EBINTRA
Manufacturer Details
INTRA LABS
INTRA LABS INDIA PVT LTD
#43/44 P.S.Lane
B.R.D.Building
Chickpet Cross
Bengaluru 560053
intralabs@yahoo.com
Compositions:
Ebastine 10mg tablets,
|
Strength
|
Rate
|
Packing Style
|
|
10mg
|
60.00
|
10s tablets
|
List of Related Indications:
List Of Drugs:
- Ebastine @ Anti-histamine-(Sep 2001)
Indication Type Description:
Pharmacology/ Pharmacokinetics
Drug Interaction:
Ebastine is metabolised by the cytochrome P450 enzyme to its carboxylated metabolite
carbastine.
Concomittant use of ketaconazole or erythromycin(drugs inhibiting CYP3A) should be avoided.
Impairment of the heaptic metabolism of terfenadine by drugs such as ketoconazole,
itraconazole, erythromycin and clarithromycin may be associated with the adverse cardiac
events observed during terfenadine therapy.
Indication:
Seasonal allergic rhinitis
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Ebastine Ani-allergic 28-09-2001
Adverse Reaction:
No serious adverse reactions have been observed
Contra-Indications:
Ebastine is contraindicated in patients with cardiac arrthythmias.
Special precautions:
Should be used with caution in patients with known QTc prolongation.
Dosages/ Overdosage Etc:
Indications
Seasonal allergic rhinitis, Perennial allergic rhinitis and chronic idiopathic urticaria.
Dosage:
Ebatine is administered orally as a single dose preferably every morning. 10mg is effective in
treatment of allergic rhinitis or chronic idiopathic urticaria
Children: 5mg daily
Caution while administering ebastine to patients with an established ECG, QTc interval
prolongation or hepatic or renal insufficiency.
Patient Information:
Caution while administering ebastine to patients with an established ECG, QTc interval
prolongation or hepatic or renal insufficiency.
Pharmacology/ Pharmacokinetics:
Pharmacology:
Ebastine significantly inhibits histamine-induced wheal and flare compared with placebo.
Significant improvement is observed in patients with seasonal or perennial allergic rhinitis or
chronic idiopathic urticaria following administration of ebastine 10mg/day or 20mg/day in
severe rhinitis.
Pharmcokinetics:
Plasma concentrations of erbatine are low upon oral administration, therefore pharmacokinetics studies generally measure the concentration of the active metabolite, carbastine. After oral administrtion ebastine undergoes extensive first-pass metabolism to its active metabolite. The pharmocokinetics of carbastine is linear.The peak plasma concentrations of carbastine ranged from 1.75 - 2.95mg/L with a time to reach Cmax of 2.6- 5.7 hrs. The elimination half-life of carbastine ranged from 10.3- 19.3. The main route of eliminatin being the kidneys.
