ZENTEL™

Albendazole
COMPOSITION

Tablet containing 200 mg or 400 mg albendazole.

4 % w/v suspension to be taken orally; 4 g albendazole per 100 ml.

USE

ZENTEL is a benzimidazole carbamate with anthelmintic and antiprotozoal activity against the
following intestinal and tissue parasites: Round-worm (Ascaris lumbricoides), pin-worm (Enterobius
vermicularis), hook-worm (Necator americanus, Ancylostoma duodenale), whip-worm (Trichuris
trichiura), thread-worm (Strongyloides stercoralis), tape-worm (Taenia spp and Hymenolepis nana only
in the case of associated parasitism), Chlonorchiasis (Chlonorchis sinensis), Opisthorchiasis
(Opisthorchis viverrini) and cutaneous larva migrans; Giardiasis (G.lamblia, G.duodenalis, G.intestinalis,
Lamblia intestinalis) in children.

DOSAGE
Indications Age Dose Period

- Round-worm adults and 400 mg [two 200 mg single dose (to be

children over 2 tablet(s) or 10 ml 4% taken on an empty
- Pin-worm* years of age suspension]# stomach)

- Hook-worms

- Whip-worm

children 1-2 years 200 mg (one 200 mg single dose (to be

of age tablet or 5 ml 4% taken on an empty
suspension) stomach)

- Strongyloidiasis adults and 400 mg (#see above) one dose per day
children over 2 for 3 days (to be
- Taeniasis years of age taken on an empty
stomach)
- Hymenolepiasis**

-Chlonorchiasis*** adults and 400 mg (#see above) two doses per day
children over 2 for 3 days (to be
-Opisthorchiasis*** years of age taken with food)

Cutaneous larva adults and 400 mg Once daily for 1

migrans children over 2 to 3 days (to be
years of age taken with food)

- Giardiasis children 2 - 12 400 mg (#see above) one dose per day

years of age only for 5 days (to be
taken on an empty
stomach)

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*
In order to obtain a complete cure in the case of pin-worm infestation, prescribe strict measures of
hygiene, also treat the relatives and individuals sharing the same housing.
**
In cases of proven Hymenolepiasis, retreatment in 10-21 days is recommended.

***Patients should be re-examined 1 month after treatment to confirm fluke eradication.

METHOD OF ADMINISTRATION
If the patient is not cured after three weeks, a second course of treatment is indicated.
No special procedures, such as fasting or purging, are required.
Some people, particularly young children, may experience difficulties swallowing the tablets whole and
should be encouraged to chew the tablets with a little water; alternatively the tablets may be crushed.

CONTRAINDICATIONS

ZENTEL should not be administered during pregnancy, or in women thought to be pregnant.

ZENTEL is contraindicated in patients with a known history of hypersensitivity to the drug (albendazole
or constituents).

WARNINGS AND PRECAUTIONS

In order to avoid administering ZENTEL during early pregnancy, women of childbearing age should
initiate treatment during the first week of menstruation or after a negative pregnancy test.

Treatment with ZENTEL may uncover pre-existing neurocysticercosis, particularly in areas with high
taenosis infection. Patients may experience neurological symptoms e.g. seizures, increased intracranial
pressure and focal signs as a result of an inflammatory reaction caused by death of the parasite within the
brain. Symptoms may occur soon after treatment, appropriate steroid and anticonvulsant therapy should
be started immediately.

Use with caution in elderly patients with evidence of hepatic dysfunction.

Patients with renal impairment should be carefully monitored.

Patients with abnormal liver function test results (transaminases) prior to commencing albendazole
therapy should be carefully monitored.

INTERACTIONS

Cimetidine, praziquantel and dexamethasone have been reported to increase the plasma levels of the
albendazole active metabolite responsible for the systemic efficicacy of the product.

Ritonavir, phenytoin, carbamazepine and phenobarbital may have the potential to reduce plasma
concentrations of the active metabolite of albendazole; albendazole sulfoxide. The clinical relevance of
this is unknown, but may result in decreased efficacy, especially in the treatment of systemic helminth
infections. Patients should be monitored for efficacy and may require alternative dose regimens or
therapies.

PREGNANCY AND LACTATION

Albendazole should not be administered during pregnancy or in women thought to be pregnant (see
Contraindications).

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It is not known whether albendazole or its metabolites are secreted in human breast milk. Thus
ZENTEL should not be used during lactation unless the potential benefits are considered to outweigh
the potential risks associated with treatment.

ADVERSE REACTIONS

Hypersensitivity reactions including rash, pruritis and urticaria (rare).

Headache and dizziness (uncommon).

Upper gastrointestinal symptoms (e.g. epigastric or abdominal pain, nausea, vomiting) and diarrhoea
(uncommon).

Elevations of hepatic enzymes (rare).

Erythema multiforme, Stevens-Johnson syndrome (very rare).

OVERDOSE

Further management should be as clinically indicated or as recommended by the national poisons centre,
where available.

FURTHER INFORMATION

Zentel exhibits larvicidal, ovicidal and vermicidal activity, and exerts its antihelmintic effect by
inhibiting tubulin polymerisation. This disrupts helminth metabolism, causing energy depletion, which
immobilises and then kills the susceptible helminth.

STORAGE CONDITION

Tablets: Store below 30°C.

Suspensions: Store below 30°C and protect from direct sunlight.

INSTRUCTIONS FOR USE/HANDLING

Suspensions: Shake well before use.

PHARMACEUTICAL PARTICULARS
List of Excipients

Zentel Tablet 200mg

Lactose
Maize starch
Polyvidone
Sodium lauryl sulphate
Sodium starch glycollate
Microcrystalline cellulose
Sodium saccharin
Magnesium stearate
Purified water

Film coating
Methylhydroxypropyl cellulose 15
Methylhydroxylpropyl 5
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Propylene glycol
Purified water

Zentel Tablet 400mg

Lactose
Microcrystalline cellulose
Maize starch
Croscarmellose sodium
Povidone
Sodium lauryl sulphate
Sunset yellow lake
Sodium saccharin
Magnesium stearate
Orange flavour
Vanilla favour
Passion fruit flavour

Zentel Suspension 400mg/10ml

Sodium Lauryl Sulfate

Glycerin
Methylparaben
Propylparaben
Sodium Carboxymethylcellulose 7MF
Sodium Carboxymethylcellulose 7HF
Saccharin sodium
Orange flavour
Vanilla favour
Passion fruit flavour

VERSION NUMBER: IPI 07SI

DATE OF ISSUE: 23 JULY 2010
Zentel is a trademark of the GlaxoSmithKline group of companies

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