Amodis Tablet 400 mg (1 Strip=10 Pieces)
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Indications
Amodis 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.
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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 Amodis 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.
- Lithium: Plasma levels of lithium may be increased by Amodis.
- Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
- Phenytoin or phenobarbital: increased elimination of Amodis 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, 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, Amodis 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 should be administered with caution to patients with hepatic encephalopathy.
- Patients should be warned that Amodis may darken urine.
Use in Special Populations
Hepatic impairment: Amodis is mainly metabolised by hepatic oxidation. Substantial impairment of Amodis 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 may contribute to the symptoms of the encephalopathy. Amodis 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 may darken urine.
Renal impairment: The elimination half-life of Amodis remains unchanged in the presence of renal failure. The dosage of Amodis therefore needs no reduction. Such patients however retain the metabolites of Amodis. The clinical significance of this is not known at present. In patients undergoing haemodialysis Amodis and metabolites are efficiently removed during an eight hour period of dialysis. Amodis should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Amodis 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 Amodis, 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 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 Amodis 400 mg Tablet
What is Amodis 400 mg Tablet?
Amodis 400 mg Tablet is an antibiotic medication that performs its action by preventing the growth of bacterias and parasites.
What are the uses of Amodis 400 mg Tablet?
Amodis 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 Amodis 400 mg Tablet?
Some side effects of Amodis 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 Amodis 400 mg Tablet before I see improvement of my conditions?
Amodis 400 mg Tablet takes 1 or 2 days before you see an improvement in your health conditions.
What are the contraindications to Amodis 400 mg Tablet?
Amodis 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 Amodis 400 mg Tablet safe to use when pregnant?
Amodis 400 mg Tablet is not recommended for use in pregnant women unless absolutely necessary.
Will Amodis 400 mg Tablet be more effective if taken in more than the recommended dose?
No, taking higher than the recommended dose of Amodis 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
- Amodis 400 mg Tablet treats infections caused by bacteria and parasites.
- Amodis 400 mg Tablet may cause side effects like nausea, stomach upset, and a metallic taste in the mouth.
- Amodis 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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