Description
NDC: 70512-866-05
Phenylephrine HCl 10% Ophthalmic Solution, 5 mL — Sola Pharmaceuticals
| Active ingredient | Phenylephrine hydrochloride 10% |
| Dosage form | Ophthalmic solution |
| Route | Topical ophthalmic |
| Size | 5 mL |
| Manufacturer | Sola Pharmaceuticals |
| NDC | 70512-866-05 |
Indications and Usage
An alpha-1 adrenergic receptor agonist indicated to dilate the pupil, for use in procedures requiring mydriasis.
Dosage and Administration
For patients 1 year of age and older, apply one drop to the conjunctival fornix at 3 to 5 minute intervals, up to a maximum of 3 drops per eye. The 10% strength should not be used in children under 1 year of age.
Warnings and Precautions
- Serious cardiovascular reactions, including fatalities, have occurred with the 10% concentration
- May cause significant elevations in blood pressure, especially in patients with cardiovascular disease
- Rebound miosis may occur the day after instillation
- Use caution in elderly patients and those with hyperthyroidism or cardiac disease
Contraindications
Contraindicated in patients with hypertension or thyrotoxicosis, and in children under 1 year of age.
Adverse Reactions
Ocular reactions include eye pain and stinging on instillation, temporary blurred vision, and photophobia. Systemic reactions may include marked increases in blood pressure, syncope, myocardial infarction, tachycardia, and arrhythmia.
Storage and Handling
Store at 20°C to 25°C (68°F to 77°F). Keep container tightly closed and protect from light and excessive heat.
How Supplied
Supplied as a sterile ophthalmic solution, 5 mL in a bottle.
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.
