What is DOBUTAMINE INJECTION USP?

DOBUTAMINE INJECTION USP 12.5 MG contains DOBUTAMINE (DOBUTAMINE HYDROCHLORIDE) : 12.5 MG. It is listed in the Health Canada Drug Product Database under DIN 02242010, held by SANDOZ CANADA INCORPORATED, supplied as LIQUID for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 06-Oct-2005. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is DOBUTAMINE INJECTION USP used for?

Dobutamine Injection USP is indicated in the treatment of adults with cardiac decompensation due to depressed contractility resulting from organic heart disease or following cardiac surgical procedures in which parenteral therapy is necessary for inotropic support.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

Product details and regulatory record

How is it administered?

Note: DOBUTAMINE INJECTION USP is a potent drug; it is not for direct injection and must be diluted exactly as directed before administration to patients as an intravenous infusion (see PRECAUTIONS). Preparation and Stability: Dobutamine Injection USP is incompatible with alkaline solutions and should not be mixed with products such as 5% sodium bicarbonate injection. Because of the occurrences of physical incompatibilities with some drugs and the potential for incompatibility with other drugs, it is recommended that Dobutamine Injection USP not be mixed with other drugs in the same solution. Dobutamine Injection USP should not be used in conjunction with other agents or diluents containing both sodium bisulfite and ethanol. The diluted solution should be inspected visually for discolouration, haziness, particulate matter and leakage prior to administration. Discard any unused portion. Dobutamine Injection USP must be diluted at the time of administration to at least 50 mL with either Dextrose 5% or Sodium Chloride 0.9% prior to administration by IV infusion. Intravenous solutions should be used within 24 hours of preparation. Solutions containing dobutamine may exhibit a colour that, if present, will increase with time. This colour change is due to slight oxidation of the drug, but there is no significant loss of potency during the reconstituted time periods stated above. Recommended Dosage: The rate of infusion needed to increase cardiac output usually ranges from 2.5 to 10 µg/kg/min (see Table). Some patients may respond to doses as low as 0.5 µg/kg/min.; whereas, on rare occasions, infusion rates up to 40 µg/kg/min. have been required to obtain the desired effect. The final volume administered should be determined by the fluid requirements of the patient. The rate of administration and duration of therapy should be adjusted according to the patient's response as determined by heart rate, presence of ectopic activity, blood pressure, urine flow and, whenever possible, measurement of central venous or pulmonary wedge pressure and cardiac output.

Included because it drives pack selection and wastage. Consult the monograph.

How is it stored and handled?

Store between 15 and 30 °C. Protect from light. Discard unused portion.

How is it supplied?

Dobutamine Injection USP is available in 20 mL single use vials, boxes of 10.

Contraindications

Dobutamine Injection USP is contraindicated in patients with pheochromocytoma, idiopathic hypertrophic subaortic stenosis, and in those patients with hypersensitivity to dobutamine.

Warnings and precautions

Dobutamine Injection USP may cause a marked increase in heart rate or blood pressure, especially systolic pressure. About 10% of patients in clinical studies have had rate increases of 30 beats per minute or more, while about 7.5% have had a 50 mm Hg or greater increase in systolic pressure. Patients with pre-existing hypertension appear to have an increased risk of developing an exaggerated pressor response. A reduction of the dosage usually reverses these effects promptly. Dobutamine may precipitate or exacerbate ventricular ectopic activity but has rarely caused ventricular tachycardia. Reactions suggestive of hypersensitivity associated with administration of Dobutamine Injection USP, including skin rash, fever, eosinophilia, and bronchospasm, have been reported occasionally. Dobutamine Injection USP contains sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms, in certain susceptible people. In patients who have atrial fibrillation with rapid ventricular response, a digitalis preparation should be used prior to instituting therapy with Dobutamine Injection USP. Because dobutamine facilitates atrioventricular conduction, patients with atrial fibrillation are at risk of developing rapid ventricular response. Dobutamine Injection USP should not be used in the presence of uncorrected tachycardia or ventricular fibrillation. No improvement may be observed in the presence of marked mechanical obstruction such as severe valvular aortic stenosis. Minimal vasoconstriction has occasionally been observed, most notably in patients recently treated with a ẞ-blocking drug. Because the inotropic effect of Dobutamine Injection USP stems from stimulation of cardiac ẞ₁ receptors, this effect is, of course, prevented by ẞ-blocking drugs.

What can be used instead?

Other Canadian products sharing ATC code C01CA07 DOBUTAMINE. 2 of 9 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.

Who else supplies DOBUTAMINE worldwide?

Nexara tracks national medicine registries and published price lists across multiple markets. DOBUTAMINE appears in 17 registered pack listings across 6 markets, published on 4 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.

Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.