Apo-Oxazepam: Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is APO-OXAZEPAM used for?

APO-OXAZEPAM is used in adults to relieve:

• short-term anxiety and tension from anxiety neurosis (a type of anxiety); and

• symptoms of sudden alcohol withdrawal (e.g., agitation and mental status changes).

If you are 65 years or older, talk to your healthcare professional before starting APO-OXAZEPAM. APO-OXAZEPAM may not be an effective treatment for you, and you may be more sensitive to experiencing side effects.

How does APO-OXAZEPAM work?

APO-OXAZEPAM belongs to the group of medicines called benzodiazepines, which are Central Nervous System (CNS) depressants. It affects certain substances in your brain called neurotransmitters to reduce symptoms cause by anxiety and stress.

What are the ingredients in APO-OXAZEPAM?

Medicinal ingredient: Oxazepam.

Non-medicinal ingredients: Colloidal silicon dioxide, croscarmellose sodium, D&C Yellow # 10 Aluminum Lake 14-18% (10 mg and 15 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, and Sunset Yellow Aluminum Lake 40% (10 mg and 15 mg).

APO-OXAZEPAM comes in the following dosage forms:

Tablets: 10 mg, 15 mg and 30 mg of oxazepam.

Do not use APO-OXAZEPAM if:

• you are allergic to benzodiazepines, such as oxazepam, or to any other ingredient in APO-OXAZEPAM;
• you are under 12 months of age;
• you have a history of glaucoma (increased pressure in your eye causing damage to the optic nerve); and
• you have myasthenia gravis (a condition characterized by weakness of your muscles used for movement).

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

• have ever had a problem with:

  • substance use, including prescribed or illegal drugs, or
  • alcohol.
• have ever had seizures or convulsions (violent uncontrollable shaking of the body with or without loss of consciousness).
• are 65 years of age or older.
• have or have had a mental health disorder (e.g., psychosis, personality disorder and obsessive-compulsive disorder).
• have depression or signs of depression.
• have a condition that causes weakness or frailty.
• have liver problems.
• have kidney problems.

• are pregnant or plan to become pregnant.

• are breastfeeding or plan to breastfeed.
• drink or plan to drink alcohol. Do NOT drink alcohol while you take APO-OXAZEPAM.
• unable to digest some milk sugars (e.g., lactose intolerance). APO-OXAZEPAM contains the milk sugar lactose.

Other warnings you should know about:

Severe Allergic Reaction: In rare cases, benzodiazepines like APO-OXAZEPAM have caused severe allergic reactions including anaphylaxis, which can be life-threatening. The symptoms of a severe allergic reaction include angioedema of the tongue or throat (swelling of tissues under the skin), shortness of breath, throat closing, nausea or vomiting. Angioedema can lead to a blocked airway and can be life-threatening. If you develop angioedema or you notice signs of a severe allergic reaction after taking APO-OXAZEPAM, you should stop taking APO-OXAZEPAM and tell your healthcare professional right away.

Withdrawal: If you suddenly stop your treatment, lower your dose too fast, or switch to another medication, you can experience withdrawal symptoms that can range from mild symptoms to severe or life threatening. Some of your withdrawal symptoms can last for months after you stop APO-OXAZEPAM.

Your risk of going through withdrawal is higher if you are taking APO-OXAZEPAM for a long time or at high doses. However, symptoms can still occur if you are taking APO-OXAZEPAM as directed for a short period of time or slowly reducing the dose.

The symptoms of withdrawal often resemble the condition that you are being treated for. After stopping your treatment, it may be hard to tell if you are experiencing withdrawal or a return of your condition (relapse).

Tell your healthcare professional right away if you experience any symptoms of withdrawal after changing or stopping your treatment.

Severe symptoms of withdrawal include:

• feeling like you cannot move or respond (catatonia),
• severe confusion, shivering, irregular heartrate and excessive sweating (delirium tremens),
• feeling depressed,
• feeling disconnected from reality (dissociation),
• seeing or hearing things that are not there (hallucinations),
• overactive behavior and thoughts (mania),
• believing in things that are not true (psychosis),
• convulsions (seizures), including some that do not stop,
• thoughts or actions of suicide.

For other symptoms of withdrawal, see the Serious side effects and what to do about them table (below).

To reduce your chances of going through withdrawal:

• always contact your healthcare professional before stopping or reducing your dose of APO-OXAZEPAM or changing medications.
• always follow your healthcare professional’s instructions on how to reduce your dose carefully and safely.
• tell your healthcare professional right away if you experience any unusual symptoms after changing or stopping your treatment.

APO-OXAZEPAM with Opioids: Taking APO-OXAZEPAM with opioid medicines can cause severe drowsiness and breathing problems.

Tell your healthcare professional if you:

• are taking opioid medicines.
• are prescribed an opioid medicine after you start taking APO-OXAZEPAM.

Driving and Using Machines: Do NOT drive or operate heavy machinery or do tasks that require special attention while taking APO-OXAZEPAM. This is especially important if you are taking other depressants like an opioid medicine.

Falls and Fractures: Benzodiazepines like APO-OXAZEPAM can cause you to feel sleepy, dizzy and affect your balance. This increases your risks of falling, which can cause fractures or other fall related-injuries especially if you:

• take other sedatives,
• consume alcohol,
• are elderly, or
• have a condition that causes weakness or frailty.

Monitoring and Testing: Your healthcare professional may conduct blood tests to assess your health, especially at the start of your treatment. Your healthcare professional will interpret your results and may adjust or stop your dose of APO-OXAZEPAM.

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-OXAZEPAM:

• alcohol. Do not take APO-OXAZEPAM if you drink alcohol;
• medicines used to treat allergies such as, sedative antihistamines;
• medicines used to prevent or treat seizures (anticonvulsants);
• medicines used to produce a local or general loss of sensation, including pain (anesthetics);
• medicines used to treat depression (antidepressants);
• medicines used to treat mental health disorders or change your mental state or mood (antipsychotic and psychotropic medications);
• medicines that inhibit certain liver enzymes, particularly cytochrome P450 (e.g., cimetidine and erythromycin). If you are unsure, talk to your healthcare professional;
• other benzodiazepines typically used to treat anxiety, insomnia and seizures.

DO NOT USE APO-OXAZEPAM along with other medications without first discussing this with your healthcare professional.

How to take APO-OXAZEPAM:

• Take APO-OXAZEPAM exactly as prescribed by your healthcare professional.
• You should take APO-OXAZEPAM with a glass of water.
• Do not consume any alcohol while taking APO-OXAZEPAM.
• Always follow your healthcare professional’s instructions on how to lower and stop your dose carefully. This helps to avoid unwanted effects. However, if you notice any signs or symptoms of withdrawal, tell your healthcare professional right away.

Usual dose:

Your healthcare professional will determine the right dose and the length of APO-OXAZEPAM treatment for you. This will depend on your age, current health, and if you take certain other medications. They may also adjust your dose to ensure that the lowest effective dose is prescribed.

Overdose:

Symptoms of an overdose with APO-OXAZEPAM include:

• drowsiness,
• muscle weakness,
• loss of coordination,
• speaking problems,
• abnormal movements (paradoxical excitement),
• slower reflexes,
• confusion,
• coma,
• low blood pressure,
• breathing difficulties.

Missed Dose:

If you forget or miss a dose of APO-OXAZEPAM, do not take the missed dose. Instead, take the next scheduled dose at the usual time. Do not try to make up for the missed dose by taking a double dose.

What are possible side effects from using APO-OXAZEPAM?

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

Side effects of APO-OXAZEPAM include:

• falls and fractures,
• drowsiness,
• dizziness,
• fatigue,
• difficulties with coordination,
• slow response,
• headache,
• vertigo,
• blurred or double vision,
• weakness,
• memory loss,
• reduced activity or lack of energy,
• speech problems,
• a feeling or state of intense excitement and happiness,
• anorexia (an eating disorder characterized by not eating or loss of appetite),
• nausea,
• constipation,
• urinating difficulties,
• changes in sex drive (libido),
• anxiety,
• uncontrollable shaking, muscle twitches or spasms.

Serious side effects and what to do about them

Serious side effects and what to do about them

Serious side effects and what to do about them

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

Storage:

Store APO-OXAZEPAM at room temperature 15˚C - 30˚C.

Keep APO-OXAZEPAM in a safe place out of reach and sight of children.

If you want more information about APO-OXAZEPAM:

• 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://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.

Last Revised: SEP 05, 2023