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Active ingredients
Loratadine
Release form
Pills
Composition
Loratadine 10 mg. Excipients: sodium methylparaben, sodium propyl paraben, sucrose, propylene glycol, citric acid, sorbitol solution, sodium saccharin, sodium benzoate, disodium edetate, sunset dye, mixed fruit flavor, American ice cream, purified water.
Pharmacological effect
Blocker of long-acting histamine H1 receptors. Inhibits the release of histamine and leukotriene C4 from mast cells. Prevents the development and facilitates the course of allergic reactions. It has antiallergic, antipruritic, antiexudative action. Reduces capillary permeability, prevents the development of tissue edema, relieves spasms of smooth muscles. Does not affect the central nervous system (does not cause drowsiness, does not affect the psychomotor functions, attention, performance, mental abilities) and does not cause addiction (since it practically does not penetrate the BBB) .; Antiallergic effect develops after 30 minutes, reaches a maximum after 8-12 hours and lasts for 24 hours.
Pharmacokinetics
Absorption; After ingestion, the drug is rapidly and completely absorbed from the gastrointestinal tract. Eating slows down the time to reach Cmax, on average, for 1 hour with the use of pills and does not affect the absorption of the drug when using syrup. Cmax of loratadine is achieved within 1.3-2.5 h after administration; Distribution; Plasma protein binding - 97%. Does not penetrate the BBB. Css loratadine and its active metabolite is reached on the 5th day of use; Metabolism; Metabolized in the liver by isoenzymes CYP3A4 and to a lesser extent CYP2D6 with the formation of an active metabolite - descarboethoxyloratadine .; Withdrawal; T1 / 2 of loratadine is 3-20 h (average 8.4 h), descarboethoxyloratadine - 8.8-92 h (average about 28 h). Loratadine is excreted in the urine and bile .; Pharmacokinetics in special clinical situations; In elderly patients, Cmax increases by 50%, in patients with alcoholic liver damage, with an increase in the severity of the disease .; T1 / 2 loratadine in elderly patients is 6.7-37 h (average 18.2 h), descarboethoxyloratadine - 11-38 h (average 17.5 h) .; With alcohol-induced liver damage, T1 / 2 loratadine increases with an increase in the severity of the disease .; In patients with chronic renal failure and during hemodialysis, the pharmacokinetics of loratadine remain virtually unchanged.
Indications
- seasonal and perennial allergic rhinitis; - allergic conjunctivitis; - pollinosis; - urticaria (includingchronic idiopathic urticaria); - allergic pruritic dermatosis; - pseudo-allergic reactions; - allergic reactions to insect bites; - itching of various etiologies; - Quincke swelling.
Contraindications
- pregnancy; - lactation (breastfeeding); - children's age up to 2 years (for syrup); - hypersensitivity to the components of the drug .; The drug should be used with caution in patients with impaired liver function (in particular, with liver failure).
Use during pregnancy and lactation
The drug is contraindicated in pregnancy and lactation (breastfeeding).
Dosage and administration
The drug is used inside. Adults (including the elderly) and children over 12 years old are prescribed 10 mg each (1 tab. Or 2 teaspoons. L. Of syrup) 1 time / day. Daily dose - 10 mg. Children aged 2 to 12 years old with a body weight of <30 kg should be prescribed 5 mg each (1/2 tab. Or 1 teaspoon syrup) 1 time / day. Daily dose - 5 mg. Children aged 2 to 12 years old with a body weight of> 30 kg should be prescribed 10 mg each (1 tab. Or 2 teaspoons liters of syrup) 1 time / day. Daily dose - 10 mg. The use of syrup in children under 2 years is not recommended .; In patients with impaired hepatic function, Claridol should be prescribed in an initial dose of 5 mg / day due to possible impaired clearance of loratadine.
Side effects
On the part of the central nervous system and peripheral nervous system: headache, fatigue, dizziness, drowsiness, irritability or lethargy (in children) .; On the part of the digestive system: dry mouth, nausea, vomiting, gastritis, abnormal liver function .; Since the cardiovascular system: palpitations, tachycardia .; Other: allergic reactions (including rash, anaphylaxis), cough, alopecia .; Adverse events with loratadine were observed with the same frequency as with placebo (≥2%).
Interaction with other drugs
With simultaneous use of Claridol with erythromycin, cimetidine, ketoconazole, it is possible to increase the concentration of loratadine in the blood plasma (which has no clinical significance and does not affect the ECG) .; Inductors of microsomal oxidation (phenytoin, barbiturates, zixorin, rifampicin, phenylbutazone, tricyclic antidepressants) and ethanol reduce the effectiveness of loratadine.
special instructions
Precautions should be prescribed the drug for liver failure .; Use in pediatrics; The use of syrup in children under 2 years of age is not recommended .; Influence on the ability to drive motor vehicles and control mechanisms; During the period of treatment should refrain from engaging in potentially hazardous activities that require increased attention and speed of psychomotor reactions.