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Venlafaxine is not recommended in patients hypersensitive to
venlafaxine. It should not be taken by anyone who is allergic
to the inactive ingredients, which include gelatin, cellulose,
ethylcellulose, iron oxide, titanium dioxide and hypromellose.
It should never be used in conjunction with a monoamine oxidase
inhibitor (MAOI), due to the potential to develop a potentially
deadly condition known as serotonin syndrome. Caution should also
be used in those with a seizure disorder. Venlafaxine is not approved
for use in children or adolescents. However, Wyeth does provide
information on precautions if venlafaxine is prescribed to this
age group for the treatment of non-approved conditions. Studies
in these age groups have not established its efficacy or safety.
Liver, Kidney and Thyroid Disorders
The prescribed dosage of venlafaxine may have to be adjusted
for those with liver, thyroid or kidney problems. It is crucial
to inform a doctor of any such disorders before taking venlafaxine.
Glaucoma
Venlafaxine can increase eye pressure, so those with glaucoma
should inform their doctors before taking venlafaxine. More frequent
eye checks may be necessary.
Pregnancy, labor, and delivery
There are no adequate and well controlled studies with venlafaxine
in pregnant women. Therefore, venlafaxine should only be used
during pregnancy if clearly needed. Prospective studies have not
shown any statistically significant congenital malformations.
There have, however, been some reports of self-limiting effects
on newborn infants. As with other Serotonin Reuptake Inhibitors,
these effects are generally short, lasting only 3 to 5 days and
rarely resulting in severe complications. Use of Venlafaxine in
pregnancy (like other Serotonin Reuptake Inhibitors) should be
considered on a case-by-case basis.
Heart Disease and Hypertension
The FDA has asked the sponsors of all SNRIs to include the potential
risk for persistent pulmonary hypertension(PPHN) in prescribing
data as of July 19, 2006. Medications containing Venlafaxine caused
a mean heart rate increase of 4 b.p.m in clinical trials, along
with a sustained increase in blood pressure in some.
Serotonin Syndrome
The development of a potentially life-threatening serotonin syndrome
may occur with Effexor XR treatment, particularly with concomitant
use of serotonergic drugs (including SSRIs, SNRIs, and triptans)
and with drugs that impair metabolism of serotonin (including
MAOIs). 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).
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