IMPORTANT SAFETY INFORMATION
Contraindication: EMVERM is contraindicated in persons with a known hypersensitivity to the drug or its excipients (mebendazole, microcrystalline cellulose, corn starch, anhydrous lactose, sodium starch glycolate, magnesium stearate, stearic acid, sodium lauryl sulfate, sodium saccharin, and FD&C Yellow #6).
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. Avoid concomitant use of mebendazole and metronidazole.
Adverse Reactions Reported in Mebendazole-treated Subjects from 39 Clinical Trials*: anorexia, abdominal pain, diarrhea, flatulence, nausea, vomiting, rash.
Adverse Reactions Identified During Postmarketing Experience with Mebendazole*: agranulocytosis, neutropenia, hypersensitivity including anaphylactic reactions, convulsions, dizziness, hepatitis, abnormal liver tests, glomerulonephritis, Stevens-Johnson syndrome/toxic epidermal necrolysis, exanthema, angioedema, urticaria, alopecia.
*Includes mebendazole formulations, dosages and treatment duration other than EMVERM 100 mg chewable tablet.
Drug Interactions: Concomitant use of EMVERM and metronidazole should be avoided.
Pregnancy: 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.
Untreated soil transmitted helminth infections in pregnancy are associated with adverse outcomes including maternal iron deficiency anemia, low birth weight, neonatal and maternal death.
Lactation: Limited data from case reports demonstrate that a small amount of mebendazole is present in human milk following oral administration. There are no reports of effects on the breastfed infant, and the limited reports on the effects on milk production are inconsistent. The limited clinical data during lactation precludes a clear determination of the risk of EMVERM to a breastfed infant; therefore, developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for EMVERM and any potential adverse effects on the breastfed infant from EMVERM or from the underlying maternal condition.
Pediatric Use: The safety and effectiveness of EMVERM 100 mg chewable tablet has not been established in pediatric patients less than two years of age. Convulsions have been reported with mebendazole use in children less than one year of age.
Geriatric Use: Clinical studies of mebendazole did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects.
Overdosage: 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.
Symptoms and signs of overdose: In the event of accidental overdose, gastrointestinal signs/symptoms may occur.
Treatment of overdose: There is no specific antidote.
Patient Counseling: Healthcare professionals should advise the patient to read the FDA-approved patient labeling (Patient Information)
Advise patients that:
EMVERM® is 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).
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. To report SUSPECTED ADVERSE REACTIONS contact Impax Laboratories, Inc. at 1-877-994-6729.
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