Generic Name
Mebendazole
Brand Names
Emverm, Vermox
FDA approval date: February 15, 2016
Classification: Anthelmintic
Form: Tablet
What is Emverm (Mebendazole)?
EMVERM ® is indicated for the treatment of patients two years of age and older with gastrointestinal infections caused by Ancylostoma duodenale , Ascaris lumbricoides , Enterobius vermicularis , Necator americanus , and Trichuris trichiura . EMVERM ® is an anthelmintic indicated for the treatment of patients two years of age and older with gastrointestinal infections caused by: Ancylostoma duodenale , Ascaris lumbricoides , Enterobius vermicularis , Necator americanus , and Trichuris trichiura , .
Approved To Treat
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Brand Information
Emverm (mebendazole)
1INDICATIONS AND USAGE
EMVERM
2DOSAGE AND ADMINISTRATION
The recommended dosage for EMVERM
Table 1: Dosage of EMVERM in Adult and Pediatric Patients (two years of age and older)
If the patient is not cured three weeks after treatment, asecond course of treatment is advised. No special procedures, such as fastingor purging, are required.
3DOSAGE FORMS AND STRENGTHS
EMVERM
4CONTRAINDICATIONS
EMVERM
5DRUG INTERACTIONS
Concomitant use of mebendazole, including EMVERM
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
EMVERM
Chemically, mebendazole is methyl 5-benzoylbenzimidazole-2-carbamate with a molecular formula of C
Mebendazole, USP is a white to slightly yellow powder with a molecular weight of 295.29. It is less than 0.05% soluble in water, dilute mineral acid solutions, alcohol, ether and chloroform, but is soluble in formic acid.
8CLINICAL STUDIES
Efficacy rates derived from various studies are shown in Table 4 below:
Table 4: Mean Cure Rates and Egg Reductions from Clinical Studies
9HOW SUPPLIED/STORAGE AND HANDLING
EMVERM
Blister package of 1 tablet NDC 64896-669-30
Store at 68° to 77°F (20° to 25°C) [See USP Controlled Room Temperature].
10PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Advise patients that:
Taking EMVERM EMVERM
11PATIENT INFORMATION
This Patient Information has been approved by the U.S. Food and Drug Administration.
Rev. 08-2021-01
12PRINCIPAL DISPLAY PANEL