Composition
Each tablet or 5 ml suspension contains: 100 mg Flubendazole.
Properties
Fluvermal is a synthetic broad spectrum anthelmintic. Fluvermal interferes with cellular tubulin formation in the worm, thus disturbing glucose uptake and the normal digestive functions of the worm to such an extent that an autolytic process occurs.
Flubendazole is poorly absorbed after oral administration. At the normal anthelmintic dosage, the bioavailability is poor because of the combination of high first-pass metabolism and a very low solubility of the drug. 90% of the small fractions that is absorbed is bound to plasma proteins.
Indications & Usage
Fluvermal is indicated for the treatment of single or mixed infestations by:
- Enterobius vermicularis (threadworm/ pinworm)
- Trichuris trichiura (whipworm)
- Ascaris lumbricoides (large round worm)
- Ancylostoma duodenale and Necator americanus (hookworm).
Contraindications
Fluvermal is contraindicated in persons who have shown hypersensitivity to the drug.
Side Effects
Only minor Side Effects to Fluvermal have been reported.
Transient abdominal pain and diarrhoea have rarely only been reported, in cases of massive infestations and expulsion of worms.
Hypersensitivity reactions such as exanthema, rash, urticaria and angio-oedema have rarely been observed.
Warnings & precautions
Use in infants < 1 year: As well-documented experience in children below 1 year of age is scarce, Fluvermal should only be given to very young children if their worm infection interferes significantly with their nutritional status and physical development.
Use during pregnancy and lactation: Although Flubendazole gives no evidence of teratogenic properties in animals, possible risks from Flubendazole during pregnancy should be weighed against the expected therapeutic benefits, particularly during the first trimester.
It is not known whether Flubendazole is excreted in human milk. Therefore caution should be exercised when Fluvermal is administered to nursing women.
Overdose
In the event of accidental overdosage, abdominal cramps, nausea, vomiting and diarrhoea may occur.
Although the maximum recommended treatment duration of Fluvermal is limited to 3 days there have been rare reports of reversible liver function disturbances, hepatitis and blood dyscrasias described in patients who were treated for hydatid disease with massive doses for prolonged periods of time.
There is no specific antidote. Gastric lavage with aqueous potassium permanganate at 20 mg/ 100 ml may be performed. Activated charcoal may be given.
Dosage & Administration
1- Enterobiasis: 1 tablet or 5 ml drinkable suspension given as a single dose. since reinfections by Enterobius vermicularis are very common, it is recommended that the treatment be repeated after 2 and 4 weeks, particularly in eradication programmes.
2-Ascariasis, Trichuriasis, Anchylostomiasis and mixed infections: 1 tablet b.i.d or 5 ml drinkable suspension morning and evening for 3 consecutive days. The dosages above apply to children as well as adults. No special procedures, such as diet or use of laxatives are required.
For infants< 1 year, see under Warnings and Precautions.
Packing
- Tablets Pack contains 1 or 167 strips X 6 tablets.
- Suspension: Pack contains bottle of 30 ml
Storage
- For Tablets: Store in a dry place, away from light at a temperature between 15-30 °C.
- For Suspension: Store in airtight container, away from light at a temperature between 15-30 °C.
Council of Arab Health Ministers and Union of Arab Pharmacists |
Produced by:Janssen Pharmaceuticals (Janssen-Cilag) -Egypt. ATC Code: P02CA05