Description
NDC: 61314-396-03
Cyclopentolate HCl 1% Ophthalmic Solution, 15 mL — Sandoz
| Active ingredients | Cyclopentolate hydrochloride 1% (10 mg/mL) |
| Dosage form | Ophthalmic solution |
| Route | Topical ophthalmic |
| Size | 15 mL |
| Manufacturer | Sandoz |
| NDC | 61314-396-03 |
Indications and Usage
Used to produce mydriasis (pupil dilation) and cycloplegia (paralysis of accommodation) for diagnostic ophthalmic procedures.
Dosage and Administration
In adults, instill one or two drops in the eye, which may be repeated in 5 to 10 minutes if needed. In infants and small children, use the lowest effective concentration, apply pressure over the nasolacrimal sac for two to three minutes, and observe closely for at least 30 minutes.
Warnings and Precautions
- Infants and young children are especially susceptible to central nervous system and cardiopulmonary effects
- May cause transient elevation of intraocular pressure
- Can precipitate angle closure in eyes with narrow or anatomically shallow anterior chamber angles
- Psychotic reactions and behavioral disturbances have occurred, particularly in children
Contraindications
Contraindicated in patients with untreated narrow-angle (angle-closure) glaucoma or anatomically narrow angles, and in those hypersensitive to any component.
Adverse Reactions
Ocular effects include burning, photophobia, blurred vision, and transient increased intraocular pressure. Systemic effects, more common in children, include psychotic reactions, behavioral disturbances, ataxia, restlessness, and tachycardia.
Storage and Handling
Store at 8°C to 25°C (46°F to 77°F).
How Supplied
Sterile ophthalmic solution in plastic dropper dispenser bottles; the 1% strength is supplied in 2 mL, 5 mL, and 15 mL sizes.
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.
