LORADE [Loratadine] 10 mg Film-coated tablets
LORADE
instructions for medical use of the medicinal product
Tradename
Lorade, Lorade
International non-proprietary name
Loratadine, Loratadine
Composition
Each film-coated tablet contains:
Active ingredient: Loratadine USP 10 mg
Excipients: corn starch, dextrin, microcrystalline cellulose, sodium starch glycolate, hypromellose, distilled water, silicon dioxide, talc, magnesium stearate.
Dosage form
Tablets.
Pharmacotherapeutic group
Antihistamines for systemic use.
Pharmacological properties
Pharmacodynamics
Blocker of histamine H 1 receptors. It has antiallergic, antipruritic, antiexudative action. Reduces capillary permeability, prevents the development of tissue edema, reduces the increased contractile activity of smooth muscles due to the action of histamine.
Pharmacokinetics
When taken orally at a therapeutic dose, loratadine is rapidly absorbed from the gastrointestinal tract and almost completely metabolized in the body. C max loratadine in plasma is reached after 1-1.3 hours, the main active metabolite, desloratadine, after about 2.5 hours.
With simultaneous ingestion of food, the bioavailability of loratadine and desloratadine increases by approximately 40% and 15%, respectively, the time to reach Cmax increased by approximately 1 hour, its values for these substances remained unchanged.
Plasma protein binding of loratadine is high - about 98%, the active metabolite is less pronounced.
On average, T 1/2 loratadine is 8.4 hours, desloratadine - 28 hours (8.8-92 hours).
About 80% of loratadine is excreted as metabolites with urine and feces in equal proportions within 10 days, about 27% - with urine during the first day.
Indications for use
·
seasonal and year-round allergic rhinitis and the elimination of symptoms associated with this disease - sneezing, itching of the nasal mucosa, rhinorrhea;
·
allergic conjunctivitis;
·
hay fever;
·
urticaria (including chronic idiopathic urticaria);
·
allergic pruritic dermatoses.
Contraindications
• hypersensitivity to loratadine;
• pregnancy, breastfeeding period ;
• children's age up to 2 years.
Dosage and administration
The drug is used inside.
Adults (including the elderly) and children over 12 years of age are prescribed 10 mg (1 tablet) 1 time per day. The daily dose is 10 mg.
Children aged 2 to 12 years weighing <30 kg are prescribed 5 mg (1/2 tablet) 1 time per day. The daily dose is 5 mg.
Children aged 2 to 12 years weighing >30 kg are prescribed 10 mg (1 tablet) 1 time per day. The daily dose is 10 mg.
Special instructions and precautions
With caution, the drug should be prescribed for liver failure. In patients with impaired liver or kidney function (renal clearance < 30 ml / min), a dose reduction is recommended at the beginning of treatment.
The drug should be discontinued at least 48 hours before skin tests, as antihistamines may prevent or reduce a positive reaction to the skin reactivity index without their use.
Influence on the ability to drive vehicles and mechanisms
During the period of treatment, one should refrain from engaging in potentially hazardous activities that require increased attention and speed of psychomotor reactions.
Use during pregnancy or lactation
Use during pregnancy and during breastfeeding is contraindicated. If you need to take the drug during lactation, then breastfeeding should be stopped.
Interaction with other drugs
With the simultaneous use of loratadine with drugs that inhibit CYP3A4 and CYP2D6 isoenzymes or are metabolized in the liver with their participation (including cimetidine, erythromycin, ketoconazole, quinidine, fluconazole, fluoxetine), it is possible to change the plasma concentration of loratadine and / or these drugs.
Microsomal oxidation inducers (phenytoin, ethanol, barbiturates, zixorin, rifampicin, phenylbutazone, tricyclic antidepressants) reduce efficacy.
Side effect
From the digestive system: rarely - dry mouth, nausea, vomiting, gastritis; in some cases - violations of the liver.
From the side of the central nervous system: rarely - increased fatigue, drowsiness, headache, excitability (in children).
From the side of the cardiovascular system: rarely - tachycardia.
Allergic reactions: rarely - skin rash, itching, swelling of the face, lips, tongue; in isolated cases - anaphylactic reactions.
Dermatological reactions: in some cases - alopecia.
Symptoms: drowsiness, tachycardia, headache.
Treatment: gastric lavage, induction of vomiting, administration of activated charcoal. If necessary, carry out symptomatic therapy.
Storage conditions
Store in a cool and dry place, at a temperature not exceeding 30º C.
Keep out of the reach of children!
Best before date
3 years. Do not use after the expiry date stated on the packaging.
Holiday conditions
Released by prescription.
Release form
10 tablets in an aluminum foil blister. 1 blister with instructions for use in a cardboard box.