Lorano

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT LORANO (LORANO)

Composition:

Active substance: loratadine;

1 tablet contains loratadine 10 mg;

Excipients: lactose monohydrate, magnesium stearate, corn starch, colloidal anhydrous silicon dioxide.

Pharmaceutical form. Tablets.

Main physicochemical characteristics: white oval tablets with a break line and marking "LT½10" on one side of the tablet.

Pharmacotherapeutic group. Antihistamines for systemic use.

ATC code R06A X13.

Pharmacological Properties.

Pharmacodynamics.

Loratadine is an antihistamine, a tricyclic selective blocker of peripheral H1-histamine receptors. When administered at the recommended dose, it does not produce clinically significant sedative or anticholinergic effects. During prolonged treatment, no clinically significant changes have been observed in vital function parameters, laboratory test results, physical examination findings, or electrocardiograms. Loratadine has no significant effect on H2-histamine receptor activity, does not inhibit norepinephrine uptake, and essentially does not affect the cardiovascular system or pacemaker activity.

After oral administration, loratadine is well absorbed and metabolized primarily by CYP3A4 and CYP2D6 into desloratadine. The time to reach maximum plasma concentration of loratadine and desloratadine is 1–1.5 hours and 1.5–3.7 hours, respectively. Loratadine and its metabolite are highly bound to plasma proteins.

Pharmacokinetics.

The bioavailability of loratadine and desloratadine is directly proportional to dose.

Food intake slightly prolongs the absorption time of loratadine but does not affect its clinical effect.

In patients with chronic renal impairment, the mean elimination half-life of loratadine and its metabolite does not significantly differ from that in healthy subjects. In patients with chronic renal impairment, hemodialysis does not influence the pharmacokinetics of loratadine and its active metabolite.

In patients with chronic alcoholic liver disease, peak plasma concentrations of loratadine are doubled, whereas the pharmacokinetic profile of the active metabolite does not significantly differ from that in patients with normal liver function. The elimination half-life of loratadine and its metabolite was 24 hours and 37 hours, respectively, and increased depending on the severity of liver disease.

Clinical characteristics.

Indications.

Symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria.

Contraindications.

The drug is contraindicated in patients with hypersensitivity to the active substance or to any other component of the drug.

Interaction with other medicinal products and other forms of interaction.

The drug does not enhance the depressant effect of alcohol on psychomotor reactions.

Concomitant use of loratadine with CYP3A4 or CYP2D6 inhibitors may lead to increased loratadine levels, which in turn may enhance adverse effects.

Concomitant administration of loratadine with ketoconazole, erythromycin, or cimetidine has been shown to increase plasma concentrations of loratadine; however, this increase was not clinically significant, including electrocardiographic data.

Children. Studies on interactions with other drugs have been conducted only in adult patients.

Special precautions for use.

Patients with severe hepatic impairment require a lower starting dose due to a possible reduction in loratadine clearance (recommended starting dose: 10 mg every other day).

Diabetic patients

One tablet contains less than 0.01 carbohydrate exchange units.

The tablets contain lactose and therefore should not be used in patients with rare hereditary forms of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome.

The drug should be discontinued at least 48 hours before skin testing, as antihistamines may neutralize or otherwise reduce the positive reaction when determining skin reactivity index.

Use during pregnancy or breastfeeding.

Pregnancy. Data on the use of loratadine in pregnant women are very limited. Animal studies have not revealed any direct or indirect adverse effects related to reproductive toxicity. As a precautionary measure, it is advisable to avoid using Lorano during pregnancy.

Breastfeeding. Physicochemical data indicate that loratadine/metabolites pass into breast milk. Since a risk to the infant cannot be excluded, Lorano should not be used during breastfeeding.

Fertility. There are no data available on the effect of the product on male or female fertility.

Ability to influence reaction rate while driving or operating machinery.

Clinical studies have not shown any effect of the drug on the patient's reaction speed. However, patients should be informed about the very rare occurrence of drowsiness or dizziness, which may affect the ability to drive or operate machinery.

Dosage and Administration

Route of Administration

Oral use. Tablets may be taken regardless of food intake.

Dosage

Adults and children aged 12 years and older should take 1 tablet (10 mg of loratadine) once daily.

For children aged 2 to 12 years, dosage depends on body weight. For body weight above 30 kg: 10 mg (1 tablet) once daily. For children with body weight below 30 kg, the use of syrup or suspension formulations is recommended.

Elderly patients

Dosage adjustment is not required for elderly patients.

Patients with hepatic impairment

In patients with severe hepatic impairment, a lower initial dose should be prescribed due to possible reduction in loratadine clearance. For adults and children with body weight above 30 kg, the recommended initial dose is 10 mg every other day.

Patients with renal impairment

Dosage adjustment is not required for patients with renal impairment.

Children

The efficacy and safety of loratadine in children under 2 years of age have not been established.

Lorano tablets should be prescribed only to children with body weight above 30 kg.

Overdose

Overdose of loratadine increases the frequency of anticholinergic symptoms. Symptoms reported in cases of overdose include somnolence, tachycardia, and headache. Symptomatic and supportive treatment is recommended for the required duration. Standard measures to remove unabsorbed drug from the stomach are advised: gastric lavage and administration of crushed activated charcoal with water.

Loratadine is not effectively removed by hemodialysis; it is unknown whether loratadine is eliminated by peritoneal dialysis.

Following emergency treatment, the patient should remain under medical supervision.

Adverse reactions.

In children aged 2 to 12 years, the following adverse events were observed: headache, nervousness, or increased fatigue. In adults and children aged 12 years and older, somnolence, headache, increased appetite, and insomnia were observed.

Isolated cases of the following adverse effects were reported:

Shelf life.

3 years.

Storage conditions.

No special storage conditions required.

Keep out of reach of children.

Packaging.

7 or 10 tablets in a blister pack; 1 (7 × 1) or 2 (10 × 2) blisters per cardboard box.

Availability. Over-the-counter (without prescription).

Manufacturer.

Salutas Pharma GmbH (bulk manufacturing, packaging, batch release).

Or

LEK S.A. (packaging, batch release).

Manufacturer's address and location of operations.

Otto-von-Guericke-Allee 1, 39179 Barleben, Germany.

Or:

Domaniewska Street 50C, 02-672 Warsaw, Poland.