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New Drug-Khedezla

New Drug-Khedezla



newdrug information,pharmacy practice

newdrug information,pharmacy practice



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    New Drug-Khedezla New Drug-Khedezla Presentation Transcript

    • INTRODUCTION  Brand Name : Khedezla  Generic Name : Desvenlafaxine  Company : OSMOTICA PHARM  Approval Date : July 10, 2013  Approved By : U.S.Food And Drug Administration (U.S.FDA)  Strength : 50MG,100MG  Dosage Form : TABLET  Marketing Status : By Prescription  CATEGORY : Selective serotonin and norepinephrine reuptake inhibitors (SNRIs)  INDICATION : Used to treat major depressive disorder. (Anti- Depressant)
    •  Strength : 50MG,100MG  Dosage Form : TABLET  Marketing Status : By Prescription  CATEGORY : Selective serotonin and norepinephrine reuptake inhibitors (SNRIs)  INDICATION : Used to treat major depressive disorder. (Anti-Depressant)
    • MECHANISM OF ACTION :  Desvenlafaxine, the major active metabolite of venlafaxine, is a selective serotonin and norepinephrine reuptake inhibitor. The clinical effect of desvenlafaxine is thought to occur via potentiation of serotonin and norepinephrine in the central nervous system. Unlike venlafaxine, desvenlafaxine is thought to have a differential serotonergic and noradrenergic activity profile.
    • PHARMACOKINETICS :  Absorption - Bioavailability is ~ 80% and is unaffected by food.  Peak plasma concentration is reached in 7.5 hours.Volume of distribution3.4 L/kg, distribution into nonvascular compartments  Protein binding~ 30%, protein binding is independent of drug concentration.  Metabolism - The primary route of metabolism is via conjugation mediated by UGT isoforms.  Desvenlafaxine also undergoes oxidative N- demethylation via cytochrome P450 3A4 to a minor extent.  Excreted in the urine.  Half life -11.1 hours and may be prolonged in patients with renal and/or moderate to severe hepatic impairment.
    • IMPORTANT INFORMATION :  Desvenlafaxine should not be used, if you are being treated with methylene blue injection.  Do not use desvenlafaxine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.  Some young people have thoughts about suicide when first taking an antidepressant. Your physician will need to check your progress at regular visits while you are using desvenlafaxine. Your family or other caregivers should also be alert to changes in your mood or symptoms.  Do not give this medication to anyone under 18 years old without the advice of a doctor
    •  FDA pregnancy : category C. Desvenlafaxine may cause problems in a newborn baby if the mother takes the medication late in pregnancy (during the third trimester). Desvenlafaxine can pass into breast milk and may harm a nursing baby.
    • Usual Adult Dose for Depression:  Initial dose: 50 mg orally once daily, with or without food. In clinical studies, doses of 50 to 400 mg/day were shown to be effective  side effects may include:  dizziness, drowsiness, anxiety;  increased sweating;  mild nausea, loss of appetite, constipation;  sleep problems (insomnia); or  Sexual impotency
    • DRUG INTERACTIONS : Major: fluoxetine ↔ desvenlafaxine Fluoxetine together with desvenlafaxine, can increase the risk of a rare but serious condition called the serotonin syndrome, which may include symptoms such as confusion, hallucination, seizure, extreme changes in blood pressure, increased heart rate, fever, excessive sweating, shivering or shaking, blurred vision, muscle spasm or stiffness, tremor, incoordination, stomach cramp, nausea, vomiting, and diarrhea.
    • PATIENT COUNSELLING :  You may take desvenlafaxine with or without food. Take the medicine at the same time each day.  It may take several weeks before your symptoms improve. Keep using the medication as directed, Do not stop using desvenlafaxine suddenly, or you could have unpleasant withdrawal symptoms.  Your blood pressure will need to be checked often.  This medication can cause you to have a false positive drug screening test. If you provide a urine sample for drug screening, tell the laboratory staff that you are taking desvenlafaxine.  Store at room temperature away from moisture and heat.
    • REFERENCES :  www.fda.gov  http://www.drugbank.com/  http://www.medindia.net/  http://www.drugs.com/
    • Thank You…