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Loratadin

Препарат Лоратадин. ООО «Фармлэнд» Республика Беларусь


Producer: LLC Pharmlend Republic of Belarus

Code of automatic telephone exchange: R06AX13

Release form: Firm dosage forms. Tablets.

Indications to use: Allergic rhinitis (cold). Pollinosis. Chronic idiopathic small tortoiseshell. Quincke's disease of Quincke. Bronchial asthma. Pseudo-allergic reactions.


General characteristics. Structure:

Active ingredient: 10 mg of a loratadin.

Excipients: cellulose microcrystallic, sodium lauryl sulfate, lactose glikolit starch, magnesium stearate, sodium.

Antihistaminic, antiallergic, anti-exudative, antipruritic drug of systemic action.




Pharmacological properties:

Pharmacodynamics. Blocker of H1-histamine receptors. Loratadin represents the selection antagonist of peripheral H1-histamine receptors of the third generation. Possesses the expressed long antiallergenic action. Drug practically does not exert impact on the central nervous system. In animal experiments low affinity of a loratadin to central H1 receptors was proved, as a result does not possess sedative and anticholinergic action. Has weak bronchodilatory activity.

Pharmacokinetics. Drug is quickly soaked up from digestive tract after oral administration. It is characterized by high extent of linkng with proteins of plasma and good volume of distribution. The effect is shown in 1-3 hours after reception and remains for 24 hours. The concentration maximum in a blood plasma is reached in 4-6 hours after a single dose of 10 mg.

It is metabolized in a liver. It is characterized by the expressed effect of "the first passing through a liver". The elimination half-life makes for a loratadin of 7-11 hours, for an active metabolite – 17-24 hours. It is removed in the form of metabolites by kidneys (окло 40%) and intestines (about 41%).

Pharmacokinetic parameters of a loratadin significantly do not change at elderly patients and patients with a renal failure.


Indications to use:

Loratadin apply at allergic rhinitises (seasonal and year-round), a pollinosis, allergic conjunctivitis, chronic idiopathic urticaria, an allergic pruritic dermatosis, a Quincke's disease, bronchial asthma (as supportive application), allergic reactions to stings of insects, pseudo-allergic reactions to gistaminoliberator.


Route of administration and doses:

Drug is accepted inside to food. To adults and children 12 years are more senior appoint 10 mg (1 tablet) once a day. To children from 2 to 12 years – 5 mg (1/2 tablets) of 1 times a day. If the body weight of the child makes more than 30 kg, appoint 10 mg of 1 times a day. Maximum daily dose of 40 mg. Course of treatment of 28 days.


Features of use:

Patients with an abnormal liver function should appoint drug in smaller doses because it can reduce clearance of creatinine.

It is recommended to cancel treatment not less than in 1 week prior to conducting skin test on allergens.

Pregnancy and period of a lactation. Safety of use of a loratadin for pregnant women is not established therefore it is necessary to appoint drug only if the estimated advantage for mother exceeds potential risk for a fruit.

As лоратадин it is allocated with breast milk, at purpose of drug it is necessary to resolve an issue of the breastfeeding termination.


Side effects:

From a nervous system: a headache, drowsiness, fatigue, in 2% and less – dizziness, nervousness, sleeplessness, concern, excitability (at children), a faint, a depression, ear, and eyes pain, a sonitus. Very seldom – spasms.

From bodies of a GIT: dryness in a mouth, nausea, vomiting, dyspepsia, gastritis, a lock or diarrhea, taste disturbance.

From respiratory system: a nose congestion, sneezing, sinusitis, dryness in a nose, cough, bronchitis, upper respiratory tract infections.

From urinogenital system: urine discoloration, a dysmenorrhea, a vaginitis, weakening of a libido, impotence, is very rare – hypostases.

Allergic reactions: hyperemia, urticaria, rash, itch.

From cardiovascular system: hypertensia or hypotension, heartbeat, tachycardia.

Others: thirst, an adynamy, an indisposition, a fever, the increased perspiration, increase in body weight.


Interaction with other medicines:

At simultaneous use of drug with ketokonazoly, erythromycin, Cimetidinum note increase in concentration of a loratidin in a blood plasma, however without any clinical manifestations.

Lowers erythromycin level in plasma for 15%. Does not exponentiate effect of alcohol on the central nervous system.


Contraindications:

Hypersensitivity to drug.


Overdose:

At overdose development of drowsiness, tachycardia, headache is possible. In this case it is necessary to wash out a stomach and to appoint absorbent carbon.


Storage conditions:

List B. In the dry, protected from light place at a temperature not above 25 °C. Period of validity 3 years.


Issue conditions:

According to the recipe


Packaging:

Tablets on 10 mg. Standard trade packaging. On 10, 20 or 30 tablets in plastic cases or in banks polymeric. On 10 tablets in a blister strip packaging. 1,2 or 3 blister strip packagings, a case or bank together with a leaf insert in secondary packaging. 1 blister strip packaging together with a leaf insert in a first-aid kit from chalk overlay paper.



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