Country: Armenia
Bahasa: Inggeris
Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
metronidazole
Hankook Korus Pharm Co.
J01XD01
metronidazole
500mg
tablets
(30/3x10/) in blister
Prescription
Registered
2020-04-15
& 120*256 DIC 433p Store in hermetic container at temperature below 25℃. Protect from moisture. Keep out of reach of children. Known hypersensitivity to nitroimidazoles, metronidazole or to any of the excipients. • Pregnancy - metronidazole should not be used in the first trimester in patients with trichomoniasis or bacterial vaginosis. • Breast feeding should be discontinued for 12-24 hours when single high dose (e.g. 2g) therapy is used. Frequency type and severity of adverse reactions in children are the same as in adults. The frequency of adverse events listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data). Serious adverse reactions occur rarely with standard recommended regimens. Frequency, type and severity of adverse reactions in children are the same as in adults. Clinicians who contemplate continuous therapy for the relief of chronic conditions, for periods longer than those recommended, are advised to consider the possible therapeutic benefit against the risk of peripheral neuropathy. Interactions to be used with caution: • _Lithium:_ Lithium retention accompanied by evidence of possible renal damage has been reported in patients treated simultaneously with lithium and metronidazole. Lithium treatment should be tapered or withdrawn before administering metronidazole. Plasma concentration of lithium, creatinine, and electrolytes should be monitored in patients under treatment with lithium while they receive metronidazole. • _Anticoagulants: _ Some potentiation of anticoagulant therapy has been reported when metronidazole has been used with the warfarin type oral anticoagulants. Dosage of the latter may require reducing. Prothrombin times should be monitored. No interactions have been reported with anticoagulants of the heparin type. However, anticoagulant activity should be routinely monitored Baca dokumen lengkap
Summary of Product Characteristics 1. NAME OF THE MEDICINAL PRODUCT Metronidazole-Asteria Tab. 500mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient No. Chemical Name Quantity/g Use 1 Metronidazole 500mg Active ingredient Excipient(s) No. Chemical Name Quantity/Tab. Use 1 Magnesium stearate 5.0mg Lubricant 2 Sodium carboxylmethylstarch 5.0mg Disintegrant 3 20% starch dextrin 36mg Adherent 4 Pregelatinized starch 20 mg Diluent/Dinste grant 3. PHARMACEUTICAL FORM Tablets 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Symptomatic Trichomoniasis: Metronidazole is indicated for the treatment of symptomatic trichomoniasis in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis: Metronidazole is indicated in the treatment of asymptomatic females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Consorts: T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in the order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her consort is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the consort should be treated with Metronidazole in cases of reinfection. Amebiasis: Metronidazole is indicated in the Baca dokumen lengkap