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|Serzone

NEFAZODONE (Systemic)†

Some commonly used brand names are:

In the U.S.—

• Serzone

† Not commercially available in Canada.

Category

• Antidepressant

Description

Nefazodone (nef-AY-zoe-done) is used to treat mental depression.

This medicine is available only with your doctor"s prescription, in the following dosage form:

• Oral
• Tablets (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For nefazodone, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to nefazodone or trazodone (e.g., Desyrel). Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies have not been done in pregnant women. However, studies in animals have shown that nefazodone causes a decrease in the number of successful pregnancies, as well as a decrease in the weight of offspring, when given in doses several times higher than the human dose. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether nefazodone passes into human breast milk. Mothers who are using this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Studies on nefazodone have been done only in adult patients, and there is no specific information comparing use of this medicine in children up to 18 years of age with use in other age groups.

Nefazodone must be used with caution in children with depression. Studies have shown occurrences of children thinking about suicide or attempting suicide in clinical trials for this medicine. More study is needed to be sure nefazodone is safe and effective in children.

Older adults—The relationship of age to the effects of nefazodone has not been systematically studied in older people. However, blood levels of nefazodone have been found to be higher in older patients. An older adult may require a lower dose of nefazodone than a younger adult.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking nefazodone, it is especially important that your health care professional know if you are taking any of the following:

• Alprazolam (e.g., Xanax) or
• Triazolam (e.g., Halcion)—Use with nefazodone may result in increased blood levels of these medicines and, therefore, increased effects. Your doctor may want to reduce the dose of these medicines if they are used at the same time as nefazodone. An older adult should not receive both triazolam and nefazodone

• Astemizole (e.g., Hismanal) or
• Cisapride (e.g., Propulsid) or
• Pimozide (e.g., ORAP) or
• Terfenadine (e.g., Seldane)—Do not use these medicines with nefazodone or you may develop a very serious change in heart rhythm

• Carbamazepine (e.g., Tegretol)—Do not take carbamazepine with nefazodone. This medicine may interfere with nefazodone and cause it to not work to help with your depression.

• Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate])—Do not take nefazodone while you are taking an MAO inhibitor or you may develop confusion, agitation, restlessness, stomach or intestinal problems, sudden high body temperature, extremely high blood pressure, and/or severe convulsions; at least 14 days should pass between stopping treatment with an MAO inhibitor and starting treatment with nefazodone and at least 7 days should pass between stopping treatment with nefazodone and starting treatment with an MAO inhibitor

Other medical problems—The presence of other medical problems may affect the use of nefazodone. Make sure you tell your doctor if you have any other medical problems, especially:

• Convulsions (seizures) (history of)—The risk of seizures may be increased

• Dehydration or
• Hypovolemia (low blood volume)—May increase the chance that low blood pressure (hypotension) will occur

• Heart disease or
• Stroke (or history of)—Nefazodone may make these conditions worse by causing low blood pressure (hypotension)

• Liver function problems—If your liver does not function well, due to liver problems or liver disease and you take nefazodone, the amount of nefazodone in your blood may be too high. This may cause serious disease or damage in your liver.

• Liver function problems when taking this medicine before and you had to stop taking it—You may have a greater chance of having liver problems if you take nefazodone again. Tell your doctor immediately if you have taken this medicine before.

• Mania (a type of mental illness) (history of)—Nefazodone may cause this problem to recur

Proper Use of This Medicine

Take this medicine only as directed by your doctor. Do not take more or less of it and do not take it more or less often than your doctor ordered.

Sometimes this medicine must be taken for several weeks before you begin to feel better.

Dosing—The dose of nefazodone will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of nefazodone. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets that you take depends on the strength of the medicine.

• For oral dosage form (tablets):
  • For mental depression:
    • Adults (18 years of age and older)—To start, 200 milligrams (mg) a day, divided into two doses. Your doctor may increase the dose if needed.
    • Older adults—To start, 100 mg a day, divided into two doses. Your doctor may increase the dose if needed.
    • Children up to 18 years of age—Use and dose must be determined by the doctor.

Missed dose—If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is important that your doctor check your progress at regular visits to allow dosage adjustments and to help reduce side effects.

Do not take astemizole, cisapride, pimozide, or terfenadine while you are taking nefazodone . If you do, you may develop a very serious change in the rhythm of your heartbeat.

Do not take carbamazepine while you are taking nefazodone. It may cause the medicine to not work or to not work as well.

This medicine may cause serious problems with your liver. Call your doctor right away for any of the following problems. Abdominal pain, nausea, vomiting, yellow eyes or skin, dark colored urine, light-colored stools, feeling very tired or weak

Do not take a monoamine oxidase (MAO) inhibitor (furazolidone, phenelzine, procarbazine, selegiline, tranylcypromine) while you are taking or less than 7 days after taking nefazodone. Do not take nefazodone less than 14 days after taking an MAO inhibitor . If you do, you may develop convulsions (seizures), extremely high fever, or other serious unwanted effects.

Nefazodone may cause some people to be agitated, irritable or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these adverse effects, tell your doctor right away.

This medicine may add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

This medicine may cause some people to become dizzy or drowsy, or to have blurred vision or other vision changes. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert and able to see well.

Dizziness, lightheadedness, or fainting may occur , especially when you get up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

This medicine may cause dryness of the mouth. For temporary relief, use sugarless gum or candy, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth feels dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Incidence not known

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

Incidence not known

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 03/06/1998
Revised: 01/25/2005

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