CLEVIPREX Emulsion for infusion (2021)
Βιβλιογραφική αναφορά
Συγγραφείς
Chiesi USA, Inc.
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
1. Indications and Usage
Cleviprex is indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable.
2. Dosage and Administration
2.1 Monitoring Monitor blood pressure and heart rate continually during infusion, and then until vital signs are stable. Patients who receive prolonged Cleviprex infusions and are not transitioned to other ...
3. Dosage Forms and Strengths
Cleviprex is a sterile, milky white injectable emulsion for intravenous use, available in the following configurations: 50 mL single use vial with 0.5 mg/mL clevidipine 100 mL single use vial with 0.5 ...
4. Contraindications
4.1 Known Allergy Cleviprex is contraindicated in patients with allergies to soybeans, soy products, eggs, or egg products. 4.2 Defective Lipid Metabolism Cleviprex is contraindicated in patients with ...
5. Warnings and Precautions
5.1 Need for Aseptic Technique Use aseptic technique and discard any unused product within 12 hours of stopper puncture <em>[see Dosage and Administration (2.3)]</em>. 5.2 Hypotension and Reflex Tachycardia ...
6. Adverse Reactions
The following risk is discussed elsewhere in the labeling: Hypotension and Reflex Tachycardia <em>[see Warnings and Precautions (5.2)]</em>
6.1. Clinical Trials Experience
Cleviprex clinical development included 19 studies, with 99 healthy subjects and 1307 hypertensive patients who received at least one dose of clevidipine (1406 total exposures). Clevidipine was evaluated ...
6.2. Postmarketing Experience
Post-Marketing and Other Clinical Experience Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or to ...
8.1. Pregnancy
Risk Summary The available data based on post-marketing reports with Cleviprex use in pregnant women are not sufficient to inform a drug-associated risk for major birth defects, miscarriage, or adverse ...
8.2. Lactation
Risk Summary There are no data on the presence of clevidipine in human milk, the effects on the breastfed infant, or the effects on milk production.
8.4. Pediatric Use
The safety and effectiveness of Cleviprex in children under 18 years of age have not been established.
8.5. Geriatric Use
Of the 1406 subjects (1307 with hypertension) treated with Cleviprex in clinical studies, 620 were ≥65 years of age and 232 were ≥75 years of age. No overall differences in safety or effectiveness were ...
10. Overdosage
There has been no experience of overdosage in human clinical trials. In clinical trials, doses of Cleviprex up to 106 mg/hour or 1153 mg maximum total dose were administered. The expected major effects ...
11. Description
Cleviprex is a sterile, milky-white emulsion containing 0.5 mg/mL of clevidipine suitable for intravenous administration. Clevidipine is a dihydropyridine calcium channel blocker. Chemically, the active ...
12.1. Mechanism of Action
Clevidipine is a dihydropyridine L-type calcium channel blocker. L-type calcium channels mediate the influx of calcium during depolarization in arterial smooth muscle. Experiments in anesthetized rats ...
12.2. Pharmacodynamics
Cleviprex is titrated to the desired reduction in blood pressure. The effect of Cleviprex appears to plateau at approximately 25% of baseline systolic pressure. The infusion rate for which half the maximal ...
12.3. Pharmacokinetics
Clevidipine is rapidly distributed and metabolized resulting in a very short half life. The arterial blood concentration of clevidipine declines in a multi-phasic pattern following termination of the infusion. ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Clevidipine displayed positive genotoxic potential <em>in vitro</em> in the Ames test, mouse lymphoma thymidine kinase locus assay, and chromosomal aberration assay, but not <em>in vivo</em> in the mouse ...
14. Clinical Studies
14.1 Perioperative Hypertension Cleviprex was evaluated in two double-blind, randomized, parallel, placebo-controlled, multicenter trials of cardiac surgery patients—pre-operative use in ESCAPE-1 (n=105) ...
16.1. How Supplied
Cleviprex (clevidipine) injectable emulsion is supplied as a sterile, milky white liquid emulsion product in single-use glass vials at a concentration of 0.5 mg/mL of clevidipine. NDC 10122-610-10: 10 ...
16.2. Storage and Handling
Storage Leave vials in cartons until use. Clevidipine is photosensitive and storage in cartons protects against photodegradation. Protection from light during administration is not required. Store vials ...
17. Patient Counseling Information
Advise patients with underlying hypertension that they require continued follow up for their medical condition, and, if applicable, encourage patients to continue taking their oral antihypertensive medication(s) ...