DOPamine Hydrochloride (Page 2 of 4)
5.4 Severe Hypersensitivity Reactions due to Sodium Metabisulfite Excipient
Dopamine HCl Injection 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.
6 ADVERSE REACTIONS
The following adverse reactions are described elsewhere in the labeling:
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- Tissue Ischemia [see Warnings and Precautions (5.1)]
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- Cardiac Arrhythmias [see Warnings and Precautions (5.2)]
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- Hypotension [see Warnings and Precautions (5.3)]
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- Severe Hypersensitivity Reactions [see Warnings and Precautions (5.4)]
The following adverse reactions have been identified during postapproval use of dopamine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiac Disorders: anginal pain, palpitation
Gastrointestinal Disorders: nausea, vomiting
Metabolism and Nutrition Disorders: azotemia
Nervous System Disorders: headache, anxiety
Respiratory Disorders: dyspnea
Skin and Subcutaneous Tissue Disorders: piloerection
Vascular Disorders: hypertension
7 DRUG INTERACTIONS
- See Table 1 for clinically significant drug interactions with dopamine.
Halogenated Anesthetics | |
Clinical Impact: | Concomitant use may increase cardiac autonomic irritability and can sensitize the myocardium to the action of dopamine which may lead to ventricular arrhythmias and hypertension. |
Intervention: | Monitor cardiac rhythm. |
Examples: | desflurane, enflurane, isoflurane, and sevoflurane. |
MAO Inhibitors | |
Clinical Impact: | Because dopamine is metabolized by monoamine oxidase (MAO), inhibition of this enzyme prolongs and potentiates the effect of dopamine which may result in severe hypertension and cardiac arrhythmia. |
Intervention: | Reduce the recommended starting dosage to no greater than one‑tenth (1/10) of the recommended dose in patients who have been treated with MAO inhibitors within two to three weeks prior to the administration of Dopamine HCl Injection. |
Examples: | isocarboxazid, phenelzine, tranylcypromine, rasagiline, selegiline, linezolid. |
Tricyclic Antidepressants | |
Clinical Impact: | Concomitant use may potentiate the cardiovascular effects of dopamine (e.g., hypertension). |
Intervention: | Monitor blood pressure. |
Examples: | amitriptyline, desipramine, doxepin, imipramine, nortriptyline. |
| |
Clinical Impact: | Concomitant use may result in severe hypertension. |
Intervention: | Monitor blood pressure. |
Examples: | norepinephrine, epinephrine, oxytocin. |
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
There are no human data with dopamine use in pregnant women. There are risks to the mother and fetus from hypotension associated with shock, which can be fatal if left untreated (see Clinical Considerations). In animal reproduction studies, adverse developmental outcomes were observed with intravenous dopamine HCl administration in pregnant rats during organogenesis at doses, on a mcg/m2 basis, of one‑third the human starting dose of 2 mcg/kg/minute (90 mcg/m2 /minute).
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies carry some risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2‑4% and 15‑20%, respectively.
Disease-Associated Maternal and/or Embryo/Fetal risk
Hypotension associated with distributive shock, or shock due to reduced cardiac output are medical emergencies in pregnancy which can be fatal if left untreated. Delaying treatment in pregnant women with hypotension associated with distributive shock, or shock due to reduced cardiac output may increase the risk of maternal and fetal morbidity and mortality. Life-sustaining therapy for the pregnant woman should not be withheld due to potential concerns regarding the effects of dopamine on the fetus.
Labor or Delivery
Vasopressor drugs, including dopamine, may cause severe maternal hypertension when used concomitantly with some oxytocic drugs [see Drug Interactions (7)].
Data
Animal Data
Animal reproduction studies in rats and rabbits at dopamine HCl dosages up to 6 mg/kg/day intravenously (on a mcg/m2 basis, one third and two thirds, respectively, the human starting dosage of 2 mcg/kg/minute) during organogenesis produced no detectable teratogenic or embryotoxic effects, although maternal toxicity consisting of mortalities, decreased body weight gain, and pharmacotoxic signs were observed in rats. In a published study, administration of 10 mg/kg/day dopamine HCl (on a mcg/m2 basis, two-thirds the human starting dosage of 2 mcg/kg/minute) to pregnant rats throughout gestation or for 5 days starting on gestation day 10 or 15 resulted in decreased body weight gain, increased mortality, and slight increase in cataract formation among the offspring.
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