Secernentea Infections Treatments
Find Secernentea Infections Treatments
Brand Name
Vermox
Generic Name
Mebendazole
View Brand Information FDA approval date: October 20, 2016
Classification: Anthelmintic
Form: Tablet
What is Vermox (Mebendazole)?
VERMOX™ CHEWABLE is indicated for the treatment of patients one year of age and older with gastrointestinal infections caused by Ascaris lumbricoides and Trichuris trichiura . VERMOX™ CHEWABLE is an anthelmintic indicated for the treatment of patients one year of age and older with gastrointestinal infections caused by: Ascaris lumbricoides and Trichuris trichiura .
Approved To Treat
Top Global Experts
Save this treatment for later
Not sure about your diagnosis?
Tired of the same old research?
Related Clinical Trials
Clinical Study to Evaluate the Possible Efficacy and Safety of Mebendazole in Patients With Ulcerative Colitis Treated With Mesalamine
Summary: To evaluate the possible efficacy and safety of mebendazole in patients with ulcerative colitis treated with mesalamine
Related Latest Advances
Brand Information
VERMOX (mebendazole)
1INDICATIONS AND USAGE
VERMOX™ CHEWABLE is indicated for the treatment of patients one year of age and older with gastrointestinal infections caused by
2DOSAGE AND ADMINISTRATION
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
3DOSAGE FORMS AND STRENGTHS
Chewable Tablet: 500 mg round, flat radius-edged white to yellowish chewable tablet that is debossed with "M/500" on one side and "J" on the other side.
4CONTRAINDICATIONS
VERMOX™ CHEWABLE is contraindicated in persons with a known hypersensitivity to the drug or its excipients.
5DRUG INTERACTIONS
Concomitant use of mebendazole and metronidazole should be avoided
6OVERDOSAGE
In patients treated at dosages substantially higher than recommended or for prolonged periods of time, the following adverse reactions have been reported: alopecia, reversible transaminase elevations, hepatitis, agranulocytosis, neutropenia, and glomerulonephritis.
7DESCRIPTION
VERMOX™ CHEWABLE (mebendazole chewable tablets) is an orally administered anthelmintic. Chemically, it is methyl 5-benzoylbenzimidazole-2-carbamate. Its molecular formula is C
Mebendazole exhibits polymorphism. The polymorph used in VERMOX™ CHEWABLE is polymorph form C. Mebendazole is a white to almost white powder. It is practically insoluble in water, in ethanol (96%) and in methylene chloride.
Each round, flat radius-edged white to yellowish chewable tablet contains 500 mg of mebendazole and is debossed with "M/500" on one side and "J" on the other side.
Inactive ingredients consist of: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, purified water, strawberry flavor and sucralose.
8CLINICAL STUDIES
The efficacy of VERMOX™ CHEWABLE 500 mg tablets was evaluated in a double-blind, randomized, placebo controlled trial conducted in Africa in 295 pediatric patients between the ages of 1 year to 16 years of age with
Clinical cure was defined as zero egg count (
In patients treated with VERMOX™ CHEWABLE 500 mg, egg count reduction rate at the end of the double-blind period (Day 19) in patients with
9HOW SUPPLIED/STORAGE AND HANDLING
VERMOX™ CHEWABLE tablets are supplied as 500 mg, round, flat radius-edged white to yellowish chewable tablets that are debossed with "M/500" on one side and "J" on the other side. They are supplied as follows:
10PATIENT COUNSELING INFORMATION
Advise patients that:
- VERMOX™ CHEWABLE tablet must be chewed completely before swallowing. For patients who have difficulty chewing the tablet, VERMOX™ CHEWABLE tablet can be turned into a soft mass with semi-solid consistency by adding 2 mL to 3 mL of drinking water to a spoon then placing the tablet into the water, which can then be swallowed.
- VERMOX™ CHEWABLE tablet must not be swallowed whole.
- VERMOX™ CHEWABLE tablet can be taken with or without food.
- Taking VERMOX™ CHEWABLE tablet and metronidazole together may cause serious skin reactions and should be avoided.
11PRINCIPAL DISPLAY PANEL - 500 mg Tablet Bottle Label
NDC 50458-675-20
Vermox™ Chewable
500 mg
Each chewable tablet contains 500 mg
200 tablets
Rx only
USUAL DOSAGE: See package insert for
Chew tablets completely before swallowing.
Store below 30°C.
Discard after _/_/_.
USA-AW_112506
© Janssen Pharmaceuticals, Inc. 2016
