Systemic vascular resistance is usually decreased hospitalization and death. Patients with NYHA Class In addition, pulmonary wedge pressure and
with administration of dobutamine. Occasionally, IV symptoms appeared to be at particular risk.
cardiac output should be monitored
minimum vasoconstriction has been observed.
whenever possible to aid in the safe and
Most clinical experience with dobutamine is effective infusion of dobutamine.
short-term–not more than several hours in duration. In Hypovolemia should be corrected with suitable the limited number of patients who were studied for Dobutamine is contraindicated in patients with 24, 48, and 72 hours, a persistent increase in cardiac idiopathic hypertrophic subaortic stenosis and in DESCRIPTION
output occurred in some, whereas output returned patients who have shown previous manifestations of presence of marked mechanical obstruction, Dobutamine Injection USP is (±)-4-[2-[[3-(p- The onset of action of dobutamine is within such as severe valvular aortic stenosis.
H y d r o x y p h e n y l ) - 1 - m e t h y l p r o p y l ] a m i n o ] e t h y l ] - 1 to 2 minutes; however, as much as 10 minutes pyrocatechol hydrochloride. It is a synthetic Usage Following Acute Myocardial Infarction– may be required to obtain the peak effect of a WARNINGS
Clinical experience with dobutamine following myocardial infarction has been insufficient to establish the safety of Dobutamine may cause a marked increase in the drug for this use. There is concern that any agent heart rate or blood pressure, especially systolic that increases contractile force and heart rate may pressure. Approximately 10% of adult patients in increase the size of an infarction by intensifying ischemia, clinical studies have had rate increases of but it is not known whether dobutamine does so.
30 beats/minute or more, and about 7.5% have Laboratory Tests–Dobutamine, like other had a 50 mm Hg or greater increase in systolic 2-agonists, can produce a mild reduction in serum pressure. Usually, reduction of dosage promptly potassium concentration, rarely to hypokalemic levels.
derivative of dobutamine is inactive.
reverses these effects. Because dobutamine Accordingly, consideration should be given to facilitates atrioventricular conduction, patients with The clinical formulation is supplied in a sterile atrial fibrillation are at risk of developing rapid form for intravenous use only. Each mL contains: of catecholamines with either reserpine or ventricular response. In patients who have atrial Drug Interactions–Animal studies indicate that Dobutamine hydrochloride, equivalent to 12.5 mg tricyclic antidepressants does not alter the fibrillation with rapid ventricular response, a dobutamine may be ineffective if the patient has (41.5 µmol) dobutamine; Sodium Bisulfite 0.28 mg digitalis preparation should be used prior to recently received a ß-blocking drug. In such a case, (added during manufacture), and water for injection, indicates that the actions of dobutamine are not institution of therapy with dobutamine. Patients the peripheral vascular resistance may increase.
q.s. Hydrochloric acid and/or sodium hydroxide may dependent on presynaptic mechanisms.
with preexisting hypertension appear to face an Preliminary studies indicate that the concomitant have been added during manufacture to adjust the The effective infusion rate of dobutamine varies increased risk of developing an exaggerated use of dobutamine and nitroprusside results in a widely from patient to patient, and titration is always higher cardiac output and, usually, a lower pulmonary necessary (see DOSAGE AND ADMINISTRATION).
wedge pressure than when either drug is used alone.
At least in pediatric patients, dobutamine-induced CLINICAL PHARMACOLOGY
increases in cardiac output and systemic pressure are There was no evidence of drug interactions in generally seen, in any given patient, at lower infusion ventricular ectopic activity, but it rarely has clinical studies in which dobutamine was administered Dobutamine is a direct-acting inotropic agent rates than those that cause substantial tachycardia concurrently with other drugs, including digitalis whose primary activity results from stimulation of the (see PRECAUTIONS, Pediatric Use).
preparations, furosemide, spironolactone, lidocaine, ß r e c e p t o r s o f t h e h e a r t w h i l e p r o d u c i n g glyceryl trinitrate, isosorbide dinitrate, morphine, comparatively mild chronotropic, hypertensive, atropine, heparin, protamine, potassium chloride, folic arrhythmogenic, and vasodilative effects. It does not INDICATIONS AND USAGE
associated with administration of dobutamine cause the release of endogenous norepinephrine, as including skin rash, fever, eosinophilia, and does dopamine. In animal studies, dobutamine Dobutamine is indicated when parenteral therapy Carcinogenesis, Mutagenesis, Impairment of bronchospasm, have been reported occasionally.
produces less increase in heart rate and less is necessary for inotropic support in the short-term Fertility–Studies to evaluate the carcinogenic or Dobutamine contains sodium bisulfite, a sulfite decrease in peripheral vascular resistance for a treatment of adults with cardiac decompensation due mutagenic potential of dobutamine, or its potential to that may cause allergic-type reactions, including given inotropic effect than does isoproterenol.
to depressed contractility resulting either from organic affect fertility, have not been conducted.
anaphylactic symptoms and life-threatening or In patients with depressed cardiac function, both heart disease or from cardiac surgical procedures.
Pregnancy–Teratogenic Effects–Pregnancy less severe asthmatic episodes, in certain dobutamine and isoproterenol increase the cardiac Experience with intravenous dobutamine in controlled Category B– Reproduction studies performed in rats at susceptible people. The overall prevalence of output to a similar degree. In the case of dobutamine, trials does not extend beyond 48 hours of repeated doses up to the normal human dose (10 mcg/kg/min sulfite sensitivity in the general population is this increase is usually not accompanied by marked for 24 h, total daily dose of 14.4 mg/kg), and in rabbits unknown and probably low. Sulfite sensitivity is increases in heart rate (although tachycardia is Whether given orally, continuously intravenously, at doses up to twice the normal human dose, have seen more frequently in asthmatic than in occasionally observed), and the cardiac stroke volume is or intermittently intravenously, neither dobutamine nor revealed no evidence of harm to the fetus due to usually increased. In contrast, isoproterenol increases any other cyclic-AMP-dependent inotrope has been dobutamine. There are, however, no adequate and the cardiac index primarily by increasing the heart rate shown in controlled trials to be safe or effective in the well-controlled studies in pregnant women. Because while stroke volume changes little or declines.
long-term treatment of congestive heart failure. In PRECAUTIONS
animal reproduction studies are not always predictiveof human response, this drug should be used during Facilitation of atrioventricular conduction has controlled trials of chronic oral therapy with various been observed in human electrophysiologic studies such agents, symptoms were not consistently During the administration of dobutamine, as
and in patients with atrial fibrillation.
alleviated, and the cyclic-AMP-dependent inotropes Labor and Delivery–The effect of dobutamine on with any adrenergic agent, ECG and blood
were consistently associated with increased risk of pressure should be continuously monitored.
Nursing Mothers–It is not known whether this be used in conjunction with other agents or diluents drug is excreted in human milk. Because many drugs Signs and Symptoms–Toxicity from dobutamine containing both sodium bisulfite and ethanol.
are excreted in human milk, caution should be is usually due to excessive cardiac ß-receptor Preparation and Stability–At the time of exercised when dobutamine is administered to a stimulation. The duration of action of dobutamine is administration, dobutamine must be further diluted in nursing woman. If a mother requires dobutamine generally short (T1/2= 2 minutes) because it is rapidly an IV container to at least a 50 mL solution using one treatment, breastfeeding should be discontinued for metabolized by catechol-0-methyltranferase. The of the following intravenous solutions as a diluent: symptoms of toxicity may include anorexia, nausea, 5% Dextrose Injection, 5% Dextrose and 0.45% Infusion Rate (mL/h) for 2000 mcg/mL concentration Pediatric Use–Dobutamine has been shown to vomiting, tremor, anxiety, palpitations, headache, Sodium Chloride Injection, 5% Dextrose and 0.9% increase cardiac output and systemic pressure in shortness of breath, and anginal and nonspecific chest Sodium Chloride Injection, 10% Dextrose Injection, pediatric patients of every age group. In premature pain. The positive inotropic and chronotropic effects Isolyte®M with 5% Dextrose Injection, Lactated Delivery
Patient Body Weight (kg)
neonates, however, dobutamine is less effective than of dobutamine on the myocardium may cause Ringer’s Injection, 5% Dextrose in Lactated Ringer’s dopamine in raising systemic blood pressure without hypertension, tachyarrhythmias, myocardial ischemia, Injection, Normosol®-M in D5-W, 20% Osmitrol® in (mcg/kg/min)
causing undue tachycardia, and dobutamine has not and ventricular fibrillation. Hypotension may result Water for Injection, 0.9% Sodium Chloride Injection, been shown to provide any added benefit when given or Sodium Lactate Injection. Intravenous solutions to such infants already receiving optimal infusions of about the treatment of overdose, a good resource is Recommended Dosage–Infusion of dobutamine your certified Regional Poison Control Center.
should be started at a low rate (0.5 to 1.0 mcg/kg/min) Telephone numbers of certified poison control centers and titrated at intervals of a few minutes, guided by ADVERSE REACTIONS
are listed in the Physicians’ Desk Reference (PDR).
the patient’s response, including systemic blood Increased Heart Rate, Blood Pressure, and In managing overdosage, consider the possibility of pressure, urine flow, frequency of ectopic activity, Concentrations of up to 5,000 mcg/mL have been Ventricular Ectopic Activity–A 10- to 20-mm increase in multiple drug overdoses, interaction among drugs, and heart rate and (whenever possible) measurements of administered to humans (250 mg/50 mL). The final systolic blood pressure and an increase in heart rate of unusual drug kinetics in your patient.
cardiac output, central venous pressure, and/or volume administered should be determined by the 5 to 15 beats/minute have been noted in most patients pulmonary capillary wedge pressure. In reported The initial actions to be taken in a dobutamine (see WARNINGS regarding exaggerated chronotropic
trials, the optimal infusion rates have varied from overdose are discontinuing administration, establishing and pressor effects). Approximately 5% of patients patient to patient, usually 2 to 20 mcg/kg/min but Parenteral drug products should be inspected an airway, and ensuring oxygenation and ventilation.
have had increased premature ventricular beats during sometimes slightly outside of this range. On rare visually for particulate matter and discoloration prior to Resuscitative measures should be initiated promptly.
infusions. These effects are dose related.
occasions, infusion rates up to 40 mcg/kg/min have administration, whenever solution and container permit.
Severe ventricular tachyarrhythmias may be been required to obtain the desired effect. Rates of Hypotension–Precipitous decreases in blood pressure successfully treated with propranolol or lidocaine.
infusion (mL/h) for dobutamine concentrations of have occasionally been described in association with Hypertension usually responds to a reduction in dose or HOW SUPPLIED
dobutamine therapy. Decreasing the dose or necessary to attain various delivery rates of discontinuing the infusion typically results in rapid Protect the patient’s airway and support ventilation Dobutamine Injection USP, 20 mL single dose dobutamine (mcg/kg/min) for patients of different return of blood pressure to baseline values. In rare and perfusion. If needed, meticulously monitor and vial contains dobutamine hydrochloride, equivalent to cases, however, intervention may be required and maintain, within acceptable limits, the patient’s vital 250 mg dobutamine per 20 mL; ten vials per carton.
signs, blood gases, serum electrolytes, etc.
NDC 55390-560-90.
Reactions at Sites of Intravenous Infusion–Phlebitis If the product is ingested, unpredictable absorption Store at controlled room temperature, 15° to 30°C has occasionally been reported. Local inflammatory may occur from the mouth and the gastrointestinal tract.
Infusion Rate (mL/h) for 500 mcg/mL concentration changes have been described following inadvertent Absorption of drugs from the gastrointestinal tract may Manufactured by: Ben Venue Laboratories, Inc., infiltration. Isolated cases of cutaneous necrosis be decreased by giving activated charcoal, which, in (destruction of skin tissue) have been reported.
Patient Body Weight (kg)
many cases, is more effective than emesis or lavage; Manufactured for: Bedford Laboratories™, Miscellaneous Uncommon Effects–The following consider charcoal instead of or in addition to gastric (mcg/kg/min)
adverse effects have been reported in 1% to 3% of emptying. Repeated doses of charcoal over time may patients: nausea, headache, anginal pain, nonspecific hasten elimination of some drugs that have been chest pain, palpitations, and shortness of breath.
absorbed. Safeguard the patient’s airway when employing gastric emptying or charcoal.
Isolated cases of thrombocytopenia have been Forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for an overdose of dobutamine.
catecholamines, can produce a mild reduction inserum potassium concentration, rarely to hypokalemic levels (see PRECAUTIONS).
Infusion Rate (mL/h) for 1000 mcg/mL concentration Note–Do not add dobutamine to 5% Sodium OVERDOSAGE
Bicarbonate Injection or to any other strongly alkaline Delivery
Patient Body Weight (kg)
solution. Because of potential physical incompatibilities, Overdoses of dobutamine have been reported it is recommended that dobutamine not be mixed with (mcg/kg/min)
rarely. The following is provided to serve as a guide if other drugs in the same solution. Dobutamine should not


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GI_800_638954.qxp 19.08.2008 15:24 Seite 1 Gebrauchsinformation: Information für den Anwender Magaldrat 800 - 1 A Pharma® Wirkstoff: Magaldrat, wasserfrei 800 mg pro Kautablette Liebe Patientin, lieber Patient! Bitte lesen Sie die gesamte Packungsbeilage sorgfältig durch, denn sie enthält wichtige Informationen für Sie. Dieses Arzneimittel ist ohne Verschreibung erhältlich. Um ei

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