Indications of Pronil DS 1 gm
Pronil DS 1 gm is indicated in-
Intestinal Amoebiasis
Hepatic Amoebiasis
Urethritis and vaginitis due to Trichomonas vaginalis
Giardiasis
Theropeutic Class
Amoebicides, Anti-diarrhoeal Antiprotozoal
Pharmacology
Pronil DS 1 gm is the first nitroimidazole to offer a 3 day antiprotozoal activity from one single dose. With its prolonged half life, Pronil DS 1 gm offers an effective treatment and thus ensures improved patient compliance because of the short duration of treatment with excellent therapeutic efficacy.Pronil DS 1 gm exhibits activity against anaerobic protozoa Entamoeba histolytica, Giardia lamblia and Trichomonas vaginalis. Pronil DS 1 gm is rapidly absorbed following oral administration. The maximum serum level is obtained after 3 hours following oral administration of 2 gm Pronil DS 1 gm.The plasma elimination half life is about 20 hours. The majority of Pronil DS 1 gm is eliminated via urine (50% of the ingested dose is excreted within 120 hours). The pharmacokinetic profile of Pronil DS 1 gm gives it the longest half-life of all the second generation nitroimidazoles, ensuring 72-hour therapeutic blood levels from a 2 gm single dose.
Dosage & Administration of Pronil DS 1 gm
Pronil DS 1 gm tablet should be administered orally. The dosage schedule of Pronil DS 1 gm tablet is mentioned below:
Pronil DS 1 gm 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 Pronil DS 1 gm 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.
Pronil DS 1 gm Suspension:
Suspension should be administered orally. The dosage schedule of Pronil DS 1 gm suspension is mentioned below:
Children of 10 to 15 kg body weight: 1 bottle of Pronil DS 1 gm 500 mg suspension.
Children of 16 to 25 kg body weight: 1½ bottle of Pronil DS 1 gm 500 mg suspension.
Children of 26 kg or more body weight: 2 bottles of Pronil DS 1 gm 500 mg suspension.
Dosage of Pronil DS 1 gm
Pronil DS 1 gm 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 Pronil DS 1 gm 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.
Interaction of Pronil DS 1 gm
Administration of Pronil DS 1 gm with disulfiram is not recommended: confusional state & paranoid reaction may occur. Use of Pronil DS 1 gm simultaneously with warfarin requires close monitoring: increased effect or oral anticoagulants and of the hemormagic risk is likely.
Contraindications
Pronil DS 1 gm is contra-indicated for those patients who are hypersensitive to imidazole derivatives.
Side Effects of Pronil DS 1 gm
The clinical studies have shown that Pronil DS 1 gm 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 1 gm 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 1 gm, gastrointestinal disorders e.g. nausea, vomiting, eoigastric pain, etc., have been reported in very rare cases.
Pregnancy & Lactation
Pronil DS 1 gm may be prescribed in pregnancy after the first trimester. As with other similar drugs, Pronil DS 1 gm should not be administered during the first trimester of pregnancy or during lactation because Pronil DS 1 gm is found in placenta and breast milk.
Precautions & Warnings
Patients should be advised not to take alcohol during treatment with Pronil DS 1 gm (because of the possibility of antabuse effect). Administration of Pronil DS 1 gmshould be avoided to patients with a history of blood dyscrasia.
Storage Conditions
Store in a cool, dry place,protected from heat.
Drug Classes
Amoebicides, Anti-diarrhoeal Antiprotozoal
Mode Of Action
Pronil DS 1 gm is rapidly absorbed following oral administration. The maximum serum level is obtained after 3 hours following oral administration of 2 gm Pronil DS 1 gm. The plasma elimination half-life is about 20 hours. The majority of Pronil DS 1 gm is eliminated via urine (50% of the ingested dose is excreted within 120 hours). The pharmacokinetic profile of Pronil DS 1 gm gives it the longest half-life of second-generation nitroimidazoles, ensuring 72-hour therapeutic blood levels from a 2 gm single dose.
Pregnancy
Pronil DS 1 gm may be prescribed in pregnancy after the first trimester. As with other similar drugs, Pronil DS 1 gm should not be administered during the first trimester of pregnancy or during lactation because Pronil DS 1 gmis found in the placenta and breast milk.