Zaditenum

Zaditenum – antiallergic means.

Form of release and structure

Dosage forms:

• Tablets (on 10 pieces in a blister strip packaging, in a box 3 packagings);
• Syrup for children (on 100 ml in bottles);
• Drops are eye: transparent, colourless or yellowish color liquid, inodorous (on 5 ml in polyethylene bottles with a dropper, in a cardboard pack 1 bottle).

Active ingredient of Zaditenum – Ketotifenum:

• 1 tablet – 1 mg (in the form of a gidrogenfumarat);
• 1 ml of syrup – 0,2 mg;
• 1 ml of drops – 0,25 mg that is equivalent to 0,345 mg of Ketotifenum of a gidrofumarat.

Auxiliary components as a part of drops: sodium hydroxide (1M solution), глицерол, a benzalkoniya chloride, water for injections.

Indications to use

Tablets and syrup for children

• Prevention and treatment of a chronic and acute small tortoiseshell, atopic dermatitis, allergic rhinitis, conjunctivitis;
• Allergic bronchitis;
• Prevention of attacks of bronchial asthma, including the mixed form;
• Hay fever (asthmatic symptoms).

Drops are eye

Allergic conjunctivitis (prevention and treatment).

Contraindications

• Pregnancy period;
• Individual hypersensitivity to Ketotifenum.

Besides, use of Zaditenum is contraindicated:

• Tablets and syrup: breastfeeding period;
• Drops are eye: the children's age is younger than 12 years.

With care it is necessary to appoint tablets and syrup the patient with a liver failure, epilepsy.

Use of drops during feeding by a breast has to be followed by careful observation of the doctor.

Route of administration and dosage

Tablets

Pill is taken inside, during food. The dosing mode for adults – on 1 mg 2 times a day (in the morning and in the evening). Course of treatment of 3 and more months. In the absence of sufficient clinical effect the single dose can be raised to 2 mg. Therapy cancellation is recommended gradual (within 2-4 weeks).

Syrup for children

Syrup is accepted inside. The recommended dosing has age restrictions:

• Age up to 6 months – on 0,05 mg on 1 kg of weight;
• 6 months-3 of year – 0,5 mg 2 times a day;
• 3 years are also more senior – 1 mg 2 times a day.

It is necessary to continue treatment not less than 3 months.

Drug withdrawal is carried out with a gradual dose decline within 0,5-1 months.

Drops are eye

Drops use konjyunktivalno. Daily dosing – on 1 drop 2 times a day within one and a half months. Instillation is made in both eyes.

Side effects

Tablets and syrup for children

• Alimentary system: nausea, vomiting, dryness in a mouth, locks, increase in appetite, a gastralgia;
• Nervous system: dizziness, drowsiness, delay of speed of response (pass in 2-3 days of therapy), feeling of fatigue, sedation; seldom – sleep disorders, concern, nervousness (especially at children);
• Urinary system: cystitis, dysuria;
• Others: allergic skin reactions, thrombocytopenia, increase in body weight.

Drops are eye

• Organ of sight: seldom – a xerophthalmus, decrease in visual acuity; in some cases – a photophobia, feeling of gripes at instillation, feeling of pain in eyes, conjunctivitis, subconjunctival hemorrhages;
• Dermatological reactions: seldom – skin rash; in some cases – allergic reactions, eczema;
• Others: seldom – increased fatigue, a headache; in some cases – dryness in a mouth.

Special instructions

Tablets and syrup are not intended for stopping of attacks of bronchial asthma. At patients with a bronkhospastichesky syndrome and bronchial asthma after purpose of Zaditenum cancellation of the previous therapy by glucocorticoids, beta-adrenergic agonists, adrenocorticotropic hormones should be carried out gradually, reducing daily doses within not less than 2 weeks.

At a concomitant use of tablets or syrup and peroral hypoglycemic means regular control of maintenance of thrombocytes in peripheral blood is necessary.

Because of risk of a recurrence of asthmatic symptoms contraindicated sharp interruption of treatment by tablets or syrup. At strong sedative effect of drug decrease in a usual dose within the first 2 weeks of therapy is recommended.

Syrup contains 2,35% (from total amount) alcohol and 600 mg/ml of carbohydrates.

It is impossible to apply drops at irritation or an inflammation of eyes, carrying contact lenses. Contact lenses are recommended to be removed before each instillation and to put on only in 15 minutes after the procedure.

At a combination of drops to other ophthalmologic means for local use of instillation it is necessary to carry out with the 5th minute break.

During use of drops by the patient it is impossible to manage vehicles and mechanisms.

At treatment by tablets or syrup it is necessary to be engaged with care in potentially dangerous types of activity which performance requires special attention and high speed of psychomotor reactions, including management of vehicles and mechanisms.

Medicinal interaction

Simultaneous use of tablets or syrup of Zaditenum strengthens effect of antihistaminic drugs, hypnagogues, ethanol.

At a combination to hypoglycemic means the risk of development of thrombocytopenia increases.

Interaction of drops with other medicines is not established.

Terms and storage conditions

To protect from children. To store at a temperature up to 25 °C. A period of validity – 2 years, after disturbance of tightness of a bottle with drops – 1 month.