Dobutamine

Overdoses of dobutamine have been reported rarely. The following is provided to serve as a guide if such an overdose is encountered.

Signs And Symptoms

Toxicity from dobutamine hydrochloride is usually due to excessive cardiac β- receptor stimulation. The duration of action of dobutamine hydrochloride is generally short (T½= 2 minutes) because it is rapidly metabolized by catechol-0-methyltransferase. The symptoms of toxicity may include anorexia, nausea, vomiting, tremor, anxiety, palpitations, headache, shortness of breath, and anginal and nonspecific chest pain. The positive inotropic and chronotropic effects of dobutamine on the myocardium may cause hypertension, tachyarrhythmias, myocardial ischemia, and ventricular fibrillation. Hypotension may result from vasodilation.

Treatment

To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physicians' Desk Reference (PDR). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient.

The initial actions to be taken in a dobutamine hydrochloride overdose are discontinuing administration, establishing an airway, and ensuring oxygenation and ventilation. Resuscitative measures should be initiated promptly. Severe ventricular tachyarrhythmias may be successfully treated with propranolol or lidocaine. Hypertension usually responds to a reduction in dose or discontinuation of therapy.

Protect the patient's airway and support ventilation and perfusion. If needed, meticulously monitor and maintain, within acceptable limits, the patient's vital signs, blood gases, serum electrolytes, etc. If the product is ingested, unpredictable absorption may occur from the mouth and the gastrointestinal tract. Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emisis of lavage; consider charcoal instead of or in addition to gastric emptying. Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Safeguard the patient's airway when employing gastric emptying or charcoal.

Forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for an overdose of dobutamine hydrochloride.

Dobutamine is a prescription medication used to improve heart function.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• antidepressants such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), desvenlafaxine (Pristiq), nefazodone (Serzone), paroxetine (Paxil, Pexeva), sertraline (Zoloft), venlafaxine (Effexor), trimipramine (Surmontil), isocarboxazid (Marplan), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil)
• beta blockers such as metoprolol (Toprol XL, Lopressor), carvedilol (Coreg), bisoprolol (Zebeta), betaxolol (Kerlone), nebivolol (Bystolic), propranolol (Inderal)
• guanethidine (Ismelin)

This is not a complete list of dobutamine drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with dobutamine including significant changes in heart rate or blood pressure and allergic reactions. Tell your healthcare provider right away if you have some or all of the following symptoms:

• irregular heartbeat
• increases in blood pressure and heart rate
• chest pain
• shortness of breath
• swelling of the lower legs and ankles
• increasing fatigue
• lightheadedness, dizziness, or faintness
• skin rash

Do not receive dobutamine if you:

• are allergic to dobutamine or to any of its ingredients
• have idiopathic hypertrophic subaortic stenosis

Receive dobutamine exactly as prescribed.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional. It must be diluted before administration.

Do not stop the infusion on your own for any reason and do not change your dosing schedule without talking to your health care provider. Heart activity and blood pressure should be monitored continuously during administration of dobutamine.

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, 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.

Read the entire FDA prescribing information for Dobutamine (Dobutamine)

Dobutamine stimulates heart muscle and improves blood flow by helping the heart pump better.

Dobutamine is used short-term to treat cardiac decompensation due to weakened heart muscle.

Dobutamine is usually given after other heart medicines have been tried without success.

Dobutamine may also be used for purposes not listed in this medication guide.

Dobutamine is injected into a vein through a catheter. A healthcare provider will give you this injection.

You will receive this medicine in a hospital or clinic setting to quickly treat any serious side effects that occur.

While using dobutamine, you may need frequent medical tests. Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregiver right away if you have:

• shortness of breath (even with mild exertion), swelling, rapid weight gain;

• chest pain, fast or pounding heartbeats;

• a light-headed feeling, like you might pass out;

• wheezing, chest tightness;

• dangerously high blood pressure-severe headache, blurred vision, buzzing in your ears, anxiety, confusion, uneven heartbeats, seizure; or

• signs of infection in your catheter--pain, swelling, warmth, redness, oozing, or skin changes where the medicine is injected.

Common side effects may include:

• nausea, vomiting;

• fever, tingly feeling;

• headache; or

• leg cramps.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Shortness of breath.
• A fast heartbeat.
• A heartbeat that does not feel normal.
• Very bad dizziness or passing out.
• Very bad headache.
• Fever.
• Pain and irritation where this medicine goes into the body.

Dobutamine Injection, USP is supplied in 20 mL single-dose glass vials containing 250 mg Dobutamine, as the hydrochloride (List No. 2344) packaged in individual cartons or in a tray of 10.

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Revised: October, 2004

Manufactured by Hospira, Inc., Lake Forest, IL 60045 USA

Novation and NOVAPLUS® are trademarks of Novation, LLC.

©Hospira 2004        EN-0583        Printed in USA

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

Cardiac decompensation: Short-term management of patients with cardiac decompensation

American College of Cardiology/American Heart Association heart failure (HF) guideline recommendations (ACCF/AHA [Yancy 2013]): To maintain systemic perfusion and preserve end-organ performance in patients with cardiogenic shock; bridge therapy in stage D HF unresponsive to guideline-directed medical therapy and device therapy in patients awaiting heart transplant or mechanical circulatory support; short-term management of hospitalized patients with severe systolic dysfunction presenting with low blood pressure and significantly depressed cardiac output; long-term management (palliative therapy) in select patients with stage D HF unresponsive to guideline-directed medical therapy and device therapy who are not candidates for heart transplant or mechanical circulatory support.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Have patient report immediately to prescriber shortness of breath, tachycardia, abnormal heartbeat, severe dizziness, passing out, injection site pain or irritation, or severe headache (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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