Kestin, 10 mg 10 pcs.

Pharmgroup: anti-allergic agent – H1-histamine receptor blocker.

Pharmaceutical action: Long-acting blocker of histamine H1-receptors. Prevents histamine-induced spasms of smooth muscles and increased vascular permeability. After oral administration, a pronounced antiallergic effect develops in 1 hour and lasts for 48 hours. After 5-day course of treatment with Kestin antihistamine activity is maintained for 72 hours due to the action of active metabolites.

The drug does not cause significant anticholinergic and sedative effects. No effect of Kestin on QT interval duration on ECG even at a dose of 80 mg has been noted.

Indications

Allergic rhinitis of various etiologies (seasonal and/or year-round, both accompanied and not accompanied by allergic conjunctivitis).

Urticaria of various etiologies, including chronic idiopathic.

Pharmacological effect

Pharmaceutical group: antiallergic agent – H1-histamine receptor blocker.

Pharmaceutical action: Long-acting histamine H1 receptor blocker. Prevents histamine-induced spasms of smooth muscles and increased vascular permeability. After taking the drug orally, a pronounced antiallergic effect develops after 1 hour and continues for 48 hours. After a 5-day course of treatment with Kestin, antihistamine activity persists for 72 hours due to the action of active metabolites.

The drug does not cause significant anticholinergic and sedative effects. There was no effect of Kestin on the duration of the QT interval on the ECG, even at a dose of 80 mg.

Special instructions

Impact on the ability to drive vehicles and other mechanisms that require increased concentration of attention

In the event of side effects from the central nervous system, there may be a minimal decrease in the ability of patients to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Active ingredient

Ebastine

Composition

Active ingredient:

ebastine microionized 10 mg.

Excipients:

microcrystalline cellulose,

corn starch,

lactose monohydrate,

sodium carboxymethylcellulose structured,

magnesium stearate,

hydroxypropyl methylcellulose,

polyethylene glycol 6000,

titanium dioxide

Pregnancy

Contraindicated during pregnancy and lactation.

Contraindications

Hypersensitivity to the components of the drug;
pregnancy and lactation;
children under 12 years of age;
lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

With caution: use in patients with an increased QT interval, hypokalemia, renal and/or liver failure.

Side Effects

Listed below are the adverse reactions observed in clinical trials and during post-registration use of the drug, taking into account the following criteria: very often (? 1/10); often (from 1/100 to <1/10); uncommon (from 1/1000 to <1/100); rare (from 1/10000 to <1/1000); very rare (<1/10000).

From the central and peripheral nervous system:

rarely: drowsiness;

very rarely: dizziness, hypoesthesia, headache, nervousness, insomnia.

From the gastrointestinal tract:

rarely: dryness of the oral mucosa;

very rarely: vomiting, abdominal pain, nausea, dyspepsia.

From the cardiovascular system:

very rarely: palpitations, tachycardia.

From the liver and biliary tract:

very rarely: abnormal liver function tests.

For the skin and subcutaneous fat:

very rare: urticaria, rash, dermatitis.

From the reproductive system:

very rare: menstrual disorders.

General and local reactions:

very rarely: edema, asthenic syndrome.

Adverse reactions observed in clinical studies in children over 12 years of age (a group of 460 children) did not differ from the reactions noted in adults.

Interaction

When using the drug Kestin® simultaneously with ketoconazole or itraconazole and erythromycin, the risk of prolongation of the QT interval on the ECG may increase.

Rifampicin reduces the concentration of ebastine in the blood plasma and has an inhibitory effect on the antihistamine effect of ebastine.

The drug Kestin® does not interact with theophylline, indirect anticoagulants, cimetidine, diazepam, ethanol and ethanol-containing drugs.

Overdose

In studies using high doses of ebastine (more than 100 mg per day), no clinically significant signs and symptoms were observed. There is no special antidote for ebastine. In case of overdose, gastric lavage, monitoring of vital body functions, and symptomatic treatment are recommended.

Storage conditions

In a place protected from light, at a temperature not exceeding 30 °C

Shelf life

3 years

Manufacturer

Industrias Pharmaceuticas Almiralle S.A., Spain