Niazid
Generic Name
Isoniazid
Manufacturer
General Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| niazid 100 mg suspension | ৳ 35.00 | N/A |
Description
Overview of the medicine
Niazid 100 mg Suspension contains Isoniazid, an antitubercular agent primarily used in the treatment and prophylaxis of tuberculosis (TB). It is a first-line drug often used in combination with other anti-TB medications.
Uses & Indications
Dosage
Adults
Active TB: 5 mg/kg body weight daily (max 300 mg/day) or 15 mg/kg (max 900 mg) twice weekly. Latent TB: 300 mg daily for 6-9 months.
Elderly
Similar to adult dosage, but with caution due to potential increased risk of peripheral neuropathy and hepatotoxicity. Pyridoxine supplementation is highly recommended.
Renal_impairment
Dose adjustment usually not required for mild-moderate impairment. For severe renal impairment (CrCl <10 mL/min), consider reducing frequency to 2-3 times per week, or dose reduction.
How to Take
Administer orally, preferably on an empty stomach (1 hour before or 2 hours after meals) for optimal absorption. However, if gastric irritation occurs, it may be taken with food. Shake the suspension well before use.
Mechanism of Action
Isoniazid is a prodrug that, once activated by mycobacterial catalase-peroxidase (KatG), inhibits the synthesis of mycolic acid, a crucial component of the mycobacterial cell wall. This leads to disruption of the cell wall and ultimately bacterial death.
Pharmacokinetics
Onset
Therapeutic effects typically observed over days to weeks with consistent use as part of a multi-drug regimen.
Excretion
Excreted mainly by the kidneys (75-95%) within 24 hours, primarily as metabolites and some unchanged drug.
Half life
Highly variable, ranging from 1-4 hours, depending on the individual's genetic acetylator status (fast vs. slow acetylators).
Absorption
Rapid and complete absorption from the gastrointestinal tract; peak plasma concentrations achieved within 1-2 hours.
Metabolism
Primarily hepatic, metabolized by N-acetyltransferase to acetylisoniazid, which is then hydrolyzed to isonicotinic acid and acetylhydrazine. Acetylhydrazine is further metabolized and can be hepatotoxic.
Side Effects
Contraindications
- Hypersensitivity to isoniazid
- Acute liver disease or a history of isoniazid-associated liver injury
- Severe adverse reactions to isoniazid, such as drug fever, chills, arthritis, etc.
Drug Interactions
Alcohol
Increased risk of hepatotoxicity and peripheral neuropathy.
Antacids
May decrease isoniazid absorption. Separate administration by at least 1 hour.
Rifampicin
Used in combination for TB treatment, but increases the risk of hepatotoxicity.
Cycloserine, Disulfiram
Increased CNS side effects.
Carbamazepine, Phenytoin, Valproate
Isoniazid inhibits the metabolism of these drugs, leading to increased plasma concentrations and potential toxicity.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose include nausea, vomiting, abdominal pain, dizziness, slurred speech, hyperreflexia, seizures (often intractable), metabolic acidosis, hyperglycemia, and coma. Management involves supportive care, gastric lavage (if recent), activated charcoal, and crucially, intravenous pyridoxine (Vitamin B6) to counteract neurotoxicity and seizures.
Pregnancy & Lactation
Pregnancy Category C. Use only if the potential benefit outweighs the potential risk to the fetus, especially in active TB. Isoniazid is excreted in breast milk; however, breastfeeding is generally considered safe if the mother is receiving appropriate anti-TB treatment and the infant is monitored. Pyridoxine supplementation for the infant may be considered.
Side Effects
Contraindications
- Hypersensitivity to isoniazid
- Acute liver disease or a history of isoniazid-associated liver injury
- Severe adverse reactions to isoniazid, such as drug fever, chills, arthritis, etc.
Drug Interactions
Alcohol
Increased risk of hepatotoxicity and peripheral neuropathy.
Antacids
May decrease isoniazid absorption. Separate administration by at least 1 hour.
Rifampicin
Used in combination for TB treatment, but increases the risk of hepatotoxicity.
Cycloserine, Disulfiram
Increased CNS side effects.
Carbamazepine, Phenytoin, Valproate
Isoniazid inhibits the metabolism of these drugs, leading to increased plasma concentrations and potential toxicity.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose include nausea, vomiting, abdominal pain, dizziness, slurred speech, hyperreflexia, seizures (often intractable), metabolic acidosis, hyperglycemia, and coma. Management involves supportive care, gastric lavage (if recent), activated charcoal, and crucially, intravenous pyridoxine (Vitamin B6) to counteract neurotoxicity and seizures.
Pregnancy & Lactation
Pregnancy Category C. Use only if the potential benefit outweighs the potential risk to the fetus, especially in active TB. Isoniazid is excreted in breast milk; however, breastfeeding is generally considered safe if the mother is receiving appropriate anti-TB treatment and the infant is monitored. Pyridoxine supplementation for the infant may be considered.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture, consult product leaflet for specific details.
Availability
Pharmacies, hospitals, clinics
Approval Status
Approved (Globally for TB treatment)
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Extensively studied and validated in numerous clinical trials for its efficacy in treating and preventing tuberculosis, often as part of multi-drug regimens.
Lab Monitoring
- Baseline liver function tests (ALT, AST, bilirubin) and repeat monthly, especially in high-risk patients or if symptoms of hepatotoxicity appear.
- Monitor for signs and symptoms of peripheral neuropathy.
- Periodic ophthalmologic examinations if visual disturbances occur.
Doctor Notes
- Emphasize patient adherence to the full course of therapy, particularly for latent TB treatment, to prevent resistance and relapse.
- Co-administer pyridoxine (Vitamin B6) to all patients, especially those at higher risk of neuropathy (e.g., malnourished, diabetic, alcoholic, pregnant, elderly).
- Closely monitor LFTs, especially in the first 3 months, and educate patients on signs of hepatotoxicity.
Patient Guidelines
- Take exactly as prescribed and complete the full course of treatment, even if you feel better, to prevent drug resistance.
- Report any signs of liver problems immediately: unexplained nausea, vomiting, dark urine, yellowing of skin/eyes, or unusual tiredness.
- Take Vitamin B6 (pyridoxine) as advised by your doctor to reduce the risk of peripheral neuropathy.
- Avoid alcohol while taking this medicine.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Isoniazid may cause dizziness, lightheadedness, or vision changes in some individuals. If you experience these effects, avoid driving or operating machinery until you know how the medicine affects you.
Lifestyle Advice
- Maintain a healthy diet to support overall health during treatment.
- Avoid or limit alcohol consumption to reduce the risk of liver damage.
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