Ketotifene SOPHARMA

Active material: Ketotifen
When ATH: R06AX17
CCF: Stabilizers fat cell membranes. Allergy medication
When CSF: 13.02.01
Manufacturer: SOPHARMA AD (Bulgaria)

DOSAGE FORM, STRUCTURE AND PACKAGING

Syrup colorless to pale yellow, clear, Coupling, with a specific smell of strawberries.

Excipients: sorbitol, metilparagidroksiʙenzoat, propilparagidroksibenzoat, citric acid monohydrate, sodium hydrogen phosphate dodecahydrate, ethanol 96%, sodium saccharin, strawberry flavor (liquid essence “Strawberry”), Purified water.

100 ml – vials of dark glass (1) complete with a measuring spoon or cup – packs cardboard.
100 ml – PET bottles dark (1) complete with a measuring spoon or cup – packs cardboard.

Pills white or white with a gray tint, round, flat, with a facet and Valium on the one hand, without smell.

Excipients: microcrystalline cellulose, calcium hydrogen phosphate, wheat starch, magnesium stearate.

10 PC. – blisters (3) – packs cardboard.

DESCRIPTION OF ACTIVE SUBSTANCES

Pharmacological action

Antiallergic agent. The mechanism of action is associated with the stabilization of mast cell membranes and decrease the release of histamine from them, leukotrienes and other biologically active substances. Suppresses induced platelet activating factor accumulation of eosinophils in the airways. Prevents asthma attacks, Some other manifestations of allergic reactions immediate type. Blocking histamine H₁-receptors.

Pharmacokinetics

Once inside almost completely absorbed from the gastrointestinal tract. Simultaneous food intake does not affect the extent of absorption of ketotifen. Metaboliziruetsya of 50% at “first pass” through the liver. C_max plasma levels reached within 2-4 no. Plasma protein binding is 75%.

Displayed dwuhfazno. T_1/2 in the initial phase of 3-5 no, at the end – 21 no. Report the news, 60-70% as metabolites, 1% – in unchanged form.

Testimony

Prevention of allergic diseases, incl. atopic asthma, allergic bronchitis, hay fever, nasal allergy, atopic dermatitis, hives, allergic conjunctivitis.

Dosage regimen

Is the inside. Adults – by 1 mg 2 times / day (in the morning and in the evening) while eating. If necessary, the daily dose can be increased to 4 mg.

The maximum daily dose: for adults – 4 mg.

For children 2-3 years – by 1 mg 2 times / day; aged 6 Months before 3 years – by 500 g 2 times / day.

Side effect

CNS: drowsiness, dizzy, slow mental reactions, usually disappear a few days after the start of treatment.

From the digestive system: possible increased appetite; rarely – dyspepsia, dry mouth.

From the hematopoietic system: thrombocytopenia.

From the urinary system: dizurija, cystitis.

Metabolism: weight gain.

Contraindications

Hypersensitivity to ketotifen.

Pregnancy and lactation

When pregnancy, especially in the I trimester, use is possible only in the case, if the potential benefit to the mother outweighs the potential risk to the fetus.

Ketotifen passes into breast milk, so if you need it, use during lactation should decide the issue of termination of breastfeeding.

Cautions

The therapeutic effect of ketotifen develops slowly, during 1-2 months.

Conductivity Antiasthma therapy should be continued, at least, during 2 weeks after the start of ketotifen.

With simultaneous use of ketotifen and bronchodilators last dose can sometimes be reduced.

Effects on ability to drive vehicles and management mechanisms

Patients, taking Ketotifenum, We should refrain from potentially hazardous activities, related to the need for increased attention and rapid psychomotor reactions.

Drug Interactions

Ketotifen may potentiate the effects of sedatives, hypnotics, antihistaminics and ethanol.

When receiving ketotifen concurrently with oral hypoglycemic agents noted a reversible decrease in the number of platelets.