PHENYLEPHRINE HYDROCHLORIDE solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Available from:

Lifestar Pharma LLC

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Phenylephrine Hydrochloride Ophthalmic Solution 2.5%, is indicated to dilate the pupil. 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)] . 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 b

Product summary:

Phenylephrine hydrochloride ophthalmic solution, USP 2.5% is supplied as a clear, colorless to yellow colored sterile, 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 70756-629-25              2 mL in 5 mL bottle NDC 70756-649-35              15 mL in 15 mL bottle After opening, Phenylephrine Hydrochloride Ophthalmic Solution, USP can be use until the expiration date on the bottle. 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PHENYLEPHRINE HYDROCHLORIDE - PHENYLEPHRINE HYDROCHLORIDE SOLUTION/
DROPS
LIFESTAR PHARMA LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PHENYLEPHRINE
HYDROCHLORIDE OPHTHALMIC SOLUTION SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION.
PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION, 2.5%.
INITIAL U.S. APPROVAL: 1939
INDICATIONS AND USAGE
Phenylephrine Hydrochloride Ophthalmic Solution is an alpha-1
adrenergic receptor agonist indicated to
dilate the pupil (1)
DOSAGE AND ADMINISTRATION
For patients 1 year of age and older: (2.1)
Apply one drop of Phenylephrine Hydrochloride Ophthalmic Solution
(2.5% strength) to conjunctival
fornix at 3 to 5 minute intervals up to a maximum of 3 drops per eye.
To obtain a greater degree of mydriasis, use 10% strength
For pediatric patients less than 1 year of age: (2.2)
Instill one drop of 2.5% strength to conjunctival fornix at 3 to 5
minute intervals up to a maximum of 3
drops per eye
DOSAGE FORMS AND STRENGTHS
Ophthalmic solution (sterile): (3)
25 mg of phenylephrine hydrochloride in one mL of solution (2.5%)
CONTRAINDICATIONS
The 10% strength is contraindicated in:
Patients with hypertension, or thyrotoxicosis (4.1)
Pediatric patients less than 1 year of age due to increased risk of
systemic toxicity (4.2)
WARNINGS AND PRECAUTIONS
Not for injection : Topical ophthalmic use only (5.1)
Serious cardiovascular reactions with 10% strength : Reactions have
included ventricular arrhythmias
and some have been fatal. Monitor blood pressure in patients with
cardiovascular disease (5.2).
Significant elevations in blood pressure : Caution in pediatric
patients less than 5 years of age, and in
patients with cardiovascular disease or hyperthyroidism. In patients
at high risk, monitor blood pressure
post treatment (5.3).
Rebound miosis : Reported one day after instillation (5.4)
ADVERSE REACTIONS
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT LIFESTAR PHARMA LLC