PHENYLEPHRINE HYDROCHLORIDE solution/ drops

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Paragon BioTeck, Inc.

Адміністрація маршрут:

OPHTHALMIC

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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 excrete

Огляд продуктів:

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 42702-102-10), and a fill volume of 15mL in a 15mL opaque, white LDPE bottle with an LLDPE dropper tip and red cap (NDC 42702-102-15). 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 42702-103-05). 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.

Статус Авторизація:

New Drug Application

Характеристики продукта

PHENYLEPHRINE HYDROCHLORIDE- PHENYLEPHRINE HYDROCHLORIDE SOLUTION/
DROPS
PARAGON BIOTECK, 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
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).
DOSAGE FORMS AND STRENGTHS
2.5% and 10% sterile ophthalmic solutions ( 3).
CONTRAINDICATIONS
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).
WARNINGS AND PRECAUTIONS
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% solution. Monitor blood pressure in patients with
cardiovascular disease ( 5.2).
S