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TIMOPTIC-XE® 0.25% AND 0.5%
(timolol maleate) Ophthalmic Gel Forming Solution
Sterile Ophthalmic Gel Forming Solution
TIMOPTIC-XE® (timolol maleate ophthalmic solution) is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-l-(tert-butylamino)-3- [(4-morpholino-l, 2, 5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is:
|[α]||in l.0N HC1 (C = 5%) = -12.2° (-11.7° to -12.5°).|
Its molecular formula is C13H24N4O3S•C4H4O4 and its structural formula is:
Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol.
TIMOPTIC-XE Sterile Ophthalmic Gel Forming Solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths. The pH of the solution is approximately 7.0, and the osmolarity is 260-330 mOsm. Each mL of TIMOPTIC-XE 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). Each mL of TIMOPTIC-XE 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: GELRITE gellan gum, tromethamine, mannitol, and water for injection. Preservative: benzododecinium bromide 0.012%
GELRITE is a purified anionic heteropolysaccharide derived from gellan gum. An aqueous solution of GELRITE, in the presence of a cation, has the ability to gel. Upon contact with the precorneal tear film, TIMOPTIC-XE forms a gel that is subsequently removed by the flow of tears.
What are the possible side effects of timolol ophthalmic?
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.
Stop using this medication and call your doctor at once if you have any of these serious side effects:
- swelling or redness of your eyelids;
- eye redness, discomfort, or sensitivity to light;
- drainage, crusting, or oozing of your eyes or eyelids;
- depressed mood, confusion, hallucinations, unusual thoughts or behavior;
- wheezing, gasping, or other breathing problems;
What are the precautions when taking timolol maleate ophthalmic gel forming solution (Timoptic-XE)?
Before using timolol, tell your doctor or pharmacist if you are allergic to it; 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 history of asthma, severe chronic obstructive pulmonary disease), certain types of irregular heartbeats (e.g., sinus bradycardia, second or third degree AV block), certain types of heart disease (e.g., severe heart failure).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease,...
Last reviewed on RxList: 10/11/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Timoptic-XE Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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