ABBOTT HEALTHCARE PVT LTD 271 BUSINESS PARK 6TH FLOOR MODEL INDUSTRIAL COLONY GOREGAON EAST MUMBAI 400063
Metronidazole 200mg/400mg tablets, Benzyl Metronidazole 200mg/5ml suspension,
List of Related Indications:
- Anaerobic infections
- Genito-urinary tract infection
- Trichomonal vaginitis
List Of Drugs:
- Metronidazole - Plain @ ( *** )- (FDC- List )- (1977)
Indication Type Description:
Dosages/ Overdosage Etc
Interaction with Food
Pregnancy and lactation
Interacting drugs - summary
barbiturates decrease the antimicrobial effectiveness of metronidazole
decreased metronidazole clearance and increased serum level occur
increase the anticoagulant effect of Warfarin oranisindione Risk of bleeding increased
concurrent use may result in acute psychosis or confusional state
Disulfram-like reaction including symptoms of flushing, palpitations, tachycardia, nausea,vomiting, etc may occur with concurrent use. Caution is advised.
total clearance of Hydantoin decreased and its elimination half-life prolonged
in patients stabilised on relatively high Lithium doses, short term metronidazole has been associated with increased lithium levels and toxicicity in some cases
Drug /Lab interactions-
the drug may interfere with chemical analyses for AST, ALT, LDH, triglycerides and hexokinase glucose. Zero vlaues may occur.ses
Dysuria,cystisis, polyuria, incontinence, sense of pelvic pressure, proliferation of Canida in the vagina, dysparenuia, decreased libido. Darkened urine deep red-brown-colour has been reported.
The pigment appears to be a metabolite of metronidazole and it seems to have no significance.
Thrombophelebitis,after IV infusion can be minimised or eliminated by prolonged use of in dwelling IV catheters.
Seizures, peripheral neuropathiy.the latter characterrised mainly by numbness or paresthesia of an extrtemity, dizziness, vertigo,incoordination, ataxia, confusion, irritabiliry, depression,weakness, insomnia, headache, syncope.
Nausea sometimes accompanied by headache, anorexia, and occassionally vomiting., diarrhea, epigastric distress, abdominal cramping, constipation, proctitis, sharp unpleaseant metallic taste, a modification of the taste of alcoholic beverages, furry tongue, glossitis, stomatitis (these may be associated with a sudden overgrowth of canidida)
Reversible neutropenia, (leukopenia) reversible thrombocytopenia (rare)
Flattening of the T-wave may be seen in ECG tracings
Urticaria, erythematous rash, flushing, nasal congestion, dryness of the mouth
(or vagia or vulva) fever
Fleeting joint pains, sometimes resembling "serum sickness " . One case of
metronidazole induced pancreatitis reported
Blood dyscrasias.Active CNs disease,hypersens,serious neurological disease and seizures.
Pregnancy. Lactation. Avoid alcohol, renal/hepatic impairment
Crohns disease- patients are known to have an increased incidence of GI and certain extraintestinal cancers. There have been some reports in the medical literature of breast and colon cancer in Crohns disease patients who have been treated with metronidazole at high doses for extended periods of time. A cause and relation effect has not been established.
Candidiasis- known or previously unrecongnized, may present more prominent symptoms during therapy and requires treatment with candicidal effect.
Hematologic effects- metronidazole is a nitronidazole , use with care in patients with a history of blood dyscrasia. Mild leukopenia has been seen during administration, however no persistent hematologic abnormalities attributabled to the drug has been reported. Perform total and differential count before and after therapy.
Amebic liver abscess- metronidazole does not obivate the need for aspiratin of pus
Drug /Lab interactions-
the drug may interfere with chemical analyses for AST, ALT, LDH, triglycerides and hexokinase glucose. Zero vlaues may occur.
Neurologic effects- seizures (associated with high cumulative doses ) and periphral neuropathy (characterised by numbness or paresthesia of an extremity ) have occured. Carefully monitor patients receiving high doses for long periods eg Crohns disease patients
Hepatic function impairment- patients with hepatic disease metabolize metronidazole slowly. Accumulation of the drug or its metabolites may occur. Cautiously administer doses below those usually recommended.
Carcinogenesis- metronidazole has shown evidence of carcinogenic activity with chronic oral administration in rodents
Elderly- since the pharmacokinetics of metronidazole may be altered in the elderly, monitoring of serum levels may be necessary to adjust dosage accordingly.
Pregnancy- restrict metronidazole for trichomoniasais in the second and third trimesters to those in whom local palliative treatment has been inadequate.
Lactation- safety for use in nursing mother has not been established
Children- safety and efficacy in children has not been established
Dosages/ Overdosage Etc:
Acute cases - 750mg 3 times daily for 5 to 10 days, others- 500 to 750mg 3 times daily.
Children- acute cases- 35 to 50mg/kg/24 hours (maximum 750mg dose) in 3 divided doses for 10 days
7 day course treatment -
Adults- 250mg 3 times daily for 7 consecutive days.
Children- 5mg/kg/dose 3 times daily for 7 days.
Nausea, vomiting, and ataxia.
Single oral doses upto 15g have reported in suicide
attempts accidental overdosage
1. No specific antidote exists.
2. Treatment consists of usual supportive measures.
1. If you miss a dose of this medicine, take it as soon as possible.
2. However, if it is almost time for next dose, skip the missed dose and go back to your regular dosing schedule.
3. Do not double doses.
1.May cause GI upset, take with food. Avoid alcoholic beverages.
2. Complete full course of therapy,take until gone. may cause darkening of urine.
3.An unpleasant metallic taste may be noticeble
4.Allergies- tell your doctor if you have ever had any unusual or allergic reaction to metronidazole. Also tell your doctor if you are allergic to any other substances, such as foods, presrvatives or dyes.
5.Pregnancy - metronidazole given by mouth has not been shown to cause birth defects or problems in animal studies.
6.Breast feeding- the small amounts of this medicine that are absorbed are unlikely to cause serious problems in nursing babies.
7. Children - rosacea is usually considered an adult disease. Therefore, topical metronidazole is not generally used in children.
8. Elderly- there is no specific information comparing use of topical metronidazole in the elderly with use in other age groups.
9. Other medicines - Tell your doctor if you are taking any other medicines. Your doctor may want to change the dose or other precautions may be necessary.
Anticoagulants - patients taking medicines anticoagulants with metronidazole may have an increased chance of bleeding.
10. Other medical problems -
Tell your doctor if you have any other medical problems especially -
Blood disease or history of blood disease- metronidazole may make the condition worse
Central nervous system - metronidazole may increase the chance of seizures or other CNS side effects.
11. Missed dose - If you miss a dose of this medicine, take it as soon as possible. however, if it is almost time for the next dose, skip the missed dose. Do not double doses.
12. Storage - Keep out of reach of children. Store away from heat or direct sunlight. Do not store the capsule in bathroom, near the kitchen sink, or in other damp places.
13. Outdated medicines - Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of reach of children.
Metronidazole, a nitroimidazole derivative is active against anaerobic bacteria and protozoa. Its mode of action is not understood. It appears to enter the cells of micro-organisms that contains nitroreductase,where a nitro group is reduced. Unstable intermediate compounds are formed which binds DNA and inhibiting synthesis,causing cell death.
Well absorbed after oral administration. Peak serum levels occurs at about 1 to 2 hours. Oral bioavailability is not affected by food. Elimination of metronidazole is via urine(60 to 80% of the dose); fecal excretion accouts for 6 to 15%.
Interaction with Food:
Pregnancy and lactation:
There are noadequate and well controlled studies in pregnant woman. Use during pregnancy only if clearly needed.
Safety for use in nursing mother has been established. Children; Safety and efficacy in children have not been established except for the treatment of amoebiasis.