VENTOLIN I.V. infusion solution - GlaxoSmithKline

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Lactic acidosis has also been reported very rarely in patients receiving intravenous salbutamol therapy for the treatment of acute asthma exacerbation. DRUG INTERACTIONS Drug-Drug Interactions Table 1: Established or Potential Drug-Drug Interactions salbutamol sulphate Ref Effect Clinical comment Monoamine oxidase inhibitors or tricyclic antideprssants. Other sympathomimetic bronchodilators or epinephrine. CS CS May potentiate action of salbutamol on cardiovascular system. May lead to deleterious cardiovascular effects. Beta-blockers CS May effectively antagonise the action of salbutamol. Diuretics CS May lead to ECG changes and/or hypokalemia, although the clinical significance of these effects is not known. Digoxin CS May lead to mean decrease in serum digoxin levels. The clinical significance of these findings for patients with obstructive airways disease who are receiving salbutamol and digoxin on a chronic basis is unclear. Legend CS = Class Statement Salbutamol should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants. Other sympathomimetic bronchodilators or epinephrine should not be used concomitantly with salbutamol. If additional adrenergic drugs are to be administered by any route to the patient using salbutamol, the adrenergic drugs should be used with caution to avoid deleterious cardiovascular effects. Such concomitant use must be individualised and not given on a routine basis. If regular co-administration is required then alternative therapy must be considered. Beta-adrenergic blocking drugs, especially the non-cardioselective ones, such as propranolol, should not usually be prescribed together. The ECG changes and/or hypokalemia that may result from the administration of nonpotassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the betaagonist is exceeded. Caution is advised in the co-administration of beta-agonists with non-potassium sparing diuretics. Mean decreases of 16-22% in serum digoxin levels were demonstrated after single doses intravenous and oral administration of salbutamol, respectively, to normal volunteers who had received digoxin for 10 days. It would be prudent to carefully evaluate serum digoxin levels in patients who are currently receiving digoxin and salbutamol. October 03, 2007 Page 8 of 21
DOSAGE AND ADMINISTRATION Recommended Dose and Dosage Adjustment Adults In severe bronchospasm and status asthmaticus Continuous intravenous infusion 5 micrograms/min., increased to 10 micrograms/min., and 20 micrograms/min. at 15 - 30 minute intervals, if necessary. A suitable solution for infusion may be prepared by diluting 5 mL of VENTOLIN ® I.V. infusion solution (1.0 mg/mL) in 500 mL of a chosen i.v. solution to provide a salbutamol concentration of 10 micrograms/mL. VENTOLIN ® I.V. INFUSION SOLUTION MUST NOT BE INJECTED UNDILUTED. THE CONCENTRATION SHOULD BE REDUCED 50% BEFORE ADMINISTRATION. VENTOLIN ® infusion solution is compatible in PVC bags and in glass bottles with Water for Injection BP, Sodium Chloride Injection BP, Dextrose Injection BP, and Sodium Chloride and Dextrose Injection BP. Dextrose-containing solutions may not be suitable for patients with diabetes mellitus due to the possible danger of glucose overload (see WARNINGS AND PRECAUTIONS). Children The dosage of VENTOLIN ® infusion solution in the pediatric age group has not been established. At present, there are insufficient data to recommend a dosage regimen for children. Administration VENTOLIN ® infusion solution is not to be administered with other medication as part of the same infusion. Continuous intravenous infusion, when practicable, is the preferred method of administration. Reconstituted Solutions:VENTOLIN ® infusion solution may be diluted with Water for Injection BP, Sodium Chloride Injection BP, Sodium Chloride and Dextrose Injection BP or Dextrose Injection BP. These are the only recommended diluents. As with all parenteral drug products, intravenous admixtures should be inspected visually for clarity, particulate matter, precipitate, discoloration and leakage prior to administration, whenever solution and container permit. All unused admixtures of VENTOLIN ® infusion solution with infusion fluids should be discarded 24 hours after preparation. October 03, 2007 Page 9 of 21
Page 1 and 2: PRODUCT MONOGRAPH Pr VENTOLIN ® I.
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Page 5 and 6: concurrently receiving corticostero
Page 7: In worsening asthma it is inadequat
Page 11 and 12: PART II: SCIENTIFIC INFORMATION PHA
Page 13 and 14: Intravenous salbutamol raised the b
Page 15 and 16: Long-Term Toxicity Chronic toxicity
Page 17 and 18: 13. Jenkins CR, Marlin GE. The meta
Page 19 and 20: IMPORTANT: PLEASE READ PART III: CO
Page 21: IMPORTANT: PLEASE READ REPORTING SU

VENTOLIN I.V. infusion solution - GlaxoSmithKline

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