Clinical Information
Gen. Code and Des.
9607 mebendazole ORAL TAB CHEW 100 MG
Strength
100 mg
Dose Form
TABLET,CHEWABLE
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
8080000 ANTHELMINTICS
Active Ingredients
2987 mebendazole 31431397
Inactive Ingredients
10143 yellow dye
2432 lactose 64044515
2600 saccharin 81072
for: Pinworm Infection (Enterobius vermicularis), Whipworm Infection (Trichuris trichiura), Hookworm Infection (Necator or Ancylostoma), Ascariasis
Emverm (mebendazole) is a chewable tablet formulation of the approved anthelmintic mebendazole for the treatment of Enterobius vermicularis (pinworm), Trichuris trichiura (whipworm), Ascaris lumbricoides (common roundworm), Ancylostoma duodenale (common hookworm), Necator americanus (American hookworm) in single or mixed infections.
These highlights do not include all the information needed to use EMVERM® safely and effectively. See full prescribing information for EMVERM®.
EMVERM® (mebendazole) chewable tablets, for oral use
Initial U.S. Approval: 1974
INDICATIONS AND USAGE
EMVERM® is an anthelmintic indicated for the treatment of patients two years of age and older with gastrointestinal infections caused by:
Ancylostoma duodenale (hookworm),
Ascaris lumbricoides (roundworm),
Enterobius vermicularis (pinworm),
Necator americanus (hookworm), and
Trichuris trichiura (whipworm), (1).
DOSAGE AND ADMINISTRATION
Adults and Pediatrics: The tablet may be chewed, swallowed, or crushed and mixed with food (2).
Pinworm (enterobiasis)
Whipworm (trichuriasis)
Roundworm (ascariasis)
Hookworm
Dose
1 tablet once
1 tablet morning and evening for 3 consecutive days
1 tablet morning and evening for 3 consecutive days
1 tablet morning and evening for 3 consecutive days
DOSAGE FORMS AND STRENGTHS
Chewable Tablet: 100 mg (3)
CONTRAINDICATIONS
Patients with a known hypersensitivity to the drug or its excipients (4)
WARNINGS AND PRECAUTIONS
Risk of Convulsions: Convulsions in infants below the age of 1 year have been reported (5.1).
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 (5.2).
Metronidazole and Serious Skin Reactions: Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) have been reported with the concomitant use of mebendazole and metronidazole. Avoid concomitant use of mebendazole and metronidazole (5.3).
ADVERSE REACTIONS
Adverse reactions reported in clinical trials were anorexia, abdominal pain, diarrhea, flatulence, nausea, vomiting and rash (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 1/2019
