Detailed Drug Information:

DRUG CLASS AND MECHANISM: Cromolyn is a synthetic compound thatis used to prevent some allergic reactions. Many of the symptoms and signsof allergic reactions are caused by chemicals such as histamine that arereleased from mast cells, a type of cell that is found throughout the bodyas well as in the lungs, nose, and eyelids. Cromolyn works by preventingthe release of these chemicals from the mast cells. Cromolyn is inhaled toprevent episodes of asthma due to allergy. It also is used as a nasalinhaler to treat seasonal allergic rhinitis (inflammation of the lining ofthe nose) and as an ophthalmic (eye) solution to treat allergicconjunctivitis (inflammation of the lining of the eyelids). Cromolyn wasapproved by the FDA in 1973. In 1997, the FDA approved over-the-counterstatus for the nasal solution.

PRESCRIPTION: no (nasal solution). yes (other forms)

PREPARATIONS: Metered oral inhaler delivering 800 &181 g ofcromolyn sodium per metered actuation in 8.1 and 14.2 g containers.

Nasal solution, 40 mg/ml cromolyn, in 13 or 26 ml metered spraycontainers. Each metered actuation delivers 5.2 mg cromolyn sodium.

Ophthalmic solution as a 4% solution of cromolyn in 10 ml bottles.

STORAGE: Cromolyn should be kept at room temperature, 4-30°C(39-86°F), and shaken well before each use.

PRESCRIBED FOR: Cromolyn oral inhaler controls episodes ofasthma caused by foreign antigens such as pollens by preventing spasm andnarrowing of the breathing tubes of the lungs. Cromolyn nasal spray isused for the control of the symptoms of allergic rhinitis, a condition inwhich the lining of the nose swells with fluid ("stuffy nose")and fluid is released into the nasal passages ("runny nose"). Inconjunctivitis, cromolyn eye solution controls swelling, tearing, itching,and redness of the eye.

DOSING: Doses vary from patient to patient.

Aerosol inhalation: The canister should be shaken well before administering. After breathing out completely, the mouthpiece is inserted between the open lips, and the lips are closed firmly around the mouthpiece. The valve of the canister then is pressed down one time while inhaling deeply and slowly. The canister then is removed from the lips, and the breath is held for a count of 10 before exhaling slowly. If more than one inhalation is being used, a minute should elapse between inhalations. An extension tube (spacer) may be useful for persons who are unable to coordinate inhaling and pressing down on the canister's valve. Following administration, the mouth should be rinsed thoroughly with water or mouthwash that is spit out. This will minimize dry mouth or throat, throat irritation, and hoarseness.

The inhaler must be cleaned frequently. To clean, the canister and capare removed from the inhaler. The inhaler is rinsed with warm waterand dried thoroughly.

If a bronchodilator aerosol spray such as albuterol (Proventil; Ventolin)is used in addition to cromolyn, the bronchodilator should be used first,and 5 minutes should elapse before the cromolyn is used.

Intranasal spray: Adults and children 6 years of age and older can useone spray in each nostril three or four times daily. If necessary,physicians may increase the dose to 6 times daily.

Ophthalmic (eye) solution: Both hands should be washed before each useof cromolyn. The head is tilted back and the lowereyelid is pulled down with the index finger to form a pouch. The bottle then issqueezed slightly to allow the prescribed number of drops into the pouch,and the eye is closed gently for one or two minutes without blinking. The tip ofthe dropper should not touch the eye or eyelid. Theusual dose in adults and children 4 years of age and older is one or twodrops in each eye 4 to 6 times per day. Several weeks of therapy may berequired before improvement is apparent.

DRUG INTERACTIONS: No drug interactions have been describedwith cromolyn.

PREGNANCY: Little cromolyn crosses the placenta, and animalstudies have not shown adverse effects of cromolyn on the fetus.

NURSING MOTHERS: Little cromolyn is secreted into breast milk.

SIDE EFFECTS: In general, cromolyn is well- tolerated, and sideeffects usually are limited to the site of application. Increased spasm ofthe breathing tubes, throat irritation, and cough are the most common sideeffects from oral inhalation of cromolyn. Taking a beta-adrenergicbronchodilator prior to the cromolyn can prevent these side effects.

Cromolyn intranasal spray can produce sneezing and nasal irritation, butthese effects generally are short-lived following each application.

Use of cromolyn eye drops can produce irritation of the eye. This effectalso is generally short-lived.