Evastin is used to treat the nasal and non-nasal symptoms associated with allergic rhinitis and also to treat idiopathic chronic cutaneous urticaria in people over 2 years of age.
Indications
- Seasonal and perennial allergic rhinitis.
- Allergic conjunctivitis
- Chronic idiopathic urticaria.
Dosage
- Adults and children over 6 years of age: The recommended dose is one Evastin tablet, or two tablespoons (10 ml) of Evastin syrup once daily.
- Dosage for children from 2 to 5 years: The recommended dose is one teaspoon (5 ml) of Evastin syrup once daily.
Although Evastin syrup should not be prescribed to children and infants less than two years old, sometimes the pediatrician may prescribe Evastin syrup for your child, in doses appropriate for his age, and you must adhere to the doses and duration of treatment decided by the doctor for your child.
- Dosage for infants from 1 to 2 years: 2.5 ml of Evastin syrup, once daily.
- Dosage for infants from 6 months to a year: 1 to 2 ml of Evastin syrup, once daily.
Composition
- Each tablet contains: Ebastine 10 mg.
- Each 5 ml of solution contains: Ebastine 5 mg.
Properties
Ebastine is non-sedating H₁ antihistamine. Ebastine does not penetrate the blood brain barrier and thus allows an effective blockade of H₁ receptors in peripheral tissues without central side effects.
Pharmacokinetics
Ebastine is well absorbed and extensively converted to its active carboxylic acid metabolite carebastine, with peak plasma concentration of the metabolite occurring 3-4 hours following oral administration and lasting up to 24 hours, as shown on the wheal and flare responses following histamine challenge. Both ebastine and carebastine are highly protein bound >95%. The elimination half-life of the metabolite is 10-16 hours.
Contra-Indications
Patients with known hypersensitivity to ebastine
Pregnancy and lactation
As with other 3rd generation antihistamines, ebastine should not be used during pregnancy and lactation unless expected benefit to the patient outweighs any possible risk to the fetus. However, ebastine showed no clinically relevant effects in a complete set of regulatory-required toxicity tests (including acute, chronic, reproductive, mutagenic and carcinogenic protocols) at doses giving blood concentrations representing high multiples of clinical exposure.
Effect of age and gender
Studies indicate that ebastine can be safely administered with no clinically important age or gender related differences in the pharmacokinetics of ebastine/carebastine.
Effect on QTc interval
Recommended doses of ebastine had no meaningful effect on QTc in young, elderly, or in patients with renal or hepatic insufficiency as was found by
electrocardiography or Holter monitoring comparing ebastine with placebo. Also no clinically relevant effect on QTC interval at up to five times the maximum recommended dose i.e. 100 mg/day.
Interaction with other medications and other forms of interaction
Interaction studies involving ebastine with ketoconazole revealed a significant increase in the serum ebastine concentration and in elimination half-life of ebastine, similar findings were observed during
coadministration of ebastine with erythromycin and this high serum concentration has no clinically meaningful effect on the QTc interval.
No QTc effects were noted when ebastine was administered with theophylline, and the QTc was similar when ebastine was administered with or without food.
Effect on ability to drive and using machines
Ebastine, at its recommended therapeutic doses of 10-20 mg, is demonstrably free from impairment on objective aspects of psychomotor and cognitive function, so patient may drive or perform tasks that require concentration.
