Indications of Amodis 400 mg

Amodis 400 mg 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. ... Read moreAmodis 400 mg 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. In the treatment of urogenital trichomoniasis. Bacterial vaginosis (also known as non-specific vaginitis). All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers). Giardiasis. Acute ulcerative gingivitis. Anaerobically infected leg ulcers and pressure sores. Acute dental infections due to anaerobic organisms. Antibiotic associated pseudomembranus colitis.

Theropeutic Class

Amoebicides, Anti-diarrhoeal Antiprotozoal

Pharmacology

Amodis 400 mg is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Amodis 400 mg is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Amodis 400 mg.

Dosage and Administration of Amodis 400 mg

Tablet and Suspension: Trichomoniasis (Adults and 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 and 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 and Asymptomatic amoebiasis (Adults and Children over 10 yrs)- 400-800 mg tid for 5-10 days Extra-intestinal and 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 and 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 and 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 and Children over 10 yrs)- 200 mg tid for 3-7 days Bacterial Vaginosis (Adults and 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 and Children over 10 yrs)- 400 mg tid for 7 days Anaerobic infections (Adults and 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 and 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 Amodis 400 mg gel (approximately 5 grams containing approximately 37.5 mg of Amodis 400 mg) intravaginally once or twice a day for 5 days. For once a day dosing, Amodis 400 mg 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: Amodis 400 mg 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.

Dosage of Amodis 400 mg

Tablet and Suspension: Trichomoniasis (Adults and 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 and 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 and Asymptomatic amoebiasis (Adults and Children over 10 yrs)- 400-800 mg tid for 5-10 days Extra-intestinal and 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 and 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 and 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 and Children over 10 yrs)- 200 mg tid for 3-7 days Bacterial Vaginosis (Adults and 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 and Children over 10 yrs)- 400 mg tid for 7 days Anaerobic infections (Adults and 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 and 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 Amodis 400 mg gel (approximately 5 grams containing approximately 37.5 mg of Amodis 400 mg) intravaginally once or twice a day for 5 days. For once a day dosing, Amodis 400 mg 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: Amodis 400 mg 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.

Interaction of Amodis 400 mg

Disulfiram: Psychotic reactions have been reported in patients who were using Amodis 400 mg 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 Amodis 400 mg. Lithium: Plasma levels of lithium may be increased by Amodis 400 mg. Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary. Phenytoin or phenobarbital: increased elimination of Amodis 400 mg 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 Amodis 400 mg, which may lead to severe busulfan toxicity.

Contraindications

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

Side Effects of Amodis 400 mg

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

Pregnancy and Lactation

US FDA Pregnancy Category of Amodis 400 mg 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. Amodis 400 mg have been shown to be excreted in human milk. So, caution should be exercised when Amodis 400 mg is administered to a nursing woman.

Precautions and Warnings

If for compelling reasons, Amodis 400 mg 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). Amodis 400 mg should be administered with caution to patients with hepatic encephalopathy. Patients should be warned that Amodis 400 mg may darken urine.

Overdose Effects of Amodis 400 mg

Single oral doses of Amodis 400 mg, 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 Amodis 400 mg overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.

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.

Drug Classes

Amoebicides, Anti-diarrhoeal Antiprotozoal

Mode Of Action

Amodis 400 mg is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Amodis 400 mg is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Amodis 400 mg.

Pregnancy

US FDA Pregnancy Category of Amodis 400 mg 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. Amodis 400 mg have been shown to be excreted in human milk. So, caution should be exercised when Amodis 400 mg is administered to a nursing woman.

Pediatric Uses

Hepatic impairment: Amodis 400 mg is mainly metabolised by hepatic oxidation. Substantial impairment of Amodis 400 mg 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 Amodis 400 mg may contribute to the symptoms of the encephalopathy. Amodis 400 mg 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 Amodis 400 mg may darken urine.Renal impairment: The elimination half-life of Amodis 400 mg remains unchanged in the presence of renal failure. The dosage of Amodis 400 mg therefore needs no reduction. Such patients however retain the metabolites of Amodis 400 mg. The clinical significance of this is not known at present. In patients undergoing haemodialysis Amodis 400 mg and metabolites are efficiently removed during an eight hour period of dialysis. Amodis 400 mg should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Amodis 400 mg need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).

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