Nalcrom (Sodium Cromoglicate)

NALCROM®

Rhône-Poulenc Rorer

Sodium Cromoglycate

Antiallergic Agent

Action And Clinical Pharmacology: Sodium cromoglycate seems to exert a stabilizing effect upon mast cells capable of releasing mediators. In gastrointestinal disease, the release of mediators causes a local inflammation which can either result in gastrointestinal symptoms or may allow absorption of antigenic material leading to systemic allergic reactions. It is most effective when given prior to antigen challenge.

Sodium cromoglycate has no antihistaminic or anti-inflammatory activity.

In humans, oral administration of sodium cromoglycate was followed by a low rate of urinary excretion. The mean urinary excretion of the administered dose over 24 hours was only 0.5%. This indicates that little of the compound is absorbed from the gastrointestinal tract.

Indications And Clinical Uses: Gastrointestinal allergy.

Contra-Indications: Hypersensitivity to sodium cromoglycate. Possible immunologic changes resulting in reactions such as, polymyositis, pneumonitis and heart failure, urticaria and anaphylaxis have been reported in conjunction with inhalation of sodium cromoglycate and are being actively investigated.

Manufacturers’ Warnings In Clinical States: Pregnancy and Children: Safety in pregnancy, and for the treatment of children under two years, has not yet been established.

The drug should not be used in such patients unless, in the opinion of the prescribing physician, the potential benefits outweigh the possible hazards.

Patients should be warned against suddenly discontinuing therapy when symptoms have been partially or completely controlled. Particular care should be taken where steroid and/or salazopyrine dosage has been reduced during sodium cromoglycate treatment.

The optimum dose required to maintain remission will need to be determined for each patient, but it is probably not less than 2 capsules 4 times daily.

Precautions: Clinical experience is limited and patients should be carefully observed while undergoing treatment.

The effect of sodium cromoglycate has been studied with those antibody systems concerned with immunity. To date, no effect was observed.

Adverse Reactions: Nausea, headache, insomnia, skin rashes and joint pains have been reported in a few cases with oral dosing.

The most frequently reported adverse reactions attributed to sodium cromoglycate on inhalation (on the basis of recurrence following readministration) involve the respiratory tract and include bronchospasm, cough, laryngeal edema (rare), nasal congestion, pharyngeal irritation and wheezing.

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.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: There have been no reported cases in humans of overdosage of the drug.

As sodium cromoglycate is absorbed to a very limited extent, no action other than medical observation should be necessary. If any symptoms appear, symptomatic treatment is recommended.

Dosage And Administration: For optimal results, dissolve the contents of the capsule in warm water and take as a solution.

Chronic inflammatory bowel disease: Initial dose: Adults: 200 mg 4 times daily 15 to 20 minutes before meals.

Initial dose: Children from 2 to 14 years: 100 mg 4 times daily 15 to 20 minutes before meals.

Maintenance dose: To prevent relapses dosage should be maintained indefinitely at 200 mg 4 times daily in adults and 100 mg 4 times daily in children.

Food allergy: Initial dose: Adults: 200 mg 4 times daily 15 to 20 minutes before meals.

Initial dose: Children from 2 to 14 years: 100 mg 4 times daily 15 to 20 minutes before meals. If satisfactory control of symptoms is not achieved within 2 to 3 weeks the dosage may be doubled but should not exceed 40 mg/kg/day.

Maintenance dose: Once a therapeutic response has been achieved the dose may be reduced to the minimum required to maintain the patient free of symptoms. Patients unable to avoid allergenic foods under certain circumstances may be able to protect themselves against the effect of these foods by taking a single dose 15 minutes before the meal. The optimum dosage will need to be determined for each patient. A suitable starting dose would be 200 mg in adults and 100 mg in children.

Availability And Storage: Each clear, hard gelatin capsule for oral use, imprinted Fisons 101 in black, contains: sodium cromoglycate 100 mg as a white powder. Nonmedicinal ingredients: iron oxide and gelatin. Sodium:

NALCROM® Rhône-Poulenc Rorer Sodium Cromoglycate Antiallergic Agent

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