INSTRUKTION for medical use of the drug KETOTIFEN
Active substance: ketotifen;
1 capsule contains ketotifen fumarate – 1,375 mg, equivalent to 1 mg ketotifen;
auxiliary substances: calcium stearate, cellulose microcrystalline, lactose monohydrate;
capsule shell: gelatin, sodium methylparaben (E 219), sodium propylparaben (E 217), titanium dioxide (E 171), patent blue V (E 131), brilliant black (E 151).
Dosage form. tabletes.
Pharmacotherapeutic group. Antihistamines for systemic use.
ATC code R06A X17.
Prevention and treatment of allergic disorders multisystemic:
• chronic urticaria;
• atopic dermatitis;
• allergic rhinitis and conjunctivitis.
Prophylactic treatment of bronchial asthma, especially in cases associated with other manifestations of atopy.
Contraindications. Hypersensitivity to ketotifen. Children's age under 6 years, since the release form of the drug. Pregnancy and breast-feeding.
Method of application and doses. Adults take 1 capsule twice a day (morning and evening) during meals. If necessary, the daily dose can be doubled.
Children over 6 years – 1 capsule 2 times a day.
The course of treatment is 2-3 weeks.
Neurological disorders: dizziness, drowsiness, disorientation, slowing of psychomotor reactions, nervousness, agitation, insomnia, in very rare cases, seizures.
Gastrointestinal disorders: loss of appetite, stomach pain, constipation, nausea, vomiting, dry mouth, dyspepsia, in very rare cases may increase the level of liver enzymes and the development of hepatitis.
Disorders of the urinary system: dysuria, cystitis.
Metabolic disorders: weight gain.
Immune system: skin rash, you may experience severe skin reactions (erythema multiforme, Stevens-Johnson syndrome).
Symptoms: languor, severe sedation; confusion and disorientation; tachycardia and hypotension, especially in children; excessive irritability and cramps, reversible coma.
Treatment. If the drug had been recently adopted, should consider the need of emptying of the stomach. It is recommended that administration of activated charcoal. If necessary, symptomatic treatment is recommended and monitoring of the cardiovascular system. If you experience irritability or the court can prescribe short-acting barbiturates or benzodiazepines.
Use during pregnancy or breast-feeding. Do not use during pregnancy and lactation.
Children. Children up to 6 years is desirable to use other forms of release of the drug.
Features of the application.
Ketotifen is not effective in cases where it is necessary to stop an asthma attack.
While taking the drug to prevent asthma full therapeutic effect may develop within a few weeks of treatment. Therefore, even in the absence of clinical effect, patients should continue treatment for at least 2 – 3 months.
Concomitant bronchodilator therapy: if ketotifen is used along with bronchodilators, frequency of taking bronchodilatators can be reduced.
If you want to stop treatment ketotifenum, dose gradually over 2 to 4 weeks to prevent re-occurrence of symptoms of asthma.
At the beginning of the long-term treatment with ketotifen you can't suddenly stop taking the symptomatic and preventive against asthma medication that the patient already uses. This applies in particular to systemic corticosteroids because sterotatic patients may be a manifestation of adrenocortical insufficiency. In these cases, the period of the return of normal hypothalamic-pituitary-adrenal response to stress can last up to 1 year.
Patients receiving simultaneously with oral antidiabetic agents and ketotifen, it is recommended to carry out continuous control of the number of platelets in the blood, in connection with a possible decrease in the number of platelets.
Because ketotifen is able to reduce seizure threshold, should be cautious to apply it to patients with epilepsy.
The drug contains lactose, it should be borne in mind in patients with hereditary lactose intolerance.
The ability to influence the rate of reaction at management of motor transport or operating other mechanisms. Not recommended for use ketotifen transport drivers and operators of potentially dangerous machinery.
Interaction with other medicinal products. Ketotifen may exacerbate the effects of drugs, oppressive Central nervous system, and antihistamines and alcohol.
The pharmacological properties.
Pharmacodynamics. Ketotifen – against against asthmatic and allergic drug. Has against allergic activity by suppressing the action of endogenous mediators of inflammation; does not show bronhorasshiratego effect. Ketotifen inhibits the release of mediators of Allergy (histamine, leukotrienes), and inhibits the sensitization eosinophilic granulocytes cytokines, which leads to a decrease eosinophilic migration of granulocytes to sites of inflammation; inhibits the development of bronchial hyperresponsiveness caused by the activation of platelets under the influence of platelet-activating factor, and stimulation simptome tics or allergens. Furthermore, ketotifen inhibits the enzyme phosphodiesterase, thereby increases the level of camp in the tissues. These properties determine its vs ketotifen asthma effect. Ketotifen also provides provides against allergic effects, competitive is not able to block H1 - receptors and so it can be used instead of the classic antagonists.
Pharmacokinetics. After oral ketotifen is almost completely absorbed, its bioavailability is approximately 50% due to metabolism during the initial passage through the liver. The maximum concentration in plasma achieved within 2 – 4 hours. Linking blood plasma proteins is 75%. The excretion of ketotifen from the body is biphasic with the half excretion of 3 – 5 hours and 21 hours.
Main physicochemical properties: hard gelatin capsules with opaque blue cap and opaque white bodies. The contents of capsules - white powder with a slightly yellowish tinge.
The expiration date. 2 years.
The storage conditions. Keep out of the reach of children, protected from light place, at temperature from 15°C to 25°C.
Packing. 10 capsules in blister. 3 blisters per pack.