Drugplain

Timoptic 2.5 mg/mL

Timolol Maleate · SOLUTION · Bausch & Lomb Incorporated

No Recall History
Plain English

Timoptic is a prescription eye drop containing timolol, a beta-blocker medication used to treat glaucoma and ocular hypertension by helping to lower eye pressure. It comes as a 2.5 mg/mL solution that is applied directly to the eye.

Key Facts

Brand Name
Timoptic
Generic Name
Timolol Maleate
NDC Code (Product)
24208-812
Manufacturer
Bausch & Lomb Incorporated
Strength
2.5 mg/mL
Dosage Form
SOLUTION
Route
OPHTHALMIC
Marketing Status
Application #
NDA018086
Marketing Start
12/30/2016

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

treatment failure1,008 reports
drug ineffective658 reports
eye pain496 reports
fatigue495 reports
eye irritation435 reports
dizziness358 reports
diarrhoea337 reports
nausea331 reports
vision blurred314 reports
dyspnoea308 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Preservative-free timolol maleate ophthalmic solution USP in the unit dose vial is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Preservative-free timolol maleate ophthalmic solution USP in the unit dose vial may be used when a patient is sensitive to the preservative in timolol maleate ophthalmic solution USP, benzalkonium chloride, or when use of a preservative-free topical medication is advisable.

Dosage & Administration

DOSAGE AND ADMINISTRATION Preservative-free timolol maleate ophthalmic solution USP in the unit dose vial is a sterile solution that does not contain a preservative. The solution from one individual unit is to be used immediately after opening for administration to one or both eyes. Since sterility cannot be guaranteed after the individual unit is opened, the remaining contents should be discarded immediately after administration. Preservative-free timolol maleate ophthalmic solution in the unit dose vial is available in concentrations of 0.25% and 0.5%. The usual starting dose is one drop of 0.25% preservative-free timolol maleate ophthalmic solution in the unit dose vial in the affected eye(s) administered twice a day. Apply enough gentle pressure on the individual vial to obtain a single drop of solution. If the clinical response is not adequate, the dosage may be changed to one drop of 0.5% solution in the affected eye(s) administered twice a day. Since in some patients the pressure-lowering response to preservative-free timolol maleate ophthalmic solution in the unit dose vial may require a few weeks to stabilize, evaluation should include a determination of intraocular pressu…

Warnings

WARNINGS As with many topically applied ophthalmic drugs, this drug is absorbed systemically. The same adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical administration. For example, severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma, and rarely death in association with cardiac failure, have been reported following systemic or ophthalmic administration of timolol maleate USP (see CONTRAINDICATIONS ). Cardiac Failure Sympathetic stimulation may be essential for support of the circulation in individuals with diminished myocardial contractility, and its inhibition by beta-adrenergic receptor blockade may precipitate more severe failure. In Patients without a History of Cardiac Failure continued depression of the myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure. At the first sign or symptom of cardiac failure, preservative-free timolol maleate ophthalmic solution USP in unit dose vial should be discontinued. Obstructive Pulmonary Disease Patients with chronic obstructive pulmonary disease (e.g., chronic bronchiti…

Contraindications

CONTRAINDICATIONS Preservative-free timolol maleate ophthalmic solution USP in the unit dose vial is contraindicated in patients with (1) bronchial asthma; (2) a history of bronchial asthma; (3) severe chronic obstructive pulmonary disease (see WARNINGS ); (4) sinus bradycardia; (5) second or third degree atrioventricular block; (6) overt cardiac failure (see WARNINGS ); (7) cardiogenic shock; or (8) hypersensitivity to any component of this product.

Drug Interactions

Drug Interactions Although timolol maleate ophthalmic solution USP used alone has little or no effect on pupil size, mydriasis resulting from concomitant therapy with timolol maleate ophthalmic solution USP and epinephrine has been reported occasionally. Beta-adrenergic blocking agents : Patients who are receiving a beta-adrenergic blocking agent orally and preservative-free timolol maleate ophthalmic solution USP in the unit dose vial should be observed for potential additive effects of beta-blockade, both systemic and on intraocular pressure. The concomitant use of two topical beta-adrenergic blocking agents is not recommended. Calcium antagonists : Caution should be used in the coadministration of beta-adrenergic blocking agents, such as preservative-free timolol maleate ophthalmic solution USP in the unit dose vial, and oral or intravenous calcium antagonists, because of possible atrioventricular conduction disturbances, left ventricular failure, and hypotension. In patients with impaired cardiac function, coadministration should be avoided. Catecholamine-depleting drugs : Close observation of the patient is recommended when a beta blocker is administered to patients receiving …

Adverse Reactions

ADVERSE REACTIONS The most frequently reported adverse experiences have been burning and stinging upon instillation (approximately one in eight patients). The following additional adverse experiences have been reported less frequently with ocular administration of this or other timolol maleate USP formulations: BODY AS A WHOLE Headache, asthenia/fatigue, and chest pain. CARDIOVASCULAR Bradycardia, arrhythmia, hypotension, hypertension, syncope, heart block, cerebral vascular accident, cerebral ischemia, cardiac failure, worsening of angina pectoris, palpitation, cardiac arrest, pulmonary edema, edema, claudication, Raynaud’s phenomenon, and cold hands and feet. DIGESTIVE Nausea, diarrhea, dyspepsia, anorexia, and dry mouth. IMMUNOLOGIC Systemic lupus erythematosus. NERVOUS SYSTEM/PSYCHIATRIC Dizziness, increase in signs and symptoms of myasthenia gravis, paresthesia, somnolence, insomnia, nightmares, behavioral changes and psychic disturbances including depression, confusion, hallucinations, anxiety, disorientation, nervousness, and memory loss. SKIN Alopecia and psoriasiform rash or exacerbation of psoriasis. HYPERSENSITIVITY Signs and symptoms of systemic allergic reactions inclu…

Frequently Asked Questions

What is Timoptic used for?

Timoptic is a prescription eye drop containing timolol, a beta-blocker medication used to treat glaucoma and ocular hypertension by helping to lower eye pressure. It comes as a 2.5 mg/mL solution that is applied directly to the eye.

Is Timoptic a controlled substance?

Timoptic is not classified as a controlled substance by the DEA.

What is the generic name for Timoptic?

The generic name for Timoptic is Timolol Maleate. There are 11 other brand versions of Timolol Maleate.

What is the NDC code for Timoptic 2.5 mg/mL?

The NDC (National Drug Code) for Timoptic 2.5 mg/mL is 24208-812, listed by Bausch & Lomb Incorporated.

Product NDC

24208-812

Package NDC

24208-812-05

Other Timolol Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)