CONTRAVE- naltrexone hydrochloride and bupropion hydrochloride tablet, film coated, 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:

Takeda Pharmaceuticals America, 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: Limitations of Use: Pregnancy Category X Risk Summary CONTRAVE is contraindicated during pregnancy, because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard of maternal weight loss to the fetus. Clinical Considerations A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese, due to the obligatory weight gain that occurs in maternal tissues during pregnancy. Human Data There are no adequate and well-controlled studies of CONTRAVE in pregnant women. In clinical studies, 21 (0.7%) of 3,024 women became pregnant while taking CONTRAVE: 11 carried to term and gave b

Product summary:

CONTRAVE 8 mg/90 mg (naltrexone HCl 8 mg and bupropion HCl 90 mg) extended-release, tri-layer tablets are blue, round, bi-convex, film-coated tablets debossed with “NB-890” on one side. CONTRAVE tablets are available as follows: NDC 64764-890-99 Bottles of 120 tablets 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

CONTRAVE- NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE TABLET,
FILM COATED, EXTENDED
RELEASE
Takeda Pharmaceuticals America, Inc.
----------
Medication Guide
CONTRAVE® (CON-trayv)
(naltrexone HCl and bupropion HCl)
Extended-Release Tablets
Read this Medication Guide before you start taking CONTRAVE and each
time you get a refill. There
may be new information. This information does not take the place of
talking with your healthcare
provider about your medical problems or treatment.
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
•
new or worse irritability
•
attempts to commit suicide
•
acting aggressive, being angry, or violent
•
new or worse depression
•
acting on dangerous impulses
•
new or worse anxiety
•
an extreme increase in activity and talking
(mania)
•
feeling very agitated or restless
•
panic attacks
•
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 yo

Summary of Product characteristics

CONTRAVE- NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE TABLET,
FILM COATED,
EXTENDED RELEASE
TAKEDA PHARMACEUTICALS AMERICA, 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 HCL AND BUPROPION HCL)
EXTENDED-RELEASE TABLETS
INITIAL U.S. APPROVAL: 2014
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS; AND NEUROPSYCHIATRIC
REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
•
•
•
•
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:
•
•
Limitations of Use:
•
•
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
Extended-Release Tablets: 8 mg naltrexone HCl /90 mg bupropion HCl (3)
CONTRAINDICATIONS
•
•
•
•
•
•
•
WARNINGS AND PRECAUTIONS
•
®
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)
SERIOUS NEUROPSYCHIATRIC EVENTS HAVE BEEN REPORTED IN PATIENTS TAKING
BUPROPION FOR SMOKING
CESSATION. (5.2)
CONTRAVE HAS NOT BEEN STUDIED IN PEDIATRIC PATIENTS. (5.1)
30 kg/m or greater (obese) or
2
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)
2
The effect of CONTRAVE on cardiovascular morbidity and mortality has
not been established. (1)
The safety and effectiveness of CONTRA