Important Information about PROZAC (fluoxetine hydrochloride)
What is PROZAC?
- PROZAC is a medicine approved by the FDA for the treatment of Major Depressive Disorder, Obsessive-Compulsive Disorder, Bulimia Nervosa and Panic Disorder in adults.
- PROZAC is also approved for the treatment of Major Depressive Disorder and Obsessive-Compulsive Disorder in pediatric patients (children and adolescents).
- PROZAC is available by prescription only.
What is the active ingredient in PROZAC?
- PROZAC contains fluoxetine hydrochloride, the same ingredient as found in Prozac® Weekly™, Sarafem®, and generic versions of PROZAC.
Who should not take PROZAC?
You should not take PROZAC if you:
- are allergic to PROZAC, or any of its components, or have had a bad reaction to PROZAC or generic fluoxetine previously.
- are taking a type of antidepressant medicine known as a monoamine oxidase inhibitor (MAOI), such as Nardil® (phenelzine sulfate) or Parnate® (tranylcypromine sulfate). Using an MAOI together with many prescription medicines, including PROZAC, can cause serious or even life-threatening reactions. You must wait at least 14 days after you have stopped taking an MAOI before you can take PROZAC. Also, you need to wait at least 5 weeks after you stop taking PROZAC before you take an MAOI.
- are taking a type of antipsychotic medicine known as Mellaril® (thioridazine). Also, you need to wait at least 5 weeks after you stop taking PROZAC before you take Mellaril.
- are taking a type of antipsychotic medicine known as Orap® (pimozide).
| In clinical studies, antidepressants increased the risk of suicidal thinking and behavior
in children, adolescents, and young
adults with depression 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. Families and caregivers should discuss with the doctor
any observation of worsening of depression symptoms, suicidal thinking and behavior, or unusual changes in behavior.
PROZAC is approved for use in pediatric patients (children and adolescents) with MDD or obsessive compulsive disorder (OCD).
|
What should I talk to my doctor or pharmacist about?
- Patients on antidepressants and their families or caregivers should watch for worsening depression symptoms, unusual changes in behavior and thoughts of suicide, as well as for anxiety, agitation, panic attacks, difficulty sleeping, irritability, hostility, aggressiveness, impulsivity, restlessness, or extreme hyperactivity. Call the doctor if you have thoughts of suicide or if any of these symptoms are severe or occur suddenly. Be especially observant within the first few months of treatment or whenever there is a change in dose. You should not stop taking PROZAC abruptly. Talk to your doctor before you stop taking PROZAC.
- If you get a rash or hives while taking PROZAC, call your doctor right away because this can be a sign of a serious medical condition.
- Be sure to tell your doctor if you are taking SARAFEM, PROZAC Weekly, or generic versions of PROZAC since these contain fluoxetine hydrochloride, the same active ingredient found in PROZAC.
- Tell your doctor about all the nonprescription and prescription medicines you are taking, including those for migraine to avoid a potentially life-threatening condition. Also, tell your doctor if you are taking or plan to take any vitamins, herbal supplements or alcohol.
- Be sure to tell your doctor if you are taking PROZAC and are taking or plan to take non-steroidal anti-inflammatory drugs or aspirin since combined use of these drug products have been associated with an increased risk of bleeding.
- You should tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding while you are taking PROZAC.
- Tell your doctor if you have diabetes. The dose of diabetes medicine may change when you start or stop taking PROZAC.
- Tell your doctor about any other medical conditions you may have especially liver disease or seizures.
- Tell your doctor if you have ever been told you had Bipolar Disorder ("Manic Depression") or have had a "manic" or "psychotic" episode.
What are possible side effects of PROZAC?
- Some people experience side effects like nausea, difficulty sleeping, drowsiness, anxiety, nervousness, weakness, loss of appetite, tremors, dry mouth, sweating, decreased sex drive, impotence, or yawning. Most of these tend to go away within a few weeks of starting treatment and, in most cases, aren't serious enough to cause people to stop taking PROZAC.
- PROZAC can cause changes in sexual desire or satisfaction.
- Do not drive a car or operate dangerous machinery until you know what effects PROZAC may have on you.
- Contact your doctor or healthcare professional if you get a rash or hives, or other side effects that concern you while taking PROZAC.
Prozac® is a registered trademark, and Prozac® Weekly™ is a trademark of Eli Lilly and Company. Sarafem® is a registered trademark of Warner Chilcott, Inc.
