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mebendazole
Overview
What is EMVERM?
Mebendazole, USP is a (synthetic) broad-spectrum anthelmintic available as chewable tablets, each containing 100 mg of mebendazole, USP. Inactive ingredients are: microcrystalline cellulose, corn starch, anhydrous lactose NF, sodium starch glycolate, magnesium stearate, stearic acid, sodium lauryl sulfate, sodium saccharin, and FD&C Yellow #6.
Mebendazole, USP is methyl 5-benzoylbenzimidazole-2-carbamate and has the following structural formula:
Molecular Formula: CHNO
Mebendazole, USP is a white to slightly yellow powder with a molecular weight of 295.29. It is less than 0.05% soluble in water, dilute mineral acid solutions, alcohol, ether and chloroform, but is soluble in formic acid.
What does EMVERM look like?
What are the available doses of EMVERM?
Sorry No records found.
What should I talk to my health care provider before I take EMVERM?
Sorry No records found
How should I use EMVERM?
Emverm (mebendazole) chewable tablet, USP is indicated for the treatment of (pinworm), (whipworm), (common roundworm), (common hookworm), (American hookworm) in single or mixed infections.
Efficacy varies as a function of such factors as preexisting diarrhea and gastrointestinal transit time, degree of infection, and helminth strains. Efficacy rates derived from various studies are shown in the table below.
The same dosage schedule applies to children and adults. The tablet may be chewed, swallowed, or crushed and mixed with food.
If the patient is not cured three weeks after treatment, a second course of treatment is advised. No special procedures, such as fasting or purging, are required.
What interacts with EMVERM?
Mebendazole is contraindicated in persons who have shown hypersensitivity to the drug.
What are the warnings of EMVERM?
Research
What are the precautions of EMVERM?
Array
Periodic assessment of organ system functions, including hematopoietic and hepatic, is advisable during prolonged therapy.
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 ).
Patients should also be informed that cleanliness is important to prevent reinfection and transmission of the infection.
Drug Interactions
Preliminary evidence suggests that cimetidine inhibits mebendazole metabolism and may result in an increase in plasma concentrations of mebendazole.
Carcinogenesis, Mutagenesis, Impairment of Fertility
In carcinogenicity tests of mebendazole in mice and rats, no carcinogenic effects were seen at doses as high as 40 mg/kg (one to two times the human dose, based on mg/m) given daily over two years. Dominant lethal mutation tests in mice showed no mutagenicity at single doses as high as 640 mg/kg (18 times the human dose, based on mg/m). Neither the spermatocyte test, the F translocation test, nor the Ames test indicated mutagenic properties. Doses up to 40 mg/kg in mice (equal to the human dose, based on mg/m), given to males for 60 days and to females for 14 days prior to gestation, had no effect upon fetuses and offspring, though there was slight maternal toxicity.
Pregnancy
Teratogenic Effects
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/m). In view of these findings the use of mebendazole is not recommended in pregnant women. Although there are no adequate and well-controlled studies in pregnant women, a post-marketing survey has been done of a limited number of women who inadvertently had consumed mebendazole during the first trimester of pregnancy. The incidence of spontaneous abortion and malformation did not exceed that in the general population. In 170 deliveries on term, no teratogenic risk of mebendazole was identified.
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.
What are the side effects of EMVERM?
Sorry No records found
What should I look out for while using EMVERM?
Mebendazole is contraindicated in persons who have shown hypersensitivity to the drug.
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.
What might happen if I take too much EMVERM?
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.
How should I store and handle EMVERM?
Unopened vials of Gemzar are stable until the expiration date indicated on the package when stored at controlled room temperature 20° to 25°C (68° to 77°F) and that allows for excursions between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature] . Emverm(mebendazole) chewable tablet USP, 100 mg is round, light peach-colored, unscored, debossed “ap” above “107” on one side and plain on the other side, supplied in cartons of one tablet, blister packaged (NDC 64896-669-30).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dist. by: Impax Specialty Pharma Hayward, CA 945441900-01Rev. 09/2016Emverm(mebendazole) chewable tablet USP, 100 mg is round, light peach-colored, unscored, debossed “ap” above “107” on one side and plain on the other side, supplied in cartons of one tablet, blister packaged (NDC 64896-669-30).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dist. by: Impax Specialty Pharma Hayward, CA 945441900-01Rev. 09/2016Emverm(mebendazole) chewable tablet USP, 100 mg is round, light peach-colored, unscored, debossed “ap” above “107” on one side and plain on the other side, supplied in cartons of one tablet, blister packaged (NDC 64896-669-30).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dist. by: Impax Specialty Pharma Hayward, CA 945441900-01Rev. 09/2016Emverm(mebendazole) chewable tablet USP, 100 mg is round, light peach-colored, unscored, debossed “ap” above “107” on one side and plain on the other side, supplied in cartons of one tablet, blister packaged (NDC 64896-669-30).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dist. by: Impax Specialty Pharma Hayward, CA 945441900-01Rev. 09/2016
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Following administration of 100 mg twice daily for three consecutive days, plasma levels of mebendazole and its primary metabolite, the 2-amine, do not exceed 0.03 mcg/mL and 0.09 mcg/mL, respectively. All metabolites are devoid of anthelmintic activity. In man, approximately 2% of administered mebendazole is excreted in urine and the remainder in the feces as unchanged drug or a primary metabolite.
Non-Clinical Toxicology
Mebendazole is contraindicated in persons who have shown hypersensitivity to the drug.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.
Preliminary evidence suggests that cimetidine inhibits mebendazole metabolism and may result in an increase in plasma concentrations of mebendazole.
Periodic assessment of organ system functions, including hematopoietic and hepatic, is advisable during prolonged therapy.
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 ).
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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