Prozac

Item	Count		Retail	Price	Order
Prozac 20 mg	30	tablets	$239.24	$199.37
Prozac 20 mg	60	tablets	$406.19	$338.49
Prozac 20 mg	90	tablets	$582.12	$485.10

Capsules
Chemical Name: FLUOXETINE (floo-OX-uh-teen)

Common uses
This medicine is a selective serotonin reuptake inhibitor (SSRI) used to treat depression, obsessive-compulsive disorder (OCD), or bulimia. This medicine may also be used to treat PMS (premenstrual syndrome). It may also be used to treat other conditions as determined by your doctor.

Before using
Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are also taking astemizole, dexfenfluramine, fenfluramine, sibutramine, terfenadine, thioridazine, tramadol, or monoamine oxidase inhibitors (MAOIs). ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking cisapride, clozapine, cyclobenzaprine, cyproheptadine, lithium, propafenone, selegiline, tricyclic antidepressants, or medicine for seizures. Inform your doctor of any other medical conditions, allergies, pregnancy, or breast-feeding. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.

Directions
Follow the directions for using this medicine provided by your doctor. TAKE THIS MEDICINE WITH FOOD if it upsets your stomach. STORE THIS MEDICINE at room temperature, away from heat and light. CONTINUE TO TAKE THIS MEDICINE even if you feel better. Do not miss any doses. IF YOU MISS A DOSE OF THIS MEDICINE, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Cautions
UP TO 4 WEEKS MAY PASS before this medicine reaches its full effect. Do not stop taking this medicine without checking with your doctor. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. THIS MEDICINE WILL ADD TO THE EFFECTS of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. This includes any medicines that contain dextromethorphan. FOR WOMEN: IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. THIS MEDICINE IS EXCRETED IN BREAST MILK. The manufacturer of this medicine states that taking this medicine while breast-feeding is not recommended. CONSULT WITH YOUR DOCTOR ABOUT BREAST-FEEDING.

Possible side effects
SIDE EFFECTS, that may go away during treatment, include nervousness, trouble sleeping, headache, drowsiness, fatigue, nausea, vomiting, diarrhea, loss of appetite, dry mouth, sweating, dizziness, lightheadedness, muscle spasms, or changes in sexual function. If they continue or are bothersome, check with your doctor. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.

Drug interactions
Drug interactions can result in unwanted side effects or prevent a medicine from doing its job. Use our drug interaction checker to find out if your medicines interact with each other. Check drug interactions

If you take too much
If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include nausea, vomiting, seizures, restlessness, fast or irregular heartbeat, and fainting.

Additional information
Do Not Share THIS MEDICINE with others for whom it was not prescribed. Do Not Use THIS MEDICINE for other health conditions. KEEP THIS MEDICINE out of the reach of children and pets. If using THIS MEDICINE for an extended period of time, obtain refills before your supply runs out.

MORE ABOUT PROZAC

Introduction

Prozac Uses

Prozac is used to treat depression, bulimia (an eating disorder), obsessive compulsive disorders (OCD), and severe symptoms of premenstrual syndrome (premenstrual dysphoric disorder-PMDD). Prozac works by helping to restore the balance of certain natural chemicals in the brain.

Prozac Directions

Take Prozac by mouth usually once daily in the morning, with or without food; or as directed by your doctor. The dosage is based on your medical condition and response to therapy. Some medical conditions may require a different dosing schedule (e.g., twice daily in the morning and at noon ) as determined by your doctor. Take this medication exactly as prescribed. It is important to continue taking Prozac even if you feel well. Also, do not stop taking Prozac without consulting your doctor. It may take up to 4 weeks before the full benefit of Prozac takes effect.

Dosage

Since it may take up to 4 or 5 weeks to reach steady state plasma levels of Prozac, sufficient time should be allowed to elapse before Prozac dosage is gradually increased. Higher Prozac dosages are usually associated with an increased incidence of adverse reactions.

Depression:
Adults: The recommended initial dosage is Prozac 20 mg administered once daily in the morning. A gradual dose increase should be considered only after a trial period of several weeks if the expected clinical improvement does not occur.

Bulimia Nervosa:
Adult: The recommended dosage is 60 mg/day of Prozac, although studies show that lower Prozac doses may also be efficacious. Electrolyte levels should be assessed prior to initiation of treatment.

Obsessive-Compulsive Disorder:
A dose range of 20 mg/day to 60 mg/day of Prozac is recommended for the treatment of obsessive-compulsive disorder.

For any indication, the total Prozac dosage should not exceed a maximum of 80 mg/day since clinical experience with doses above 80 mg/day is very limited.

During maintenance therapy with Prozac, the Prozac dosage should be kept at the lowest effective level.

A lower or less frequent Prozac dosage should be used in patients with kidney and/or liver impairment and in those on multiple medications.

Geriatrics:
A lower or less frequent Prozac dosage is also recommended in the elderly.

Children:
The safety and effectiveness of Prozac in patients below the age of 18 years have not been established.

Prozac Drug Interactions

Certain medications taken with Prozac could result in serious, even fatal, drug interactions. Avoid taking MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, selegiline, tranylcypromine) within 2 weeks, and avoid taking thioridazine within 5 weeks, before or after treatment with Prozac. Consult your doctor or pharmacist for additional information. Prozac is not recommended for use with: weight loss medicine (e.g., sibutramine, phentermine), thioridazine, terfenadine, astemizole. Ask your doctor or pharmacist for more details. Tell your doctor of all prescription and nonprescription medication you may use, especially: other SSRI antidepressants (e.g., citalopram, sertraline), nefazodone, trazodone, venlafaxine, "triptan" migraine drugs (e.g., sumatriptan, zolmitriptan), tramadol, tricyclic antidepressants (e.g., amitriptyline, nortriptyline), flecainide, propafenone, haloperidol, clozapine, lithium, tryptophan, "blood thinners" (e.g., warfarin), anti-seizure drugs (e.g., carbamazepine, phenytoin/hydantoins), herbal/natural products (e.g., St John`s wort, ayahuasca). Tell your doctor if you take any drugs that cause drowsiness such as: medicine for sleep, tranquilizers, anti-anxiety drugs (e.g., alprazolam), narcotic pain relievers (e.g., codeine), muscle relaxants, psychiatric medicine (e.g., phenothiazines such as chlorpromazine), certain antihistamines (e.g., diphenhydramine). Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of these products. Report other drugs which affect the heart rhythm (QTc prolongation), such as: dofetilide, pimozide, sotalol, quinidine, procainamide, sparfloxacin, "water pills" (diuretics such as furosemide or hydrochlorothiazide). Ask your doctor or pharmacist for more details. Fluoxetine may affect the amount of glucose (sugar) in your blood. If you take any anti-diabetes medication (e.g., glipizide, glyburide, metformin), your dosage of these drugs may need to be adjusted when fluoxetine is started or discontinued. Consult your doctor. Do not start or stop any medicine without doctor or pharmacist approval.

Prozac Missed Dose

If you miss a dose of Prozac, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose of Prozac to catch up.

Pharmacology

The antidepressant and anti-obsession actions of Prozac are presumed to be linked to its ability to inhibit the reuptake of serotonin by receptors in the brain.

Prozac preferentially inhibited the reuptake of serotonin into brain nervous tissue and platelets in rats and humans. In receptor binding studies, Prozac was shown to have only weak affinity for various receptor systems. Unlike most clinically effective antidepressants, Prozac does not down-regulate beta-adrenergic receptors; however, like all tested antidepressants, it caused up-regulation of GABA-B receptors. Mixed effects have been observed on serotonergic receptor sensitivity.

Pharmacokinetics:
Prozac is well absorbed after oral administration. In man, following a single 40 mg dose of Prozac, peak plasma concentrations of Prozac ranged from 15 to 55 ng/mL 6 to 8 hours after dosing (range=1.5 to 12 hours). The capsule and oral solution dosage forms of Prozac are equivalent. Food appears to affect the rate but not the extent of absorption. Prozac is extensively metabolized in the liver to norfluoxetine, and other, unidentified metabolites. Elimination of Prozac metabolites occurs primarily in the urine with a smaller amount also being present in the feces.

Clinical Issues Related to Metabolism/Elimination:
The complexity of Prozac's metabolism has several consequences which may potentially affect its clinical use.

Accumulation and Slow Elimination:
The half-life of Prozac after a single dose is 2 days (range 1 to 4 days) and after multiple dosing 4 days (range 2 to 7 days). After 30 days of dosing at 40 mg/day, plasma concentrations of Prozac ranged from 91 to 302 ng/mL and 72 to 258 ng/mL respectively. Plasma concentrations of Prozac were higher than those predicted from single dose studies, presumably because Prozac's metabolism is not proportional to dose.

Steady state plasma levels of Prozac are attained after 4 to 5 weeks of continuous drug administration. Patients receiving Prozac at doses of 40 to 80 mg/day over periods as long as 3 years exhibited, on average, plasma concentrations similar to those seen among patients treated for 4 to 5 weeks.

Similarly because of the long half-lives of Prozac, it may take up to 1 to 2 months for Prozac to disappear from the body. This is of potential consequence in withdrawal of Prozac.

Liver Disease:
Liver impairment can affect the elimination of Prozac. In patients with alcohol-induced cirrhosis, the elimination half-life of Prozac was prolonged, with a mean of 7.6 days compared to the range of 2 to 3 days seen in subjects without liver disease. This suggests that the use of Prozac in patients with liver disease must be approached with caution.

Kidney Disease:
In single dose studies, the pharmacokinetics of Prozac were similar among subjects with all levels of impaired kidney function including patients without kidneys at all who were on chronic hemodialysis. However, with chronic administration, additional accumulation of Prozac may occur in patients with severely impaired kidney function and use of a lower or less frequent dose is advised.

Age:
The effects of age upon the metabolism of Prozac have not been fully explored. The disposition of single doses of Prozac in healthy elderly subjects (greater than 65 years of age) did not differ significantly from that in younger normal subjects. However, given the long half-life of Prozac, a single-dose study is not adequate to rule out the possibility of altered pharmacokinetics in the elderly, particularly if they have systemic illness or are receiving multiple drugs for concomitant diseases.

Indications of Prozac

Depression:
For the symptomatic relief of depressive illness.

Bulimia Nervosa:
Prozac has been shown to significantly decrease binge-eating and purging activity when compared with placebo treatment.

Obsessive-Compulsive Disorder:
Prozac has been shown to significantly reduce the symptoms of obsessive-compulsive disorder in double-blind, placebo-controlled clinical trials.

The obsessions or compulsions must be experienced as intrusive, markedly distressing, time-consuming, or interfering significantly with the person's social or occupational functioning.

The effectiveness of Prozac in long-term use (i.e., for more than 5 to 6 weeks in depression, for more than 16 weeks in bulimia nervosa, or for more than 13 weeks in obsessive compulsive disorder), has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Prozac for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Contraindications

In patients with known hypersensitivity to Prozac.

MAO Inhibitors:
There have been reports of serious, sometimes fatal, reactions (including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma) in patients receiving Prozac in combination with a MAO inhibitor and in patients who have recently discontinued Prozac and then started on a MAO inhibitor. Some cases presented with features resembling neuroleptic malignant syndrome. Therefore, Prozac should not be used in combination with a MAO inhibitor or within 14 days of discontinuing therapy with a MAO inhibitor. Since Prozac have very long elimination half-lives, at least 5 weeks should be allowed after stopping Prozac before starting a MAO inhibitor.

Warnings

Allergic Reactions (Rash and Accompanying Events) with Prozac:
During premarketing testing of more than 5600 patients given Prozac, approximately 4% developed a rash and/or urticaria. Among these cases, almost a third were withdrawn from treatment with Prozac because of the rash and/or systemic signs or symptoms associated with the rash. Clinical findings reported in association with these allergic reactions include rash, fever, leukocytosis, arthralgias, edema, carpal tunnel syndrome, respiratory distress, lymphadenopathy, proteinuria, and mild transaminase elevation. Most patients improved promptly with discontinuation of Prozac and/or adjunctive treatment with antihistamines or steroids, and all patients experiencing these events were reported to recover completely.

Since the introduction of Prozac, systemic events, possibly related to vasculitis, have developed in patients with rash. Although these events are rare, they may be serious, involving the lung, kidney, or liver. Death has been reported to occur in association with these systemic events.

Anaphylactoid events, including bronchospasm, angioedema, and urticaria alone and in combination, have been reported in patients taking Prozac.

Pulmonary events, including inflammatory processes of varying histopathology and/or fibrosis, have been reported rarely in patients taking Prozac. These events have occurred with dyspnea as the only preceding symptom.

Whether these systemic events and rash have a common underlying cause or are due to different etiologies or pathogenic processes is not known. Furthermore, a specific underlying immunologic basis for these events has not been identified. Upon the appearance of rash or of other allergic phenomena for which an alternative etiology cannot be identified, Prozac should be discontinued. Particular caution should be exercised in patients with a history of allergic reactions.

Implications of the Long Elimination Half-Life of Prozac :
Because of the long elimination half-lives of Prozac, changes in dose will not be fully reflected in plasma for several weeks, affecting both strategies for titration to final dose and withdrawal from treatment. Even when Prozac dosing is stopped, active drug substance will persist in the body for weeks due to the long elimination half-lives of Prozac. This is of potential consequence when drug discontinuation is required or when drugs are prescribed that might interact with Prozac following discontinuation of Prozac.

Precautions

Anxiety and Insomnia:
During premarketing clinical trials, anxiety, nervousness and insomnia were reported by 10 to 15% of patients treated with Prozac. These symptoms led to discontinuation of Prozac in 5% of the patients.

Weight Change:
Significant weight loss, especially in underweight depressed patients, may be an undesirable result of treatment with Prozac.

Mania/Hypomania:
During premarketing clinical trials in a patient population comprised primarily of unipolar depressives, hypomania or mania occurred in approximately 1% of Prozac treated patients. The incidence in a general patient population which might also include bipolar depressives is unknown. The likelihood of hypomanic or manic episodes with Prozac may be increased at the higher Prozac dosage levels. Such reactions require a reduction in dosage or discontinuation of Prozac.

Seizures:
Prozac should be used with caution in patients with a history of convulsive disorders. The incidence of seizures associated with Prozac during clinical trials did not appear to differ from that reported with other marketed antidepressants; however, patients with a history of convulsive disorders were excluded from these trials.

Concurrent administration of Prozac with electroshock therapy should be avoided because of the absence of experience in this area. There have been rare reports of a prolonged seizure in patients on Prozac receiving ECT treatment.

Suicide:
The possibility of a suicide attempt is inherent in depression and may persist until significant remission occurs. Therefore, high risk patients should be closely supervised throughout therapy and consideration should be given to the possible need for hospitalization. In order to minimize the opportunity for overdosage, prescriptions for Prozac should be written for the smallest quantity of drug consistent with good patient management.

Concomitant Illness:
Clinical experience with Prozac in patients with concomitant systemic illness is limited and it should be used cautiously in such patients, especially those with diseases or conditions that could affect metabolism or hemodynamic responses.

Prozac has not been evaluated or used to any appreciable extent in patients with a recent history of myocardial infarction or unstable heart disease. Patients with these diagnoses were systematically excluded from premarketing clinical studies. Retrospective evaluation of ECGs in some of these studies showed no conduction abnormalities that resulted in heart block with Prozac use.

Prozac should be given with caution to patients suffering from anorexia nervosa and only if the expected benefits (e.g., co-morbid depression) markedly outweigh the potential weight reducing effect of Prozac.

In patients with diabetes, Prozac may alter glucose control. Hypoglycemia has occurred during therapy with Prozac and hyperglycemia has developed following discontinuation of Prozac. As is true with many other types of medication when taken concurrently by patients with diabetes, insulin and/or oral hypoglycemic dosage may need to be adjusted when therapy with Prozac is instituted or discontinued.

Since Prozac is extensively metabolized, excretion of unchanged drug in urine is a minor route of elimination. However, until adequate numbers of patients with severe kidney impairment have been evaluated in the course of chronic treatment, Prozac should be used with caution in such patients.

Since clearances of Prozac may be decreased in patients with impaired liver function including cirrhosis, a lower or less frequent dose should be used in such patients.

Hyponatremia:
Several cases of hyponatremia (some with serum sodium lower than 110 mmol/L) have been reported in patients taking Prozac. The hyponatremia appeared to be reversible when Prozac was discontinued. Although these cases were complex with varying possible etiologies, some were possibly due to the syndrome of inappropriate antidiuretic hormone secretion (SIADH). The majority of these occurrences have been in older patients and in patients taking diuretics or who were otherwise volume depleted while taking Prozac.

Platelet Function:
There have been rare reports of altered platelet function and/or abnormal results from laboratory studies in patients taking Prozac. While there have been reports of abnormal bleeding in several patients taking Prozac, it is unclear whether Prozac had a causative role.

Occupational Hazards:
Patients should be cautioned against driving an automobile or performing hazardous tasks until they are reasonably certain that treatment with Prozac does not affect them adversely.

Pregnancy and Lactation:
Safe use of Prozac during pregnancy and lactation has not been established. Therefore, it should not be administered to women of childbearing potential or nursing mothers unless, in the opinion of the treating physician, the expected benefits to the patient markedly outweigh the possible hazards to the child or fetus. In 1 breast milk sample, the concentration of Prozac was 70.4 ng/mL. The concentration in the mother's plasma was 295 ng/mL. No adverse effects on the infant were reported from the mother's use of Prozac in these instances.

Children:
Safety and effectiveness of Prozac in patients below the age of 18 have not been established.

Geriatrics:
Elderly patients should initially receive Prozac in low dosage with slow progressive increases only if required and tolerated. Patients who have concomitant systemic illnesses or who are receiving other drugs concomitantly should be under careful observation at all Prozac dosage levels.

Drug Interactions:
Combined use of Prozac and MAO inhibitors is contraindicated.

There have been greater than 2-fold increases of previously stable plasma levels of other antidepressants when Prozac has been administered in combination with these agents.

There have been reports of both increased and decreased lithium levels when lithium was used concomitantly with Prozac. Cases of lithium toxicity have been reported. Lithium levels should be monitored when Prozac is administered concomitantly.

Five patients receiving Prozac in combination with tryptophan experienced adverse reactions, including agitation, restlessness and gastrointestinal distress.

The half-life of concurrently administered diazepam may be prolonged in some patients. Experience with the use of Prozac in combination with other CNS-active drugs is limited and caution is advised if such concomitant medication is required in patients taking Prozac.

General Anesthetics:
Since little is known about the interaction between Prozac and general anesthetics, Prozac should be discontinued for as long as clinically possible prior to elective surgery.

Dependence Liability:
Prozac has not been systematically studied, in animals or humans, for its potential for abuse, tolerance, or physical dependence. Physicians should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of Prozac.

Adverse Effects

Commonly Observed:
In clinical trials, the most commonly observed adverse events associated with the use of Prozac and not seen at an equivalent incidence among placebo treated patients were: CNS complaints, including headache, nervousness, insomnia, drowsiness, fatigue or asthenia, anxiety, tremor, and dizziness or lightheadedness; gastrointestinal complaints, including nausea, diarrhea, dry mouth and anorexia; and excessive sweating.

Adverse Events Leading to Discontinuation of Treatment:
Fifteen percent of approximately 4000 patients who received Prozac in North American clinical trials discontinued treatment due to an adverse event. The more common events causing discontinuation included: Psychiatric, primarily nervousness, anxiety, and insomnia; digestive, primarily nausea; nervous system, primarily dizziness, asthenia and headaches; skin, primarily rash and pruritus. In obsessive compulsive disorder studies, 12.1% of Prozac treated patients discontinued treatment early because of adverse events. Anxiety, and rash, at incidences of less than 2%, were the most frequently reported events. In bulimia nervosa studies, 10.2% of Prozac treated patients discontinued treatment early because of adverse events. Insomnia, anxiety and rash, at incidences of less than 2%, were the most frequently reported events.

Serious Adverse Reactions with Prozac :
Suicidal thoughts and acts are far more common among depressed patients than in the general population. It is estimated that suicide is 22 to 36 times more prevalent in depressed persons than in the general population. A comprehensive meta-analysis of pooled data from 17 double blind clinical trials in patients with major depressive disorder compared Prozac (n=1765) with a tricyclic antidepressant (n=731) or placebo (n=569), or both. The pooled incidence of emergence of substantial suicidal ideation was 1.2% for Prozac, 2.6% for placebo, and 3.6% for tricyclic antidepressants.

In countries where the drug has already been marketed, the following potentially serious adverse reactions have been reported with Prozac: Interactions with MAO inhibitors and possibly other drugs, allergic reactions, cardiovascular reactions, syndrome of inappropriate ADH secretion, and grand mal seizure. Death and life-threatening events have been associated with some of these reactions, although causal relationship to Prozac has not been established.

Postmarketing experience also confirms the profile of adverse reactions commonly reported during clinical trials with Prozac, including allergic skin reactions.

Adverse Experience Reports:
The pattern of adverse events for both Prozac and placebo was somewhat different in bulimia and obsessive compulsive disorder trials than in the depression studies.

The following adverse reactions, were reported on at least one occasion by patients during treatment with Prozac either during clinical trials or after marketing. All reported events are included except those where a drug cause was remote or the event term so general as to be unhelpful. Multiple events may have been reported by a single patient and related to a single condition, which may have preexisted. Therefore, while the following events occurred during treatment with Prozac, they were not necessarily caused by it.

Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: Frequent adverse events are defined as those occurring on 1 or more occasions in at least 1% of patients; infrequent adverse events are those occurring in less than 1% but at least 1/1000 patients; rare events are those occurring in less than 1/1000 patients.

Allergic or Toxic:
Frequent: Rash, pruritus.

Infrequent: Chills and fever, urticaria, maculopapular rash.

Rare: Allergic reaction, erythema multiforme, vesiculobullous rash, serum sickness, contact dermatitis, erythema nodosum, purpuric rash, leukocytoclastic vasculitis, leukopenia, thrombocythemia, arthralgia, angioedema, bronchospasm, lung fibrosis, allergic alveolitis, larynx edema, respiratory distress.

Neurologic:
Frequent: Headache, tremor, dizziness or lightheadedness, asthenia.

Infrequent: Abnormal gait, ataxia, akathisia, buccoglossal syndrome, hyperkinesia, hypertonia, incoordination, neck rigidity, extrapyramidal syndrome, convulsions, photophobia, myoclonus, vertigo, migraine, tinnitus, hypesthesia, neuralgia, neuropathy, acute brain syndrome.

Rare: Dysarthria, dystonia, torticollis, decreased reflexes, nystagmus, paralysis, paresthesia, carpal tunnel syndrome, stupor, coma, abnormal EEG, chronic brain syndrome, dyskinesia and other movement disorders (including worsening of preexisting conditions or appearance in patients with risk factors [e.g., Parkinson's disease, treatment with neuroleptics or other drugs known to be associated with movement disorders]) neuroleptic malignant syndrome-like events.

Behavioral:
Frequent: Insomnia, anxiety, nervousness, agitation, abnormal dreams, drowsiness and fatigue.

Infrequent: Confusion, delusions, hallucinations, manic reaction, paranoid reaction, psychosis, depersonalization, apathy, emotional lability, euphoria, hostility, amnesia, increased libido.

Rare: Antisocial reaction, hysteria, suicidal ideation, violent behaviors.

Autonomic:
Frequent: Excessive sweating.

Infrequent: Dry mouth, constipation, urinary retention, vision disturbance, diplopia, mydriasis, hot flushes.

Cardiovascular:
Infrequent: Chest pain, hypertension, syncope, hypotension (including postural hypotension), angina pectoris, arrhythmia, tachycardia.

Rare: Bradycardia, ventricular arrhythmia, first degree AV block, bundle branch block, myocardial infarct, cerebral ischemia, cerebral vascular accident, thrombophlebitis.

Gastrointestinal:
Frequent: Nausea, disturbances of appetite, diarrhea.

Infrequent: Vomiting, stomatitis, dysphagia, eructation, esophagitis, gastritis, gingivitis, glossitis, melena, thirst, abnormal liver function tests.

Rare: Bloody diarrhea, hematemesis, gastrointestinal hemorrhage, duodenal ulcer, stomach ulcer, mouth ulceration, hyperchlorhydria, colitis, enteritis, cholecystitis, cholelithiasis, hepatitis, hepatomegaly, liver tenderness, jaundice, increased salivation, salivary gland enlargement, tongue discoloration, fecal incontinence, pancreatitis.

Respiratory:
Frequent: Bronchitis, rhinitis, yawn.

Infrequent: Asthma, dyspnea, hyperventilation, pneumonia, hiccups, epistaxis.

Rare: Apnea, lung edema, hypoxia, pleural effusion, hemoptysis.

Endocrine:
Frequent: Weight loss.

Infrequent: Generalized edema, peripheral edema, face edema, tongue edema, hypoglycemia, hypothyroidism, weight gain.

Rare: Dehydration, gout, goitre, hyperthyroidism, hypercholesteremia, hyperglycemia, hyperlipemia, hyperprolactinemia, hypokalemia, hyponatremia, iron deficiency anemia, syndrome of inappropriate ADH secretion.

Hematologic:
Infrequent: Anemia, lymphadenopathy, hemorrhage.

Rare: Bleeding time increased, leukocytosis, lymphocytosis, thrombocytopenia, thrombocytopenic purpura, thrombocythemia, retinal hemorrhage, petechia, purpura, sedimentation rate increased, aplastic anemia, pancytopenia, immune-related hemolytic anemia.

Dermatologic:
Infrequent: Acne, alopecia, dry skin, herpes simplex.

Rare: Eczema, psoriasis, seborrhea, skin hypertrophy, skin discoloration, herpes zoster, fungal dermatitis, hirsutism, ecchymoses.

Musculoskeletal:
Frequent: Muscle pain, back pain, joint pain.

Infrequent: Arthritis, bone pain, bursitis, tenosynovitis, twitching.

Rare: Bone necrosis, osteoporosis, pathological fracture, chrondrodystrophy, myositis, rheumatoid arthritis, muscle hemorrhage.

Urogenital:
Frequent: Painful menstruation, sexual dysfunction, urinary tract infection, frequent micturition.

Infrequent: Abnormal ejaculation, impotence, menopause, amenorrhea, menorrhagia, ovarian disorder, vaginitis, leukorrhea, fibrocystic breast, breast pain, cystitis, dysuria, urinary urgency, urinary incontinence.

Rare: Breast enlargement, galactorrhea, abortion, dyspareunia, uterine spasm, vaginal hemorrhage, metrorrhagia, hematuria, albuminuria, polyuria, pyuria, epididymitis, orchitis, pyelonephritis, salpingitis, urethritis, kidney calculus, urethral pain, urolithiasis.

Miscellaneous:
Frequent: Chills.

Infrequent: Amblyopia, conjunctivitis, cyst, ear pain, eye pain, jaw pain, neck pain, pelvic pain, hangover effect, malaise.

Rare: Abdomen enlarged, blepharitis, cataract, corneal lesion, glaucoma, iritis, ptosis, strabismus, deafness, taste loss, moniliasis, hydrocephalus, LE syndrome.

Overdose

During clinical trials, there were 2 deaths among approximately 38 reports of acute overdose with Prozac, either alone or in combination with other drugs and/or alcohol. One death involved a combined overdose with approximately 1800 mg of Prozac and an undetermined amount of maprotiline. Plasma concentrations of Prozac and maprotiline were 4.57 mg/L and 4.18 mg/L, respectively.

A second death involved 3 drugs yielding plasma concentrations as follows: Prozac, 1.93 mg/L; norfluoxetine, 1.10 mg/L; codeine, 1.80 mg/L; temazepam 3.80 mg/L.

One other patient who reportedly took up to 3000 mg of Prozac experienced 2 grand mal seizures that remitted spontaneously without specific treatment. Since vomiting occurred, the amount of Prozac absorbed may have been less than that ingested.

In the postmarketing phase, there have been 16 confirmed reports of overdose of Prozac taken alone. The amount of Prozac ingested has varied from 80 mg to 2000 mg and the patients have ranged in age from 13 to 51 years. There have been no deaths in this group of patients, some of whom were treated vigorously with activated charcoal in the acute phase. Furthermore, patient recoveries were remarkable in the absence of serious adverse events with the exception of a 13 year old male who ingested 1880 mg of Prozac and experienced 2 brief seizures but thereafter had an uneventful recovery.

Since introduction, reports of death attributed to overdose of Prozac alone have been rare.

Symptoms:
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, including seizures.

Treatment:
Establish and maintain an airway; ensure adequate oxygenation and ventilation. Activated charcoal, which may be used with sorbitol, may be as or more effective than emesis or lavage, and should be considered in treating overdose.

Cardiac and vital signs monitoring is recommended, along with general symptomatic and supportive measures. Based on experience in animals, which may not be relevant to humans, Prozac -induced seizures which fail to remit spontaneously may respond to diazepam.

There are no specific antidotes for Prozac.

Due to the large volume of distribution of Prozac, forced diuresis, dialysis, hemoperfusion, and exchange transfusion are unlikely to be of benefit.

In managing Prozac overdosage, consider the possibility of multiple drug involvement. The physician should consider contacting a poison control centre on the treatment of any overdosage.

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