NEDOCROMIL SODIUM solution/ drops

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

Nedocromil Sodium (UNII: ET8IF4KS1T) (Nedocromil - UNII:0B535E0BN0)

Saatavilla:

Akorn

INN (Kansainvälinen yleisnimi):

Nedocromil Sodium

Koostumus:

Nedocromil Sodium 20 mg in 1 mL

Antoreitti:

OPHTHALMIC

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Nedocromil Sodium Ophthalmic Solution is indicated for the treatment of itching associated with allergic conjunctivitis. Nedocromil Sodium Ophthalmic Solution is contraindicated in those patients who have shown hypersensitivity to nedocromil sodium or to any of the other ingredients.

Tuoteyhteenveto:

Nedocromil Sodium Ophthalmic Solution, 2% is supplied sterile in opaque white LDPE plastic bottles with dropper tips and white polypropylene caps as follows: 5 mL in a 10 cc bottle - NDC 17478-066-10 Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Manufactured by: Akorn Lake Forest, IL 60045 NS00N Revision: April 2009

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

NEDOCROMIL SODIUM- NEDOCROMIL SODIUM SOLUTION/ DROPS
AKORN
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NEDOCROMIL SODIUM OPHTHALMIC SOLUTION, 2%
STERILE
Rx only
DESCRIPTION
Nedocromil Sodium Ophthalmic Solution, 2% is a clear, yellow, sterile
solution for topical
ophthalmic use.
Nedocromil sodium is represented by the following structural formula:
CHEMICAL NAME: 4H-Pyrano[3,2-g] quinoline-2, 8-dicarboxylic acid,
9-ethyl-6,9-dihydro-
4,6-dioxo-10-propyl-, disodium salt.
Each mL contains: ACTIVE: Nedocromil Sodium 20 mg/mL (2%);
PRESERVATIVE:
Benzalkonium Chloride 0.01%; INACTIVES: Edetate Disodium 0.05%,
Purified Water, and
Sodium Chloride 0.5%. It has a pH of 4.0 to 5.5 and osmolality range
of 270 to 330
mOsm/kg.
CLINICAL PHARMACOLOGY
Nedocromil sodium is a mast cell stabilizer. Nedocromil sodium
inhibits the release of
mediators from cells involved in hypersensitivity reactions. Decreased
chemotaxis and
decreased activation of eosinophils have also been demonstrated.
_In vitro_ studies with adult human bronchoalveolar cells showed that
nedocromil sodium
inhibits histamine release from a population of mast cells having been
defined as
belonging to the mucosal sub type and inhibits beta-glucuronidase
release from
macrophages.
PHARMACOKINETICS AND BIOAVAILABILITY
Nedocromil sodium exhibits low systemic absorption. When administered
as a 2%
ophthalmic solution in adult human volunteers, less than 4% of the
total dose was
systemically absorbed following multiple dosing. Absorption is mainly
through the
nasolacrimal duct rather than through the conjunctiva. It is not
metabolized and is
eliminated primarily unchanged in urine (70%) and feces (30%).
INDICATIONS AND USAGE
Nedocromil Sodium Ophthalmic Solution is indicated for the treatment
of itching
associated with allergic conjunctivitis.
CONTRAINDICATIONS
Nedocromil Sodium Ophthalmic Solution is contraindicated in those
patients who have
shown hypersensitivity to nedocromil sodium or to any of the other
ingredients.
PRECAUTIONS
INFORMATION FOR PATIENTS
Patients should be advised to follow the patient