Timolol 0.25% Ophthalmic Solution 10mL

NDC: 70756-655-30

Timolol Maleate Ophthalmic Solution 0.25%, 10 mL — Lifestar Pharma

Active ingredient	Timolol maleate 3.4 mg/mL (equivalent to timolol 2.5 mg/mL, 0.25%)
Dosage form	Ophthalmic solution, sterile, isotonic, buffered (preserved with benzalkonium chloride 0.01%)
Route	Ophthalmic (topical)
Size	10 mL dropper bottle
Manufacturer	Manufactured for Lifestar Pharma LLC; product of Germany
NDC	70756-655-30

Indications and Usage

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

Dosage and Administration

Usual starting dose is one drop in the affected eye(s) twice daily. If clinical response is inadequate, dosage may be changed to the 0.5% solution twice daily. If intraocular pressure is well controlled, dosage may be reduced to once daily. Doses above one drop of 0.5% twice daily generally produce no further IOP reduction. Concomitant use of two topical beta-blockers is not recommended.

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
• Contains benzalkonium chloride, which may be absorbed by soft contact lenses; remove lenses before use and wait at least 15 minutes before reinsertion

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

Most frequently reported reaction is burning and stinging upon instillation (approximately 1 in 8 patients). Other reported reactions include headache, bradycardia, hypotension, dizziness, ocular irritation, conjunctivitis, keratitis, dry eyes, and, rarely, systemic allergic reactions including anaphylaxis.

Storage and Handling

Store at 20°C to 25°C (68°F to 77°F). Protect from freezing and light. After opening, may be used until the expiration date on the bottle.

How Supplied

Supplied as a clear, colorless solution in a 10 mL natural LDPE bottle with a controlled drop tip and yellow HDPE 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.