Timolol 0.5% Ophthalmic Gel Topical Ointment

NDC: 72266-200-01

Timolol Maleate Ophthalmic Gel Forming Solution 0.5%, 5 mL — Fosun Pharma

Active ingredient	Timolol maleate 6.8 mg/mL (equivalent to timolol 5 mg/mL, 0.5%)
Dosage form	Ophthalmic gel-forming solution, sterile, isotonic, buffered; gels upon contact with the tear film (preserved with benzododecinium bromide 0.012%)
Route	Ophthalmic (topical)
Size	5 mL dropper bottle
Manufacturer	Distributed by Fosun Pharma USA Inc.; made in India
NDC	72266-200-01

Indications and Usage

Indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

Dosage and Administration

One drop in the affected eye(s) once daily. Invert the closed container and shake once before each use. If other topical ophthalmic medications are used concomitantly, administer them at least 10 minutes before this product. Dosages above one drop of 0.5% once daily have not been studied. Concomitant use of two topical beta-blockers is not recommended. Has not been studied in patients wearing contact lenses.

Warnings and Precautions

• Systemically absorbed; may cause the same cardiac and respiratory reactions as systemic beta-blockers, including death from bronchospasm in asthmatic patients and rarely death associated with cardiac failure
• May precipitate cardiac failure in patients with diminished myocardial reserve; discontinue at first sign of cardiac failure
• Should generally not be used in patients with chronic obstructive pulmonary disease or bronchospastic disease
• May mask signs of hypoglycemia in diabetic patients or signs of hyperthyroidism (e.g., tachycardia); avoid abrupt withdrawal in suspected thyrotoxicosis
• Use with caution in patients with cerebrovascular insufficiency
• Bacterial keratitis has been reported with contaminated multi-dose ophthalmic containers; avoid touching the dropper tip to the eye or surrounding structures
• Should not be used alone in angle-closure glaucoma, as it has little to no effect on the pupil
• Patients with a history of atopy or severe anaphylactic reactions may be unresponsive to usual epinephrine doses used to treat anaphylaxis while on beta-blocker therapy
• May potentiate muscle weakness in patients with myasthenia gravis or myasthenic symptoms
• Transient blurred vision (30 seconds to 5 minutes) is common following instillation and may impair the ability to drive or operate machinery

Contraindications

Contraindicated in patients with bronchial asthma or history of bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, second- or third-degree atrioventricular block, overt cardiac failure, cardiogenic shock, or hypersensitivity to any component of this product.

Adverse Reactions

Transient blurred vision upon instillation reported in approximately 1 in 3 patients. Burning and stinging upon instillation reported in approximately 1 in 8 patients. Other reactions (1–5% of patients) include ocular pain, conjunctivitis, discharge, foreign body sensation, itching, tearing, headache, dizziness, and upper respiratory infection.

Storage and Handling

Store at 15°C to 25°C (59°F to 77°F). Avoid freezing. Protect from light.

How Supplied

Supplied as a colorless to nearly colorless, slightly opalescent, slightly viscous solution in a 5 mL white LDPE dispenser with a controlled drop tip and yellow polypropylene cap.

Professional use only. Clinical information summarized from FDA-approved prescribing information (Structured Product Labeling); refer to the full prescribing information via DailyMed for complete details.