Roletra 10 mg. 30 tablets
Each tablet contains 10 mg of Loratadine
3. Pharmaceutical Form
Tablets for oral use
4. Clinical data
Roletra is indicated for the relief of symptoms associated with seasonal and perennial allergic rhinitis, such as sneezing, rhinorrhea and itching and itching and burning eyes. Nasal and ocular signs and symptoms are relieved rapidly after oral administration. Roletra also indicated for the relief of symptoms associated with chronic idiopathic urticaria.
4.2. Dosage and method of administration
Children 6 to 12 years of age (under 30 kg): 1/2 tablet daily
Children 6 to 12 years of age (over 30 kg): 1 tablet daily
Children over 12 years of age and older: 1 tablet a day /
Hypersensitivity or idiosyncrasy to loratadine or any component of the tablet.
4.4. Special warnings and special precautions
Administered concomitantly with alcohol, loratadine has no potentiating effect, measured in psychomotor studies. Loratadine is metabolized by hepatic cytochrome P450 enzymes ZA4 and 2D6. Concomitant therapy with drugs that inhibit or are metabolised by these enzymes, may increase plasma concentrations of either drug, as a result, have side effects.
4.5. Special warnings and special precautions
Studies have shown that cimetidine, which inhibits both enzymes (P450 ZA4 and 2D6), and erythromycin or ketoconazole, which inhibit P450 ZA4, each individually have increased the concentration of loratadine, although not observed adverse effects, clinical, or electro. Other medicinal products known to inhibit or ZA4 P450 or P450 2D6 are: quinidine, fluconazole or fluoxetine.
Interactions with laboratory tests
Taking antihistamines should be discontinued about four days before skin testing, since this group of drugs may mask or reduce otherwise positive reactions to dermal reactivity.
4.6. Pregnancy and lactation
Loratadine should not be used during pregnancy. There is no experience with its use during pregnancy. In animal studies, he was not teratogenic at high doses, however, embryotoxic effects were observed.
Loratadine is excreted in breast milk it should not be used during breastfeeding.
4.7. Effects on ability to drive and use machines
Loratadine has no clinically significant sedative effect at recommended doses.
4.8. Undesirable effects
In controlled clinical trials, the incidence of adverse reactions associated with treatment with loratadin, was comparable to that of the placebo group.
Loratadine has no clinically significant sedative or anticholinergic effect. Rarely reported fatigue, nausea and headache.
Tachycardia and syncope have been reported rarely. Causality has not been established.
Occasional side effects reported rarely include: alopecia, anaphylaxis, abnormal hepatic function and supraventricular tachyarrhythmias.
In case of overdose should be immediately begin treatment, which is symptomatic and supportive. The patient should be induced to vomit, even if it occurred spontaneously (ipecacuanha is a preferred method), but not in patients with impaired consciousness vomiting may be administered activated charcoal as a slurry with water. If vomiting is unsuccessful or contraindicated, should be done gastric lavage. It is not known whether loratadine is dialysable. After emergency treatment the patient should remain under medical supervision.
5.1. Pharmacodynamic data
Loratadine is tsiproheptadinovo derivative structurally similar to azatadine. It exhibits potent long acting H1- antihistamine activity without central sedative or anticholinergic effect. In humans after oral administration is prepared quickly relieve nasal and other signs and symptoms of allergic rhinitis.
5.2. Pharmacokinetic data
Loratadine is well absorbed and almost completely metabolised. His time of life is one hour and the half-life of 15.3 hours. About 81% of the 14C labeled dose is excreted in urine (40%) and in the feces (41%) over a period of 10 days. In the first 24 hours about 27% of the dose is eliminated in urine. Framakokinetichnite parameters in healthy volunteers and healthy elderly are comparable. Sound levels are reached after the fifth dose of loratadine.
5.3. Preclinical safety data
Loratadine is relatively non-toxic when administered orally or intraperitoneally in a single dose to mice or rats. For both the measurement values of the oral LD 50 is greater than 5000 mg / kg. Rising single doses up to 1280 mg / kg were relatively well tolerated by monkeys.
In repeated dose studies, rats were treated per os doses ranging from 2 240 mg / kg daily in 12 months; a monkey within 17 months were given doses ranging from 0.4- 90 mg / kg daily. Anticholinergic effects were observed in both species. Also seen cases of phospholipidosis; frequency and severity were dose dependent and more pronounced in rats appeared to be reversible.
No evidence of phospholipidosis in humans after treatment with 40 mg / kg per day loratadine within 3 months. Studies demonstrate that loratadine is not carcinogenic, mutagenic or teratogenic.
6. Pharmaceutical data
6.1. List of excipients
Lactose ingredients: mg / tabl.
Lactose monohydrate 78.25
Maize starch 7.50
Pregelatinised maize starch 2.00
Purifued water q.s.
Pregelatinised maize starch 1.50
Magnesium stearate 0.75
6.3. Expiration date
6.4. Special storage conditions
Do not store above 25 ° C.
Protect from moisture.