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 above) 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:

EMVERM 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 above).

  • 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.

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.