Apo-Dexamethasone: Uses, Side Effects and Dosage

What is APO-DEXAMETHASONE used for?

APO-DEXAMETHASONE is used:

• in the treatment of various conditions. These include allergy or inflammation;
• to replace corticosteroid hormone when the body does not produce enough. This is due to problems with the adrenal glands;

• for diagnostic testing of:

  • adrenocortical hyperfunction. This is a condition where the adrenal glands produce too much of certain hormones.

  • neonatal respiratory distress of fetus during pregnancy. This is a breathing disorder in newborns caused by immature lungs.

How does APO-DEXAMETHASONE work?

APO-DEXAMETHASONE contains dexamethasone as the active ingredient. Dexamethasone belongs to a group of medicines called corticosteroids. It decreases the body’s immune response to some diseases. This reduces symptoms such as swelling and redness.

What are the ingredients in APO-DEXAMETHASONE?

Medicinal ingredients: dexamethasone

Non-medicinal ingredients: anhydrous lactose, corn starch, D&C Yellow #10 Aluminium Lake 14-18 % (in 0.5 mg tablet only) and magnesium stearate.

APO-DEXAMETHASONE comes in the following dosage forms:

Tablets: 0.5 mg and 4 mg.

Do not use APO-DEXAMETHASONE if:

• you are allergic to dexamethasone or any of the other ingredients of this medicine.
• you have fungal infection that affects the whole body.
• you are planning to receive a type of vaccine called live vaccines.

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

• have or have had any type of infection, like:

  • parasitic infection (ex. cerebral malaria, or amebiasis)
  • bacterial infection (ex. tuberculosis)
  • viral infection (ex. eye herpes)
  • fungal infection that affects the whole body.
• have high blood pressure.
• have heart disease or recently had a heart attack.
• have low levels of potassium and calcium in your blood.
• have an underactive thyroid gland.
• have a bowel disorder or a stomach (peptic) ulcer.
• have osteoporosis (thinning of the bones).
• have myasthenia gravis (a condition causing weak muscles).
• have liver problems (liver cirrhosis).
• have received vaccines for smallpox, measles or chickenpox in the past.
• have eye problems like cataract (clouding of the lens in the eye leading to a decrease in vision) or glaucoma (raised eye pressure).
• have had certain mental or mood conditions like feeling high, sleeping problems, mood swings or severe depression.
• have kidney problems.
• have low sperm count and decreased motility of sperm cells.
• have lactose intolerance.
• have conditions like rheumatoid arthritis or systemic lupus erythematosus.
• are 65 years of age or older.

Other warnings you should know about:

Stopping treatment:

• If you suddenly stop taking APO-DEXAMETHASONE, you may experience:

  • Adrenal insufficiency, a condition where your body does not make enough of the cortisol hormone.
  • “Withdrawal syndrome”. This includes symptoms such as nausea, fatigue, decreased appetite, shortness of breath, low blood pressure, low blood sugar levels, muscle pain, fever, general discomfort, joint pain, dizziness, peeling of skin and fainting.
  • Tell your healthcare professional right away if you experience any symptoms of withdrawal after changing or stopping your treatment. Some of these symptoms can last for months after you stop taking APO-DEXAMETHASONE.

Infections:

• Treatment with APO-DEXAMETHASONE may reduce your body’s ability to fight infections. This can sometimes lead to infections caused by germs that rarely cause infection under normal situations.
• Taking APO-DEXAMETHASONE with other medicines that weakens your immune system may increase your risk of infections.
• During treatment, avoid contact with anyone who has chickenpox, shingles or measles. If you were in contact with any of these infections, contact your healthcare professional right away, even if there are no symptoms.

Female patients:

• If you are pregnant or planning on becoming pregnant while taking APO-DEXAMETHASONE, there are specific risks that you should discuss with your healthcare professional.
• This medicine can cross the placenta and harm your baby.
• Tell your healthcare professional right away if you become pregnant while taking APO-DEXAMETHASONE.
• APO-DEXAMETHASONE can pass into your breast milk and harm your baby. Before taking this medicine, talk to your healthcare professional about the best way to feed your baby during treatment.

Children (less than 18 years of age): APO-DEXAMETHASONE can affect growth in children. Your healthcare professional will regularly monitor growth and development in growing children.

Suppressed reaction to lab tests: If you are doing the following lab tests, tell your healthcare professional that you are taking APO-DEXAMETHASONE. It may interfere with the results.

• Skin test for allergy
• Test for bacterial infection

Check-ups and testing: You will have regular visits with your healthcare professional during treatment with APO-DEXAMETHASONE. They may:

• Check your blood pressure and body weight.
• Take a chest x-ray at regular intervals, during long-term treatment.
• Do urine tests and blood tests to check your blood sugar (2 hours after you start eating a meal), potassium levels and blood health.

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-DEXAMETHASONE:

• acetylsalicylic acid, indomethacin or other Non-Steroidal Anti-Inflammatory Drugs used to reduce fever, pain and inflammation.
• phenytoin used to treat epilepsy.
• phenobarbital used to to aid sleep and relieve anxiety.
• ephedrine used as nasal decongestant.
• rifampin, an antibiotic used to treat tuberculosis.
• coumarin anticoagulants used to prevent the formation of blood clots.
• potassium-depleting diuretics used to treat high blood pressure.
• immunosuppressants used to treat auto immune disorders.
• vaccination with live vaccines.
• other corticosteroids.

How to take APO-DEXAMETHASONE:

• Take APO-DEXAMETHASONE exactly as your healthcare professional tells you.
• Take by mouth.

Usual dose:

APO-DEXAMETHASONE used as treatment:

• Your healthcare professional will decide the best dosage for you based on your condition. They will give you the lowest dose possible for your treatment.
• When your condition has improved, your healthcare professional will reduce your dose gradually. Do NOT change your dose or stop taking APO-DEXAMETHASONE before talking to your healthcare professional.

• Your healthcare professional will monitor your health. They may change your dose, temporarily or completely stop treatment. This may happen if you:

  • Experience serious side effects; or
  • Your disease gets worse.

APO-DEXAMETHASONE used as diagnostic testing (dexamethasone suppression test):

• Your healthcare professional will decide the best dosage for you based on the condition they want to diagnose.

Overdose:

Missed Dose:

• If you forget to take a dose of APO-DEXAMETHASONE, take it as soon as you remember.
• If it is nearly time for the next dose, skip the missed dose. Take the next dose at the usual time.
• Do NOT take a double dose to make up for a forgotten dose.

What are possible side effects from using APO-DEXAMETHASONE?

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

Side effects may include:

• Stomach and intestinal problems:

  • nausea, vomiting
  • diarrhea, constipation
  • stomach irritation
  • abdominal pain
  • changes in appetite

• Musculoskeletal problems:

  • loss of muscle mass
  • muscle pain
  • malaise (feeling of general discomfort or uneasiness)

• Nervous system problems:

  • headache
  • dizziness
  • amnesia
  • vertigo
  • impaired sensation, strength, and reflexes
  • sensation of tingling, tickling, prickling, or burning of a person's skin

• Psychiatric problems:

  • drug dependence
  • abnormal behavior

  • irritability

    • difficulty sleeping

    • Skin problems including:

      • thin fragile skin
      • rash
      • red spots containing blood
      • stretch marks
      • petechiae (reddish spot containing blood that appears in skin)
      • ecchymoses (discoloration of skin due to bleeding under the skin)
      • facial redness
      • abscess

    • Hormone and metabolism problems:

      • suppression of growth in children
      • weight gain
      • abnormal fat deposits
      • acne
      • thinning hair
      • acne
      • increased sweating
  • lightening or darkening of an area of skin
  • hirsutism (a condition in women that results in excessive growth of dark or coarse hair in a male-like pattern),
  • Slow wound healing

  • hypopituitarism (a condition in which your pituitary gland

    • fails to produce one or more of its hormones or does not produce enough of them).
    • thyroid gland problems

    • Other

      • high cholesterol
      • fatigue
      • hiccups

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 at 15°C to 30°C.

Keep out of reach and sight of children.

If you want more information about APO-DEXAMETHASONE:

• 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. Find the Product Monograph on the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708.

Last Revised MAR 16, 2022