Mebendazole

VERMOX™ 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).

Take mebendazole exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The Mebendazole dose your doctor recommends will be based on the following (use any or all that apply):

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

Mebendazole is available in the following doses:

• Mebendazole 100 Mg Oral Tablet, Chewable
• Mebendazole Compounding Powder

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include upper stomach pain, loss of appetite, dark urine, or jaundice (yellowing of the skin or eyes).

Administration

Oral Administration

Administer orally107 without regard to meals.107

Tablets may be chewed, swallowed whole, or crushed and mixed with food.107 Special diets, fasting, or purgation prior to administration not necessary.107

Dosage

Pediatric Patients

100 mg twice daily for 3 consecutive days.107 147

Alternatively, single 500-mg dose has been recommended.147

Manufacturer recommends a second course of treatment if patient is not cured 3 weeks after mebendazole therapy.107

Single 100-mg dose.107 147 Some clinicians recommend a second 100-mg dose 2 weeks later.147

Manufacturer recommends a second course of treatment if patient is not cured 3 weeks after mebendazole therapy.107

100 mg twice daily for 30 days.147

100 mg twice daily for 3 consecutive days.107 147

Alternatively, single 500-mg dose has been recommended.147

Manufacturer recommends a second course of treatment if patient is not cured 3 weeks after mebendazole therapy.107

100 mg twice daily for 3 consecutive days.147

100–200 mg twice daily for 5 days.147 Optimum duration of therapy not known; some clinicians recommend treatment for up to 20 days.147

Alternatively, 1 g 3 times daily (50 mg/kg daily) for 21 days reportedly was curative in a least one patient.123

200–400 mg 3 times daily for 3 days followed by 400–500 mg 3 times daily for 10 days.147

100 mg twice daily for 3 consecutive days.147

100 mg twice daily for 3 consecutive days.107 147

Alternatively, single 500-mg dose has been recommended.147

Manufacturer recommends a second course of treatment if patient is not cured 3 weeks after mebendazole therapy.107

200 mg twice daily for 20 days.147

400–800 mg daily for 6 days.147

Adults

100 mg twice daily for 3 consecutive days.107 147

Alternatively, single 500-mg dose has been recommended.147

Manufacturer recommends a second course of treatment if patient is not cured 3 weeks after mebendazole therapy.107

Single 100-mg dose.107 147 Some clinicians recommend a second 100-mg dose 2 weeks later.147

Manufacturer recommends a second course of treatment if patient is not cured 3 weeks after mebendazole therapy.107

100 mg twice daily for 30 days.147

1 g twice daily for 28 days.114 115 116

100 mg twice daily for 3 consecutive days.107 147

Alternatively, single 500-mg dose has been recommended.147

Manufacturer recommends a second course of treatment if patient is not cured 3 weeks after mebendazole therapy.107

100 mg twice daily for 3 consecutive days.147

100–200 mg twice daily for 5 days.147 Optimum duration of therapy not known; some clinicians recommend treatment for up to 20 days.147

Alternatively, 1 g 3 times daily (50 mg/kg daily) for 21 days reportedly was curative in a least one patient.123

200–400 mg 3 times daily for 3 days followed by 400–500 mg 3 times daily for 10 days.147

100 mg twice daily for 3 consecutive days.147

100 mg twice daily for 3 consecutive days.107 147

Alternatively, single 500-mg dose has been recommended.147

Manufacturer recommends a second course of treatment if patient is not cured 3 weeks after mebendazole therapy.107

200 mg twice daily for 20 days.147

400–800 mg daily for 6 days.147

Special Populations

No special population dosage recommendations at this time.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For mebendazole, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to mebendazole or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Vermox™ Chewable tablets in children. However, safety and efficacy have not been established in children younger than 1 year of age.

Appropriate studies have not been performed on the relationship of age to the effects of Emverm™ chewable tablets in children younger than 2 years of age. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of mebendazole in geriatric patients.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking mebendazole, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using mebendazole with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Metronidazole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of mebendazole. Make sure you tell your doctor if you have any other medical problems, especially:

• Bone marrow problems (eg, agranulocytosis, neutropenia)—Use with caution. May make these conditions worse.

• Liver disease—Use with caution. May increase risk for more serious side effects.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take mebendazole or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to mebendazole. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Gastrointestinal

Transient symptoms of abdominal pain and diarrhea in cases of massive infection and expulsion of worms.

Hypersensitivity

Rash, urticaria and angioedema have been observed on rare occasions.

Central Nervous System

Very rare cases of convulsions have been reported.

Liver

There have been liver function test elevations [AST (SGOT), ALT (SGPT), and GGT] and rare reports of hepatitis when Mebendazole was taken for prolonged periods and at dosages substantially above those recommended.

Hematologic

Neutropenia and agranulocytosis. (See WARNINGS).

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

Mebendazole Tabs USP 100 mg 12 Chewable Tabs Box Text

NDC 0093-9107-29

Mebendazole
Tablets, USP
100 mg

Each tablet contains:
Mebendazole, USP 100 mg
USUAL DOSAGE: See package insert for dosage information.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Rx only

12 CHEWABLE TABLETS

TEVA

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet Chewable, Oral:

Emverm: 100 mg [contains fd&c yellow #6 (sunset yellow), saccharin sodium]

• Anthelmintic

Store at 20°C to 25°C (68°F to 77°F).

Consult your pharmacist.

Consult your pharmacist.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

100 mg orally twice a day for 3 days. If biliary obstruction is also present, piperazine citrate 150 mg/kg initially, followed by 65 mg/kg every 12 hours for 6 doses by nasogastric tube is also recommended.

100 mg orally one time. This dose should be repeated in 2 weeks. All family members and close contacts should also be examined.

Mansonella perstans infection - 100 mg twice daily for 30 days.

Case Series (n=769)
Hepatic Cystic infection - Larval (tissue stage): 40 to 50 mg/kg per day, administered in three divided doses, in conjunction with percutaneous aspiration-injection-reaspiration (PAIR) drainage, 1 week before and 4 weeks after PAIR drainage.