Dobutamine Hydrochloride

Prescription

Nama merek: Dobutamine Hydrochloride in Dextrose

Bentuk Sediaan

Injection

Rute Pemberian

INTRAVENOUS

Produsen

Baxter Healthcare Corporation

About This Medication

DESCRIPTION Dobutamine Hydrochloride in 5% Dextrose Injection is a sterile, nonpyrogenic solution of Dobutamine Hydrochloride, USP and Dextrose, USP in Water for Injection, USP. Dobutamine hydrochloride is chemically designated as (±)-4-[2-[[3-(p-hydroxyphenyl)-1-methylpropyl]amino]ethyl]-pyrocatechol hydrochloride. It is a synthetic catecholamine. Dextrose Hydrous, USP is chemically designated as D-Glucopyranose monohydrate. Structural formulas are shown below: Dobutamine Hydrochloride, USP (D-Glucopyranose monohydrate) Dextrose Hydrous, USP Dobutamine Hydrochloride in 5% Dextrose Injection is intended for intravenous use only. It contains no antimicrobial agents. The pH is adjusted with sodium hydroxide and/or hydrochloric acid. Sodium bisulfite is added as a stabilizer. The solution is intended for single use only. When smaller doses are required, the unused portion should be discarded. Composition, osmolarity, pH and caloric content are given in Table 1. Table 1. Composition Approximately 5 mEq/L sodium bisulfite is added as a stabilizer. Dobutamine Hydrochloride in 5% Dextrose Injection. Dobutamine (mg/Container) Dobutamine (mcg/mL) Dextrose Hydrous, USP (g/L) Osmolarity (mOsmol/L) (calc) Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (≥ 600 mOsmol/L) may cause vein damage. pH kcal/L 250 mg/250 mL 1000 50 259 3.5 (2.5 to 5.5) 170 500 mg/250 mL 2000 50 266 3.5 (2.5 to 5.5) 170 1000 mg/250 mL 4000 50 280 3.5 (2.5 to 5.5) 170 This Viaflex Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 2207 Plastic). Viaflex containers, including Viaflex Plus containers, are made of flexible plastic and are for parenteral use. Viaflex Plus on the container indicates the presence of a drug additive in a drug vehicle. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies. Dobutamine Hydrochloride Structural Formula D-Glucopyranose monohydrate - Dextrose Hydrous Structural Formula

Bahan Aktif

Bahan	Kekuatan
Dobutamine Hydrochloride	-

Indikasi & Penggunaan

INDICATIONS AND USAGE Dobutamine Hydrochloride in 5% Dextrose Injection 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.

Dosis & Cara Pemberian

DOSAGE AND ADMINISTRATION Recommended Dosage Dobutamine Hydrochloride in 5% Dextrose Injection 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 (0.5-1.0 mcg/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 2-20 mcg/kg/min but sometimes slightly outside of this range. On rare occasions, infusion rates up to 40 mcg/kg/min have been required to obtain the desired effect. Rates of infusion in mL/hour for dobutamine hydrochloride concentrations of 1,000, 2,000 and 4,000 mcg/mL are in Table 2. This container system may be inappropriate for the dosage requirements of pediatric patients under 30 kg. Other dosage forms may be more appropriate. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Dobutamine Hydrochloride in 5% Dextrose Injection solutions may exhibit a pink color that, if present, will increase with time. This color change is due to slight oxidation of the drug, but there is no significant loss of potency. 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. Do not add supplementary medications to Dobutamine Hydrochloride in 5% Dextrose Injection. Do not administer Dobutamine Hydrochloride in 5% Dextrose Injection simultaneously with solutions containing sodium bicarbonate or strong alkaline solutions.

Side Effects Overview

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, nonspecific chest pain, palpitations, and shortness of breath. Administration of dobutamine, like other catecholamines, has been associated with decreases in serum potassium concentrations, rarely to hypokalemic values.

Peringatan & Tindakan Pencegahan

WARNINGS Increase in Heart Rate or Blood Pressure Dobutamine Hydrochloride in 5% Dextrose Injection 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. Patients with preexisting hypertension appear to face an increased risk of developing an exaggerated pressor response. In patients who have atrial fibrillation with rapid ventricular response, a digitalis preparation should be used prior to institution of therapy with Dobutamine in D 5 W. Ectopic Activity Dobutamine Hydrochloride in 5% Dextrose Injection may precipitate or exacerbate ventricular ectopic activity, but it rarely has caused ventricular tachycardia. Hypersensitivity Reactions suggestive of hypersensitivity associated with administration of dobutamine including skin rash, fever, eosinophilia, and bronchospasm, have been reported occasionally. Dobutamine Hydrochloride in 5% Dextrose Injection contains sodium bisulfite, 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. Solutions containing dextrose should not be administered through the same administration set as blood, as this may result in pseudoagglutination or hemolysis. The intravenous administration of solutions may cause fluid overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of the injections. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration of the injections. Excess administration of potassium-free solutions may result in significant hypokalemia.

Kontraindikasi

CONTRAINDICATIONS Dobutamine Hydrochloride in 5% Dextrose Injection is contraindicated in patients with idiopathic hypertrophic subaortic stenosis and in patients who have shown previous manifestations of hypersensitivity to dobutamine. Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

Frequently Asked Questions

INDICATIONS AND USAGE Dobutamine Hydrochloride in 5% Dextrose Injection 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 …

DOSAGE AND ADMINISTRATION Recommended Dosage Dobutamine Hydrochloride in 5% Dextrose Injection 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 (0.5-1.0 mcg/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 …

WARNINGS Increase in Heart Rate or Blood Pressure Dobutamine Hydrochloride in 5% Dextrose Injection 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 …

CONTRAINDICATIONS Dobutamine Hydrochloride in 5% Dextrose Injection is contraindicated in patients with idiopathic hypertrophic subaortic stenosis and in patients who have shown previous manifestations of hypersensitivity to dobutamine. Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

Dobutamine Hydrochloride is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

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References & Data Sources

• DailyMed — Dobutamine Hydrochloride drug label (National Library of Medicine)
• openFDA — Dobutamine Hydrochloride label data (U.S. Food & Drug Administration)
• RxNorm — RXCUI 309985 (NLM Normalized Drug Names)
• NDC Directory — Dobutamine Hydrochloride (FDA National Drug Code)

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Sumber data: DailyMed (NLM), openFDA, MFDS