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Name Flagentyl 500 mg Secnidazole Composition Each film-coated tablet contains as active ingredient: secnidazole 500 mg Excipients: Calcium hydrogen phosphate, microcrystalline cellulose, wheat starch, hydrated silica, sodium starch glycolate, gelatin, magnesium stearate, hypromellose. Therapeutic indications Antiamoebic & antiprotozoal - Urethritis and vaginitis caused by Trichomonas vaginalis - Intestinal amoebiasis - Hepatic amoebiasis - Giardiasis Dosage and administration Urethritis and vaginitis caused by Trichomonas vaginalis: - Adults: 2 g in a single dose before meals. Intestinal amoebiasis: Acute, symptomatic amoebiasis (histolytica form): - Adults: 2 g in a single dose before meals. - Children: 30 mg/kg/day in a single dose in a single day. Asymptomatic amoebiasis (minuta and cystica forms): same daily dose for 3 days. Hepatic amoebiasis: - Adults: 1.5 g per day in one or more doses before meals, for 5 days. - Children: 30 mg/kg/day in one or more doses before meals, for 5 days. In the suppurative phase of hepatic amoebiasis, combine secnidazole treatment and removal of pus or lancing of abscesses Giardiasis: - Children: 30 mg/kg/day in a single dose in a single day. Route of administration Oral route. Contraindications - Hypersensitivity to imidazole derivatives. - Pregnant and breastfeeding women (see Pregnancy and Lactation). Warnings and special precautions - Alcoholic drinks should be avoided during secnidazole treatment. - Do not administer to subjects with a history of blood dyscrasia. Drug and other interactions Contraindicated combination therapy: - Disulfiram: Delirious episodes, confusion. - Alcohol: Hotness, redness, vomiting, tachycardia. Avoid alcoholic drinks and alcohol-containing medicine. Combinations subject to precautions: - Oral anticoagulants (warfarin): Potentiation of the oral anticoagulant and increased risk of hemorrhage by lowering of its hepatic catabolism. More frequent determination of the prothrombin time and monitoring of the INR. Adjustment of the oral anticoagulant dose during secnidazole treatment and 8 days after its withdrawal. Pregnancy and lactation Pregnancy: No teratogenic effects are observed during animal experimentation. However, in view of the absence of data in humans, it is not recommended to take secnidazole during pregnancy. Lactation: Secnidazole is excreted in breast milk. Effect ability to drive/operate machine Effects on the ability to drive vehicles and operate machinery: Rare cases of dizziness have been reported with imidazole derivatives. Undesirable effects The following undesirable effects seen with imidazole derivatives may occur: - Most frequently: digestives disorders, with abdominal pain, change in taste (metallic), glossitis, stomatitis. - Urticaria. - Moderate leucopenia, reversible upon withdrawal of treatment. - Rarely dizziness, lack of coordination and ataxia, paresthesia, sensitive and motor polyneuritis. - Rare cases of digestive disorders have been reported (nausea, vomiting, gastric pain). Pharmacological Properties Antiparasitic Tissular Amoebicide - Contact Amoebicide Pharmacodynamic properties Synthetic derivative of the nitro-imidazole series. Essentially tissular amoebicide. Active against Entamoeba histolytica and Giardia lamblia. Pharmacokinetic properties The peak serum concentration is reached 3 hours after oral administration of 2 g of secnidazole in the form of 500 mg tablets. The plasma half-life is about 25 hours. Elimination is essentially in the urine and is slow (approximately 50% of the dose ingested is excreted in 120 hours). Secnidazole crosses the placenta and is excreted in breast milk. Storage Store below 25 C. Keep all medicines out of reach of children. Expiry date Do not use later than the expiry date printed on the package. Presentation Box of 4 film-coated tablets. Company Produced by sanofi-aventis Egypt s.a.e. Under license of: sanofi-aventis / France