Download Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5

MYDRIATICS AND CYCLOPLEGICS
Phenylephrine Hydrochloride
Ophthalmic Solution, USP
2.5% — Sterile
Phenylephrine Hydrochloride 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 Ophthalmic Solution may also be used
for funduscopy and other diagnostic procedures
Ophthalmic solutions of phenylephrine hydrochloride are
contraindicated in patients with anatomically narrow angles or
narrow angle glaucoma
Phenylephrine hydrochloride may be contraindicated in low birth
weight infants and in some elderly adults with severe arteriosclerotic
cardiovascular or cerebrovascular disease
Phenylephrine hydrochloride may be contraindicated during
intraocular operative procedures when the corneal epithelial barrier
has been disturbed
Contraindicated in persons with a known sensitivity to phenylephrine
hydrochloride or any of its components
Available direct or through your authorized wholesaler or distributor
Phenylephrine Hydrochloride Ophthalmic Solution, USP
NDC #
DESCRIPTION
SIZE
UNIT
OF SALE
BRAND NAME
17478-200-20
2.5% Sterile Ophthalmic Solution
2 mL
1
Mydfrin® by Alcon Labs
17478-200-12
2.5% Sterile Ophthalmic Solution
15 mL
1
Mydfrin® by Alcon Labs
EACH mL CONTAINS:
ACTIVE:
Phenylephrine Hydrochloride 2.5%;
PRESERVATIVE:
Benzalkonium Chloride 0.1 mg (0.01%);
INACTIVES:
Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Sodium Hydroxide and/or Phosphoric Acid may be added to adjust pH (4.0 to 7.5) and Purified Water USP.
STORAGE:
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light and excessive heat.
Do not use if solution is brown or contains precipitate.
NDC #
CARDINAL
AMERISOURCEBERGEN
MCKESSON
MORRIS DICKSON
17478-200-20
3256138
862-086
2740751
087387
17478-200-12
1479450
862-508
1720085
084376
Scan with
smart phone
to visit
akorn.com
To order products call 800-932-5676 or fax 800-943-3694 • www.akorn.com
NOT FOR PRESCRIBING PURPOSES. PLEASE REFER TO PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION.
1925 West Field Court, Suite 300 • Lake Forest, IL 60045
P258 Rev. 07/12
Phenylephrine Hydrochloride
Ophthalmic Solution, USP
2.5% — Sterile
WARNING: PHYSICIANS SHOULD COMPLETELY
FAMILIARIZE THEMSELVES WITH THE COMPLETE
CONTENTS OF THIS LEAFLET BEFORE PRESCRIBING
PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC
SOLUTION.
DESCRIPTION: Phenylephrine Hydrochloride Ophthalmic
Solution, USP is a vasoconstrictor and mydriatic for use in
ophthalmology. Phenylephrine is a synthetic sympathomimetic
compound structurally similar to epinephrine and ephedrine.
Phenylephrine Hydrochloride Ophthalmic Solution is supplied
as a sterile topical ophthalmic solution. The active ingredient,
phenylephrine hydrochloride is represented by the chemical
structure:
ESTABLISHED NAME: Phenylephrine Hydrochloride
CHEMICAL NAME: (-)-m-Hydroxy-α-[(methyl-amino)methyl]
benzyl alcohol hydrochloride
Each mL of solution contains:
Active: Phenylephrine Hydrochloride 2.5%. Inactives: Sodium
Phosphate Dibasic, Sodium Phosphate Monobasic, Sodium
Hydroxide and/or Phosphoric Acid may be added to adjust pH
(4.0 to 7.5), and Purified Water USP. Preservative:
Benzalkonium Chloride 0.1 mg (0.01%).
CLINICAL PHARMACOLOGY:
Phenylephrine Hydrochloride 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.
Although rare, systemic absorption of sufficient quantities of
phenylephrine may lead to systemic α-adrenergic affects, such
as a rise in blood pressure which may be accompanied by a
reflex atropine-sensitive bradycardia.
INDICATIONS AND USAGE: Phenylephrine Hydrochloride
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 Ophthalmic Solution may also be used for
funduscopy and other diagnostic procedures.
CONTRAINDICATIONS: Ophthalmic solutions of phenylephrine
hydrochloride are contraindicated in patients with anatomically
narrow angles or narrow angle glaucoma. Phenylephrine
hydrochloride may be contraindicated in low birth weight
infants and in some elderly adults with severe arteriosclerotic
cardiovascular or cerebrovascular disease. Phenylephrine
hydrochloride may be contraindicated during intraocular
operative procedures when the corneal epithelial barrier has
been disturbed. This preparation is also contraindicated in
persons with a known sensitivity to phenylephrine
hydrochloride or any of its components.
WARNINGS: Not for intraocular use. As with other adrenergic
drugs, when Phenylephrine Hydrochloride Ophthalmic Solution
is 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. The pressor
response of adrenergic agents may also be potentiated by
tricyclic antidepressants. Systemic side effects are more
common in patients taking beta adrenergic blocking agents
such as propranolol. Concomitant use of phenylephrine and
atropine may enhance the pressor effects and induce
tachycardia in some patients, especially infants.1
There have been rare reports associating the use of
phenylephrine hydrochloride 10% ophthalmic solutions with
the development of serious cardiovascular reactions, including
ventricular arrhythmias and myocardial infarctions. These
episodes, some ending fatally, have usually occurred in elderly
patients with preexisting cardiovascular diseases.
PRECAUTIONS:
General: Ordinarily, any mydriatic, including phenylephrine
hydrochloride, 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
hydrochloride ophthalmic solutions, and reinstillation of the
drug may produce less mydriasis than previously. 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, older individuals may also develop transient pigment
floaters in the aqueous humor 40 to 45 minutes following the
administration of phenylephrine hydrochloride ophthalmic
solution. 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 Ophthalmic Solution. Prolonged exposure to air
or strong light may cause oxidation and discoloration. Monitor
blood pressure in geriatric patients with known cardiac disease.
Use caution in infants with known cardiac anomalies.
Exceeding recommended dosages or applying Phenylephrine
Hydrochloride Ophthalmic Solution to the instrumented,
traumatized, diseased or postsurgical eye or adnexa, or to
patients with suppressed lacrimation, as during anesthesia,
may result in the 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. DO NOT USE IF SOLUTION IS BROWN OR
CONTAINS A PRECIPITATE.
Drug Interaction: As with all other adrenergic drugs, when
Phenylephrine Hydrochloride Ophthalmic Solution is 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 occur. The pressor response of adrenergic agents may
also be potentiated by tricyclic antidepressants, propranolol,
reserpine, guanethidine, methyldopa, and atropine-like drugs.
Phenylephrine hydrochloride ophthalmic solutions may potentiate
the cardiovascular depressant effects of potent inhalation
anesthetic agents.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Carcinogenicity studies with phenylephrine hydrochloride have
been completed in mice at doses up to 2500 ppm in feed and
in rats at doses up to 1250 ppm in feed. Phenylephrine
hydrochloride demonstrated no carcinogenic effect in male or
female mice and rats.
Pregnancy: Pregnancy Category C. Animal reproduction
studies have not been conducted with phenylephrine
hydrochloride ophthalmic solution. It is also not known
whether phenylephrine hydrochloride ophthalmic solution can
cause fetal harm when administered to a pregnant woman or
can affect reproduction capacity. Phenylephrine Hydrochloride
Ophthalmic Solution should be given to a pregnant woman
only if clearly needed.
Nursing Mothers: It is not known whether this drug is excreted
in human milk. Because many drugs are excreted in human
milk, caution should be exercised when Phenylephrine
Hydrochloride Ophthalmic Solution is administered to a
nursing woman.
Pediatric Use: Phenylephrine Hydrochloride Ophthalmic
Solution may be contraindicated in low birth weight neonates
and infants. For use in older children see DOSAGE AND
ADMINISTRATION.
Exceeding recommended dosages or applying Phenylephrine
Hydrochloride Ophthalmic Solution to the instrumented,
traumatized, diseased or post surgical eye or adnexa, or to
patients with suppressed lacrimation, as during anesthesia,
may result in the absorption of sufficient quantities of
phenylephrine to produce a systemic vasopressor response.
The hypertensive effects of phenylephrine may be treated with
an alpha-adrenergic blocking agent such as phentolamine
mesylate, 5 mg to 10 mg intravenously, repeated as necessary.
The oral LD50 of phenylephrine in the rat: 350 mg/kg, in the
mouse: 120 mg/kg.
Concomitant use of phenylephrine and atropine may enhance
the pressor effects and induce tachycardia in some patients,
especially infants.
Use with caution in infants with known cardiac anomalies.
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.2
Other reactions include bradycardia, headache, and excitability.
DOSAGE AND ADMINISTRATION:
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.
HOW SUPPLIED: Phenylephrine Hydrochloride Ophthalmic
Solution, USP is supplied as a sterile solution in plastic dropper
bottles in the following sizes:
2 mL-NDC 17478-200-20
15 mL-NDC 17478-200-12
Storage: Store at 20° to 25°C (68° to 77°F) [see USP
Controlled Room Temperature]. Keep container tightly closed.
Protect from light and excessive heat.
Do not use if solution is brown or contains precipitate.
REFERENCES:
1. Fraunfelder, F.T., and Meyer, S.M.: Possible Cardiovascular
Effects Secondary to Topical Ophthalmic 2.5%
Phenylephrine, Am. J. Oph. 99:3:362, 1985.
2. Ibid.
DLA0N
Rev. 07/11
MYDRIATICS AND CYCLOPLEGICS
Phenylephrine Hydrochloride
Ophthalmic Solution, USP
10% — Sterile
Phenylephrine Hydrochloride 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
Ophthalmic solutions of phenylephrine hydrochloride are
contraindicated in patients with anatomically narrow angles or
narrow angle glaucoma
Phenylephrine hydrochloride is contraindicated in infants and in
some elderly adults with severe arteriosclerotic cardiovascular or
cerebrovascular disease
Phenylephrine hydrochloride may be contraindicated during
intraocular operative procedures when the corneal epithelial barrier
has been disturbed
Contraindicated in persons with a known sensitivity to phenylephrine
hydrochloride or any of its components
Available direct or through your authorized wholesaler or distributor
Phenylephrine Hydrochloride Ophthalmic Solution, USP
NDC #
DESCRIPTION
SIZE
UNIT
OF SALE
BRAND NAME
17478-205-10
10% Sterile Ophthalmic Solution
5 mL
1
Mydfrin® by Alcon Labs
EACH mL CONTAINS:
ACTIVE:
Phenylephrine Hydrochloride 10%;
PRESERVATIVE:
Benzalkonium Chloride 0.1 mg (0.01%);
INACTIVES:
Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Sodium Hydroxide and/or Phosphoric Acid may be used to adjust pH (4.0 to 7.5) and Purified Water USP.
STORAGE:
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light and excessive heat.
Do not use if solution is brown or contains precipitate.
NDC #
CARDINAL
AMERISOURCEBERGEN
MCKESSON
MORRIS DICKSON
17478-205-10
1465293
862-375
1603885
084616
Scan with
smart phone
to visit
akorn.com
To order products call 800-932-5676 or fax 800-943-3694 • www.akorn.com
NOT FOR PRESCRIBING PURPOSES. PLEASE REFER TO PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION.
1925 West Field Court, Suite 300 • Lake Forest, IL 60045
P258 Rev. 07/12
Phenylephrine Hydrochloride
Ophthalmic Solution, USP
10% — Sterile
WARNING: PHYSICIANS SHOULD COMPLETELY
FAMILIARIZE THEMSELVES WITH THE COMPLETE
CONTENTS OF THIS LEAFLET BEFORE PRESCRIBING
PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC
SOLUTION.
DESCRIPTION: Phenylephrine Hydrochloride Ophthalmic
Solution, USP is a vasoconstrictor and mydriatic for use in
ophthalmology. Phenylephrine is a synthetic sympathomimetic
compound structurally similar to epinephrine and ephedrine.
Phenylephrine Hydrochloride Ophthalmic Solution is supplied
as a sterile topical ophthalmic solution. The active ingredient,
phenylephrine hydrochloride is represented by the chemical
structure:
ESTABLISHED NAME: Phenylephrine Hydrochloride
CHEMICAL NAME: (-)-m-Hydroxy-α-[(methyl-amino)methyl]
benzyl alcohol hydrochloride
Each mL of solution contains:
Active: Phenylephrine Hydrochloride 10%. Inactives: Sodium
Phosphate Dibasic, Sodium Phosphate Monobasic, Sodium
Hydroxide and/or Phosphoric Acid may be used to adjust pH
(4.0 to 7.5) and Purified Water USP q.s. Preservative:
Benzalkonium Chloride 0.1 mg (0.01%).
CLINICAL PHARMACOLOGY:
Phenylephrine Hydrochloride 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.
Although rare, systemic absorption of sufficient quantities of
phenylephrine may lead to systemic α-adrenergic affects, such
as a rise in blood pressure which may be accompanied by a
reflex atropine-sensitive bradycardia.
INDICATIONS AND USAGE: Phenylephrine Hydrochloride
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.
CONTRAINDICATIONS: Ophthalmic solutions of phenylephrine
hydrochloride are contraindicated in patients with anatomically
narrow angles or narrow angle glaucoma. Phenylephrine
hydrochloride is contraindicated in infants and in some elderly
adults with severe arteriosclerotic cardiovascular or cerebrovascular disease. Phenylephrine hydrochloride may be
contraindicated during intraocular operative procedures when
the corneal epithelial barrier has been disturbed. This preparation
is also contraindicated in persons with a known sensitivity to
phenylephrine hydrochloride or any of its components.
WARNINGS: Not for intraocular use. As with other adrenergic
drugs, when Phenylephrine Hydrochloride Ophthalmic Solution
is 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. The pressor
response of adrenergic agents may also be potentiated by
tricyclic antidepressants. Systemic side effects are more
common in patients taking beta adrenergic blocking agents
such as propranolol. Concomitant use of phenylephrine and
atropine may enhance the pressor effects and induce
tachycardia in some patients, especially infants.1
There have been rare reports associating the use of
phenylephrine hydrochloride 10% ophthalmic solutions with
the development of serious cardiovascular reactions, including
ventricular arrhythmias and myocardial infarctions. These
episodes, some ending fatally, have usually occurred in elderly
patients with preexisting cardiovascular diseases.
PRECAUTIONS:
General: Ordinarily, any mydriatic, including phenylephrine
hydrochloride, 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
hydrochloride ophthalmic solutions, and reinstillation of the
drug may produce less mydriasis than previously. 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, older individuals may also develop transient pigment
floaters in the aqueous humor 40 to 45 minutes following the
administration of phenylephrine hydrochloride ophthalmic
solution. 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 Ophthalmic Solution. Prolonged exposure to air
or strong light may cause oxidation and discoloration. Monitor
blood pressure in geriatric patients with known cardiac disease.
Exceeding recommended dosages or applying Phenylephrine
Hydrochloride Ophthalmic Solution to the instrumented,
traumatized, diseased or postsurgical eye or adnexa, or to
patients with suppressed lacrimation, as during anesthesia,
may result in the 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. DO NOT USE IF SOLUTION IS BROWN OR
CONTAINS A PRECIPITATE.
Drug Interaction: As with all other adrenergic drugs, when
Phenylephrine Hydrochloride Ophthalmic Solution is
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 occur. The pressor
response of adrenergic agents may also be potentiated by
tricyclic antidepressants, propranolol, reserpine, guanethidine,
methyldopa, and atropine-like drugs. Phenylephrine
hydrochloride ophthalmic solutions may potentiate the
cardiovascular depressant effects of potent inhalation
anesthetic agents.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Carcinogenicity studies with phenylephrine hydrochloride have
been completed in mice at doses up to 2500 ppm in feed and
in rats at doses up to 1250 ppm in feed. Phenylephrine
hydrochloride demonstrated no carcinogenic effect in male or
female mice and rats.
Pregnancy: Pregnancy Category C. Animal reproduction
studies have not been conducted with phenylephrine
hydrochloride ophthalmic solution. It is also not known
whether phenylephrine hydrochloride ophthalmic solution can
cause fetal harm when administered to a pregnant woman or
can affect reproduction capacity. Phenylephrine Hydrochloride
Ophthalmic Solution should be given to a pregnant woman
only if clearly needed.
Nursing Mothers: It is not known whether this drug is excreted
in human milk. Because many drugs are excreted in human
milk, caution should be exercised when Phenylephrine
Hydrochloride Ophthalmic Solution is administered to a
nursing woman.
Pediatric Use: Phenylephrine Hydrochloride Ophthalmic
Solution is contraindicated in pediatric patients.
Exceeding recommended dosages or applying Phenylephrine
Hydrochloride Ophthalmic Solution to the instrumented,
traumatized, diseased or post surgical eye or adnexa, or to
patients with suppressed lacrimation, as during anesthesia,
may result in the absorption of sufficient quantities of
phenylephrine to produce a systemic vasopressor response.
The hypertensive effects of phenylephrine may be treated with
an alpha-adrenergic blocking agent such as phentolamine
mesylate, 5 mg to 10 mg intravenously, repeated as necessary.
The oral LD50 of phenylephrine in the rat: 350 mg/kg, in the
mouse: 120 mg/kg.
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.2
Other reactions include bradycardia, headache, and excitability.
DOSAGE AND ADMINISTRATION:
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.
HOW SUPPLIED: Phenylephrine Hydrochloride Ophthalmic
Solution, USP is supplied as a sterile solution in plastic dropper
bottles in the following sizes:
2 mL-NDC 17478-205-20
5 mL-NDC 17478-205-10
Storage: Store at 20° to 25°C (68° to 77°F) [see USP
Controlled Room Temperature]. Keep container tightly closed.
Protect from light and exessive heat.
Do not use if solution is brown or contains precipitate.
REFERENCES:
1. Fraunfelder, F.T., and Meyer, S.M.: Possible Cardiovascular
Effects Secondary to Topical Ophthalmic 2.5%
Phenylephrine, Am. J. Oph. 99:3:362, 1985.
2. Ibid.
DLB0N
Rev. 07/11