ZENTEL® TABLETS 200 mg (tablets) ZENTEL® SUSPENSION 20 mg/mL (suspension)

ZENTEL® TABLETS 200 mg (tablets)
ZENTEL® SUSPENSION 20 mg/mL (suspension)

SCHEDULING STATUS:
S4

PROPRIETARY NAMES
(and dosage form):

ZENTEL^® TABLETS 200 mg (tablets)
ZENTEL^® SUSPENSION 20 mg/mL (suspension)

COMPOSITION:
The chemical name of albendazole is methyl [5-(propylthio)-1H-benzimidazol-2-yl] carbamate.
Each ZENTEL 200 mg tablet contains 200 mg albendazole.
The suspension contains 100 mg albendazole in each 5 mL, preserved with potassium sorbate 0,39% m/v, benzoic acid 0,2% m/v and sorbic acid 0,08% m/v.

PHARMACOLOGICAL CLASSIFICATION:
A12 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,

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.
INDICATIONS:
ZENTEL 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.
ZENTEL has been shown to be effective in the treatment of Giardia (duodenalis or intestinalis or lamblia) infections in children.

CONTRA-INDICATIONS:
Albendazole is known to be teratogenic and embryotoxic in animals. The safety of albendazole during pregnancy has not been established, and ZENTEL 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. ZENTEL is contra-indicated in patients with a known history of hypersensitivity to albendazole or constituents.

DOSAGE AND DIRECTIONS FOR USE:
Usual Dose:
400 mg (two ZENTEL 200 mg tablets) or 20 mL (400 mg) of ZENTEL suspension as a single dose in both adults and children over two years of age. The tablets may be chewed, swallowed or crushed and mixed with food. The usual dose in children between one and two years of age is 10 mL (200 mg) of ZENTEL suspension as a single dose. 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 (two 200 mg tablets or 20 mL suspension) for five days.
The tablets may be chewed, swallowed or crushed and they should be taken with food.

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:
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.

IDENTIFICATION:
ZENTEL 200 mg tablets are off-white, circular, bevel-edged, film-coated tablets incorporating a slightly raised, pentagonal projection on both sides, odourless or almost odourless.
ZENTEL suspension is a white, pleasant tasting, orange-vanilla flavoured suspension.

PRESENTATION:
ZENTEL 200 mg tablets are available in blister pack strips of two tablets and packs of 100 x 2 tablets. ZENTEL suspension is available in 20 mL bottles.

STORAGE INSTRUCTIONS:
Store in a cool place (below 25°C). Protect suspension from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
ZENTEL Tablets 200 mg:                       Q/12/74ZENTEL Suspension 20 mg/mL:        Q/12/75Zimbabwe:
ZENTEL Tablets 200 mg:                       83/7.7/1655 PZENTEL Suspension 20 mg/mL:        83/7.7/1656 P
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
GlaxoSmithKline South Africa (Pty) Ltd.
57 Sloane Street, Bryanston, 2021.
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