Category: Tablets
Classification:Amebicide & Antibiotic
Product English Name: MEDZOL FORTE-1000
Product Arabic Name: ميدزول فورت-1000
Scientific Name English: Secnidazole
Scientific Name Arabic: سيكنيدازول
Product Unit: 2 tablets
Product Strength: 1000 mg/Tablet
Mechanism of Action
Secnidazole is a nitroimidazole derivative, 5-nitroimidazoles, enters the bacterial and/or protozoal cells where the nitro group is reduced by nitroreductase enzyme(s) leading to the production of radical anions and a series of intermediates, depletion of thiols, DNA damage, and death of susceptible isolates of Gram positive bacteria, Gram negative bacteria, and T. vaginalis and other protozoa.
| Composition | Each film coated tablet contains: Secnidazole 1000mg |
|---|---|
| Pharmacodynamics | Secnidazole share miscellaneous actions as an antimicrobial and antiprotozoal. As antibacterial secnidazole is active in vitro against most isolates of the following organisms reported to be associated with bacterial vaginosis: Bacteroides spp., Gardnrella vaginalis, Prevotella spp., Mobiluncus spp., Megasphaera-like type I/II, and as anti-protozoal activity, amebicidal effect on entamoeba histolytica. It is also active against Giardia lamblia and Trichomonas vaginalis. |
| Pharmacokinetics | Absorption: After oral administration of 2 g secnidazole, the peak plasma concentration of about 41.2mcg/mL is reached within 3 to 4 hours in fasted state. Distribution: The apparent volume of distribution of secnidazole is approximately 42 L, and the plasma protein binding of secnidazole is <5%. Metabolism: Secnidazole is metabolized in vitro via oxidation by human hepatic CYP450 enzyme system with ≤1% conversion to metabolites. Elimination and excretion: The total body clearance of secnidazole is approximately 25mL/min. The renal clearance of secnidazole is approximately 3.9mL/min, and the plasma elimination half-life for secnidazole is approximately 17 hours, and 15% of a 2 g oral dose of secnidazole is excreted unchanged in the urine. |
| Indications and Dosage | Urethritis and Vaginitis: Bacterial Vaginosis (female patients 12 years of age and older): Adults: 2 g taken as a single dose at the beginning of a meal. Trichomoniasis (patients 12 years of age and older): Adults: 2 g taken as a single dose at the beginning of a meal. Note: Treat sexual partners with the same dose and at the same time. Intestinal Amebiasis: Symptomatic acute amebiasis (E.histolytica form) Adults: 2 g taken as a single dose at the beginning of a meal. Children: 30mg/kg/day taken as a single dose duration of treatment for one day. Asymptomatic amebiasis (minuta and cyst forms): Same daily dose of acute ambeasis for 3 days. Hepatic amebiasis: Adults: 1.5 g daily taken as one or several doses at the beginning of a meal for 5 days. Children: 30 mg/kg/day taken as one or several doses at the beginning of a meal for 5 days. Note: During the suppurative phase of hepatic amebiasis, pus or abscess drainage should be carried out as the same time as secnidazole administration. Giardiasis: Adults: 2g taken as a single dose. Children: 30 mg/kg/day taken as a single dose for one day only. The oral solution is recommended for children aged under 6 years. |
| Contraindications | – History of hypersensitivity to secnidazole, or other nitroimidazole derivatives. – Patients who use cocaine. |
| Warnings and Precautions | Vulvo vaginal candidiasis: This may develop with Secnidazole and require treatment with an antifungal agent. Adverse reactions: – Rare gastrointestinal disorders (nausea, vomiting, gastric pain). – Rare immediate hypersensitivity reactions: fever, erythema, urticaria, and angioedema. |
| Drug Interactions | Oral anticoagulants like warfarin: such concomitant administration may potentiate the oral anticoagulant effect, with increased risk of bleeding, due to decreased hepatic catabolism. Prothrombin times should be checked more frequently and the International Normalized Ratio must be monitored. Oral anticoagulant dosage should be adjusted during treatment with secnidazole and for 8 days after its discontinuation. |
| Use in Specific Populations | Pregnancy: There are currently not enough relevant clinical data to evaluate possible teratogenic or ferotoxic effects of secnidazole when administered during pregnancy. Therefore, as a precautionary measure, secnidazole should preferably not be used during pregnancy. Lactation: Breastfeeding is not recommended. Discontinue breastfeeding for 96 hours after administration of secnidazole. |
| Storage Conditions | Store below 30°C. |
| Pack Size | 1 blister (Alu / PVC), contains 2 tablets. |
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