DOBUTAMINE
Generic: DOBUTAMINE
Basic Information
Manufacturer
HF Acquisition Co LLC, DBA HealthFirst
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
7b9ea626-7072-2e77-e053-2a91aa0a9215
Indications & Usage
INDICATIONS & USAGE Dobutamine Injection, USP is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of adults with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures.
In patients who have atrial fibrillation with rapid ventricular response, a digitalis preparation should be used prior to institution of therapy with dobutamine hydrochloride.
In patients who have atrial fibrillation with rapid ventricular response, a digitalis preparation should be used prior to institution of therapy with dobutamine hydrochloride.
Warnings
WARNINGS Increase in Heart Rate or Blood Pressure Dobutamine hydrochloride may cause a marked increase in heart rate or blood pressure, especially systolic pressure.
Approximately 10% of patients in clinical studies have had rate increases of 30 beats/minute or more, and about 7.5% have had a 50 mm Hg or greater increase in systolic pressure.
Usually, reduction of dosage promptly reverses these effects.
Because dobutamine hydrochloride facilitates atrioventricular conduction, patients with atrial fibrillation are at risk of developing rapid ventricular response.
Patients with pre-existing hypertension appear to face an increased risk of developing an exaggerated pressor response.
Ectopic Activity Dobutamine hydrochloride may precipitate or exacerbate ventricular ectopic activity, but it rarely has caused ventricular tachycardia.
Hypersensitivity 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 and life-threatening or less severe asthmatic episodes, in certain susceptible people.
The overall prevalence of sulfite sensitivity in the general population is unknown and probably low.
Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
Approximately 10% of patients in clinical studies have had rate increases of 30 beats/minute or more, and about 7.5% have had a 50 mm Hg or greater increase in systolic pressure.
Usually, reduction of dosage promptly reverses these effects.
Because dobutamine hydrochloride facilitates atrioventricular conduction, patients with atrial fibrillation are at risk of developing rapid ventricular response.
Patients with pre-existing hypertension appear to face an increased risk of developing an exaggerated pressor response.
Ectopic Activity Dobutamine hydrochloride may precipitate or exacerbate ventricular ectopic activity, but it rarely has caused ventricular tachycardia.
Hypersensitivity 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 and life-threatening or less severe asthmatic episodes, in certain susceptible people.
The overall prevalence of sulfite sensitivity in the general population is unknown and probably low.
Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
Adverse Reactions
ADVERSE REACTIONS Increased Heart Rate, Blood Pressure, and Ventricular Ectopic Activity − A 10 to 20 mm increase in systolic blood pressure and an increase in heart rate of 5 to 15 beats/minute have been noted in most patients (see WARNINGS regarding exaggerated chronotropic and pressor effects).
Approximately 5% of patients have had increased premature ventricular beats during infusions.
These effects are dose related.
Hypotension − Precipitous decreases in blood pressure have occasionally been described in association with dobutamine therapy.
Decreasing the dose or discontinuing the infusion typically results in rapid return of blood pressure to baseline values.
In rare cases, however, intervention may be required and reversibility may not be immediate.
Reactions at Sites of Intravenous Infusion − Phlebitis has occasionally been reported.
Local inflammatory changes have been described following inadvertent infiltration.
Isolated cases of cutaneous necrosis (destruction of skin tissue) have been reported.
Miscellaneous Uncommon Effects − The following adverse effects have been reported in 1% to 3% of patients: nausea, headache, anginal pain, nonspecific chest pain, palpitations, and shortness of breath.
Isolated cases of thrombocytopenia have been reported.
Administration of dobutamine hydrochloride, like other catecholamines, can produce a mild reduction in serum potassium concentration, rarely to hypokalemic levels (see PRECAUTIONS).
Longer-Term Safety − Infusions of up to 72 hours have revealed no adverse effects other than those seen with shorter infusions.
Approximately 5% of patients have had increased premature ventricular beats during infusions.
These effects are dose related.
Hypotension − Precipitous decreases in blood pressure have occasionally been described in association with dobutamine therapy.
Decreasing the dose or discontinuing the infusion typically results in rapid return of blood pressure to baseline values.
In rare cases, however, intervention may be required and reversibility may not be immediate.
Reactions at Sites of Intravenous Infusion − Phlebitis has occasionally been reported.
Local inflammatory changes have been described following inadvertent infiltration.
Isolated cases of cutaneous necrosis (destruction of skin tissue) have been reported.
Miscellaneous Uncommon Effects − The following adverse effects have been reported in 1% to 3% of patients: nausea, headache, anginal pain, nonspecific chest pain, palpitations, and shortness of breath.
Isolated cases of thrombocytopenia have been reported.
Administration of dobutamine hydrochloride, like other catecholamines, can produce a mild reduction in serum potassium concentration, rarely to hypokalemic levels (see PRECAUTIONS).
Longer-Term Safety − Infusions of up to 72 hours have revealed no adverse effects other than those seen with shorter infusions.