Description
NDC: 72603-264-02
Atropine Sulfate 1% Ophthalmic Solution, 5 mL — Northstar Rx
| Active ingredients | Atropine sulfate 1% (10 mg/mL) |
| Dosage form | Ophthalmic solution |
| Route | Topical ophthalmic |
| Size | 5 mL |
| Manufacturer | Northstar Rx |
| NDC | 72603-264-02 |
Indications and Usage
An anticholinergic indicated for cycloplegia, mydriasis, and penalization of the healthy eye in the treatment of amblyopia, in adults and pediatric patients 3 months of age and older.
Dosage and Administration
Apply one drop topically to the cul-de-sac of the conjunctiva 40 minutes before the intended maximal dilation time. Patients 3 years and older may repeat up to twice daily as needed; pediatric patients 3 months to under 3 years should be limited to one drop per eye daily.
Warnings and Precautions
- Photophobia and blurred vision from cycloplegia and pupil unresponsiveness may last up to about two weeks
- Systemic absorption may cause elevated blood pressure and anticholinergic effects
- Increased risk of systemic effects in patients with Down syndrome, spastic paralysis, or brain damage
- Avoid touching the dropper tip to the eye or any surface to prevent contamination
Contraindications
Contraindicated in patients with hypersensitivity or allergic reaction to any ingredient in the formulation.
Adverse Reactions
Ocular reactions include eye pain and stinging on instillation, blurred vision, photophobia, and decreased lacrimation. Systemic anticholinergic effects may include increased heart rate, elevated blood pressure, and dryness of the mouth and throat.
Storage and Handling
Store at 20°C to 25°C (68°F to 77°F); keep the container tightly closed.
How Supplied
Sterile 1% ophthalmic solution in dropper bottles, including 5 mL size.
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.
