PHENYLEPHRINE HYDROCHLORIDE solution/ drops

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Bausch & Lomb Americas Inc.

Ievadīšanas:

OPHTHALMIC

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10% is indicated to dilate the pupil. Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% is contraindicated in patients with hypertension, or thyrotoxicosis. Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% should be used in these patients. Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% is contraindicated in pediatric patients less than 1 year of age due to the increased risk of systemic toxicity. Phenylephrine Hydrochloride Ophthalmic Solution, USP 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 Ophthalmic Solution, USP 2.5% and 10% should be given to a pregnant woman only if clearly needed. It is not known whether this drug is excreted in human breas

Produktu pārskats:

Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% is supplied as a sterile, aqueous, topical ophthalmic solution with a fill volume of 10 mL in a 10 mL opaque, white low density polyethylene (LDPE) bottle with a linear low density polyethylene (LLDPE) dropper tip and red cap (NDC 82260-102-10). Phenylephrine HCl Ophthalmic Solution, USP 10% is supplied as a sterile, aqueous, topical ophthalmic solution supplied with a fill volume of 5 mL in a 10 mL opaque, white LDPE bottle with an LLDPE dropper tip and red cap (NDC 82260-103-05). Storage and Handling: Store at 2°C to 25°C (36°F to 77°F). Keep container tightly closed. Do not use if solution is brown or contains a precipitate. After opening, Phenylephrine Hydrochloride Ophthalmic Solution, USP can be used until the expiration date on the bottle.

Autorizācija statuss:

New Drug Application Authorized Generic

Produkta apraksts

PHENYLEPHRINE HYDROCHLORIDE- PHENYLEPHRINE HYDROCHLORIDE SOLUTION/
DROPS
BAUSCH & LOMB AMERICAS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PHENYLEPHRINE
HYDROCHLORIDE OPHTHALMIC SOLUTION, USP 2.5% AND 10% SAFELY AND
EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR PHENYLEPHRINE HYDROCHLORIDE
OPHTHALMIC SOLUTION,
USP 2.5% AND 10%.
PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP 2.5% AND 10%, FOR
TOPICAL
OPHTHALMIC USE
INITIAL U.S. APPROVAL: 1939
INDICATIONS AND USAGE
Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10% is
an alpha-1 adrenergic receptor
agonist indicated to dilate the pupil (1).
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
2.5% and 10% sterile ophthalmic solutions (3).
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
ADVERSE REACTIONS
•
•
DRUG INTERACTIONS
•
•
For patients 1 year of age and older, apply one drop of Phenylephrine
Hydrochloride Ophthalmic
Solution, USP 2.5% or 10% at 3 to 5 minute intervals up to a maximum
of 3 drops per eye (2.1).
In pediatric patients less than 1 year of age, one drop of
Phenylephrine Hydrochloride Ophthalmic
Solution, USP 2.5% should be instilled at 3 to 5 minute intervals up
to a maximum of 3 drops per eye
(2.2).
Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% is
contraindicated in patients with
hypertension, or thyrotoxicosis. Phenylephrine Hydrochloride
Ophthalmic Solution, USP 2.5% should
be used in these patients (4.1).
Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% is
contraindicated in pediatric patients
less than 1 year of age due to the increased risk of systemic
toxicity. Phenylephrine Hydrochloride
Ophthalmic Solution, USP 2.5% should be used in these patients (4.2).
Not for injection. Phenylephrine Hydrochloride Ophthalmic Solution,
USP is indicated for topical
ophthalmic use (5.1).
Reports of serious cardiovascular reactions, some fatal, with
Phenylephrine Hydrochloride Ophthalmic
Solution, USP 10