Xylac: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

XYLAC^TM is used to help relieve the symptoms of schizophrenia.

What it does:

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

When it should not be used:

You should not use XYLAC^TM if you:

• Have an allergy to loxapine, to any of the ingredients in XYLAC^TM or components of the container, or to phenothiazines.
• Have a medical condition known as pheochromocytoma (a tumor of the adrenal gland).
• Have a severe heart or blood vessel disorder.
• Have a severe kidney problem.
• Have had brain damage.
• Have a liver disease.
• Have a blood cell disorder such as anemia, low white blood cell counts, or low platelets.
• Have drowsiness, slow breathing, or a weak pulse.

• Have decreased alertness caused by taking certain medications or drinking alcohol.

• Are going to receive anesthesia in the spine or for a region (such as an arm, leg or the lower part of your body).
• Have a circulatory collapse.

What the medicinal ingredient is:

Tablet: Loxapine 2.5, 5, 10, 25 & 50 mg per tablet (as loxapine succinate).

Oral concentrate: Loxapine 25mg/mL (as loxapine hydrochloride).

What the non-medicinal ingredients are:

XYLAC^TM tablets: Colloidal Silicon Dioxide, Croscarmellose Sodium, Hydroxypropyl Methylcellulose, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Pregelatinized Starch and Titanium Dioxide.

Additional ingredients:

2.5 mg tablets also contain FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and Polysorbate 80

5 mg tablets also contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and Polysorbate 80.

10 mg tablets also contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Red No. 40 Aluminum Lake and Polysorbate 80.

25 mg tablets also contain D&C Red No. 27 Aluminum Lake, FD&C Red No. 40 Aluminum Lake and Polysorbate 80.

50 mg tablets also contain hydroxypropyl cellulose.

Oral concentrate contains propylene glycol, purified water and sodium hydroxide.

What dosage forms it comes in:

Tablets: 2.5, 5, 10, 25 and 50 mg

Oral concentrate: 25 mg/mL

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions Studies with various medicines of the group to which XYLAC^TM belongs, when used in the elderly patients with dementia, have been associated with an increased rate of death.

XYLAC^TM is not indicated in elderly patients with dementia.

Before you use XYLAC^TM talk to your doctor or pharmacist if:

• You have heart disease, glaucoma or prostatic hypertrophy.

• You have risk factors for developing blood clots

  such as: a family history of blood clots, age over 65, smoking, obesity, recent major surgery (such as hip or knee replacement), immobility due to air travel or other reason, or take oral contraceptives ("The Pill").

• You are addicted to alcohol. You should not take XYLAC^TM if you are under the effects of alcohol.

• You are pregnant. XYLAC^TM should not be used during pregnancy unless your doctor considers that the benefits to you markedly outweigh 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 breast feeding.
• You have difficulty urinating.
• You have a history of breast cancer.

XYLAC^TM 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 XYLAC^TM 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 XYLAC^TM are cautioned:

• Against exposure to extreme heat.

• That drugs such as XYLAC^TM 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 XYLAC^TM.

  If you have any of these other conditions, you may need a dose adjustment or special tests to safely use XYLAC^TM.

INTERACTIONS WITH THIS MEDICATION

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

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

Before using XYLAC^TM, 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 XYLAC^TM if you have drowsiness caused by other medications.

Drugs that may interact with XYLAC^TM include: anti-anxiety agents, antidepressants, muscle relaxants, anti-seizure 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,

dehydroepiandrosterone, metoclopramide, and zotepine 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 XYLAC^TM.

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:

XYLAC^TM is not recommended to:

Overdose symptoms may include agitation and confusion, drowsiness, dizziness, muscle stiffness or twitching, increased salivation, trouble swallowing, weakness, loss of balance or coordination, weak pulse, slow heart rate, weak or shallow breathing, fainting, or seizure (convulsions).

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, XYLAC^TM 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 or difficulty urinating, severe constipation, 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, blurred vision, itching, flaky skin, insomnia, weakness, and unusual bruising or bleeding.

If any of these affects you severely, tell your doctor.

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

Your doctor should take blood tests before starting XYLAC^TM to 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.

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

HOW TO STORE IT

Store XYLAC^TM tablets and oral concentrate at room temperature (15°C to 30°C) in tightly closed containers.

Do not use after the expiry date shown on the bottle.

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

REPORTING SUSPECTED 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:

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• 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, Ontario K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ 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 obtained by contacting the sponsor, PENDOPHARM, Division of Pharmascience Inc., at:

1-888-550-6060

Last revised: May 15, 2012.