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VERMOX® (mebendazole) is a (synthetic) broad-spectrum anthelmintic available as chewable tablets, each containing 100 mg of mebendazole. Inactive ingredients are: colloidal silicon dioxide, corn starch, hydrogenated vegetable oil, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium saccharin, sodium starch glycolate, talc, tetrarome orange, and FD&C yellow No. 6.

Mebendazole is methyl 5-benzoylbenzimidazole-2-carbamate. Mebendazole 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.

Last updated on RxList: 5/13/2008

VERMOX® (mebendazole) is indicated for the treatment of Enterobius vermicularis (pinworm), Trichuris trichiura (whipworm), Ascaris lumbricoides (common roundworm), Ancylostoma duodenale (common hookworm), Necator americanus (American hookworm) in single or mixed infections.

Efficacy varies as a function of such factors as pre-existing diarrhea and gastrointestinal transit time, degree of infection, and helminth strains. Efficacy rates derived from various studies are shown in the table below:

	Pinworm (enterobiasis)	Whipworm (trichuriasis)	Common Roundworm (ascariasis)	Hookworm
Cure rates mean	95%	68%	98%	96%
Egg reduction mean	-	93%	99%	99%

The same dosage schedule applies to children and adults. The tablet may be chewed, swallowed, or crushed and mixed with food.

	Pinworm (enterobiasis)	Whipworm (trichuriasis)	Common Roundworm (ascariasis)	Hookworm
Dose	1 tablet, once	1 tablet morning and evening for 3 consecutive days.	1 tablet morning and evening for 3 consecutive days.	1 tablet morning and evening for 3 consecutive days.

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.

VERMOX® (mebendazole) is available as chewable tablets, each containing 100 mg of mebendazole, and is supplied in boxes of twelve tablets.

NDC 50458-110-01 (blister package of 12)

Store at controlled room temperature (59°-77° F/ 15°-25° C).

Last updated on RxList: 5/13/2008

Transient symptoms of abdominal pain and diarrhea have occurred in cases of massive infection and expulsion of worms. Hypersensitivity reactions such as rash, urticaria and angioedema have been observed on rare occasions. Very rare cases of convulsions have been reported.

Preliminary evidence suggests that cimetidine inhibits mebendazole metabolism and may result in an increase in plasma concentrations of mebendazole.

Last updated on RxList: 5/13/2008

There is no evidence that VERMOX® (mebendazole), even at high doses, is effective for hydatid disease. There have been rare reports of neutropenia and liver function elevations, including hepatitis, when VERMOX® is taken for prolonged periods and at dosages substantially above those recommended.

Carcinogenesis and Mutagenesis

In carcinogenicity tests of mebendazole in mice and rats, no carcinogenic effects were seen at doses as high as 40 mg/kg given daily over two years. Dominant lethal mutation tests in mice showed no mutagenicity at single doses as high as 640 mg/kg. Neither the spermatocyte test, the F₁ translocation test, nor the Ames test indicated mutagenic properties.

Impairment of Fertility

Doses up to 40 mg/kg in mice, 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.

Use in Pregnancy

Pregnancy Category C. Mebendazole has shown embryotoxic and teratogenic activity in pregnant rats at single oral doses as low as 10 mg/kg. In view of these findings the use of VERMOX® is not recommended in pregnant women. In humans, a post-marketing survey has been done of a limited number of women who inadvertently had consumed VERMOX® 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 VERMOX® was identified. During pregnancy, especially during the first trimester, VERMOX® should be used only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether VERMOX® is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when VERMOX® 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.

Last updated on RxList: 5/13/2008

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.

VERMOX® (mebendazole) is contraindicated in persons who have shown hypersensitivity to the drug.

Last updated on RxList: 5/13/2008

Following administration of 100 mg twice daily for three consecutive days, plasma levels of VERMOX® (mebendazole) and its primary metabolite, the 2-amine, do not exceed 0.03 µg/mL and 0.09 µg/mL, respectively. All metabolites are devoid of anthelmintic activity. In man, approximately 2% of administered VERMOX® is excreted in urine and the remainder in the feces as unchanged drug or a primary metabolite.

Mode of Action

VERMOX® inhibits the formation of the worms' microtubules and causes the worms' glucose depletion.

Last updated on RxList: 5/13/2008

Patients should be informed of the potential risk to the fetus in women taking VERMOX® (mebendazole) during pregnancy, especially during the first trimester (see PRECAUTIONS: Use in Pregnancy).

Patients should also be informed that cleanliness is important to prevent reinfection and transmission of the infection.

Last updated on RxList: 5/13/2008

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

MEBENDAZOLE CHEWABLE TABLET - ORAL

(meh-BEN-duh-zole)

COMMON BRAND NAME(S): Vermox

USES: Mebendazole is used to treat intestinal worm infections such as pinworm, roundworm, and hookworm.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used for worm infections elsewhere in the body (e.g., trichinosis). In these cases, it is usually taken more often and for a longer time.

HOW TO USE: This medication is taken by mouth and can be taken with or without food. It may be chewed, swallowed whole, or crushed and mixed with food.

Dosage is based on your medical condition and response to therapy.

For treatment of pinworm infections, the medication is usually given as a single dose. If necessary, a second treatment may be given in a few weeks. For other types of common worm infections (e.g., roundworm, hookworm), take mebendazole by mouth for 3 days, usually twice a day in the morning and in the evening, or as directed by your doctor. If necessary, a second treatment may be given in a few weeks. For other types of infections, follow your doctor's directions. Your doctor may order you to take this medication more often than twice a day and for longer than 3 days.

It is very important to continue taking this medication exactly as prescribed by your doctor. Do not skip any doses. Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear. Stopping the medication too early may result in a return of the infection.

Inform your doctor if your condition persists or worsens.

SIDE EFFECTS: Stomach/abdominal pain, vomiting, diarrhea, headache, dizziness, or drowsiness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: severe abdominal pain, easy bleeding/bruising, signs of serious infection (e.g., fever, persistent sore throat), unusual/extreme tiredness, seizures, weakness, dark or pinkish urine, yellowing eyes/skin.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking mebendazole, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

Tell your doctor your medical history, especially of: low blood count (anemia), liver disease, intestinal problems (e.g., Crohn's disease, ulcerative colitis).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following medication because very serious interactions may occur: metronidazole.

If you are currently using the medication listed above, tell your doctor or pharmacist before starting mebendazole.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: certain anticonvulsants (carbamazepine, phenytoin), cimetidine.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents should call the US National Poison Hotline at 1-800-222-1222. Canada residents should call a provincial poison control center.

NOTES: Do not share this medication with others.

If you are taking this medication for a long time, laboratory and/or medical tests (e.g., complete blood count, liver/kidney function tests) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Pinworm infections can easily spread to others. All family members in close contact with the patient should be treated to decrease the chance of spreading the infection.

Practice strict hygiene to prevent another infection. Wash hands frequently, especially after using the bathroom. Disinfect toilets daily. Change and launder undergarments, towels, and bedclothes daily.

MISSED DOSE: If you are taking more than one dose and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-77 degrees F (15-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.