Ketotifenum

Ketotifenum – antiallergic means, the stabilizer of membranes of mast cells.

Form of release and structure

Dosage forms:

• Tablets: a round, ploskotsilindrichesky form, white color, with a facet and dividing risky, with a slight smell or without it (on 10 pieces in a blister strip packaging, in a cardboard pack of 1, 2, 3, 4 or 5 packagings);
• Syrup (on 100 ml in dark glass bottles, in a cardboard pack 1 bottle complete with a measured glass).

Active agent – Ketotifenum fumarates:

• 1 tablet – 1,3 mg that corresponds to 1 mg of Ketotifenum;
• 5 ml of syrup – 1 mg.

Auxiliary components as a part of tablets: lactoses monohydrate (sugar milk), potato starch, magnesium stearate.

Indications to use

Use of Ketotifenum in the form of tablets is shown:

• Atopic bronchial asthma;
• Seasonal allergic rinokonjyunktivit (pollinosis);
• Atopic dermatitis;
• Allergic conjunctivitis;
• Allergic rhinitis;
• Small tortoiseshell.

Drug in the form of syrup is accepted for prevention stated above and other allergic diseases, including an allergic bronchitis.

Contraindications

• Breastfeeding period;
• Hypersensitivity to drug components.

Besides, a contraindication to use of tablets is:

• Pregnancy period;
• Age up to 3 years.

Babies cannot appoint syrup aged up to 6 months.

With care it is recommended to appoint:

• Tablets: at a liver failure and the patient with epilepsy;
• Syrup: the pregnancy period, especially in the I trimester.

Route of administration and dosage

• Tablets: accept orally, in the morning and in the evening during food. The recommended dosing for adults and children – on 1 tablet 2 times a day, in hard cases is allowed increase in a dose for adults to 2 mg 2 times a day. The treatment period – 3 and more months. Drug withdrawal should be carried out gradually, within 2-4 weeks;
• Syrup: accept inside in the morning and in the evening during food. Dosing for adults and children aged from 3 years – on 1 mg (5 ml) 2 times a day; for children from 6 months to 3 years – on 0,5 mg 2 times a day. The daily dose for adults if necessary can be raised to 4 mg.

Side effects

Use of Ketotifenum can cause side effects:

• From a nervous system: dizziness (at syrup reception – a lung), drowsiness, delay of speed of mental reactions (as a rule, are temporary and pass within several days of use);
• From urination: cystitis, dysuria;
• From a metabolism: increase in body weight;
• From system of a hemopoiesis: thrombocytopenia.

Besides, at reception of tablets can arise:

• From a nervous system: feeling of fatigue, sedation; seldom – sleep disorders, concern, nervousness (it is especially frequent at children);
• From the alimentary system: nausea, dryness in a mouth, vomiting, a lock, increase in appetite, a gastralgia;
• Others: skin allergic reactions.

At syrup reception side effects can also become:

• From the alimentary system: increase in appetite is possible; seldom – dryness in a mouth, dispeptic symptoms.

Special instructions

The therapeutic effect of Ketotifenum occurs after 1-2 months of use.

The previous use of glucocorticosteroids, beta адреностимуляторов, adrenocorticotropic hormones (AKTG) at patients with a bronkhospastichesky syndrome and bronchial asthma it is necessary to continue after purpose of Ketotifenum within 2 or more weeks before cancellation, reducing gradually doses.

Sharp cancellation of Ketotifenum can cause a recurrence of asthmatic symptoms therefore it is recommended to stop reception gradually, within from 2 to 4 weeks.

At simultaneous use with syrup the dose decline of bronchodilators is allowed.

Tablets are not intended for stopping of attacks of bronchial asthma.

At a concomitant use of tablets with peroral hypoglycemic means, at patients it is recommended to control the maintenance of thrombocytes in peripheral blood.

At sensitivity to sedative action drug small doses is recommended to accept the first 2 weeks of treatment by the patient.

During use of Ketotifenum it is necessary to abstain from control of vehicles and mechanisms, and also occupations those types of activity which performance demands high concentration of attention and bystry psychomotor reactions.

Medicinal interaction

At a combination with antihistaminic, hypnagogues and ethanol Ketotifenum strengthens their action.

Simultaneous use of each of dosage forms with peroral hypoglycemic drugs: the risk of development of thrombocytopenia increases.

Syrup increases activity of sedatives.

Terms and storage conditions

To store in the dry, protected from light place at a temperature up to 25 °C.

To protect from children.

Period of validity – 3 years.