CORLOPAM Solution for injection (2020)
Βιβλιογραφική αναφορά
Συγγραφείς
Hospira, Inc.
Λέξεις κλειδιά
0409-2304 0409-3373
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1. Indications and Usage
Adult Patients Fenoldopam is indicated for in-hospital, short-term (up to 48 hours) management of severe hypertension when rapid, but quickly reversible, emergency reduction of blood pressure is clinically ...
2. Dosage and Administration
2.1 Recommended Dosage Adult Patients Initiate dosing at 0.01 to 0.3 mcg/kg/min as a continuous intravenous infusion. Dosing may be increased in increments of 0.05 to 0.1 mcg/kg/minute every 15 minutes ...
3. Dosage Forms and Strengths
10 mg/mL solution in single-dose vial 10 mg/mL solution in single-dose ampule
4. Contraindications
None.
5. Warnings and Precautions
5.1 Tachycardia Fenoldopam causes a dose-related tachycardia, particularly with infusion rates above 0.1 mcg/kg/min in adults and >0.8 mcg/kg/min in pediatric patients. Tachycardia in adults may diminish ...
6.1. Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...
6.2. Postmarketing Experience
The following adverse reactions have been identified during post approval use of CORLOPAM. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...
7. Drug Interactions
7.1 Beta-Blockers Avoid concomitant use of fenoldopam with beta-blockers. If the drugs are used together, blood pressure should be monitored frequently because hypotension could result from beta-blocker ...
8.1. Pregnancy
Risk Summary There are insufficient data regarding CORLOPAM use in pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal ...
8.2. Lactation
Risk Summary There are no data on the presence of fenoldopam in human milk, the effects on the breastfed child, or the effects on milk production. Fenoldopam is present in rat milk. When a drug is present ...
8.4. Pediatric Use
Safety and effectiveness of fenoldopam have been established in the age groups age <1 month (at least 2 kg or full term) to 12 years old requiring blood pressure reduction <em>[see Clinical Pharmacology ...
8.5. Geriatric Use
Clinical studies of fenoldopam did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has ...
10. Overdosage
The most likely reaction in a fenoldopam overdose would be excessive hypotension which should be treated with drug discontinuation and appropriate supportive measures.
11. Description
CORLOPAM (Fenoldopam Mesylate Injection, USP) is a dopamine D<sub>1</sub>-like receptor agonist. The product is formulated as a solution to be diluted for intravenous infusion. Chemically it is 6-chloro-2,3,4,5-tetrahydro-1-(4-hydroxyphenyl)-[1 ...
12.1. Mechanism of Action
Fenoldopam is a rapid-acting vasodilator. It is an agonist for D<sub>1</sub>-like dopamine receptors and binds with moderate affinity to α<sub>2</sub>-adrenoceptors. It has no significant affinity for ...
12.2. Pharmacodynamics
Mild to Moderate Hypertension In a randomized double-blind, placebo-controlled, 5-group study in 32 patients with mild to moderate essential hypertension (diastolic blood pressure between 95 and 119 mm ...
12.3. Pharmacokinetics
Adult Patients Fenoldopam, administered as a constant infusion at dosages of 0.01 to 1.6 mcg/kg/min, produced steady-state plasma concentrations that were proportional to infusion rates. The elimination ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
In a 24-month study, mice treated orally with fenoldopam at 12.5, 25, or 50 mg/kg/day, reduced to 25 mg/kg/day on day 209 of study, showed no increase above controls in the incidence of neoplasms. Female ...
13.2. Animal Toxicology and/or Pharmacology
Unusual toxicologic findings (arterial lesions in the rat) with fenoldopam are summarized below. These findings have not been observed in mice or dogs. No evidence of a similar lesion in humans has been ...
16.1. How Supplied
Unit of Sale Concentration <b>NDC 0409-3373-01</b> 1 Single-dose vial in a carton 10 mg/mL <b>NDC 0409-3373-02</b> 1 Single-dose vial in a carton 20 mg/2 mL (10 mg/mL) <b>NDC 0409-2304-01</b> ...
16.2. Storage and Handling
Store at 2 to 30°C (35.6 to 86°F).
17. Patient Counseling Information
This products labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA