazepine is a drug first used in the 1950s to treat epilepsy. It has also been used as a mood stabilizer in cases of sudden mood swings (such as bipolar disorder). Side effects of carbamazepine include poor coordination, headaches, and drowsiness.

This review is about the efficacy of carbamazepine in the treatment of patients with schizophrenia. In July 2012, the Cochrane Schizophrenia Group clinical trial registry was searched. Ten studies were found, involving 283 people. Carbamazepine was compared with no active treatment (dummy or placebo), with an antipsychotic, or with a combination of carbamazepine and an antipsychotic. However, all 10 studies were small and lacked information.Therefore, there is no evidence as to whether carbamazepine reduces symptoms and side effects in patients with schizophrenia or similar mental health problems. Before carbamazepine can be recommended for the treatment of people with schizophrenia, extensive well-designed studies are needed to provide more convincing evidence of its effectiveness.

This plain language summary is written by consumer Ben Gray, an expert in the service user department.Rethink Mental Illness, a support organization for people with mental illness.

Rapid-release carbamazepine versus sustained-release carbamazepine as a drug for patients with epilepsy

Relevance

Epilepsy is a common brain disorder that is often treated with carbamazepine. Treatment usually reduces the frequency of seizures, but many people have side effects.When taking carbamazepine, it is rapidly absorbed into the bloodstream and there is a sharp rise in the concentration of the drug in the blood. These peaks can cause side effects such as dizziness, double vision, drowsiness, unsteadiness, and poor coordination. A slow-release formulation of carbamazepine in the body can reduce these “peaks” in blood levels, possibly resulting in fewer side effects.

This review compares studies on the differences between “fast-release” and “slow-release” carbamazepine.

Participants

All participants had to be diagnosed with epilepsy to be included in this review, and they had to either just start treatment or already on treatment with carbamazepine, but with severely tolerated side effects. Participants could be of any age or gender.

Research

10 trials with 296 epileptic participants were included in this review. All 10 trials were randomized controlled trials (comparing patients who were randomly assigned to different groups).In all studies, there were at least two groups: in one group, patients took fast-release carbamazepine, in the other, with slow-release; some studies also had a control group (a group of people without epilepsy). The evidence is current to August 2016.

Results

Only 1 in 10 studies found a significant difference between the two types of carbamazepine in terms of the number of seizures that occurred: patients who were prescribed slow-release carbamazepine had fewer seizures compared with patients who were prescribed rapid-release carbamazepine.Patients taking slow-release carbamazepine were prone to fewer side effects.

Quality of evidence

Of the 10 trials included in this review, only one was of good quality; therefore, the quality of the evidence in this review was rated as low. It should be emphasized that there are not many studies evaluating the differences between the two types of carbamazepine, and more research is needed in order to make a definitive conclusion on the benefits of one over the other.

Applications: Latest news from Russia and the world – Kommersant Healthcare (61750)

The use of drugs “off label” (“off label”) has become a common medical practice. There are cases when a drug registered for the treatment of colon cancer is prescribed to improve vision, a medicine for stomach ulcers stimulates labor, and weight is lost with the help of a drug for diabetes mellitus.

Childbirth to order

Recently, the League for the Protection of Patients wrote an appeal to the Ministry of Health and Social Development, Roszdravnadzor, the Investigative Committee of the Russian Federation, and the Prosecutor General’s Office regarding the increased use of off-label drugs.The League asks the Ministry of Health and Social Development to instruct the experts of insurance companies through the FFOMS, and Roszdravnadzor, in the course of monitoring the safety of drugs, to identify the facts of the use of drugs for an unauthorized purpose, which to report to Rospotrebnadzor. Rospotrebnadzor, in turn, is invited to come forward with inspections or initiate the initiation of administrative and criminal cases through the Investigative Committee of the Russian Federation.

Human rights activists have compiled a list of drugs most commonly used off-label.It got: cytotec, methotrexate, tegretol, gabapentin, metformin and others. There are a lot of complaints about the initiative of doctors in relation to these drugs to patient organizations, but no one can assess the scale of the problem: it is difficult to imagine a doctor who will knock on himself if a medication prescribed for him inappropriately leads to complications.

Cytotec, registered as a drug for the treatment of gastritis and stomach ulcers, is the first in the top-list of off-label drugs.Several years ago, it firmly entered the practice of Russian obstetricians: it is still used to speed up labor in maternity hospitals, and on Internet forums, doctors exchange their experience of using this medicine for rhodostimulation. And this is despite the high-profile case initiated against one of the capital’s maternity hospitals in 2001. Then the woman in labor died of a ruptured uterus after she was injected with Cytotec to stimulate labor. The fact that death was caused by this particular drug was proved by the Timiryazevsky court.In addition, the Patient Defense League has tried six patients who were injured after using the drug.

Since 2010, the Ministry of Health and Social Development has authorized the use of siteotek for early termination of pregnancy. In practice, however, pregnancy is “terminated” with its help at a much later date. And often even when there is no indication for stimulation. “Incentives can be carried out by unscrupulous specialists so that a woman gives birth at the right time – for example, if a physician wants to receive income on his watch,” says Professor Vasily Vlasov, president of the Society of Evidence-Based Medicine Specialists.

“Our study showed that in Russian maternity hospitals on weekends, women give birth three times less often than in workers, which indirectly confirms this assumption,” adds Alexander Saversky, head of the Patient Protection League.

According to the formulary committee of the Russian Academy of Medical Sciences, the use of a siteotek for rhodostimulation is a very dangerous practice. In women in labor, the number of bleeding increases, labor is accelerated up to 112 (!) Times, many cases of uterine rupture, amniotic fluid embolism have been recorded, and there are several deaths.But most importantly, the craving of obstetricians for this particular drug is completely incomprehensible: they have at their disposal a lot of other proven means to stimulate labor.

Also for early termination of pregnancy and for the treatment of ectopic pregnancy, doctors have recently begun to use the drug methotrexate. In fact, the instructions for its use include several different types of cancer, severe psoriasis, and rheumatoid arthritis. The list of complications that this drug can cause is several times longer than the list of indications for its use.Among them are pancreatitis, cirrhosis, blood cancer, hormonal disorders, headaches, various severe forms of allergies.

Not so long ago, eye diseases in Russia began to be treated with a drug for intestinal cancer. According to the instructions, the medicine should be used intravenously, but ophthalmologists came up with … to prick it in the sclera of the eye.

“The drug has a whole page of contraindications and possible complications, including heart attacks, strokes and visual impairment!On the Internet, one mommy reports on a medical forum how this medicine was injected into the vitreous body of her eye … to a five-month-old baby! The number of strokes with this use of the drug increases by more than 20%, “says Mr. Saversky.

The manufacturer of the drug reported that in a number of cases, when using it for the treatment of vision, there were undesirable effects. There were no comments from Roszdravnadzor.

With antiepileptic drugs tegretol and hepabentin, we treat “tired legs syndrome”, postoperative pain, senile dementia and even carry out migraine prophylaxis.For weight loss, the “harmless” metformin is increasingly prescribed, which is actually registered as a drug for the treatment of insulin-dependent diabetes. It supposedly burns fat and suppresses appetite and is not dangerous. This is not true. The drug is very dangerous, with a huge list of side effects, however, according to Mr. Saversky, he saw how on the Internet it was recommended to a newborn baby.

Human experiments

Often the prescription of off-label drugs is used to test the possibility of their use in this capacity and to reflect the research results in scientific papers and dissertations.Only patients in such cases – in contrast to real clinical trials – are often not informed about this.

It is known that the thesis on the application of the sitetek in childbirth was prepared at MONIIAG in 2002 and, according to available information, was defended. In addition, the Siberian State Medical University managed to obtain a Russian patent for the use of cytotek to stimulate labor, despite the fact that the manufacturer does not recommend using this drug in obstetrics.

“The use of drugs outside the registered indications for dissertation work is permissible, but for this you need to obtain voluntary informed consent of all participants, insure patients, obtain approval from the Ethics Council under the Ministry of Health and Social Development and permission from the Ministry to conduct a study,” says Svetlana, Executive Director of the Association of Clinical Research Organizations Zavidova. – At the same time, according to the Declaration of Helsinki of the World Medical Association, clinical trials are possible only when the importance of the research goal outweighs the associated risks and inconveniences for patients.And I think that in addition to the obligatory assessment of the scientific validity of the planned research in the Council on Ethics and the Ministry of Health and Social Development, the candidate should notify the manufacturer of the drug about the planned research. No one knows the characteristics of a drug better than the manufacturer. “

Pediatricians most often use drugs “outside the instructions”. And this can be called a compulsory necessity. Only a small percentage of drugs undergo clinical trials in minors and are officially approved for use in childhood.There are many legal, ethical and financial reasons for this: the requirements for such research are very strict, they cost much more than usual.

“According to WHO experts, for 75% of childhood diseases there are still no special pediatric drugs, there is very little data on the safety of drugs in children and there is clearly not enough specific pediatric dosage forms. The shortage of pediatric drugs leads to the fact that doctors are faced with a dilemma – or risk by prescribing drugs for children in the absence of approved indications for use, or to refuse treatment altogether, “says Ms. Zavidova.

Advantageous fine

The use of drugs for other purposes was not invented at all in Russia. This practice has been common in other countries for many years. A 2001 US study found that of the 725 million recorded off-label prescriptions, about 150 million (21%) were used. At the same time, two-thirds of the prescribed “off-label” drugs had no evidence of efficacy for the prescribed prescriptions. Most often, anticonvulsant, cardiovascular and anti-asthma drugs were prescribed outside the instructions.

Approximately the same situation is in Europe. In France, between 1990 and 2002, off-label anticancer drugs were treated from 6.7 to 33.2% of patients. It was noted that only a few of them got better as a result of such treatment.

As noted in the Scientific Center for the Expertise of Medicinal Products, practitioners are not prohibited from prescribing medicines that are not according to indications. Including during scientific research on the use of certain drugs outside the scope of “their powers”.So, a couple of years ago, Western scientists studied the effect of intravenous immunoglobulin in various pathologies. It turned out that it helps with multiple sclerosis, thrombocytopenia (blood disease).

In addition to the obvious negative aspects, pharmaceutical experts see the use of drugs as an “off label” and a number of positive aspects. For example, for some unrecognized conditions, such treatment may be the only correct one. Sometimes the beneficial properties of a medicine come to light by accident. For example, recently, many infectious disease specialists have been prescribing acyclovir for the treatment of acute respiratory viral infections, in the indications for the use of which mainly herpes infection is listed.However, as doctors say, it helps.

Doctors prescribe off-label drugs for various reasons: sometimes because of their own ignorance, sometimes due to aggressive promotion of the drug by the manufacturer, and sometimes because of vital necessity. But not a single law today prohibits doctors from prescribing medicines outside the indications mentioned in the instructions.

“The use of off label drugs in individual cases is permissible. However, the doctor must warn the patient about this and take his consent.At the same time, the promotion of the drug for unregistered indications by pharmaceutical companies and doctors is unacceptable, “says Svetlana Zavidova.

From an ethical point of view, of course, unacceptable. But in practice, this happens at every step. Sometimes it comes to courts. True, not with us. But even in America and Europe, pharmaceutical companies have long understood that it is cheaper to pay huge fines than to think about ethics and the law. Many giants of the pharmaceutical industry even include funds in their budgets for such cases.In the United States, a pharmaceutical company paid doctors $ 3,000 to promote a drug registered for the treatment of epilepsy as a treatment for alcohol addiction and schizophrenia. She was fined $ 80 thousand, while $ 2.7 billion was received from the sale of the drug in 2008 alone.

In America and Europe, such things are not uncommon. Americans are forced to introduce new requirements for the sale and advertising of drugs every year; in Germany, the government has created a special commission that approves the lists of drugs that cannot be used off-label.

As for Russian practice, the order of the Ministry of Health and Social Development allows in individual cases the use of drugs unregistered in the Russian Federation “for health reasons.”

Despite the fact that Roszdravnadzor has long planned to cover the entire country with strict pharmacological supervision, in practice, almost nothing comes of it. Doctors do not send messages about side effects of drugs. As noted by Professor Vlasov, most often Russian doctors learn about new side effects of drugs from Finnish, American and other Western sources.In addition, almost all medicines from us are easy to buy in pharmacies without a prescription. Vasily Vlasov notes that “any doctor can come to the pharmacy and buy a cheap website to stimulate their labor later.”

Arina Petrova

90,000 Treatment of trigeminal neuralgia in 30 minutes!

Pain from inflammation of the trigeminal nerve takes the first place in the pain rating! Experts from the Institute of Anesthesiology and Pain Research at Stanford University have compiled a “pain” rating, naming the most severe types of pain that a person can experience.The leader of the rating was pain with inflammation of the trigeminal nerve. People who have experienced it rate these sensations at ten on a ten-point scale. Women recognize that this pain is greater than the pain during childbirth. We will talk about such a disease below.
Clinical manifestations of trigeminal neuralgia . Often trigeminal neuralgia debuts with dental pain. The patient goes to the dentist, however, even after a complete sanitation of the oral cavity, toothaches continue to bother and the dentist decides to remove the tooth.Even healthy teeth are often removed.

In this case, pain begins to appear in the adjacent teeth. It has an intolerable character, twitching, like an electric shock. Provoked by eating, talking, brushing teeth. With an attack of trigeminal neuralgia, the patient freezes, is afraid to move. Sometimes squeezes or rubs the affected area of the face hard (antagonist gesture). Sometimes twitching pains in the mouth, tongue join. Patients often remove several healthy teeth in a row.Only after that they get an appointment with a neurologist.

Treatment of trigeminal neuralgia

1. Conservative treatment: In the conservative stage of treatment of trigeminal neuralgia is the use of anticonvulsants: carbamazepine (finlepsin, tegretol). Second-line drugs are gabapentin (gabagamma, thebantin, neuralgin), pregabalin (lyrics). But over time, they stop working with drug therapy. In this case, there is only one way out – operation.

2.Surgical treatment: Currently, there are two methods of surgical treatment widely used in the world. The first is microvascular decompression of the trigeminal nerve root. Microvascular decompression consists in trepanation of the posterior cranial fossa, revision of the relationship between the trigeminal nerve root, superior and inferior anterior cerebellar arteries, and superior petrosal vein. When the root is compressed by the vessels, they are isolated, and a gasket is placed between the vessels and the root, preventing contact between them and the effect of the vessel on the root.However, neurovascular conflict is not always the cause of the disease. In addition, in patients suffering from severe concomitant somatic pathology, and patients in old age, this operation is risky. For such patients, the Second –
became a real salvation
Currently, the leading neurosurgical clinics of the world, one of the most common methods of treating trigeminal neuralgia is radiofrequency destruction of the trigeminal nerve roots. This method is the most effective, more controllable, and practically free of serious complications.Radiofrequency destruction of the trigeminal nerve roots, when, without incision and anesthesia, through a tiny oval hole 3 mm in diameter at the base of the skull, neurosurgeons enter the desired area of the brain and selectively, focusing on the patient’s sensations, select the painful branch of the nerve and “turn it off” with high-frequency currents. All manipulation takes place under the control of an X-ray machine and has practically no serious complications. And it is quite easily tolerated: On the same day, the patient is allowed to go home. Radiofrequency destruction is based on the physical principle of thermocoagulation and is based on the effect of the release of thermal energy when ultrahigh frequency currents pass through biological tissues.An electrode connected to a current generator is brought to the destruction site through an insulated cannula. The intensity of tissue heating depends on its resistance. An electric current passes between an active or damaging electrode immersed in body tissue and an indifferent or scattered electrode. Heat production, and therefore tissue destruction, occurs only around the non-insulated tip of the active electrode. The main advantage of the radio-frequency destruction method is that the size of the damaged zone can be adequately controlled, and the electrode with a thermal sensor registers the temperature in the damaged zone.It is possible to set the exact time of damage, and control of electrical stimulation and resistance level allows you to correctly and accurately position the electrode. The effect of the treatment occurs instantly and the patient gets rid of pain during the operation. The use of local anesthesia provides a short recovery period and the patient sometimes gets rid of pain once and for all for many years. In foreign sources, statistics on the effectiveness of treatment is over 90%. If you or your loved ones have such a problem, we are ready to help.In our clinic, we carry out radio frequency destruction of the trigeminal nerve, we have the greatest experience in these technologies. Patients undergoing successful treatment allows us to occupy a leading position in the treatment of trigeminal neuralgia in Uzbekistan.

Visit Chinobod Fayz Plyus Neurosurgical Clinic for trigeminal neuralgia.

Tel: +998 91 609 56 41 Khurshidbek. Telegram: @ hurshid1717

Preparations and medicines with active substance Carbamazepine

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Indications for use

Epilepsy (excluding petit mal), manic states, prevention of manic-depressive disorders, alcohol withdrawal, trigeminal and lingopharyngeal neuralgia, diabetic neuropathy.

Pharmacological action

analgesic, antipsychotic, antiepileptic, anticonvulsant, normotimic, thymoleptic Blocks sodium channels of membranes of hyperactive nerve cells, reduces the effect of excitatory neurotransmitter amino acids (glutamate, aspartate), enhances inhibitory (GABAergic) processes and interaction with central adenosine receptors.Antimanic properties are due to inhibition of dopamine and norepinephrine metabolism. The anticonvulsant effect is manifested in partial and generalized seizures (grand mal). Effective (especially in children and adolescents) for relieving symptoms of anxiety and depression, as well as reducing irritability and aggression (epilepsy). Prevents attacks of trigeminal neuralgia, reduces the severity of clinical manifestations of alcohol withdrawal (including agitation, tremors, gait disturbances) and reduces seizure activity.In diabetes insipidus, it reduces urine output and thirst. In the gastrointestinal tract, it is absorbed, albeit slowly, but almost completely. food does not affect the rate and extent of absorption. Cmax with a single dose of a conventional tablet is achieved after 12 hours. With a single or repeated administration of retard tablets, Cmax (25% less than after a conventional tablet) is noted within 24 hours. The retard form allows you to reduce daily fluctuations in plasma levels (determined after 1-2 weeks) without changing the minimum value of the equilibrium concentration.Bioavailability when taking retard tablets is 15% lower than after using other dosage forms. The blood protein binding is 70–80%. In the cerebrospinal fluid and saliva, concentrations are created in proportion to the proportion of the active substance not bound to proteins (20–30%). Penetrates into breast milk (25-60% of the plasma level) and through the placental barrier. The apparent volume of distribution is 0.8-1.9 l / kg. It is biotransformed in the liver (mainly by the epoxy pathway) with the formation of several metabolites – 10,11-trans-diol derivative and its conjugates with glucuronic acid, monohydroxylated derivatives, as well as N-glucuronides.T1 / 2 – 25–65 hours, with prolonged use – 8–29 hours (due to the induction of metabolic enzymes). in patients taking inducers of the monoxygenase system (phenytoin, phenobarbital), T1 / 2 is 8-10 hours. After a single oral intake of 400 mg, 72% of the dose is excreted by the kidneys and 28% through the intestines. In urine, 2% of unchanged carbamazepine, 1% of the active (10,11-epoxy derivative) and about 30% of other metabolites are determined. In children, excretion is accelerated (higher doses may be required in terms of body weight).The onset of anticonvulsant action varies from several hours to several days (sometimes up to 1 month). The anti-neuralgic effect develops after 8–72 hours, the antimanic effect – after 7–10 days.

Overdose of

Symptoms: disorientation, drowsiness, agitation, hallucinations and coma, blurred vision, dysarthria, nystagmus, ataxia, dyskinesia, hyper- / hyporeflexia, convulsions, myoclonus, hypothermia.respiratory depression, pulmonary edema. tachycardia, hypo- / hypertension, cardiac arrest, accompanied by loss of consciousness. vomiting, decreased motility of the colon. fluid retention, oliguria or anuria, changes in laboratory parameters: hyponatremia, metabolic acidosis, hyperglycemia, increased muscle creatinine phosphokinase fraction; Treatment: induction of vomiting or gastric lavage, administration of activated charcoal and saline laxative, forced diuresis. To maintain airway patency – tracheal intubation, artificial respiration and / or oxygen.With hypotension or shock – plasma substitutes, dopamine or dobutamine, with the appearance of seizures – the introduction of benzodiazepines (diazepam) or other anticonvulsants (in children, increased respiratory depression is possible, with the development of hyponatremia – fluid restriction, careful intravenous infusion of isotonic sodium chloride solution. When severe poisoning is combined with renal failure, renal dialysis is indicated. There is no specific antidote. A repeated increase in overdose symptoms should be foreseen on the 2nd and 3rd day after its onset, which is associated with slow absorption of the drug.

Contraindications

Hypersensitivity (including to tricyclic antidepressants), AV blockade, myelosuppression or acute porphyria in history.

Application during pregnancy and lactation

FDA category of action on the fetus – D.

TEGRETOL CR tablets – instructions for use, price, dosages, analogs, contraindications

Active ingredient

– carbamazepine

Composition and release form of the drug

Extended release tablets brown orange, oval, slightly biconvex, scored on each side; on one side it is marked “ENE / ENE”, on the other – “CG / CG”.

	1 tab.
carbamazepine	400 mg

Excipients: microcrystalline cellulose (Ph202), croscarmellose sodium, methyl methacrylate and ethyl acrylate copolymer dispersion 30% (polyacrylate dispersion 30%), ethyl cellulose aqueous dispersion (ethyl cellulose, sodium lauryl silicon dioxide) colloidal anhydrous, magnesium stearate.

Shell composition: hypromellose, talc, titanium dioxide, macrogol glyceryl hydroxystearate, white dye suspension (titanium dioxide (E171), hypromellose), yellow dye suspension (iron dye yellow oxide (E172), hypromellose) (iron dye yellow oxide red (E172), hypromellose).

10 pcs. – blisters (3) – cardboard packs.

Pharmacological action

Antiepileptic drug derived from tricyclic iminostilbene. It is believed that the anticonvulsant effect is associated with a decrease in the ability of neurons to maintain a high frequency of development of repeated action potentials through inactivation of sodium channels. In addition, inhibition of the release of neurotransmitters by blocking presynaptic sodium channels and the development of action potentials, which in turn reduces synaptic transmission, appears to be important.

Has a moderate antimanic, antipsychotic effect, as well as an analgesic effect for neurogenic pain. Mechanisms of action possibly involve GABA receptors, which may be associated with calcium channels; also, apparently, the effect of carbamazepine on the systems of modulators of neurotransmission.

The antidiuretic effect of carbamazepine may be associated with a hypothalamic effect on osmoreceptors, which is mediated through the secretion of ADH, and also due to a direct effect on the renal tubules.

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Pharmacokinetics

After oral administration, carbamazepine is almost completely absorbed from the gastrointestinal tract. Plasma protein binding is 75%. It is an inducer of liver enzymes and stimulates its own metabolism.

T _1/2 is 12-29 hours. 70% is excreted in the urine (in the form of inactive metabolites) and 30% in the feces.

Indications

Epilepsy: large, focal, mixed (including large and focal) epileptic seizures.Pain syndrome of predominantly neurogenic genesis, incl. essential neuralgia of the trigeminal nerve, neuralgia of the trigeminal nerve in multiple sclerosis, essential glossopharyngeal neuralgia. Prevention of seizures in alcohol withdrawal syndrome. Affective and schizoaffective psychoses (as a means of prevention). Diabetic neuropathy with pain syndrome. Diabetes insipidus of central origin, polyuria and polydipsia of neurohormonal nature.

Contraindications

AV block, previous myelodepression, intermittent porphyria in history, concomitant use of MAO inhibitors and lithium preparations, hypersensitivity to carbamazepine.

Dosage

Set individually. For oral administration for adults and adolescents 15 years of age and older, the initial dose is 100-400 mg. If necessary and taking into account the clinical effect, the dose is increased by no more than 200 mg / day with an interval of 1 week. The frequency of admission is 1-4 times / day. The maintenance dose is usually 600-1200 mg / day in divided doses. The duration of treatment depends on the indications, the effectiveness of treatment, the patient’s response to therapy.

In children under 6 years of age, use 10-20 mg / kg / day in 2-3 divided doses; if necessary and taking into account tolerance, the dose is increased by no more than 100 mg / day with an interval of 1 week.; the maintenance dose is usually 250-350 mg / day and does not exceed 400 mg / day. Children aged 6-12 years – 100 mg 2 times / day on the first day, then the dose is increased by 100 mg / day with an interval of 1 week. until the optimal effect is obtained; the maintenance dose is usually 400-800 mg / day.

Maximum doses: for oral administration in adults and adolescents 15 years of age and older – 1.2 g / day, for children – 1 g / day.

Side effects

From the side of the central nervous system and peripheral nervous system: often – dizziness, ataxia, drowsiness; headache, diplopia, accommodation disturbances are possible; rarely – involuntary movements, nystagmus; in some cases – oculomotor disorders, dysarthria, peripheral neuritis, paresthesias, muscle weakness, paresis symptoms, hallucinations, depression, fatigue, aggressive behavior, agitation, impaired consciousness, increased psychosis, taste disturbances, conjunctivitis, tinnitus, hyperacusis.

From the digestive system: nausea, increased GGT, increased alkaline phosphatase activity, vomiting, dry mouth; rarely – increased activity of transaminases, jaundice, cholestatic hepatitis, diarrhea or constipation; in some cases – decreased appetite, abdominal pain, glossitis, stomatitis.

From the side of the cardiovascular system: rarely – myocardial conduction disorders; in some cases – bradycardia, arrhythmias, AV block with syncope, collapse, heart failure, manifestations of coronary insufficiency, thrombophlebitis, thromboembolism.

From the hematopoietic system: leukopenia, eosinophilia, thrombocytopenia; rarely – leukocytosis; in some cases – agranulocytosis, aplastic anemia, erythrocytic aplasia, megaloblastic anemia, reticulocytosis, hemolytic anemia, granulomatous hepatitis.

From the side of metabolism: hyponatremia, fluid retention, edema, weight gain, decrease in plasma osmolality; in some cases – acute intermittent porphyria, folic acid deficiency; disorders of calcium metabolism, increased cholesterol and triglyceride levels.

From the endocrine system: gynecomastia or galactorrhea; rarely – dysfunction of the thyroid gland.

From the urinary system: rarely – renal dysfunction, interstitial nephritis and renal failure.

On the part of the respiratory system: in some cases – dyspnea, pneumonitis or pneumonia.

Allergic reactions: skin rash, itching; rarely – lymphadenopathy, fever, hepatosplenomegaly, arthralgia.

Drug interaction

With the simultaneous use of inhibitors of the isoenzyme CYP3A4, it is possible to increase the concentration of carbamazepine in the blood plasma.

With the simultaneous use of inducers of the CYP3A4 isoenzyme system, it is possible to accelerate the metabolism of carbamazepine, decrease its concentration in blood plasma, and decrease the therapeutic effect.

With the simultaneous use of carbamazepine stimulates the metabolism of anticoagulants, folic acid.

With simultaneous use with valproic acid, it is possible to reduce the concentration of carbamazepine and a significant decrease in the concentration of valproic acid in the blood plasma. This increases the concentration of the carbamazepine metabolite, carbamazepine epoxide (probably due to inhibition of its conversion to carbamazepine-10,11-trans-diol), which also has anticonvulsant activity, so the effects of this interaction can be leveled, but more often side reactions occur – blurred vision, dizziness, vomiting, weakness, nystagmus.With the simultaneous use of valproic acid and carbamazepine, a hepatotoxic effect may develop (apparently due to the formation of a minor metabolite of valproic acid, which has a hepatotoxic effect).

With the simultaneous use of valpromide reduces the metabolism in the liver of carbamazepine and its metabolite carbamazepine-epoxide due to inhibition of the enzyme epoxide hydrolase. The specified metabolite has anticonvulsant activity, but with a significant increase in plasma concentration, it can have a toxic effect.

With simultaneous use with verapamil, diltiazem, isoniazid, dextropropoxyphene, viloxazine, fluoxetine, fluvoxamine, cimetidine, acetazolamide, danazol, desipramine, nicotinamide (in adults, only in high doses), erythromycin, troleandamycin with azoles (including itraconazole, ketoconazole, fluconazole), terfenadine, loratadine, it is possible to increase the concentration of carbamazepine in the blood plasma with the risk of side effects (dizziness, drowsiness, ataxia, diplopia).

When used simultaneously with hexamidine, the anticonvulsant effect of carbamazepine is weakened; with hydrochlorothiazide, furosemide – a decrease in the sodium content in the blood is possible; with hormonal contraceptives – the weakening of the effect of contraceptives and the development of acyclic bleeding is possible.

With simultaneous use with thyroid hormones, it is possible to increase the elimination of thyroid hormones; with clonazepam – an increase in the clearance of clonazepam and a decrease in the clearance of carbamazepine are possible; with lithium preparations – mutual enhancement of neurotoxic action is possible.

With simultaneous use with primidone, it is possible to reduce the concentration of carbamazepine in the blood plasma. There are reports that primidone can increase the plasma concentration of a pharmacologically active metabolite, carbamazepine-10,11-epoxide.

Simultaneous administration with ritonavir may increase the side effects of carbamazepine; with sertraline – a decrease in the concentration of sertraline is possible; with theophylline, rifampicin, cisplatin, doxorubicin – a decrease in the concentration of carbamazepine in the blood plasma is possible; with tetracycline – the effects of carbamazepine may be weakened.

With simultaneous use with felbamate, a decrease in the concentration of carbamazepine in the blood plasma is possible, but an increase in the concentration of the active metabolite of carbamazepine-epoxide, while a decrease in the plasma concentration of felbamate is possible.

When used simultaneously with phenytoin, phenobarbital, the concentration of carbamazepine in the blood plasma decreases. Mutual weakening of the anticonvulsant action is possible, and in rare cases – its enhancement.

Special instructions

Carbamazepine is not used for atypical or generalized small epileptic seizures, myoclonic or atonic epileptic seizures.Should not be used to relieve common pain; as a prophylactic agent during long periods of remission of trigeminal neuralgia.

Use with caution in concomitant diseases of the cardiovascular system, severe liver and / or kidney dysfunction, diabetes mellitus, increased intraocular pressure, with indications of a history of hematological reactions to the use of other drugs, hyponatremia, urinary retention, hypersensitivity to tricyclic antidepressants, with a history of indications of interruption of the course of treatment with carbamazepine, as well as children and elderly patients.

Treatment should be carried out under the supervision of a physician. With long-term treatment, it is necessary to monitor the blood picture, the functional state of the liver and kidneys, the concentration of electrolytes in the blood plasma, and conduct an ophthalmological examination. Periodic determination of the level of carbamazepine in blood plasma is recommended to monitor the effectiveness and safety of treatment.

At least 2 weeks before starting therapy with carbamazepine, treatment with MAO inhibitors should be discontinued.

Avoid drinking alcohol during treatment.

Influence on the ability to drive vehicles and mechanisms

During treatment, one should refrain from engaging in potentially hazardous activities that require increased attention, speed of psychomotor reactions.

Pregnancy and lactation

If it is necessary to use it during pregnancy (especially in the first trimester) and during lactation, the expected benefits of treatment for the mother and the risk for the fetus or child should be carefully weighed.In this case, carbamazepine is recommended to be used only as monotherapy in the minimum effective doses.

Women of childbearing age are recommended to use non-hormonal contraception during treatment with carbamazepine.

Use in children

Use with caution in children.

For impaired renal function

Use with caution in severe renal impairment.

In case of impaired liver function

Use with caution in case of severe impaired liver function.

Use in the elderly

Use with caution in elderly patients.

Description of the preparation TEGRETOL CR is based on the officially approved instructions for use and approved by the manufacturer.

The price information provided for the drugs does not constitute an offer to sell or buy a product. The information is intended solely for comparing prices in inpatient pharmacies operating in accordance with Article 55 of the Federal Law “On Circulation of Medicines”.