NAPHAZOLINE- naphazoline hydrochloride solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Naphazoline Hydrochloride (UNII: MZ1131787D) (Naphazoline - UNII:H231GF11BV)

Available from:

Proficient Rx LP

INN (International Name):

Naphazoline Hydrochloride

Composition:

Naphazoline Hydrochloride 1 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Naphazoline Hydrochloride Ophthalmic Solution is indicated for use as a topical ocular vasoconstrictor. Contraindicated in the presence of an anatomically narrow angle or in narrow angle glaucoma or in persons who have shown hypersensitivity to any component of this preparation.

Product summary:

Naphazoline Hydrochloride Ophthalmic Solution, USP, is supplied as a sterile 0.1% solution in 15 mL plastic dropper bottles. NDC 63187-412-15 Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Akorn Manufactured by: Akorn, Inc. Lake Forest, IL 60045 GNH00N Rev. 12/11 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NAPHAZOLINE- NAPHAZOLINE HYDROCHLORIDE SOLUTION/ DROPS
PROFICIENT RX LP
----------
NAPHAZOLINE HYDROCHLORIDE
OPHTHALMIC SOLUTION USP, 0.1%
RX ONLY
DESCRIPTION:
Naphazoline Hydrochloride, an ocular vasoconstrictor, is an
imidazoline derivative sympathomimetic
amine. It occurs as a white, odorless crystalline powder having a
bitter taste and is freely soluble in
water and in alcohol. The active ingredient is represented by the
structural formula:
CHEMICAL NAME:
2-(1-naphthylmethyl)-2-imidazole monohydrochloride
EACH ML CONTAINS:
ACTIVE: Naphazoline Hydrochloride 1 mg (0.1%).
INACTIVES: Boric Acid, Edetate Disodium, Sodium Carbonate, Sodium
Chloride and Hydrochloric Acid
may be added to adjust pH (5.5 to 7.0), and Purified Water USP.
PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%). Naphazoline
Hydrochloride Ophthalmic
Solution, USP, 0.1% is a sterile solution with a pH between 5.5 and
7.0.
CLINICAL PHARMACOLOGY:
Naphazoline constricts the vascular system of the conjunctiva. It is
presumed that this effect is due to
direct stimulation of the drug upon the alpha adrenergic receptors in
the arterioles of the conjunctiva
resulting in decreased conjunctival congestion. Naphazoline belongs to
the imidazoline class of
sympathomimetics.
INDICATIONS AND USAGE:
Naphazoline Hydrochloride Ophthalmic Solution is indicated for use as
a topical ocular
vasoconstrictor.
CONTRAINDICATIONS:
Contraindicated in the presence of an anatomically narrow angle or in
narrow angle glaucoma or in
persons who have shown hypersensitivity to any component of this
preparation.
WARNINGS:
Patients under therapy with MAO inhibitors may experience a severe
hypertensive crisis if given a
sympathomimetic drug. Use in children, especially infants, may result
in CNS depression leading to
coma and marked reduction in body temperature.
PRECAUTIONS:
GENERAL: For topical ophthalmic use only. Use with caution in presence
of hypertension, cardiovascular
abnormalities, hyperglycemia (diabetes), hyperthyroidism, infection or
injury.
PATIENT INFORMATION: Patient