Opinidazole 1000 mg
DESCRIPTION
Opinidazole is the trade name of secnidazole, a nitro-imidazole antiprotozoal agent.
Opinidazole 1000 is a parasiticidal drug, and a tissue- and contact-amoebicidal agent.
Each film-coated Opinidazole Tablet contains 1000 mg secnidazole.
CHEMISTRY
secnidazole is: 1-(2-methyl-5-nitroimidazol-l-yl)propan-2-ol.
CLINICAL PHARMACOLOGY
secnidazole is a nitro-imidazole structurally similar to metronidazole. secnidazole enters the microorganism by passive diffusion and undergoes activation by reduction of the 5-nitro group. Reduced secnidazole interacts with DNA to cause a loss in helical structure, strand breakage, and resultant inhibition in nucleic acid synthesis and cell death. Opinidazole has a selective toxicity against anaerobic microorganisms. secnidazole has a mean absolute bioavailability of 100% after oral administration. The half life of secnidazole is about 25 hours, which allows for easy dosage regimens with secnidazole.
INDICATIONS
- Urethritis and vaginitis caused by Trichomonas vaginalis.
- Intestinal amoebiasis caused by Entamoeba histolytica.
- Hepatic amoebiasis caused by Entamoeba histolytica.
- Giardiasis caused by Giardia lamblia.
USE IN PREGNANCY
There are no adequate or well controlled studies in humans. In animals, no teratogenic effects have been demonstrated with secnidazole. However, secnidazole is distributed to the placenta, and because animal findings do not necessarily correlate with human findings, the use of secnidazole is contraindicated in pregnant women.
USE IN LACTATION
secnidazole is excreted in breast milk, and its use is contraindicated in lactation.
INTERFERENCE WTH CLINICAL AND LABORATORY TESTS
Not documented.
DOSAGE
ADVERSE EFFECTS
DRUG INTERACTIONS
CONTRAINDICATIONS
WARNINGS
OVERDOSE
PRECAUTIONS
HOW SUPPLIED
DOSAGE
Usual adult dose:
-Urethritis and vaginitis caused by Trichomonas vaginalis: 2 Opinidazole Tablets (2 gm/day)as a single Intake at the beginning of a meal. -Intestinal amebiasis: * Symptomatic acute amoebiasis caused by Entamoeba histolytica: 2 Opinidazole Tablets(2 gm/day) as a single Intake at the beginning of a meal. *Asymptomatic amoebiasis, including focal and cystic forms: 2 Opinidazole Tablets(2 gm/day) as a single daily dose, at the beginning of meals for 3 days. -Hepatic amoebiasis: 2 Opinidazole Tablets daily(2 gm/day), given in a single daily dose or in divided doses, at the beginning of meals for 5 days. - Giardiasis: 2 Opinidazole Tablets(2 gm/day), one time for one day. Usual pediatric dose ( > 3 years old): -Intestinal amoebiasis: *Symptomatic acute amoebiasis caused by Entamoeba histolytica: 30 mg/kg/day in a single intake, administrated for one day. *Asymptomatic amoebiasis, including focal and cystic forms: 30 mg/kg/day as a single daily dose, for 3 days. -Hepatic amoebiasis: 30 mg/kg/day in a single daily dose or in divided doses, at the beginning of meals for 5 days. -Giardiasis: 30 mg/kg/day in a single intake, administrated for one day. Note:In the suppurative phase of hepatic amoebiasis, in conjunction with Opinidazole treatment, pus and abscess must be evacuated.ADVERSE EFFECTS
The adverse effects for imidazole derivatives in general include the following: More frequent effects: gastrointestinal disturbances with nausea, gastralgia, taste modification (metallic), glossitis or stomatitis. Less frequent effects: urticarial eruptions and moderate reversible leukopenia. However, with secnidazole, the only effects reported up to date include rare cases of gastrointestinal disturbances (nausea, vomiting, gastralgia).DRUG INTERACTIONS
Disulfiram: hot flushes and a state of confusion may result from concomitant administration with secnidazole. Concomitant use is not advisable. - Alcohol: an antabuse effect may be provoked (pyrexia, flushing, vomiting, tachycardia). Patients should avoid alcoholic drinks and medications containing alcohol while using secnidazole. - Oral anticoagulants: secnidazole may potentiate oral anticoagulants, particularly warfarin, via reducing its hepatic catabolism, thus increasing the risk of bleeding. Prothrombin ratio and International Normalization Ratio (INR) should be closely monitored during concomitant treatment. Oral anticoagulant dose should be adjusted during secnidazole treatment and 8 days after its cessation.CONTRAINDICATIONS
Hypersensitivity to secnidazole or other imidazole derivatives, Pregnancy and Lactation.WARNINGS
secnidazole treatment should be avoided in patients with history of blood dyscrasias.OVERDOSE
Limited information is available on the acute toxicity of secnidazole in humans.PRECAUTIONS
There have been rare reports of vertigo with imidazole derivatives. Accordingly, caution should be exercised when driving or operating machinery while using secnidazole.HOW SUPPLIED
- Carton box containing F.C. tablets in PVC-Al. blisters as:
- ( 2 x 1 ) ( 2 x 2 ) ( 2 x 3) + pamphlet
- ( 4 x 1 ) ( 4 x 2 ) ( 4 x 3) + pamphlet
- ( 8 x 1 ) ( 8 x 2 ) ( 8 x 3) + pamphlet
- Hospital packs of different presentations.
