Finished product reference
Mebendazole
Tablet, Chewable · Oral · 100 mg
- List code
- 786
- Pharmacologic class
- Anthelmintic
What it is and how it works
Mechanism of Action Mebendazole, a benzimidazole, is an anthelmintic .
Indications
VERMOX™ CHEWABLE is indicated for the treatment of patients one year of age and older with gastrointestinal infections caused by Ascaris lumbricoides (roundworm) and Trichuris trichiura (whipworm). VERMOX™ CHEWABLE is an anthelmintic indicated for the treatment of patients one year of age and older with gastrointestinal infections caused by: Ascaris lumbricoides (roundworm) and Trichuris trichiura (whipworm) .
Dosage and administration (summary)
The recommended dosage in patients one year of age and older is one VERMOX™ CHEWABLE 500 mg tablet taken as a single dose. Chew VERMOX™ CHEWABLE 500 mg tablet completely before swallowing. Do not swallow the tablet whole. For patients who have difficulty chewing the tablet, approximately 2 mL to 3 mL of drinking water can be added to a suitably sized spoon and the VERMOX™ CHEWABLE 500 mg tablet placed into the water. Within 2 minutes, the tablet absorbs the water and turns into a soft mass with semi-solid consistency, which can then be swallowed. VERMOX™ CHEWABLE 500 mg tablet can be taken without regard to food intake .
Contraindications
VERMOX™ CHEWABLE is contraindicated in persons with a known hypersensitivity to the drug or its excipients. Patients with a known hypersensitivity to the drug or its excipients
Warnings and precautions
Risk of Convulsions: Convulsions in infants below the age of 1 year have been reported Hematologic Effects: Neutropenia and agranulocytosis have been reported in patients receiving mebendazole at higher doses and for prolonged duration. Monitor blood counts in these patients Metronidazole and Serious Skin Reactions: Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) have been reported with the concomitant use of mebendazole and metronidazole.
Pregnancy
Pregnancy Risk Summary The available published literature on mebendazole use in pregnant women has not reported a clear association between mebendazole and a potential risk of major birth defects or miscarriages . There are risks to the mother and fetus associated with untreated helminthic infection during pregnancy .
Storage and supply
Store below 30°C. Keep container tightly closed. Unused tablets should be discarded 1 month after the bottle is first opened. When the bottle is first opened this Discard After date should be written on the bottle label in the place provided.
Source: Mebendazole (Vermox) — US FDA prescribing information, 2021-10-05, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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