Apo-Loxapine: Uses, Side Effects and Dosage

What is APO-LOXAPINE used for?

• APO-LOXAPINE is used to help relieve the symptoms of schizophrenia.

How does APO-LOXAPINE work?

APO-LOXAPINE affects chemicals in the brain that allow communication between nerve cells. These chemicals are called dopamine and serotonin. Exactly how APO-LOXAPINE works is unknown. However, it seems to readjust the balance of dopamine and serotonin.

What are the ingredients in APO-LOXAPINE?

Medicinal ingredients: loxapine (as succinate)

Non-medicinal ingredients: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, D&C yellow #10 aluminum lake (5 mg and 10 mg tablets), FD&C yellow #6 aluminium lake (5 mg tablets only), FD&C blue #1 aluminum lake (10 mg tablets only) and D&C red #30 aluminum lake (25 mg tablets only).

APO-LOXAPINE comes in the following dosage forms:

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

Do not use APO-LOXAPINE if:

• you have an allergy to loxapine, to any of the ingredients in APO-LOXAPINE or

Serious Warnings and Precautions

• APO-LOXAPINE is not for use in elderly patients with dementia.

• There is a higher risk of death when medicines like APO-LOXAPINE are used in elderly patients with dementia

  components of the container, or to phenothiazines

  • You have a medical condition known as pheochromocytoma (a tumor of the adrenal gland)
  • you have a severe heart or blood vessel disorder
  • you have a severe kidney problem
  • you have had brain damage
  • you have a liver disease
  • you have a blood cell disorder such as anemia, low white blood cell counts, or low platelets

  • you have drowsiness, slow breathing, or a weak pulse, caused by some medications or by 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)

If you have any of these conditions, you may need a dose adjustment or special tests to use APO-LOXAPINE safely.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-LOXAPINE. Talk about any health conditions or problems you may have, including if you:

• have heart disease
• have glaucoma
• have prostatic hypertrophy

• 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
  • take oral contraceptives ("The Pill")
• are addicted to alcohol. You should not take APO-LOXAPINE if you are under the effects of alcohol

• are pregnant. APO-LOXAPINE should not be used during pregnancy unless your doctor considers that the benefits to you markedly outweigh the potential risks to the fetus

• are taking

  • barbiturates
  • painkillers
  • narcotics
  • antihistamines
  • other drugs that make you drowsy
• have any allergies to this drug or its ingredients
• have or ever had a blackout or seizure
• are breast feeding
• have difficulty urinating
• have had or have prolonged and/or painful erection
• have Parkinson’s disease or Dementia with Lewy Bodies (DLB)
• have a history of breast cancer

Before using APO-LOXAPINE, tell your doctor if you use other medicines

• that make you sleepy, such as

  • cold or allergy medicine,
  • narcotic pain medicine,
  • sleeping pills,
  • muscle relaxants,
  • medicine for seizures,
  • medicine for depression, or
  • medicines for anxiety

You should not take APO-LOXAPINE if you experience drowsiness caused by other medications.

Other warnings you should know about:

Driving and using machines: Do not drive or operate machinery until you know how you respond to APO-LOXAPINE. Some people experience drowsiness, or blurred vision while taking APO-LOXAPINE.

Falls: The following symptoms have been reported with the use of antipsychotic drugs:

• feeling sleepy,
• a fall in blood pressure when you stand up from sitting or lying down,
• vision or speech problems

This can lead to falls that may cause fractures or other fall-related injuries. Certain medications, diseases or conditions can make this worse.

Dysphagia: Tell your doctor if you have difficulty swallowing food or have esophageal dysmotility (problems with your food pipe) as there is a risk of pneumonia caused by inhaling food or liquid that gets into your lungs.

Effects in Newborns: Babies born to mothers taking APO-LOXAPINE while they are pregnant can have serious health problems. Sometimes, the problems may get better on their own. Be prepared to get immediate medical help for your baby if they:

• have trouble breathing
• are overly sleepy
• have muscle stiffness or floppy muscles (like a rag doll)
• are shaking
• are having trouble feeding

Thoughts of Suicide and Worsening of your Depression or Other Mental Illnesses: You may sometimes have thoughts of harming or killing yourself if you are:

• depressed and/or
• have other mental illnesses

Since medicines like APO-LOXAPINE take time to work, usually about two weeks but sometimes longer, these thoughts occur more often when you first start treatment.

If you have thoughts of harming or killing yourself at any time, contact your healthcare professional or go to a hospital right away. You may find it helpful to tell a relative or close friend that you are depressed or have other mental illnesses. Ask them to read this leaflet. You might ask them to tell you if they:

• think your depression or mental illness is getting worse, or
• if they are worried about changes in your behavior

Before using APO-LOXAPINE, 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 APO-LOXAPINE if you have drowsiness caused by other medications.

APO-LOXAPINE is not recommended for:

• Patients under 18 years of age
• Patients 65 years of age or older
• Elderly patients with dementia.

People who take APO-LOXAPINE are

cautioned:

• Against exposure to extreme heat;

• That drugs such as APO-LOXAPINE may 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 APO-LOXAPINE.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with APO-LOXAPINE:

• 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)
• drugs that may make you drowsy
• dehydroepiandrosterone
• metoclopramide
• 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.

How to take APO-LOXAPINE:

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:

Take one dose 2 to 4 times daily as directed by your

doctor. Take the tablets with a full glass of water.

Overdose:

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,

If you think you, or a person you are caring for, have taken too much APO-LOXAPINE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

• weak or shallow breathing,
• fainting, or
• seizure (convulsions).

Missed Dose:

If you miss a dose, take it as soon as possible. However, if it is almost time to take your next dose, skip the missed dose and go back to the regular dosing schedule. Do not double dose.

What are possible side effects from using APO-LOXAPINE?

These are not all the possible side effects you may have when taking APO-LOXAPINE. If you experience any side effects not listed here, tell your healthcare professional.

Like other medications, APO-LOXAPINE 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 APO-LOXAPINE and continue to check it for as long as you are being treated.

Your doctor should take blood tests before starting APO-LOXAPINE to monitor blood sugar, and white blood cells that fight infection. Your doctor should continue to monitor your blood for as long as you are being treated.

You may be at risk of breaking a bone due to osteoporosis if you have:

• high levels of a hormone called prolactin (measured with a blood test) and
• a condition called hypogonadism (low sex hormones). This can occur in men and women.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health- canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store at room temperature (15°C to 25°C). Do not use after the expiry date shown on the bottle.

Keep out of reach and sight of children.

If you want more information about APO-LOXAPINE:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp). Find the Patient Medication Information on the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708.

Apotex Inc.

Toronto, Ontario

M9L 1T9

Last Revised February 3, 2022