Amezol
Generic Name
Metronidazole
Manufacturer
Local Pharmaceutical Company
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
amezol 400 mg tablet | ৳ 1.25 | N/A |
Description
Overview of the medicine
Metronidazole is an antibiotic and antiprotozoal medication used to treat a wide variety of bacterial and parasitic infections. It belongs to the nitroimidazole class of antimicrobial agents.
Uses & Indications
Dosage
Adults
Dosage varies by indication. For amoebiasis: 400-800 mg three times daily for 5-10 days. For anaerobic infections: 400-800 mg three times daily. Consult a physician for specific dosing instructions.
Elderly
No specific dose adjustment is usually required for elderly patients, but monitoring of liver and kidney function is advisable.
Renal_impairment
Dose reduction may be necessary in patients with severe renal impairment (creatinine clearance <10 mL/min). Consult a physician.
How to Take
Take orally with or without food. To minimize gastrointestinal upset, it can be taken with food. Swallow the tablet whole with water, do not crush or chew.
Mechanism of Action
Metronidazole enters anaerobic microorganisms and is reduced to active metabolites. These metabolites disrupt DNA synthesis and cause damage to DNA, leading to bacterial and protozoal cell death.
Pharmacokinetics
Onset
Therapeutic effects typically begin within a few hours.
Excretion
Mainly excreted in urine (60-80%) as unchanged drug and metabolites, with some fecal excretion (6-15%).
Half life
Approximately 6-11 hours.
Absorption
Well absorbed orally, with peak plasma concentrations occurring within 1-3 hours.
Metabolism
Primarily metabolized in the liver via oxidation, followed by glucuronide conjugation.
Side Effects
Contraindications
- Hypersensitivity to metronidazole or other nitroimidazole derivatives.
- First trimester of pregnancy (relative contraindication, use only if clearly needed).
- Concurrent use with disulfiram (within 2 weeks).
- Alcohol consumption during treatment and for at least 3 days after stopping metronidazole.
Drug Interactions
Alcohol
Disulfiram-like reaction (nausea, vomiting, abdominal cramps, headache, flushing).
Lithium
Increases serum lithium levels, leading to potential lithium toxicity.
Busulfan
Increases busulfan toxicity.
Cimetidine
Increases metronidazole levels, potentially enhancing side effects.
Disulfiram
Psychotic reactions.
Phenobarbital, Phenytoin
Decreases metronidazole levels, reducing its effectiveness.
Warfarin and other oral anticoagulants
Enhances anticoagulant effect, increasing risk of bleeding.
Storage
Store below 30°C in a cool, dry place. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include nausea, vomiting, ataxia, and disorientation. Management is supportive and symptomatic; there is no specific antidote. Gastric lavage may be performed.
Pregnancy & Lactation
Pregnancy Category B (2nd and 3rd trimesters); generally avoided in the 1st trimester unless essential. Metronidazole is excreted into breast milk; breastfeeding should be temporarily discontinued or an alternative drug considered if treatment is necessary.
Side Effects
Contraindications
- Hypersensitivity to metronidazole or other nitroimidazole derivatives.
- First trimester of pregnancy (relative contraindication, use only if clearly needed).
- Concurrent use with disulfiram (within 2 weeks).
- Alcohol consumption during treatment and for at least 3 days after stopping metronidazole.
Drug Interactions
Alcohol
Disulfiram-like reaction (nausea, vomiting, abdominal cramps, headache, flushing).
Lithium
Increases serum lithium levels, leading to potential lithium toxicity.
Busulfan
Increases busulfan toxicity.
Cimetidine
Increases metronidazole levels, potentially enhancing side effects.
Disulfiram
Psychotic reactions.
Phenobarbital, Phenytoin
Decreases metronidazole levels, reducing its effectiveness.
Warfarin and other oral anticoagulants
Enhances anticoagulant effect, increasing risk of bleeding.
Storage
Store below 30°C in a cool, dry place. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include nausea, vomiting, ataxia, and disorientation. Management is supportive and symptomatic; there is no specific antidote. Gastric lavage may be performed.
Pregnancy & Lactation
Pregnancy Category B (2nd and 3rd trimesters); generally avoided in the 1st trimester unless essential. Metronidazole is excreted into breast milk; breastfeeding should be temporarily discontinued or an alternative drug considered if treatment is necessary.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture, refer to the product packaging for exact expiry.
Availability
Pharmacies, Hospitals
Approval Status
Approved by regulatory authorities (e.g., FDA, DGDA)
Patent Status
Generic
WHO Essential Medicine
YesClinical Trials
Metronidazole has been extensively studied in numerous clinical trials since its introduction, demonstrating efficacy across its various indications. Research continues on new formulations and resistance patterns.
Lab Monitoring
- Liver function tests (in patients with hepatic impairment).
- Complete blood count (for prolonged therapy or a history of blood dyscrasias).
- Renal function tests (in patients with severe renal impairment).
Doctor Notes
- Emphasize strict adherence to alcohol avoidance during and after treatment due to disulfiram-like reaction.
- Monitor for neurological adverse effects (e.g., paresthesia, numbness, seizures) particularly with prolonged therapy.
- Consider dose adjustment in severe hepatic impairment, and possibly in severe renal impairment.
- Counsel patients on completing the full course of therapy to prevent resistance and ensure eradication of infection.
Patient Guidelines
- Complete the full prescribed course of medication, even if symptoms improve.
- Avoid alcohol during treatment and for at least 3 days after stopping the medicine.
- Report any severe or persistent side effects, especially neurological symptoms (e.g., numbness, tingling, convulsions).
- Take the medicine with food if stomach upset occurs.
Missed Dose Advice
If you miss a dose, 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
Metronidazole may cause dizziness, drowsiness, or visual disturbances. If these effects occur, avoid driving or operating machinery.
Lifestyle Advice
- Maintain good personal hygiene to prevent reinfection.
- For sexually transmitted infections, ensure sexual partners are also treated to prevent re-infection.
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