Filmet Tablet 400mg

Indications

Filmet is indicated in the treatment of following diseases:

The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).

The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.

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Pharmacology

Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.

Dosage & Administration

Tablet and Suspension:

Trichomoniasis (Adults & Children over 10 yrs)-

200 mg tid or 400 mg bid for 7 days

800 mg in the morning and 1-2 gm at night for 2 days

2 gm as a single dose for 1 days

Trichomoniasis (Children)-

Children 7-10 yrs: 100 mg tid

Children 3-7 yrs: 100 mg bid

Children 1-3 yrs: 50 mg tid

Intestinal amoebiasis (Adults & Children over 10 yrs)-

800 mg tid for 5 days

Intestinal amoebiasis (Children)-

Children 7-10 yrs: 400 mg tid

Children 3-7 yrs: 200 mg qid

Children 1-3 yrs: 200 mg tid

Extra-intestinal & Asymptomatic amoebiasis (Adults & Children over 10 yrs)-

400-800 mg tid for 5-10 days

Extra-intestinal & Asymptomatic amoebiasis (Children)-

Children 7-10 yrs: 200-400 mg tid

Children 3-7 yrs: 100-200 mg qid

Children 1-3 yrs: 100-200 mg tid

Giardiasis (Adults & Children over 10 yrs)-

2 gm once daily for 3 days

Giardiasis (Children)-

Children 7-10 yrs: 1 gm once daily

Children 3-7 yrs: 600-800 mg once daily

Children 1-3 yrs: 500 mg once daily

Acute ulcerative gingivitis (Adults & Children over 10 yrs)-

200 mg tid for 3 days

Acute ulcerative gingivitis (Children)-

Children 7-10 yrs: 100 mg tid

Children 3-7 yrs: 100 mg bid

Children 1-3 yrs: 50 mg tid

Acute dental infections (Adults & Children over 10 yrs)-

200 mg tid for 3-7 days

Bacterial Vaginosis (Adults & Children over 10 yrs)-

400 mg bid for 7 days

2 gm as a single dose for 1 days

Leg ulcers and pressure sores (Adults & Children over 10 yrs)-

400 mg tid for 7 days

Anaerobic infections (Adults & Children over 10 yrs)-

800 mg initially and then 400 mg tid for 7 days

Anaerobic infections (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Surgical prophylaxis (Adults & Children over 10 yrs)-

400 mg tid started 24 hours before surgery for 1 days

Surgical prophylaxis (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Vaginal Gel:

The recommended dose is one applicator full of Metronidazole gel (approximately 5 grams containing approximately 37.5 mg of Metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole gel should be administered at bedtime.

Suppository:

Anaerobic Infections-

Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.

Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.

Surgical Prophylaxis-

Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.

Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.

IV Infusion:

Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.

Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.

Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.

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Interaction

Disulfiram: Psychotic reactions have been reported in patients who were using Filmet 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): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with Filmet.

Lithium: Plasma levels of lithium may be increased by Filmet.

Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.

Phenytoin or phenobarbital: increased elimination of Filmet 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 Filmet, which may lead to severe busulfan toxicity.

Contraindications

Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.

Side Effects

Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.

Pregnancy & Lactation

US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.

Precautions & Warnings

If for compelling reasons, Filmet 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).

Filmet should be administered with caution to patients with hepatic encephalopathy.

Patients should be warned that Filmet may darken urine.

Use in Special Populations

Hepatic impairment: Filmet is mainly metabolised by hepatic oxidation. Substantial impairment of Filmet clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of Filmet may contribute to the symptoms of the encephalopathy. Filmet should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that Filmet may darken urine.

Renal impairment: The elimination half-life of Filmet remains unchanged in the presence of renal failure. The dosage of Filmet therefore needs no reduction. Such patients however retain the metabolites of Filmet. The clinical significance of this is not known at present. In patients undergoing haemodialysis Filmet and metabolites are efficiently removed during an eight hour period of dialysis. Filmet should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Filmet need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).

Overdose Effects

Single oral doses of Filmet, 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 Filmet overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.

Therapeutic Class

Amoebicides, Anti-diarrhoeal Antiprotozoal

Storage Conditions

Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.

Common Questions about Filmet 400 mg Tablet

What is Filmet 400 mg Tablet?

Filmet 400 mg Tablet is an antibiotic medication that performs its action by preventing the growth of bacterias and parasites.

What are the uses of Filmet 400 mg Tablet?

Filmet 400 mg Tablet is used for the treatment and prevention from viral and parasitic infections. It also prevents bacterial infections such as cold, cough, flu and vaginal infections. It also controls liver, skin, joints, brain and respiratory tract infections.

What are the side effects of Filmet 400 mg Tablet?

Some side effects of Filmet 400 mg Tablet which are diarrhoea, headache, weakness, painful urination, trouble sleeping, numbness, muscle weakness and mouth ulcer.

How long do I need to use Filmet 400 mg Tablet before I see improvement of my conditions?

Filmet 400 mg Tablet takes 1 or 2 days before you see an improvement in your health conditions.

What are the contraindications to Filmet 400 mg Tablet?

Filmet 400 mg Tablet should not be used if you have the following conditions such as hives, flushing, nasal congestion, dryness of the mouth, fever, etc.

Is Filmet 400 mg Tablet safe to use when pregnant?

Filmet 400 mg Tablet is not recommended for use in pregnant women unless absolutely necessary.

Will Filmet 400 mg Tablet be more effective if taken in more than the recommended dose?

No, taking higher than the recommended dose of Filmet 400 mg Tablet lead to increased chances of side effects such as diarrhoea, excessive production of urine, headache, nausea, pain in the upper part of the stomach, painful and difficult urination, serious eating disorder (anorexia), etc.

Quick Tips

Filmet 400 mg Tablet treats infections caused by bacteria and parasites.

Filmet 400 mg Tablet may cause side effects like nausea, stomach upset, and a metallic taste in the mouth.

Filmet 400 mg Tablet used in a high dose or for a prolonged time increases the risk of side effects such as nerve damage. Take it only as prescribed by your doctor.

Do not drink alcohol during or for 2-3 days after treatment with this medicine. You may develop nausea, vomiting, flushing and headache.

Inform your doctor if you have liver disease. Your dose may need to be adjusted in severe liver disease.

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