Trilafon

Yes

Tablets: 2, 4, 8 and 16 mg.

Perphenazine tablets should be stored between 2 C and 25 C (36 and 77 F).

Trilafon is a prescription medication used to treat schizophrenia and to control severe nausea and vomiting in adults. Trilafon belongs to a group of drugs called first generation or "typical" antipsychotics. The exact way it works is unknown, however it is thought to work by affecting certain chemicals in the brain.

Trilafon comes in tablet form. It is usually taken 2 to 4 times daily.

Common side effects include dry mouth, blurred vision, drowsiness, and dizziness. Do not drive or operate heavy machinery until you know how it affects you.

Common side effects include:

• drowsiness
• dizziness
• blurred vision
• dry mouth
• excess saliva
• stuffed nose
• headache
• nausea
• vomiting
• diarrhea
• constipation
• loss of appetite
• unusual, slowed, or uncontrollable movements of any part of the body
• restlessness
• difficulty falling asleep or staying asleep
• difficult or frequent urination
• breast enlargement
• breast milk production
• impotence

This is not a complete list of Trilafon side effects. Ask your doctor or pharmacist for more information.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• tricyclic antidepressants such as trimipramine (Surmontil), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil)

• selective serotonin reuptake inhibitors (SSRIs) such as escitalopram (Lexapro), sertraline (Zoloft), citalopram (Celexa), vilazodone (Viibryd), paroxetine (Paxil), fluoxetine (Prozac, Sarafem, Symbyax), and fluvoxamine (Luvox)
• medications that block a protein in the body (CYP2D6) such as quinidine (Qualaquin)
• atropine
• other central nervous system depressants such as opiates, analgesics, antihistamines, and barbiturates

This is not a complete list of Trilafon drug interactions. Ask your doctor or pharmacist for more information.

Take Trilafon exactly as prescribed.

Trilafon  comes in tablet form and is taken up to four times every day, with or without food.

The use of alcohol should be avoided, since additive effects and low blood pressure may occur. Patients should be cautioned that their response to alcohol may be increased while they are being treated with Trilafon. The risk of suicide and the danger of overdose may be increased in patients who use alcohol excessively due to its potentiation of the drug’s effect.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Trilafon  at the same time.

• Store Trilafon at 20° – 25°C (68° – 77°F).
• Keep this and all medicines out of the reach of children.

WARNING

Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Trilafon is not approved for the treatment of patients with dementia-related psychosis.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid drinking alcohol. It can increase some of the side effects of perphenazine.

Avoid exposure to sunlight or tanning beds. Perphenazine can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these signs of a serious movement disorder:

• tremors or shaking in your arms or legs;

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement); or

• any new or unusual muscle movements you cannot control.

Also call your doctor at once if you have:

• feeling restless, jittery, or agitated;

• confusion, unusual thoughts or behavior;

• seizure (convulsions);

• extreme drowsiness or dizziness, feeling like you might pass out;

• severe bloating or stomach cramps;

• little or no urinating;

• slow heart rate, weak pulse, weak or shallow breathing;

• sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, red or swollen gums, trouble swallowing; or

• severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, fast or uneven heartbeats.

Older adults may be more likely to have side effects from this medication.

Common side effects may include:

• mild dizziness or drowsiness;

• blurred vision, headache;

• sleep problems (insomnia), strange dreams;

• loss of appetite, vomiting, diarrhea, constipation;

• increased sweating or urination;

• dry mouth or stuffy nose;

• breast swelling or discharge; or

• mild itching or skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.