ALPHAGAN
Manufacturer Details
ALLERGAN
1st Floor North Wing
Silver Jubilee Block
Unity Building Complex
Mission Road
Bangalore 560227
Compositions:
Brimonidine 2mg/ml eye drops,
|
Strength
|
Rate
|
Packing Style
|
|
2mg/ml
|
325.02
|
5ml eye drops
|
List of Related Indications:
List Of Drugs:
- Brimonidine tartarate- @ -Agents for Glaucoma- (FDC -List) (1996)
Indication Type Description:
Drug Interaction:
MAOIs , anti-depressants affecting nor-adrenergic transmission CNS depressants , Anti-hypertensives, Cardiac glycosides, sympathomimetics agonists or antagonists
Indication:
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
Brimonidine Tartrate Ophthalmic Solution, 0.15% safely and effectively.
See full prescribing information for Brimonidine Tartrate Ophthalmic Solution, 0.15%. Brimonidine Tartrate Ophthalmic Solution, 0.15%, Sterile
Initial U.S. Approval: 1996
U.S FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
83. Brimonidine Tartrate Opthlamic solution 0.1% 07-03-08
(with purite as preservation 0.005% )
(Addl.stgth)
For lowering of IOP in patients with open angle
glaucoma occular hypertension
Glaucoma or ocular hypertension
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1. Brimonidine Ophthalmic 18-05-1999
Tartarate
Alpha2 -adrenoreceptor agonist- adjunct in glaucoma
2.Brimonidine tarttate ophthalmic solution 01% 07003-2008
with purite as preservation 0-0005%
Addl.stgth.
For lowering of IOP in patients with open angle glucoma
ocular hypertension
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
Brimonidine Tartrate 2mg/1.5mg + 25-11-2005
Timolol Hcl 5mg/5mg per ml
Ophthalmic
Adverse Reaction:
Ocular hyperaremia, conjuntivitival follicles. Stinging pruritus, oedema Blurring,itching, burning, allergy, Dryness, pain, Dry mouth, headache, Fatigue, asthenia, drowsiness, dizziness, Dysgeusia, visual disturbances Upper respiratory symptoms GI upset Foreign body sensation Corneal staining Photophobia Blepharitis
Contra-Indications:
Neonates and infants less than 2 years of age Concurrent MAOIs therapy Lactation
Special precautions-
Severe cardio-vascular disease
Depression, cerbral or coronary insufficiency
Reynauds syndrome Orthostatic hypotension Thrombo-angilis obliterans
Renal or hepatic impairment Soft contact lenses Wait minimum 15 minutes before inserting Pregnancy
Dosages/ Overdosage Etc:
Indication-
Glaucoma or ocular hypertension
Dosage-
1 drop in the affected eye(s ) twice daily approx. 12 hours apart
Children- not recommended
Patient Information:
PATIENT COUNSELING INFORMATION
As with other drugs in this class, Brimonidine Tartrate Ophthalmic Solution, 0.15% may cause fatigue and/or drowsiness in some patients.
Patients who engage in hazardous activities should be cautioned of the potential for a decrease in mental alertness. Rx Only
Distributed by: Falcon Pharmaceuticals, Ltd. Fort Worth, Texas 76134 Manufactured by: Alcon Research, Ltd. Fort Worth, Texas 76134 Printed in USA
Pregnancy and lactation:
Use contraindicated Observe caution if required to be used
