Dosing & Uses
Dosage Forms & Strengths
tablet: Schedule IV
extended-release tablet: Schedule IV
Indicated as an adjunct to a reduced-calorie diet and exercise for chronic weight management with initial BMI ≥30 kg/m² (obese) or ≥27 kg/m² (overweight) with 1 weight-related comorbid condition (eg, hypertension, dyslipidemia, type 2 diabetes mellitus)
Tablets: 10 mg PO q12hr, OR
Extended-release tablets: 20 mg PO qDay
- Mild (CrCl >50 mL/min): No dosage adjustment required
- Moderate (CrCl 30-50 mL/min): Use caution
- Severe (CrCl <30 mL/min) or ESRD: Not recommended
- Mild-to-moderate (Child-Pugh score 5-9): No dosage adjustment required
- Severe (Child-Pugh score >9): Use caution
Safety and efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
Upper respiratory tract infection (13.7%)
Urinary tract infection (6.5%)
Back pain (6.3%)
Dry mouth (5.3%)
Musculoskeletal pain (2%)
Prior hypersensitivity reaction
Monitor for serotonin syndrome or NMS-like reactions
Studies suggest possibility of regurgitant valvular heart disease (not likely); monitor if patient has congestive heart failure
Advise patient to take caution when operating hazardous machinery Monitor for worsening of depression, suicidal thoughts or behavior, or any other unusual changes in mood or behavior
Monitor for hypoglycemia with type 2 diabetes mellitus; if hypoglycemia occurs while on therapy; adjust antidiabetic drug regimen
Caution in men with predisposed conditions to priapism (eg sickle cell anemia, multiple myeloma, or leukemia) or anatomical deformation of the penis
Caution with bradycardia or a history of heart block
May cause decrease in white blood cell count and other hematological changes; consider periodic monitoring of CBC
Moderately elevates prolactin levels; obtain prolactin levels if hyperprolactinemia symptoms (eg, gynecomastia) occur
May cause pulmonary hypertension (insufficient data)
May cause confusion, somnolence, fatigue and cognitive impairment; use caution when operating heavy machinery or tasks that require mental alertness
Use in patients with severe hepatic impairment not studied; use caution
Use not recommended in patients with severe renal impairment or end stage renal disease;use caution in moderate renal impairment
Pregnancy & Lactation
Pregnancy Category: X
Lactation: Unknown whether distributed in breast milk; may increase prolactin and result in increased breast milk production
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Exact mechanism of action unknown
Thought to decrease food consumption and promote satiety by selectively activates 5-HT2C receptors on anorexigenic pro-opiomelanocortin neurons located in the hypothalamus
Peak Plasma Time: 1.5-2 hr (delayed by 1 hr when administered with food, but not clinically significant)
Peak Plasma Concentration: Increased ~9% with food
AUC: Increased ~5% with food
Protein Bound: 70%
Distributed into CSF and CNS
Metabolized by liver by multiple pathways (extensive)
Metabolites: lorcaserin sulfamate is the major circulating metabolite (Cmax exceeds lorcaserin by 1- to 5-fold); N-carbamoyl glucuronide lorcaserin is the major urinary metabolite
Principal metabolites exert no pharmacological activity at serotonin receptors
Half-life: 11 hr
Excretion: Urine 92.3% (mostly as metabolites), feces 2.2%
May take with or without food
Discontinue if 5% weight loss not achieved by week 12
Do not exceed recommended dose
- Swallow whole; do not chew, crush, or divide
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