Applies to the following strengths: 10 mg; 20 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Weight Loss
10 mg orally twice per day
Comments: Response to therapy should be evaluated by week 12. If a patient has not lost at least 5% of baseline body weight, discontinue this drug as it is unlikely the patient will achieve and sustain clinically meaningful weight loss with continued treatment.
Use: Adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) OR 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity such as hypertension, type 2 diabetes mellitus, or dyslipidemia.
Renal Dose Adjustments
-Mild renal impairment (CrCl 50 to 80 mL/min): No adjustment recommended.
-Moderate renal impairment (CrCl 30 to 50 mL/min): Use with caution.
-Severe renal impairment (CrCl less than 30 mL/min) or end stage renal disease: Not recommended.
Liver Dose Adjustments
-Mild liver impairment (Child-Pugh 5 to 6): No adjustment recommended.
-Moderate liver impairment (Child-Pugh 7 to 9): No adjustment recommended.
-Severe liver impairment (Child-Pugh greater than 9): Not recommended.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
US Controlled Substance: Schedule IV
-Hemodialysis: This drug is not eliminated to a therapeutically significant degree by hemodialysis; no dose adjustment guidelines have been reported.
-Peritoneal Dialysis: Data not available.
-Do not exceed recommended dose.
-Take with or without food.
-The effect of this drug on cardiovascular morbidity and mortality has not been established.
-The safety and effectiveness of this drug in combination with other weight loss products, including prescription and over-the-counter drugs and herbal preparations, have not been established.
-This drug's ability to produce hallucinations, euphoria, and positive subjective responses at supratherapeutic doses suggest this drug may produce psychic dependence. There are no controlled data in animal or human studies that evaluate dependence.
Endocrine: Blood glucose levels (prior to and during treatment in type 2 diabetic patients), prolactin (when prolactin excess is suspected)
Hematologic: CBC (periodically during treatment)
Nervous: Serotonin syndrome/Neuroleptic Malignant Syndrome-like signs and symptoms
Psychiatric: Depression, suicidal thoughts or behavior, unusual changes in mood or behavior
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