UNCOVERING PINWORM
IN YOUR PRACTICE

Perianal pruritus is the hallmark symptom of pinworm infection1,†

  • Perianal and perineal itching are the most common symptoms of pinworm infection.
    • The itching is often worse at night when female pinworms are migrating out of the anus to lay eggs
    • Sleep disturbance, restlessness, and irritability are other symptoms attributed to pinworm
  • Pinworm should be suspected in young children with perianal pruritus and restless sleep2

Other symptoms may include1,3:

Abdominal pain Dysuria Teeth grinding
Anorexia Enuresis Weight loss


According to the Centers for Disease Control and Prevention (CDC), additional symptoms in females with pinworm infection include4:

Vulvovaginitis Pelvic granulomas Peritoneal granulomas

†Not all potential symptoms are included on this page.

Diagnostic approaches

Symptoms of intense scratching of the anal area and sleep disturbance are generally strong indications of pinworm infection.

Visual identification of pinworms in the perianal region after the infected person is asleep is one possible way of diagnosing pinworm. The most common diagnostic method is called the "tape test."3

A tape test diagnosis is made by applying clear adhesive tape to the perianal area, then examining the tape under a microscope for the presence of pinworm eggs. For the highest level of accuracy, this test should be conducted on 3 consecutive mornings.3

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.

References:
1. Meinking TL, Burkhart CN, Burkhart CG. Clin Dermatol. 2003;21(5):407-416. 2. Kucik CJ, Martin GL, Sortor BV. Am Fam Physician. 2004;69(5):1161-1168. 3. American Academy of Pediatrics. Red Book: 2018-2021 Report of the Committee on Infectious Diseases. 31st ed. Itasca, IL: American Academy of Pediatrics; 2018:634-635, 994. 4. Enterobiasis. Centers for Disease Control and Prevention website. https://www.cdc.gov/dpdx/enterobiasis/index.html. Updated December 8, 2017. Accessed March 5, 2019.

IMPORTANT SAFETY INFORMATION

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.

Are You a Healthcare Professional?

The information contained in this website is intended for US healthcare professionals only. Click "OK" if you are a US healthcare professional.