INTAL® INHALER INTAL® SYNCRONER®
Rh´ne-Poulenc Rorer
Sodium Cromoglycate
Asthma Prophylaxis
Action And Clinical Pharmacology: In vitro and in vivo animal studies have shown that sodium cromoglycate inhibits sensitized mast cell degranulation which occurs after exposure to specific antigens. Sodium cromoglycate acts by inhibiting the release of mediators from mast cells. Studies show that sodium cromoglycate indirectly blocks calcium ions from entering the mast cell, thereby preventing mediator release.
Sodium cromoglycate inhibits both the immediate and non-immediate bronchoconstrictive reactions to inhaled allergens. Sodium cromoglycate also attenuates bronchospasm caused by exercise, toluene diisocyanate, ASA, cold air, sulfur dioxide and environmental pollutants in some patients.
Sodium cromoglycate has no intrinsic bronchodilator antihistaminic or anti-inflammatory activity.
Indications And Clinical Uses: As an adjunct in the management of intrinsic and extrinsic asthma. It is used on a continuous basis to prevent the symptoms associated with asthma.
Also indicated for use in the prevention of bronchospasm induced by known precipitating factors such as exercise, cold air, allergens and environmental pollutants.
Contra-Indications: Hypersensitivity to any of its components.
Manufacturers’ Warnings In Clinical States: Sodium cromoglycate has no role in the treatment of an acute attack of asthma, especially status asthmaticus.
Severe anaphylactic reactions can occur after sodium cromoglycate administration. The recommended dosage should be decreased in patients with decreased renal or hepatic function. Sodium cromoglycate should be discontinued if the patient develops eosinophilic pneumonia (or pulmonary infiltrates with eosinophilia).
The number of inhalations per day should be specified to the patient. Regular dosage is important and treatment must not be discontinued abruptly, especially when benefit has been obtained. If troublesome symptoms occur, particularly breathlessness at rest, no benefit is likely to be obtained by increasing the dosage above 16 mg/day, and the patient should be advised to consult his physician immediately, so that additional measures can be instituted if necessary.
Precautions: Mild throat irritation, coughing and transient bronchospasm may occur. Very rarely, severe bronchospasm associated with a marked fall in pulmonary function has been reported. In such cases treatment shoud be stopped and should not be reintroduced.
Possible immunologic changes resulting in reactions, such as, polymyositis, pneumonitis and heart failure, urticaria and anaphylaxis have been reported.
Fluorocarbon propellants may be hazardous if they are deliberately abused. Inhalation of high concentrations of aerosol sprays has brought about cardiovascular toxic effects and even death, especially under conditions of hypoxia. However, evidence attests to the relative safety of aerosols when used properly and with adequate ventilation.
Pregnancy: There are no adequate and well controlled studies in pregnant women. However, during clinical use there have been, to date, no reports of adverse effects on the fetus that could be ascribed to the use of sodium cromoglycate. Nevertheless, as with all medications, caution must be exercised during pregnancy.
Lactation: It is not known whether this drug is excreted in human milk; therefore, caution should be exercised when sodium cromoglycate is administered to a nursing woman, and the attending physician must make a benefit/risk assessment in regard to its use in this situation.
Adverse Reactions: In controlled studies the most frequently reported adverse reactions attributed to sodium cromoglycate treatment were: throat irritation or dryness, bad taste, cough, wheeze and nausea.
Bronchospasm [sometimes severe, associated with precipitous fall in pulmonary function (FEV1)], laryngeal edema (rare), nasal congestion (sometimes severe) and pharyngeal irritation have been reported.
Adverse reactions which occur infrequently and are associated with administration of the drug are: anaphylaxis, angioedema, dizziness, dysuria and urinary frequency, joint swelling and pain, lacrimation, headache, rash, swollen parotid gland, urticaria, pulmonary infiltrates with eosinophilia, substernal burning and myopathy.
The following adverse reactions have been reported as rare events and it is unclear whether they are attributable to the drug: anemia, exfoliative dermatitis, hemoptysis, hoarseness, myalgia, nephrosis, periarteritic vasculitis, pericarditis, peripheral neuritis, photodermatitis, sneezing, drowsiness, nasal itching, nasal bleeding, nasal burning, serum sickness, stomach ache, polymyositis, vertigo and liver disease.
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: Adults and Children over 6 Years of Age: Sodium chromoglycate is used on a continuous basis to prevent the symptoms of asthma and has no role in the treatment of acute attacks.
Initial Treatment: Two puffs four times daily at 4 to 6 hourly intervals. In more severe cases or during periods of high antigen challenge, the interval between doses may be 3 hours (i.e., up to 16 puffs daily may be taken).
For protection against bronchospasm induced by exercise, sodium cromoglycate should be used 15 to 30 minutes beforehand.
Maintenance Therapy: When adequate response has been obtained, frequency of inhalations may be reduced to 2 puffs every 8 to 12 hours (i.e., 4 to 6 puffs/day). If chest symptoms are troublesome at night, it is important that the final dose be taken, if awakened, during the night.
Patients should be warned against suddenly discontinuing therapy when symptoms have been partially or completely controlled by sodium cromoglycate.
Concomitant Therapy: Other asthma therapy should be continued until clinical improvement permits a progressive reduction in dosage. However, sodium cromoglycate alone may prevent symptoms of mild to moderate asthma, especially in children and young adults.
In severe asthma, particularly in older patients, sodium cromoglycate therapy alone is insufficient to prevent symptoms. In a proportion of such cases, significant improvement can be obtained by combining sodium cromoglycate with corticosteroid therapy, even when inadequate relief is obtained from either drug alone.
In steroid-dependent patients the addition of sodium cromoglycate to the regimen may permit a slow, progressive and significant reduction in maintenance dose of steroids.
Reduction or Withdrawal of Corticosteroids: The dangers of sudden withdrawal of corticosteroids are well recognized, particularly in steroid-treated patients who have received long-term administration of oral steroids, or injections of adrenocorticotrophic hormone (ACTH).
When the physician attempts to reduce the corticosteroid dosage, it is important that the reduction be gradual and that close surveillance and frequent examination of the patient is maintained. It should be remembered that adrenal cortex is suppressed by the administration of oral steroids, and that in both oral steroid and ACTH therapy, the ability of the patient to react to stress is usually impaired. In such patients, acute renal insufficiency and severe asthma can be precipitated by an increase in stress and/or reduction or withdrawal of either steroid or ACTH therapy. In order to identify such a risk in patients who have received long-term steroid therapy, and where substantial reduction or complete withdrawal of corticosteroid is contemplated, it is advisable to assess adrenal and pituitary function.
Method of Reducing Steroid Dosage: The reduction in the daily maintenance dose of steroids should be stepwise at a suggested rate equivalent to about 1%/day (e.g., a maintenance dose of 10 mg prednisolone/day is reduced to 9 mg/day after 1 week). The gradual reduction should be continued until either the patient cannot tolerate a further reduction, or it is found possible to withdraw corticosteroids completely.
Note: If troublesome symptoms recur during the period of reduction, the daily dose should be raised immediately. A larger increase in the steriod dose may be essential at times, as a temporary measure, to control a severe relapse induced by antigen challenge, infections or stress. The increased physical or mental activity resulting from subjective improvement can also constitute a stress. When symptoms are brought under control, a progressive reduction may be attempted as before.
Method of Withdrawing ACTH: The same principles apply as discussed above. In practice, either the number of units of ACTH per injection can be reduced, or the interval between injections can be extended (e.g., from 1/day, to 1 on alternate days, to 1 biweekly).
Withdrawal of Sodium Cromoglycate Therapy: As the action of sodium cromoglycate is essentially preventive, 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 sodium cromoglycate dosage gradually over a period of 1 week. It should be borne in mind that symptoms of asthma may recur when the drug is discontinued.
Caution: In cases where sodium cromoglycate has permitted a reduction in the maintenance dose of steroids, it is recommended that the steroid dose first be restored to at least pre-sodium cromoglycate level at the commencement of withdrawal of sodium cromoglycate, followed by slow reduction of the steroid dose to tolerance. This is to avoid risk of acute relapse. It is also recommended that adrenal function be assessed before restoring the pre-sodium cromoglycate steroid dose.
Availability And Storage: Inhaler: Each actuation contains sodium cromoglycate (micronized) 1 mg. Nonmedicinal ingredients: dichlorodifluoromethane, dichlorotetrafluoroethane and sorbitan trioleate. Pressurized aerosol containers of 10 mL delivering either 112 or 200 metered inhalations.
Syncroner: Each actuation contains: sodium cromoglycate (micronized) 1 mg. Nonmedicinal ingredients: dichlorodifluoromethane, dichlorotetrafluoroethane and sorbitan trioleate. Pressurized aerosol containers of 10 mL delivering 200 metered inhalations.
Intal Syncroner differs from Intal Inhaler in the design of the mouthpiece only. The Syncroner is an elongated mouthpiece of approximately 8 cm in length, with a portion of its upper surface cut away.
Store at room temperature. Contents under pressure. Do not place in hot water or near radiators, stoves or other sources of heat. Do not puncture or incinerate container or store at temperatures over 30°C.
INTAL® INHALER INTAL® SYNCRONER® Rh´ne-Poulenc Rorer Sodium Cromoglycate Asthma Prophylaxis
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