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.
If you have any questions related to DSCSA compliance, transaction history, regulatory data or quality assurance, please contact our team at compliance@dryeyerescue.com for more information.
