Albenda Tablets, Suspension

Broad-Spectrum Anthelmintic

Composition

Tablets

Each tablet contains:

• Active ingredient: Albendazole 200 mg
• Excipients: Starch, lactose, cross-linked starch, povidone, saccharin sodium, polysorbate, cellulose, vanilla and blood orange flavours, stearic acid, magnesium stearate, aerosil, sodium lauryl sulfate, hypromellose, talc, titanium dioxide, and polyethylene glycol.

Suspension

Each teaspoonful (5 mL) of the suspension contains:

• Active ingredient: Albendazole 100 mg
• Excipients: Saccharin sodium, potassium sorbate, propylene glycol, xanthan gum, fruit flavour, polysorbate, citric acid, vanilla and blood orange flavours, and purified water.

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Properties

Albendazole, the active ingredient in Albenda, is a benzimidazole carbamate anthelmintic with broad-spectrum activity against most helminths. It is vermicide for many parasites and ovicidal/larvicidal for others. It acts on the parasite in all stages of its life cycle. Although its exact mechanism of action is not fully understood, it appears to work by selectively degenerating the cytoplasmic microtubules of intestinal cells, impairing glucose uptake and choline-esterase secretion, leading to energy depletion, immobilization, and death of the parasite.

Albendazole is poorly absorbed after oral administration and undergoes extensive first-pass metabolism to produce an active sulfoxide metabolite, which is excreted in the urine along with other minor metabolites. The sulfoxide metabolite is approximately 70% protein-bound, with a half-life of 8.5 hours.

Albenda is effective against a variety of nematodes, cestodes, and trematodes, including infections such as:

• Enterobiasis (pinworms or threadworms)
• Trichuriasis (whipworms)
• Ascariasis (large roundworms)
• Strongyloidiasis (small roundworms)
• Taeniasis (tapeworms)
• Hookworm infections (Ancylostoma and Necator)
• Infestations of some species of liver flukes

It has been designated an orphan product for use in the treatment of hydatid disease and neurocysticercosis.

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Dosage

Adults and Children Over 2 Years of Age

1. Enterobiasis, Ascariasis, Trichuriasis, Trichostrongyliasis, and Hookworm Infections:

• Single dose of 400 mg.
• If reinfection occurs after 3 weeks, the treatment may be repeated.

1. Strongyloidiasis and Taeniasis:

• 400 mg as a single dose for three days.

1. Hydatid Disease:

• Adults 60 kg or above: 400 mg twice daily with meals for 28 days, followed by 14 albendazole-free days. Up to 3 cycles may be given.
• Adults below 60 kg: 15 mg/kg/day in divided doses twice daily with meals for the same period. Maximum total daily dose should not exceed 800 mg.

1. Neurocysticercosis:

• Same dosage as in hydatid disease but the duration of therapy is 8–30 days.

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If You Missed a Dose

Take the missed dose as soon as possible. If it is almost time for your next regular dose, skip the missed dose. Do not take two doses at the same time.

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Contraindications

Administration in patients with hypersensitivity to the benzimidazole drug class is not recommended. In pregnancy, albendazole is better avoided due to teratogenic results in laboratory animals.

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Precautions

• In pinworm infections, the whole family should be careful and might need to administer the medicine.
• If the helminth is a hookworm or whipworm, it is advisable to take iron supplements.
• It is advised to use an effective form of birth control while taking this medicine and for at least one month after your last dose.
• Caution is recommended in lactating women.
• Since albendazole may cause a reduction in total white cell counts and an elevation in hepatic enzymes with prolonged use, it is recommended that blood counts and liver function tests be carried out at the beginning of each 28-day cycle of therapy and every 2 weeks during therapy. Retreatment with albendazole should not be initiated if significant depression in total white cell counts or elevation in liver enzymes persists.
• Patients with a history of liver disease or currently having liver problems may need special care.

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Overdosage

In animals, symptoms were demonstrated in a dose-response relationship and included diarrhea, vomiting, tachycardia, and respiratory distress. In case of overdosage, symptomatic therapy (e.g., gastric lavage and activated charcoal) and general supportive measures are recommended.

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Side Effects

Patients may experience nausea, vomiting, stomach pain, dizziness, and headache. Co-administration of cimetidine, praziquantel, or dexamethasone with albendazole seems to increase the risk of albendazole side effects.

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Packaging

• Albenda Tablets: Pack of 2 tablets.
• Albenda Suspension: Bottle of 20 mL.

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Storage

Store at a temperature of 15–25°C.

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Important Information

This is a Medicament.
Medicaments are products that affect your treatment, and misuse contrary to instructions is dangerous for you. Follow strictly the prescribed dosage, the method of use, and the advice of the physician and pharmacist. Do not alter or repeat the treatment prescribed for you without consulting a healthcare professional.

Do not repeat the same prescription without consulting your doctor or pharmacist.

Do not use any medicaments outside the recommendation of your healthcare provider.

Council of Arab Health Inspectors Union of Arab Pharmacists

For inquiries, call Toll-Free: 71)800·4994

Produced by Jumma Gen Pharmaceuticals, PO Box 9205, UAE, Date: 04/05/2006