Niclosamide (Oral)

Niclosamide is part of a group of medicines called anthelmintics. Anthelmintics are used to treat infections caused by worms.

Niclosamide is used to treat infections from broad or fish tapeworm, dwarf tapeworm, and beef tapeworm. Your doctor may also prescribe Niclosamide for other tapeworm infections. It will not work for other types of worm infections, such as pinworms or roundworms.

Niclosamide kills tapeworms when it comes into contact with them. The dead worms are then passed out of the body in the stool. However, you might not see them since they can be broken down in the intestine.

You can get Niclosamide only with a prescription from your doctor.

It is important that your doctor check your progress at regular visits. This is to make sure that the infection is cleared up completely.

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This decision is made between you and your doctor. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

This medicine has been tested in a limited number of children 2 years of age or older and, at effective doses, has not been reported to cause different side effects or problems in children compared to adults.

Geriatric

Many medicines have not been specifically studied in older adults. Therefore, it may not be known if they work the same way in older people as they do in younger adults or if they cause different side effects or problems in older individuals. There is no specific information comparing the use of niclosamide in the elderly with its use in other age groups.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might occur. In these situations, your doctor may want to adjust the dose, or other precautions may be necessary. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around meal times, or with certain types of food, as interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they might need medical attention.

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Less common

• Abdominal or stomach cramps or pain
• diarrhea
• loss of appetite
• nausea or vomiting

Rare

• Dizziness or lightheadedness
• drowsiness
• itching of the rectal area
• skin rash
• unpleasant taste

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

No special preparations or additional steps (for example, special diets, fasting, other medicines, laxatives, or enemas) are necessary before, during, or immediately after taking niclosamide.

Niclosamide may be taken on an empty stomach (either 1 hour before or 2 hours after a meal). However, to prevent stomach upset, it is best taken after a light meal (for example, breakfast).

Niclosamide tablets should be thoroughly chewed or crushed and then swallowed with a small amount of water. If this medicine is being given to a young child, the tablets should be crushed to a fine powder and mixed with a small amount of water to form a paste.

For patients taking this medicine for beef tapeworms or broad or fish tapeworms:

• To help clear up your infection completely, take this medicine exactly as directed by your doctor. Usually one dose is enough. However, in some patients a second dose of this medicine may be required to clear up the infection completely.

For patients taking this medicine for dwarf tapeworms:

• To help clear up your infection completely, keep taking this medicine for the full time of treatment (usually 7 days), even if your symptoms begin to clear up after a few days. In some patients, a second course of this medicine may be required to clear up the infection completely. If you stop taking this medicine too soon, your infection may return. Do not miss any doses. Some patients with tapeworm infections may not notice any symptoms or may have only mild symptoms.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets): For fish tapeworm or beef tapeworm: Adults—2 grams as a single dose. Treatment may be repeated in seven days if needed. Children—Dose is based on body weight and must be determined by your doctor. For children weighing 11 to 34 kilograms (kg) (24.2 to 74.8 pounds): 1 gram as a single dose. Treatment may be repeated in seven days if needed. For children weighing over 34 kg (74.8 pounds): 1.5 grams as a single dose. Treatment may be repeated in seven days if needed. For dwarf tapeworm: Adults—2 grams a day for seven days. Treatment may be repeated in seven to fourteen days if needed. Children—Dose is based on body weight and must be determined by your doctor. For children weighing 11 to 34 kg (24.2 to 74.8 pounds): 1 gram on the first day. Then 500 milligrams (mg) once a day for the next six days. Treatment may be repeated in seven to fourteen days if needed. For children weighing over 34 kg (74.8 pounds): 1.5 grams on the first day. Then 1 gram once a day for the next six days. Treatment may be repeated in seven to fourteen days if needed.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.