Amitriptyline and perphenazine

Name: Amitriptyline and perphenazine

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of amitriptyline and perphenazine can be fatal.

Overdose symptoms may include uneven heartbeats, extreme drowsiness, confusion, agitation, hallucinations, vomiting, feeling hot or cold, muscle stiffness, fainting, seizure (convulsions), or coma.

Amitriptyline and perphenazine side effects

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

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

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:

  • severe constipation;

  • a light-headed feeling, like you might pass out;

  • fast, slow, or uneven heart rate;

  • chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

  • sudden numbness or weakness, slurred speech, problems with vision or balance;

  • sudden ill feeling, fever, chills, sore throat, easy bruising, unusual bleeding, pale skin;

  • dark urine, jaundice (yellowing of the skin or eyes);

  • urinating more or less than usual;

  • a seizure (convulsions); or

  • severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Common side effects may include:

  • drowsiness, headache;

  • strange dreams or nightmares;

  • sleep problems (insomnia);

  • blurred vision;

  • dry mouth, loss of appetite;

  • nausea, vomiting, diarrhea, constipation;

  • breast changes; or

  • decreased sex drive, impotence, or difficulty having an orgasm.

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.

What do I need to tell my doctor BEFORE I take Amitriptyline and Perphenazine?

  • If you have an allergy to amitriptyline, perphenazine, or any other part of amitriptyline and perphenazine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Bone marrow disease or recent heart attack.
  • If you have recently drunk a lot of alcohol or taken a big amount of drugs that may slow your actions like phenobarbital or some pain drugs like oxycodone.
  • If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking this medicine within 14 days of those drugs can cause very bad high blood pressure.

This is not a list of all drugs or health problems that interact with amitriptyline and perphenazine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

How is this medicine (Amitriptyline and Perphenazine) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food. Take with food if it causes an upset stomach.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

Index Terms

  • Perphenazine and Amitriptyline Hydrochloride

ALERT U.S. Boxed Warning

Suicidality in children and adolescents:

Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of perphenazine/amitriptyline or any other antidepressant in a child or adolescent 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 wand 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. Perphenazine/amitriptyline is not approved for use in pediatric patients.

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 17 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 (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies sugges 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. Perphenazine and amitriptyline is not approved for the treatment of patients with dementia-related psychosis.

Monitoring Parameters

Mental status; suicidal ideation (especially at the beginning of therapy or when doses are increased or decreased); vital signs (as clinically indicated); weight, height, BMI, waist circumference (baseline; at every visit for the first 6 months; quarterly with stable antipsychotic dose); CBC (as clinically indicated; monitor frequently during the first few months of therapy in patients with preexisting low WBC or history of drug-induced leukopenia/neutropenia); electrolytes, renal and liver function (annually and as clinically indicated; if BUN becomes abnormal, discontinue treatment); fasting plasma glucose level/HbA1c (baseline, then yearly; in patients with diabetes risk factors or if gaining weight, repeat 4 months after starting antipsychotic, then yearly); lipid panel (baseline; repeat every 2 years if LDL level is normal; repeat every 6 months if LDL level is >130 mg/dL); changes in menstruation, libido, development of galactorrhea, erectile and ejaculatory function (at each visit for the first 12 weeks after the antipsychotic is initiated or until the dose is stable, then yearly); abnormal involuntary movements or Parkinsonian signs (baseline; repeat weekly until dose stabilized for at least 2 weeks after introduction and for 2 weeks after any significant dose increase); tardive dyskinesia (every 6 months; high-risk patients every 3 months); visual changes (inquire yearly); ocular examination (yearly in patients >40 years; every 2 years in younger patients) (ADA 2004; Lehman 2004; Marder 2004).

For the Consumer

Applies to amitriptyline / perphenazine: oral tablet

Along with its needed effects, perphenazine (included in this combination medicine) can sometimes cause serious side effects. Tardive dyskinesia (a movement disorder) may occur and may not go away after you stop using the medicine. Signs of tardive dyskinesia include fine, worm-like movements of the tongue, or other uncontrolled movements of the mouth, tongue, cheeks, jaw, or arms and legs. Other serious but rare side effects may also occur. These include severe muscle stiffness, fever, unusual tiredness or weakness, fast heartbeat, difficult breathing, increased sweating, loss of bladder control, and seizures (neuroleptic malignant syndrome). You and your doctor should discuss the good this medicine will do as well as the risks of taking it.

Stop taking amitriptyline / perphenazine and get emergency help immediately if any of the following effects occur:

Rare
  • Convulsions (seizures)
  • difficulty in breathing
  • fast heartbeat
  • fever
  • high or low blood pressure
  • increased sweating
  • loss of bladder control
  • muscle stiffness (severe)
  • unusual tiredness or weakness
  • unusually pale skin

Check with your doctor as soon as possible if any of the following side effects occur while taking amitriptyline / perphenazine:

More common
  • Blurred vision or any change in vision
  • difficulty in speaking or swallowing
  • fainting
  • inability to move eyes
  • lip smacking or puckering
  • loss of balance control
  • mask-like face
  • muscle spasms, especially of face, neck, and back
  • nervousness, restlessness, or need to keep moving
  • puffing of cheeks
  • rapid or fine, worm-like movements of tongue
  • shuffling walk
  • stiffness of arms and legs
  • trembling and shaking of fingers and hands
  • tic-like or twitching movements
  • twisting movements of body
  • uncontrolled chewing movements
  • uncontrolled movements of arms or legs
  • weakness of arms and legs
Less common
  • Confusion
  • constipation
  • difficult urination
  • eye pain
  • hallucinations (seeing, hearing, or feeling things that are not there)
  • increased skin sensitivity to sun
  • shakiness
  • slow pulse or irregular heartbeat
Rare
  • Abdominal or stomach pain
  • aching muscles or joints
  • back or leg pain
  • fever and chills
  • hair loss
  • hot, dry skin or lack of sweating
  • irritability
  • loss of appetite
  • muscle weakness or twitching
  • nausea, vomiting, or diarrhea
  • nosebleeds
  • prolonged, painful, inappropriate penile erection
  • ringing, buzzing, or other unexplained noises in ears
  • skin discoloration
  • skin rash and itching
  • sore throat and fever
  • swelling of face and tongue
  • swelling of testicles
  • unusual bleeding or bruising
  • yellow eyes or skin
Symptoms of overdose
  • Agitation
  • confusion
  • convulsions (seizures)
  • drowsiness (severe)
  • enlarged pupils
  • fast, slow, or irregular heartbeat
  • fever
  • hallucinations (seeing, hearing, or feeling things that are not there)
  • shortness of breath or troubled breathing
  • unusual tiredness or weakness (severe)
  • vomiting (severe)

Some side effects of amitriptyline / perphenazine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Decreased sweating
  • dizziness
  • drowsiness
  • dryness of mouth
  • headache
  • increased appetite for sweets
  • nasal congestion
  • tiredness or weakness (mild)
  • unpleasant taste
  • weight gain (unusual)
Less common
  • Changes in menstrual period
  • decreased sexual ability
  • heartburn
  • increased sweating
  • swelling or pain in breasts or unusual secretion of milk

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

  • Dizziness
  • nausea or vomiting
  • stomach pain
  • trembling of fingers and hands
  • symptoms of tardive dyskinesia, including lip smacking or puckering, puffing of cheeks, rapid or fine, worm-like movements of tongue, uncontrolled chewing movements, or uncontrolled movements of arms or legs

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

  • Diarrhea
  • headache
  • irritability
  • restlessness
  • trouble in sleeping, with vivid dreams
  • unusual excitement

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