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Drug overview for CYCLOMYDRIL (cyclopentolate hcl/phenylephrine hcl):
Generic name: CYCLOPENTOLATE HCL/PHENYLEPHRINE HCL
Drug class: Ophthalmic Cycloplegics/Mydriatics
Therapeutic class: Ophthalmic Agents
Cyclopentolate hydrochloride, a tertiary amine antimuscarinic, is a Phenylephrine hydrochloride, a synthetic sympathomimetic amine, is a Phenylephrine hydrochloride, synthetic sympathomimetic amine, is a mydriatic and cycloplegic. mydriatic. vasoconstrictor.
Cyclopentolate hydrochloride is used to produce mydriasis and cycloplegia for refraction (e.g., retinal and optic disc examination, measurement of refractive error). Cyclopentolate usually is preferred over atropine for such use because cyclopentolate has a more rapid onset and shorter duration of action relative to atropine. The combination preparation containing cyclopentolate hydrochloride 0.2%
and phenylephrine hydrochloride 1% is used to produce pronounced mydriasis with little accompanying cycloplegia for ophthalmologic examination; this combination may be particularly useful for providing maximal mydriasis during examination of patients with retinal detachment. The fixed combination also may be useful in dilation of pupils in young infants for ophthalmologic examinations (e.g., screening for retinopathy of prematurity). (See Cautions: Pediatric Precautions.)
Generic name: CYCLOPENTOLATE HCL/PHENYLEPHRINE HCL
Drug class: Ophthalmic Cycloplegics/Mydriatics
Therapeutic class: Ophthalmic Agents
Cyclopentolate hydrochloride, a tertiary amine antimuscarinic, is a Phenylephrine hydrochloride, a synthetic sympathomimetic amine, is a Phenylephrine hydrochloride, synthetic sympathomimetic amine, is a mydriatic and cycloplegic. mydriatic. vasoconstrictor.
Cyclopentolate hydrochloride is used to produce mydriasis and cycloplegia for refraction (e.g., retinal and optic disc examination, measurement of refractive error). Cyclopentolate usually is preferred over atropine for such use because cyclopentolate has a more rapid onset and shorter duration of action relative to atropine. The combination preparation containing cyclopentolate hydrochloride 0.2%
and phenylephrine hydrochloride 1% is used to produce pronounced mydriasis with little accompanying cycloplegia for ophthalmologic examination; this combination may be particularly useful for providing maximal mydriasis during examination of patients with retinal detachment. The fixed combination also may be useful in dilation of pupils in young infants for ophthalmologic examinations (e.g., screening for retinopathy of prematurity). (See Cautions: Pediatric Precautions.)
DRUG IMAGES
CYCLOMYDRIL EYE DROPS
The following indications for CYCLOMYDRIL (cyclopentolate hcl/phenylephrine hcl) have been approved by the FDA:
Indications:
Mydriasis
Professional Synonyms:
None.
Indications:
Mydriasis
Professional Synonyms:
None.
The following dosing information is available for CYCLOMYDRIL (cyclopentolate hcl/phenylephrine hcl):
To produce mydriasis and cycloplegia for refraction in adults, 1 or 2 drops of a 0.5, 1, or 2% cyclopentolate hydrochloride solution may be instilled onto the eye(s) approximately 40-50 minutes before the procedure; if necessary, a second dose may be instilled in 5-10 minutes. In adults with darkly pigmented irides, more doses or use of the 2% solution may be needed.
Although recovery from mydriasis and cycloplegia usually occurs within 24 hours, 1 or 2 drops of a 1 or 2% pilocarpine solution instilled onto the eye(s) may reduce recovery time to 3-6 hours in most patients.
For cycloplegic refraction in children, 1 drop of a 0.5, 1, or 2% solution may be instilled onto the eye(s); if necessary, this dose may be followed by a second drop of a 0.5 or 1% solution 5-10 minutes later.
The concentration of cyclopentolate hydrochloride used in pediatric patients should be selected based on the patient's weight, iris coloration, and dilation history. In small infants, 1 drop of the 0.5% solution may be instilled into the eye(s).
Following instillation, infants should be observed closely for at least 30 minutes. (See Cautions: Pediatric Precautions.)
To produce mydriasis for funduscopic examination with the combination preparation (Cyclomydril(R)), 1 drop of the solution containing 0.2% cyclopentolate hydrochloride and 1% phenylephrine hydrochloride instilled onto each eye will generally provide rapid mydriasis and permit ready visual access to the fundus. The dose may be repeated every 5-10 minutes if necessary.
When used in infants to produce mydriasis for screening for retinopathy of prematurity, instillation 30 minutes before the examination is recommended.
To produce decongestion of the conjunctiva, 1 or 2 drops of a 0.12-0.25% ophthalmic solution of phenylephrine hydrochloride may be applied topically to the conjunctiva every 3-4 hours (up to 4 times daily for self-medication) as needed.
Vasoconstriction for diagnosis of ocular congestion or to improve visualization of ocular blood vessels in sickle-cell disease may be achieved by application of 1 or 2 drops of a 2.5% solution. In the ''blanching test'', congestion probably is caused by conjunctivitis rather than iridocyclitis if the drug produces perilimbal blanching in the congested eye.
A 2.5 or 10% solution of the drug may also be administered prior to surgery to produce mydriasis and aid in controlling hemorrhage. (See Phenylephrine Hydrochloride 52:24.)
To produce nasal decongestion in adults and children 12 years of age or older, the usual dosage is 2 or 3 drops, 1-3 sprays, or 1-3 metered sprays instilled in each nostril. In cases of extreme nasal congestion in adults, a 1% solution may be used initially. To produce nasal decongestion in children 6-12 years of age, 2 or 3 drops or 1 or 2 sprays of a 0.25%
solution may be instilled in each nostril. Doses of the drug as drops or spray may be repeated in 4 hours if needed. Phenylephrine nasal solutions should not be used for self-medication for longer than 3 days; if symptoms persist, the drug should be discontinued and a physician consulted.
Intranasal application of phenylephrine should generally be used for no longer than 3-5 days.
For use with local anesthetics, phenylephrine hydrochloride may be used in concentrations of 1:2500 to 1:20,000.
Although recovery from mydriasis and cycloplegia usually occurs within 24 hours, 1 or 2 drops of a 1 or 2% pilocarpine solution instilled onto the eye(s) may reduce recovery time to 3-6 hours in most patients.
For cycloplegic refraction in children, 1 drop of a 0.5, 1, or 2% solution may be instilled onto the eye(s); if necessary, this dose may be followed by a second drop of a 0.5 or 1% solution 5-10 minutes later.
The concentration of cyclopentolate hydrochloride used in pediatric patients should be selected based on the patient's weight, iris coloration, and dilation history. In small infants, 1 drop of the 0.5% solution may be instilled into the eye(s).
Following instillation, infants should be observed closely for at least 30 minutes. (See Cautions: Pediatric Precautions.)
To produce mydriasis for funduscopic examination with the combination preparation (Cyclomydril(R)), 1 drop of the solution containing 0.2% cyclopentolate hydrochloride and 1% phenylephrine hydrochloride instilled onto each eye will generally provide rapid mydriasis and permit ready visual access to the fundus. The dose may be repeated every 5-10 minutes if necessary.
When used in infants to produce mydriasis for screening for retinopathy of prematurity, instillation 30 minutes before the examination is recommended.
To produce decongestion of the conjunctiva, 1 or 2 drops of a 0.12-0.25% ophthalmic solution of phenylephrine hydrochloride may be applied topically to the conjunctiva every 3-4 hours (up to 4 times daily for self-medication) as needed.
Vasoconstriction for diagnosis of ocular congestion or to improve visualization of ocular blood vessels in sickle-cell disease may be achieved by application of 1 or 2 drops of a 2.5% solution. In the ''blanching test'', congestion probably is caused by conjunctivitis rather than iridocyclitis if the drug produces perilimbal blanching in the congested eye.
A 2.5 or 10% solution of the drug may also be administered prior to surgery to produce mydriasis and aid in controlling hemorrhage. (See Phenylephrine Hydrochloride 52:24.)
To produce nasal decongestion in adults and children 12 years of age or older, the usual dosage is 2 or 3 drops, 1-3 sprays, or 1-3 metered sprays instilled in each nostril. In cases of extreme nasal congestion in adults, a 1% solution may be used initially. To produce nasal decongestion in children 6-12 years of age, 2 or 3 drops or 1 or 2 sprays of a 0.25%
solution may be instilled in each nostril. Doses of the drug as drops or spray may be repeated in 4 hours if needed. Phenylephrine nasal solutions should not be used for self-medication for longer than 3 days; if symptoms persist, the drug should be discontinued and a physician consulted.
Intranasal application of phenylephrine should generally be used for no longer than 3-5 days.
For use with local anesthetics, phenylephrine hydrochloride may be used in concentrations of 1:2500 to 1:20,000.
Cyclopentolate hydrochloride is applied topically to the eye in the form of a solution. To avoid excessive systemic absorption, finger pressure should be applied on the lacrimal sac during and for 2-3 minutes following topical instillation of the solution, particularly if the 2% solution is used and especially in children. Phenylephrine hydrochloride ophthalmic solutions are applied topically to the conjunctiva.
Digital pressure should be applied on the lacrimal sac for 1-2 minutes following topical instillation of ophthalmic solutions to minimize drainage into the nose and throat and reduce the risk of absorption and systemic reactions. Excess solution around the eye should be removed with a tissue. For intranasal applications, phenylephrine may be administered in solution as drops or spray.
Vicks Sinex(R) (with mist spray nozzle) nasal solution is administered by nasal inhalation using a special nasal inhaler that produces metered droplet sprays. Care must be taken to avoid contamination of the dropper, inhaler, or spray. Except in young children in whom sprays are difficult to use, nasal sprays may be preferable to drops because of the lesser risk of swallowing the drug and resultant systemic absorption.
Drops should be applied to the dependent (lower) nostril, with the patient in a lateral head-low position. The patient should remain in the same position for 5 minutes, then the solution should be applied to the other nostril in a similar manner. Alternatively, drops may be instilled when the patient is reclining with the head tilted back as far as possible.
Sprays should be delivered or pumped (Vicks Sinex(R) metered spray) into each nostril with the patient's head erect so that excess solution is not released. The nose should be blown thoroughly 3-5 minutes later. Prior to initial use of the metered sprays, the nasal inhaler must be primed by depressing the pump firmly several times.
To minimize the risk of spreading infections, droppers, inhalers, and spray dispensers should not be used by more than one person, and tips of the dispensers, inhalers, or droppers should be rinsed with hot water following use. Phenylephrine nasal solutions also may be applied to a tampon or nasal pack for insertion into nasal passages. However, this method of application should be restricted to use in diagnostic or surgical procedures performed under medical supervision because mechanical injury may occur.
Phenylephrine hydrochloride ophthalmic solutions are applied topically to the conjunctiva or cornea. A local anesthetic other than butacaine (See Chemistry and Stability: Stability) may be instilled prior to phenylephrine to prevent stinging and lacrimation.
Digital pressure should be applied on the lacrimal sac for 1-2 minutes following topical instillation of ophthalmic solutions to minimize drainage into the nose and throat and reduce the risk of absorption and systemic reactions. Excess solution around the eye should be removed with a tissue. For intranasal applications, phenylephrine may be administered in solution as drops or spray.
Vicks Sinex(R) (with mist spray nozzle) nasal solution is administered by nasal inhalation using a special nasal inhaler that produces metered droplet sprays. Care must be taken to avoid contamination of the dropper, inhaler, or spray. Except in young children in whom sprays are difficult to use, nasal sprays may be preferable to drops because of the lesser risk of swallowing the drug and resultant systemic absorption.
Drops should be applied to the dependent (lower) nostril, with the patient in a lateral head-low position. The patient should remain in the same position for 5 minutes, then the solution should be applied to the other nostril in a similar manner. Alternatively, drops may be instilled when the patient is reclining with the head tilted back as far as possible.
Sprays should be delivered or pumped (Vicks Sinex(R) metered spray) into each nostril with the patient's head erect so that excess solution is not released. The nose should be blown thoroughly 3-5 minutes later. Prior to initial use of the metered sprays, the nasal inhaler must be primed by depressing the pump firmly several times.
To minimize the risk of spreading infections, droppers, inhalers, and spray dispensers should not be used by more than one person, and tips of the dispensers, inhalers, or droppers should be rinsed with hot water following use. Phenylephrine nasal solutions also may be applied to a tampon or nasal pack for insertion into nasal passages. However, this method of application should be restricted to use in diagnostic or surgical procedures performed under medical supervision because mechanical injury may occur.
Phenylephrine hydrochloride ophthalmic solutions are applied topically to the conjunctiva or cornea. A local anesthetic other than butacaine (See Chemistry and Stability: Stability) may be instilled prior to phenylephrine to prevent stinging and lacrimation.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for CYCLOMYDRIL (cyclopentolate hcl/phenylephrine hcl):
There are 0 contraindications.
There are 0 severe interactions.
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Sympathomimetics/Rauwolfia Alkaloids SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Reserpine depletes catecholamine stores within the peripheral vascular adrenergic nerve endings, thus indirect acting sympathomimetics are unable to trigger the release of catecholamines. The reserpine-induced catecholamine release increases sensitivity to the effects of direct acting sympathomimetics. CLINICAL EFFECTS: Increased effects of direct acting sympathomimetics. Decreased effects of indirect acting sympathomimetics. Mixed acting sympathomimetics will show effects based on the predominance of either direct or indirect activity. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: If these agents are administered concurrently, monitor blood pressure. The dose of the sympathomimetic may need to be adjusted. DISCUSSION: This interaction has been well documented in animal studies and human case reports have confirmed the interaction. Reserpine has been shown to decrease the response to epinephrine administered for hypotension. Reserpine has also been shown to decrease the effectiveness of ophthalmic epinephrine, a direct acting sympathomimetic. Ophthalmic phenylephrine has been shown to decrease the hypotensive effects of reserpine. |
RESERPINE |
The following contraindication information is available for CYCLOMYDRIL (cyclopentolate hcl/phenylephrine hcl):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 0 contraindications.
There are 2 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Angle-closure glaucoma |
| Predisposition to glaucoma |
There are 8 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Atherosclerotic cardiovascular disease |
| Benign prostatic hyperplasia |
| Cardiac arrhythmia |
| Coronary artery disease |
| Diabetes mellitus |
| Down's syndrome |
| Hypertension |
| Hyperthyroidism |
The following adverse reaction information is available for CYCLOMYDRIL (cyclopentolate hcl/phenylephrine hcl):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 19 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Blepharoconjunctivitis Conjunctivitis Punctate keratitis |
| Rare/Very Rare |
|---|
|
Acute cognitive impairment Ataxia Behavioral disorders Cardiac arrhythmia Dizziness Drug-induced psychosis Hallucinations Hyperhidrosis Hypertension Ocular hypertension Pallor Seizure disorder Slurred speech Tachycardia Tremor Urinary retention |
There are 17 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Eye tearing Headache disorder Ocular irritation Ocular pain Photophobia |
Blurred vision Ocular irritation Photophobia |
| Rare/Very Rare |
|---|
|
Disorder of the digestive system Drowsy Fatigue Fever General weakness Skin rash Tachycardia Vasodilation of blood vessels Xerostomia |
The following precautions are available for CYCLOMYDRIL (cyclopentolate hcl/phenylephrine hcl):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Animal reproduction studies have not been performed with cyclopentolate, and it is also not known whether the drug can cause fetal harm when administered to pregnant women. Cyclopentolate should be used during pregnancy only when clearly needed. Animal reproduction studies have not been performed with phenylephrine.
It is not known whether topically applied phenylephrine can cause fetal harm when administered to pregnant women. Parenterally administered phenylephrine in late pregnancy or labor may cause fetal anoxia. (See Cautions: Pregnancy and Lactation, in Phenylephrine Hydrochloride 12:12.04.) Topically applied phenylephrine should be used during pregnancy only when clearly needed.
Animal reproduction studies have not been performed with phenylephrine. It is not known whether topically applied phenylephrine can cause fetal harm when administered to pregnant women. Parenterally administered phenylephrine in late pregnancy or labor may cause fetal anoxia.
(See Cautions: Pregnancy and Lactation, in Phenylephrine Hydrochloride 12:12.04.) Topically applied phenylephrine should be used during pregnancy only when clearly needed.
It is not known whether topically applied phenylephrine can cause fetal harm when administered to pregnant women. Parenterally administered phenylephrine in late pregnancy or labor may cause fetal anoxia. (See Cautions: Pregnancy and Lactation, in Phenylephrine Hydrochloride 12:12.04.) Topically applied phenylephrine should be used during pregnancy only when clearly needed.
Animal reproduction studies have not been performed with phenylephrine. It is not known whether topically applied phenylephrine can cause fetal harm when administered to pregnant women. Parenterally administered phenylephrine in late pregnancy or labor may cause fetal anoxia.
(See Cautions: Pregnancy and Lactation, in Phenylephrine Hydrochloride 12:12.04.) Topically applied phenylephrine should be used during pregnancy only when clearly needed.
It is not known whether cyclopentolate is distributed into milk. Because many drugs are distributed into milk, caution should be exercised when cyclopentolate is used in nursing women. Since it is not known whether phenylephrine is distributed into milk, the drug should be used with caution in nursing women. Since it is not known whether phenylephrine is distributed into milk, the drug should be used with caution in nursing women.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for CYCLOMYDRIL (cyclopentolate hcl/phenylephrine hcl):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for CYCLOMYDRIL (cyclopentolate hcl/phenylephrine hcl)'s list of indications:
| Mydriasis | |
| Z01.0 | Encounter for examination of eyes and vision |
| Z01.00 | Encounter for examination of eyes and vision without abnormal findings |
| Z01.01 | Encounter for examination of eyes and vision with abnormal findings |
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