Flagyl Forte

Flagyl Forte 500 mg film coated tablets: Each contains 500 mg metronidazole.

Trichomoniacide, anaerobicide.
Pharmacology: Pharmacodynamics: Disposition of Metronidazole given orally or by intravenous injection remains constant, with average elimination time of 8 hours in healthy man. Metronidazole was detected in cerebrospinal fluid, saliva and breast milk in same concentration as in plasma. Metronidazole was also detected in the pus of hepatic abscess.

Urethritis and vaginitis due to Trichomonas vaginalis; Amoebiasis (intestinal and hepatic amoebiasis); Prevention of post-operative anaerobic infection; Giardiasis due to Giardia lamblia.

Amoebiasis: Adults, intestinal amoebiasis: 750 mg, three times daily for 5 to 10 days; Adults, hepatic amoebiasis: 750 mg, three times daily for 5 to 10 days; Children: 35-50 mg/kg/24 hours, divided into three doses, for 10 days.
Trichomoniasis: Treatment for men is as same as for women. The dosage regimen should individualized, to reduce the reinfection. Adults: 2 gram, given either as a single dose in one day or 500 mg, two times daily or 250 mg, three times daily for 7 consecutive days; Children: 15 mg/kg bodyweight daily, divided into three doses, for 7 to 10 days.
Giardiasis: Adults: 250 mg to 500 mg, three times daily for 5 to 7 days or 2 gram daily as a single dose for 3 days; Children: 5 mg/kg bodyweight three times daily for 5 to 7 days.
Anaerobic bacterial infections: In serious infection, metronidazole intravenous has to be given as an initial treatment. Adults: 7.5 mg/kg every 6 hours (approximately 500 mg for a 70 kg adult), maximum 4 gram daily for 7 to 10 days.

Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosage. In cases of suspected massive overdose, symptomatic and supportive treatment should be instituted.

Hypersensitivity to metronidazole or to other nitroimidazoles.
During the first trimester of pregnancy.

Treatment should be discontinued in case of ataxia, vertigo, hallucinations mental confusion.
Metronidazole should be used with caution in patients with active or chronic severe peripheral and central nervous system diseases due to the risk of neurological aggravation. Disturbances of central nervous system has been reported in some cases but disappeared if therapy is discontinued or dose decreased.
Patients should be advised not to take alcohol during metronidazole therapy and for at least one day afterwards because of the possibility of a disulfiram­ like (Antabuse effect) reaction.

The use of Flagyl for prolonged treatment duration should be carefully weighed.
If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
Flagyl should be administered with caution to patients with hepatic encephalopathy.
Patients should be warned that metronidazole may darken urine (due to metronidazole metabolite).
Safety in children has not been established, except in amoebiasis.
Used with caution in nursing mothers as metronidazole is excreted in breast milk, during first and second trimesters of pregnancy as metronidazole crosses the placental barrier.
Doses should be reduced and administered with caution to patients with hepatic diseases.
Safety and effectiveness in pediatric patients have not been established, except in the treatment of amoebiasis.
Effects on ability to drive and use machines: Patients should be warned about the potential for drowsiness, dizziness, confusion, hallucinations, convulsions or transient visual disorders, and advised not to drive or operate machinery if these symptoms occur.
Carcinogenicity: Metronidazole has been shown to be carcinogenic in the mouse and in the rat. However similar studies in the hamster have given negative results and extensive human epidemiological studies in humans have provided no evidence of an increased carcinogenic risk in humans. Therefore, the use of Flagyl for longer treatment than usually required prolonged treatment duration should be carefully weighed.
Mutagenicity: Metronidazole has been shown to be mutagenic in bacteria in vitro. In studies conducted in mammalian cells in vitro as well as in rodent or humans in vivo, there was inadequate evidence of a mutagenic effect of metronidazole, with some studies reporting mutagenic effects, while other studies were negative. Therefore, the use of Flagyl for longer treatment than usually required prolonged treatment duration should be carefully weighed.

Pregnancy: As metronidazole crosses the placental barrier and as its effects on human fetal organogenesis are not known, its use in pregnancy should be carefully evaluated.
Lactation: As metronidazole is excreted in human milk, unnecessary exposure to the drug should be avoided.

Gastrointestinal disorders: Epigastric pain, nausea, vomiting, diarrhea.
Oral mucositis, taste disorders, anorexia.
Reversible cases of pancreatitis.
Tongue discoloration/furry tongue (e.g. due to fungal overgrowth).
Immune system disorders: Angioedema, anaphylactic shock.
Nervous system disorders: Peripheral sensory neuropathy.
Headache, convulsions, dizziness.
Reports of encephalopathy (e.g. confusion) and subacute cerebellar syndrome (e.g. ataxia, dysarthria, gait impairment, nystagmus, and tremor) which may resolve with discontinuation of the drug.
Aspetic meningitis.
Psychiatric disorders: psychiatric disorders including confusion, hallucinations.
Depressed mood.
Eye disorders: Transient vision disorders such as diplopia, myopia, blurred vision, decreased visual acuity, changes in colored vision.
Optic neuropathy/neuritis.
Blood and lymphatic system disorders: Cases of agranulocytosis, neutropenia and thrombocytopenia have been reported.
Mild reversible leucopenia in some patients has been reported.
Hepatobiliary disorders: Increase in liver enzymes (AST, ALT, alkaline phosphatase), cholestatic or mixed hepatitis and hepatocellular liver injury, sometimes with jaundice, have been reported.
Cases of liver failure requiring liver transplant have been reported in patients treated with metronidazole in combination with other antibiotic drugs.
Skin and subcutaneous tissue disorders: Rash, pruritus, flushing, urticaria.
Pustular eruptions.
General disorders and administration site conditions: Fever.

Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia).
Oral anticoagulant therapy (warfarin type): Potention of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of coadministration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
Flagyl may be given alone. In combination with other antibiotic given in full normal therapeutic doses. metronidazole both should be.
Cimetidine prolongs the plasma clearance of metronidazole, presumably by inhibiting metabolic enzymes, toxic concentrations of metronidazole may be produced.
Lithium: Plasma levels of lithium may be increased by metronidazole. Plasma concentration of lithium, creatinine and electrolytes should be monitored in patients under treatment with lithium while they receive metronidazole.
Ciclosporin: Risk of elevation of ciclosporin serum levels. Serum ciclosporin and serum creatine should be closely monitored when coadministration is necessary.
Phenytoin or Phenobarbital: Increased elimination of metronidazole resulting in reduced plasma levels.
5 Fluorouracil: Reduced clearance of 5 fluorouracil resulting in increased toxicity of 5 fluorouracil.
Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.
In order to prevent possible interactions the patient must inform physician or pharmacist about the current treatment.
It is recommended to use metronidazole as single drug. In combination with other antibiotic, both should be given in a full dose for normal therapy Cimetidine might prolonged metronidazole plasma clearance which lead to toxic concentration of metronidazole.
Psychotic reaction has been reported when concomitant metronidazole, disulfiram and alcohol was taken simultaneously.

Store below 30°C. Protected from light.
Shelf life: 3 years.

Other Antibiotics / Antiamoebics / Preparations for Vaginal Conditions

P01AB01 - metronidazole ; Belongs to the class of nitroimidazole derivatives antiprotozoals. Used in the treatment amoebiasis and other protozoal diseases.

K