Ketotifen, tablets 1 mg - Product - ATC Classification

Patient information leaflet

KETOTIFEN

Trade name: Ketotifen

International non-proprietary name: Ketotifen

Description: white to almost white biconvex tablets, without odour or with slight characteristic odour.

Composition: each tablet contains: active substance: ketotifen (as ketotifen fumarate) – 1 mg; excipients: microcrystalline cellulose (E-460), croscarmellose sodium (E-468), magnesium stearate (E-470), anhydrous colloidal silicon dioxide (E-551), lactose monohydrate.

Formulation: tablets 1 mg.

Pharmacotherapeutic group: antihistaminic agents for systemic use.

ATC code: R06AX17.

Pharmacological action

Pharmacological action is membrane-stabilizing, antiallergic, antihistamine, antiasthmatic. It prevents bronchospasm development (does not produce bronchodilatory effect). The drug has an inhibitory action on the central nervous system.

Indications for use

Symptomatic treatment of allergic conditions, including rhinitis and conjunctivitis.

Method of administration and posology

The drug is administered during meals.

For adults the drug is administered as 1 mg (1 tablet) twice per day (in the morning and in the evening).

In case of expressed sedative effect, during the first two weeks the drug is administered as 0.5 mg (1/2 of a tablet) BID. If necessary, the daily dose can be increased up to 4 mg (4 tablets) and divided into two intakes.

For children over the age of 3 years the drug is administered in the following way:

If the body weight is less than 25 kg – 0.5 mg (1/2 of a tablet) twice per day (in the morning and in the evening);

If the body weight is more than 25 kg – 1 mg (1 tablet) twice per day. In case of insufficient therapeutic effect after 4-weeks treatment of children with body weight less than 25 kg, the drug dose can be increased up to 1 mg (1 tablet) twice per day.

Treatment duration – not less than 3 months. Treatment cessation takes place during 2-4 weeks by gradual dose reduction (asthmatic symptoms relapse may occur).

Side effects

Nervous system disorders: somnolence, headache, dizziness, response rate deceleration (disappears after several days of therapy), sedative effect, fatigue feeling; rare – anxiety, sleep disorder, nervousness (especially in children).

Gastrointestinal disorders: oral mucosa dryness, appetite increase, nausea, vomiting, gastralgia, constipation,

Urinary tract disorders: dysuria, cystitis.

Others: thrombocytopenia, body weight increase, allergic skin reactions.

Contraindications

Hypersensitivity, pregnancy, lactation (in case of required treatment it is necessary to stop breast-feeding), children under 3 years old.

Use with caution: epilepsy, liver insufficiency.

Overdose

Symptoms: somnolence, nystagmus, confused consciousness, disorientation, brady- or tachycardia, arterial pressure decrease, dyspnea, cyanosis, seizures, increased excitability (especially in children), coma is possible.

Treatment: vomiting induction, gastric lavage (if it is little time after intake), administration of activated charcoal, saline laxative agents; symptomatic treatment, in case of convulsive disorders – short-acting barbiturates and benzodiazepines. Dialysis in ineffective.

Peculiarities of use

Abrupt cessation of the previous treatment with beta adrenoreceptors, glucocorticosteroids, adrenocorticotropic hormone drugs in patients with asthma and bronchospastic syndrome after addition of ketotifen is undesirable, and cessation is performed during at least 2 weeks by gradual dose reduction.

Treatment is gradually withdrawn during 2-4 weeks (asthmatic symptoms relapse may occur).

For patients with sensitivity to sedative effect, the drug is administered in low doses for the first 2 weeks.

The drug is not indicated for asthma attack rapid relief.

Peripheral blood thrombocytes level should be monitored in patients concomitantly receiving oral hypoglycemic drugs.

Use in pregnancy and lactation. It is not recommended to use ketotifen during pregnancy, though there are no evidence of teratogenic effects. Ketotifen is excreted into human milk, therefore mothers receiving the drug should not breast-feed.

Precautions

Ketotifen tablets contain lactose. Patients with rare congenital galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption should not take ketotifen.

Effects on ability to drive and use other potentially dangerous mechanisms. During the treatment period, it is recommended to exercise caution while driving and performing other work, requiring increased attention, concentration and psychomotor abilities quick response rate.

Interaction with other medicinal products

It enhances the effect of sedative, sleeping, antihistamine drugs, ethanol. In combination with hypoglycemic drugs, thrombocytopenia development possibility increases.

Storage conditions

Store in protected from moisture and light place at temperature below 25 °С.

Keep out of reach of children.

Shelf life

3 years.

Do not use after expiration date, stated on the packaging.

Packaging

10 tablets per blister container. One, three blister containers together with the leaflet are placed into a packaging.

Prescription status

Over the counter

Manufacturer:

Belmedpreparaty RUE