APO®-CROMOLYN
Apotex
Sodium Cromoglycate
Seasonal Rhinitis Prophylaxis
Action And Clinical Pharmacology: In the immediate allergic reaction (Type I) the union of antigen with reaginic antibody leads to the formation and release of spasmogens and other mediators of the anaphylactic reaction. Sodium cromoglycate appears to block a step in the chain of events triggered by this union. This property accounts for the prophylactic rather than symptomatic approach to the management of seasonal rhinitis.
Sodium cromoglycate has no antihistaminic, anti-inflammatory or decongestant activity.
Indications And Clinical Uses: For the prophylaxis of seasonal rhinitis.
Contra-Indications: Hypersensitivity to any of the components of the product.
Manufacturers’ Warnings In Clinical States: The number of sprays to be administered per day should be specified to the patient. Regular dosage is important – treatment must not be discontinued abruptly, especially when benefit has been obtained.
Patients with nasal polyps should not use this product except on advice of a doctor. If you do not obtain relief of your symptoms within 7 days consult a doctor.
Precautions: The experience in patients with nasal polyps is limited and therefore these patients should be carefully observed while undergoing treatment.
Possible immunologic changes resulting in reactions such as polymyositis, pneumonitis and heart failure, urticaria and anaphylaxis, have been reported.
Children: Clinical experience in children under 5 years of age is limited.
Pregnancy: During clinical use there have been, to date, no reports of adverse effects on the mother or the fetus which could be ascribed to the use of sodium cromoglycate. Nevertheless, as with all medications, caution must be exercised during pregnancy.
Adverse Reactions: Occasionally, slight irritation of the nasal mucosa may occur. Cases of erythema, urticaria or maculopapular rash have been reported and these have cleared within a few days on withdrawal of the drug. Occasional headache, sneezing, cough and unpleasant taste in the mouth have been reported. Eosinophilic pneumonia has been reported rarely.
Symptoms And Treatment Of Overdose: Symptoms and Treatment: There have been no reported cases in humans of overdosage of the drug. Symptomatic treatment is suggested should overdosage occur.
Dosage And Administration: It is recommended that treatment be instituted prior to the time at which the seasonal symptoms normally occur, and continued through the season. This medication is a preventative measure, not a treatment.
Adults and Children over 5 Years of Age: One mist into each nostril 6 times daily. One mist delivers approximately 0.13 mL (2.6 mg) of sodium cromoglycate 2% solution.
Maintenance Therapy: When adequate response has been obtained, the frequency of inhalations may be reduced to one spray to each nostril every 8 to 12 hours.
Concomitant Therapy: Other rhinitis therapy should be used as required.
Withdrawal of Therapy: Patients should be warned against suddenly discontinuing therapy when symptoms have been partially or completely controlled by sodium cromoglycate.
As the action of sodium cromoglycate is essentially preventative, continuity of therapy is important in patients who have gained benefit.
If for any reason sodium cromoglycate is withdrawn, a suggested regimen for withdrawal is to reduce the dosage gradually over a period of 1 week. It should be borne in mind that symptoms of rhinitis may recur when sodium cromoglycate is discontinued.
Availability And Storage: Each mL of clear, colorless to slightly yellowish solution, contains: sodium cromoglycate 2% w/v. Nonmedicinal ingredients: benzalkonium chloride, edetate disodium, purified water and sodium hydroxide. High density polyethylene bottle containing not less than 26 mL (or not less than 13 mL) of solution; with a pump attached to the bottle. The pump delivers approximately 2.6 mg of sodium cromoglycate (0.13 mL of the 2% w/v solution) per mist. Store at controlled room temperature (20 to 25°C). Preserve in tight, light-resistant containers.
APO®-CROMOLYN Apotex Sodium Cromoglycate Seasonal Rhinitis Prophylaxis
Posted by RxMed