PINWORM INFECTS APPROXIMATELY 40 MILLION PEOPLE IN THE US1

PINWORM INFECTS APPROXIMATELY 40 MILLION PEOPLE IN THE US

Pinworm is extremely contagious2,3

Transmission often occurs in schools and within families1,2

Enterobius vermicularis, or pinworm, is a parasitic nematode occurring worldwide. Pinworm is the most common helminthic parasitic infection in the US, affecting people of all ages and socioeconomic levels.1,2

Pinworm infection transmission is most prevalent among:

  • Daycare facilities2
  • Preschool- and school-age children (3-14 years)2,4
  • Institutionalized groups2
  • Household members and caregivers2
Pinworm infects three times the number of people as head lice.
  • Pinworm is more prevalent than head lice, but may be more difficult to diagnose1,5
    • There are approximately 40 million pinworm cases versus up to 12 million head lice cases in the United States

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.

References:
1. Maguire JH. Intestinal nematodes (roundworms). In: Bennett JE, Dolin R, Blaser MJ, eds. Mandell, Douglas, and Bennett’s Principles and Practice of Infectious Diseases. 8th ed. Philadelphia, PA: Elsevier Saunders; 2015:3199-3207.e2. 2. Committee on Infectious Diseases, American Academy of Pediatrics. Red Book: 2015 Report of the Committee on Infectious Diseases. 30th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2015:621-622, 934. 3. Kucik CJ, Martin GL, Sortor BV. Common intestinal parasites. Am Fam Physician. 2004;69(5):1161-1168. 4. Centers for Disease Control and Prevention website. http://www.cdc.gov/ncbddd/childdevelopment/positiveparenting/preschoolers.html. Updated January 3, 2017. Accessed March 30, 2017. 5. Centers for Disease Control and Prevention. Epidemiology & risk factors. Centers for Disease Control and Prevention website. http://www.cdc.gov/parasites/lice/head/epi.html. Updated September 24, 2013. Accessed March 30, 2017.

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 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.