CROMOLYN SODIUM solution/ drops

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

Cromolyn Sodium (UNII: Q2WXR1I0PK) (Cromolyn - UNII:Y0TK0FS77W)

Доступно од:

Akorn

INN (Међународно име):

Cromolyn Sodium

Састав:

Cromolyn Sodium 40 mg in 1 mL

Пут администрације:

OPHTHALMIC

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Cromolyn Sodium Ophthalmic Solution is indicated in the treatment of vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis. Cromolyn Sodium Ophthalmic Solution is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium or to any of the other ingredients.

Резиме производа:

Cromolyn Sodium Ophthalmic Solution USP 4% is supplied as 10 mL of solution in an opaque polyethylene bottle with a controlled dropper tip. NDC 17478-291-11 Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light-store in original carton. Keep tightly closed. Keep out of reach of children. Akorn Manufactured By: AKORN, INC. Lake Forest, IL 60045 CR00N                              Rev. 06/16 PHARMACIST – DETACH HERE AND GIVE INSTRUCTIONS TO PATIENTS

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

CROMOLYN SODIUM- CROMOLYN SODIUM SOLUTION/ DROPS
AKORN
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CROMOLYN SODIUM
OPHTHALMIC SOLUTION USP, 4%
STERILE
RX ONLY
DESCRIPTION
Cromolyn Sodium Ophthalmic Solution USP, 4% is a clear, colorless,
sterile solution
intended for topical ophthalmic use.
Cromolyn Sodium is represented by the following structural formula:
Chemical Name: disodium 5-5' - [(2-hydroxytrimethylene)dioxy] bis
[4-oxo-4H-
1-_benzopyran_-2-carboxylate].
Pharmacologic Category: Mast cell stabilizer.
Each mL contains: ACTIVE: Cromolyn sodium 40 mg (4%); INACTIVES:
Edetate disodium
0.1% and Water for Injection. It has a pH of 4.0 to 7.0; PRESERVATIVE:
Benzalkonium
chloride 0.01%.
CLINICAL PHARMACOLOGY
_In vitro_ and _in vivo_ animal studies have shown that cromolyn
sodium inhibits the
degranulation of sensitized mast cells which occurs after exposure to
specific antigens.
Cromolyn sodium acts by inhibiting the release of histamine and SRS-A
(slow-reacting
substance of anaphylaxis) from the mast cell.
Another activity demonstrated _in vitro_ is the capacity of cromolyn
sodium to inhibit the
degranulation of non-sensitized rat mast cells by phospholipase A and
the subsequent
release of chemical mediators. Another study showed that cromolyn
sodium did not
inhibit the enzymatic activity of released phospholipase A on its
specific substrate.
Cromolyn sodium has no intrinsic vasoconstrictor, antihistamine, or
anti-inflammatory
activity.
Cromolyn sodium is poorly absorbed. When multiple doses of cromolyn
sodium
ophthalmic solution are instilled into normal rabbit eyes, less than
0.07% of the
administered dose of cromolyn sodium is absorbed into the systemic
circulation
(presumably by way of the eye, nasal passages: buccal cavity and
gastrointestinal tract).
Trace amounts (less than 0.01%) of the cromolyn sodium dose penetrate
into the
aqueous humor and clearance from this chamber is virtually complete
within 24 hours
after treatment is stopped.
In normal volunteers, analysis of drug excretion indicates that
approximately 0.03% of
cromolyn sodium