2. 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)
3. 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)
4. 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.
5. 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.
6. 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
7. 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.
8. 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
9. 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.
10. 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.
