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Comprehensive Guide to Adverse Effects of Isoniazid: Oral Route, Intramuscular Route Side Effects

What are the common and serious side effects of the antibiotic isoniazid taken orally or by intramuscular injection? Discover the potential risks, precautions, and management strategies for isoniazid therapy.

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Understanding Isoniazid and Its Therapeutic Use

Isoniazid is a potent antibiotic primarily used in the treatment of active tuberculosis (TB) infections. It is often prescribed in combination with other anti-tuberculosis medications to effectively combat the bacterial growth and eradicate the infection. Additionally, isoniazid is utilized as a preventive measure, administering it alone to individuals who may have been exposed to TB but do not yet have an active infection.

Potential Adverse Effects of Isoniazid

While isoniazid is generally well-tolerated, it is essential to be aware of the potential adverse effects associated with its use. The most concerning side effect is the rare but serious risk of liver disease, which can be potentially fatal. The likelihood of developing liver complications is increased in individuals aged 35 and above, those who consume alcohol or use illegal injectable drugs, and those with pre-existing liver problems.

Recognizing the Symptoms of Liver Toxicity

Patients taking isoniazid should be vigilant for the following symptoms that may indicate liver toxicity: persistent nausea or vomiting, severe abdominal pain, unusual weakness or fatigue, dark urine, and yellowing of the eyes or skin (jaundice). If any of these symptoms arise, it is crucial to immediately notify the healthcare provider so that appropriate monitoring and management can be initiated.

Importance of Liver Function Monitoring

To mitigate the risk of liver complications, healthcare providers will typically order regular liver function tests while a patient is taking isoniazid. It is essential for patients to attend all scheduled medical and laboratory appointments to ensure close monitoring and timely detection of any liver abnormalities.

Additional Potential Side Effects of Isoniazid

Beyond the concern of liver toxicity, isoniazid may also cause other side effects, including nausea, vomiting, stomach upset, numbness or tingling in the arms and legs, joint pain, increased thirst and urination, vision changes, mood or mental changes, and seizures. While these side effects are less common, patients should report any persistent or concerning symptoms to their healthcare provider.

Precautions and Interactions with Isoniazid

Patients taking isoniazid should be aware of potential interactions with certain foods and medications. Isoniazid may interact with foods containing tyramine or histamine, such as cheese, red wine, and certain types of fish, leading to increased blood pressure, flushing, headaches, dizziness, or a rapid heartbeat. Healthcare providers may recommend a specialized diet to manage these interactions.

Additionally, isoniazid may interact with certain medications, including antacids containing aluminum. Patients should inform their healthcare providers about all medications, including over-the-counter drugs and supplements, they are taking to ensure appropriate management of potential interactions.

Adherence to Isoniazid Therapy

It is crucial for patients to strictly adhere to the prescribed isoniazid regimen, even if symptoms improve or disappear. Stopping the medication too early or skipping doses may allow the bacteria to continue to grow, potentially leading to the development of drug-resistant strains and a more challenging treatment process.

Patients should follow their healthcare provider’s instructions carefully, including taking the medication at the same time each day or on the same day(s) of the week. Maintaining a consistent dosing schedule and completing the full course of treatment are essential for the optimal effectiveness of isoniazid therapy.

In summary, while isoniazid is an important and effective antibiotic in the treatment and prevention of tuberculosis, it is crucial for patients to be aware of the potential adverse effects, particularly the risk of liver toxicity. Regular monitoring, adherence to the prescribed regimen, and prompt reporting of any concerning symptoms are essential for the safe and successful use of isoniazid.

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

Warnings:

Isoniazid has rarely caused very serious (possibly fatal) liver disease. The risk of liver disease is increased in people who are 35 years and older, who use alcohol or illegal injection drugs, or who currently have long-term liver problems. Tell your doctor right away if you develop symptoms of liver disease, including nausea/vomiting that doesn’t stop, severe stomach/abdominal pain, unusual weakness/tiredness, dark urine, yellowing eyes/skin.

Your doctor should order liver function tests while you are taking this medication. Keep all medical and laboratory appointments.

Warnings:

Isoniazid has rarely caused very serious (possibly fatal) liver disease. The risk of liver disease is increased in people who are 35 years and older, who use alcohol or illegal injection drugs, or who currently have long-term liver problems. Tell your doctor right away if you develop symptoms of liver disease, including nausea/vomiting that doesn’t stop, severe stomach/abdominal pain, unusual weakness/tiredness, dark urine, yellowing eyes/skin.

Your doctor should order liver function tests while you are taking this medication. Keep all medical and laboratory appointments.

… Show More

Uses

Isoniazid is used with other medications to treat active tuberculosis (TB) infections. It is also used alone to prevent active TB infections in people who may be infected with the bacteria (people with positive TB skin test). Isoniazid is an antibiotic and works by stopping the growth of bacteria.This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

How to use Isoniazid

Take this medication by mouth on an empty stomach (1 hour before or 2 hours after meals) as directed by your doctor. If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

If you also take antacids that contain aluminum, take this medication at least 1 hour before the antacid.

Dosage is based on your age, weight, medical condition, and response to treatment.

For the best effect, take this drug at evenly spaced times. If you are taking this medication daily, take it at the same time each day. If you are taking this medication on a weekly schedule, take it on the same day(s) of the week and at the same time each day. Mark the days on the calendar when you need to take the medication.

Continue to take this medication (and other TB medications) until the full prescribed amount is finished, even if symptoms disappear. Stopping the medication too early or skipping doses may allow the bacteria to continue to grow, which may result in a return of the infection and cause the infection to be more difficult to treat (resistant).

Your doctor may also direct you to take vitamin B6 (pyridoxine) to help prevent certain side effects (such as nerve problems) from isoniazid. Follow your doctor’s instructions carefully.

Isoniazid may interact with foods containing tyramine/histamine (such as cheese, red wine, certain types of fish). This interaction may cause increased blood pressure, flushing of the skin, headache, dizziness, or fast/pounding heartbeat. Tell your doctor right away if any of these symptoms occur. Your doctor may recommend that you follow a special diet while taking this medication. Consult your doctor for more details.

Tell your doctor if your condition lasts or gets worse.

Side Effects

See also Warning section.

Nausea/vomiting or stomach upset may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: numbness/tingling of arms/legs, painful/swollen joints.

Tell your doctor right away if any of these rare but serious side effects occur: increased thirst/urination, vision changes, easy bruising/bleeding, mental/mood changes (such as confusion, psychosis), seizures.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever that doesn’t go away, new or worsening lymph node swelling, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

See also Warning section.

Before taking isoniazid, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: previous severe reaction from isoniazid (such as liver disease), liver disease, alcohol use, HIV infection, kidney disease, diabetes, numbness/tingling of arms/legs (peripheral neuropathy), recent childbirth.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Alcohol may increase the risk of liver disease. Avoid alcoholic beverages while using this medication.

This product may cause live bacterial vaccines (such as BCG vaccine) to not work well. Tell your health care professional that you are using this medication before having any immunizations/vaccinations.

Liquid forms of this medication may contain sugar. Caution is advised if you have diabetes or any other condition that requires you to limit/avoid sugar. Ask your doctor or pharmacist about using this product safely.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This product passes into breast milk but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

Interactions

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Some products that may interact with this drug include: acetaminophen, certain azole antifungals (itraconazole, ketoconazole), disulfiram, MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine), phenytoin, SSRI antidepressants (such as fluoxetine, sertraline), valproic acid.

This medication may interfere with certain laboratory tests (including urine glucose tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Does Isoniazid interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: vision changes, slow/shallow breathing, severe drowsiness.

Do not share this medication with others.

Lab and/or medical tests (such as sputum test, kidney/liver function, complete blood count) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to take each dose of this medication as scheduled. If you are taking this medication daily and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

If you are taking this drug on a weekly schedule and miss a dose, take it as soon as you remember if it is on the same day. If you remember on the next day or later, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Images

isoniazid 300 mg tablet

Color: whiteShape: roundImprint: West-ward 261

This medicine is a white, round, scored, tablet imprinted with “West-ward 261”.

isoniazid 300 mg tablet

Color: whiteShape: ovalImprint: b 071 300

This medicine is a white, round, scored, tablet imprinted with “West-ward 261”.

isoniazid 50 mg/5 mL oral solution

Color: light yellowShape: Imprint:

This medicine is a white, round, scored, tablet imprinted with “West-ward 261”.

isoniazid 100 mg tablet

Color: whiteShape: roundImprint: b 066 100

This medicine is a white, round, scored, tablet imprinted with “West-ward 261”.

isoniazid 300 mg tablet

Color: whiteShape: roundImprint: LAN 1109

This medicine is a white, round, scored, tablet imprinted with “West-ward 261”.

isoniazid 100 mg tablet

Color: whiteShape: roundImprint: E 4354

This medicine is a white, round, scored, tablet imprinted with “West-ward 261”.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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Adult Medication

This information from Lexicomp® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider.

Brand Names: Canada

Isotamine; PDP-Isoniazid

Warning

  • Severe and sometimes deadly liver problems have happened with this drug. Call your doctor right away if you have signs of liver problems like dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • The chance of liver problems is higher the older you are. The chance may also be raised by drinking alcohol every day, long-term liver problems, or injection drug use. The chance of liver problems may also be raised in females, mainly females who are Black or Hispanic or who have just had a baby. Most of the time, liver problems caused by this drug happen within the first 3 months of care, but they can happen at any time. Most of the time, liver function has gone back to normal but sometimes it has not. Blood work will need to be done before starting this drug and while taking it. If you have questions, talk with the doctor.
  • If you have liver disease, talk with your doctor. This drug may not be right for you.

What is this drug used for?

  • It is used to treat TB (tuberculosis).
  • It is used to prevent TB (tuberculosis).

What do I need to tell my doctor BEFORE I take this drug?

  • If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
  • If you have had very bad side effects while taking isoniazid in the past, like liver problems, drug fever, chills, or arthritis.
  • If you had liver problems while taking some other drug in the past.

This is not a list of all drugs or health problems that interact with this drug.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take this drug?

  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Talk with your doctor before you drink alcohol.
  • Take vitamin B6 (pyridoxine) as you were told by your doctor.
  • If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
  • Have your blood work checked and eye exams as you have been told by your doctor.
  • Some foods and drinks, like cheese and red wine, may cause sudden, severe high blood pressure when you are taking this drug. This effect can be deadly. Talk with your doctor about your risk for this effect. Get a list of foods and drinks to avoid. Avoid these foods and drinks for as long as your doctor has told you after this drug is stopped.
  • Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high blood sugar like confusion, feeling sleepy, unusual thirst or hunger, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • Signs of lupus like a rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
  • Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
  • Signs of too much acid in the blood (acidosis) like confusion; fast breathing; fast heartbeat; a heartbeat that does not feel normal; very bad stomach pain, upset stomach, or throwing up; feeling very sleepy; shortness of breath; or feeling very tired or weak.
  • A burning, numbness, or tingling feeling that is not normal.
  • Seizures.
  • Feeling confused.
  • Memory problems or loss.
  • Change in eyesight.
  • Mood changes.
  • Fever, chills, or sore throat; any unexplained bruising or bleeding; or feeling very tired or weak.
  • Joint pain or swelling.
  • Enlarged breasts.
  • Severe skin reactions may happen with this drug. These include toxic epidermal necrolysis (TEN) and other serious reactions. Sometimes, body organs may also be affected. These reactions can be deadly. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or any areas of skin; fever; chills; body aches; shortness of breath; or swollen glands.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

All products:
  • Upset stomach or throwing up.
Injection:
  • Irritation where the shot is given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to your national health agency.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

How is this drug best taken?

Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.

All oral products:
  • Take on an empty stomach. Take 1 hour before or 2 hours after meals.
  • Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.
Liquid (solution):
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
Injection:
  • It is given as a shot into a muscle.

What do I do if I miss a dose?

All oral products:
  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
Injection:
  • Call your doctor to find out what to do.

How do I store and/or throw out this drug?

All oral products:
  • Store at room temperature protected from light. Store in a dry place. Do not store in a bathroom.
Injection:
  • If you need to store this drug at home, talk with your doctor, nurse, or pharmacist about how to store it.
All products:
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

General drug facts

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

This generalized information is a limited summary of diagnosis, treatment, and/or medication information. It is not meant to be comprehensive and should be used as a tool to help the user understand and/or assess potential diagnostic and treatment options. It does NOT include all information about conditions, treatments, medications, side effects, or risks that may apply to a specific patient. It is not intended to be medical advice or a substitute for the medical advice, diagnosis, or treatment of a health care provider based on the health care provider’s examination and assessment of a patient’s specific and unique circumstances. Patients must speak with a health care provider for complete information about their health, medical questions, and treatment options, including any risks or benefits regarding use of medications. This information does not endorse any treatments or medications as safe, effective, or approved for treating a specific patient. UpToDate, Inc. and its affiliates disclaim any warranty or liability relating to this information or the use thereof. The use of this information is governed by the Terms of Use, available at https://www.wolterskluwer.com/en/know/clinical-effectiveness-terms.

Last Reviewed Date

2022-10-25

Copyright

© 2023 UpToDate, Inc. and its affiliates and/or licensors. All rights reserved.

Last Updated

Monday, December 12, 2022

Isoniazid instructions for use: indications, contraindications, side effects – description Isoniazid tab.

300 mg: 100, 500 or 1000 pcs. (19012)

💊 Ingredients of Isoniazid

✅ Use of Isoniazid

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Description of the active ingredients of the preparation

Isoniazid
(Isoniazid)

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

Update date: 2022.03.31

Marketing authorization holder:

PHARMASINTEZ JSC
(Russia)

ATX code:

J04AC01

(Isoniazid)

Active substance:
isoniazid
(isoniazid)

Rec. INN

WHO registered

Dosage form

Isoniazid

Tab. 300 mg: 100, 500 or 1000 pcs.

reg. No.: R N000519/01
dated 01.07.08
– Indefinitely

Release form, packaging and composition
drug Isoniazid

10 pcs. – cellular contour packings (10) – packs of cardboard.
100 pcs. – plastic bags (1) – polymer cans.
500 pcs. – plastic bags (1) – polymer cans.
1000 pcs. – plastic bags (1) – polymer cans.

Clinical and pharmacological group:

anti-tuberculosis drug

Pharmacotherapeutic group:

Anti-tuberculosis agent

Pharmacological action

Anti-tuberculosis agent. It has a bactericidal effect. Isoniazid is active against extra- and intracellular Mycobacterium tuberculosis, primarily against actively dividing. Its exact mechanism of action is unknown. It is assumed that it is associated with the suppression of the synthesis of mycolic acids, which are part of the cell wall of mycobacteria.

Pharmacokinetics

After oral administration, it is rapidly absorbed from the gastrointestinal tract. When taken with food, absorption and bioavailability are reduced. Widely distributed in all tissues and body fluids, including cerebrospinal, pleural, ascitic; high concentrations are created in lung tissue, kidneys, liver, muscles, saliva and sputum. Plasma protein binding is very low (0-10%). V d – 0.57-0.76 l/kg. Metabolized in the liver. It is excreted in the urine, a small amount – with feces.

Crosses the placental barrier, excreted in breast milk.

Indications of the active substances of the drug

Isoniazid

Treatment and prevention of all forms of tuberculosis caused by isoniazid-susceptible M. tuberculosis as part of combination therapy.

Open list of ICD-10 codes

A15 Tuberculosis of the respiratory organs, confirmed bacteriologically and histologically
A17 Tuberculosis of the nervous system
A18 Tuberculosis of other organs

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.

Isoniazid is used orally, intramuscularly, intravenously, into the cavity. Doses, method and schedule of application, duration of treatment with isoniazid are set individually, depending on the nature and severity of the disease, the rate of acetylation and tolerability.

The dose for children is set according to body weight.

Side effects

On the part of the hematopoietic system: frequency unknown – eosinophilia, bone marrow depression, granulocytopenia, thrombocytopenia, agranulocytosis, sideroblastic anemia, hemolytic or megaloblastic anemia, pyridoxine deficiency anemia, co agulopathy, aplastic anemia.

From the immune system: frequency unknown – exanthema (including acne, especially in young patients), exfoliative dermatitis, Stevens-Johnson syndrome, photosensitivity, fever, asthma, myalgia and arthralgia, anaphylactic reactions, anaphylactic shock , systemic lupus erythematosus, lupus-like syndrome, lymphadenopathy.

From the endocrine system: frequency unknown – hyperfunction of the adrenal cortex (Cushing’s syndrome) and the anterior pituitary gland (with menstrual irregularities in women or gonadotropic disorders / gynecomastia in men) – these phenomena are mostly reversible.

From the side of metabolism: very rarely – hypoglycemia; frequency unknown – hyperglycemia, metabolic acidosis, pellagra (nicotinic acid deficiency).

From the side of the psyche: the frequency is unknown – mental disorders (irritability, anxiety), decreased concentration, depression, psychoses (manifest, catatonic or paranoid), euphoria.

From the side of the nervous system: often – peripheral polyneuropathy with paresthesia, sensory disturbances, headache, dizziness; frequency unknown – convulsions, drowsiness, lethargy, hyperreflexia.

On the part of the organ of vision: rarely – atrophy of the optic nerve; frequency unknown – optic neuritis, diplopia, strabismus.

On the part of the organ of hearing and labyrinth disorders: the frequency is unknown – deafness, tinnitus, vertigo (in patients with end-stage renal disease).

From the side of the cardiovascular system: the frequency is unknown – arrhythmia, vasculitis, increase or decrease in blood pressure.

Respiratory side: frequency unknown – acute respiratory distress syndrome, interstitial lung disease.

From the digestive system: often – diarrhea, constipation, regurgitation, bloating, vomiting; frequency unknown – pancreatitis, dry mouth.

From the side of the liver and biliary tract: very often – increased activity of hepatic transaminases; infrequently – hepatitis; the frequency is unknown – acute liver failure, liver damage, jaundice, acute hepatitis (including fatal).

From the musculoskeletal system: often – muscle tremor; frequency unknown – rheumatic syndrome, rhabdomyolysis.

From the urinary system: the frequency is unknown – glomerulonephritis (mostly reversible), dysuria.

From the skin and subcutaneous tissues: rarely – toxic epidermal necrolysis, drug rash with eosinophilia and systemic manifestations (DRESS syndrome).

Contraindications for use

Hypersensitivity to isoniazid; drug-induced hepatitis and / or other severe adverse reactions that have developed against the background of previous treatment with isoniazid; liver disease in the acute stage; severe liver failure; children’s age up to 3 years (for oral administration).

Precautions: alcoholism, mild to moderate hepatic impairment, history of or chronic hepatic impairment, renal insufficiency, seizures, age over 35 years, long-term use of other potentially hepatotoxic drugs, withdrawal of isoniazid therapy history, peripheral neuropathy, HIV infection, decompensated diseases of the cardiovascular system (chronic heart failure, angina pectoris, arterial hypertension), hypothyroidism, diabetes mellitus, malnutrition, history of mental illness, “slow acetylators”, female gender, pregnancy (for parenteral use).

Pregnancy and lactation

Isoniazid crosses the placenta. During pregnancy, it should be used only in cases where the intended benefit to the mother outweighs the potential risk to the fetus.

Isoniazid crosses the placental barrier and is excreted in breast milk. If necessary, use during lactation should decide on the termination of breastfeeding.

Use in hepatic dysfunction

The use of isoniazid is contraindicated in patients with severe hepatic insufficiency, with liver diseases in the acute stage.

Use with caution in patients with moderate to mild hepatic impairment, strict monitoring of liver enzymes is required.

Use in impaired renal function

Use with caution in patients with renal insufficiency.

Use in children

Isoniazid is contraindicated for oral use in children under 3 years of age.

Use in elderly patients

Use with caution in elderly patients.

Special instructions

Isoniazid is used in combination with other anti-tuberculosis drugs to prevent rapid development of resistance in Mycobacterium tuberculosis.

In some cases, fatal drug-induced hepatitis develops during treatment with isoniazid, which can occur even after several months of stopping use. The risk increases with age (highest incidence in the 35-64 age group), especially with daily ethanol use. Therefore, in all patients, it is necessary to monitor liver function monthly, for people over 35 years old, liver function is additionally examined before starting treatment. With an increase in the activity of ALT, ACT by 4 or more times, or an increase in the concentration of bilirubin in the blood, treatment with isoniazid should be discontinued.

Pyridoxine (oral or IM) or glutamic acid (oral) or thiamine (IM) is given concomitantly with isoniazid to reduce side effects.

Note that isoniazid is metabolized in the liver by acetylation to inactive metabolites. The degree of acetylation is determined by genetic factors. Due to the unequal degree of metabolism, before using isoniazid, it is advisable to determine the rate of its inactivation by the content of the active substance in the blood and urine. In patients who experience rapid inactivation, isoniazid is used at higher doses.

During treatment with isoniazid, cheese (especially Swiss or Cheshire), fish (especially tuna, sardinella) should be avoided, since their simultaneous use with isoniazid may cause reactions (skin flushing, itching, feeling hot or cold, palpitations, increased sweating , chills, headache, dizziness) associated with the suppression of the activity of MAO and DAO and leading to a violation of the metabolism of tyramine and histamine contained in fish and cheese. It should be borne in mind that isoniazid can cause hyperglycemia with secondary glucosuria; copper ion reduction tests may be false positive; the drug does not affect enzyme tests for glucose. The simultaneous use of alcohol contributes to increased hepatotoxic reactions.

Patients intolerant to ethionamide, pyrazinamide, nicotinic acid, or other chemically similar substances may be intolerant to isoniazid. Laboratory indicators of ALT and AST, the concentration of bilirubin in the blood serum can increase transiently without clinical manifestations.

After the injection, the patient must remain in bed for 1-1.5 hours.

Influence on the ability to drive vehicles and mechanisms

During the period of treatment, patients should avoid driving vehicles and other activities that require a high concentration of attention and speed of psychomotor reactions, due to the possibility of developing adverse reactions from the nervous system.

Drug interactions

Isoniazid inhibits the isoenzymes CYP2C19, CYP1A2, CYP2A6, CYP2E1 and CYP3A of the liver cytochrome P450 system, which can lead to a slower elimination of drugs metabolized by these enzymes.

In “slow acetylators” and in patients receiving concomitant aminosalicylic acid, tissue concentrations of isoniazid may be increased and the incidence of side effects may be increased.

Prednisolone can significantly reduce isoniazid plasma concentrations. Antacids (especially aluminum-containing drugs) slow down the absorption and reduce the concentration of isoniazid in the blood (antacids should be taken no earlier than 1 hour after taking isoniazid).

Isoniazid increases the incidence and severity of liver dysfunction in combination with rifampicin in patients with pre-existing liver disease.

Isoniazid increases the concentration of phenytoin in the blood, increasing its side effects such as drowsiness and ataxia, reduces the effectiveness of oral combined contraceptive drugs, glipizide, tolbutamide, tolazamide, thiamine; inhibits the excretion of triazolam; reduces the content of zinc ions in the blood. Isoniazid enhances the action of coumarin, indandione, benzodiazepines, carbamazepine, theophylline derivatives, as it reduces their metabolism.

Isoniazid increases the concentration of valproic acid in the blood (monitoring of the concentration of valproic acid is necessary: ​​dosage adjustment may be required).

Combining isoniazid with paracetamol increases hepato- and nephrotoxicity.

Isoniazid reduces metabolic transformations and increases the concentration of alfentanil in the blood.

Cycloserine and disulfiram increase the adverse central effects of isoniazid.

The combination of isoniazid with pyridoxine reduces the risk of developing peripheral neuritis.

Caution should be exercised in combining isoniazid with potentially neuro-, hepato-, and nephrotoxic drugs due to the risk of increased side effects

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Isoniazid . Description of the drug in the reference book Vidal.

Memorial Sloan Kettering Cancer Center

Adult Medication

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This document provided by Lexicomp ® contains all the information you need to know about the drug, including indications, directions for use, side effects, and when you should contact your healthcare provider.

Brand names: Canada

Isotamine; PDP-Isoniazid

Warning

  • Severe and sometimes fatal liver disease has been reported with this drug. Call your doctor right away if you develop signs of liver problems such as dark urine, fatigue, lack of appetite, nausea or abdominal pain, light-colored stools, vomiting, yellowing of the skin or eyes.
  • The risk of liver disease increases with age. The risk may also be increased with daily alcohol consumption, with long-term liver problems, or with the injectable form of the drug. The risk of liver disease may also be increased in women, especially blacks and Hispanics, and in women who have recently given birth. Liver problems caused by this drug may occur at any time but are more common during the first 3 months of treatment. In most cases, liver function subsequently returns to normal, but sometimes abnormalities persist. You will need to have blood tests before and during treatment with this drug. If you have any questions, please consult your doctor.
  • If you have liver disease, please consult your doctor. This drug may not be right for you.

What is this drug used for?

  • Used to treat tuberculosis.
  • Used to prevent tuberculosis (TB).

What should I tell my doctor BEFORE taking this drug?

  • If you have an allergy to this drug, any of its ingredients, other drugs, foods or substances. Tell your doctor about your allergies and how they have manifested.
  • If you have had very bad side effects such as liver problems, drug fever, chills or arthritis in the past while taking isoniazid.
  • If you have had liver problems in the past after taking any other drug.

This list of drugs and conditions that may interfere with this drug is not all-inclusive.

Tell your doctor and pharmacist about all medicines you take (both prescription and over-the-counter, natural products and vitamins) and any health problems you have. You need to make sure that this drug is safe for your conditions and in combination with other drugs you are already taking. Do not start or stop taking any drug or change the dosage without your doctor’s advice.

What do I need to know or do while taking this drug?

  • Tell all your health care workers that you are taking this drug. These are doctors, nurses, pharmacists and dentists.
  • Consult your doctor before drinking alcohol.
  • Take vitamin B6 (pyridoxine) as directed by your doctor.
  • If you have high blood sugar (diabetes), you should check your blood sugar regularly.
  • Get a blood test and an eye exam as directed by your doctor.
  • Some foods and drinks, such as cheese and red wine, can cause your blood pressure to rise sharply and severely while you are taking this drug. This effect can be deadly. Find out from your doctor what is the risk of developing this effect in your case. Get a list of foods and drinks to avoid. You should not consume these foods and drinks, even after you have stopped taking this drug, for the period prescribed by your doctor.
  • Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding. The benefits and risks for you and your child will need to be discussed.

What side effects should I report to my doctor immediately?

WARNING. In rare cases, this drug can cause serious and sometimes deadly side effects in some patients. Call your doctor right away or get medical help if you have any of the following signs or symptoms that could be associated with serious side effects:

  • Signs of an allergic reaction, such as rash, hives, itching, red and swollen skin with blisters or peeling, possibly accompanied by fever, wheezing or wheezing, tightness in the chest or throat, difficulty breathing, swallowing or speaking, unusual hoarseness, swelling in the mouth, face, lips, tongue or throat.
  • Signs of high blood sugar such as confusion, drowsiness, unusual thirst and hunger, increased urination, flushing, rapid breathing, and fruity breath.
  • Symptoms of lupus, such as a rash on the cheeks or other parts of the body, quick sunburn, muscle or joint pain, chest pain or shortness of breath, and swelling in the arms and legs.
  • Signs of problems with the pancreas (pancreatitis), such as severe abdominal pain, severe back pain, severe indigestion, and vomiting.
  • Symptoms of increased acidity in the blood (acidosis), such as confusion, rapid breathing, tachycardia, irregular heartbeat, very severe abdominal pain, nausea or vomiting, severe drowsiness, shortness of breath, increased fatigue or weakness.
  • Unusual sensations of burning, numbness, or tingling.
  • Seizures.
  • Confusion of consciousness.
  • Impairment or loss of memory.
  • Vision change.
  • Mood changes.
  • fever, chills, sore throat; the appearance of bruising and bleeding for unexplained reasons; pronounced feeling of tiredness or weakness.
  • Pain or inflammation in the joints.
  • Enlarged chest.
  • Against the background of the use of this drug, severe reactions from the skin are possible. These include toxic epidermal necrolysis (TEN) and other serious skin reactions. Sometimes other organs may be affected. Such reactions can lead to death. Seek immediate medical attention if you experience skin symptoms such as redness, swelling, blisters, or peeling; with redness or irritation of the eyes; sores in the mouth, throat, nose, eyes or genitals, or any other area of ​​the skin; with high fever, chills, body pain, shortness of breath, or swollen lymph nodes.

What are some other side effects of this drug?

Any medicine can have side effects. However, for many people, side effects are either minor or non-existent. Contact your doctor or seek medical attention if these or any other side effects bother you or do not go away:

All formulations:
  • Nausea or vomiting.
Injection:
  • Irritation at the injection site.

This list of possible side effects is not exhaustive. If you have any questions about side effects, please contact your doctor. Talk to your doctor about side effects.

You can report side effects to the National Health Board.

You can report side effects to the FDA at 1-800-332-1088. You can also report side effects at https://www.fda.gov/medwatch.

What is the best way to take this drug?

Use this drug as directed by your doctor. Read all the information provided to you. Strictly follow all instructions.

All oral preparations:
  • Take this medicine on an empty stomach. Take 1 hour before meals and 2 hours after meals.
  • Keep taking this drug as instructed by your doctor or other health care professional, even if you feel well.
Liquid (solution):
  • Liquid doses should be measured with caution. Use the dispenser that comes with the medicine. If the dispenser is not provided in the package, ask the pharmacist for a dosing agent for this drug.
Injection:
  • For intramuscular injections.

What if I miss a dose of a drug?

All oral preparations:
  • Take the missed dose as soon as you can.
  • If it’s time for your next dose, don’t take the missed dose and then go back to your regular dosing schedule.
  • Do not take 2 doses or an additional dose at the same time.
Injection:
  • See your doctor for further instructions.

How do I store and/or discard this drug?

All oral preparations:
  • Store at room temperature, protected from light. Store in a dry place. Do not store in the bathroom.
Injection:
  • If you need to store this drug at home, check with your doctor, nurse, or pharmacist for storage conditions.
All forms:
  • Keep all medicines in a safe place. Keep all medicines out of the reach of children and pets.
  • Dispose of unused or expired drugs. Do not empty into a toilet or sewer unless instructed to do so. If you have any questions about disposing of medicines, ask your pharmacist. Drug disposal programs may be in place in your area.

General information about drugs

  • If your health does not improve or even worsens, see your doctor.
  • Do not give your medicine to anyone and do not take other people’s medicines.
  • Some medicines may come with other patient information leaflets. If you have questions about this drug, talk with your doctor, nurse, pharmacist, or other health care professional.
  • Some medicines may come with other patient information leaflets. Check with your pharmacist. If you have questions about this drug, talk with your doctor, nurse, pharmacist, or other health care professional.
  • If you think you have overdosed, call a poison control center or get medical help right away. Be prepared to tell or show what drug you took, how much, and when it happened.

Consumer Use of Information and Limitation of Liability

This summary information includes summaries of diagnosis, treatment, and/or drug product. It is not intended to be a comprehensive source of data and should be used as a tool to help the user understand and/or evaluate potential diagnostic and treatment options. It does NOT include all information about conditions, treatments, medications, side effects, or risks that may apply to a particular patient. It should not be considered medical advice or a substitute for medical advice, diagnosis or treatment provided by a physician based on a medical examination and assessment of the patient’s specific and unique circumstances. Patients should consult with their physician for full information about their health, medical issues, and treatment options, including any risks or benefits regarding the use of medications. This information is not a guarantee that a treatment or drug is safe, effective, or approved for a particular patient.