Phenylephrine Hydrochloride by is a Prescription medication manufactured, distributed, or labeled by Lifestar Pharma LLC, Mankind Pharma Limited. Drug facts, warnings, and ingredients follow.
Phenylephrine Hydrochloride Ophthalmic Solution is an alpha-1 adrenergic receptor agonist indicated to dilate the pupil (1)
For patients 1 year of age and older: (2.1)
For pediatric patients less than 1 year of age: (2.2)
Ophthalmic solution (sterile): (3)
To report SUSPECTED ADVERSE REACTIONS, contact Lifestar Pharma LLC at 1-888-995-4337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 5/2023
In patients 1 year of age or greater, apply one drop of either phenylephrine hydrochloride ophthalmic solution 2.5% or 10% every 3 to 5 minutes to the conjunctival fornix as required up to a maximum of 3 drops per eye per day
In order to obtain a greater degree of mydriasis, phenylephrine hydrochloride ophthalmic solution 10% may be needed
Phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in patients with hypertension or thyrotoxicosis. Phenylephrine hydrochloride ophthalmic solution 2.5% should be used in these patients.
Phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in pediatric patients less than 1 year of age due to the increased risk of systemic toxicity. Phenylephrine hydrochloride ophthalmic solution 2.5% should be used in these patients [See Dosage and Administration (2.2)].
Phenylephrine hydrochloride ophthalmic solution 10% is not indicated for injection.
There have been reports of serious cardiovascular reactions, including ventricular arrhythmias and myocardial infarctions, in patients using phenylephrine 10%. These episodes, some fatal, have usually occurred in patients with pre-existing cardiovascular diseases. Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% should be used in these patients.
A significant elevation in blood pressure is not common but has been reported following conjunctival instillation of recommended doses of phenylephrine 10%. The risk is less with phenylephrine 2.5%. Caution should be exercised with the use of phenylephrine 10% in pediatric patients less than 5 years of age and patients with hyperthyroidism, or cardiovascular disease. The post-treatment blood pressure of patients with cardiac and endocrine diseases and any patients who develop symptoms should be carefully monitored.
The following serious adverse reactions are described below and elsewhere in the labeling:
The following adverse reactions have been identified following use of phenylephrine hydrochloride ophthalmic solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Eye pain and stinging on instillation, temporary blurred vision and photophobia, and conjunctival sensitization may occur.
A marked increase in blood pressure has been reported particularly, but not limited to low weight premature neonates, infants and hypertensive patients.
Cardiovascular effects which have been seen primarily in hypertensive patients following topical ocular use of phenylephrine hydrochloride ophthalmic solution 10% include marked increase in blood pressure, syncope, myocardial infarction, tachycardia, arrhythmia and subarachnoid hemorrhage [See Warnings and Precautions (5.2 and 5.3)].
Animal reproduction studies have not been conducted with topical phenylephrine. It is also not known whether phenylephrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Phenylephrine hydrochloride should be given to a pregnant woman only if clearly needed.
It is not known whether this drug is excreted in human breast milk. Because many drugs are excreted in human milk, caution should be exercised when phenylephrine hydrochloride ophthalmic solution 2.5% and 10% is administered to a nursing woman.
Phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in pediatric patients less than 1 year of age [See Contraindications (4.2)].
Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless to yellow color solution, topical α -adrenergic agonist for ophthalmic use. The active ingredient is represented by the chemical structure
Chemical Name: (R)-3-hydroxy-α[(methylamino)methyl]benzenemethanol hydrochloride.
Molecular Formula: C9H13NO2.HCl
Molecular Weight: 203.67 g/mol
Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: Phenylephrine Hydrochloride 100 mg (10%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 985 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%).
Phenylephrine hydrochloride is an α-1 adrenergic agonist drug that is used in ophthalmology mainly for its mydriatic effect. After topical application to the conjunctiva, phenylephrine acts directly on α-adrenergic receptors in the eye, producing contraction of the dilator muscle of the pupil and constriction of the arterioles in the conjunctiva.
Maximal mydriasis occurs in 20 to 90 minutes with recovery after 3 to 8 hours.
Systemic absorption of sufficient quantities of phenylephrine may lead to systemic α-adrenergic effects, such as rise in blood pressure which may be accompanied by a reflex atropine-sensitive bradycardia.
Pupillary dilation following topical administration of phenylephrine hydrochloride ophthalmic solution has been demonstrated in controlled clinical studies in adults and pediatric patients with different levels of iris pigmentation. Pupil movement is generally seen within 15 minutes, maximal mydriasis between 20 to 90 minutes and recovery after 3 to 8 hours. Darker irides tend to dilate slower than lighter irides.
Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% is supplied as a sterile, clear, colorless to yellow color, aqueous, topical ophthalmic solution in an opaque, white low density polyethylene (LDPE) bottle with a natural LDPE dropper tip and red cap in the following sizes:
NDC: 70756-614-30 5 mL in 10 mL bottle
After opening, Phenylephrine Hydrochloride Ophthalmic Solution, USP can be used until the expiration date on the bottle.
Advise patients not to touch the dropper tip to any surface as this may contaminate the solution. Inform patients that they may experience sensitivity to light and should protect their eyes in bright illumination while their pupils are dilated.
Manufactured for:
Lifestar Pharma LLC
1200 MacArthur Blvd.
Mahwah, NJ 07430 USA
Made in India
Revised: March 2023, V-04
NDC: 70756-614-30
Phenylephrine
Hydrochloride Ophthalmic
Solution, USP
10%
For Topical Application in the Eye.
Not for Injection
Rx only
5 mL
NDC: 70756-614-30
Phenylephrine Hydrochloride
Ophthalmic
Solution, USP
10%
For Topical Application in the Eye.
Not for Injection
Rx only
5 mL
PHENYLEPHRINE HYDROCHLORIDE
phenylephrine hydrochloride solution/ drops |
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Labeler - Lifestar Pharma LLC (080268943) |
Registrant - Mankind Pharma Limited (915834068) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Mankind Pharma Limited | 916512493 | MANUFACTURE(70756-614) , ANALYSIS(70756-614) , PACK(70756-614) |