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:

Akorn

INN (International Name):

Phenylephrine Hydrochloride

Composition:

Phenylephrine Hydrochloride 25 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, 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 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) ]. No overall differences in safety and effectiveness have been observed between elderly and younger adult patients.

Product summary:

Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% is supplied as a 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 17478-201-02         2 mL in 6 cc bottle NDC 17478-201-15         15 mL in 15 cc bottle Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% is supplied as a 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 17478-206-05         5 mL in 10 cc bottle After opening, Phenylephrine Hydrochloride Ophthalmic Solution, USP can be used until the expiration date on the bottle. Storage: Store at 20° to 25°C (68° to 77°F). Keep container tightly closed. Protect from light and excessive heat. Do not use if solution is brown or contains precipitate.

Authorization status:

New Drug Application

Summary of Product characteristics

PHENYLEPHRINE HYDROCHLORIDE- PHENYLEPHRINE HYDROCHLORIDE SOLUTION/
DROPS
AKORN
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PHENYLEPHRINE
HYDROCHLORIDE OPHTHALMIC SOLUTION, USP SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING
INFORMATION FOR PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP.
PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP 2.5% AND 10%.
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% or 10% 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%)
100 mg of phenylephrine hydrochloride in one mL of solution (10%)
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