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lorcaserin hydrochloride
Overview
What is BELVIQ XR Extended Release?
BELVIQ XR (lorcaserin hydrochloride) extended-release tablets for oral use is a serotonin 2C receptor agonist for oral administration used for chronic weight management. Its chemical name is ()-8-chloro-1-methyl-2,3,4,5-tetrahydro-1-3-benzazepine hydrochloride hemihydrate. The empirical formula is CHClN·0.5HO, and the molecular weight of the hemihydrate form is 241.16 g/mol.
The structural formula is:
Lorcaserin hydrochloride hemihydrate is a white to off-white powder with solubility in water greater than 400 mg/mL. Each BELVIQ XR tablet contains 20.8 mg of crystalline lorcaserin hydrochloride hemihydrate, equivalent to 20.0 mg anhydrous lorcaserin hydrochloride, and the following inactive ingredients: microcrystalline cellulose NF; mannitol USP; hypromellose 2208 USP; ethylcellulose dispersion Type B NF; hypromellose 2910 USP; colloidal silicon dioxide NF; polyvinyl alcohol USP; polyethylene glycol NF; titanium dioxide USP; talc USP; FD&C yellow #6/sunset yellow FCF; aluminum lake; iron oxide yellow NF; iron oxide red NF; and magnesium stearate NF.
What does BELVIQ XR Extended Release look like?
What are the available doses of BELVIQ XR Extended Release?
20 mg film-coated tablet ()
What should I talk to my health care provider before I take BELVIQ XR Extended Release?
How should I use BELVIQ XR Extended Release?
BELVIQ XR (lorcaserin hydrochloride) extended-release tablet is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of:
[
]
Limitations of Use:
The recommended dose of BELVIQ XR is 20 mg administered orally once daily. BELVIQ XR tablet must be swallowed whole and must not be chewed, crushed, or divided. Do not exceed recommended dose [
].
BELVIQ XR can be taken with or without food.
Response to therapy should be evaluated by week 12. If a patient has not lost at least 5% of baseline body weight, discontinue BELVIQ XR, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment [
].
BMI is calculated by dividing weight (in kg) by height (in meters) squared.
A BMI chart for height in inches and weight in pounds is provided below:
What interacts with BELVIQ XR Extended Release?
Sorry No Records found
What are the warnings of BELVIQ XR Extended Release?
Sorry No Records found
What are the precautions of BELVIQ XR Extended Release?
Sorry No Records found
What are the side effects of BELVIQ XR Extended Release?
Sorry No records found
What should I look out for while using BELVIQ XR Extended Release?
● Pregnancy: Weight loss in a pregnant woman offers no benefit and may result in fetal harm
● Hypersensitivity: BELVIQ XR is contraindicated in patients with prior hypersensitivity reactions to lorcaserin or to any of the product components. Hypersensitivity reactions have been reported
What might happen if I take too much BELVIQ XR Extended Release?
No experience with overdose of lorcaserin is available. In clinical studies that used doses that were higher than the recommended dose, the most frequent adverse reactions associated with lorcaserin were headache, nausea, abdominal discomfort, and dizziness. Single 40- and 60-mg doses of immediate-release lorcaserin hydrochloride caused euphoria, altered mood, and hallucination in some subjects. Treatment of overdose should consist of lorcaserin discontinuation and general supportive measures in the management of overdosage. Lorcaserin is not eliminated to a therapeutically significant degree by hemodialysis.
How should I store and handle BELVIQ XR Extended Release?
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light. BELVIQ XR 20-mg tablets are supplied as orange-colored, round, biconvex, film-coated tablets debossed with “A” on one side and “20” on the other side and are available as follows:Store at 25°C (77°F): excursions permitted to 15–30°C (59–86°F) [see USP controlled room temperature]. BELVIQ XR 20-mg tablets are supplied as orange-colored, round, biconvex, film-coated tablets debossed with “A” on one side and “20” on the other side and are available as follows:Store at 25°C (77°F): excursions permitted to 15–30°C (59–86°F) [see USP controlled room temperature].
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Lorcaserin is believed to decrease food consumption and promote satiety by selectively activating 5-HT receptors on anorexigenic pro-opiomelanocortin neurons located in the hypothalamus. The exact mechanism of action is not known.
Lorcaserin at the recommended daily dose selectively interacts with 5-HT receptors as compared to 5-HT and 5-HT receptors (see Table 5), other 5-HT receptor subtypes, the 5-HT receptor transporter, and 5-HT reuptake sites.
Non-Clinical Toxicology
● Pregnancy: Weight loss in a pregnant woman offers no benefit and may result in fetal harm● Hypersensitivity: BELVIQ XR is contraindicated in patients with prior hypersensitivity reactions to lorcaserin or to any of the product components. Hypersensitivity reactions have been reported
The effects of metoclopramide on gastrointestinal motility are antagonized by anticholinergic drugs and narcotic analgesics. Additive sedative effects can occur when metoclopramide is given with alcohol, sedatives, hypnotics, narcotics, or tranquilizers.
The finding that metoclopramide releases catecholamines in patients with essential hypertension suggests that it should be used cautiously, if at all, in patients receiving monoamine oxidase inhibitors.
Absorption of drugs from the stomach may be diminished (e.g., digoxin) by metoclopramide, whereas the rate and/or extent of absorption of drugs from the small bowel may be increased (e.g., acetaminophen, tetracycline, levodopa, ethanol, cyclosporine).
Gastroparesis (gastric stasis) may be responsible for poor diabetic control in some patients. Exogenously administered insulin may begin to act before food has left the stomach and lead to hypoglycemia. Because the action of metoclopramide will influence the delivery of food to the intestines and thus the rate of absorption, insulin dosage or timing of dosage may require adjustment.
BELVIQ XR is a serotonergic drug. The development of a potentially life-threatening serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions have been reported during use of serotonergic drugs, including, but not limited to, selective serotonin-norepinephrine reuptake inhibitors (SNRIs) and selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), bupropion, triptans, dietary supplements such as St. John’s Wort and tryptophan, drugs that impair metabolism of serotonin (including monoamine oxidase inhibitors [MAOIs]), dextromethorphan, lithium, tramadol, antipsychotics or other dopamine antagonists, particularly when used in combination [ ].
Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Serotonin syndrome, in its most severe form, can resemble neuroleptic malignant syndrome, which includes hyperthermia, muscle rigidity, autonomic instability with possible rapid fluctuation of vital signs, and mental status changes. Patients should be monitored for the emergence of serotonin syndrome or NMS-like signs and symptoms.
The safety of BELVIQ XR when coadministered with other serotonergic or antidopaminergic agents, including antipsychotics, or drugs that impair metabolism of serotonin, including MAOIs, has not been systematically evaluated and has not been established.
If concomitant administration of BELVIQ XR with an agent that affects the serotonergic neurotransmitter system is clinically warranted, extreme caution and careful observation of the patient is advised, particularly during treatment initiation and dose increases. Treatment with BELVIQ XR and any concomitant serotonergic or antidopaminergic agents, including antipsychotics, should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated [ ].
The following important adverse reactions are described below and elsewhere in labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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