DOPAMINE HCI injection, solution, concentrate

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

DOPAMINE HYDROCHLORIDE (UNII: 7L3E358N9L) (DOPAMINE - UNII:VTD58H1Z2X)

Հասանելի է:

HF Acquisition Co. LLC, DBA Health First

Կառավարման երթուղին:

INTRAVENOUS

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Dopamine HCl is indicated for the correction of hemodynamic imbalances present in the shock syndrome due to myocardial infarction, trauma, endotoxic septicemia, open-heart surgery, renal failure, and chronic cardiac decompensation as in congestive failure. Patients most likely to respond adequately to dopamine HCl are those in whom physiological parameters, such as urine flow, myocardial function, and blood pressure, have not undergone profound deterioration. Multiclinic trials indicate that the shorter the time interval between onset of signs and symptoms and initiation of therapy with blood volume correction and dopamine HCl, the better the prognosis. Where appropriate, blood volume restoration with a suitable plasma expander or whole blood should be accomplished prior to administration of dopamine HCl. Poor Perfusion of Vital Organs – Urine flow appears to be one of the better diagnostic signs by which adequacy of vital organ perfusion can be monitored. Nevertheless, the physician should also observe the patient for signs of reversal of confusion or reversal of comatose condition. Loss of pallor, increase in toe temperature, and/or adequacy of nail bed capillary filling may also be used as indices of adequate dosage. Clinical studies have shown that when dopamine HCl is administered before urine flow has diminished to levels of approximately 0.3 mL/minute, prognosis is more favorable. Nevertheless, in a number of oliguric or anuric patients, administration of dopamine HCl has resulted in an increase in urine flow, which in some cases reached normal levels. Dopamine HCl may also increase urine flow in patients whose output is within normal limits and thus may be of value in reducing the degree of pre-existing fluid accumulation. It should be noted that at doses above those optimal for the individual patient, urine flow may decrease, necessitating reduction of dosage. Low Cardiac Output – Increased cardiac output is related to dopamine's direct inotropic effect on the myocardium. Increased cardiac output at low or moderate doses appears to be related to a favorable prognosis. Increase in cardiac output has been associated with either static or decreased systemic vascular resistance (SVR). Static or decreased SVR associated with low or moderate movements in cardiac output is believed to be a reflection of differential effects on specific vascular beds with increased resistance in peripheral beds (e.g., femoral) and concomitant decreases in mesenteric and renal vascular beds. Redistribution of blood flow parallels these changes so that an increase in cardiac output is accompanied by an increase in mesenteric and renal blood flow. In many instances the renal fraction of the total cardiac output has been found to increase. Increase in cardiac output produced by dopamine is not associated with substantial decreases in systemic vascular resistance as may occur with isoproterenol. Hypotension – Hypotension due to inadequate cardiac output can be managed by administration of low to moderate doses of dopamine HCl which have little effect on SVR. At high therapeutic doses, dopamine's alpha-adrenergic activity becomes more prominent and thus may correct hypotension due to diminished SVR. As in the case of other circulatory decompensation states, prognosis is better in patients whose blood pressure and urine flow have not undergone profound deterioration. Therefore, it is suggested that the physician administer dopamine HCl as soon as a definite trend toward decreased systolic and diastolic pressure becomes evident. Dopamine HCl should not be used in patients with pheochromocytoma. Dopamine HCl should not be administered to patients with uncorrected tachyarrhythmias or ventricular fibrillation.

Ապրանքի ամփոփագիր:

DOPAMINE HCI INJ., USP is supplied in the following dosage forms. NDC 51662-1220-1 DOPAMINE HCI INJ., USP 400mg (40mg/mL) 10mL VIAL NDC 51662-1220-2 DOPAMINE HCI INJ., USP 400mg (40mg/mL) 10mL VIAL, 1 VIAL PER POUCH NDC 51662-1220-3 DOPAMINE HCI INJ., USP 400mg (40mg/mL) 10mL VIAL, 1 VIAL PER POUCH, 25 POUCHES PER CASE HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Avoid contact with alkalies (including sodium bicarbonate), oxidizing agents or iron salts. Do not use the injection if it is darker than slightly yellow or discolored in any other way. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA [Hospira Logo] LAB-1154-1.0 Revised: 03/2018

Լիազորման կարգավիճակը:

New Drug Application

Ապրանքի հատկությունները

DOPAMINE HCI- DOPAMINE HCI INJECTION, SOLUTION, CONCENTRATE
HF ACQUISITION CO. LLC, DBA HEALTH FIRST
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DOPAMINE HCI INJ., USP 400MG (40MG/ML) 10ML VIAL
SPL UNCLASSIFIED
Injection, USP
Fliptop Vial
Pintop Vial
MUST BE DILUTED PRIOR TO ADMINISTRATION
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 of hydrochloric acid. It is freely soluble in water and soluble
in alcohol. Dopamine HCl is sensitive to
alkalies, iron salts, and oxidizing agents. Chemically it is
designated as 4-(2-aminoethyl) pyrocatechol
hydrochloride, and its molecular formula is C8H11NO2 • HCl.
The structural formula is:
and the molecular weight is 189.64.
Dopamine hydrochloride injection is a clear, practically colorless,
sterile, pyrogen-free, aqueous solution of
dopamine HCl for intravenous infusion after dilution. Each milliliter
of the 40 mg/mL preparation contains 40
mg of dopamine hydrochloride (equivalent to 32.31 mg of dopamine
base). Each milliliter of the 80 mg/mL
preparation contains 80 mg of dopamine hydrochloride (equivalent to
64.62 mg of dopamine base). Each
milliliter of both preparations contains the following: Sodium
metabisulfite 9 mg added as an antioxidant; citric
acid, anhydrous 10 mg; and sodium citrate, dihydrate 5 mg added as a
buffer. May contain additional citric
acid and/or sodium citrate for pH adjustment. pH is 3.3 (2.5 to 5.0).
Dopamine must be diluted in an appropriate sterile parenteral solution
before intravenous administration. (
See Dosage and Administration)
CLINICAL PHARMACOLOGY
Dopamine is a natural catecholamine formed by the decarboxylation of
3,4-dihydroxyphenylalanine (DOPA). It
is a precursor to norepinephrine in noradrenergic nerves and is also a
neurotransmitter in certain areas of the
central nervous system, especially in the nigrostriatal tract, and in
a few peripheral sympathetic nerves.
Dopamine produces positive chr