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Query: UMLS:C0027497 (nausea)
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Limited toxicity information is available in the medical literature on the antidepressant fluoxetine (Prozac, Dista Products Co, Indianapolis, IN). The goal of this prospective multicenter study was to develop a toxicity profile of initial signs and symptoms observed in an acute fluoxetine overdose. A prospective study was made of patients reported to one of four American Association of Poison Control Centers' regional poison control centers after ingesting an acute overdose of fluoxetine. A standard data collection form was used on all patients ingesting fluoxetine. Information obtained included age, current medications, dose, coingested drugs, presenting symptoms, vital signs, electrocardiogram abnormalities, outcome, and fluoxetine levels. The authors collected 272 cases; 234 cases met the criteria of the study. Fluoxetine was ingested alone in 87 cases and with ethanol or other drugs in the remaining 147 cases. Of the 87 cases where fluoxetine was ingested alone, 67 patients were adults and 20 were children. Symptoms that were seen in the adult group included: tachycardia (15/67), drowsiness (14/67), tremor (five/67), vomiting (four/67), or nausea (four/67). Thirty patients did not develop symptoms. Twelve of the adult overdose patients had total fluoxetine levels ranging from 232 to 1390 ng/mL. The authors conclude that symptoms that develop after an acute overdose of fluoxetine appear minor and of short duration. Aggressive supportive care is the only intervention necessary.
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PMID:Acute fluoxetine overdose: a report of 234 cases. 158 2

Fluoxetine is a bicyclic antidepressant that is a specific and potent inhibitor of the presynaptic reuptake of serotonin. It has essentially no effect on the reuptake of norepinephrine or other neurotransmitters. Similarly, it has negligible binding affinity for neurotransmitter receptor sites. It is well absorbed after oral administration, with absolute bioavailability in dogs of approximately 72 +/- 27.6%. The mean Tmax is between 4 and 8 hours, and it is approximately 94% protein bound. After a single dose, the elimination half-life is 1-3 days. After long-term administration, the elimination half-life averages 4 days. Its pharmacokinetics appear nonlinear. It is metabolized to an active metabolite norfluoxetine, which is also specific for the inhibition of serotonin reuptake. Norfluoxetine's elimination half-life averaged 7 days after long-term administration. Little is known about potential drug interactions; however, fluoxetine appears to have minimal clinically relevant interactions. Fluoxetine is indicated in the treatment of major depression. Its efficacy is comparable to the tricyclics and it has a similar onset of action. Although doses as high as 80 mg/day have been used, the optimal dosage range appears to be 20-40 mg once daily. Fluoxetine has been used with success in obsessive-compulsive disorder and intention myoclonus, however, its use in these disorders remains investigational. The frequency of side effects is low and dose related; the most common effects are nausea, anxiety, insomnia, anorexia, diarrhea, nervousness, and headache. Eight reports of intentional overdose with fluoxetine alone resulted in no deaths and mild adverse effects. It will be marketed as 20-mg capsules under the brand name of Prozac. Although fluoxetine should be added to formularies, its use should be reserved for treatment of those who do not respond to or do not tolerate tricyclic agents.
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PMID:Fluoxetine: a serotonin-specific, second-generation antidepressant. 355 56

The multicenter trials were performed in a group of 86 depressive inpatients (among them 64 with endogenous depression) managed with fluoxetine (Prozac). It was established that the drug is most effective in managing psychogenic depressions and may also be of use in endogenous depressions, among them in drug resistant ones. Tolerance to the drug was satisfactory, 62% did not show any unwanted side-effects. The rest of the group displayed sleep disorders, increased anxiety, lost of appetite and nausea. Changes in the laboratory parameters and non-specific changes in the electrocardiogram were observed sporadically. Fluoxetine seemed not to have any direct cholinolytic effect.
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PMID:[Clinical evaluation of fluoxetine]. 799 12