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Niclosamide, 500 mg chewable tablets

Drug formTablets

ATC categoryAntiparasitic agents

ATC subcategoryAntihelmintics

Brand nameNiclosamide

Generic nameNiclosamide

Composition

Each chewable tablet contains:

active ingredient: niclosamide – 500.0 mg;
excipients: xylitol, maize starch, sodium starch glycolate, magnesium stearate, vanillin, sodium saccharin.

Pharmacological group and ATC code
Anthelmintic; P02DA01.
Chemical name and CAS number
5-chloro-N-(2- chloro-4-nitrophenyl)-2-hydroxybenzamide; 50-65-7.
Pharmacology

Niclosamide is an anthelmintic, which is active against most tapeworms, including the beef tapeworm (Taenia saginata), the pork tapeworm (T. solium), the fish tapeworm (Diphyllobothrium latum), the dwarf tapeworm (Hymenolepis nana) and the dog tapeworm (Dipylidium caninum).

The activity of Niclosamide against these worms appears to be due to inhibition of mitochondrial oxidative phosphorylation; anaerobic ATP production is also affected.

Pharmacokinetics

Niclosamide is not significantly absorbed from the gastrointestinal tract.

Uses
Infections with:

– Taenia saginata (beef tapeworm);

– Taenia solium (pork tapeworm);

– Diphyllobothrium latum (fish tapeworm);

– Hymenolepis nana (dwarf tapeworm);

– Dipylidium caninum (dog tapeworm).

Dosage and administration

Niclosamide is administered in tablets, which must be chewed thoroughly before swallowing and washed down with water.

For infections with pork tapeworm a single 2-g dose is given after a light breakfast. Niclosamide is not active against the larval form (cysticerci) and although the risk of inducing cysticercosis appears to be theoretical, a laxative is given about 2 hours after the dose to expel the killed worms and minimize the possibility of the migration of ova of T. solium into the stomach; also an antiemetic may be given before treatment.

For infections with beef or fish tapeworms the 2-g dose of Niclosamide may be divided, with 1 g taken after breakfast and 1 g an hour later.

In dwarf-tapeworm infections an initial dose of 2 g is given on the first day followed by 1 g daily for 6 days.

Children aged 2 to 6 years are given half the above doses and those under 2 years of age are given one-quarter the above doses.

Unless expulsion of the worm is aided by a laxative, portions are voided in a partially digested form after treatment with Niclosamide; the scolex is rarely identifiable.

Adverse effects
Gastrointestinal disturbances may occur occasionally with Niclosamide. Lightheadedness and pruritus have been reported less frequently.
Contraindications
– Hypersensitivity to niclosamide.

Niclosamide may be given safely to patients with liver, biliary and kidney diseases.

Precautions

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.

No alcohol should be taken during treatment.

Pregnancy and breastfeeding

Niclosamide has not been studied in pregnant women. However, it has not been shown to cause birth defects or other problems in animal studies.

It is not known whether niclosamide passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine should discuss this with their doctor.

Overdosage

Niclosamide is only slightly absorbed, so that toxic effects are not expected.

Identification

Yellow with dark spots, scored cylindrical form chewable tablets with characteristic vanillin odor and taste.

Presentation

4 tablets in a plastic bottle with leaflet in the cardboard box .

Expiry date

3 years. Do not use after the expiration date.

Prescription status

To be dispensed with prescription.

Storage conditions

Store at a room temperature (15-250C), in a dry place, out of the reach of children. Protect from light.