Instructions Loratadine syrup 5mg/5ml can 90 ml
Composition
active ingredient: loratadine;
1 ml of syrup contains 1 mg of loratadine;
excipients: propylene glycol; sodium saccharin; glycerin; citric acid, monohydrate; sorbitol non-crystallizing solution (contains E 420); methyl parahydroxybenzoate (E 218); propyl parahydroxybenzoate (E 216); Wild Strawberry flavoring (contains: Ponceau 4 R (E 124), azorubine E 122)); purified water.
Dosage form
Syrup.
Main physicochemical properties: transparent syrupy liquid of bright red color with a characteristic odor, sweet and sour taste.
Pharmacotherapeutic group
Antihistamines for systemic use. ATX code R06A X13.
Pharmacological properties
Pharmacodynamics
Loratadine is a tricyclic antihistamine with selective activity at peripheral H1 receptors.
When used in the recommended dose, it does not have a clinically significant sedative and anticholinergic effect. During long-term treatment, no clinically significant changes in vital signs, laboratory tests, physical examination data or electrocardiogram were detected. Loratadine has no significant effect on the activity of H2-histamine receptors. It does not block norepinephrine uptake and has virtually no effect on the cardiovascular system or pacemaker activity.
After a single dose of the drug (10 mg), based on histamine skin tests, it was found that the antihistamine effect is clinically noticeable after 1-3 hours, reaches a peak value in the interval from 8 to 12 hours from the onset of action and lasts for 24 hours. No development of resistance was noted when taking the drug for 28 days.
Pharmacokinetics
Absorption. Loratadine is rapidly and well absorbed after oral administration. Food slightly prolongs the absorption period of loratadine, but does not affect the clinical effect. The bioavailability of loratadine and desloratadine is directly proportional to the dose.
Distribution: Loratadine is highly bound (97 to 99%) to plasma proteins, and its active metabolite is moderately bound (73 to 76%). The plasma elimination half-lives of loratadine and its active metabolite in healthy volunteers are approximately 1 and 2 hours after administration, respectively.
Biotransformation. After oral administration, loratadine is rapidly and well absorbed and metabolized by CYP3A4 and CYP2D6, mainly to desloratadine. The main metabolite, desloratadine, is pharmacologically active and is largely responsible for the clinical effect. The time to reach maximum plasma concentrations of loratadine and desloratadine is 1-1.5 hours and 1.5-3.7 hours, respectively.
Excretion: Approximately 40% of the administered dose is excreted in the urine and 42% in the feces within 10 days, mainly as conjugated metabolites. Approximately 27% of the administered dose is excreted in the urine within the first 24 hours. Less than 1% of the active substance is excreted in unchanged active form - both loratadine and desloratadine.
The mean terminal elimination half-life in healthy adult volunteers is 8.4 hours (range 3 to 20 hours) for loratadine and 28 hours (range 8.8 to 92 hours) for its major active metabolite.
Renal impairment. In patients with renal impairment, the area under the concentration-time curve (AUC) and maximum plasma concentration (Cmax) of loratadine and its active metabolite were higher than those in patients with normal renal function. The mean elimination half-lives of loratadine and its active metabolite were not significantly different from those in healthy volunteers. In patients with chronic renal impairment, hemodialysis did not affect the pharmacokinetics of loratadine and its active metabolite.
Hepatic impairment. In patients with chronic alcoholic liver disease, the AUC and Cmax of loratadine were twice as high, and the corresponding values of its active metabolite were not significantly changed when compared with those in patients with normal liver function. The half-lives of loratadine and its active metabolite are 24 and 37 hours, respectively, and increase with the severity of liver disease.
Elderly patients: The pharmacokinetics of loratadine and its active metabolite were similar in healthy adult volunteers, including the elderly.
Indication
Symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria.
Contraindication
Hypersensitivity to loratadine or to any of the other ingredients of the drug.
Interaction with other medicinal products and other types of interactions
Loratadine does not enhance the inhibitory effect of alcohol on psychomotor reactions.
Concomitant use of loratadine with CYP3A4 or CYP2D6 inhibitors may lead to increased levels of loratadine, which in turn may increase side effects.
With simultaneous use of the drug with ketoconazole, erythromycin, cimetidine, an increase in the concentration of loratadine in the blood plasma was noted, but this increase did not manifest itself clinically, including according to electrocardiogram data.
Children.
Drug interaction studies have only been conducted in adult patients.
Application features
Loratadine should be used with caution in patients with severe hepatic impairment.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
The drug should be discontinued no later than 48 hours before skin diagnostic allergy tests to prevent false results.
Loratadine contains an azo dye (azorubine and ponso 4 R) and methyl parahydroxybenzoate, propyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed).
Ability to influence reaction speed when driving vehicles or other mechanisms
Loratadine has no or negligible influence on the ability to drive and use machines. However, the patient should be informed that drowsiness has been reported very rarely, which may affect the ability to drive and use machines.
Use during pregnancy or breastfeeding
Pregnancy: There are very limited data on the use of loratadine in pregnant women. As a precautionary measure, it is preferable to avoid the use of loratadine during pregnancy.
Breastfeeding: Physicochemical data indicate that loratadine/metabolites are excreted in breast milk. Since a risk to the child cannot be excluded, Loratadine should not be used during breast-feeding.
Fertility: There are no data on the effect of the drug on female or male fertility.
Method of administration and doses
Method of application.
Administer orally. The syrup can be taken regardless of meals.
Dosage.
Adults and children over 12 years of age should take 10 ml of syrup (10 mg of loratadine) once a day.
Doses for children aged 2 to 12 years depend on their body weight.
Children weighing more than 30 kg - 10 ml of syrup (10 mg of loratadine) once a day.
Children weighing up to 30 kg - 5 ml of syrup (5 mg of loratadine) once a day.
Elderly patients.
Does not require dosage adjustment for the elderly.
Patients with liver dysfunction.
Patients with severe hepatic impairment should be given a lower initial dose as clearance of loratadine may be reduced. For adults and children weighing more than 30 kg, the recommended initial dose is 10 mg every other day, and for children weighing up to 30 kg, 5 mg every other day.
Patients with renal impairment.
No dose adjustment is necessary for patients with renal impairment.
Children
The efficacy and safety of the drug in children under 2 years of age have not been established.
Overdose
In case of overdose, anticholinergic symptoms were observed: drowsiness, tachycardia and headache. In case of overdose, symptomatic and supportive treatment is recommended for the necessary period of time. Standard measures are recommended to remove the drug that has not been absorbed from the stomach: gastric lavage, use of crushed activated charcoal with water.
Loratadine is not removed by hemodialysis, and it is not known whether loratadine is removed by peritoneal dialysis.
After emergency care, the patient should remain under medical supervision.
Adverse reactions
In children aged 2 to 12 years, adverse events such as headache, nervousness, or increased fatigue were observed.
In adults and children aged 12 years and over, drowsiness, headache, increased appetite and insomnia have been reported.
The frequency of adverse reactions was defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), isolated cases (≥1/10,000 to <1/1000), rare cases (<1/10,000) and frequency unknown (cannot be estimated from the available data).
Side effects
| Organ classes/systems | Frequency | |
| Immune system | rare cases | anaphylaxis, including angioedema |
| Nervous system | rare cases | dizziness, convulsions |
| Cardiovascular system | rare cases | tachycardia, feeling of palpitations |
| Gastrointestinal tract | rare cases | nausea, dry mouth, gastritis |
| Hepatobiliary system | rare cases | liver dysfunction |
| Skin and subcutaneous tissue | rare cases | rash, alopecia |
| General disorders | rare cases | increased fatigue |
| Research | frequency unknown | weight gain |
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 °C out of the reach of children.
Packaging
90 ml in a bottle or jar with a dosing cup in a pack.
Vacation category
Without a prescription.
Producer
LLC "SKP "Pharmaceutical Factory".
Location of the manufacturer and its business address
Ukraine, 12430, Zhytomyr region, Zhytomyr district, Stanyshivka village, Koroleva st., bldg. 4.
