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Drug Uses
Prozac is a drug used medically in the treatment of depression, obsessive-compulsive disorder, bulimia nervosa, premenstrual dysphoric disorder, and many other disorders. It is a psychotropic drug for oral administration.

How Taken
Prozac usually is taken once or twice a day. To be effective, it should be taken regularly. Make a habit of taking it at the same time you do some other daily activity. It may be 4 weeks before you feel any relief from your depression, but the drug's effects should last about 9 months after a 3-month treatment regimen. For obsessive-compulsive disorder, the full effect may take 5 weeks to appear.

Warnings/Precautions
Unless you are directed to do so by your doctor, do not take this medication if you are recovering from a heart attack or if you have liver disease or diabetes. Prozac may cause you to become drowsy or less alert and may affect your judgment. Therefore, driving or operating dangerous machinery or participating in any hazardous activity that requires full mental alertness is not recommended. While taking this medication, you may feel dizzy or light-headed or actually faint when getting up from a lying or sitting position. If getting up slowly doesn't help or if this problem continues, notify your doctor. If you develop a skin rash or hives while taking Prozac, discontinue use of the medication and notify your doctor immediately. Prozac should be used with caution if you have a history of seizures. You should discuss all of your medical conditions with your doctor before taking this medication. Prozac can occasionally cause decreased appetite and weight loss, especially in depressed people who are already underweight and in those with bulimia. If you notice changes in your weight or appetite, tell your doctor. The effects of Prozac during pregnancy have not been adequately studied. If you are pregnant or plan to become pregnant, inform your doctor immediately. This medication appears in breast milk, and breastfeeding is not recommended while you are taking Prozac.

Missed Dose
If you miss a dose of Prozac and you remember the same day, take it as soon as possible. If you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Possible Side Effects
Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Prozac.
More common side effects may include: \

Abnormal dreams, abnormal ejaculation, abnormal vision, anxiety, diminished sex drive, dizziness, dry mouth, flu-like symptoms, flushing, gas, headache, impotence, insomnia, itching, loss of appetite, nausea, nervousness, rash, sinusitis, sleepiness, sore throat, sweating, tremors, upset stomach, vomiting, weakness, yawning.

Less common side effects may include:

Abnormal taste, agitation, bleeding problems, chills, confusion, ear pain, emotional instability, fever, frequent urination, high blood pressure, increased appetite, loss of memory, palpitations, ringing in the ears, sleep disorders, weight gain.

In children and adolescents, less common side effects may also include Agitation, excessive menstrual bleeding, frequent urination, hyperactivity, mania or hypomania (inappropriate feelings of elation and/or rapid thoughts), nosebleeds, personality changes, and thirst.

A wide variety of other very rare reactions have been reported during Prozac therapy. If you develop any new or unexplained symptoms, tell your doctor without delay.

Storage
Store in a dry place at 20-25 degrees C (68-77 F).

Overdose
Any medication taken in excess can have serious consequences. An overdose of Prozac can be fatal. In addition, combining Prozac with certain other drugs can cause symptoms of overdose. If you suspect an overdose, seek medical attention immediately. Common symptoms of Prozac overdose include Nausea, rapid heartbeat, seizures, sleepiness, vomiting. Other symptoms of Prozac overdose include: Coma, delirium, fainting, high fever, irregular heartbeat, low blood pressure, mania, rigid muscles, sweating, stupor.

More Information
Do not take with MAO inhibitors or for at least two weeks after their discontinuation. MAO inhibitor medications should not be taken for at least five weeks after discontinuing Prozac. Most medications affecting the brain have the potential to slow reflexes or impair judgment and caution is advised. This medication has not been studied extensively in the US and re-evaluation periodically by your physician is advised. Check with your pharmacist when taking with other medications.

Prozac® (fluoxetine capsules, USP and fluoxetine oral solution, USP) is a psychotropic drug for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated

(±)-N-methyl-3-phenyl-3-[(α,αα , -trifluoro-p-tolyl)oxy]propylamine hydrochloride

and has the empirical formula of C17H18F3NO•HCl. Its molecular weight is 345.79.

Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water.

Each Pulvule® contains fluoxetine hydrochloride equivalent to 10 mg (32.3 µ mol), 20 mg (64.7 µ mol), or 40 mg (129.3 µ mol) of fluoxetine. The Pulvules also contain starch, gelatin, silicone, titanium dioxide, iron oxide, and other inactive ingredients. The 10- and 20-mg Pulvules also contain FD&C Blue No. 1, and the 40-mg Pulvule also contains FD&C Blue No. 1 and FD&C Yellow No. 6.

The oral solution contains fluoxetine hydrochloride equivalent to 20 mg/5 mL (64.7 µ mol) of fluoxetine. It also contains alcohol 0.23%, benzoic acid, flavoring agent, glycerin, purified water, and sucrose.

Prozac Weekly™ capsules, a delayed-release formulation, contain enteric-coated pellets of fluoxetine hydrochloride equivalent to 90 mg (291 µ mol) of fluoxetine. The capsules also contain D&C Yellow No. 10, FD&C Blue No. 2, gelatin, hypromellose, hypromellose acetate succinate, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, and other inactive ingredients.

WARNING

Suicidality and Antidepressant Drugs — Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Prozac or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Prozac is approved for use in pediatric patients with MDD and obsessive compulsive disorder (OCD). (See WARNINGS, Clinical worsening and suicide risk, PRECAUTIONS, Information for patients and precautions, Pediatric Use.)