Please sign in so that we can notify you about a reply
Indications/Uses
PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution is recommended as a vasoconstrictor, decongestant, and mydriatic in a variety of ophthalmic conditions and procedures. Some of its uses are for pupillary dilation in uveitis (to prevent or aid in the disruption of posterior synechia formation), for many ophthalmic surgical procedures and for refraction without cycloplegia. PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution may also be used for funduscopy and other diagnostic procedures.
Dosage/Direction for Use
Vasoconstriction and Pupil Dilation: PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution is especially useful when rapid and powerful dilation of the pupil without cycloplegia and reduction of congestion in the capillary bed are desired.
A drop of a suitable topical anesthetic may be applied, followed in a few minutes by 1 drop of PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution on the upper limbus. The anesthetic prevents stinging and consequent dilution of the solution by lacrimation. It may occasionally be necessary to repeat the instillation after one hour, again preceded by the use of the topical anesthetic.
Uveitis: Posterior Synechiae: PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution may be used in patients with uveitis when synechiae are present or may develop. The formation of synechiae may be prevented by the use of this solution and atropine or other cycloplegic to produce wide dilation of the pupil. For recently formed posterior synechiae one drop of PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution may be applied to the upper surface of the cornea and be repeated as necessary, not to exceed three times. Treatment may be continued the following day, if necessary. Atropine sulfate and the application of hot compresses should also be used if indicated.
Glaucoma: PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution may be used with miotics in patients with open angle glaucoma. It reduces the difficulties experienced by the patient because of the small field produced by miosis, and still it permits and often supports the effect of the miotic in lowering the intraocular pressure in open angle glaucoma. Hence, there may be marked improvement in visual acuity after using PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution in conjunction with miotic drugs.
Surgery: When a short-acting mydriatic is needed for wide dilation of the pupil before intraocular surgery, PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution may be applied topically from 30 to 60 minutes before the operation.
Refraction: PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution may be used effectively to increase mydriasis with homatropine hydrobromide, cyclopentolate hydrochloride, tropicamide hydrochloride and atropine sulfate.
FOR ADULTS: One drop of the preferred cycloplegic is placed in each eye, followed in 5 minutes by one drop of PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution.
Since adequate cycloplegia is achieved at different time intervals after the instillation of the necessary number of drops, different cycloplegics will require different waiting periods to achieve adequate cycloplegia.
FOR CHILDREN: For a "one application method", PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution may be combined with one of the preferred rapid acting cycloplegics to produce adequate cycloplegia.
Ophthalmoscopic Examination: One drop of PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution is placed in each eye. Sufficient mydriasis to permit examination is produced in 15 to 30 minutes. Dilation lasts from one to three hours.
Diagnostic Procedures: Provocative Test for Angle Closure Glaucoma: PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution may be used cautiously as a provocative test when interval narrow angle closure glaucoma is suspected. Intraocular tension and gonioscopy are performed prior to and after dilation of the pupil with phenylephrine HCl. A "significant" intraocular pressure (IOP) rise combined with gonioscopic evidence of angle closure indicates an anterior segment anatomy capable of angle closure. A negative test does not rule this out. This pharmacologically induced angle closure glaucoma may not simulate real life conditions, and other causes for transient elevations of IOP should be excluded.
Retinoscopy (Shadow Test): When dilation of the pupil without cycloplegic action is desired for retinoscopy, PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution may be used.
NOTE: Heavily pigmented irides may require larger doses in all of the above procedures.
Blanching Test: One or two drops of PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution should be applied to the injected eye. After five minutes, examine for perilimbal blanching. If blanching occurs, the congestion is superficial and probably does not indicate iridocyclitis.
A drop of a suitable topical anesthetic may be applied, followed in a few minutes by 1 drop of PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution on the upper limbus. The anesthetic prevents stinging and consequent dilution of the solution by lacrimation. It may occasionally be necessary to repeat the instillation after one hour, again preceded by the use of the topical anesthetic.
Uveitis: Posterior Synechiae: PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution may be used in patients with uveitis when synechiae are present or may develop. The formation of synechiae may be prevented by the use of this solution and atropine or other cycloplegic to produce wide dilation of the pupil. For recently formed posterior synechiae one drop of PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution may be applied to the upper surface of the cornea and be repeated as necessary, not to exceed three times. Treatment may be continued the following day, if necessary. Atropine sulfate and the application of hot compresses should also be used if indicated.
Glaucoma: PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution may be used with miotics in patients with open angle glaucoma. It reduces the difficulties experienced by the patient because of the small field produced by miosis, and still it permits and often supports the effect of the miotic in lowering the intraocular pressure in open angle glaucoma. Hence, there may be marked improvement in visual acuity after using PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution in conjunction with miotic drugs.
Surgery: When a short-acting mydriatic is needed for wide dilation of the pupil before intraocular surgery, PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution may be applied topically from 30 to 60 minutes before the operation.
Refraction: PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution may be used effectively to increase mydriasis with homatropine hydrobromide, cyclopentolate hydrochloride, tropicamide hydrochloride and atropine sulfate.
FOR ADULTS: One drop of the preferred cycloplegic is placed in each eye, followed in 5 minutes by one drop of PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution.
Since adequate cycloplegia is achieved at different time intervals after the instillation of the necessary number of drops, different cycloplegics will require different waiting periods to achieve adequate cycloplegia.
FOR CHILDREN: For a "one application method", PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution may be combined with one of the preferred rapid acting cycloplegics to produce adequate cycloplegia.
Ophthalmoscopic Examination: One drop of PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution is placed in each eye. Sufficient mydriasis to permit examination is produced in 15 to 30 minutes. Dilation lasts from one to three hours.
Diagnostic Procedures: Provocative Test for Angle Closure Glaucoma: PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution may be used cautiously as a provocative test when interval narrow angle closure glaucoma is suspected. Intraocular tension and gonioscopy are performed prior to and after dilation of the pupil with phenylephrine HCl. A "significant" intraocular pressure (IOP) rise combined with gonioscopic evidence of angle closure indicates an anterior segment anatomy capable of angle closure. A negative test does not rule this out. This pharmacologically induced angle closure glaucoma may not simulate real life conditions, and other causes for transient elevations of IOP should be excluded.
Retinoscopy (Shadow Test): When dilation of the pupil without cycloplegic action is desired for retinoscopy, PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution may be used.
NOTE: Heavily pigmented irides may require larger doses in all of the above procedures.
Blanching Test: One or two drops of PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution should be applied to the injected eye. After five minutes, examine for perilimbal blanching. If blanching occurs, the congestion is superficial and probably does not indicate iridocyclitis.
Overdosage
In case of accidental ingestion, phenylephrine may cause hypertension, headache, seizures, cerebral haemorrhage, palpitation, paresthesia, or vomiting. Pulmonary oedema or cardiac arrest may occur. Phenylephrine has a rapid onset and short duration of action, thus treatment of toxicity is supportive. The use of beta blockers and calcium channel blockers for the treatment of acute hypertension secondary to vasoconstriction should be avoided.
Contraindications
PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution is contraindicated in patients with anatomically narrow angles or narrow angle glaucoma. PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution is contraindicated in newborns and infants with cardiovascular or cerebrovascular disease and in some elderly adults with severe arteriosclerotic cardiovascular or cerebrovascular disease. PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution may be contraindicated during intraocular operative procedures when the corneal epithelial barrier has been disturbed. This preparation is also contraindicated in persons with hypersensitivity to the active substance or to any of the excipients.
Warnings
PHYSICIANS SHOULD COMPLETELY FAMILIARIZE THEMSELVES WITH THE COMPLETE CONTENTS OF THIS LEAFLET BEFORE PRESCRIBING PHENYLEPHRINE HYDROCHLORIDE.
Nasolacrimal occlusion or gently closing the eyelid after administration is recommended. This may reduce the systemic absorption or medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions.
Contains sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible persons.
The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
Not for intraocular use.
Use with caution in children and elderly or in patients with sympathetic denervation (e.g. patients with insulin dependent diabetes, orthostatic hypotension, hypertension, hyperthyroidism).
Use with caution, if at all, in patients taking monamine oxidase inhibitors, tricyclic antidepressants, certain antihypertensive agents, or atropine.
This product contains benzalkonium chloride which may cause eye irritation and is known to discolor soft contact lenses. Avoid contact with soft contact lenses. Patients must be instructed to remove contact lenses prior to application of PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution and wait 15 minutes before reinsertion.
The use in preterm and newborn infants is not recommended unless clearly necessary. The lowest possible dose should be used. Instillation of more than one drop per eye must be avoided. Full-term, but especially low birth weight and premature infants may be at an increased risk for systemic adverse reactions including transient increases in blood pressure. The infant should be monitored after instillation and routines to adequately deal with emergency situations should be in place.
Nasolacrimal occlusion or gently closing the eyelid after administration is recommended. This may reduce the systemic absorption or medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions.
Contains sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible persons.
The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
Not for intraocular use.
Use with caution in children and elderly or in patients with sympathetic denervation (e.g. patients with insulin dependent diabetes, orthostatic hypotension, hypertension, hyperthyroidism).
Use with caution, if at all, in patients taking monamine oxidase inhibitors, tricyclic antidepressants, certain antihypertensive agents, or atropine.
This product contains benzalkonium chloride which may cause eye irritation and is known to discolor soft contact lenses. Avoid contact with soft contact lenses. Patients must be instructed to remove contact lenses prior to application of PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution and wait 15 minutes before reinsertion.
The use in preterm and newborn infants is not recommended unless clearly necessary. The lowest possible dose should be used. Instillation of more than one drop per eye must be avoided. Full-term, but especially low birth weight and premature infants may be at an increased risk for systemic adverse reactions including transient increases in blood pressure. The infant should be monitored after instillation and routines to adequately deal with emergency situations should be in place.
Special Precautions
Ordinarily, any mydriatic, including phenylephrine HCI, is contraindicated in patients with glaucoma, since it may occasionally raise intraocular pressure. However, when temporary dilation of the pupil may free adhesions, this advantage may temporarily outweigh the danger from coincident dilation of the pupil. Rebound miosis has been reported in older persons one day after receiving phenylephrine eye drops, and reinstillation of the drug may produce a reduction in mydriasis. This may be of clinical importance in dilating the pupils of older subjects prior to retinal detachment or cataract surgery. The lacrimal sac should be compressed by digital pressure for two to three minutes after instillation to avoid excessive systemic absorption.
Due to a strong action of the drug on the dilator muscle, the use of phenylephrine in the eye may liberate pigment granules from the iris, especially when given in high doses to elderly patients. The appearance may be similar to anterior uveitis or to a microscopic hyphema. To prevent pain, a drop of suitable topical anesthetic may be applied before using PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution. Prolonged exposure to air or strong light may cause oxidation and discoloration. Do not use if solution is brown or contains a precipitate. Monitor blood pressure in geriatric patients with known cardiac disease. Use with caution in infants with known cardiac anomalies.
Exceeding recommended dosages or applying PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution to the instrumented, traumatized, diseased or postsurgical eye or adnexa, or to patients with suppressed lacrimation, as during anesthesia, may result in absorption of sufficient quantities of phenylephrine to produce a systemic vasopressor response.
Information for patients: Do not touch dropper tip to any surface as this may contaminate the solution.
Effects on Ability to Drive and Use Machines: Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machinery.
Carcinogenesis, Mutagenesis, Impairment of Fertility: There have been no long-term studies done using phenylephrine HCl in animals to evaluate carcinogenic potential.
Fertility: Studies have not been performed to evaluate the effect of ocular administration of PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution on fertility.
Use in Children: The lowest dose necessary to produce the desired effect should always be used.
Parents should be warned not to get this preparation in their children's mouth or cheeks and to wash their hands and the child's hands or cheeks following administration.
Due to a strong action of the drug on the dilator muscle, the use of phenylephrine in the eye may liberate pigment granules from the iris, especially when given in high doses to elderly patients. The appearance may be similar to anterior uveitis or to a microscopic hyphema. To prevent pain, a drop of suitable topical anesthetic may be applied before using PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution. Prolonged exposure to air or strong light may cause oxidation and discoloration. Do not use if solution is brown or contains a precipitate. Monitor blood pressure in geriatric patients with known cardiac disease. Use with caution in infants with known cardiac anomalies.
Exceeding recommended dosages or applying PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution to the instrumented, traumatized, diseased or postsurgical eye or adnexa, or to patients with suppressed lacrimation, as during anesthesia, may result in absorption of sufficient quantities of phenylephrine to produce a systemic vasopressor response.
Information for patients: Do not touch dropper tip to any surface as this may contaminate the solution.
Effects on Ability to Drive and Use Machines: Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machinery.
Carcinogenesis, Mutagenesis, Impairment of Fertility: There have been no long-term studies done using phenylephrine HCl in animals to evaluate carcinogenic potential.
Fertility: Studies have not been performed to evaluate the effect of ocular administration of PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution on fertility.
Use in Children: The lowest dose necessary to produce the desired effect should always be used.
Parents should be warned not to get this preparation in their children's mouth or cheeks and to wash their hands and the child's hands or cheeks following administration.
Use In Pregnancy & Lactation
Use in Pregnancy: Pregnancy Category C: There are no or limited amount of data from the use of PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution in pregnant women. However, there is data with the systemic use of phenylephrine that suggest risk.
PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution is not recommended during pregnancy.
Use in Lactation: It is not known whether phenylephrine/metabolites are excreted into human milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution is not recommended during pregnancy.
Use in Lactation: It is not known whether phenylephrine/metabolites are excreted into human milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Adverse Reactions
A marked increase in blood pressure has been reported in low weight premature neonates, infants and adult patients with idiopathic orthostatic hypotension. Cardiovascular reactions which have occurred primarily in elderly patients include marked increase in blood pressure, syncope, myocardial infarction, tachycardia, arrhythmia and fatal subarachnoid hemorrhage.
The following adverse reactions have been reported following administration of PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution. Frequency cannot be estimated from the available data.
Within each SOC, undesirable effects are presented in decreasing order of seriousness: See table.
The following adverse reactions have been reported following administration of PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution. Frequency cannot be estimated from the available data.
Within each SOC, undesirable effects are presented in decreasing order of seriousness: See table.
Description of selected adverse reactions: Systemic toxicity can result from topical application of sympathicomimetic drugs: headache, blood pressure elevation, extrasystoles, tachycardia, syncope and cerebrovascular accidents have been reported.
Drug Interactions
When administered simultaneously with, or up to 21 days after, administration of monoamine oxidase (MAO) inhibitors, careful supervision and adjustment of dosages are required since exaggerated adrenergic effects may result.
Use with caution, if at all, in patients taking tricyclic antidepressants and certain antihypertensive agents (guanethidine, reserpine, and non-selective beta blockers such as propanolol) as the pressor response is potentiated.
Concomitant use of phenylephrine and atropine may enhance the pressor effects and induce tachycardia in some patients, especially infants.
Phenylephrine may potentiate the cardiovascular depressant effects of potent inhalation anesthetic agents.
Use with caution, if at all, in patients taking tricyclic antidepressants and certain antihypertensive agents (guanethidine, reserpine, and non-selective beta blockers such as propanolol) as the pressor response is potentiated.
Concomitant use of phenylephrine and atropine may enhance the pressor effects and induce tachycardia in some patients, especially infants.
Phenylephrine may potentiate the cardiovascular depressant effects of potent inhalation anesthetic agents.
Storage
Store at a temperature not exceeding 25°C. Protect from light. Do not freeze.
Action
Pharmacology: PHENYLEPHRINE hydrochloride (MYDFRIN) 2.5% Sterile Ophthalmic Solution is an alpha receptor sympathetic agonist used in local ocular disorders because of its vasoconstrictor and mydriatic action. It exhibits rapid and moderately prolonged action, and it produces little rebound vasodilation. Systemic side effects are uncommon.
MedsGo Class
Mydriatic Drugs
Features
Dosage
25 mg / ml (2.5% w/v)
Ingredients
- Phenylephrine
Packaging
Sterile Ophthalmic Solution 5ml
Generic Name
Phenylephrine Hydrochloride
Registration Number
DR-XY16997
Classification
Prescription Drug (RX)
Reviews
No reviews found
Product Questions
Questions
