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Uses

What is Fucagar® (Mebendazole) used for?

Fucagar® is commonly used for

• Preventing worms from growing or multiplying in your body.
• Treating infections caused by worms such as whipworm, pinworm, roundworm, and hookworm.
• Treating infections caused by more than one of these worms at the same time.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using Fucagar® (Mebendazole).

What is the dose of Fucagar® (Mebendazole) for an adult?

Consult your doctor for information about the dose of Fucagar®.

Usual adult dose for angiostrongylosis:

100 mg orally twice a day for 5 days.

Usual adult dose for ascariasis:

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.

Usual adult dose for capillariasis:

200 mg orally twice a day for 20 days. Relapses may be treated with prolonged courses of therapy.

Usual adult dose for trichostrongylosis:

100 mg orally twice a day for 3 days.

Usual adult dose for filariasis:

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

Usual adult dose for hookworm infection (necator or ancylostoma):

100 mg orally twice a day for 3 days.

Usual adult dose for whipworm infection (trichuris trichiura):

100 mg orally twice a day for 3 days.

Usual adult dose for pinworm infection (enterobius vermicularis):

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

Usual adult dose for trichinosis:

200 to 400 mg orally three times a day for 3 days, then 400 to 500 mg three times a day for 10 days. Concomitant steroid therapy may be administered if patient is symptomatic.

Usual adult dose for visceral larva migrans (toxocariasis):

100 to 200 mg orally twice daily for 5 days. Co-administration of anti-inflammatory agents might be considered.

Usual adult dose for echinococcus infection:

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

Usual adult dose for hydatid disease:

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

Usual adult dose for dracunculiasis:

400 to 800 mg per day for 6 days.

What is the dose of Fucagar® (Mebendazole) for a child?

Consult your doctor for information about the dose of Fucagar®.

Usual pediatric dose for angiostrongylosis:

Greater than or equal to 2 years: 100 mg orally twice a day for 5 days.

Usual pediatric dose for ascariasis:

Greater than or equal to 2 years: 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.

Usual pediatric dose for capillariasis:

Greater than or equal to 2 years: 200 mg orally twice a day for 20 days. Relapses may be treated with prolonged courses of therapy.

Usual pediatric dose for filariasis:

Greater than or equal to 2 years: 100 mg orally one time. This dose should be repeated in 2 weeks. All family members and close contacts should also be examined.

Usual pediatric dose for hookworm infection (necator or ancylostoma):

Greater than or equal to 2 years: 100 mg orally twice a day for 3 days.

Usual pediatric dose for whipworm infection (trichuris trichiura):

Greater than or equal to 2 years: 100 mg orally twice a day for 3 days.

Usual pediatric dose for pinworm infection (enterobius vermicularis):

Greater than or equal to 2 years: 100 mg orally one time. This dose should be repeated in 2 weeks. All family members and close contacts should also be examined.

Usual pediatric dose for trichinosis:

Greater than or equal to 2 years: 200 to 400 mg orally three times daily for 3 days, then 400 to 500 mg three times daily for 10 days.

Usual pediatric dose for visceral larva migrans (toxocariasis):

Greater than or equal to 2 years: 100 to 200 mg orally twice daily for 5 days. Co-administration of anti-inflammatory agents might be considered.

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

Directions

How should I take Fucagar® (Mebendazole)?

For orally taken form, you should:

• Take Fucagar® by mouth as directed by your doctor concerning: dose, schedule.
• Read the label carefully before using Fucagar®.
• Consult your doctor for any information on the label that you do not clearly understand.
• 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.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

Symptoms of overdose include:

• Nausea;
• Vomiting;
• Diarrhea;
• Abdominal pain.

What should I do if I miss a dose?

If you miss a dose of Fucagar®, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Side effects

What side effects can occur from Fucagar® (Mebendazole)?

As taking others medicines, taking Fucagar® can cause some side effects. Most of them are rarely occurring and do not need any supplementary treatment. However, it is always important for you to consult your doctor if you have any problem after taking this medicine.

Some of side effects are listed below:

• Stomach/abdominal pain;
• Vomiting;
• Diarrhea;
• Headache;
• Dizziness;
• Drowsiness;
• 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;
• Serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat);
• Trouble breathing.

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

Precautions/Warnings

What should I know before using Fucagar® (Mebendazole)?

Before using Fucagar®, tell your doctor if you have:

• Allergic reaction: to Fucagar®, excipients using for dosage form containing Fucagar®. The information is detailed in the leaflet.
• Allergic reaction to any other medicines, foods, dyes, preservatives, or animals.
• Pediatric.
• Geriatric.
• Used any other health conditions, drugs that have a risk of interaction with Fucagar® such as Crohn’s disease, liver disease or ulcerative colitis.

Is it safe in specific conditions (e.g. pregnancy, breastfeeding, or surgery)?

There are no adequate studies in women for determining risk when using Fucagar® during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Fucagar®. Fucagar® is pregnancy risk category C, according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

• A=No risk;
• B=No risk in some studies;
• C=There may be some risk;
• D=Positive evidence of risk;
• X=Contraindicated;
• N=Unknown.

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 breastfeeding a baby.

Interactions

What drugs may interact with Fucagar® (Mebendazole)?

Fucagar® may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

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.

Does food or alcohol interact with Fucagar® (Mebendazole)?

Fucagar® may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

How do I store Fucagar® (Mebendazole)?

Fucagar® is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Fucagar® in the bathroom or the freezer. There may be different brands of Fucagar® that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Fucagar® down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

How is Fucagar® (Mebendazole) available?

Fucagar® is available in the following dosage forms and strengths:

• Chewable tablet, 500 mg.