"The US Food and Drug Administration (FDA) has approved Akorn Inc's phenylephrine hydrochloride ophthalmic solution (2.5% and 10%), the company has announced.
The alpha-1 adrenergic receptor agonist is commonly used by optometrists, ophtha"...
(brimonidine tartrate/timolol maleate) Ophthalmic Solution
COMBIGAN® (brimonidine tartrate/timolol maleate) Ophthalmic Solution 0.2%/0.5%, sterile, is a relatively selective alpha-2 adrenergic receptor agonist with a non-selective beta-adrenergic receptor inhibitor (topical intraocular pressure lowering agent).
The structural formulae are:
5-bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate; MW= 442.24
(-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)-oxy]-2-propanol maleate (1:1) (salt); MW= 432.50 as the maleate salt
In solution, COMBIGAN® (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% has a clear, greenish-yellow color. It has an osmolality of 260-330 mOsmol/kg and a pH during its shelf life of 6.5-7.3.
Brimonidine tartrate appears as an off-white, or white to pale-yellow powder and is soluble in both water (1.5 mg/mL) and in the product vehicle (3 mg/mL) at pH 7.2. Timolol maleate appears as a white, odorless, crystalline powder and is soluble in water, methanol, and alcohol.
Each mL of COMBIGAN® contains the active ingredients brimonidine tartrate 0.2% and timolol 0.5% with the inactive ingredients benzalkonium chloride 0.005%; sodium phosphate, monobasic; sodium phosphate, dibasic; purified water; and hydrochloric acid and/or sodium hydroxide to adjust pH.
What are the possible side effects of brimonidine and timolol ophthalmic (Combigan)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- severe swelling, itching, burning, redness, pain, or discomfort in or around your eye;
- bronchospasm (wheezing, chest tightness, trouble breathing);
- pounding heartbeats or fluttering in your chest;
- slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);
- feeling like...
What are the precautions when taking brimonidine tartrate, timolol maleate ophthalmic solution .2%/.5% (Combigan)?
Before using this product, tell your doctor or pharmacist if you are allergic to brimonidine or timolol; or to apraclonidine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: lung disease (e.g., current or past asthma, severe chronic obstructive pulmonary disease-COPD), certain types of irregular heartbeats (sinus bradycardia, second- or third-degree AV block), certain types of heart disease (severe heart failure, cardiogenic shock).
Before using this medication, tell your doctor or pharmacist your...
Last reviewed on RxList: 10/19/2012
This monograph has been modified to include the generic and brand name in many instances.
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