Erius is intended for children from 1 year of age, adolescents, and adults to reduce symptoms caused by allergic rhinitis and urticaria, including sneezing, itching, nasal discharge, skin rash, and eye irritation.
1 ml of syrup contains:
Active ingredient: Desloratadine – 0.5 mg
Excipients: Propylene glycol, liquid sorbitol, citric acid, sodium citrate dihydrate, disodium edetate, sodium benzoate, sucrose, flavoring agent (#15864), yellow dye #6 (E110), purified water.
Pharmacodynamics:
Desloratadine is a long-acting, non-sedating antihistamine that selectively antagonizes peripheral H1 histamine receptors. Following oral administration, desloratadine selectively blocks peripheral H1 receptors as it does not cross the blood-brain barrier.
The safety of Erius syrup has been demonstrated in 3 studies involving pediatric patients. Plasma concentrations of desloratadine at recommended doses were comparable in adults and children. Since the safety and pharmacological profile of desloratadine in allergic rhinitis and chronic idiopathic urticaria are similar in both adults and children, data from adult patients may be extrapolated to children.
Desloratadine does not cross the blood-brain barrier. In controlled clinical trials, at the recommended dose (5 mg daily in adults and adolescents), the incidence of somnolence was not higher than in the placebo group.
In clinical pharmacology studies in adults, desloratadine did not enhance alcohol-induced impairment of psychomotor performance or somnolence. Results of psychomotor tests did not significantly differ between those who took desloratadine and placebo, either alone or with alcohol.
In addition to the established classification of rhinitis (seasonal and perennial), allergic rhinitis can also be classified as intermittent and persistent based on the duration of symptoms:
Intermittent: symptoms occur <4 days per week or <4 weeks.
Persistent: symptoms occur ≥4 days/week and last >4 weeks.
Pharmacokinetics:
Desloratadine is measurable in plasma within 30 minutes of administration in adults and adolescents. Maximum plasma concentration occurs approximately 3 hours after administration. Terminal half-life is approximately 27 hours. Accumulation is consistent with the half-life and once-daily dosing.
Desloratadine has dose-proportional pharmacokinetics within the range of 5-20 mg and is moderately bound to plasma proteins (83-87%). No significant accumulation of the drug was observed with daily administration (5-20 mg) for 14 days.
Single-dose crossover studies demonstrated bioequivalence between Erius tablets and syrup.
The enzyme responsible for desloratadine metabolism has not been identified, so potential interactions with other medications cannot be completely excluded.
To relieve symptoms associated with:
Allergic rhinitis (including hay fever or dust mite allergy) in adults, adolescents, and children from 1 year of age. Symptoms include sneezing, nasal itching, runny nose, palatal and ocular itching, eye redness, and tearing.
Urticaria (allergic skin conditions) – relieves symptoms such as itching and rash. Erius provides all-day symptom relief and helps restore normal daily functioning and sleep.
Taken orally, with or without food.
Children:
1–5 years: 2.5 ml syrup (1.25 mg desloratadine) once daily.
6–11 years: 5 ml syrup (2.5 mg desloratadine) once daily.
Adults and adolescents (12+ years):
10 ml syrup (5 mg desloratadine) once daily.
For intermittent allergic rhinitis, therapy should be guided by medical history: discontinue after symptoms resolve and resume upon recurrence.
For persistent allergic rhinitis, continue treatment during the entire allergen exposure period.
If you miss a dose, take it as soon as possible. Do not take a double dose to make up for a missed one.
Children under 1 year: Safety and efficacy have not been established; data are unavailable. Most rhinitis cases in children under 2 are infectious in origin, and Erius has not been shown to treat infectious rhinitis.
Elderly patients: Safety and efficacy have not been established.
Patients with renal impairment: Use with caution in patients with severe renal insufficiency.
Patients with hepatic impairment: No data available regarding use in hepatic insufficiency.
As with all medicines, side effects may occur, although not everyone experiences them.
Severe allergic reactions (e.g., difficulty breathing, wheezing, itching, hives, and swelling) are very rare, but if they occur, stop taking the medicine and consult a doctor immediately.
Most common side effects (in clinical trials):
Children under 2 years: Diarrhea, fever, insomnia.
Adults: Fatigue, dry mouth, headache (compared to placebo).
Reported post-marketing side effects:
Adults (very rare; ≤1 in 10,000):
Unknown frequency: general weakness, yellowing of the skin/eyes, photosensitivity (sunlight or UV rays), abnormal behavior, aggression, increased appetite, weight gain.
Children (frequency unknown):
Hypersensitivity to desloratadine, loratadine, or any other ingredient in the formulation.
Use desloratadine with caution in patients (especially children) with a personal or family history of seizures. Discontinue treatment if seizures occur.
Erius syrup contains sucrose and sorbitol, and should not be used by patients with hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency.
Each 10 ml contains 1 mmol (23 mg) of sodium – essentially sodium-free.
Consult a healthcare professional before use if you have kidney or liver problems.
If you take more Erius than prescribed, follow general overdose management. Serious adverse effects are not expected with accidental overdose. Symptoms may include intensified common side effects.
Inform your doctor or pharmacist immediately in case of overdose.
Erius is not recommended during pregnancy as safety data are insufficient.
Desloratadine is excreted in breast milk, so breastfeeding women should not use Erius.
At recommended doses, Erius does not impair the ability to drive or operate machinery. However, some people may still feel drowsy, so caution is advised until individual response is known.
Store below 30°C, out of reach of children.
