Consumer Information for: PERPHENAZINE

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

Perphenazine is used to:

  • To treat psychotic disorders
  • To control nausea and vomiting
What it does

PERPHENAZINE is an antipsychotic medication which affects chemicals in the brain that allow communications between nerve cells (neurotransmitters). These chemicals are called dopamine and serotonin. Exactly how PERPHENAZINE works is unknown. However, it seems to readjust the balance of dopamine and serotonin.

When it should not be used

You should not use PERPHENAZINE if you have:

  • An allergy to Perphenazine, to any of its ingredients or to phenothiazines
  • A medical condition known as pheochromocytoma (a tumor of the adrenal gland)
  • A severe heart or blood vessel disorder
  • Severe kidney problems
  • Had brain damage
  • Liver disease
  • A blood cell disorder such as anemia, low white blood cell counts, or low platelets
  • Drowsiness, slow breathing, weak pulse
  • Decreased alertness caused by taking certain medications or drinking alcohol
  • You are going to receive anesthesia in the spine or for a region (such as an arm, leg or the lower part of your body)
What the medicinal ingredient is

Perphenazine

What the non-medicinal ingredients are

Carnauba wax, croscarmellose sodium, dextrates and magnesium stearate; film coat: D&C Yellow No. 10 Lake, FD&C Yellow No. 6 Lake, hydroxypropyl methylcellulose, polyethylene glycol and titanium dioxide.

What dosage form it comes in

Tablets: 2, 4, 8 and 16 mg

Warnings and precautions

Serious Warnings and Precautions

Studies with various medicines of the group to which PERPHENAZINE belongs, when used in the elderly patients with dementia, have been associated with an increased rate of death. PERPHENAZINE is not indicated in elderly patients with dementia.

Before you use PERPHENAZINE talk to your doctor or pharmacist if:

  • You have heart disease, glaucoma or prostatic hypertrophy
  • You are addicted to alcohol. You should not take PERPHENAZINE if you are under the effects of alcohol.
  • You are pregnant. PERPHENAZINE should not be used during pregnancy unless your doctor considers the benefits to you markedly outweighs the potential risks to the fetus
  • You are taking barbiturates, painkillers, narcotics or, antihistamines or other drugs that make you drowsy.
  • You have any allergies to this drug or its ingredients
  • You have or ever had a blackout or seizure
  • You are breastfeeding.
  • You are breastfeeding.

PERPHENAZINE may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery, especially during the first few days of therapy. You should be cautious when performing potentially hazardous tasks.

Effects on Newborns:
In some cases, babies born to a mother taking PERPHENAZINE during pregnancy have experienced symptoms that are severe and require the newborn to be hospitalized. Sometimes, the symptoms may resolve on their own. Be prepared to seek immediate emergency medical attention for your newborn if they have difficulty breathing, are overly sleepy, have muscle stiffness, or floppy muscles (like a rag doll), are shaking, or are having difficulty feeding.

People who take PERPHENAZINE are cautioned:

  • Against exposure to extreme heat
  • That drugs such as PERPHENAZINE increase the toxicity of certain types of insecticides ("organophosphorous" insecticides) including insecticides for agriculture (farming), treating animals (flea and tick control) and for treating pests around the house and garden. Be cautious if you must use these products while taking PERPHENAZINE
Interactions with this medication

PERPHENAZINE can add to the effects of alcohol. You should avoid consuming alcoholic beverages while on PERPHENAZINE therapy.

Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products (such as St. John’s Wort), and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Before using PERPHENAZINE, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxants, and medicine for seizures, depression, or anxiety). You should not take PERPHENAZINE if you have drowsiness caused by other medications.

Drugs that may interact with PERPHENAZINE include: anti-anxiety agents, antidepressants, muscle relaxants, antiseizure medicine, high blood pressure medicine, cabergoline, metrizamide, guanethidine, guanadrel, grepafloxacin, sparfloxacin, lithium, cisapride, atropine-like drugs, narcotic pain relievers (e.g., codeine), drugs used to aid sleep, drowsiness-causing antihistamines (e.g., diphenhydramine), other drugs that may make you drowsy.

Many cough-and-cold products contain ingredients that may add a drowsiness effect. Before using cough-and-cold medications, ask your doctor or pharmacist about the safe use of those products. Do not start or stop any medicine without doctor or pharmacist approval.

This list is not complete and there may be other drugs that can interact with PERPHENAZINE.

Proper use of this medication

Take this medication by mouth exactly as prescribed. During the first few days your doctor may gradually increase your dose to allow your body to adjust to the medication. Do not take this more often or increase your dose without consulting your doctor. Your condition will not improve any faster but the risk of serious side effects will be increased. Do not stop taking this drug suddenly without your doctor's approval.

Your doctor will decide which dose is best for you.

Usual dose

Your doctor should adjust your dose according to the severity of your condition and the response obtained. Unless you are hospitalized, your dose ordinarily should not exceed 24 mg. Severely disturbed hospitalized psychiatric patients or those with resistant mental and emotional disorders may temporarily require more than 24 mg daily, especially during early management. It is very important to use the lowest effective dose since extrapyramidal symptoms increase in frequency and severity with increased dosage. If you are taking PERPHENAZINE to control severe nausea and vomiting, you may be prescribed daily doses of 8 to 16 mg given in divided amounts. The lower range of adult dosage may be used in children over 12.

To treat psychotic disorders:

Moderately disturbed nonhospitalized patients with schizophrenia

4 to 8 mg three times a day initially; reduce as soon as possible to the lowest effective dose.

Hospitalized patients with schizophrenia
8 to 16 mg two to four times a day; the dose should not exceed 64 mg a day.

To control nausea and vomiting:

8 to 16 mg daily in divided doses; 24 mg occasionally may be necessary; early dosage reduction is desirable.

Overdose

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Overdose symptoms may include agitation, and confusion, drowsiness, dizziness, muscle stiffness or twitching, increased salivation, trouble swallowing, weakness, loss of balance or coordination, and fainting

Missed Dose

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not double your dose to make up the missed dose.

Side effects and what to do about them

Like other medications, PERPHENAZINE may cause some side effects. These side effects may be minor and temporary. However, some may be serious and need medical attention.

Side effects may include: sweating, urinary incontinence, dizziness, drowsiness, dry mouth, nasal congestion, nausea and vomiting, headache, menstrual changes, change in libido, swelling of the breasts and milk production in both men and women, weight changes and blurred vision. If any of these affects you severely, tell your doctor.

Your doctor should check your body weight before starting PERPHENAZINE and continue to monitor it for as long as you are being treated.

Your doctor should take blood tests before starting PERPHENAZINE. They will monitor blood sugar, and the number of infection fighting white blood cells. Your doctor should continue to monitor your blood for as long as you are being treated.

If you have high levels of prolactin (measured with a blood test) and a condition called hypogonadism you may be at increased risk of breaking a bone due to osteoporosis. This occurs in both men and women.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor or pharmacist Only if severe Talk with your doctor or pharmacist In all cases Stop taking drug and talk with your doctor or pharmacist
Unknown
Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing     ✔
Neuroleptic Malignant Syndrome: any group of symptoms which may include high fever, sweating, stiff muscles, fast heartbeat, fast breathing and feeling confused, drowsy or agitated     ✔
Extrapyramid al Symptoms: muscle stiffness, body spasm, upward eye rolling, exaggeration of reflexes, drooling, difficulty moving how and when you want.     ✔
Fast or irregular heartbeat   ✔  
Seizures or fits     ✔
Long-lasting (greater than 4 hours in duration) and painful erection of the penis     ✔
Tardive Dyskinesia: uncontrollable movements or twitches of the body, face, eyes or tongue, stretching the neck and body   ✔  
Low Blood Pressure: feeling of Lightheadedness or fainting especially when getting up from a lying or sitting position)   ✔  
High Blood Pressure: headaches, vision disorders, nausea and vomiting   ✔  
Decreased sweating   ✔  
Jaundice: yellow colour to skin and eyes, dark urine   ✔  
Respiratory Infection: fever, flu-like symptoms, coughing, difficult or fast breathing   ✔  
New or worsening constipation   ✔  
Blood Clots: swelling, pain and redness in an arm or leg that is warm to touch. You may develop sudden chest pain, difficulty breathing and heart palpitations   ✔  
Akathisia: a feeling of restlessness, inability to remain motionless   ✔  
Vision Changes: blurred vision, glaucoma or other eye disorder   ✔  
Increased Blood Sugar: frequent urination, thirst and hunger   ✔  

This is not a complete list of side effects. For any unexpected effects while taking PERPHENAZINE, contact your doctor or pharmacist.

How to store

Store at controlled room temperature (between 15 to 30°C). Do not use after the expiry date shown on the bottle.

Keep this and all medications out of the reach and sight of children.

Reporting side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
                    Health Canada
                    Postal Locator 0701E
                    Ottawa, Omtario
                    K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

This document plus the full product monograph, prepared for health professionals can be found at:
http://www.aapharma.ca
or by contacting the sponsor, AA Pharma Inc.
at:
(905)669-0528 or 1-800-667-4708

This leaflet was prepared by AA Pharma Inc.,
                                              1165 Creditstone Road, Unit#1,
                                              Vaughan, ON
                                              L4K 4N7

Last revised: June 6, 2012

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