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ZADITEN tablet

16-06-2009

Generic Name

Ketotifen - allergy

Drug Class Description

Zaditen Tablets 1mg; Ketotifen hydrogen fumarate 1.38 mg (equivalent to 1mg Ketotifen base). Zaditen Elixir 1 mg/5 ml; Ketotifen hydrogen fumarate 1.38 mg/5 ml

Presentation

Zaditen Tablets 1mg; White tablets, 7 mm diameter, with break-line on one side and Zaditen 1 on the other. Zaditen Elixir 1 mg/5 ml; Clear, colourless strawberry flavoured elixir.

Indications

Symptomatic treatment of allergic conditions including rhinitis and conjunctivitis.

Adult Dosage

Tablets

Adults

1mg twice daily with food. If necessary the dose may be increased to 2mg twice daily.

Children (From 3 years of age)

1mg twice daily with food. For patients for whom a tablet form may not be suitable, an alternative dosage form should be considered.

Elixir

Adults

1mg twice daily with food. If necessary the dose may be increased to 2mg twice daily.

Children: (From 3 years of age)

1mg twice daily with food.

Use in the elderly

No evidence exists that elderly patients require different dosages or show different side-effects from younger patients.

Patients known to be easily sedated should be given 0.5 -1mg at night for the first few days (for a 0.5mg dose, an alternative dosage form to capsules should be given).

Method of Administration: Oral

Child Dosage

Under 2 years, not recommended; over 2 years, 1 mg twice daily with food.

Contra Indications

Hypersensitivity to ketotifen or any of the excipients. A reversible fall in the thrombocyte count in patients receiving Zaditen concomitantly with oral anti-diabetic agents has been observed in a few cases. This combination of drugs should therefore be avoided until this phenomenon has been satisfactorily explained.

Special Precautions

Zaditen Tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, of severe lactase deficiency or of glucose-galactose malabsorption should not take this medicine.

Zaditen Elixir contains maltitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Convulsions have been reported very rarely during Zaditen therapy. As Zaditen may lower the seizure threshold it should be used with caution in patients with a history of epilepsy.

Interactions

Zaditen may potentiate the effects of sedatives, hypnotics, antihistamines and alcohol. Patients should be warned not to take charge of vehicles or machinery until the effect of Zaditen treatment on the individual is known.

Adverse Reactions

Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common (GREATER-THAN OR EQUAL TO (8805) 1/10); common (GREATER-THAN OR EQUAL TO (8805) 1/100, < 1/10); uncommon (GREATER-THAN OR EQUAL TO (8805) 1/1,000, < 1/100); rare (GREATER-THAN OR EQUAL TO (8805) 1/10,000, < 1/1,000) very rare (< 1/10,000), including isolated reports. Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.

Infections and infestations
Uncommon: Cystitis
Immune system disorders
Very rare: Erythema multiforme, Stevens-Johnson syndrome, severe skin reaction
Metabolism and nutrition disorders
Rare: Weight increased
Psychiatric disorders
Common: Excitation, irritability, insomnia, nervousness
Nervous system disorders
Uncommon: Dizziness
Rare: Sedation
Very rare: Convulsions
Gastrointestinal disorders
Uncommon: Dry mouth
Hepatobiliary disorders
Very rare: Hepatitis, increase in liver enzymes

Sedation, dry mouth and dizziness may occur at the beginning of treatment, but usually disappear spontaneously with continued medication. Symptoms of CNS stimulation, such as excitation, irritability, insomnia, and nervousness, have been observed particularly in children.

Manufacturer

Novartis

Drug Availability

(POM)