CONTRAVE EXTENDED-RELEASE- naltrexone hydrochloride and bupropion hydrochloride tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NALTREXONE HYDROCHLORIDE (UNII: Z6375YW9SF) (NALTREXONE - UNII:5S6W795CQM), BUPROPION HYDROCHLORIDE (UNII: ZG7E5POY8O) (BUPROPION - UNII:01ZG3TPX31)

Available from:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

NALTREXONE HYDROCHLORIDE

Composition:

NALTREXONE HYDROCHLORIDE 8 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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/m 2 or greater (obese) or - 27 kg/m 2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia). Limitations of Use: - The effect of CONTRAVE on cardiovascular morbidity and mortality has not been established. - The safety and effectiveness of CONTRAVE in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established. 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 bupropion-containing products

Product summary:

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

Authorization status:

New Drug Application

Patient Information leaflet

EXTENDED RELEASE
PD-Rx Pharmaceuticals, Inc.
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration
Revised:
11/2021
MEDICATION GUIDE
CONTRAVE ® (CON-trayv)
(naltrexone HCl and bupropion HCl) extended-release tablets
What is the most important information I should know about CONTRAVE?
CONTRAVE can cause serious side effects, including:
•
Suicidal thoughts or actions. One of the ingredients in CONTRAVE is
bupropion. Bupropion has
caused some people to have suicidal thoughts or actions or unusual
changes in behavior, whether or
not they are taking medicines used to treat depression.
Bupropion may increase suicidal thoughts or actions in some children,
teenagers, and young adults
within the first few months of treatment.
If you already have depression or other mental illnesses, taking
bupropion may cause it to get worse,
especially within the first few months of treatment.
Stop taking CONTRAVE and call a healthcare provider right away if you,
or your family member,
have any of the following symptoms, especially if they are new, worse,
or worry you:
•
thoughts about suicide or dying
•
attempts to commit suicide
•
new or worse depression
•
new or worse anxiety
•
feeling very agitated or restless
•
panic attacks
•
new or worse irritability
•
acting aggressive, being angry,
or violent
•
acting on dangerous impulses
•
an extreme increase in activity
and talking (mania)
•
other unusual changes in
behavior or mood
•
trouble sleeping (insomnia)
•
While taking CONTRAVE, you or your family members should:
•
Pay close attention to any changes, especially sudden changes, in
mood, behaviors, thoughts,
or feelings. This is very important when you start taking CONTRAVE or
when your dose
changes.
•
Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare
provider between visits as needed, especially if you have concerns
about symptoms.
CONTRAVE has not been studied in and is not approved for use in
children under the age of 18.
W

Summary of Product characteristics

CONTRAVE EXTENDED-RELEASE- NALTREXONE HYDROCHLORIDE AND BUPROPION
HYDROCHLORIDE TABLET, EXTENDED RELEASE
PD-RX PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CONTRAVE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CONTRAVE.
CONTRAVE (NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE)
EXTENDED-RELEASE
TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2014
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN,
ADOLESCENTS, AND YOUNG
ADULTS TAKING ANTIDEPRESSANTS FOR MAJOR DEPRESSIVE DISORDER AND OTHER
PSYCHIATRIC
DISORDERS. ( 5.1)
MONITOR FOR WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND
BEHAVIORS. ( 5.1)
CONTRAVE HAS NOT BEEN STUDIED IN PEDIATRIC PATIENTS. ( 5.1)
RECENT MAJOR CHANGES
Dosage and Administration ( 2.2, 2.3)
8/2020
Contraindications, Pregnancy (4)
Removed 8/2020
INDICATIONS AND USAGE
CONTRAVE is a combination of naltrexone, an opioid antagonist, and
bupropion, an aminoketone
antidepressant, 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/m
or greater (obese) or
27 kg/m
or greater (overweight) in the presence of at least one weight-related
comorbidity (e.g.,
hypertension, type 2 diabetes mellitus, or dyslipidemia). ( 1)
Limitations of Use:
The effect of CONTRAVE on cardiovascular morbidity and mortality has
not been established. ( 1)
The safety and effectiveness of CONTRAVE in combination with other
products intended for weight loss,
including prescription and over-the-counter drugs, and herbal
preparations, have not been established.
( 1)
DOSAGE AND ADMINISTRATION
CONTRAVE dose escalation schedule ( 2.1):
MORNING DOSE
EVENING DOSE
WEEK 1
1 tablet
None
WEEK 2
1 tablet
1 tablet
WEEK 3
2 tablets
1 tablet
WEEK 4 – ONWARD
2 tablets
2 tablets
DOSAGE FORMS AND STRENGTHS
Exten