milrinone lactate injection FLEXIBLE PLASTIC CONTAINER ()

milrinone FLEXIBLE PLASTIC CONTAINER NDC 0409-2776-XX Quick Finder

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Resources

INDICATIONS AND USAGE

Milrinone lactate injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. Patients receiving milrinone should be observed closely with...

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DOSAGE AND ADMINISTRATION

Milrinone should be administered with a loading dose followed by a continuous infusion (maintenance dose) according to the following guidelines:

LOADING DOSE

50...

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CONTRAINDICATIONS

Milrinone lactate is contraindicated in patients who are hypersensitive to it.

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WARNINGS

Whether given orally or by continuous or intermittent intravenous infusion, milrinone has not been shown to be safe or effective in the longer (greater than 48 hours) treatment of patients with...

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ADVERSE REACTIONS

Cardiovascular Effects

In patients receiving milrinone in Phase II and III clinical trials, ventricular arrhythmias were reported in 12.1%:...

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OVERDOSAGE

Doses of milrinone may produce hypotension because of its vasodilator effect. If this occurs, administration of milrinone should be reduced or temporarily discontinued until the patient's condition stabilizes. No...

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DESCRIPTION

Milrinone lactate injection is a member of a new class of bipyridine inotropic/vasodilator agents with phosphodiesterase inhibitor activity, distinct from digitalis glycosides or catecholamines. Milrinone lactate...

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CLINICAL PHARMACOLOGY

Milrinone is a positive inotrope and vasodilator, with little chronotropic activity different in structure and mode of action from either the digitalis glycosides or catecholamines.

Milrinone, at...

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HOW SUPPLIED

Milrinone Lactate Injection in 5% Dextrose is supplied as follows:

...

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INSTRUCTIONS FOR USE

To Open

Tear outer wrap at notch and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed....

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In 5% Dextrose Injection

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Rx only

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Report Adverse Event

Pfizer Safety

To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.