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PHENYLEPHRINE HYDROCHLORIDE solution/ drops
[Akorn, Inc.]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL unapproved drug other
NOTE:THIS DRUG HAS NOT BEEN FOUND BY FDA TO BE SAFE AND EFFECTIVE, AND THIS LABELING HAS NOT BEEN APPROVED BY FDA. For further information about unapproved drugs, click here.
Drug Label Sections

2.5% — Sterile

WARNING: PHYSICIANS SHOULD COMPLETELY FAMILIARIZE THEMSELVES WITH THE COMPLETE CONTENTS OF THIS LEAFLET BEFORE PRESCRIBING PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION.

Rx only

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:

C9H13NO2•HCl            Molecular weight 203.67

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.

Akorn

Manufactured by: Akorn, Inc.
Lake Forest, IL 60045

DLA0N
Rev. 07/11

Principal Display Panel Text for Container Label:

NDC 17478-200-20

Phenylephrine

Hydrochloride

Ophthalmic

Solution, USP

2.5%

2 mL

Sterile

Rx only [Akorn logo]

Principal Display Panel Text for Container Label

Principal Display Panel Text for Carton Label:

NDC 17478-200-20

Phenylephrine

Hydrochloride

Ophthalmic

Solution, USP

2.5%

2 mL

Sterile

Rx only [Akorn logo]

Principal Display Panel Text for Carton Label
PHENYLEPHRINE HYDROCHLORIDE 
phenylephrine hydrochloride solution/ drops
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:17478-200
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
sodium phosphate, dibasic 
sodium phosphate, monobasic 
sodium hydroxide 
phosphoric acid 
water 
benzalkonium chloride 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17478-200-201 in 1 CARTON
12 mL in 1 BOTTLE, DROPPER
2NDC:17478-200-121 in 1 CARTON
215 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/01/1991
Labeler - Akorn, Inc. (062649876)
Establishment
NameAddressID/FEIBusiness Operations
Akorn, Inc.155135783MANUFACTURE, REPACK, ANALYSIS

Revised: 9/2011
 
Akorn, Inc.

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