PMS-Dexamethasone Elixir: Uses, Side Effects and Dosage

What is pms-DEXAMETHASONE ELIXIR used for?

pms-DEXAMETHASONE ELIXIR is used in adults:

• 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 the fetus during pregnancy. This is a breathing disorder in newborns caused by immature lungs.

How does pms-DEXAMETHASONE ELIXIR work?

pms-DEXAMETHASONE ELIXIR contains dexamethasone. 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 pms-DEXAMETHASONE ELIXIR?

Medicinal ingredients: dexamethasone

Non-medicinal ingredients: alcohol (5% v/v), artificial raspberry flavor, benzoic acid, citric acid, FD&C Red No. 40, methylparaben, propylparaben, propylene glycol (93 mg/mL), sodium citrate dehydrate, sucrose and purified water.

pms-DEXAMETHASONE ELIXIR comes in the following dosage forms:

Elixir (oral solution): 0.5 mg / 5 mL

Do not use pms-DEXAMETHASONE ELIXIR if:

• you are allergic to dexamethasone or any of the other ingredients of pms-DEXAMETHASONE

  • ELIXIR.
• you have a fungal infection that affects your whole body.
• you have any other type of infection that affects your whole body that is not being treated.
• you have a stomach ulcer or duodenal ulcer.
• you have an infection with tropical worms.
• you have or think you might have an eye infection.
• you have advanced glaucoma (increased eye pressure).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take pms-DEXAMETHASONE ELIXIR. 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, amebiasis or threadworm)
  • bacterial infection (ex. tuberculosis)
  • viral infection (ex. eye herpes)
  • fungal infection
• have received or are going to receive a live or live-attenuated vaccine or vaccines for smallpox, measles or chickenpox.
• have a cancer of the blood. You may be at risk of a very rare, potentially life-threatening condition resulting from a sudden breakdown of tumour cells (tumour lysis syndrome).
• have kidney problems
• have liver problems (cirrhosis)
• have high blood pressure
• have heart disease or recently had a heart attack
• have low levels of potassium and calcium in your blood
• have diabetes or a family history of diabetes
• have thinning of the bones (osteoporosis), particularly if you are a female who has been through menopause
• have myasthenia gravis (a condition causing muscle weakness)
• have had muscle weakness after using pms-DEXAMETHASONE ELIXIR or other corticosteroids
• have eye problems like cataract (clouding of the lens leading to a decrease in vision) or glaucoma (increased eye pressure)
• have a bowel disorder
• have had certain mental or mood conditions like feeling high, sleeping problems, mood swings or severe depression or a condition which was made worse by this type of medicine such as ‘steroid psychosis’
• have an underactive thyroid gland
• have a tumour of the adrenal glands (pheochromocytoma)
• have a low sperm count and decreased motility of sperm cells
• are 65 years of age or older

Other warnings you should know about:

Serious Side Effects:

• Skin cancer (Kaposi’s sarcoma): Kaposi’s sarcoma has been reported with corticosteroid use, such as pms-DEXAMETHASONE ELIXIR. Stopping treatment with pms-DEXAMETHASONE ELIXIR may result in signs of the cancer going away.
• Tumour of the adrenal glands (pheochromocytoma): This tumour has been reported with corticosteroid use, such as pms-DEXAMETHASONE ELIXIR. Pheochromocytoma may cause death.

Stopping Treatment: If you suddenly stop taking pms-DEXAMETHASONE ELIXIR, 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, dizziness, peeling of the skin, 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 pms-DEXAMETHASONE ELIXIR.

Infections:

• Treatment with pms-DEXAMETHASONE ELIXIR may reduce your body’s ability to fight infections. This can sometimes lead to infections caused by germs that rarely cause infections under normal situations.
• Taking pms-DEXAMETHASONE ELIXIR with other medicines that weaken your immune system may increase your risk of infections.
• During treatment, avoid contact with anyone who has chickenpox, shingles or measles. If you are 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 with taking pms-DEXAMETHASONE ELIXIR, 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 pms-DEXAMETHASONE ELIXIR.
• pms-DEXAMETHASONE ELIXIR can pass into your breastmilk and harm your baby. Before taking this medicine, talk to your healthcare professional about the best way to feed your baby during treatment.

Driving and using Machines: pms-DEXAMETHASONE ELIXIR can cause confusion, hallucinations, dizziness, tiredness, sleepiness, fainting and blurred vision. Give yourself time after taking pms-DEXAMETHASONE ELIXIR to see how you feel before driving a vehicle or using machinery.

Suppressed Reaction to Lab Tests: If you are doing the following lab tests, tell your healthcare professional that you are taking pms-DEXAMETHASONE ELIXIR. 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 pms-DEXAMETHASONE ELIXIR. They may:

• Check your blood pressure, body weight and eye health.
• 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.

Surgery: If you are going to have surgery, including at the dentist office, tell your healthcare professional that you are taking pms-DEXAMETHASONE ELIXIR.

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 pms-DEXAMETHASONE ELIXIR:

• Medicines to treat heart and blood problems, such as warfarin and digitalis, high blood pressure medicine and water tablets (diuretics)
• Medicines used to lower high cholesterol such as cholestyramine
• Antibiotics used to treat bacterial infections such as rifampicin, erythromycin
• Medicines to treat epilepsy, such as phenytoin, carbamazepine
• Medicines to treat stomach problems, such as antacids
• Medicines used to reduce fever, pain and inflammation, such as aspirin, ibuprofen or similar non-steroidal anti-inflammatories (NSAIDs)
• Medicines used to treat diabetes
• Medicines used to lower potassium levels
• Medicines used to treat myasthenia gravis
• Medicines used to treat HIV such as indinavir
• Medicines used to reduce anxiety and help you sleep
• Oral birth control containing estrogen and progestogen
• Medicines used to treat cancer such as aminoglutethimide
• Ephedrine used as a nasal decongestant
• Isoniazid used to treat tuberculosis
• Cyclosporine used to supress the immune system
• Ketoconazole used to treat fungal infections
• Praziquantel used to treat parasitic infections
• Vaccines

How to take pms-DEXAMETHASONE ELIXIR:

• Take pms-DEXAMETHASONE ELIXIR exactly your healthcare professional tells you.
• Take by mouth.

• pms-DEXAMETHASONE ELIXIR should be taken with food or milk to reduce the chance of stomach upset.

Usual dose:

pms-DEXAMETHASONE ELIXIR used as treatment:

• Your healthcare professional will decide on the best dose 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 pms-DEXAMETHASONE ELIXIR before talking to your healthcare professional.

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

  • experience serious side effects; or
  • your condition gets worse.

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

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

Overdose:

Missed Dose:

• If you forget to take a dose of pms-DEXAMETHASONE ELIXIR, take it as soon as you remember.
• If it is almost time for your 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 pms-DEXAMETHASONE ELIXIR?

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

Side effects may include:

• Stomach and intestinal problems:

  • nausea
  • bloating
  • changes in appetite

• Musculoskeletal problems:

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

• Nervous system problems:

  • headache
  • dizziness
  • vertigo
  • impaired sensation, strength and reflexes
  • sensation of tingling, tickling, prickling or burning of your skin

• Psychiatric problems:

  • drug dependence
  • abnormal behavior
  • emotional instability

• Skin problems:

  • thin fragile skin
  • rash
  • stretch marks
  • petechiae (reddish spots containing blood that appear in the skin)
  • ecchymoses (discolouration of skin due to bleeding under the skin)
  • redness
  • dry, scaly skin
  • itching

  • hives

    • Hormone and metabolism problems:

      • suppression of growth in children
      • weight gain
      • abnormal fat deposits
      • acne
      • thinning hair
      • increased sweating
      • 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 of more of its hormones or does not produce enough of them)
      • thyroid gland problems

    • Other:

      • high cholesterol
      • 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 room temperature (15°-30°C). Protect from light.

Keep out of reach and sight of children.

If you want more information about pms-DEXAMETHASONE ELIXIR:

• Talk to your healthcare professional
• Find the full prescribing information 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; or by calling the manufacturer’s phone number, 1-888-550-6060.

Pharmascience Inc.

Montréal, QC, Canada

H4P 2T4

www.pharmascience.com

Last Revised June 06, 2022