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.
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
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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
*Tryptophan: (please note that tryptophan is present in high quantities in turkey and milk, so caution must be taken if ingesting these foods.)
*Warfarin and other blood thinners
*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.
Safety and effectiveness in the pediatric population have not been established
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 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.
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
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