PRECEDEX Solution for injection (2020)
Βιβλιογραφική αναφορά
Συγγραφείς
Hospira, Inc.
Λέξεις κλειδιά
0409-1434 0409-1638 0409-1660
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
1.1 Intensive Care Unit Sedation Precedex is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Precedex should be administered ...
2. Dosage and Administration
2.1 Dosing Guidelines Precedex dosing should be individualized and titrated to desired clinical response. Precedex is not indicated for infusions lasting longer than 24 hours. Precedex should be administered ...
3. Dosage Forms and Strengths
Precedex Injection is clear and colorless and is available as follows. Precedex Injection Precedex Injection, 200 mcg dexmedetomidine/2 mL (100 mcg/mL) in a glass vial. To be used after dilution. Precedex ...
4. Contraindications
None.
5. Warnings and Precautions
5.1 Drug Administration Precedex should be administered only by persons skilled in the management of patients in the intensive care or operating room setting. Due to the known pharmacological effects of ...
6. Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the labeling: Hypotension, bradycardia and sinus arrest <em>[see Warnings and Precautions (5.2)]</em> Transient hypertension ...
6.1. Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reactions 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 Precedex. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...
7. Drug Interactions
7.1 Anesthetics, Sedatives, Hypnotics, Opioids Co-administration of Precedex with anesthetics, sedatives, hypnotics, and opioids is likely to lead to an enhancement of effects. Specific studies have confirmed ...
8.1. Pregnancy
Pregnancy Category C. There are no adequate and well-controlled studies of Precedex use in pregnant women. In an <em>in vitro</em> human placenta study, placental transfer of dexmedetomidine occurred. ...
8.2. Labor and Delivery
The safety of Precedex during labor and delivery has not been studied.
8.3. Nursing Mothers
It is not known whether Precedex is excreted in human milk. Radio-labeled dexmedetomidine administered subcutaneously to lactating female rats was excreted in milk. Because many drugs are excreted in human ...
8.4. Pediatric Use
Safety and efficacy have not been established for Procedural or ICU Sedation in pediatric patients. One assessor-blinded trial in pediatric patients and two open label studies in neonates were conducted ...
8.5. Geriatric Use
Intensive Care Unit Sedation A total of 729 patients in the clinical studies were 65 years of age and over. A total of 200 patients were 75 years of age and over. In patients greater than 65 years of age, ...
8.6. Hepatic Impairment
Since Precedex clearance decreases with increasing severity of hepatic impairment, dose reduction should be considered in patients with impaired hepatic function <em>[see Dosage and Administration (2.2, ...
9.1. Controlled Substance
Precedex (dexmedetomidine hydrochloride) is not a controlled substance.
9.3. Dependence
The dependence potential of Precedex has not been studied in humans. However, since studies in rodents and primates have demonstrated that Precedex exhibits pharmacologic actions similar to those of clonidine, ...
10. Overdosage
The tolerability of Precedex was studied in one study in which healthy adult subjects were administered doses at and above the recommended dose of 0.2 to 0.7 mcg/kg/hr. The maximum blood concentration ...
11. Description
Precedex (dexmedetomidine hydrochloride) injection is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Precedex (dexmedetomidine hydrochloride) in 0.9% Sodium Chloride ...
12.1. Mechanism of Action
Precedex is a relatively selective alpha<sub>2</sub>-adrenergic agonist with sedative properties. Alpha<sub>2</sub> selectivity is observed in animals following slow intravenous infusion of low and medium ...
12.2. Pharmacodynamics
In a study in healthy volunteers (N=10), respiratory rate and oxygen saturation remained within normal limits and there was no evidence of respiratory depression when Precedex was administered by intravenous ...
12.3. Pharmacokinetics
Following intravenous administration, dexmedetomidine exhibits the following pharmacokinetic parameters: a rapid distribution phase with a distribution half-life (t<sub>1/2</sub>) of approximately 6 minutes; ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis Animal carcinogenicity studies have not been performed with dexmedetomidine. Mutagenesis Dexmedetomidine was not mutagenic <em>in vitro</em>, in either the bacterial reverse mutation assay ...
13.2. Animal Toxicology and/or Pharmacology
There were no differences in the adrenocorticotropic hormone (ACTH)-stimulated cortisol response in dogs following a single dose of dexmedetomidine compared to saline control. However, after continuous ...
14. Clinical Studies
The safety and efficacy of Precedex has been evaluated in four randomized, double-blind, placebo-controlled multicenter clinical trials in 1,185 adult patients. 14.1 Intensive Care Unit Sedation Two randomized, ...
16.1. How Supplied
Precedex Injection Precedex (dexmedetomidine hydrochloride) injection 200 mcg/2 mL (100 mcg/mL) is clear and colorless, and available in 2 mL clear glass vials. The strength is based on the dexmedetomidine ...
16.2. Storage and Handling
Store at USP controlled room temperature, 20 to 25°C (68 to 77°F) with excursions allowed from 15 to 30°C (59 to 86°F).
17. Patient Counseling Information
Precedex is indicated for short-term intravenous sedation. Dosage must be individualized and titrated to the desired clinical effect. Blood pressure, heart rate and oxygen levels will be monitored both ...