Prozac (Fluoxetine)
Prozac is in a class of drugs called selective serotonin reuptake inhibitors.
Prozac affects chemicals in the brain that may become unbalanced and cause
depression, panic or anxiety, or obsessive or compulsive symptoms.
Prozac is indicated for the treatment of depression, obsessive compulsive
disorder and bulimia nervosa.
Side Effects
Prozac has numerous side effects on all the body systems
*Body as a Whole: Headache, Asthenia (lack or loss of strength and energy),
flue syndrome, fever
*Cardiovascular: Palpitation, Vasodilation (increase in the internal diameter
of a blood vessel causing increased blood flow)
*Dermatologic: Sweating, Rash, pruritis (itching)
*Gastrointestinal: Nausea, Dry Mouth, Decreased Appetite, Flatulence, vomiting,
diarrhea, dyspepsia (impairment of digestive function)
*Metabolic and Nutritional Disorders: Weight loss
*Nervous System: Dizziness, Insomnia, Tremor, Nervousness, Anxiety, Libido
Decreased, Confusion
*Respiration: Yawn, Pharyngitis (sore throat)
*Special Senses: Abnormal vision
Precautions and drug interactions:
Prozac has adverse interactions with many drugs. Prozac should not be taken
with the following medications:
*Anticonvulsants: phenytoin, Tegretol
*Antipsychotics: haloperidol, clozapine
*Benzodiazepines: Valium, Xanax
*Lithium
*Tryptophan:(please note that tryptophan is present in high quantities in
turkey and milk, so caution must be taken if ingesting these foods.)
*MAOI'S
*Other Antidepressants
*Warfarin and other blood thinners
Other precautions
*Rash and Possibly Allergic Events: In U.S. Prozac clinical trials, 7% of
10,782 patients developed various types of rashes and/or urticaria (hives).
*Anxiety and Insomnia: In U.S. placebo-controlled clinical trials for depression,
12% to 16% of patients treated with Prozac reported anxiety, nervousness,
or insomnia.
* Altered Appetite and Weight: Significant weight loss, especially in underweight
depressed or bulimic patients may be an undesirable result of treatment
with Prozac.
* Suicide: The possibility of a suicide attempt is inherent in depression
and may persist until significant remission occurs. Close supervision of
high risk patients should accompany initial drug therapy. Prescriptions
for Prozac should be written for the smallest quantity of capsules consistent
with good patient management, in order to reduce the risk of overdose.
Because of well-established comorbidity between both OCD and depression
and bulimia and depression, the same precautions observed when treating
patients with depression should be observed when treating patients with
OCD or bulimia.
Pregnancy and Nursing Mothers
Prozac is in pregnancy category C. Studies in rats have resulted in deaths
and damage to the fetus. There are no adequate and well-controlled studies
in pregnant women. Because animal reproduction studies are not always predictive
of human response, this drug should be used during pregnancy only if the
potential benefit justifies the potential risk to the fetus.
The effect of Prozac on labor and delivery in humans is unknown. However,
because Prozac crosses the placenta and because of the possibility that
Prozac may have adverse effects on the newborn, Prozac should be used during
labor and delivery only if the potential benefit justifies the potential
risk to the fetus.
Like many other drugs, Prozac is secreted in human milk, and caution should
be exercised when PROZAC is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in the pediatric population have not been established
Geriatric Use
No overall differences in safety or effectiveness were observed between
these subjects and younger subjects, and other reported clinical experience
has not identified differences in responses between the elderly and younger
patients, but greater sensitivity of some older individuals cannot be ruled
out. As with other SSRIs, Prozac has been associated with cases of clinically
significant hyponatremia (low sodium levels) in elderly patients
Drug Abuse and Dependence
Prozac is not a controlled substance.
Recommended Dosage
Recommended dosage differs depending upon the condition being treated.
*Depression: A dose of 20 mg/day, administered in the morning, is recommended
as the initial dose. A dose increase may be considered after several weeks
if no clinical improvement is observed. Doses above 20 mg/day may be administered
on a once a day (morning) or twice a day (i.e., morning and noon) and should
not exceed a maximum dose of 80 mg/day.
*Obsessive Compulsive Disorder: a dose of 20 mg/day, administered in the
morning, is recommended as the initial dose. Doses above 20 mg/day may be
administered on a once a day (i.e., morning) or twice a day (i.e., morning
and noon). A dose range of 20 to 60 mg/day is recommended, however, doses
of up to 80 mg/day have been well tolerated in open studies of OCD. The
maximum Prozac dose should not exceed 80 mg/day.
*Bulimia Nervosa: the recommended dose is 60 mg/day, administered in the
morning. For some patients it may be advisable to slowly ease up to this
target dose over several days. Prozac doses above 60 mg/day have not been
systematically studied in patients with bulimia.
Overdose
As of December 1987, there were 2 deaths among approximately 38 reports
of acute overdose with Prozac, either alone or in combination with other
drugs and/or alcohol. Nausea and vomiting were prominent in overdoses involving
higher Prozac doses. Other prominent symptoms of overdose included agitation,
restlessness, hypomania and other signs of CNS excitation