Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1415
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DOBUTamine (Injection, Solution, Concentrate)
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Note���Do not
add Dobutamine Injection, USP to 5% Sodium Bicarbonate Injection or to any
other strongly alkaline solution. Because of potential physical incompatibilities,
it is recommended that dobutamine hydrochloride not be mixed with other drugs
in the same solution. Dobutamine hydrochloride should not be used in conjunction
with other agents or diluents containing both sodium bisulfite and ethanol. Preparation and Stability���At the time
of administration, Dobutamine Injection, USP must be further diluted in an
I.V. container to at least a 50 mL solution using one of the following intravenous
solutions as a diluent: 5% Dextrose Injection, USP; 5% Dextrose and 0.45%
Sodium Chloride Injection, USP; 5% Dextrose and 0.9% Sodium Chloride Injection,
USP; 10% Dextrose Injection, USP; Isolyte' M with 5% Dextrose Injection;
Lactated Ringer's Injection; 5% Dextrose in Lactated Ringer's
Injection; Normosol'-M in D5-W; 20% Osmitrol' in Water for Injection;
0.9% Sodium Chloride Injection, USP; or Sodium LactateInjection, USP. Intravenous
solutions should be used within 24 hours. Recommended
Dosage���The rate of infusion needed to increase cardiac
output usually ranged from 2.5 to 15 mcg/kg/min (see Table 1). On rare occasions,
infusion rates up to 40 mcg/kg/min have been required to obtain the desired
effect. Rates of infusion in mL/h for Dobutamine concentrations
of 500 mcg/mL, 1,000 mcg/mL, and 2,000 mcg/mL are given in Table 2. The rate of administration and
the 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. Concentrations of
up to 5,000 mcg/mL have been administered to humans (250 mg/50 mL). The final
volume administered should be determined by the fluid requirements of the
patient. Parenteral drug products should be inspected
visually for particulate matter and discoloration prior to administration,
whenever solution and container permit. Directions
for Dispensing From Pharmacy Bulk Package Use Aseptic Technique - Not for Direct Infusion The
Pharmacy Bulk Package is for use in the Pharmacy Admixtures Service only.
For hanger application, peel off the paper liner from both ends of the tape
hanger to expose��inch long adhesive portions. Adhere each end to the
label on the bottle. The vials should be suspended as a unit in the laminar
flow hood. A single entry through the vial closure should
be made with a sterile dispensing set or transfer device. Transfer individual
doses to appropriate intravenous infusion solutions. Use of a syringe with
needle is not recommended as it may cause leakage and multiple entries will
increase the potential ofmicrobial and particulate contamination. The
above process should be carried out under a laminar flow hood using aseptic
technique. Discard any unused
portion within 4 hours after initial closure entry.
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dailymed-instance:descripti... |
Dobutamine Injection, USP is a clear, practically colorless,
sterile, nonpyrogenic solution of dobutamine hydrochloride for intravenous
use only. Each milliliter contains 12.5 mg (41.5��mol) dobutamine, as
the hydrochloride and sodium metabisulfite, 0.2 mg added as antioxidant. May
contain hydrochloric acid and/or sodium hydroxide for pH adjustment. pH is
3.3 (2.5 to 5.5). A Pharmacy Bulk Package is a container
of a sterile preparation for parenteral use that contains many single doses.
The contents are intended for use in a pharmacy admixture program and are
restricted to the preparation of admixtures for intravenous infusion. Dobutamine
Hydrochloride, USP is chemically designated (��)-4-[2-[[3-(��-hydroxyphenyl)-1-methylpropyl]amino]ethyl]-pyrocatechol
hydrochloride. It is a synthetic catecholamine. Molecular
Weight: 337.85 Molecular Formula: CHNO���HCl
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dailymed-instance:clinicalP... |
Dobutamine hydrochloride is a direct-acting inotropic agent
whose primary activity results from stimulation of the��receptors of
the heart while producing comparatively mild chronotropic, hypertensive, arrhythmogenic,
and vasodilative effects. It does not cause the release of endogenous norepinephrine,
as does dopamine. In animal studies, dobutamine hydrochloride produces less
increase in heart rate and less decrease in peripheral vascular resistance
for a given inotropic effect than does isoproterenol. In
patients with depressed cardiac function, both dobutamine hydrochloride and
isoproterenol increase the cardiac output to a similar degree. In the case
of dobutamine hydrochloride, this increase is usually not accompanied by marked
increases in heart rate (although tachycardia is occasionally observed), and
the cardiac stroke volume is usually increased. In contrast, isoproterenol
increases the cardiac index primarily by increasing the heart rate while stroke
volume changes little or declines. Facilitation of atrioventricular
conduction has been observed in human electrophysiologic studies and in patients
with atrial fibrillation. Systemic vascular resistance
is usually decreased with administration of dobutamine hydrochloride. Occasionally,
minimum vasoconstriction has been observed. Most clinical
experience with dobutamine hydrochloride is short-term���not more than
several hours in duration. In the limited number of patients who were studied
for 24, 48, and 72 hours, a persistent increase in cardiac output occurred
in some, whereas output returned toward baseline values in others. The
onset of action of dobutamine is within 1 to 2 minutes; however, as much as
10 minutes may be required to obtain the peak effect of a particular infusion
rate. The plasma half-life of dobutamine hydrochloride
in humans is 2 minutes. The principal routes of metabolism are methylation
of the catechol and conjugation. In human urine, the major excretion products
are the conjugates of dobutamine and 3-O-methyl dobutamine. The 3-O-methyl
derivative of dobutamine is inactive. Alteration of
synaptic concentrations of catecholamines with either reserpine or tricyclic
antidepressants does not alter the actions of dobutamine in animals, which
indicates that the actions of dobutamine hydrochloride are not dependent on
presynaptic mechanisms.
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Dobutamine hydrochloride is contraindicated in patients with
idiopathic hypertrophic subaortic stenosis and in patients who have shown
previous manifestations of hypersensitivity to Dobutamine Injection, USP solution.
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Dobutamine Injection, USP is supplied in individually-cartoned
100 mL Pharmacy Bulk Package containing 12.5 mg/mL dobutamine, as the hydrochloride
(List No. 4729). Store at controlled room temperature,
15��to 30��C (59��to 86��F). [See USP.] June, 2004 ��Hospira 2004 EN-0205 Printed in USA HOSPIRA, INC., LAKE FOREST, IL 60045 USA
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General: Usage Following Acute Myocardial
Infarction���Clinical experience with dobutamine
hydrochloride following myocardial infarction has been insufficient to establish
the safety of the drug for this use. There is concern that any agent that
increases contractile force and heart rate may increase the size of an infarction
by intensifying ischemia, but it is not known whether dobutamine hydrochloride
does so.<br/>Laboratory Tests���: Dobutamine, like other��-agonists, can
produce a mild reduction in serum potassium concentration, rarely to hypokalemic
levels. Accordingly, consideration should be given to monitoring serum potassium.<br/>Drug Interactions���: Animal studies indicate that dobutamine may be ineffective
if the patient has recently received a��-blocking drug. In such a case,
the peripheral vascular resistance may increase. Preliminary
studies indicate that the concomitant use of dobutamine and nitroprusside
results in a higher cardiac output and, usually, a lower pulmonary wedge pressure
than when either drug is used alone. There was no evidence
of drug interactions in clinical studies in which dobutamine was administered
concurrently with other drugs, including digitalis preparations, furosemide,
spironolactone, lidocaine, nitroglycerin, isosorbide dinitrate, morphine,
atropine, heparin, protamine, potassium chloride, folic acid, and acetaminophen.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility���: Studies to evaluate the carcinogenic or mutagenic potential
of dobutamine hydrochloride, or its potential to affect fertility, have not
been conducted.<br/>Pregnancy���: Teratogenic Effects-Pregnancy
Category B���Reproduction studies performed in rats at doses
up to 3.5 times the normal human dose (10 mcg/kg/min for 24 h, total daily
dose of 14.4 mg/kg) and in rabbits at doses up to 2 times the normal
human dose have revealed no evidence of harm to the fetus due to dobutamine
hydrochloride. There are, however, no adequate and well-controlled studies
in pregnant women. Because animal reproduction studies are not always predictive
of human response, this drug should be used during pregnancy only if clearly
needed.<br/>Labor and Delivery���: The effect of Dobutamine Injection, USP on labor and delivery
is unknown.<br/>Nursing Mothers���: It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised
when dobutamine hydrochloride is administered to a nursing woman. If a mother
requires dobutamine hydrochloride treatment, breast-feeding should be discontinued
for the duration of the treatment.<br/>Pediatric Use���: The safety and effectiveness of Dobutamine Injection, USP
for use in pediatric patients have not been studied.
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dailymed-instance:overdosag... |
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
is usually due to excessive cardiac��-receptor stimulation. The duration
of action of dobutamine is generally short (T= 2 minutes)
because it is rapidly metabolized by catechol-O-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
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 emesis or 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.
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Dobutamine
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DOBUTamine (Injection, Solution, Concentrate)
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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.
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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.
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DOBUTamine
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