Indications of Ebaril 5 mg/5 ml
Ebaril 5 mg/5 ml is indicated for the symptomatic treatment of:
Seasonal and Perennial Allergic Rhinitis.
Chronic Idiopathic Urticaria.
Theropeutic Class
Non-sedating antihistamines
Pharmacology
Ebaril 5 mg/5 ml, a piperidine derivative, is a long-acting, nonsedating, second-generation histamine receptor antagonist that binds preferentially to peripheral H1 receptors. It is metabolised to active metabolite, carEbaril 5 mg/5 ml. It has antihistaminic, antiallergic activity and prevents histamine-induced bronchoconstriction. It does not have significant sedative or antimuscarinic actions.
Dosage of Ebaril 5 mg/5 ml
Tablet:
Adults (more than 12 years of age): 10 mg (one tablet) once daily.
Children (6-12 years of age): 5 mg (half tablet) once daily.
Syrup:
Children (2-5 years of age): 2.5 ml once daily (upto 5 ml in severe cases such as Perennial Allergic Rhinitis).
Children (6-12 years of age): 5 ml once daily (upto 10 ml in severe cases such as Perennial Allergic Rhinitis).
Ebaril 5 mg/5 ml may be taken with or without food.
Administration of Ebaril 5 mg/5 ml
Ebaril 5 mg/5 ml may be taken with or without food.
Interaction of Ebaril 5 mg/5 ml
Ebaril 5 mg/5 ml in combination with either ketoconazole or erythromycin increases in plasma level of Ebaril 5 mg/5 ml and prolonged QTc interval. Ebaril 5 mg/5 ml does not interact with the pharmacokinetics of theophylline, warfarin, cimetidine, diazepam or alcohol. The sedation effect of alcohol and diazepam may be enhanced.
Contraindications
Patients with a known hypersensitivity to Ebaril 5 mg/5 ml or any of its ingredients.
Side Effects of Ebaril 5 mg/5 ml
The most common side-effects are headache, dry mouth and drowsiness. Less commonly reported side effects include abdominal pain, dyspepsia, nausea and insomnia.
Pregnancy & Lactation
The safety of Ebaril 5 mg/5 ml during pregnancy and lactation has not been established.
Precautions & Warnings
It is advisable to exercise caution when using Ebaril 5 mg/5 ml in patients known to have the following conditions: long QT syndrome, hypokalaemia, treatment with any medicine known to produce an increase in QT interval or inhibit CYP3A4 enzyme systems such as azole antifungals and macrolide antibiotics. Use in Pregnancy and Lactation The safety of Ebaril 5 mg/5 ml during pregnancy and lactation has not been established. Ebaril 5 mg/5 ml should not be used during pregnancy only if clearly needed. It is not known whether Ebaril 5 mg/5 ml is excreted in milk, therefore, Ebaril 5 mg/5 ml should not be used during lactation.
Overdose Effects of Ebaril 5 mg/5 ml
No clinically meaningful signs or symptoms were observed up to 100 mg given once daily. There is no specific antidote for Ebaril 5 mg/5 ml. In case of accidental overdoses, gastric lavage, monitoring of vital functions including ECG and symptomatic treatment should be carried out.
Storage Conditions
Store below 30°C at a cool and dry place, away from light. Keep out of reach of children
Drug Classes
Non-sedating antihistamines
Mode Of Action
Ebaril 5 mg/5 ml is a long-acting and selective H1-histamine receptor antagonist. After repeated administration, inhibition of peripheral receptors remains at a constant level. Ebaril 5 mg/5 ml is rapidly absorbed and undergoes extensive first-pass metabolism following oral administration. Ebaril 5 mg/5 ml is almost totally converted to the pharmacologically active acid metabolite, carEbaril 5 mg/5 ml.