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dopamine hydrochloride injection, USP VIAL

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dopamine hydrochloride injection, USP VIAL Quick Finder

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HIGHLIGHTS OF PRESCRIBING INFORMATION

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1 INDICATIONS AND USAGE

Dopamine HCl Injection is indicated to improve hemodynamic status in patients in distributive shock or shock due to reduced cardiac output.

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2 DOSAGE AND ADMINISTRATION

2.1 Preparation and Administration Instructions

Correct Hypovolemia, Acidosis, and Hypoxia

Address...

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3 DOSAGE FORMS AND STRENGTHS

The following strengths of Dopamine HCL, USP, are supplied in single-dose vials (the solution is clear practically colorless):

•
200 mg/5 mL (40 mg/mL)
•
400...
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4 CONTRAINDICATIONS

Dopamine is contraindicated in patients with pheochromocytoma.

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5 WARNINGS AND PRECAUTIONS

5.1 Tissue Ischemia

Administration of dopamine to patients who are hypotensive from hypovolemia can result in severe peripheral and...

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6 ADVERSE REACTIONS

The following adverse reactions are described elsewhere in the labeling:

•
Tissue Ischemia [see Warnings and...
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7 DRUG INTERACTIONS

 
See Table 1 for clinically significant drug interactions with dopamine.
...
Table 1: Clinically Significant Drug Interactions with Dopamine
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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There are no human data with dopamine use in pregnant women. There are...

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10 OVERDOSAGE

Manifestations of overdosage include excessive blood pressure elevation.

In the case of accidental overdosage, reduce rate of Dopamine HCl Injection administration or temporarily discontinue the dopamine...

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11 DESCRIPTION

Dopamine, a sympathomimetic amine vasopressor, is the naturally occurring immediate precursor of norepinephrine. Dopamine hydrochloride is a white to off-white crystalline powder, which may have a slight odor...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Dopamine is a natural catecholamine formed by the decarboxylation of 3,4 dihydroxyphenylalanine (DOPA). It is a...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Long term animal studies...

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16 HOW SUPPLIED/STORAGE AND HANDLING

Dopamine Hydrochloride Injection, USP is a clear, practically colorless solution supplied as follows:

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17 PATIENT COUNSELING INFORMATION

Risk of Tissue Damage

Advise the patient, family, or caregiver to report signs of extravasation urgently [see...

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