Ami

Uses

Ami is used for Intestinal Amoebiasis, Hepatic Amoebiasis, Urethritis and Vaginitis due to Trichomonas vaginalis, Giardiasis

Ami is also used to associated treatment for these conditions: Bacterial Vaginosis (BV), Candidiasis, Trichomonas Vaginitis, Trichomoniasis

How Ami works

Ami enters the bacterial cell as a prodrug without an antimicrobial activity. The drug is converted to an active form via reduction of nitro groups to radical anions by bacterial enzymes. The radical anions are thought to interfere with bacterial DNA synthesis of susceptible isolates .

Dosage

Ami dosage

Ami tablet should be administered orally. The dosage schedule of Ami tablet is mentioned below:

Ami Tablet:

Amoebiasis:Acute intestinal amoebiasis:

• Adults: 2 gm single dose (2x1000 mg tablet), taken preferably just before meal.
• Children: 30 mg/kg single dose, taken preferably just before meal.

Asymptomatic amoebiasis (minute & cystic form):

• Adults: 2 gm once daily (2x1000 mg tablet) for only 3 days, taken preferably just before meal.
• Children: 30 mg/kg once daily for only 3 days, taken preferably just before meal.

Hepatic amoebiasis :

• Adults: 1.50 gm/day, in a single or divided dose, just before meal for 5 days.
• Children: 30 mg/kg/day, in a single or divided dose, just before meal for 5 days.

N.B.: Evacuation of pus must be performed simultaneously with Ami treatment at the suppurative stage of hepatic amoebiasis.Giardiasis :

• Adults: 2 gm single dose (2x1000 mg tablet), taken preferably just before meal.
• Children: 35-50 mg/kg single dose, taken preferably just before meal.

Trichomoniasis :

• Adults: 2 gm single dose (2x1000 mg tablet), taken preferably just before meal.
• Children: 30 mg/kg single dose, taken preferably just before meal. The partner should also receive the same treatment concomitantly.

Ami Suspension:

Suspension should be administered orally. The dosage schedule of Ami suspension is mentioned below:

• Children of 10 to 15 kg body weight: 1 bottle of Ami 500 mg suspension.
• Children of 16 to 25 kg body weight: 1½ bottle of Ami 500 mg suspension.
• Children of 26 kg or more body weight: 2 bottles of Ami 500 mg suspension.

Side Effects

The clinical studies have shown that secnidazole is characterized by very good tolerance and no serious adverse reactions have been reported to date. The following side-effects may be observed with secnidazole as with all nitroimidazole derivatives & are rarely serious

Most frequent side-effects: Gastrointestinal disturbances, nausea, epigastric pain, metallic taste, glossitis, and stomatitis.

Occasional side-effects: Urticaria, moderate leukopenia which is reversible on treatment discontinuation.

Rare side-effects: Vertigo, ataxia and motor incoordination, paresthesia, and peripheral neuropathy. With secnidazole, gastrointestinal disorders e.g. nausea, vomiting, epigastric pain, etc. have been reported in very rare cases.

Toxicity

Oral LD50 in mouse, rabbit and rat is 300 mg/kg, 3200 mg/kg and 980 mg/kg, in a respective order . Ami was positive in the Bacterial Reverse Mutation Assay, but was negative for the rat micronucleus test and mouse lymphoma test. No parental toxicity or signs of reproductive toxicity were observed in female rat fertility studies at doses of up to the maximum tolerated dose of 300 mg/kg/day .

Precaution

Patients should be advised not to take alcohol during treatment with secnidazole (because of possibility of antabuse effect). Administration of secnidazole should be avoided to patients with a history of blood dyscrasia.

Interaction

Administration of secnidazole with disulfiram is not recommended: confusional state & paranoid reaction may occur.

Use of secnidazole simultaneously with warfarin requires close monitoring: increased effect of oral anticoagulants and of the hemorrhagic risk is likely.

Food Interaction

• Take with or without food. Sprinkle onto applesauce, yogurt, or pudding and ingest without crushing the granules.

Ami Drug Interaction

Unknown: amoxicillin, amoxicillin / clavulanate, caffeine / ergotamine, calcium / vitamin d, diclofenac, ciprofloxacin, sulfamethoxazole / trimethoprim, artemether / lumefantrine, ubiquinone, pyrimethamine / sulfadoxine, glipizide, magaldrate / simethicone, sodium chloride, acetaminophen, ceftriaxone, sulfamethoxazole / trimethoprim, potassium chloride, multivitamin, ascorbic acid, zinc sulfate

Ami Disease Interaction

Moderate: alcoholism

Volume of Distribution

The apparent volume of distribution of secnidazole is approximately 42-49 L .

Elimination Route

Ami is rapidly and completely absorbed after oral administration . Following a single oral dose of 2 g in healthy adult female subjects, the mean (SD) secnidazole peak plasma concentration (Cmax) of 45.4 (7.64) mcg/mL and mean (SD) systemic exposure (AUC0-inf) of 1331.6 (230.16) mcg x hr/mL was reached. Median (range) time to peak concentration (Tmax) was 4.0 (3.0-4.0) hours .

Half Life

The plasma elimination half-life for secnidazole is approximately 17 hours .

Clearance

The total body clearance of secnidazole is approximately 25 mL/min. The renal clearance of secnidazole is approximately 3.9 mL/min .

Elimination Route

The predominant route of elimination is renal elimination. Following a single oral dose of 2g secnidazole, approximately 15% of the drug is excreted as unchanged compoung in the urine .

Pregnancy & Breastfeeding use

Ami may be prescribed in pregnancy after the first trimester. As with other similar drugs, secnidazole should not be administered during the first trimester of pregnancy or during lactation because secnidazole is found in placenta and breast milk.

Contraindication

Ami is contraindicated for those patients who are hypersensitive to imidazole derivatives.

Storage Condition

Store in a cool dry place, protected from heat.

Innovators Monograph

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