What are the side effects for Contrave
Contrave if you are overweight
The US Food and Drug Administration has approved Contrave (naltrexone hydrochloride and bupropion hydrochloride) as a treatment option for obesity in addition to a reduced-calorie diet and physical activity.
The drug from Takeda Pharmaceuticals America Inc. has been approved for use in adults with a body mass index (BMI) of 30 or higher (obesity) or adults with a BMI of 27 or more (overweight) who have at least one weight-related Have a condition such as high blood pressure (hypertension), type 2 diabetes or high cholesterol (dyslipidemia).
Contrave anti-obesity is a combination of two FDA-approved drugs, naltrexone and bupropion, in an extended-release formula.
The effectiveness of Contrave has been evaluated in several clinical studies with approximately 4,500 obese and overweight patients treated for one year. All patients made lifestyle changes to a reduced calorie diet and regular physical activity.
Results from a clinical trial in non-diabetic patients showed that patients experienced an average weight loss of 4.1 percent from placebo treatment in one year. In this study, 42 percent of Contrave-treated patients lost 5 percent or more of their body weight, compared with 17 percent who received placebo.
Results from other clinical studies in patients with type 2 diabetes showed that patients experienced an average weight loss of 2 percent versus placebo treatment after one year. In this study, 36 percent of patients treated with Contrave lost at least 5 percent of their body weight, compared with 18 percent of patients treated with placebo.
Patients treated with Contrave should be evaluated after 12 weeks for treatment effectiveness. If a patient has not lost at least 5 percent of their original weight, Contrave should be discontinued as the patient is unlikely to experience clinically significant weight loss during the course of treatment.
Because it contains bupropion, Contrave has a boxed warning for health care professionals and patients warning of the increased risk of suicidal ideation and antidepressant-related behaviors. The warning also implies that serious neuropsychiatric events have been observed in patients taking bupropion for smoking cessation.
Contrave can induce seizures and should not be used on patients with seizures. The risk of convulsions is dose-dependent. Contrave should be discontinued and not restarted in patients who had a seizure while being treated with Contrave.
Contrave can also increase blood pressure and heart rate and must not be used in patients with uncontrolled high blood pressure. The clinical significance of the increases in blood pressure and heart rate seen with Contrave treatment is unclear, especially for patients with cardiac and cerebrovascular disease, as those with a history of heart attack or stroke in the past six months life-threatening arrhythmias or heart failure were excluded from the clinical trials. Blood pressure and pulse should be checked before starting treatment and at regular intervals during treatment, especially in patients with high blood pressure.
- Other products containing bupropion should not be taken with Contrave.
- The drug should not be used in patients with eating disorders (bulimia or anorexia nervosa).
- Contrave should also not be used by patients taking opioids or drugs used to treat opioid addiction, or who are experiencing acute opiate withdrawal.
- Patients who suddenly stop alcohol, benzodiazepines, barbiturates, or anti-epileptic drugs should not take Contrave.
- Women who are pregnant or trying to become pregnant should not take the drug.
The most common adverse reactions reported with treatment with Contrave were:
- A headache,
- dry mouth and
Post Marketing Requirements
The FDA has the following post-marketing requirements:
- a cardiovascular outcome study that assessed cardiovascular risk;
- two efficacy, safety and clinical pharmacological studies in pediatric patients (one in patients 12 to 17 years old and one in patients 7 to 11 years old);
- a non-clinical (animal) juvenile toxicity study with a special focus on growth and development, behavior, learning and memory;
- a study to evaluate the effect on the cardiac conduction system;
- clinical trials to evaluate dosage in patients with hepatic or renal insufficiency;
- a clinical study to evaluate the potential for interactions between Contrave and other drugs.
© arznei-news.de - Source: Food and Drug Administration (FDA), September 2014
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This information is NOT intended to be a recommendation for any particular drug. Even if these reports, studies, experiences can be helpful, they are no substitute for the experience and expertise of doctors.
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