Indication
SEZOL® is indicated for the treatment of :
- Intestinal amebiasis infections.
- Hepatic amebiasis infections.
- Giardiasis infections.
- Urogenital trichomoniasis in both males and females.
- Anaerobic septicaemias.
- Non specific Vaginitis.
Composition
Each film-coated tablet of SEZOL® 1000 contains:
- Secnidazole 1000 mg
Each film-coated tablet of SEZOL® 500 contains:
- Secnidazole 500 mg
Dosage
SEZOL® is recommended to be taken at the beginning of meals.
¤ Intestinal amebiasis:
Acute symptomatic amebiasis (histolytic form).
- Adult : 2g as a single dose.
- Children : 30 mg/kg/day as a single dose.
The dose is to be taken for only one day.
¤ Asymptomatic amebiasis (minute and cystic form):
- The above dose dialy for 3 days.
¤ Hepatic amebiasis:
- Adult : 1.5 g per day as a single or divided doses for 5 days.
- Children: 30 mg/kg/day as a single or divided doses for 5 days.
During the sever stage of hepatic amebiasis, any pus or abscess should be drained in conjunction with SEZOL® treatment.
¤ Trichomoniasis, Giardiasis and Bacterial Vaginosis:
- Adult : 2 g as a single dose.
- Children: 30 -40 mg/kg/ day as a single dose.
Note:
- Dose should be repeated another time if necessary.
- Secnidazole is 5-nitroimidazole derivative, it has activity against anaerobic bacteria and protozoa with properties similar to those of metronidazole.
- Secnidazole enters micro–organisms by passive diffusion and undergo activation by reduction of 5-nitro group .In anaerobic micro –organisms such as Trichomonas, Giardia and Entamoeba spp, this intracellular reduction occurs via the pyruvateferredoxin oxidoreductase complex and result in concentration gradient across the cell membrane which, in turn, enhance transport of the parent drug into the cell. The electron affinity of the Secnidazole is greater than that of reduced ferredoxin hence the drug interrupt the normal electron flow.
- The mean absolute bioavailability of Secnidazole is 100% (+26%) after oral administration of single doses of 0.5 to 2g and the maximum plasma concentration occurs within 3 hours.
- Secnidazole is rapidly, but not extensively, distributed in the body after oral administration.
- Secnidazole crosses the placenta and can be found in breast milk.
- The principle metabolite of Secnidazole RP 35843, is thought to result from oxidation, presumably in the liver. No biological activity has been reported for the metabolite,
- Secnidazole does not appear to cause induction or inhibiton of hepatic cytochrome P450 isoenzyme.
- The plasma elemination half life is about 25 hours.
- Secnidazole is mainly eleminated in urine (50% of the ingested dose is excreted with 25 hours).
Each film-coated tablet of SEZOL® 1000 contains:
- Secnidazole 1000 mg
Each film-coated tablet of SEZOL® 500 contains:
- Secnidazole 500 mg
SEZOL® is indicated for the treatment of :
- Intestinal amebiasis infections.
- Hepatic amebiasis infections.
- Giardiasis infections.
- Urogenital trichomoniasis in both males and females.
- Anaerobic septicaemias.
- Non specific Vaginitis.
- Hypersensitivity to the derivatives of Imidazole.
- Patient who suffer from organic neurological disorders and blood dyscrasis.
- SEZOL® potentiate the effect of Warfarin hence prothrombin levels should be checked frequently and eight days after drug discontinuation.The dosage of oral anticoagulant should be adjusted during treatment with SEZOL®.
- Concomitant administration of Disulfiram with SEZOL® may cause delirium and confusion.
- It is not recommended to use during the first trimester of pregnancy or during lactation.
- Gastrointestinal tract: nausea, vomiting, anorexia, diarrhea and sense of metallic taste.
- Hypersensitivity reactions: rarely occur but sever : urticaria and odema.
- Blood reactions : moderate leukopenia, which disappears after treatment discontinuation.
- Neurological disorders: rarely, dizziness, ataxia, paraesthesia, incoordination, sensory and motor polyneuritis.
- Headache, tiredness, furred tongue and darkening of the urine
SEZOL® is recommended to be taken at the beginning of meals.
¤ Intestinal amebiasis:
Acute symptomatic amebiasis (histolytic form).
- Adult : 2g as a single dose.
- Children : 30 mg/kg/day as a single dose.
The dose is to be taken for only one day.
¤ Asymptomatic amebiasis (minute and cystic form):
- The above dose dialy for 3 days.
¤ Hepatic amebiasis:
- Adult : 1.5 g per day as a single or divided doses for 5 days.
- Children: 30 mg/kg/day as a single or divided doses for 5 days.
During the sever stage of hepatic amebiasis, any pus or abscess should be drained in conjunction with SEZOL® treatment.
¤ Trichomoniasis, Giardiasis and Bacterial Vaginosis:
- Adult : 2 g as a single dose.
- Children: 30 -40 mg/kg/ day as a single dose.
Note:
- Dose should be repeated another time if necessary.
- Avoid alcohol drinking during treatment with SEZOL® because of the possibility of the risk of abdominal cramps, flushing and vomiting.
- If various neurological signs develop while using the drug,discontinuation must be done immediately.
- Doses should be reduced in patient with sever liver disease.
- Blood test should be carried out before and after therapy in patient suffering from leukopenia.
SEZOL® 1000 film-coated tablets
- (Blister of 2 tablets, packs of one blister).
SEZOL® 500 film-coated tablets
- (Blister of 4 tablets, packs of one blister).
Hospital packs of different sizes.
- Store in a dry place at a temperature below 30°C.