Zarontin 250mg/5ml Syrup

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ethosuximide

Available from:

Essential Pharma Ltd

ATC code:

N03AD; N03AD01

INN (International Name):

Ethosuximide

Dosage:

250mg/ml micromole(s)

Pharmaceutical form:

Syrup

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Succinimide derivatives; ethosuximide

Authorization status:

Marketed

Authorization date:

1979-04-01

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zarontin 250mg/5ml Syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml contains ethosuximide 250mg.
Excipients with known effect:
Each 5ml contains sucrose 3g and glucose 4.6mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Syrup.
A clear, slightly yellowish to slightly pinkish, dye-free, raspberry
flavoured syrup.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Primarily useful in absence seizures. When generalised tonic clonic
seizures (grand mal) and other forms of epilepsy
co-exist with absence seizures, Zarontin may be administered in
combination with other antiepileptic drugs.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral use.
Adults, the Elderly and Children over 6 Years:
Start with a small dose - 500mg (2x 5ml) daily with increments of
250mg every five to seven days until control is
achieved with 1000 - 1500 mg daily. Occasionally 2000 mg in divided
doses may be necessary.
Children aged 0-6 years:
Begin with a daily dose of 250 mg (5ml) and increase the dose
gradually by small increments every few days until
control is achieved. The optimal dose in most children is 20
mg/kg/day. The maximum dose should be 1000 mg.
Effective plasma levels of ethosuximide normally lie between 40 and
100 mcg per ml, but the clinical response should
be the criteria for the regulation of the dosage. The half-life of
ethosuximide in the plasma is more than 24 hours but
the daily dose if large is more comfortably divided between morning
and evening.
Currently available clinical trial data regarding the use of
ethosuximide in the paediatric population are described in
section 5.1.
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