Cyclopentolate Hydrochloride And Phenylephrine Hydrochloride
Generic Name: cyclopentolate hydrochloride and phenylephrine hydrochloride
Brand Names:
Cyclomydril
DESCRIPTION CYCLOMYDRIL ® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) is a mydriatic prepared as a sterile topical ophthalmic solution. The active ingredients are represented by the chemical structures: Established Name: Cyclopentolate Hydrochloride Chemical Name: 2-(Dimethylamino)ethyl 1 - hydroxy-α-phenylcyclopentaneacetate hydrochloride) Molecular Formula: C 17 H 25 NO 3 • HCl Molecular Weight: 327.85 g/mol Established Name: Phenylephrine Hydrochloride C...
Overview
DESCRIPTION CYCLOMYDRIL ® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) is a mydriatic prepared as a sterile topical ophthalmic solution. The active ingredients are represented by the chemical structures: Established Name: Cyclopentolate Hydrochloride Chemical Name: 2-(Dimethylamino)ethyl 1 - hydroxy-α-phenylcyclopentaneacetate hydrochloride) Molecular Formula: C 17 H 25 NO 3 • HCl Molecular Weight: 327.85 g/mol Established Name: Phenylephrine Hydrochloride C...
Uses
INDICATIONS AND USAGE For the production of mydriasis.
Dosage
DOSAGE AND ADMINISTRATION Instill one drop in each eye every five to ten minutes. To minimize systemic absorption, apply pressure over the nasolacrimal sac for two to three minutes following instillation. Observe infants closely for at least 30 minutes.
Side Effects
ADVERSE REACTIONS Ocular The following ocular adverse experiences have been associated with the use of CYCLOMYDRIL ® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution): increased intraocular pressure, burning/irritation upon instillation, photophobia, blurred vision and superficial punctate keratitis. Nonocular Use of cyclopentolate hydrochloride has been associated with psychotic reactions and behavioral disturbances in children. These disturbances include ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place. This drug produces reactions similar to those of other adrenergic and anticholinergic drugs; however, the central nervous system manifestations as noted above are most common.
Warnings
WARNINGS FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION. There have been reports of serious cardiovascular reactions, including ventricular arrhythmias and myocardial infarctions, in patients using higher concentrations of phenylephrine. These episodes, some fatal, have usually occurred in patients with pre-existing cardiovascular diseases. This preparation may cause central nervous system (CNS) disturbances. This is especially true in younger age groups, but may occur at any age, especially with the stronger solutions. Infants are especially prone to CNS and cardiopulmonary side effects from cyclopentolate. CONTRAINDICATIONS Do not use in patients with hypersensitivity to any component of this preparation.
Pregnancy
Pregnancy Animal reproduction studies have not been conducted with cyclopentolate hydrochloride and/or phenylephrine hydrochloride. It is also not known whether cyclopentolate hydrochloride and/or phenylephrine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. CYCLOMYDRIL ® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) should be given to a pregnant woman only if clearly needed.
Storage
HOW SUPPLIED CYCLOMYDRIL ® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) is supplied as a sterile solution in 2 mL and 5 mL, in plastic DROP-TAINER® dispensers. 2 mL NDC 0065-0359-02 5 mL NDC 0065-0359-05 Storage: Store at 8°C to 25°C (46°F - 77°F)
Frequently Asked Questions
What is Cyclopentolate Hydrochloride And Phenylephrine Hydrochloride used for?▼
INDICATIONS AND USAGE For the production of mydriasis.
What are the side effects of Cyclopentolate Hydrochloride And Phenylephrine Hydrochloride?▼
ADVERSE REACTIONS Ocular The following ocular adverse experiences have been associated with the use of CYCLOMYDRIL ® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution): increased intraocular pressure, burning/irritation upon instillation, photophobia, blurred vision and superficial punctate keratitis. Nonocular Use of cyclopentolate hydrochloride has been associated with psychotic reactions and behavioral disturbances in children. These disturbances include ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place. This drug produces reactions similar to those of other adrenergic and anticholinergic drugs; however, the central nervous system manifestations as noted above are most common.
Can I take Cyclopentolate Hydrochloride And Phenylephrine Hydrochloride during pregnancy?▼
Pregnancy Animal reproduction studies have not been conducted with cyclopentolate hydrochloride and/or phenylephrine hydrochloride. It is also not known whether cyclopentolate hydrochloride and/or phenylephrine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. CYCLOMYDRIL ® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) should be given to a pregnant woman only if clearly needed.
What are the important warnings for Cyclopentolate Hydrochloride And Phenylephrine Hydrochloride?▼
WARNINGS FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION. There have been reports of serious cardiovascular reactions, including ventricular arrhythmias and myocardial infarctions, in patients using higher concentrations of phenylephrine. These episodes, some fatal, have usually occurred in patients with pre-existing cardiovascular diseases. This preparation may cause central nervous system (CNS) disturbances. This is especially true in younger age groups, but may occur at any age, especially with the stronger solutions. Infants are especially prone to CNS and cardiopulmonary side effects from cyclopentolate. CONTRAINDICATIONS Do not use in patients with hypersensitivity to any component of this preparation.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.