Composition
Each 5 ml suspension contains Mebendazole USP 100 mg.
Pharmacology
Helben (Mebendazole) is a synthetic broad-spectrum anthelmintic that is active against most nematodes and some other worms. Helben (Mebendazole) is principally used in the treatment of intestinal nematode infection. Helben (Mebendazole) inhibits the formation of the worms’ microtubules and causes the worms’ glucose depletion. After oral administration about 2-10 % of oral dose is absorbed from Gl tract and peak plasma concentration occurs within 30 minutes to 7 hours. Helben (Mebendazole) is highly bound to plasma protein. Elimination half-life is 2.8 to 9 hours.
Indications
Helben (Mebendazole) is indicated for the treatment of threadworms, whipworms, roundworms and hookworms.
Dosage & Administration
Adult and Child over 2 years-
- Threadworms: 100 mg or 1 teaspoonful: Single dose.
- Whipworms, Roundworms, Hookworms: 100 mg or 1 teaspoonful: Twice daily for 3 days.
If reinfection occurs the second dose may be needed after 2 weeks.
Interaction
Preliminary evidence suggests that cimetidine inhibits mebendazole metabolism and may result in an increase in plasma concentration.
Contraindications
Helben (Mebendazole) is contraindicated in patients with known hypersensitivity to Mebendazole or to any component of the formulation.
Precautions & Warnings
General: Periodic assessment of organ system functions, including haematopoietic and hepatic is advisable during prolonged therapy.
Information for Patients: Patients should be informed of the potential risk to the fetus in women taking Helben (Mebendazole) during pregnancy. Especially during the first trimester. Patients should also be informed that cleanliness is important to prevent reinfection & transmission of the infection.
Side Effects
- Gastrointestinal: Transient symptoms of abdominal pain and diarrhoea in case of massive infection and expulsion of worms.
- Hypersensitivity: Rash, urticaria and angioedema have been observed on rare occasions.
- Central Nervous System: Very rare cases of convulsions have been reported.
- Haematologic: Neutropenia and agranulocytosis.
Pregnancy & Lactation
Helben (Mebendazole) is not recommended in pregnant women. It is not known whether mebendazole is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when it is administered to a nursing mother.
Use in Special Populations
Pediatric use: The drug has not been extensively studied in children under two years; therefore, in the treatment of children under two years the relative benefit/risk should be considered.
Overdose
In the event of accidental overdosage, gastrointestinal complaints lasting up to a few hours may occur. Vomiting and purging should be induced.
Storage
Store below 30°C, protect from light and moisture. Keep out of reach of children.
Packaging
Each PET bottle contains 30 ml suspension and a measuring cup.
