Drugs Details

Drugs Info of Vermox
Drugs Details
  • Drugs Type  : FDA
  • Date : 24th Feb 2015 03:39 am
  • Brand Name : Vermox
  • Generic Name : mebendazole (Pronunciation: me BEN da zole)
Descriptions

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.

 

What are the possible side effects of mebendazole (Vermox)?

Stop taking mebendazole and seek emergency medical attention if you experience an allergic reaction (swelling of your lips, tongue, or face; shortness of breath; closing of your throat; or hives).

Other, less serious side effects may be more likely to occur. Continue to take mebendazole and talk to your doctor if you experience abdominal pain, diarrhea, or a fever.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at...

Read All Potential Side Effects and See Pictures of Vermox »

What are the precautions when taking mebendazole (Vermox)?

Before taking mebendazole, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

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...

Read All Potential Precautions of Vermox »

 

This monograph has been modified to include the generic and brand name in many instances.

Indications

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 andgastrointestinal 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%

 

 
 

Dosage Administration

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.

How Supplied

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).

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

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. 

Read the Vermox (mebendazole) Side Effects Center for a complete guide to possible side effects

Learn More

Interactions

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

Read the Vermox Drug Interactions Center for a complete guide to possible interactions

Learn More »
 

This monograph has been modified to include the generic and brand name in many instances.

 
 

Warnings

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

Precautions

Carcinogenesis and Mutagenesis

In carcinogenicity tests of mebendazole in mice and rats, no carcinogeniceffects 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 F1translocation 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 andteratogenic activity in pregnant rats at single oral doses as low as 10 mg/kg. In view of these findings the use of VERMOX® (mebendazole) 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® (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 VERMOX® (mebendazole) was identified. During pregnancy, especially during the first trimester, VERMOX® (mebendazole) should be used only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

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

This monograph has been modified to include the generic and brand name in many instances.

OverDose

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.

ContrainDications

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

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

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® (mebendazole) is excreted in urine and the remainder in the feces as unchanged drug or a primary metabolite.

Mode of Action

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

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

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

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

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

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.

Consumer Overview Side Effect

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 (especially of the face/tongue/throat), 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.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Vermox (mebendazole) Side Effects Center for a complete guide to possible side effects

Learn More »
 

PRECAUTIONS: Before taking mebendazole, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

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.

Consumer Overview Missed Dose

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include: certain anticonvulsants (carbamazepine, phenytoin), cimetidine, metronidazole.

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can 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 March 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Vermox

Generic Name: mebendazole (Pronunciation: me BEN da zole)

  • What is mebendazole (Vermox)?
  • What are the possible side effects of mebendazole (Vermox)?
  • What is the most important information I should know about mebendazole (Vermox)?
  • What should I discuss with my healthcare provider before taking mebendazole (Vermox)?
  • How should I take mebendazole (Vermox)?
  • What happens if I miss a dose (Vermox)?
  • What happens if I overdose (Vermox)?
  • What should I avoid while taking mebendazole (Vermox)?
  • What other drugs will affect mebendazole (Vermox)?
  • Where can I get more information?

What is mebendazole (Vermox)?

 

Mebendazole is an "antihelmintic," or anti-worm, medication. It prevents worms from growing or multiplying in your body.

Mebendazole is used to treat infections caused by worms such as whipworm, pinworm, roundworm, and hookworm. It is also used to treat infections caused by more than one of these worms at the same time.

Mebendazole may also be used for purposes other than those listed in this medication guide.

Mebendazole 100 mg-TEV

round, peach, imprinted with COPLEY 107

What are the possible side effects of mebendazole (Vermox)?

 

Stop taking mebendazole and seek emergency medical attention if you experience an allergic reaction (swelling of your lips, tongue, or face; shortness of breath; closing of your throat; or hives).

Other, less serious side effects may be more likely to occur. Continue to take mebendazole and talk to your doctor if you experience abdominal pain, diarrhea, or a fever.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Vermox (mebendazole) Side Effects Center for a complete guide to possible side effects

Learn More »
 

What is the most important information I should know about mebendazole (Vermox)?

 

Follow your doctor's instructions about treatment; about the washing of clothes, linens, and towels; and about household disinfecting. Pinworm infections are easily spread from one person to another.

Mebendazole tablets may be swallowed, chewed, or crushed and mixed with food.

Side Effects Centers
  • Vermox

Patient Detailed How Take

What should I discuss with my healthcare provider before taking mebendazole (Vermox)?

 

Before taking mebendazole, tell your doctor about any other medical conditions that you have.

Mebendazole is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not take mebendazole without first talking to your doctor if you are pregnant or could become pregnant during treatment.

It is not known whether mebendazole passes into breast milk and how it might affect a nursing baby. Do not take mebendazole without first talking to your doctor if you are breast-feeding a baby.

Children younger than 2 years of age should not take mebendazole unless otherwise directed by your doctor.

How should I take mebendazole (Vermox)?

 

Take mebendazole exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

Mebendazole tablets may be swallowed, chewed, or crushed and mixed with food.

Take all of the mebendazole that has been prescribed for you even if you begin to feel better. Your symptoms may start to improve before the infection is completely treated.

It may be up to 3 days after treatment before the worm is removed from your stomach and intestines. The amount of time it takes to cure the infection depends on how susceptible the worm is to mebendazole, and how quickly your own digestive system is moving. If the infection has not been cured within 3 weeks, a second treatment may be necessary.

Fasting, laxatives, and purging will not help cure this infection.

Treatment of family members and other close contacts may be necessary. Pinworm is spread very easily to others in close contact with the infected person.

To prevent reinfection, toilets must be disinfected daily, and clothing, linens, towels, and pajamas must be changed and washed daily.

Store mebendazole at room temperature away from moisture and heat.

Side Effects Centers
  • Vermox

Patient Detailed Avoid Taking

What happens if I miss a dose (Vermox)?

 

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose (Vermox)?

 

Seek emergency medical attention if an overdose is suspected.

Symptoms of a mebendazole overdose include nausea, vomiting, diarrhea, and abdominal pain.

What should I avoid while taking mebendazole (Vermox)?

 

Treatment of family members and other close contacts may be necessary. Pinworm is spread very easily to others in close contact with the infected person.

To prevent reinfection, toilets must be disinfected daily, and clothing, linens, towels, and pajamas must be changed and washed daily.

What other drugs will affect mebendazole (Vermox)?

 

Medicines used to treat seizures, such as phenytoin (Dilantin), ethotoin (Peganone), mephenytoin (Mesantoin), and carbamazepine (Tegretol), may decrease the effects of mebendazole. Tell your doctor if you are taking any of these medications so that your therapy can be monitored.

Drugs other than those listed here may also interact with mebendazole. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

Where can I get more information?

 

Your pharmacist can provide more information about mebendazole.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 3.02. Revision date: 12/15/2010.

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