`
`Sterile Phenylephrine Hydrochloride Ophthalmic Solution 2.5% USP Rx Only
`
`Sterile Phenylephrine Hydrochloride Ophthalmic Solution 2.5% USP Rx Only
`
`WARNING:
`PHYSICIANS SHOULD COMPLETELY FAMILIARIZE THEMSELVES WITH THE COMPLETE CONTENTS OF THIS
`LEAFLET BEFORE PRESCRIBING PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION.
`
`DESCRIPTION:
`Phenylephrine Hydrochloride Ophthalmic Solution is a sterile solution used as a vasoconstrictor and mydriatic for use in ophthalmology.
`Phenylephrine hydrochloride is a synthetic sympathomimetic compound structurally similar to epinephrine and ephedrine. Phenylephrine
`hydrochloride has the following structural formula:
`
`()mHydroxyα[(methylamino)methyl] benzyl alcohol hydrochloride Phenylephrine Hydrochloride Ophthalmic Solution is available in
`two strengths, 2.5% and 10%.
`Each mL of the 2.5% solution contains: Phenylephrine Hydrochloride 2.5%. Dibasic and Monobasic Sodium Phosphates, Boric Acid, with
`Benzalkonium Chloride as preservative in Water for Injection q.s.
`Each mL of the 10% solution contains: Phenylephrine Hydrochloride 10%, Dibasic and Monobasic Sodium Phosphates with Benzalkonium
`Chloride as preservative in Water for Injection q.s.
`Hydrochloric Acid and/or Sodium Hydroxide may have been used to adjust pH of both solutions.
`
`CLINICAL PHARMACOLOGY:
`Phenylephrine Hydrochloride Ophthalmic Solution possesses predominantly (αadrenergic effects. In the eye, phenylephrine acts locally as
`a potent vasoconstrictor and mydriatic, by constricting ophthalmic blood vessels and radial muscle of the iris.
`The ophthalmologic usefulness of phenylephrine hydrochloride is due to its rapid effect and moderately prolonged action, as well as to the
`fact that it produces no compensatory vasodilatation.
`The action of different concentrations of ophthalmic solutions of phenylephrine hydrochloride is shown in the following table:
`
`Although rare, systemic absorption of sufficient quantities of phenylephrine may lead to system (αadrenergic effects, such as rise in blood
`pressure which may be accompanied by a reflex atropinesensitive bradycardia.
`
`INDICATIONS AND USAGE:
`Phenylephrine hydrochloride is recommended for use as a decongestant and vasoconstrictor and for pupil dilation in uveitis (posterior
`synechiae). Wide angle glaucoma, prior to surgery, refraction, ophthalmoscopic examination, and diagnostic procedures.
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`Sterile Phenylephrine Hydrochloride Ophthalmic Solution 2.5% USP Rx Only
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`CONTRAINDICATIONS:
`Ophthalmic solutions of phenylephrine hydrochloride are contraindicated in persons with narrow angle glaucoma (and in those individuals
`who are hypersensitive to phenylephrine or to any of the components of the product). Phenylephrine Hydrochloride Ophthalmic Solution
`in the 10% strength is contraindicated in infants and in patients with aneurysms.
`
`WARNINGS:
`There have been rare reports associating the use of Phenylephrine Hydrochloride Ophthalmic Solution 10%, 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:
`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, any result in the absorption of
`sufficient quantities of phenylephrine to produce a systemic vasopressor response.
`A significant elevation in blood pressure is rare but has been reported following conjunctional instillation of recommended doses of
`Phenylephrine Hydrochloride Ophthalmic Solution,10%. Caution, therefore, should be exercised in administering the 10% solution to
`children of low body weight, the elderly, and patients with insulindependent diabetes, hypertension, hyperthyroidism, generalized
`arteriosclerosis, or cardiovascular disease. The posttreatment blood pressure of these patients, and any patients who develop symptoms,
`should be carefully monitored.
`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 or when vasoconstriction of intrinsic vessels
`may lower intraocular tension, these advantages may temporarily outweigh the danger from coincident dilation of the pupil. Rebound
`miosis has reported in older persons one day after receiving Phenylephrine Hydrochloride Ophthalmic Solutions, and reinstillation of the
`drug produced a reduction in mydriasis. This may be of clinical importance in dilating the pupils of older subjects prior to retinal
`detachment or cataract surgery.
`Due to a strong action of the drug on the dilator muscle, older individuals may also develop transient pigment floaters in the aqueous humor
`30 to 45 minutes following the administration of Phenylephrine Hydrochloride Ophthalmic Solutions. The appearance may be similar to
`anterior uveitis or a microscopic hyphema.
`To prevent pain, a drop of suitable topical anesthetic may be applied before using the 10% ophthalmic solution.
`
`Drug Interaction:
`As with all other adrenergic drugs, when Phenylephrine Hydrochloride Solutions 10% or 2.5% are 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 atropinelike drugs.
`
`Carcinogenesis, Mutagenesis, Impairment of Fertility:
`No longterm animal studies have been done to evaluate the potential of Phenylephrine Hydrochloride Ophthalmic Solution in these areas.
`
`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 milk; many are. Caution should be exercised when Phenylephrine Hydrochloride
`Ophthalmic Solution is administered to a nursing woman.
`
`Pediatric Use:
`Phenylephrine Hydrochloride Ophthalmic Solution, 10% is contraindicated in infants. (See CONTRAINDICATIONS.) 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 alphaadrenergic blocking agent such as phentolamine mesylate, 5 mg to
`10 mg intravenously repeated as necessary.
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`Sterile Phenylephrine Hydrochloride Ophthalmic Solution 2.5% USP Rx Only
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`The oral LD 50 of phenylephrine in the rat: 350 mg/kg, in the mouse: 120 mg/kg.
`
`DOSAGE AND ADMINISTRATION:
`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 shortacting mydriatic is needed for wide dilation of the pupil before intraocular surgery, the 10% or 2.5% ophthalmic solutions
`may be applied topically from 3060 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 5060 minutes, the eyes are ready for refraction.
`For CHILDREN, a drop of atropine sulfate 1% is placed in each eye, followed in 1015 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.
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`Sterile Phenylephrine Hydrochloride Ophthalmic Solution 2.5% USP Rx Only
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`HOW SUPPLIED:
`Phenylephrine Hydrochloride Ophthalmic Solution, 2.5%, is available in a sterile 15 mL plastic dropper bottle. Phenylephrine
`Hydrochloride Ophthalmic Solution, 10%, is available in sterile 5 mL plastic dropper bottle.
`Keep container tightly closed.
`Store below 40°C ( 104°F), preferably between 15°30°C (59°86°F).
`PROTECT FROM LIGHT.
`Solution should be colorless to light yellow. Do not use if it is brown or contains a precipitate.
`Keep this and all medications out of the reach of children.
`Rx Only
`August 2010
`Manufactured For: HUB Pharmaceuticals, LLC
` Rancho Cucamonga, CA 91730
`
`Image 1. Label for Bottle
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`Sterile Phenylephrine Hydrochloride Ophthalmic Solution 2.5% USP Rx Only
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`Image 2. Label for Box
`
`PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC
`phenylephrine hydrochloride solution/ drops
`
`Product Information
`Product Type
`
`HUMAN PRESCRIPTION DRUG
`
`Item Code (Source)
`
`NDC:17238193
`
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`Sterile Phenylephrine Hydrochloride Ophthalmic Solution 2.5% USP Rx Only
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`Route of Administration
`
`OPHTHALMIC
`
`DEA Schedule
`
`
`
`Active Ingredient/Active Moiety
`
`Ingredient Name
`PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE UNII:1WS297W6MV)
`
`Basis of Strength
`PHENYLEPHRINE HYDROCHLORIDE
`
`Strength
`25 mg in 1 mL
`
`Inactive Ingredients
`
`Ingredient Name
`SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)
`SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)
`BORIC ACID (UNII: R57ZHV85D4)
`BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
`WATER (UNII: 059QF0KO0R)
`
`Strength
`1.9 mg in 1 mL
`0.3 mg in 1 mL
`1 mg in 1 mL
`0.0001 mg in 1 mL
`
`
`Packaging
`#
`Item Code
`1 NDC:1723819315
`1
`
`Marketing Information
`Marketing Category
`unapproved drug other
`
`Package Description
`
`Marketing Start Date
`
`Marketing End Date
`
`1 in 1 BOX
`15 mL in 1 BOTTLE, DROPPER
`
`Application Number or Monograph Citation
`
`Marketing Start Date
`01/01/2011
`
`Marketing End Date
`
`Labeler HUB Pharmaceuticals, LLC (611747945)
`
`
`Revised: 1/2011
`
`HUB Pharmaceuticals, LLC
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