Description
NDC: 69315-325-10
Timolol Maleate 0.5% Ophthalmic Solution, 10 mL — Leading Pharma, LLC
| Active ingredient | Timolol maleate 0.5% (5 mg timolol per mL) |
| Dosage form | Sterile ophthalmic solution |
| Route | Topical ophthalmic |
| Size | 10 mL |
| Manufacturer | Leading Pharma, LLC |
| NDC | 69315-325-10 |
Indications and Usage
Treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
Dosage and Administration
Instill one drop of the 0.5% solution in the affected eye(s) twice a day. Therapy is often initiated at 0.25% and increased to 0.5% if the response is inadequate; if pressure is controlled, dosing may be reduced to once daily.
Warnings and Precautions
- Can be absorbed systemically; severe respiratory and cardiac reactions, including death from bronchospasm in asthmatics and cardiac failure, have occurred
- May mask signs of hypoglycemia in diabetics and symptoms of hyperthyroidism
- Use caution in patients undergoing major surgery and those with cerebrovascular insufficiency
- May potentiate muscle weakness in patients with myasthenic symptoms
Contraindications
Contraindicated in bronchial asthma or history of asthma, severe COPD, sinus bradycardia, second- or third-degree AV block, overt cardiac failure, cardiogenic shock, or hypersensitivity to any component.
Adverse Reactions
The most common reaction is burning and stinging on instillation; systemic effects may include bradycardia, bronchospasm, and cardiovascular and CNS reactions.
Storage and Handling
Store at 15°C to 25°C (59°F to 77°F); protect from light and freezing.
How Supplied
Sterile ophthalmic solution supplied in a plastic dropper bottle, including a 10 mL fill.
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.
