Dobutamine 250 mg/20mL
dobutamine · INJECTION · Slate Run Pharmaceuticals
Dobutamine is a injection containing dobutamine at 250 mg/20mL, taken intravenous. Manufactured by Slate Run Pharmaceuticals.
Key Facts
- Brand Name
- Dobutamine
- Generic Name
- dobutamine
- NDC Code (Product)
70436-203- Manufacturer
- Slate Run Pharmaceuticals
- Strength
- 250 mg/20mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA216131
- Marketing Start
- 04/03/2023
Recall History
Hospira Inc.
Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the vial, also glass particulate was found within the solution.
Walgreens Infusion Services
Lack of sterility assurance.
Hospira Inc.
Lack of Assurance of Sterility: Confirmed report of leaking in the primary container.
Sentara Infusion Services
Lack of sterility assurance
Pfizer Inc.
Discoloration; discolored solution from cracked vials
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Sentara Enterprises
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Baptist Health Medical Towers Pharmacy and Infusion Services
Lack of Sterility Assurance.
Hospira Inc.
Discoloration: Firm received complaints of product discoloration and particulates.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Dobutamine in 5% Dextrose Injection, USP is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of patients with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. Experience with intravenous dobutamine in controlled trials does not extend beyond 48 hours of repeated boluses and/or continuous infusions. Whether given orally, continuously intravenously, or intermittently intravenously, neither dobutamine nor any other cyclic-AMP-dependent inotrope has been shown in controlled trials to be safe or effective in the long-term treatment of congestive heart failure. In controlled trials of chronic oral therapy with various such agents, symptoms were not consistently alleviated, and the cyclic-AMP-dependent inotropes were consistently associated with increased risks of hospitalization and death. Patients with NYHA Class IV symptoms appeared to be at particular risk.
Dosage & Administration
Recommended Dosage Dobutamine in 5% Dextrose Injection, USP is administered intravenously through a suitable intravenous catheter or needle. A calibrated electronic infusion device is recommended for controlling the rate of flow in mL/hour or drops/minute. Infusion of dobutamine should be started at a low rate (0.5 to 1.0 µg/kg/min) and titrated at intervals of a few minutes, guided by the patient's response, including systemic blood pressure, urine flow, frequency of ectopic activity, heart rate, and (whenever possible) measurements of cardiac output, central venous pressure, and/or pulmonary capillary wedge pressure. In reported trials, the optimal infusion rates have varied from patient to patient, usually 2 to 20 µg/kg/min but sometimes slightly outside of this range. On rare occasions, infusion rates up to 40 µg/kg/min have been required to obtain the desired effect. Rates of infusion in mL/hour for dobutamine hydrochloride concentrations of 500, 1,000, 2,000 and 4,000 mg/L may be calculated using the following formula: This container system may be inappropriate for the dosage requirements of pediatric patients under 30 kg. Parenteral drug products should be inspected visually…
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 adult 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 reverses these effects. Because dobutamine facilitates atrioventricular conduction, patients with atrial fibrillation are at risk of developing rapid ventricular response. In patients who have atrial fibrillation with rapid ventricular response, a digitalis preparation should be used prior to institution of therapy with dobutamine. Patients with pre-existing hypertension appear to face an increased risk of developing an exaggerated pressure response. Ectopic Activity Dobutamine may precipitate or exacerbate ventricular ectopic activity, but it rarely has caused ventricular tachycardia. Hypersensitivity Reactions suggestive of hypersensitivity associated with administration of Dobutamine in 5% Dextrose Injection, USP, including skin rash, fever, eosinophilia, and bronchospasm, have been reported occasionally. Dobutamin…
Contraindications
Dobutamine in 5% Dextrose Injection, USP is contraindicated in patients with idiopathic hypertrophic subaortic stenosis and in patients who have shown previous manifestations of hypersensitivity to dobutamine or any of its components.
Adverse Reactions
Increased Heart Rate, Blood Pressure, and Ventricular Ectopic Activity: A 10- to 20-mm Hg 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 adult 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. Stress Cardiomyopathy: Stress cardiomyopathy has been reported with dobutamine in association with cardiac stress testing. Reactions at Sites of Intravenous Infusion: Phlebitis has occasionally been reported. Local inflammatory changes have been described following inadvertent infiltration. Miscellaneous Uncommon Effects: The following adverse effects have been reported in 1% to 3% of adult patients: nausea, headache, anginal pain, nonspec…
Frequently Asked Questions
What is Dobutamine used for?
Dobutamine contains dobutamine. It is a injection taken intravenous. Consult your doctor for specific uses.
Is Dobutamine a controlled substance?
Dobutamine is not classified as a controlled substance by the DEA.
What is the generic name for Dobutamine?
The generic name for Dobutamine is dobutamine. There are 10 other brand versions of dobutamine.
What is the NDC code for Dobutamine 250 mg/20mL?
The NDC (National Drug Code) for Dobutamine 250 mg/20mL is 70436-203, listed by Slate Run Pharmaceuticals.
Other Dobutamine Dosages
Other Dobutamine Brands
See all →- DOBUTAMINE200 mg/100mL51662-1330
- Dobutamine Hydrochloride in Dextrose200 mg/100mL0338-1075
- Dobutamine in Dextrose200 mg/100mL0409-0151
- Dobutamine in Dextrose100 mg/100mL0409-2346
- Dobutamine Hydrochloride in Dextrose100 mg/100mL0338-1073
- DOBUTAMINE12.5 mg/mL0409-2344
- Dobutamine in Dextrose400 mg/100mL0409-3724
- DOBUTAMINE12.5 mg/mL51662-1337
- DOBUTAMINE IN DEXTROSE100 mg/100mL51662-1664
- Dobutamine in Dextrose400 mg/100mL0409-1100
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)