DOPAMINE HYDROCHLORIDE 1.6 mg/mL

DOPAMINE HYDROCHLORIDE · INJECTION, SOLUTION · HF Acquisition Co LLC, DBA HealthFirst

1 Recall on RecordCurrently in Shortage

Plain English

DOPAMINE HYDROCHLORIDE is a injection, solution containing dopamine hydrochloride at 1.6 mg/mL, taken intravenous. Manufactured by HF Acquisition Co LLC, DBA HealthFirst.

Key Facts

Brand Name: DOPAMINE HYDROCHLORIDE
Generic Name: DOPAMINE HYDROCHLORIDE
NDC Code (Product): 51662-1316
Manufacturer: HF Acquisition Co LLC, DBA HealthFirst
Strength: 1.6 mg/mL
Dosage Form: INJECTION, SOLUTION
Route: INTRAVENOUS
Marketing Status
Application #: NDA018826
Marketing Start: 10/19/2018

Recall History

1 Recall on Record

Class II09/29/2014

Baxter Healthcare Corp.

Lack of Assurance of Sterility: A small cut in the solution bag may have been introduced during the manufacturing process, resulting in a leak of the bag into the overpouch.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective51 reports

hypotension50 reports

pneumonia47 reports

platelet count decreased45 reports

pyrexia44 reports

renal impairment41 reports

blood pressure decreased39 reports

cardiac failure36 reports

condition aggravated36 reports

sepsis36 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Dopamine Hydrochloride in Dextrose Injection is indicated to improve hemodynamic status in patients in distributive shock, or shock due to reduced cardiac output. Dopamine HCl in Dextrose Injection is a catecholamine indicated to improve hemodynamic status in patients in shock. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION • Correct hypovolemia, acidosis, and hypoxia prior to use. ( 2.1 ) • Administer in a large vein with an infusion pump preferably in an intensive care setting. ( 2.1 ) • Recommended starting dosage in adults and pediatric patients is 2 to 5 mcg/kg/minute as a continuous intravenous infusion. Titrate in 5 to 10 mcg/kg/minute increments based on hemodynamic response and tolerability, up to not more than 50 mcg/kg/minute. ( 2.2 ) • See the Full Prescribing Information for important preparation instructions and drug incompatibilities. ( 2.3 ) 2.1 Administration Instructions Correct Hypovolemia, Acidosis, and Hypoxia Address hypovolemia, acidosis, and hypoxia before initiating Dopamine HCl in Dextrose Injection. If patient does not respond to therapy, suspect occult hypovolemia. Acidosis may reduce the effectiveness of dopamine [see Warnings and Precautions (5.1) ] . Administration Dopamine HCl in Dextrose Injection is a premixed infusion solution that does not require dilution prior to intravenous administration. Administer Dopamine HCl in Dextrose Injection into a large vein [see Warnings and Precautions (5.1) ] with the use of an infusion pump preferably in…

Contraindications

4 CONTRAINDICATIONS Dopamine is contraindicated in patients with pheochromocytoma. Patients with pheochromocytoma. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS See Table 1 for clinically significant drug interactions with dopamine. Table 1: 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 in Dextrose Injection. Examples: isocarboxazid, phenelzine, tranylcypromine, rasagiline, selegiline, linezolid. Tricyclic Antidepressants Clinical Impact: Concomitant use may potentiate the cardiovascular effects of dopamine (e.g., hypertension). Interventi…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling: • Tissue Ischemia [see Warnings and Precautions (5.1) ] • Cardiac Arrhythmias [see Warnings and Precautions (5.2) ] • Hypotension [see Warnings and Precautions (5.3) ] • Severe Hypersensitivity Reactions [see Warnings and Precautions (5.4) ] The following adverse reactions have been identified during post-approval 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 The most common adverse reaction is localized vasoconstriction due to extravasation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Frequently Asked Questions

What is DOPAMINE HYDROCHLORIDE used for?

DOPAMINE HYDROCHLORIDE contains DOPAMINE HYDROCHLORIDE. It is a injection, solution taken intravenous. Consult your doctor for specific uses.

Is DOPAMINE HYDROCHLORIDE a controlled substance?

DOPAMINE HYDROCHLORIDE is not classified as a controlled substance by the DEA.

What is the generic name for DOPAMINE HYDROCHLORIDE?

The generic name for DOPAMINE HYDROCHLORIDE is DOPAMINE HYDROCHLORIDE. There are 11 other brand versions of DOPAMINE HYDROCHLORIDE.

What is the NDC code for DOPAMINE HYDROCHLORIDE 1.6 mg/mL?

The NDC (National Drug Code) for DOPAMINE HYDROCHLORIDE 1.6 mg/mL is 51662-1316, listed by HF Acquisition Co LLC, DBA HealthFirst.

Product NDC

51662-1316

Package NDC

51662-1316-1

Other Dopamine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)