Cromolyn Sodium Vaginal Cream

4% 30 mL Topi-Click PERL Vaginal Dispenser

Cromolyn is a synthetic mast cell stabilizer. Although cromolyn has no bronchodilator activity, it was found to inhibit antigen-induced bronchospasm. The drug is used as an inhaled prophylactic agent in the treatment of mild to moderate asthma, via nasal inhalation to treat seasonal allergic rhinitis, or as an ophthalmic solution to treat allergic or vernal conjunctivitis. The oral dosage form has limited therapeutic usage and is approved to treat systemic mastocytosis; the oral dosage form has fared no better than placebo in the treatment of inflammatory bowel disease. The topical use of cromolyn sodium to treat atopic dermatitis and other skin allergies has been demonstrated in a verity of studies including pediatric uses. Cromolyn sodium vaginal cream was evaluated in the treatment of burning, irritation, erythema, and tenderness related to recalcitrant idiopathic vulvar vestibulitis and shown to be effective in some patients.

Cromolyn works at the surface of the mast cell to inhibit its degranulation. This, in turn, prevents the release of histamine and slow-reacting substance of anaphylaxis (SRS-A), mediators of type I allergic reactions. Cromolyn also may reduce the release of inflammatory leukotrienes. It has been postulated that cromolyn produces these effects by inhibiting calcium influx, but its exact mechanism of action is unclear. Cromolyn does not interfere with the binding of IgE to the mast cell or with the binding of antigen to IgE. Because cromolyn is not a bronchodilator, an antihistamine, or a vasoconstrictor, its beneficial effects in the treatment of asthma are largely prophylactic. Cromolyn can reduce hyperreactivity of the bronchi, inhibiting asthmatic responses to antigenic challenge (e.g., cold air, allergens, environmental pollutants) or to exercise. Cromolyn also has been administered orally to treat inflammatory bowel disease.

Topical application of cromolyn sodium results in localized action. Cromolyn on masts cell to inhibit degranulation. This, in turn, prevents the release of histamine and slow-reacting substance of anaphylaxis (SRS-A), mediators of type I allergic reactions. Cromolyn also may reduce the release of inflammatory leukotrienes.

Cromolyn sodium has been shown to produce severe anaphylactoid reactions; it is contraindicated for use in patients with a known hypersensitivity to cromolyn or to other product ingredients.

Cromolyn sodium is classified as pregnancy category B. Animal studies have not shown adverse effects on the fetus when cromolyn was administered alone. However, when administered to mice (at doses similar to the maximum recommended adult oral dose on a mg/m2 basis) with isoproterenol via SC injection the incidence of major malformations (primarily cleft palate) was increased; no such reaction was observed with coadministration of the 2 drugs in rats or rabbits. Cromolyn sodium is considered an alternative therapy to inhaled corticosteroids for mild persistent asthma during pregnancy according to the 2004 guidelines of the National Asthma Education and Prevention Program (NAEPP) Asthma and Pregnancy Working Group. It should be noted that inhaled corticosteroids are the preferred treatment due to greater efficacy. However, maintaining a previously established treatment regimen may be more beneficial to the patient. Therefore, selection of any pharmacologic treatment for asthma control during pregnancy should include the specific needs of the patient, based on an individual evaluation, and consideration of the potential benefits or risks to the fetus.

It is not known if cromolyn sodium is distributed into breast milk; however, after administration via the oral and inhaled routes only small amounts of drug are absorbed. The manufacturer recommends that the drug be used with caution during breast-feeding. Cromolyn sodium is considered an alternative therapy to inhaled corticosteroids for mild persistent asthma during pregnancy and lactation according to the 2004 guidelines of the National Asthma Education and Prevention Program (NAEPP) Asthma and Pregnancy Working Group.Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.

Severe anaphylactoid reactions have been reported, though rarely, in association with cromolyn sodium administration.
Cardiovascular adverse reactions have been reported with cromolyn administration. With the oral solution, ventricular tachycardia, atrial tachycardia, premature ventricular contractions (PVCs), chest pain (unspecified), and palpitations have been reported. Periarteritic vasculitis and pericarditis were reported with nebulized oral inhalation administration.
Dermatologic reactions have been reported with cromolyn use. Oral administration, as the oral solution or via nebulization, and ophthalmic administration have been associated with rash (unspecified) (2% with the oral solution). Urticaria has been reported with both the oral solution and oral nebulization. Patients receiving the oral solution have reported flushing, pruritus (< 4%), purpura, lupus-like symptoms, erythema or burning, and photosensitivity. Patients using the orally inhaled nebulizer solution have reported exfoliative dermatitis and photodermatitis.
Cromolyn sodium vaginal cream is generally well tolerated but dermatologic and cardiovascular adverse reactions may also occur with topical administration.

Store this medication in its original container at 68°F to 77°F (20°C to 25°C) and away from heat, moisture and light. Keep all medicine out of the reach of children. Throw away any unused medicine after the beyond use date. Do not flush unused medications or pour down a sink or drain.