Prescribing Details
Description
Yellowish white, caplet shaped, film coated tablets, engraved with SEZOL DS in one side and breakline in other side. Each tablet contains 1000 mg secnidazole INN.
Uses
No Data
Indications
No Data
Dosage and administration
Amoebiasis
Acute Intestinal Amoebiasis
Asymptomatic Amoebiasis (minutes & cystic form)
Acute Intestinal Amoebiasis
Adults :
2g once only (2X 1000 mg) preferably taken just before meal.
Childre :
30 mg/kg once only.
Asymptomatic Amoebiasis (minutes & cystic form)
Adults :
Same daily dose as above for 3 days.
Childre :
Same daily dose as above for 3 days.
Hepatic Amoebiasis
Adults :
1.5 g/day in a single or divided dose just before meals for 5 days.
Childre :
30 mg/kg/day in a single or divided dose, just before meals for 5 days.
SEZOL DS treatment at the suppurative stage of hepatic amoebiasis.
Note: Evacuation of pus must be performed simultaneously with SEZOL DS treatment at the suppurative stage of hepatic amoebiasis.
Giardiasis >
Adults : 2g (2 tablets) once only.
Children : 35-50 mg/kg once only.
Trichomoniasis
2g (2 tablets) once only. The consort should receive the®same treatment concomitantly.
Use in pregnancy & lactation
- Intestinal Amoebiasis
- Hepatic Amoebiasis
- Urethritis and Vaginitis due to Trichomonas vaginalis ®- Giardiasis
Use in pregnancy
Use in pregnancy Secnidazole may be prescribed in pregnancy after the first trimester. As with all drugs, secnidazole should not be administered during the first trimster of pregnancy or during lactation because secnidazole is found in placenta andbreast milk.
- Hepatic Amoebiasis
- Urethritis and Vaginitis due to Trichomonas vaginalis ®- Giardiasis
Use in pregnancy
Use in pregnancy Secnidazole may be prescribed in pregnancy after the first trimester. As with all drugs, secnidazole should not be administered during the first trimster of pregnancy or during lactation because secnidazole is found in placenta andbreast milk.
Geriatric use
No Data
Precautions
Patients should be advised not to take alcohol during treatment with secnidazole (antabuse effect). Administration of secnidazole should be avoided to patients with a history of blood dyscrasia.
Side effects
The clinical studies have shown that secnidazole is characterised by very good tolerance and to date, no adverse reactions have been reported.The following side-effectsmay be observed with secnidazole as with all nitroimidazole derivatives and are rarely serious.
With SEZOL DS Gastrointestinal disorders (nausea, vomiting, epigastric pain) have been reported in very rare cases.
Most frequently :
Gastrointestinal disturbances, nausea, epigastric pain, metallic taste, glossitis, stomatitis.
Occasionally :
Urticaria,moderate leukopenia which is reversible on treatment withdrawal.
Rarely :
Vertigo, ataxia and motor incoordination, paresthesia, peripheral neuropathy.
With SEZOL DS Gastrointestinal disorders (nausea, vomiting, epigastric pain) have been reported in very rare cases.
Contraindications
Known hypersensitivity to imidazole derivatives.
Drug interactions
Administration of secnidazole with disulfiram is not recommended. Confusional state and paranoid reaction may®occur. Use of secnidazole simultaneously with warfarin requires close monitoring: increased effect of oral anticoagulants and of the haemorrhagic risk.
Overdose
No Data
Preparation
No Data
Pharmaceutical precautions
Store in a cool and dry place
Presentation
No Data
Package quantities
Blister pack of 1X 2s tablets.
