"SILVER SPRING, MD â€” The US Food and Drug Administration (FDA) is warning of several treatment-related serious adverse events in association with implantable left ventricular assist devices (LVADs) in heart-failure patients.
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Do NOT add DOPAMINE (dopamine hydrochloride) to any alkaline diluent solution, since the drug is inactivated in alkaline solution.
Patients who have been treated with monoamine oxidase (MAO) inhibitors prior to the administration of DOPAMINE (dopamine hydrochloride) will require substantially reduced dosage. See DRUG INTERACTIONS, below.
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.
Careful monitoring required - Close monitoring of the following indices-urine flow, cardiac output and blood pressure - during DOPAMINE (dopamine hydrochloride) infusion is necessary as in the case of any adrenergic agent.
Avoid hypovolemia - Prior to treatment with DOPAMINE (dopamine hydrochloride) , hypovolemia should be fully corrected, if possible with either whole blood or plasma as indicated. Monitoring of central venous pressure of left ventricular filling pressure may be helpful in detecting and treating hypovolemia.
Hypoxia, Hypercapnia, Acidosis - These conditions which may also reduce the effectiveness and/or increase the incidence of adverse effects of dopamine (dopamine hydrochloride) , must be identified and corrected prior to, or concurrently with administration of dopamine (dopamine hydrochloride) HCl.
Ventricular Arrhythmias - If an increased number of ectopic beats are observed, the dose should be reduced if possible.
Decreased Pulse Pressure - If a disproportionate rise in the diastolic pressure (i.e., a marked decrease in the pulse pressure) is observed in patients receiving DOPAMINE (dopamine hydrochloride) , the infusion rate should be decreased and the patient observed carefully for further evidence of predominant vasoconstrictor activity, unless such an effect is desired.
Hypotension - At lower infusion rates, if hypotension occurs, the infusion rate should be rapidly increased until adequate blood pressure is obtained. If hypotension persists, dopamine (dopamine hydrochloride) HCl should be discontinued and a more potent vasoconstrictor agent such as norepinephrine should be administered.
Extravasation - DOPAMINE (dopamine hydrochloride) should be infused into a large vein whenever possible to prevent the possibility of extravasation into tissue adjacent to the infusion site. Extravasation may cause necrosis and sloughing of surrounding tissue. Large veins of the actecubital fossa are preferred to veins in the dorsum of the hand or ankle. Less suitable infusion sites should be used only if the patient's condition requires immediate attention. The physician should switch to more suitable sites as rapidly as possible. The infusion site should be continuously monitored for free flow.
Occlusive vascular disease - Patients with a history of occlusive vascular disease (for example, atheroscierosis, arterial embolism, and Raynaud's disease, cold injury, diabetic endarteritis, and Buergers disease) should be closely monitored for any changes in color or temperature of the skin in the extremities. If a change in skin color or temperature occurs and is thought to be the result of compromised circulation to the extremities, the benefits of continued DOPAMINE (dopamine hydrochloride) infusion should be weighed against the risk of possible necrosis. This condition may be reversed by either decreasing or discontinuing the rate of infusion.
IMPORTANT - Antidote for Peripheral Ischemia - To prevent sloughing and necrosis in ischemic areas, the area should be infiltrated as soon as possible with 10 to 15 mL of saline solution containing 5 to 10 mg of Regitine® (brand of phentolamine), an adrenergic blocking agent. A syringe with a fine hypodermic needle should be used, and the solution liberally infiltrated throughout the ischemic area. Sympathetic blockade with phentolamine causes immediate and conspicuous local hyperemic changes if the area is infiltrated within 12 hours. Therefore, phentolamine should be given as soon as possible after the extravasation is noted.
Weaning - When discontinuing the infusion, it may be necessary to gradually decrease the dose of dopamine (dopamine hydrochloride) HCl while expanding blood volume with IV fluids, since sudden cessation may result in marked hypotension.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term animal studies have not been performed to evaluate carcinogenic potential of dopamine hydrochloride.
Dopamine hydrochloride at doses approaching maximal solubility shows no clear genotoxic potential in the Ames test. Although there was a reproducible dose-dependent increase in the number of revertant colonies with strains TA100 and TA98, both with and without metabolic activation, the small increase was considered inconclusive evidence of mutagenicity. In the L5178Y TK+/- mouse lymphoma assay, dopamine hydrochloride at the highest concentrations used of 750 mcg/mL without metabolic activation, and 3000 mcg/mL with activation, was toxic and associated with increases in mutant frequencies when compared to untreated and solvent controls; at the lower concentrations no increases over controls were noted.
No clear evidence of clastogenic potential was reported in the in vivo mouse or male rat bone marrow micronucleus test when the animals were treated intravenously with up to 224 mg/kg and 30 mg/kg of dopamine hydrochloride, respectively.
Pregnancy: Pregnancy Category C
Teratogenic Effects: Teratogenicity studies in rats and rabbits at dopamine hydrochloride dosages up to 6 mg/kg/day intravenously during organogenesis produced no detectable teratogenic or embryotoxic effects, although maternal toxicity consisting of mortalities, decrease body weight gain, and pharmacotoxic signs were observed in rats. In a published study, dopamine hydrochloride administered at 10 mg/kg subcutaneously for 30 days, markedly prolonged metestrus and increased mean pituitary and ovary weights in female rats. Similar administration to pregnant rats throughout gestation or for 5 days starting on gestation day 10 or 15 resulted in decreased body weight gains, increased mortalities and slight increases in cataract formation among the offspring. There are no adequate and well-controlled studies in pregnant women, and it is not known if dopamine hydrochloride crosses the placental barrier. Dopamine hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Labor and Delivery: In obstetrics, if vasopressor drugs are used to correct hypotension or are added to a local anesthetic solution the interaction with some oxytocic drugs may cause severe hypertension.
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 DOPAMINE (dopamine hydrochloride) is administered to a nursing mother.
Pediatric Use: Safety and effectiveness in children have not been established. Dopamine (dopamine hydrochloride) HCl has been used in a limited number of pediatric patients, but such use has been inadequate to fully define proper dosage and limitations for use. Peripheral gangrene has been reported in neonates and children.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/4/2010
Additional Dopamine Information
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