Effexor (EFFEXOR)
Effexor is indicated for the treatment of major depressive disorder. A major
depressive episode implies a prominent and relatively persistent (nearly
every day for at least 2 weeks) depressed or dysphoric mood that usually
interferes with daily functioning, and includes at least five of the following
nine symptoms: depressed mood, loss of interest in usual activities, significant
change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation
or retardation, increased fatigue, feelings of guilt or worthlessness, slowed
thinking or impaired concentration, a suicide attempt or suicidal ideation.
Side Effects:
Common side effects include:
*Body as a Whole: Asthenia (weakness), Headache
*Digestive System: Dry Mouth, Nausea, Anorexia, Vomiting
*Metabolic and Nutritional Disorders: Weight Gain, Peripheral Edema (swelling
of the arms and/or legs), Edema (body swelling)
*Musculoskeletal System: Myalgia (muscle pain)
*Nervous System: Somnolence (sleepiness), Dizziness, Tremor, Confusion,
Nervousness
*Skin: Sweating
* Urogenital System: Impotence
Drug Abuse and Dependence
Effexor is not a controlled substance. While Effexor has not been systematically
studied in clinical trials for its potential for abuse, there was no indication
of drug-seeking behavior in the clinical trials. However, physicians should
carefully evaluate patients for history of drug abuse and follow such patients
closely, observing them for signs of misuse or abuse.
Precautions and Drug Interactions:
Adverse reactions, some of which were serious, have been reported in patients
who have recently been discontinued from a monoamine oxidase inhibitor (MAOI)
and started on Effexor, or who have recently had Effexor therapy discontinued
prior to initiation of an MAOI. These reactions have included tremor, myoclonus(muscle
spasms), diaphoresis(excessive sweating), nausea, vomiting, flushing, dizziness,
seizures and death.
Other Precautions
Effexor treatment is associated with sustained increases in blood pressure
in some patients.
Mydriasis: Mydriasis (prolonged dilation of the eye) has been reported in
association with Effexor; therefore patients with raised intraocular pressure
or those at risk of acute narrow-angle glaucoma should be monitored.
In depressed patients, the possibility of suicide should always be considered
and adequate precautions taken. It is recommended that careful observations
of patients undergoing Effexor treatment be maintained until control of
depression is achieved. If necessary, additional measures (ECT, hospitalization,
etc) should be instituted.
Discontinuation of Treatment with Effexor: Discontinuation symptoms have
been systematically evaluated in patients taking Effexor. Reported symptoms
include agitation, anorexia, anxiety, confusion, coordination impaired,
diarrhea, dizziness, dry mouth, dysphoric mood, fasciculation, fatigue,
headaches, hypomania, insomnia, nausea, nervousness, nightmares, sensory
disturbances (including shock-like electrical sensations), somnolence, sweating,
tremor, vertigo, and vomiting.
Pregnancy and Nursing Mothers
There are no adequate and well-controlled studies in pregnant women. Because
of this, the drug should be used during pregnancy only if clearly needed.
Effexor has been reported to be excreted in human milk. Because of the potential
for serious adverse reactions in nursing infants from Effexor, a decision
should be made whether to discontinue nursing or to discontinue the drug,
taking into account the importance of the drug to the mother.
Pediatric Use
Effexor is not recommended for pediatric patients under 16 years of age,
since there are no controlled studies of safety in this age group
Geriatric Use
Approximately 190 elderly individuals participated in clinical studies with
Effexor. This drug is known to be substantially excreted by the kidney (75%),
and the risk of decreased clearance of this drug is greater in patients
with impaired renal function. Because elderly patients are more likely to
have decreased renal function, care should be taken in dose selection. Sedating
drugs may cause confusion and over-sedation in the elderly.
Recommended Dosage
Effexor should be administered in a single dose with food either in the
morning or in the evening at approximately the same time each day. Each
capsule should be swallowed whole with fluid and not divided, crushed, chewed,
or placed in water, or it may be administered by carefully opening the capsule
and sprinkling the entire contents on a spoonful of applesauce. This drug/food
mixture should be swallowed immediately without chewing and followed with
a glass of water to ensure complete swallowing of the pellets. For most
patients, the recommended starting dose for Effexor XR is 75 mg/day, administered
in a single dose.
Overdose
There is very limited experience with Effexor overdose.