Loratadine-Teva 10mg 30 pills

1 tablet contains: Active substance: loratadine 10.0 mg. Excipients: lactose monohydrate 62.5 mg, corn starch 2.0 mg, pregelatinized starch 25.0 mg, magnesium stearate 0.5 mg.

Pharmacotherapeutic group: anti-allergic agent - H1-histamine receptors blocker.

ATX code: R06AX13

Pharmacological properties

Pharmacodynamics

Loratadine, the active substance of the drug Loratadine-Teva, is a tricyclic compound with a pronounced antihistamine effect and is a selective blocker of peripheral H1-histamine receptors. It has a fast and long-lasting anti-allergic effect. The beginning of the action is within 30 minutes after taking the drug Loratadine-Teva orally. The antihistamine effect reaches a maximum 8-12 hours after the start of action and lasts more than 24 hours.

Loratadine does not penetrate the blood-brain barrier and does not affect the central nervous system. It does not have a clinically significant anticholinergic or sedative effect, i.e. does not cause drowsiness and does not affect the rate of psychomotor reactions when used at the recommended doses. Taking the drug Loratadine-Teva does not lead to an extension of the QT interval on the ECG.

During long-term treatment, there were no clinically significant changes in vital functions, physical examination data, laboratory results or electrocardiography.

Loratadine does not have significant selectivity in relation to H2-histamine receptors. Does not inhibit reverse capture of norepinephrine and has little effect on the cardiovascular system or rhythm driver function.

Pharmacokinetics

Loratadine is quickly and well absorbed in the gastrointestinal tract. The time to reach the maximum concentration (Tmax) of loratadine in blood plasma is 1-1.5 hours, and its active metabolite desloratadine is 1.5-3.7 hours. Eating increases the time to reach the maximum concentration (Tmax) of loratadine and desloratadine by about 1 hour, but does not affect the effectiveness of the drug. The maximum concentration (Cmax) of loratadine and desloratadine does not depend on meals. In patients with chronic kidney diseases, the maximum concentration (Cmax) and area under the concentration-time curve (AUC) of loratadine and its active metabolite increase compared to patients with normal kidney function. The half-life of loratadine and its active metabolite does not differ from that in healthy patients. In patients with alcoholic liver damage, Cmax and AUC loratadine and its active metabolite are doubled compared to these indicators in patients with normal liver function. Loratadine has a high degree (97-99%), and its active metabolite has a moderate degree (73-76%) of binding to plasma proteins.

Loratadine is metabolized into desloratadine by means of the cytochrome P450 3A4 system and, to a lesser extent, the cytochrome P450 2D6 system. It is excreted through the kidneys (approximately 40% of the dose taken orally) and through the intestines (approximately 42% of the dose taken orally) for more than 10 days, mainly in the form of conjugated metabolites. Approximately 27% of the dose taken orally is excreted through the kidneys within 24 hours after taking the drug. Less than 1% of the active substance is excreted through the kidneys unchanged within 24 hours after taking the drug.

The bioavailability of loratadine and its active metabolite is dose-dependent.

Pharmacokinetic profiles of loratadine and its active metabolite in adult and elderly healthy volunteers were comparable.

The half-life of loratadine is from 3 to 20 hours (average 8.4 hours), and desloratadine - from 8.8 to 92 hours (average 28 hours); in elderly patients, respectively, from 6.7 to 37 hours (average 18.2 hours) and 11 to 39 hours (average 17.5 hours). The half-life increases in case of alcoholic liver damage (depending on the severity of the disease) and does not change in the presence of chronic renal failure.

Hemodialysis in patients with chronic renal failure does not affect the pharmacokinetics of loratadine and its active metabolite.

• seasonal (pollinosis) and year-round allergic rhinitis, allergic conjunctivitis - elimination of symptoms associated with these diseases: sneezing, itching of the nasal mucosa, rhinorea, burning sensations and itching in the eyes, tears;
• chronic idiopathic hives.

There are not enough clinical data on the use of loratadine in pregnant women. Application is possible only if the intended benefit to the mother exceeds the potential risk to the fetus. Loratadine is released with breast milk. If it is necessary to use loratadine during lactation, breastfeeding should be stopped.

Hypersensitivity to loratadine and other components of the drug; lactose intolerance, lactase deficiency, glucose-galactose malabsorption; breastfeeding period; children under 3 years of age and body weight less than 30 kg.

With caution

Severe liver disorders.

Pregnancy (see section "Use during pregnancy and breastfeeding").

Clinical studies involving children aged 2 to 12 years who took loratadine more often than in the placebo ("dummy" group showed headaches (2.7%), nervousness (2.3%), fatigue (1%). In adult clinical trials, adverse events observed more often than when using placebo were found in 2% of patients taking loratadine. Adults had headache (0.6%), drowsiness (1.2%), increased appetite (0.5%) and insomnia (0.1%) when using loratadine more often than in the placebo group. In addition, in the post-marketing period there were very rare reports (<1/10 000) about dizziness, fatigue, dry mouth, gastrointestinal disorders (nausea, gastritis), allergic reactions in the form of rashes, anaphylaxis, including angioedema, alopecia, liver dysfunction, heartbeat, tachycardia, seizures and increased body weight. If any of the side effects specified in the instructions are aggravated, or you notice any other side effects not specified in the instructions, please inform your doctor.

Loratadine does not potentiate the effect of alcohol. Eating does not affect the effectiveness of loratadine. Erythromycin and ketoconazole (CYP3A4 isoenzyme inhibitors), cimetidine (cyP3A4 and CYP2D6 isoenzyme inhibitor) increase Cmax loratadine and its active metabolite in the blood. There are no clinically significant changes.

Inside, regardless of meals.

Adults, including the elderly and adolescents over 12 years of age, 10 mg once a day.

Children from 3 to 12 years old:

• with a body weight of more than 30 kg 10 mg once a day;
• with a body weight of less than 30 kg, 5 mg once a day.

The duration of treatment depends on the duration of the symptoms of the disease. If the patient's condition does not improve within 3 days after the start of treatment, then loratadine is ineffective.

When using the drug in elderly patients and patients with chronic renal failure, dose correction is not required.

Adults and children with a body weight of more than 30 kg with severe liver disorders, the initial dose should be 10 mg (1 tablet) every other day.

If there is no improvement after treatment or new symptoms appear, you should consult a doctor.

Symptoms: headache, drowsiness, tachycardia. In case of an overdose, you should see a doctor immediately. Treatment: symptomatic and supportive therapy. It is possible to wash the stomach, take adsorbents (grimmed activated carbon with water). Loratadine is not excreted by hemodialysis. After emergency care, it is necessary to continue monitoring the patient's condition.

White oval-shaped tablets. On one side - separating risk and engraving "L" and "10" on both sides of the risks. The other side is smooth.

Loratadine should be discontinued 48 hours before skin samples, as antihistamine drugs may distort the results of the diagnostic study.

Read the instructions carefully before you start using the drug. Save the instruction, it may be needed again. If you have any questions, consult a doctor. The drug you are being treated with is intended for you personally and should not be transferred to others, as it can harm them even if there are the same symptoms as you.

Impact on the ability to drive vehicles and mechanisms

No negative effect of the drug Loratadin-Teva on the ability to drive a car or carry out other activities that require increased concentration have not been detected.

However, in very rare cases, some patients experience drowsiness when taking the drug Loratadine-Teva, which may affect their ability to drive vehicles and work with mechanisms.

Tablets 10 mg. 7 or 10 tablets in a PVC/PVDH aluminum foil blister. 1 blister of 7 tablets or 1 or 3 blisters of 10 tablets with instructions for use are placed in a cardboard pack with the control of the first opening.

Store at a temperature not exceeding 25°C. Keep out of reach of children!

3 years. Do not apply after the expiration date.