Gynecological Medicine - Secnidazole Capsules (FS01-A027FC)

Product Description

ITEM NO.: FS01-A027FC

[DRUG NAME]generic name: Secnidazole Capsule

[INDICATIONS]It is indicated for the treatment of the following infections canused by anaerobic organisms and ectosarc such as all kinds of amebiasis, giardiasis, richomoniasis and bacterial vaginitis.
1. Urethritis and vaginitis caused by trichomonas vaginalis;
2. Intestinal amebiasis, hepatic amebiasis;
3. Giardiasis;
4. Therapy and precaution of anaerobic infection, treatment of oral cavity, lung and gynecological infections; The prevention of anaerobic infections after operations on abdominal regions including colon, gastrointestinal tract, women genitourinary system.

[INGREDIENTS]The main composition is secnidazole.

[DESCRIPTION Off-white or yellowish powder in hard capsules.

[PHARMACOKINETICS]Absorption: Secnidazole was absorbed quickly after oral administration and peak concentrations were achieved within 1.5-3 hours. Absolute bioavailability was near 100% when a single dose of 0.5-2g secnidazole was taken orally. In the range of the application dose, the dose was in direct ratio with peak plasma concertration(Cmax)and plasma drug concertration-timetable area under the curve(AUC).
Distribution: Secnidazole was not widely distributed in vivo. Steady state volume(49.2L)was very small and only 15% total plasma blood dosage was combined with plasma protein or globulin. Serum drug concentration was similar to that in gingival crevice secretion, thus this product can easily infiltrates into gingiva. Besides, it can also permeate placental membrane and recover in milk.
Metabolism: Secnidazole is mainly metabolized in the liver, whose metabolic product is RP35843.
Excretion: Secnidazole was excreted unchanged in urine at a relatively slow cleaning speed of 1.68L/h (28ml/min), therefore about 10-25% secnidazole (including metabolin) was able to be detected in the urine 72 hours after oral administration of single dose of 2g, and accumulation of 50% was excreted via urine in 96 hours. Elimination half-life of secnidazole was 17-29 hours.

[DOSAGE AND ADMINISTRATION]
1) In treatment of anaerobic infections: For adults and children over 12 years, 2g to be taken orally once on the first day, then 1g (4 tablets) every 24 hours; 5-6 days in a course of treatment or as directed by the physician.
2) oral infections: For adults, 1g (4 tablets) once daily for 3 days and the first dose is doubled, or as directed by the physician.
3) urethritis and vaginitis caused by Trichomonas vainalis: For adults, 2g (8 tablets) is taken orally one time. And the same dose should be given to the spouse at the same time.
4) intestinal amebiasis: For adults with symptomatic acute amebiasis: 2g(8 tablets)is taken one time; For children with symptomatic acute amebiasis: , 30mg/kg is given one time. For adults with asymptomatic acute amebiasis: 2g (8 tablets) once daily for 3 days. For children with asymptomatic acute amebiasis: 30mg/kg is used once daily for 3 days.
5) hepatic amebiasis: For adults, 1.5g (6 tablets) to be taken one time or divided into several doses for 5 days. For children, 30mg/kg to be taken once or several times daily for 5 days.
6) giardiasis: For children, 30mg/kg once.

[SPECIFICATION]0.25g

[STORAGE]Keep tightly closed and Store in a dry place. Protect from direct light.

[PACKAGE] 8 tablets * 1 blister in PVC/aluminium blister packaging.

[SHELF LIFE ]24 months.