Phenylephrine Hydrochloride Solution/ Drops

Prolonged exposure to air or strong light may cause oxidation and discoloration. Do not use if solution is brown or contains a precipitate.

Vasoconstriction and Pupil Dilation:

Phenylephrine Hydrochloride Ophthalmic Solution, 10%, is especially useful when rapid and powerful dilation of the pupil and reduction of congestion in the capillary bed are desired. A drop of suitable topical anesthetic may be applied, followed in a few minutes by 1 drop of the Phenylephrine Hydrochloride Ophthalmic Solution, 10%, 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 to the topical anesthetic.

Uveitis: Posterior Synechiae:

Phenylephrine Hydrochloride Ophthalmic Solution, 10%, may be used in patients with uveitis when synechiae are present or may develop. The formulation of synechiae may be prevented by the used of the 10% ophthalmic solution and atropine to produce wide dilation of the pupil. It should be emphasized, however, that the vasoconstrictor effect of the phenylephrine hydrochloride may be antagonistic to the increase of local blood flow in uveal infection.

To free recently formed posterior synechiae, 1 drop of the 10% ophthalmic solution may be applied to the upper surface of the cornea. On the following day, treatment may be continued if necessary. In the interim, hot compresses should be applied for five or ten minutes three times a day, with 1 drop of a 1% or 2% solution of atropine sulfate before and after each series of compresses.

Glaucoma:

In certain patients with glaucoma, temporary reduction of intraocular tension may be attained by producing vasoconstriction of the intraocular vessels; this may be accomplished by placing 1 drop of the 10% ophthalmic solution on the upper surface of the cornea. This treatment may be repeated as often as necessary.

Phenylephrine hydrochloride may be used with miotics in patients with wide 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. Hence, there may be marked improvement in visual acuity after using phenylephrine hydrochloride in conjunction with miotic drugs.

Surgery:

When a short-acting mydriatic is needed for wide dilation of the pupil before intraocular surgery, the 10% or 2.5% ophthalmic solutions may be applied topically from 30-60 minutes before the operation.

Refraction:

Prior to determination of refractive errors, Phenylephrine Hydrochloride Ophthalmic Solution, 2.5% may be used effectively with homatropine hydrobromide, atropine sulfate, or a combination of homatropine and cocaine hydrochloride.

For ADULTS, a drop of the preferred cycloplegic is placed in each eye, followed in five minutes by 1 drop of Phenylephrine Hydrochloride Ophthalmic Solution, 2.5%, and in 10 minutes by another drop of cycloplegic. In 50-60 minutes, the eyes are ready for refraction.

For CHILDREN, a drop of atropine sulfate 1% is placed in each eye, followed in 10-15 minutes by 1 drop of Phenylephrine Hydrochloride Ophthalmic Solution, 2.5%, and in five to ten minutes by a second drop of atropine sulfate 1%. In one to two hours, the eyes are ready for refraction.

For a “one application method”, Phenylephrine Hydrochloride Ophthalmic Solution, 2.5%, may be combined with a cycloplegic to elicit synergistic action.  The additive effect varies depending on the patient.  Therefore, when using a “one application method”, it may be desirable to increase the concentration of the cycloplegic. Ophthalmoscopic Examination:

One drop of Phenylephrine Hydrochloride Ophthalmic Solution, 2.5%, is placed in each eye. Sufficient mydriasis to permit examination is produced in 15 to 30 minutes. Dilations lasts from one to three hours.

Diagnostic Procedures:

PROVOCATIVE TEST FOR ANGLE BLOCK IN PATIENTS WITH GLAUCOMA: The 2.5% ophthalmic solution may be used as a provocative test when latent increased intraocular pressure is suspected. Tension is measured before application of the phenylephrine hydrochloride and again after dilation. A 3 to 5 mm of mercury rise in pressure suggest the presence of angle block in patients with glaucoma; however, failure to obtain such a rise does not preclude the presence of glaucoma form other causes.

SHADOW TEST (RETINOSCOPY): When dilation of the pupil without cycloplegic action is desired for the shadow test, the 2.5% ophthalmic solution may be used alone.

BLANCHING TEST: One or two drops of the 2.5% 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 iritis.

Prolonged exposure to air or strong light may cause oxidation and discoloration. Do not use if solution is brown or contains a precipitate.

Vasoconstriction and Pupil Dilation:

Phenylephrine Hydrochloride Ophthalmic Solution, 10%, is especially useful when rapid and powerful dilation of the pupil and reduction of congestion in the capillary bed are desired. A drop of suitable topical anesthetic may be applied, followed in a few minutes by 1 drop of the Phenylephrine Hydrochloride Ophthalmic Solution, 10%, 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 to the topical anesthetic.

Uveitis: Posterior Synechiae:

Phenylephrine Hydrochloride Ophthalmic Solution, 10%, may be used in patients with uveitis when synechiae are present or may develop. The formulation of synechiae may be prevented by the used of the 10% ophthalmic solution and atropine to produce wide dilation of the pupil. It should be emphasized, however, that the vasoconstrictor effect of the phenylephrine hydrochloride may be antagonistic to the increase of local blood flow in uveal infection.

To free recently formed posterior synechiae, 1 drop of the 10% ophthalmic solution may be applied to the upper surface of the cornea. On the following day, treatment may be continued if necessary. In the interim, hot compresses should be applied for five or ten minutes three times a day, with 1 drop of a 1% or 2% solution of atropine sulfate before and after each series of compresses.

Glaucoma:

In certain patients with glaucoma, temporary reduction of intraocular tension may be attained by producing vasoconstriction of the intraocular vessels; this may be accomplished by placing 1 drop of the 10% ophthalmic solution on the upper surface of the cornea. This treatment may be repeated as often as necessary.

Phenylephrine hydrochloride may be used with miotics in patients with wide 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. Hence, there may be marked improvement in visual acuity after using phenylephrine hydrochloride in conjunction with miotic drugs.

Surgery:

When a short-acting mydriatic is needed for wide dilation of the pupil before intraocular surgery, the 10% or 2.5% ophthalmic solutions may be applied topically from 30-60 minutes before the operation.

Refraction:

Prior to determination of refractive errors, Phenylephrine Hydrochloride Ophthalmic Solution, 2.5% may be used effectively with homatropine hydrobromide, atropine sulfate, or a combination of homatropine and cocaine hydrochloride.

For ADULTS, a drop of the preferred cycloplegic is placed in each eye, followed in five minutes by 1 drop of Phenylephrine Hydrochloride Ophthalmic Solution, 2.5%, and in 10 minutes by another drop of cycloplegic. In 50-60 minutes, the eyes are ready for refraction.

For CHILDREN, a drop of atropine sulfate 1% is placed in each eye, followed in 10-15 minutes by 1 drop of Phenylephrine Hydrochloride Ophthalmic Solution, 2.5%, and in five to ten minutes by a second drop of atropine sulfate 1%. In one to two hours, the eyes are ready for refraction.

For a “one application method”, Phenylephrine Hydrochloride Ophthalmic Solution, 2.5%, may be combined with a cycloplegic to elicit synergistic action.  The additive effect varies depending on the patient.  Therefore, when using a “one application method”, it may be desirable to increase the concentration of the cycloplegic. Ophthalmoscopic Examination:

One drop of Phenylephrine Hydrochloride Ophthalmic Solution, 2.5%, is placed in each eye. Sufficient mydriasis to permit examination is produced in 15 to 30 minutes. Dilations lasts from one to three hours.

Diagnostic Procedures:

PROVOCATIVE TEST FOR ANGLE BLOCK IN PATIENTS WITH GLAUCOMA: The 2.5% ophthalmic solution may be used as a provocative test when latent increased intraocular pressure is suspected. Tension is measured before application of the phenylephrine hydrochloride and again after dilation. A 3 to 5 mm of mercury rise in pressure suggest the presence of angle block in patients with glaucoma; however, failure to obtain such a rise does not preclude the presence of glaucoma form other causes.

SHADOW TEST (RETINOSCOPY): When dilation of the pupil without cycloplegic action is desired for the shadow test, the 2.5% ophthalmic solution may be used alone.

BLANCHING TEST: One or two drops of the 2.5% 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 iritis.

Vasoconstriction and Pupil Dilatation: Phenylephrine Hydrochloride Ophthalmic Solution is especially useful when rapid and powerful dilatation 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 Ophthalmic Solution to 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 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 cycloplegics to produce wide dilation of the pupil. For recently formed posterior synechiae one drop of Phenylephrine Hydrochloride 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 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 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 Ophthalmic Solution may be applied topically from 30 to 60 minutes before the operation.

Refraction: Phenylephrine Hydrochloride 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 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 Ophthalmic Solution may be combined with one of the preferred rapid acting cycloplegics to produce adequate cycloplegia.

Opthalmoscopic Examination: One drop of Phenylephrine Hydrochloride Ophthalmic Solution is placed in each eye. Sufficient mydriasis to permit examination is produced in 15 to 30 minutes. Dilation lasts one to three hours.

Diagnostic Procedures: Provocative Test for Angle Closure Glaucoma:

Phenylephrine Hydrochloride 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 hydrochloride. 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 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 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.

Vasoconstriction and Pupil Dilatation: Phenylephrine Hydrochloride Ophthalmic Solution is especially useful when rapid and powerful dilatation 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 Ophthalmic Solution to 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 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 cycloplegics to produce wide dilatation of the pupil. It should be emphasized, however, that the vasoconstrictor effect of Phenylephrine Hydrochloride Ophthalmic Solution may be antagonistic to the increase of local blood flow in uveal infection.

To free recently formed posterior synechiae, one drop of Phenylephrine Hydrochloride Ophthalmic Solution may be applied to the upper surface of the cornea. On the following day, treatment may be continued if necessary. In the interim, hot compresses should be applied for five or ten minutes three times a day, with one drop of a 1% or 2% solution of atropine sulfate before and after each series of compresses.

Glaucoma: In certain patients with glaucoma, temporary reduction of intraocular tension may be attained by producing vasoconstriction of the intraocular vessels; this may be accomplished by placing 1 drop of Phenylephrine Hydrochloride Ophthalmic Solution on the upper surface of the cornea. This treatment may be repeated as often as necessary.

Phenylephrine Hydrochloride Ophthalmic Solution may be used with miotics in patients with wide 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. Hence, there may be marked improvement in visual acuity after using Phenylephrine Hydrochloride 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 Ophthalmic Solution may be applied topically from 30 to 60 minutes before the operation.

Vasoconstriction and Pupil Dilatation: Phenylephrine Hydrochloride Ophthalmic Solution is especially useful when rapid and powerful dilatation 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 Ophthalmic Solution to 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 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 cycloplegics to produce wide dilation of the pupil. For recently formed posterior synechiae one drop of Phenylephrine Hydrochloride 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 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 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 Ophthalmic Solution may be applied topically from 30 to 60 minutes before the operation.

Refraction: Phenylephrine Hydrochloride 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 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 Ophthalmic Solution may be combined with one of the preferred rapid acting cycloplegics to produce adequate cycloplegia.

Opthalmoscopic Examination: One drop of Phenylephrine Hydrochloride Ophthalmic Solution is placed in each eye. Sufficient mydriasis to permit examination is produced in 15 to 30 minutes. Dilation lasts one to three hours.

Diagnostic Procedures: Provocative Test for Angle Closure Glaucoma:

Phenylephrine Hydrochloride 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 hydrochloride. 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 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 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.

2.1 General Dosing Recommendations

In patients 1 year of age or greater, apply one drop of either Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% or 10% every 3 to 5 minutes to the conjunctival fornix as required up to a maximum of 3 drops. If necessary, this dose may be repeated.

In order to obtain a greater degree of mydriasis, Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% may be needed.

2.2 Pediatric Patients Less Than 1 Year of Age

In pediatric patients less than 1 year of age, one drop of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% should be instilled at 3 to 5 minute intervals up to a maximum of 3 drops per eye.