Serzone

(Generic versions may still be available.)

DRUG DESCRIPTION

SERZONE® (nefazodone hydrochloride) is an antidepressant for oral administration with a chemical structure unrelated to selective serotonin reuptake inhibitors, tricyclics, tetracyclics, or monoamine oxidase inhibitors (MAOI).

Nefazodone hydrochloride is a synthetically derived phenylpiperazine antidepressant. The chemical name for nefazodone hydrochloride is 2-[3-[4-(3-chlorophenyl) -1-piperazinyl]propyl] -5-ethyl-2,4-dihydro-4-(2-phenoxyethyl) -3H-1,2,4-triazol-3-one monohydrochloride. The molecular formula is C25H32ClN5O2 HCl, which corresponds to a molecular weight of 506.5. The structural formula is:

Nefazodone hydrochloride is a nonhygroscopic, white crystalline solid. It is freely soluble in chloroform, soluble in propylene glycol, and slightly soluble in polyethylene glycol and water.

SERZONE (nefazodone) is supplied as hexagonal tablets containing 50 mg, 100 mg, 150 mg, 200 mg, or 250 mg of nefazodone hydrochloride and the following inactive ingredients: microcrystalline cellulose, povidone, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, and iron oxides (red and/or yellow) as colorants.

What are the precautions when taking nefazodone (Serzone)?

See also Warning section.

Before taking nefazodone, tell your doctor or pharmacist if you are allergic to it; or to trazodone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, personal or family history of psychiatric disorder (e.g., bipolar/manic-depressive disorder), personal or family history of suicide attempts, heart/blood vessel disease (e.g., history of stroke/heart attack), loss of too much body water (dehydration), seizures, intestinal ulcers/bleeding (peptic ulcer disease).

Before having surgery, tell your doctor or...

Read All Potential Precautions of Serzone »


Serzone Consumer (continued)

SIDE EFFECTS: See also Warning section.

Dizziness, drowsiness, lightheadedness, nausea, dry mouth, or constipation may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: vision changes (e.g., blurred vision), confusion, weakness, fainting, seizures, easy bleeding/bruising.

Seek immediate medical attention if any of these rare but very serious side effects occur: black stools, vomit that looks like coffee grounds.

For males, in the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Warning section.

Before taking nefazodone, tell your doctor or pharmacist if you are allergic to it; or to trazodone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, personal or family history of psychiatric disorder (e.g., bipolar/manic-depressive disorder), personal or family history of suicide attempts, heart/blood vessel disease (e.g., history of stroke/heart attack), loss of too much body water (dehydration), seizures, intestinal ulcers/bleeding (peptic ulcer disease).

Before having surgery, tell your doctor or dentist that you are using this medication.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages since they can make you dizzy or drowsy and also cause liver disease.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially dizziness/drowsiness or bleeding.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.



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