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Long term side effects of pregabalin: Pregabalin Side Effects: Common, Severe, Long Term

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Understand the Risks of Taking Pregabalin (Lyrica) for Fun

Pregabalin is the generic name for Lyrica — a prescription-only medicine that is part of the drug group, anticonvulsants (antiepileptic or antiseizure drugs). Since 2015, there has been a significant increase in pregabalin prescriptions in the US and the UK. 

Due to the sedative and euphoric effects of pregabalin, the danger of addiction is now a serious concern of the medical profession. Read on to learn everything you need to know about potential pregabalin side effects, withdrawal symptoms, and pregabalin addiction treatment.

What is Pregabalin Used For?

Initially, the FDA approved pregabalin for the treatment of epilepsy. In the UK, generic versions of pregabalin mean GPs can prescribe this medication for any treatment. However, it has now become widely prescribed for treating neuropathic pain and generalised anxiety disorder (GAD). This has led to a significant increase in the number of prescriptions and subsequent abuse of pregabalin.  

Available in 25mg to 300mg tablets, capsules, and liquid form, the maximum prescribed pregabalin dose is 600 mg, spread out over 24 hours in two to three doses. However, the pregabalin dose taken recreationally is typically between 600 mg and 3,000 mg. Pregabalin is often used in high doses for its sedative effect and to produce feelings of euphoria, which is why pregabalin can make you “high”. Pregabalin is also used to intensify the euphoric effects of alcohol and other drugs, such as opioids.

Other pregabalin side effects include:

  • feelings of relaxation
  • dissociation
  • loss of inhibitions
  • hallucinations.

Pregabalin Abuse and Addiction

Another serious danger is the potential to become addicted to pregabalin. This is more likely to happen when pregabalin is abused. Gradually increasing the amount you take, and regularly taking more than prescribed, over time, is likely to cause addiction.  

Medicines and Healthcare products Regulatory Agency (MHRA)

Pregabalin (Lyrica), gabapentin (Neurontin) and risk of abuse and dependence: new scheduling requirements from 1st April

As of 1st April 2019, pregabalin and gabapentin are controlled under the Misuse of Drugs Act 1971 as Class C substances and scheduled under the Misuse of Drugs Regulations 2001 as Schedule 3. Evaluate patients carefully for a history of drug abuse before prescribing pregabalin and gabapentin and observe patients for the development of signs of abuse and dependence. GOV.UK

You should always call 999 or go to your local A&E if you experience symptoms, including:

  • Loss of control of body movements 
  • Tremors
  • Confusion 
  • Difficulty speaking
  • Involuntary muscle contractions (twitching). 

Pregabalin Side Effects

Pregabalin has various associated side effects, even when it is taken exactly as prescribed.  

Common physical side effects of pregabalin include:

  • Dizziness
  • Drowsiness
  • Dry mouth
  • Weight gain
  • Headaches
  • Constipation
  • Vomiting and nausea
  • Insomnia
  • Blurred vision
  • Poor concentration
  • Lack of coordination
  • Swelling of hands and feet.

These pregabalin effects tend to be mild and short lasting.

Rare physical side effects of pregabalin include:

  • Rashes, hives, or blisters
  • Respiratory depression (breathing problems)
  • Heart problems (including heart failure).

When these side effects occur, pregabalin will be immediately discontinued.

Mental side effects of pregabalin include:

  • Suicidal thoughts and attempts
  • Depression or anxiety (or these symptoms becoming worse)
  • Agitation and irritability 
  • Aggression
  • Lack of inhibition, which can lead to risky behaviours
  • Panic attacks
  • Mania (excessive energy and talking. )

These symptoms will need close monitoring, and if they last longer than two weeks, pregabalin is usually gradually discontinued.

Pregabalin  (Lyrica) Death

Pregabalin can cause death and has serious risks when taken in any dose, different from that prescribed. Although death from pregabalin poisoning is rare, when pregabalin is taken with opioids, alcohol, and SSRI antidepressants, death may occur. Respiratory depression is also a side effect of taking opioids, such as codeine with pregabalin.

Pregabalin (Lyrica): Links to severe respiratory depression

The Medicines and Healthcare products Regulatory Agency (MHRA) issued a warning about pregabalin and severe respiratory failure. This serious condition occurs when lung function is compromised, and there is insufficient oxygen in the blood. This makes breathing harder, which can be life-threatening if medical treatment is not received fast enough.  

Pregabalin has been associated with infrequent reports of severe respiratory depression, including some cases without the presence of concomitant opioid medicines. Patients with compromised respiratory function, respiratory or neurological disease, renal impairment; those using concomitant central nervous system (CNS) depressants; and people older than 65 years might be at higher risk of experiencing these events, and adjustments in dose or dosing regimen may be necessary.” GOV.UK

Pregabalin vs Gabapentin

Pregabalin and gabapentin are prescription drugs used to treat epilepsy, nerve pain, and mood disorders. They can both have some of the same side effects, the most common being dizziness and drowsiness. The potential for addiction seems higher with pregabalin.  

Both pregabalin and gabapentin are commonly used for their sedative and euphoric effects and cause withdrawal symptoms. Withdrawal from pregabalin is usually a lot more difficult, with a greater degree of unpleasant withdrawal symptoms when it has been taken for recreational use. 

Coping with Pregabalin Withdrawal

The effect of withdrawal if you have an addiction to pregabalin is the same as for class A drugs, such as heroin or cocaine. This is because addiction is classified as a brain disorder, and it causes changes in the circuits forming part of the reward system. Numerous research has shown that once a person is addicted, they are driven by their brain to continue using the substance. 

Studies that have analysed brain imaging MRI scans from people with an addiction have noted changes in the front of the brain that controls the reward system and the region responsible for planning, decision-making, and impulse control. Over time with repeated use, the unpleasant withdrawal effects of the substance leaving your system become more difficult to cope with. 

The brain reward system wants to alleviate any discomfort or pain you are experiencing. Without the ability to make decisions based on long-term consequences, you cannot control your impulse behaviour and are driven to take more of the substance to alleviate the withdrawal symptoms.

When you stop taking pregabalin, it can be difficult to manage withdrawal symptoms without support. The longer you take the drug and the higher the dose, the more severe your withdrawal symptoms are likely to be. Physical withdrawal symptoms typically begin around 12 hours after the last dose.

Over the next couple of days, symptoms will usually become more severe. Common pregabalin withdrawal symptoms include:

  • Extreme anxiety and depression
  • Psychosis including hallucinations
  • Delirium (extreme confusion)
  • Suicidal thoughts 
  • Headaches
  • Excessive sweating
  • Nausea and vomiting
  • Stomach cramps
  • Diarrhoea.

It is important to remember that withdrawal symptoms will differ from person to person, and you may not experience all of these symptoms. When you seek addiction treatment, you can access a medically assisted detox and if required, drugs can be prescribed to alleviate withdrawal symptoms. You will also undergo addiction therapy. This can be obtained through your local NHS drug treatment service.

FAQS

Q. Can I drive on pregabalin?

A. Pregabalin can slow your reflexes and make you tired and dizzy. When using pregabalin for recreational use, you should never drive a car as you don’t know how it will affect you. If you take pregabalin as prescribed, you may be able to drive and should speak to your GP.

Q. Can I drink alcohol with pregabalin?

A. If you are not taking pregabalin as prescribed or should not be taking it at all, you should avoid alcohol. Alcohol and pregabalin increase the effects of each other, which means together, they can make you feel dizzy and drowsy and impair your ability to make sound decisions. This could result in dangerous and risky behaviour, injury, and even death. If you have been prescribed pregabalin and are not using it as directed, you should speak to your GP about drinking alcohol.

Q. Can pregabalin cause seizures?

A. Although pregabalin is an anti-seizure medication, side effects from pregabalin especially when taken for recreational use in large doses, include seizures.

Q. How long do pregabalin withdrawal symptoms last?

A. Acute physical withdrawal symptoms will generally last around three days. Psychological withdrawal symptoms typically last for several weeks but can last longer, depending on how much pregabalin you have taken and how often.

Q. Is pregabalin a controlled drug?

A. Pregabalin is a Schedule 3 controlled drug, and it is illegal to possess without a prescription in your name.

Q. Can I get NHS addiction treatment for pregabalin?

A. The NHS provides addiction treatment for all drugs, regardless of how you obtained them. 

 

At Step by Step Recovery, we offer free advice on supporting and treating addiction.

We want to help individuals live a life free from addiction permanently. Please complete our online assessment form or call our free phone number on 0800 170 1222 for free, confidential advice.

Pregabalin: medicine to treat epilepsy and anxiety

1. About pregabalin

Pregabalin is used to treat epilepsy and anxiety.

It’s also taken to treat nerve pain. Nerve pain can be caused by different conditions including diabetes and shingles, or an injury.

Pregabalin works in different ways:

  • in epilepsy it stops seizures by reducing the abnormal electrical activity in the brain
  • with nerve pain it blocks pain by affecting the pain messages travelling through the brain and down the spine
  • in anxiety it stops your brain from releasing the chemicals that make you feel anxious

Pregabalin is only available on prescription. It comes as capsules, tablets, or a liquid that you swallow.

2. Key facts

  • You’ll usually take pregabalin 2 or 3 times a day. You can take it with or without food.
  • Pregabalin is often used for epilepsy, but you can also take it to help with pain or anxiety if you do not have epilepsy.
  • It takes at least a few weeks for pregabalin to work.
  • The side effects of pregabalin are usually mild and go away by themselves. The most common ones are feeling sleepy, dizziness and headaches.
  • If you have epilepsy it’s important to take pregabalin regularly. Missing doses could trigger a seizure.

3. Who can and cannot take pregabalin

Pregabalin is only suitable for adults. It might not be suitable for people older than 65. Do not give it to children under 18.

Pregabalin is not suitable for some people. To make sure it’s safe for you, tell your doctor if you:

  • have ever had an allergic reaction to pregabalin or any other medicine
  • have ever abused or been addicted to a medicine
  • are trying to get pregnant, already pregnant or breastfeeding
  • are on a controlled sodium diet, or your kidneys do not work well – some brands of pregabalin liquid contain sodium, so speak to your pharmacist or doctor before taking it
  • have any problems that affect your breathing

4. How and when to take pregabalin

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

Dosage

The usual dose of pregabalin is between 150mg and 600mg a day, split into 2 or 3 separate doses.

If you are taking pregabalin as a liquid, 2.5ml is usually the same as taking a single 50mg capsule. Always check the label.

How to take it

You can take pregabalin with or without food, but it’s best to take it in the same way each day. Try to space your doses evenly through the day.

Swallow pregabalin tablets or capsules whole with a drink of water or juice. Do not chew them.

If you are taking pregabalin as a liquid, it will come with a syringe or spoon to measure your dose. If you do not have a measuring spoon or syringe, ask your pharmacist for one. Do not use a kitchen teaspoon as it will not measure the right amount.

How long to take it for

If you have epilepsy, it’s likely that once your condition is under control you will continue to take pregabalin for many years.

If you’re taking pregabalin for nerve pain or anxiety it’s likely that once your symptoms have gone you will continue to take it for several months to stop them coming back.

Changes to your dose

To prevent side effects, your doctor will prescribe a low dose to start with and then increase it over a few days.

Once you find a dose that suits you, it will usually then stay the same.

If you forget to take it

If you forget a dose, take it as soon as you remember. If it’s within 2 hours of your next dose, skip the missed dose and take your next dose at the usual time.

Never take 2 doses at the same time. Never take an extra dose to make up for a forgotten one.

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

If you often forget doses, 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.

If you take too much

Taking too much pregabalin may cause unpleasant side effects.

Urgent advice: Contact 111 for advice now if:

  • you take more than your prescribed dose of pregabalin

Go to 111.nhs.uk or call 111

Immediate action required: Go to A&E now if:

You take more than your prescribed dose of pregabalin and you:

  • feel sleepy
  • feel confused or agitated
  • have a seizure
  • pass out

If you need to go to A&E, do not drive yourself. Get someone else to drive you or call for an ambulance.

Take the pregabalin packet or leaflet inside it plus any remaining medicine with you.

5. Side effects

Like all medicines, pregabalin can cause side effects although not everyone gets them.

Common side effects

These common side effects may happen in more than 1 in 100 people. They are usually mild and go away by themselves.

Keep taking the medicine but tell your doctor if these side effects bother you or do not go away:

  • headaches
  • feeling sleepy, tired or dizzy
  • diarrhoea
  • mood changes
  • feeling sick
  • swollen hands, arms, legs and feet
  • blurred vision
  • difficulties with getting an erection
  • weight gain – because pregabalin can make you feel hungry
  • memory problems

If you have diabetes, pregabalin can upset your blood sugar control. Monitor your blood sugar more often for the first few weeks of treatment with pregabalin and adjust your diabetes treatment if you need to. Talk to your doctor or diabetes nurse if you want more advice on what to do.

Serious side effects

Very few people taking pregabalin have serious problems. Call a doctor or contact 111 straight away if you get:

  • thoughts of harming or killing yourself – a small number of people taking pregabalin have had suicidal thoughts, sometimes after only a week of treatment
  • severe dizziness or you pass out
  • hallucinations (seeing or hearing things that are not real)
  • problems going to the toilet, including blood in your pee, needing to pee more often, or constipation

Go to 111.nhs.uk or call 111.

Serious allergic reaction

In rare cases, it’s possible to have a serious allergic reaction (anaphylaxis) to pregabalin.

Immediate action required: Call 999 or go to A&E now if:

  • you get a skin rash that may include itchy, red, swollen, blistered or peeling skin
  • you’re wheezing
  • you get tightness in the chest or throat
  • you have trouble breathing or talking
  • your mouth, face, lips, tongue or throat start swelling

You could be having a serious allergic reaction and may need immediate treatment in hospital.

These are not all the side effects of pregabalin. For a full list see the leaflet inside your medicines packet.

Information:

You can report any suspected side effect using the Yellow Card safety scheme.

Visit Yellow Card for further information.

6. How to cope with side effects of pregabalin

What to do about:

  • headaches – make sure you rest and drink plenty of fluids. Try not to drink too much alcohol. Ask your pharmacist to recommend a painkiller. Headaches should usually go away after the first week of taking pregabalin. Talk to your doctor if they last longer than a week or are severe.
  • feeling sleepy, tired or dizzy – do not drive, cycle or use machinery until you feel better. As your body gets used to pregabalin, these side effects should wear off. If they do not wear off within a week or 2, your doctor may reduce your dose or increase it more slowly. If that does not work you may need to switch to a different medicine.
  • diarrhoea – drink lots of fluids, such as water or squash, to avoid dehydration. Signs of dehydration include peeing less than usual or having dark, strong-smelling pee. Do not take any other medicines to treat diarrhoea without speaking to a pharmacist or doctor.
  • mood changes – if you feel this medicine is causing mood changes, speak to your doctor as you may need a change of medicine.
  • feeling sick – take pregabalin with or after a meal or snack to ease your symptoms. It may also help if you avoid rich or spicy food.
  • swollen hands, arms, legs and feet – if your feet are swollen, try sitting with your feet up on a chair or bed and try not to stand for a long time. Exercise might help if your arms are swollen. If that does not help or it becomes painful, contact your doctor.
  • blurred vision – do not drive, cycle or use tools or machinery while this is happening. If it lasts for more than a day or 2 speak to your doctor as they may need to change your treatment.
  • difficulties with getting an erection – speak to your doctor, as they may be able to change your medicine or offer other treatments that might help with this problem.
  • weight gain – pregabalin can make you hungrier so it can be quite a challenge to stop yourself putting on weight. Try to eat well without increasing your portion sizes. Do not snack on foods that contain a lot of calories, such as crisps, cakes, biscuits and sweets. If you’re hungry between meals, eat fruit and vegetables and low-calorie foods. Increasing your level of exercise will also help to keep your weight stable.
  • memory problems – if you’re having problems with your memory, speak to your doctor. They may want to try a different medicine.

7. Pregnancy and breastfeeding

Pregabalin and pregnancy

Taking pregabalin during pregnancy may slightly increase the chance of birth defects in the baby.

You’ll usually only be advised to take it if your doctor thinks the benefits of the medicine outweigh the risks.

If you take pregabalin and become pregnant, do not stop taking the medicine without talking to your doctor first. If you take pregabalin for epilepsy, it is particularly important that this is well treated during pregnancy, as seizures can harm you and your baby.

It’s recommended to use effective contraception while taking pregabalin. If you plan to get pregnant, talk to your doctor first, as they may want to review your treatment.

If you’re trying to get pregnant or have become pregnant while taking pregabalin, it is recommended to take high dose folic acid (5mg a day). You can get this from your doctor or midwife.

Ideally, you’ll take high dose folic acid for 3 months before you start trying to get pregnant and for the first 12 weeks of pregnancy. Do not worry if you have not taken it before you get pregnant, but start taking it as soon as possible once you know that you are pregnant. It helps your baby to grow normally.

If you take pregabalin around the time of giving birth, your baby may need extra monitoring for a few days after they’re born. This is because they may have pregabalin withdrawal symptoms.

Pregabalin and breastfeeding

If your doctor or health visitor says your baby is healthy, you can take pregabalin while breastfeeding. It’s important to keep taking pregabalin to keep you well.

Pregabalin passes into breast milk in small amounts, and it’s unlikely to cause side effects in your baby.

If you’re breastfeeding or planning to breastfeed, talk to your doctor or pharmacist, as other medicines we know more about might be better while you’re breastfeeding, but they will help you decide.

If your baby is not feeding as well as usual, or seems unusually sleepy, or if you have any other concerns about your baby, talk to your doctor, pharmacist, health visitor or midwife.

Non-urgent advice: Tell your doctor if you’re:

  • trying to get pregnant
  • pregnant
  • breastfeeding

For more information about how pregabalin can affect you and your baby during pregnancy, visit the Best Use of Medicines in Pregnancy (BUMPS) website.

8. Cautions with other medicines

Pregabalin can usually be taken safely with other medicines.

For safety, tell your doctor if you’re taking any of these medicines before you start taking pregabalin:

  • strong painkillers such as morphine
  • medicines that make you feel sleepy or dizzy – pregabalin can make these side effects worse

Mixing pregabalin with herbal remedies and supplements

There are no known problems with taking herbal remedies and supplements with pregabalin.

However there’s not enough information to say that complementary medicines and herbal remedies are always safe to take with pregabalin. They’re not tested in the same way as pharmacy and prescription medicines.

Important:
Medicine safety

Tell your doctor or pharmacist if you’re taking any other medicines, including herbal medicines, vitamins or supplements.

9. Common questions about pregabalin

How does pregabalin work?

It’s not clear exactly how pregabalin works.

In epilepsy, it’s thought that it stops seizures by reducing the abnormal electrical activity in the brain.

With nerve pain, it’s thought to block pain by interfering with pain messages travelling through the brain and down the spine.

In anxiety, it’s thought that it stops your brain from releasing the chemicals that make you feel anxious.

Is it safe to take it for a long time?

There’s no evidence that pregabalin has lasting harmful effects, even if you take it for many months or years.

Do I need to take the same brand of pregabalin?

Most people do not have to stay on the same brand of pregabalin as there is very little difference between brands. Talk to your doctor if you have been asked to switch to a different brand and you’re worried about it.

If your epilepsy has been hard to control in the past and the brand you are now taking is working well for you, your doctor may recommend you stay on the same one.

Can I get addicted to pregabalin?

Some people have become addicted to pregabalin after taking it for a long time. If this happens, you will have withdrawal symptoms after you stop taking the medicine.

Talk to your doctor if you’re concerned you are becoming physically dependant on pregabalin.

What happens when I stop taking pregabalin?

Do not stop taking pregabalin suddenly, even if you feel fine. Stopping suddenly can cause serious problems.

If you have epilepsy, stopping pregabalin suddenly can cause seizures that will not stop.

If you are taking it for any reason and stop suddenly, you may have severe withdrawal syndrome. This can have unpleasant symptoms, including:

  • anxiety
  • difficulty sleeping
  • feeling sick
  • pain
  • sweating

It’s possible to prevent withdrawal seizures and other symptoms by gradually reducing the dose of pregabalin.

Do not stop taking pregabalin without talking to your doctor.

Can I get epilepsy medicines for free?

If you have epilepsy, you’re entitled to free prescriptions for all of your medicines, not just your epilepsy ones.

To claim your free prescriptions you’ll need to have a medical exemption certificate. The application form for the medical exemption certificate is called FP92A. You can get this from your doctor’s surgery.

You will need to fill in the form, then your doctor will sign it and send it off.

Are there similar medicines to pregabalin?

Gabapentin (also called Neurontin) is a medicine that works in a similar way to pregabalin. Like pregabalin, it can be taken to treat epilepsy and nerve pain. It can also be taken for migraines.

However, there are other differences between pregabalin and gabapentin. Gabapentin is taken in different doses to pregabalin.

If you need to change to gabapentin treatment, your doctor will explain how to safely swap from pregabalin.

Is pregabalin a controlled medicine?

Pregabalin is a controlled medicine. This means there are strict rules about how it’s prescribed and dispensed to make sure it’s not given to the wrong person or misused.

When you collect pregabalin your pharmacist will ask for proof of identity such as your passport or driving licence. You’ll also be asked to sign the back of your prescription, to confirm that you’ve received it.

If you’re collecting pregabalin for someone else, you’re legally required to show the pharmacist proof of your identity if asked.

How do I pick up a prescription for a controlled medicine?

Your pregabalin prescription will probably need to be hand signed by a doctor. This can take longer than normal repeat prescriptions.

It’s best to hand in your repeat prescription request up to 5 days before you’re due to run out of pregabalin. This will give your doctor enough time to sign it.

Once your prescription has been written, you’ll need to collect your medicine from a pharmacist within 28 days. If you wait longer than 28 days, your prescription will become invalid and you’ll need to get a new one.

If your pharmacist is unable to give you the whole amount prescribed, you’ll need to go back to pick up your remaining medicine within 28 days of receiving your prescription. After 28 days your prescription will become invalid and your pharmacist will not be able to give you your remaining medicine without a new prescription.

Will it affect my contraception?

Pregabalin does not stop any contraception working. You can safely use any type of contraception alongside pregabalin, including the combined pill and emergency contraception.

However, if pregabalin makes you have severe diarrhoea for more than 24 hours, your contraceptive pills may not protect you from pregnancy. Look on the pill packet to find out what to do.

Read more about what to do if you’re on the pill and you have diarrhoea.

Will it affect my fertility?

There’s no evidence to suggest that taking pregabalin reduces fertility in either men or women.

But speak to a pharmacist or your doctor before taking it if you’re trying to get pregnant.

Can I drive or ride a bike?

Do not drive a car or ride a bike if pregabalin makes you sleepy, gives you blurred vision or makes you feel dizzy, clumsy or unable to concentrate or make decisions. This may be more likely when you first start taking pregabalin but it could happen at any time, for example when starting another medicine.

It’s an offence to drive a car if your ability to drive safely is affected. It’s your responsibility to decide if it’s safe to drive. If you’re in any doubt, do not drive.

Talk to your doctor or pharmacist if you’re unsure whether it’s safe for you to drive while taking pregabalin. GOV.UK has more information on the law on drugs and driving.

If you have epilepsy, you’re not allowed to drive until you have had no seizures for 1 year.

If you change your epilepsy medicine, your doctor will tell you whether you need to stop driving and for how long.

Information:

Epilepsy Action: rules if you change or withdraw your epilepsy medicine

GOV.UK: epilepsy and driving

Can I drink alcohol with it?

It’s best to avoid drinking alcohol with pregabalin, because it may make you feel sleepy or make you lose your focus. It might also affect your breathing.

Will recreational drugs affect it?

Pregabalin can intensify the highs of recreational drugs like cannabis and heroin. So, if you use recreational drugs alongside pregabalin, there may be more chance of unpleasant side effects like panic attacks, anxiety and memory loss.

Pregabalin in the treatment of spondylogenic radiculopathy | Amelin A.V.

Back pain is one of the most common forms of chronic pain [1] with predominant localization in the lumbar region (15–45%) [2–4] and neck (13–24%) [5–7]. Traditionally, back pain is considered as nociceptive, resulting from the excitation of nociceptors, widely represented in the vertebral bodies, facet joints, intervertebral discs, dura mater, ligaments, muscles. The neuropathic mechanism of pain is revealed in 10–19% of patients with back pain [8–10] and is associated with damage and irritation of the spinal cord, fibers of the spinal root due to their compression, inflammation, edema, ischemia, demyelination, and axonal degeneration. An important role in the formation of neuropathic pain is played by changes in the neurophysiological characteristics of nerve fibers, neurons of the spinal ganglia and dorsal horns of the spinal cord.

The main causes of radiculopathy are spinal stenosis, herniated disc, spondylosis with the formation of osteophytes, hypertrophy of the articular facets, ligaments, less often herpes zoster, diabetes mellitus, neurinomas or other causes. It is known that the intensity of pain does not correlate with the degree of disc protrusion or the severity of root compression. The presence of the neuropathic component of pain significantly exacerbates the course of back pain syndrome, contributes to its chronicity and rapid maladaptation of patients, impairs their quality of life, increases the cost of treatment [10–12], contributes to the development of insomnia, anxiety, and depression [13–15]. For many physicians, the management of patients with chronic neuropathic pain remains a challenge [16].
Traditionally, for the treatment of back pain, most physicians use non-steroidal anti-inflammatory drugs (NSAIDs) [10-12], which relieve nociceptive pain well, but are ineffective in neuropathic pain that occurs with radiculopathies. The wrong choice of tactics for the treatment of patients with spondylogenic radiculopathies contributes to a decrease in its effectiveness and a significant increase in duration [18–20]. The results of recent systematic reviews indicate that among the antidepressants, opioids and anticonvulsants used for the treatment of neuropathic pain, gabapentin and pregabalin have the most favorable efficacy/tolerability ratio, which makes them currently the first choice drugs for the treatment of pain with a neuropathic component [16]. Pregabalin is a modern anticonvulsant and has proven to be an effective drug for the treatment of any neuropathic pain, fibromyalgia, anxiety and seizures. It is an analogue of g-aminobutyric acid with high selectivity for the α-2-delta subunit of the voltage-gated calcium channel of the neuron. In placebo-controlled clinical trials, pregabalin demonstrated not only high analgesic activity, but also efficacy against comorbid affective disorders and insomnia in patients with peripheral diabetic polyneuropathy [23–26], postherpetic neuralgia [27–29], spinal central neuropathic pain [30]. In real world clinical practice, pregabalin efficacy was studied in patients with cervical and lumbar radiculopathy [49]. This study showed that more than 2-fold reduction in pain was observed in 63% of patients treated with pregabalin monotherapy and in 56% of patients treated with pregabalin as an adjunct to conventional therapy, which included NSAIDs, gabapentin, tranquilizers, amitriptyline, and fentanyl [49] (Fig. 1).
A domestic study also demonstrated the high efficacy of pregabalin in the treatment of neuropathic pain associated with spondylogenic lumbosacral radiculopathies [50]. According to the authors, in some patients, even with obvious signs of radiculopathy, the neuropathic component is not dominant in the structure of the pain syndrome, and therefore they recommend the mandatory use of the DN-4 questionnaire for the differential diagnosis of nociceptive and neuropathic pain in the structure of spondylogenic pain syndrome. These data support previous randomized controlled trials in which pregabalin was effective in 39 patients.-48% of patients with diabetic polyneuropathy [23–26], 28–50% with postherpetic neuralgia (27–29%), and 22% of patients with central neuropathic pain associated with spinal cord injury [30]. It was previously shown that the correction of affective disorders and insomnia associated with neuropathic pain can significantly reduce both direct and indirect costs of treating patients with neuropathic pain and improve their quality of life [47]. Given the frequent co-occurrence of chronic pain with the above disorders, the role of pregabalin in their management appears to be highly beneficial, especially given the evidence that opioids, which are effective in the treatment of neuropathic pain [16, 21], do not improve long-term emotional distress and quality of life. life of patients [45, 46], and tricyclic antidepressants have a number of psychotropic side effects and anticholinergic effects, which significantly limit their use in a large category of patients. One of the previous studies showed a positive effect of pregabalin on comorbid sleep disorders, depression and anxiety in patients with cervical and lumbosacral radiculopathy [49].
Of particular interest is the discussion of the effective average daily dose of pregabalin for the treatment of neuropathic pain. In randomized clinical trials using a flexible dosing regimen, it was found that the effective therapeutic range of pregabalin for various neuropathic pain syndromes ranges from 150 to 600 mg / day. [26]. However, a number of studies conducted in real clinical practice have demonstrated high analgesic activity of pregabalin at lower daily doses [20, 43]. For example, in patients with lumbar and cervical radiculopathy, to reduce pain by 2 times or more, compared with the initial period, it took an average of 190 mg of pregabalin per day, while to obtain a similar result in the treatment of postherpetic neuralgia and diabetic polyneuropathy, a dose of almost 2 times more was required [26]. Whether lower doses of pregabalin can be recommended for actual clinical practice remains unclear.
Currently, the most effective and safe is the individual selection of the dose of pregabalin. The recent appearance of a dosage form containing 25 mg of the drug makes it possible to use a very flexible dosing regimen. It is important to understand that one should not rush to negative assessment of the effectiveness of the treatment of neuropathic pain and refuse the use of pregabalin, unless its dose has been increased to the individually maximum and well tolerated. A guideline can be a dose of 150-300 mg / day, indicated in the annotation for the use of the drug. In cases of insufficient efficacy and good tolerability of the drug, a second agent from another class can be added to it. It has been shown that the combined use of gabapentin and pregabalin with antidepressants significantly increases the effectiveness of the treatment of patients with chronic pain and depression [16, 21]. The combined use of an anticonvulsant and an antidepressant in a number of patients reduces the average daily dose of each of them and the risk of side effects [21].
Of particular interest for discussion is the question of the possibility and expediency of combining an anticonvulsant and NSAIDs in patients with spondylogenic back pain and radiculopathy. The theoretical validity of this combination is beyond doubt, since the pathogenesis of most back pain syndromes suggests the presence of both nociceptive and neuropathic pain mechanisms. There is evidence that the combined use of pregabalin and celecoxib was more effective than either drug alone in patients with chronic back pain [48]. In this study, the combination of pregabalin and celecoxib reduced the intensity of chronic back pain by 38.2%, while pregabalin monotherapy reduced pain by 10.4% and celecoxib by 12.4%. The effectiveness of back pain treatment largely depended on the presence of the neuropathic pain component in the clinical picture, which was identified and assessed using the LANSS diagnostic questionnaire. For more details: si-sv.com In patients with severe neuropathic pain component (LANSS >12 points), the maximum reduction in pain compared with the baseline period (by 51.8%) was achieved only when using the combination of pregabalin and celecoxib (Fig. 2).
Thus, there is now evidence that pregabalin monotherapy, and especially its combination with NSAIDs, is effective for the treatment of patients with chronic back pain and radiculopathy. The inclusion of pregabalin in the treatment regimen for patients with this pathology not only contributes to more effective pain relief, but also reduces the symptoms of anxiety and insomnia that often accompany chronic pain.

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Pregabalin instructions for use: indications, contraindications, side effects – description Pregabalin caps. 150 mg: 14, 28 or 56 pcs. (45091)

💊 Ingredients of Pregabalin

✅ Use of Pregabalin

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⚠️ The registration certificate for this product expired on 11/11/21

Description of the active ingredients of the preparation

pregabalin
(Pregabalin)

The scientific information provided is general and cannot be used to make decisions.
decisions about the use of a particular drug.

Update date: 2020.05.14

Marketing authorization holder:

GEROPHARM LLC
(Russia)

Manufactured:

DONGBANG FUTURE TECH & LIFE Co.,Ltd

(Republic of Korea)

ATX code:

N03AX16

(Pregabalin)

Active substance:
pregabalin
(pregabalin)

Rec.INN

WHO registered

Dosage form

pregabalin

Caps. 150 mg: 14, 28 or 56 pcs.

reg. No.: LP-003308
from 11.11.15
– Expired

Release form, packaging and composition
drug Pregabalin

Capsules, hard gelatin, #2, with white body and white cap; the contents of the capsules are a powder or compacted mass of white or white with a yellowish tint, which disintegrates when pressed with a glass rod.

Excipients : lactose monohydrate – 16.5 mg, corn starch – 28.5 mg, talc – 5 mg.

Capsule composition: body – titanium dioxide – 2%, gelatin – up to 100%; cap – titanium dioxide – 2%, gelatin – up to 100%.

14 pcs. – blister packs (1) – cardboard packs.
14 pcs. – blister packs (2) – cardboard packs.
14 pcs. – blister packs (4) – cardboard packs.

Clinical and pharmacological group:

Anticonvulsant drug

Pharmacotherapeutic group:

Anticonvulsant

Pharmacological action

Anticonvulsant with analgesic and anxiolytic action. Pregabalin is a GABA analogue.

It is assumed that the analgesic and anticonvulsant effect is due to the binding of pregabalin to an additional subunit (α 2 -delta protein) of voltage-gated calcium channels in the CNS, which leads to an irreversible replacement of [3H]-gabapentin.

Pregabalin reduces the clinical manifestations of generalized anxiety disorder.

Pharmacokinetics

After oral administration on an empty stomach, pregabalin is rapidly absorbed from the gastrointestinal tract. C max in plasma is achieved after 1 hour, both with a single and repeated intake. The oral bioavailability of pregabalin is ≥ 90% and is dose independent. With repeated use, the equilibrium state is reached after 24-48 hours. When used after a meal C max decreases by approximately 25-30%, and the time to reach C max increases to approximately 2.5 hours. However, food intake does not have a clinically significant effect on the total absorption of pregabalin.

The pharmacokinetics of pregabalin in the range of recommended daily doses is linear, inter-individual variability is low (<20%).

Apparent V d pregabalin after oral administration is approximately 0.56 l/kg. Pregabalin does not bind to plasma proteins.

Pregabalin is practically not metabolized. After administration of labeled pregabalin, approximately 98% of the radioactive label was determined in the urine in unchanged form. The proportion of the N-methylated derivative of pregabalin, which is the main metabolite found in urine, was 0.9% of the dose. There were no signs of racemization of the S-enantiomer of pregabalin to the R-enantiomer.

Pregabalin is excreted mainly by the kidneys unchanged. The average T 1/2 is 6.3 hours. Plasma clearance of pregabalin and renal clearance are directly proportional to CC.

Pregabalin pharmacokinetic parameters at steady state in healthy volunteers, in patients with epilepsy who received antiepileptic therapy, and in patients who received it for chronic pain syndromes, were similar.

In case of impaired renal function, it should be borne in mind that the clearance of pregabalin is directly proportional to CC. Pregabalin is effectively removed from plasma by hemodialysis (after a 4-hour hemodialysis session, plasma pregabalin concentrations are reduced by about 50%).

The pharmacokinetics of pregabalin has not been specifically studied in patients with hepatic impairment. Pregabalin is practically not metabolized and is excreted mainly unchanged in the urine, so impaired liver function should not significantly alter plasma concentrations of the drug.

When prescribing the drug to elderly patients over 65 years of age, it should be taken into account that the clearance of pregabalin tends to decrease with age, which reflects the age-related decrease in CC. Elderly people with impaired renal function may need to reduce the dose of the drug.

Indications of the active substances of the drug

pregabalin

Treatment of neuropathic pain in adults.

Treatment of fibromyalgia in adults.

Epilepsy: as adjunctive therapy in adults with partial seizures with or without secondary generalization.

Treatment of generalized anxiety disorder in adults.

Open list of ICD-10 codes

F41.1 Generalized anxiety disorder
G40 Epilepsy
G53. 0 Neuralgia after herpes zoster (B02.2)
G63.2 Diabetic polyneuropathy
M79.7 Fibromyalgia (including fibromyositis, fibrositis)
R52.2 Other persistent pain (chronic)

Dosage regimen

The method of administration and dosing regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. Compliance of the dosage form of a particular drug with indications for use and dosing regimen should be strictly observed.

Take orally, regardless of food intake, in a daily dose of 150 to 600 mg in 2 or 3 doses.

If treatment must be discontinued, it is recommended that this be done gradually over a period of at least 1 week.

In patients with impaired renal function , the dose is selected individually, taking into account QC.

In patients with impaired liver function, dose adjustment is not required.

Elderly patients over 65 years of age may require a dose reduction of pregabalin due to decreased renal function.

If a dose of pregabalin is missed, the next dose should be taken as soon as possible, but the missed dose should not be taken if the next dose is about to be taken.

Side effects

From the side of the psyche: often – euphoria, confusion, decreased libido, irritability, insomnia, disorientation; infrequently – depersonalization, anorgasmia, anxiety, depression, agitation, mood lability, depressed mood, difficulty in choosing words, hallucinations, unusual dreams, increased libido, panic attacks, apathy, increased insomnia; rarely – disinhibition, high spirits.

From the side of the nervous system: very often – dizziness, drowsiness; often – ataxia, impaired attention, impaired coordination, memory impairment, tremor, dysarthria, paresthesia, imbalance, amnesia, sedation, lethargy; infrequently – cognitive disorders, hypesthesia, nystagmus, speech disturbance, myoclonic convulsions, weakening of reflexes, dyskinesia, psychomotor agitation, postural dizziness, hyperesthesia, loss of taste sensations, burning sensation on the mucous membranes and skin, intentional tremor, stupor, fainting; rarely – hypokinesia, parosmia, dysgraphia; frequency unknown – headache.

From the senses: often – dizziness, blurred vision, diplopia; infrequently – hyperacusis, narrowing of the visual fields, decreased visual acuity, eye pain, asthenopia, dry eyes, swelling of the eyes, increased lacrimation; rarely – flashing sparks before the eyes, eye irritation, mydriasis, oscillopsia (subjective sensation of fluctuation of the objects in question), impaired perception of depth of vision, loss of peripheral vision, strabismus, increased brightness of visual perception; frequency unknown – keratitis.

From the side of metabolism: often – increased appetite, weight gain; infrequently – anorexia, hypoglycemia; rarely – weight loss.

From the side of the cardiovascular system: infrequently – tachycardia, AV block I degree, hot flashes, lowering blood pressure, cold extremities, increased blood pressure; rarely – sinus tachycardia, sinus arrhythmia, sinus bradycardia; the frequency is unknown – chronic heart failure, prolongation of the QT interval.

From the respiratory system: infrequently – shortness of breath, cough, dryness of the nasal mucosa, nasopharyngitis; rarely – nasal congestion, nosebleeds, rhinitis, snoring, tightness in the throat; infrequently – pulmonary edema.

From the digestive system: often – dry mouth, constipation, vomiting, flatulence, bloating; infrequently – increased salivation, gastroesophageal reflux, hypoesthesia of the oral mucosa; rarely – ascites, dysphagia, pancreatitis; frequency unknown – swelling of the tongue, nausea, diarrhea.

From the musculoskeletal system: infrequently – muscle twitching, joint swelling, muscle spasms, myalgia, arthralgia, back pain, pain in the extremities, muscle stiffness; rarely – spasm of the cervical muscles, neck pain, rhabdomyolysis.

From the urinary system: infrequently – dysuria, urinary incontinence; rarely – oliguria, renal failure.

From the reproductive system: often – erectile dysfunction; infrequently – delayed ejaculation, sexual dysfunction; rarely – amenorrhea, pain in the mammary glands, discharge from the mammary glands, dysmenorrhea, enlargement of the mammary glands in volume.

From the side of the hematopoietic system: rarely – neutropenia.

Dermatological reactions: infrequently – skin flushing, sweating, papular rash; rarely – cold sweat; frequency unknown – pruritus, Stevens-Johnson syndrome.

Allergic reactions: rarely – urticaria; frequency unknown – angioedema, hypersensitivity.

On the part of laboratory parameters: infrequently – increased activity of ALT, AST, CPK, a decrease in the number of platelets; rarely – an increase in the content of glucose and creatinine in the blood, a decrease in the level of potassium in the blood, a decrease in the number of leukocytes in the blood.

Other: often – fatigue, peripheral edema, feeling of intoxication, gait disturbance; infrequently – asthenia, falls, thirst, chest tightness, generalized edema, chills, pain; rarely – hyperthermia.

Contraindications for use

Children and adolescents up to 17 years of age, hypersensitivity to pregabalin.

Use in pregnancy and lactation

Adequate, well-controlled safety studies of the use of pregabalin during pregnancy have not been conducted. Women of reproductive age should use adequate methods of contraception when using pregabalin.

It is not known if pregabalin is excreted in human breast milk. If it is necessary to use pregabalin during lactation, the issue of stopping breastfeeding should be considered.

In animal studies , pregabalin produced reproductive toxicity. Pregabalin has been found to be excreted in breast milk in rats.

Special instructions

Use with caution in renal failure, in heart failure. In connection with the reported isolated cases of uncontrolled use of pregabalin, it must be used with caution in patients with a history of drug dependence (during the treatment period, strict medical supervision is required in such cases).

In patients with diabetes mellitus, in case of weight gain during treatment with pregabalin, dose adjustment of hypoglycemic drugs may be required.

Pregabalin should be discontinued if symptoms of angioedema develop (such as swelling of the face, perioral edema, or swelling of the tissues of the upper respiratory tract).

Pregabalin, like other anticonvulsants, may increase the risk of suicidal thoughts or behavior. Therefore, during the period of treatment, patients require careful medical monitoring for the occurrence or worsening of depression, the appearance of suicidal thoughts or behavior.

Treatment with pregabalin has been associated with dizziness and drowsiness, which increase the risk of accidental injury (falls) in the elderly. During post-marketing use, there have also been cases of loss of consciousness, confusion and cognitive impairment. Therefore, until patients appreciate the possible effects of pregabalin, they should exercise caution.

Data on the possibility of withdrawal of other anticonvulsants in the suppression of seizures with pregabalin and the advisability of monotherapy with pregabalin are insufficient. There are reports of the development of seizures, incl. epileptic status and small seizures, against the background of the use of pregabalin or immediately after the end of therapy.

There have also been cases of renal failure, in some cases, after discontinuation of pregabalin, renal function was restored.

The following adverse events have been observed with discontinuation of pregabalin after long-term or short-term therapy: insomnia, headache, nausea, diarrhea, flu-like syndrome, depression, sweating, dizziness, convulsions and anxiety. Information on the frequency and severity of manifestations of pregabalin withdrawal syndrome depending on the duration of therapy with the latter and its dose is not available.

Post-marketing experience with pregabalin has reported the development of chronic heart failure during pregabalin therapy, predominantly in elderly patients with impaired cardiac function and receiving the drug for neuropathy. Therefore, pregabalin should be used with caution in this category of patients. After the abolition of pregabalin, the manifestations of such reactions may disappear.

The frequency of adverse reactions from the CNS, especially such as drowsiness, is increased in the treatment of central neuropathic pain due to spinal cord injury, which, however, may be due to the summation of the effects of pregabalin and other concomitantly taken drugs (for example, antispastic). This circumstance should be taken into account when pregabalin is prescribed for this indication.

Dependence has been reported with pregabalin. Patients with a history of drug dependence need careful medical monitoring for symptoms of pregabalin dependence.

Cases of encephalopathy have been reported, especially in patients with concomitant diseases that can lead to the development of encephalopathy.

Influence on the ability to drive vehicles and mechanisms

Pregabalin can cause dizziness and drowsiness and, accordingly, affect the ability to drive vehicles and use complex equipment.

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