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AD-Albendazole

Adpharm Pharmaceuticals Limited
60, Ajao Road, Surulere, Lagos State, Nigeria
Email: adpharm2010@yahoo.com; info@adpharmltd.com
Tel: +234(0)818-839-0519, +234(0)807-408-4334. Mobile: 08033481022
Website: http://adpharmltd.com/

Brand Name

AD-Albendazole

Manufacturer

Globela Pharma Pvt Ltd. 357, G.I.D.C., Sachin Surat -394 230. Gujarat. (India) www.globelapharma.com

Therapeutic Class

Anthelmintics

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Tablet (NRN: B4-0380): Each uncoated chewable tablet contains: Albendazole USP 400 mg. Excipients q.s.

Pack size: AD-ALBENDAZOLE 400 mg tablets are available in blister pack of one tablets. 

AD Albendazole Tablet

 

Pharmacology

PHARMACOLOGICAL CLASSIFICATION: A 12 Anthelmintics.

PHARMACOLOGICAL ACTION: Albendazole is a benzimidazole carbamate with anthelmintic and antiprotozoal activity against intestinal and tissue parasites. Animal studies have shown that albendazole exhibits vermicidal, ovacidal and larvacidal activity and exerts its anthelmintic effect by inhibiting tubulin polymerization.

This causes the disruption of the helminth metabolism, including energy depletion, which immobilises and then kills the susceptible helminth. In man, after oral administration, albendazole is absorbed and completely metabolized. At a dose of 6.6 mg/kg of albendazole the plasma concentration of its main metabolite, the sulfoxide, attains a maximum of 0.25 to 0.30 micrograms/mL after approximately 2½ hours. The half-life of the sulfoxide in the plasma is 8% hours. The metabolite is essentially eliminated via the urine.

PHARMACOLOGICAL CLASSIFICATION:

Indications

AD-ALBENDAZOLE is indicated in the treatment of single or mixed intestinal parasites. Clinical studies have shown albeneffective in the treatment of Ascaris lumbricoides (roundworm), Trichuris trichiura (whipworm), Enterobius vermicularis (pinworm/threadworm), Ancylostoma duodenale and Necator americanus (hookworm), Taenia spp. (tapeworm) and Strongyloides stercoralis.

AD-ALBENDAZOLE has been shown to be effective in the treatment of Giardia (duodenalis or intestinalis or lamblia) infections in children. In order to avoid administering albendazole during early pregnancy, women of childbearing age should initiate treatment during the first week of menstruation or after a negative pregnancy test.

Contra-indications

Albendazole is known to be teratogenic and embryotoxic in animals. The safety of albendazole during pregnancy has not been established, and AD-ALBENDAZOLE should not be taken by pregnant women at any stage of their pregnancy or by women who are likely to become pregnant, during or shortly after the course of therapy.

AD-ALBENDAZOLE is contra-indicated in patients with a known history of hypersensitivity to albendazole or constituents.

Precautions/Warnings

It has been noted that leucopaenia has occurred when used for periods longer than recommended. In order to avoid administering albendazole during early pregnancy, women of childbearing age should initiate treatment during the first week of menstruation or after a negative pregnancy test.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:

Gastrointestinal discomfort, diarrhoea, headache and dizziness have been reported. Hypersensitivity reactions including rash, pruritus and urticaria have been reported less frequently.

Interactions

Interactions: Praziquantel has been reported to increase the plasma levels of the albendazole active metabolite.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:

If poisoning or excessive overdosage is suspected it is recommended, on general principles, that vomiting be induced or gastric lavage be performed, and such symptomatic supportive therapy be administered as appears indicated.

Adverse Effects

Gastrointestinal discomfort, diarrhoea, headache and dizziness have been reported. Hypersensitivity reactions including rash, pruritus and urticaria have been reported less frequently.

Dosage & Administration

Usual Dose: 400 mg (one AD-ALBENDAZOLE 400 mg tablets) in both adults and children over two years of age.

The tablets may be chewed, swallowed or crushed and mixed with food. In heavy mixed infestation involving Strongyloides or Taeniasis, a single daily dose may be inadequate and the dose may be given for three consecutive days.

Note: If the patient is not cured after three weeks, a second course of treatment may be given.

No special procedures, such as fasting or purging, are required. Albendazole has not been adequately studied in children under one year of age. Giardiasis (dose in children over 2 years of age):

A single 400 mg daily dose (One 400 mg tablets) for five days. The tablets may be chewed, swallowed or crushed and they should be taken with food.

Storage/Handling Recommendations

Store in a cool place below 25oC.

Review Date

2016-10-05 06:27:11