NAPHCON- naphazoline hydrochloride solution

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

naphazoline hydrochloride (UNII: MZ1131787D) (naphazoline - UNII:H231GF11BV)

Tilgængelig fra:

Alcon

INN (International Name):

naphazoline hydrochloride

Lægemiddelform:

SOLUTION

Sammensætning:

1 mg in 1 mL

Indgivelsesvej:

OPHTHALMIC

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

NAPHCON® FORTE (Naphazoline Hydrochloride Ophthalmic Solution USP), 0.1% 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.

Produkt oversigt:

NAPHCON® FORTE (Naphazoline Hydrochloride Ophthalmic Solution USP), 0.1% is available in 15 mL in DROP-TAINER® dispenser. NDC 0998-0079-15. Storage: Store at 8° - 27°C (46° - 80°F). Caution: Federal ( USA) law prohibits dispensing without prescription. ALCON ( Puerto Rico) INC. Humacao, Puerto Rico 00791 USA Printed in USA September 1996 236185

Produktets egenskaber

NAPHCON- NAPHAZOLINE HYDROCHLORIDE SOLUTION
ALCON
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NAPHCON® FORTE
(NAPHAZOLINE HYDROCHLORIDE
OPHTHALMIC SOLUTION USP), 0.1%
DESCRIPTION
NAPHCON® FORTE (Naphazoline Hydrochloride Ophthalmic Solution USP),
0.1% is a sterile
preparation. Naphazoline HCl, 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:
C
H N HCl
MW=246.74
Chemical name:
2-(1-naphthylmethyl)-2-imidazoline monohydrochloride
EACH ML CONTAINS: ACTIVE: Naphazoline Hydrochloride 0.1%.
PRESERVATIVE: Benzalkonium Chloride
0.01%. INACTIVES: Boric Acid, Sodium Chloride, Potassium Chloride,
Edetate Disodium, Sodium
Carbonate and/or Hydrochloric Acid (to adjust pH), Purified Water.
DM-00
The solution has a pH of 5.5 to 7.0.
CLINICAL PHARMACOLOGY
Naphazoline constricts the vascular system of the conjunctiva. It is
presumed that this effect is due to
direct stimulation action 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
NAPHCON® FORTE (Naphazoline Hydrochloride Ophthalmic Solution USP),
0.1% 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.
14
14
2
WARNINGS
NOT FOR INJECTION – FOR OPHTHALMIC USE ONLY. 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.
Remove contact lenses before using.
PRECAUTIONS
GENERAL
For topical ophthalmic use only. Use with caution in the presence of
hyper