DROTAVEX

DROTAVEX 

Capsules
DROTAVEX
COMPOSITION:
Each Hard gelatin capsule contains:
Active ingredients:
Nifuroxazide 200mg
Inactive ingredients: Maize starch, mannitol, polyvinilpyrrolidone,
croscarmellose sodium, magnesium starate, gelatin, sunset
yellow, titanium dioxide, quinoline yellow.
PHARMACEUTICAL FORM:
Hard gelatin capsule.
THERAPEUTIC INDICATIONS:
Suspected acute bacterial diarrhea in the absence of suspected
invasive phenomena (poor general condition, fever. toxic signs
of infection). The treatment does not eliminate dietary measures
and rehydration if necessary. The importance of rehydration with
oral rehydration solution or intravenous administration should
be adjusted according to the intensity of diarrhea, age and
characteristics of the patient (associated diseases).
DOSAGE AND ADMINISTRATION:
Reserved for adults (from 15 years). 1 capsule 4 times daily.
The duration of treatment is limited to 3 days.
CONTRAINDICATIONS:
Hypersensitivity to nitrofuran derivatives.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE:
Warnings: If the diarrhea persists for more than 2 days of
treatment, you should ask for medical advice (revaluation of the
Way of treatment and re-diagnosis of disease should be
and the need for oral or intravenous rehydration
should be considered. In cases of infectious diarrhea with clinical
manifestations suggesting an invasive phenomenon, the use of
systemic broad spectrum antibacterial is must. Precautions
The patient should be informed of the need to: Rehydrate by
plenty of drinks, salty or sweet, to compensate for fluid loss due
to diarrhea (average daily intake of water for adults is 2 liters).
Eat enough food during diarrhea specially grilled meat & rice
excluding in particular raw vegetables fruits, green vegetables,
spicy foods, and frozen foods or beverages.
INTERACTION WITH OTHER MEDICINAL PRODUCTS:
Not applicable.
PREGNANCY AND LACTATION:
Studies in animals have not revealed any evidence of
teratogenic effects. In the absence of teratogenic effects in
arumals, a teratogenic effect in humans is not expected. In
clinical practice, there is currently no adequate data to assess
a possible teratogenic or fetotoxic effect of nifuroxazide when
administered during pregnancy. Consequently, as a
precautionary measure, it is preferable not to use the
nifuroxazide during pregnancy. Breastfeeding is still possible
if brief treatment with this drug.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:
Not applicable.
UNDESIRABLE EFFECTS:
Possibility of allergic react,iorw
OVERDOSE:
Not applicable.
PHARMACOLOGICAL CLASS:
Other intestinal anti-infectious.
PHARMACOKINETIC PROPERTIES:
The absorption is extremely low when the intestinal mucosa is
not attered.
STORAGE:
Keep the medicine out of reach of children. This product should
'be stored in a dry place at a temperature not exceeding 300C.
PACK:
Carton box containing 1, 2 or 3 blisters (AL /transparent PVC)
each Of 12 hard gelatin capsules and insert leaflet.
P1074.OO/OO/OO