Pronil DS Tablet

Pronil DS is indicated in-

• Intestinal Amoebiasis
• Hepatic Amoebiasis
• Urethritis and vaginitis due to Trichomonas vaginalis
• Giardiasis

Secnidazole is rapidly absorbed following oral administration. The maximum serum level is obtained after 3 hours following oral administration of 2 gm Secnidazole. The plasma elimination half-life is about 20 hours. The majority of Secnidazole is eliminated via urine (50% of the ingested dose is excreted within 120 hours). The pharmacokinetic profile of Secnidazole gives it the longest half-life of second-generation nitroimidazoles, ensuring 72-hour therapeutic blood levels from a 2 gm single dose.

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

Acute Intestinal Amoebiasis:

• Adults: 2 gm single dose, 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 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: Evacuation of pus must be performed simultaneously with Secnidazole treatment at the suppurative stage of hepatic amoebiasis.

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

Giardiasis:

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

Trichomoniasis:

• Adults: 2 gm single dose, taken preferably just before meal. The partner should also receive the same treatment concomitantly.

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

Use of Pronil DS simultaneously with warfarin requires close monitoring: increased effect or oral anticoagulants and of the hemormagic risk is likely.

Secnidazole is contra-indicated for those patients who are hypersensitive to imidazole derivatives.

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

• Most frequent side-effects: Gastrointestinal disturbances, nausea, epigastric pain, metallic taste, glossitis, stomatitis.
• Occasional side effects: Urticaria, moderate leukopenia which is reversible on treatment discontinuation.
• Rare side-effects: Vertigo, ataxia and motor incoordination, paresthesia, peripheral neuropathy. With Pronil DS, gastrointestinal disorders e.g. nausea, vomiting, eoigastric pain, etc., have been reported in very rare cases.

Secnidazole 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 Secnidazoleis found in the placenta and breast milk.

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

Amoebicides, Anti-diarrhoeal Antiprotozoal

Store in a cool, dry place,protected from heat.