CONTRAVE Extended-release tablet (2022)

Βιβλιογραφική αναφορά

Συγγραφείς

Nalpropion Pharmaceuticals LLC

Λέξεις κλειδιά

51267-890

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

BOXED WARNING SECTION

SUICIDALITY AND ANTIDEPRESSANT DRUGS CONTRAVE is not approved for use in the treatment of major depressive disorder or other psychiatric disorders. CONTRAVE contains bupropion, the same ...

1. Indications and Usage

CONTRAVE is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of: 30 kg/m² or greater (obese) ...

2. Dosage and Administration

2.1 Recommended Dosing CONTRAVE dosing should be escalated according to the following schedule:   Morning Dose Evening Dose Week 1 1 tablet None Week 2 1 tablet 1 tablet Week 3 2 tablets ...

3. Dosage Forms and Strengths

CONTRAVE extended-release tablets: 8 mg/90 mg are blue, round, bi-convex, film-coated, and debossed with NB-890 on one side.

4. Contraindications

CONTRAVE is contraindicated in Uncontrolled hypertension [see Warnings and Precautions (5.5)]. Seizure disorder or a history of seizures [see Warnings and Precautions (5.3)]. Use of other ...

5. Warnings and Precautions

5.1 Suicidal Behavior and Ideation CONTRAVE contains bupropion, a dopamine and norepinephrine re-uptake inhibitor that is similar to some drugs used for the treatment of depression; therefore, the following ...

6. Adverse Reactions

The following adverse reactions are discussed in other sections of the labeling: Suicidal Behavior and Ideation [see Boxed Warning, Warnings and Precautions (5.1)] Neuropsychiatric Adverse Events ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post approval use of CONTRAVE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

7. Drug Interactions

7.1 Monoamine Oxidase Inhibitors (MAOI) Concomitant use of MAOIs and bupropion is contraindicated. Bupropion inhibits the re-uptake of dopamine and norepinephrine and can increase the risk for hypertensive ...

8.1. Pregnancy

Risk Summary Weight loss offers no benefit to a pregnant patient and may cause fetal harm. When a pregnancy is recognized, advise the pregnant patient of the risk to the fetus, and discontinue CONTRAVE ...

8.2. Lactation

Risk Summary Data from published literature report the presence of bupropion and its metabolites in human milk. Limited data from postmarketing reports with bupropion use during lactation have not identified ...

8.4. Pediatric Use

The safety and effectiveness of CONTRAVE in pediatric patients below the age of 18 have not been established and the use of CONTRAVE is not recommended in pediatric patients.

8.5. Geriatric Use

Of the 3,239 subjects who participated in clinical trials with CONTRAVE, 62 (2%) were 65 years and older and none were 75 years and older. Clinical studies of CONTRAVE did not include sufficient numbers ...

8.6. Renal Impairment

In a pharmacokinetic study conducted for CONTRAVE in subjects with renal impairment (mild, moderate and severe), exposure to naltrexone metabolite, 6-beta naltrexol, and bupropion metabolites, threohydrobupropion, ...

8.7. Hepatic Impairment

In a pharmacokinetic study conducted for CONTRAVE in subjects with hepatic impairment (mild, moderate, and severe), exposure to naltrexone, bupropion, and their metabolites were increased. Therefore, the ...

9.2. Abuse

Humans CONTRAVE has not been systematically studied in humans for its potential for abuse, tolerance, or physical dependence. However, in outpatient clinical studies of up to 56 weeks in duration, there ...

10. Overdosage

Animal Experience In the mouse, rat, and guinea pig, the oral LD50s for naltrexone were 1,100 to 1,550 mg/kg; 1,450 mg/kg; and 1,490 mg/kg; respectively. High doses of naltrexone (generally ...

11. Description

CONTRAVE extended-release tablets contain naltrexone hydrochloride (HCl) and bupropion HCl. Naltrexone HCl, USP, an opioid antagonist, is a synthetic congener of oxymorphone with no opioid agonist properties. ...

12.1. Mechanism of Action

CONTRAVE has two components: naltrexone, an opioid antagonist, and bupropion, a relatively weak inhibitor of the neuronal reuptake of dopamine and norepinephrine. Nonclinical studies suggest that ...

12.2. Pharmacodynamics

Combined, bupropion and naltrexone increased the firing rate of hypothalamic pro-opiomelanocortin (POMC) neurons in vitro, which are associated with regulation of appetite. The combination of ...

12.3. Pharmacokinetics

Absorption Naltrexone Following single oral administration of CONTRAVE (two 8 mg naltrexone/90 mg bupropion tablets) to healthy subjects, mean peak naltrexone concentration (Cmax) was 1.4 ng/mL, ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies to evaluate carcinogenesis, mutagenesis, or impairment of fertility with the combined products in CONTRAVE have not been conducted. The following findings are from studies performed individually ...

14. Clinical Studies

The effects of CONTRAVE on weight loss in conjunction with reduced caloric intake and increased physical activity was studied in double-blind, placebo-controlled trials (BMI range 27 to 45 kg/m²) with ...

16.1. How Supplied

CONTRAVE 8 mg/90 mg (naltrexone HCl 8 mg and bupropion HCl 90 mg) extended-release tablets are blue, round, bi-convex, film-coated tablets debossed with NB-890 on one side. CONTRAVE tablets are available ...

16.2. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide) Patient information is printed at the end of this insert. This information and the instructions provided in the Medication ...