CROMOLYN SODIUM solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CROMOLYN SODIUM (UNII: Q2WXR1I0PK) (CROMOLYN - UNII:Y0TK0FS77W)

Available from:

Woodward Pharma Services LLC

INN (International Name):

CROMOLYN SODIUM

Composition:

CROMOLYN SODIUM 20 mg in 2 mL

Administration route:

INTRABRONCHIAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cromolyn sodium inhalation solution USP is a prophylactic agent indicated in the management of patients with bronchial asthma. In patients whose symptoms are sufficiently frequent to require a continuous program of medication, cromolyn sodium inhalation solution USP is given by inhalation on a regular daily basis (see DOSAGE AND ADMINISTRATION ). The effect of cromolyn sodium is usually evident after several weeks of treatment, although some patients show an almost immediate response. In patients who develop acute bronchoconstriction in response to exposure to exercise, toluene diisocyanate, environmental pollutants, etc., cromolyn sodium should be given shortly before exposure to the precipitating factor (see DOSAGE AND ADMINISTRATION ). Cromolyn sodium inhalation solution is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium.

Product summary:

Cromolyn Sodium Inhalation Solution USP Unit-Dose 2 mL Vial is supplied as a colorless to pale yellow solution containing 20 mg cromolyn sodium, USP, in water for injection, USP, with 30 vials per foil pouch in a carton as listed below. 60 vials per carton (NDC 70556-102-60). Each vial is made from a low density polyethylene (LDPE) resin. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Do not use if solution is discolored or contains a precipitate. Retain in foil pouch until time of use. PROTECT FROM LIGHT. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Marketed by: Woodward Pharma Services LLC Birmingham, MI 48009

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CROMOLYN SODIUM- CROMOLYN SODIUM SOLUTION
WOODWARD PHARMA SERVICES LLC
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CROMOLYN SODIUM INHALATION SOLUTION, USP
PRESCRIBING INFORMATION
RX ONLY
FOR ORAL INHALATION USE ONLY - NOT FOR INJECTION
DESCRIPTION
The active ingredient of cromolyn sodium inhalation solution USP is
cromolyn sodium,
USP. It is an inhaled anti-inflammatory agent for the preventive
management of asthma.
Cromolyn sodium, USP is chemically designated as disodium 5,5'- [(2-
hydroxytrimethylene)dioxy] bis
[4-oxo-4_H_-1-benzopyran-2-carboxylate]. The molecular
formula is C
H
Na O
; the molecular weight is 512.34. Cromolyn sodium, USP is a
water-soluble, odorless, white, hydrated crystalline powder. It is
tasteless at first, but
leaves a slightly bitter aftertaste. Cromolyn sodium inhalation
solution USP is clear,
colorless to pale yellow, sterile and has a target pH of 5.5.
The structural formula is:
Each 2 mL vial for oral inhalation use only contains 20 mg cromolyn
sodium, USP in
water for injection, USP.
CLINICAL PHARMACOLOGY
_In vitro_ and _in vivo_ animal studies have shown that cromolyn
sodium inhibits sensitized
mast cell degranulation which occurs after exposure to specific
antigens. Cromolyn
sodium acts by inhibiting the release of mediators from mast cells.
Studies show that
cromolyn sodium indirectly blocks calcium ions from entering the mast
cell, thereby
preventing mediator release.
Cromolyn sodium inhibits both the immediate and non-immediate
bronchoconstrictive
reactions to inhaled antigen. Cromolyn sodium also attenuates
bronchospasm caused
by exercise, toluene diisocyanate, aspirin, cold air, sulfur dioxide,
and environmental
23
14
2
11
pollutants.
Cromolyn sodium has no intrinsic bronchodilator or antihistamine
activity.
After administration by inhalation, approximately 8% of the total
cromolyn sodium dose
administered is absorbed and rapidly excreted unchanged, approximately
equally divided
between urine and bile. The remainder of the dose is either exhaled or
deposited in the
oropharynx, swallowed and excreted via th