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ABOUT EMVERM

ABOUT PINWORM

CONTAGION CONTROL

EMVERM SAVINGS

PATIENT RESOURCES

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

Adverse Reactions from Clinical Trials*: Anorexia, abdominal pain, diarrhea, flatulence, nausea, vomiting, rash.
Adverse Reactions from 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.

Use in Specific Populations:

  • Pregnancy: Mebendazole use in pregnant women has not reported a clear association between mebendazole and a potential risk of major birth defects or miscarriages. However, there are risks to the mother and fetus associated with untreated helminthic infection during pregnancy.

  • 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.

  • 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.

  • 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:

  • Taking EMVERM and metronidazole together may cause serious skin reactions and should be avoided.

  • EMVERM can be taken with or without food.

INDICATION

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).

To report SUSPECTED ADVERSE REACTIONS, contact Amneal Specialty, a division of Amneal Pharmaceuticals LLC at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please click here for Full Prescribing Information.

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

Contraindications:

Mebendazole is contraindicated in persons who have shown hypersensitivity to the drug.

Warnings:

There is no evidence that mebendazole, even at high doses, is effective for hydatid disease. There have been rare reports of neutropenia and agranulocytosis when mebendazole was taken for prolonged periods and at dosages substantially above those recommended.

Precautions:

Periodic assessment of organ system functions, including hematopoietic and hepatic, is advisable during prolonged therapy.

Adverse Reactions Include:

Transient symptoms of abdominal pain and diarrhea with expulsion of worms in cases of massive infection; liver function test elevations [AST (SGOT), ALT (SGPT), and GGT]; and on rare occasions hypersensitivity (rash, urticaria and angioedema); rare reports of neutropenia, agranulocytosis (see WARNINGS) and hepatitis when mebendazole was taken for prolonged periods and at dosages substantially above those recommended; and very rare cases of convulsions.

Drug Interactions:

Preliminary evidence suggests that cimetidine inhibits mebendazole metabolism and may result in an increase in plasma concentrations of mebendazole.

Pregnancy Category C:

Mebendazole has shown embryotoxic and teratogenic activity in pregnant rats at single oral doses as low as 10 mg/kg (approximately equal to the human dose, based on mg/m2). In view of these findings the use of mebendazole is not recommended in pregnant women.

Nursing Mothers:

It is not known whether mebendazole is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when mebendazole is administered to a nursing woman.

Pediatric Use:

The drug has not been extensively studied in children under two years; therefore, in the treatment of children under two years the relative benefit/risk should be considered.

Overdosage:

In the event of accidental overdosage, gastrointestinal complaints lasting up to a few hours may occur. Vomiting and purging should be induced. Activated charcoal may be given.

Information for Patients:

  • Patients should be informed of the potential risk to the fetus in women taking mebendazole during pregnancy, especially during the first trimester (see Pregnancy Category C).

  • Patients should also be informed that cleanliness is important to prevent reinfection and transmission of the infection.

INDICATION

EMVERM (mebendazole) 100 mg chewable tablet is indicated in adults and children over 2 years of age for the treatment of Enterobius vermicularis (pinworm), Trichuris trichiura (whipworm), Ascaris lumbricoides (common roundworm), Ancylostoma duodenale (common hookworm), and Necator americanus (American hookworm) in single or mixed infections.

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.

Please see full Prescribing Information for EMVERM.

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