Amobin 400 mg Tablet

Indications

Amobin 400 mg is indicated in the treatment of the following diseases:

• The prevention of post-operative infections due to anaerobic bacteria (particularly species of Bacteroides and anaerobic streptococci).
• The treatment of septicemia, bacteremia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis, and postoperative wound infections caused by anaerobes.
• In the treatment of urogenital trichomoniasis.
• Bacterial vaginosis (also known as non-specific vaginitis).
• All forms of amoebiasis (intestinal, extra-intestinal disease, and symptomless cyst passers).
• Giardiasis.
• Acute ulcerative gingivitis.
• Anaerobically infected leg ulcers and pressure sores.
• Acute dental infections due to anaerobic organisms.
• Antibiotic-associated pseudomembranous colitis.

Pharmacology

Amobin 400 is a member of the imidazole class of antibacterial drugs 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 Amobin.

Amobin Tablet Price In Bangladesh

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 day

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 day

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-hour 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 Amobin 400 mg and disulfiram concurrently.
• Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterward 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 the case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
• Lithium: Plasma levels of lithium may be increased by metronidazole.
• Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration 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.

Contraindications

Amobin 400 is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.

Side Effects

Metallic taste, nausea, vomiting, diarrhea, drowsiness, and 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 on pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Amobin has 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, 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).
• Metronidazole should be administered with caution to patients with hepatic encephalopathy.
• Patients should be warned that metronidazole may darken the urine.

Use in Special Populations

Hepatic impairment: Metronidazole is mainly metabolized by hepatic oxidation. Substantial impairment of metronidazole 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 metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole 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 metronidazole may darken the urine.

Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole, therefore, needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing hemodialysis metronidazole and metabolites are efficiently removed during an eight-hour period of dialysis. Metronidazole should therefore be re-administered immediately after hemodialysis. No routine adjustment in the dosage of Metronidazole 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 Amobin 400, 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 overdosages. In case of suspected massive overdosages, 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 it later than the date of expiry.