Physicians Academy
Established in December 2006 by the Kashmir Academy Of Private Physicians
Table Of Contents
Editorial :
 The Metabolic Menace
Article 1 :
 Time to evolve Universal Health Coverage policy framework for the state of Jammu and Kashmir
Article 2 :
 Meningocele in a Neonate
Medicine Plus :
 Consequences of Braid Chopping in Kashmir
Picture of The Month :
 Picture of The Month October 2017
Drug Update :
 ADEMPAS (Riociguat)
Abstracts from Other Journals :
 Abstracts from Other Journals-October 2017

Locations of visitors to this page
 
     
 
 
Sep 2017 ( Volume -11 Number -9)

Drug Update
BELVIQ (Lorcaserin)
Rapid Response  |  Back

DRUG UPDATE

SEPTEMBER 2017

  BELVIQ (Lorcaserin)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use BELVIQ safely and effectively.

See full prescribing information for BELVIQ.

BELVIQ (lorcaserin hydrochloride) tablets, for oral use Initial U.S. Approval: 2012

INDICATIONS AND USAGE BELVIQ is a serotonin 2C receptor agonist 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: • 30 kg/m2 or greater (obese) (1) or • 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition, (e.g., hypertension, dyslipidemia, type 2 diabetes) (1) Limitations of Use: • The safety and efficacy of coadministration with other products for weight loss have not been established (1) • The effect of BELVIQ on cardiovascular morbidity and mortality has not been established (1)

DOSAGE AND ADMINISTRATION • One tablet of 10 mg twice daily (2) • Discontinue if 5% weight loss is not achieved by week 12 (2) DOSAGE FORMS AND STRENGTHS 10 mg film-coated tablets (3)

CONTRAINDICATIONS Pregnancy (4)

WARNINGS AND PRECAUTIONS • Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)- like Reactions: The safety of coadministration with other serotonergic or antidopaminergic agents has not been established. Manage with immediate BELVIQ discontinuation and provide supportive treatment. (5.1) • Valvular heart disease: If signs or symptoms develop consider BELVIQ discontinuation and evaluate the patient for possible valvulopathy. (5.2) • Cognitive Impairment: May cause disturbances in attention or memory. Caution with use of hazardous machinery when starting BELVIQ treatment (5.3) • Psychiatric Disorders, including euphoria and dissociation: Do not exceed recommended dose of 10 mg twice daily (5.4) • Monitor for depression or suicidal thoughts. Discontinue if symptoms develop. (5.4) • Use of Antidiabetic Medications: weight loss may cause hypoglycemia. Monitor blood glucose. BELVIQ has not been studied in patients taking insulin. (5.5) • Priapism: Patients should seek emergency treatment if an erection lasts >4 hours. Use BELVIQ with caution in patients predisposed to priapism. (5.6)

ADVERSE REACTIONS Most common adverse reactions (greater than 5%) in non-diabetic patients are headache, dizziness, fatigue, nausea, dry mouth, and constipation, and in diabetic patients are hypoglycemia, headache, back pain, cough, and fatigue. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Eisai Inc. at 1-888-274-2378 or FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

DRUG INTERACTIONS Serotonergic drugs (selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), triptans, bupropion, dextromethorphan, St. John’s Wort): use with extreme caution due to the risk of serotonin syndrome. (7.1)

USE IN SPECIFIC POPULATIONS • Nursing Mothers: Discontinue drug or nursing. (8.3) • Pediatric Use: Safety and effectiveness not established and use not recommended. (8.4)


For Detailed Product Information CLICK HERE to download in PDF (401 KB). Or go back to TOCs and download.

Rapid Response  |  Back
 
 
 
 
 
  Listed in Directory Of Open Access Journals (DOAJ).   ||    Google Scholar  
  Copyright © 2017 Physicians Academy (ISSN : 0973-998X). All rights reserved.  |   Developed By: DZ International