openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings
WARNINGS Do not add any alkalinizing substance since dopamine is inactivated in alkaline solution. Patients who have been treated with monoamine oxidase (MAO) inhibitors prior to the administration of dopamine will require substantially reduced dosage. See Drug Interactions below. This product contains sodium metabisulfite, 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. Evidence is inadequate for fully defining proper dosage and limitation for use in children. (See PRECAUTIONS ) Solutions containing dextrose without electrolytes should not be administered simultaneously with blood through the same infusion set because of the possibility of agglomeration of erythrocytes. The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. Excess administration of potassium-free solutions may result in significant hypokalemia. Because dosages of this drug are titrated to response (see DOSAGE AND ADMINISTRATION ), no additives should be mixed with Dopamine Hydrochloride in 5% Dextrose Injection USP.
ADVERSE REACTIONS The following adverse reactions have been observed, but there are not enough data to support an estimate of their frequency. Cardiovascular System - Ventricular arrhythmia (at very high doses), ectopic beats, tachycardia, anginal pain, palpitation, cardiac conduction abnormalities, widened QRS complex, bradycardia, hypotension hypertension and vasoconstriction. Respiratory System — Dyspnea. Gastrointestinal System — Nausea and vomiting. Metabolic/Nutritional System — Azotemia. Central Nervous System — Headache and anxiety. Dermatological System — Piloerection. Other – Gangrene of the extremities has occurred when high doses were administered for prolonged periods or in patients with occlusive vascular disease receiving low doses of dopamine HCl. Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.