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    Active Ingredient
    Lorcaserin Hydrochloride (hemihydrate) 10.4 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Film Coated Tablets

    60 X 10.4 mg

    not in the basket chart 27192 2573

    Film Coated Tablets

    29G: 60 X 10.4 mg

    not in the basket chart 62440

    Dosage

    The recommended dose of Lorcaserin hydrochloride is 10 mg administered orally twice daily. Do not exceed recommended dose. Lorcaserin hydrochloride 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 Lorcaserin hydrochloride, 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.


    Indications

    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: 30 kg/m2 or greater (obese), 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).


    Contra-Indications

    Pregnancy.


    Special Precautions

    Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions: Lorcaserin 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.
    Valvular Heart Disease: Regurgitant cardiac valvular disease, primarily affecting the mitral and/or aortic valves, has been reported in patients who took serotonergic drugs with 5-HT2B receptor agonist activity. The etiology of the regurgitant valvular disease is thought to be activation of 5-HT2B receptors on cardiac interstitial cells. At therapeutic concentrations, Lorcaserin is selective for 5-HT2C receptors as compared to 5-HT2B receptors. In clinical trials of 1-year duration, 2.4% of patients receiving Lorcaserin and 2.0% of patients receiving placebo developed echocardiographic criteria for valvular regurgitation at one year (mild or greater aortic regurgitation and/or moderate or greater mitral regurgitation): none of these patients was symptomatic.
    Cognitive impairment: Since Lorcaserin has the potential to impair cognitive function, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that Lorcaserin therapy does not affect them adversely.
    Psychiatric Disorders: Events of euphoria, hallucination, and dissociation were seen with Lorcaserin at supratherapeutic doses in shortterm studies.
    Priapism: Priapism (painful erections greater than 6 hours in duration) is a potential effect of 5-HT2C receptor agonism. If not treated promptly, priapism can result in irreversible damage to the erectile tissue. Men who have an erection lasting greater than 4 hours, whether painful or not, should immediately discontinue the drug and seek emergency medical attention.
    See prescribing information for full details.


    Manufacturer
    Arena Pharmaceuticals GmbH, Switzerland
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