Download secnidazole 500 mg Excipien

Name
Flagentyl 500 mg
Secnidazole
Composition
Each film-coated tablet contains as active ingredient:
secnidazole 500 mg
Excipients:
Calcium hydrogen phosphate, microcrystalline cellulose, wheat starch, hydrated silica, sodium
starch glycolate, gelatin, magnesium stearate, hypromellose.
Therapeutic indications
Antiamoebic & antiprotozoal
- Urethritis and vaginitis caused by Trichomonas vaginalis
- Intestinal amoebiasis
- Hepatic amoebiasis
- Giardiasis
Dosage and administration
Urethritis and vaginitis caused by Trichomonas vaginalis:
- Adults: 2 g in a single dose before meals.
Intestinal amoebiasis:
Acute, symptomatic amoebiasis (histolytica form):
- Adults: 2 g in a single dose before meals.
- Children: 30 mg/kg/day in a single dose in a single day.
Asymptomatic amoebiasis (minuta and cystica forms): same daily dose for 3 days.
Hepatic amoebiasis:
- Adults: 1.5 g per day in one or more doses before meals, for 5 days.
- Children: 30 mg/kg/day in one or more doses before meals, for 5 days.
In the suppurative phase of hepatic amoebiasis, combine secnidazole treatment and removal of
pus or lancing of abscesses
Giardiasis:
- Children: 30 mg/kg/day in a single dose in a single day.
Route of administration
Oral route.
Contraindications
- Hypersensitivity to imidazole derivatives.
- Pregnant and breastfeeding women (see Pregnancy and Lactation).
Warnings and special precautions
- Alcoholic drinks should be avoided during secnidazole treatment.
- Do not administer to subjects with a history of blood dyscrasia.
Drug and other interactions
Contraindicated combination therapy:
- Disulfiram: Delirious episodes, confusion.
- Alcohol: Hotness, redness, vomiting, tachycardia. Avoid alcoholic drinks and alcohol-containing
medicine.
Combinations subject to precautions:
- Oral anticoagulants (warfarin): Potentiation of the oral anticoagulant and increased risk of
hemorrhage by lowering of its hepatic catabolism.
More frequent determination of the prothrombin time and monitoring of the INR. Adjustment of the
oral anticoagulant dose during secnidazole treatment and 8 days after its withdrawal.
Pregnancy and lactation
Pregnancy:
No teratogenic effects are observed during animal experimentation. However, in view of the
absence of data in humans, it is not recommended to take secnidazole during pregnancy.
Lactation:
Secnidazole is excreted in breast milk.
Effect ability to drive/operate machine
Effects on the ability to drive vehicles and operate machinery:
Rare cases of dizziness have been reported with imidazole derivatives.
Undesirable effects
The following undesirable effects seen with imidazole derivatives may occur:
- Most frequently: digestives disorders, with abdominal pain, change in taste (metallic), glossitis,
stomatitis.
- Urticaria.
- Moderate leucopenia, reversible upon withdrawal of treatment.
- Rarely dizziness, lack of coordination and ataxia, paresthesia, sensitive and motor polyneuritis.
- Rare cases of digestive disorders have been reported (nausea, vomiting, gastric pain).
Pharmacological Properties
Antiparasitic
Tissular Amoebicide - Contact Amoebicide
Pharmacodynamic properties
Synthetic derivative of the nitro-imidazole series.
Essentially tissular amoebicide.
Active against Entamoeba histolytica and Giardia lamblia.
Pharmacokinetic properties
The peak serum concentration is reached 3 hours after oral administration of 2 g of secnidazole in
the form of 500 mg tablets. The plasma half-life is about 25 hours. Elimination is essentially in the
urine and is slow (approximately 50% of the dose ingested is excreted in 120 hours). Secnidazole
crosses the placenta and is excreted in breast milk.
Storage
Store below 25 C.
Keep all medicines out of reach of children.
Expiry date
Do not use later than the expiry date printed on the package.
Presentation
Box of 4 film-coated tablets.
Company
Produced by sanofi-aventis Egypt s.a.e.
Under license of: sanofi-aventis / France