What Cortef is used for and how to use it
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Cortef - Consumer Medicine Information

Manufacture: Pfizer Inc.
Country: Canada
Condition: Addison's Disease, Adrenocortical Insufficiency, Asthma, acute, Allergy (Allergies), Inflammatory Conditions, Inflammatory Bowel Disease, Shock
Class: Glucocorticoids
Form: Tablets
Ingredients: hydrocortisone, calcium stearate, cornstarch, lactose, mineral oil, sorbic acid, sucrose, sodium

About This Medication

What the Medication is Used For

Cortef (hydrocortisone) is used in the treatment of various conditions such as allergy or inflammation; it is used to replace corticosteroid hormone when the body does not produce enough due to problems with the adrenal glands (e.g. adrenal insufficiency).

What It Does

Cortef is a corticosteroid hormone (glucocorticoid). It decreases the body’s immune response to certain diseases and reduces symptoms such as swelling and redness

When It Should not be Used

Do not use CORTEF if you have:

  • had an allergic reaction to hydrocortisone or any other steroid medicine or any of the ingredients in Cortef tablets; or
  • any fungal infection or any untreated infection
  • herpes simplex of the eye
  • chickenpox or smallpox
  • received a type of vaccine called a live or live / attenuated vaccine

What the Medicinal Ingredient Is

Hydrocortisone.

What the Nonmedicinal Ingredients Are

CORTEF tablets contain calcium stearate, cornstarch, lactose, mineral oil, sorbic acid, sucrose and sodium.

What Dosage Forms It Comes In

CORTEF 10 mg: each tablet is available as a white, round scored tablet, engraved with “CORTEF 10”. Supplied in bottles of 100 tablets

CORTEF 20 mg: each tablet is available as a white round, unscored tablet, engraved with “CORTEF 20”. Supplied in bottles of 100 tablets.

Warnings and Precautions

Before taking CORTEF, talk to your doctor or pharmacist if:

  • you have or have had an infection (such as herpes simplex, chicken pox, tuberculosis, threadworm); If you or your child isexposed to measles or chickenpox during treatment with CORTEF, contact you doctor immediately.
  • you have bleeding problem; blood clotting problem
  • you have brittle bone (osteoporosis)
  • you have high blood pressure
  • you have heart problems such as heart failure
  • you have kidney disease
  • you have or have had seizures (convulsions) or other neurological problems
  • you have thyroid problem
  • you have muscle pain or weakness (such as myasthenia gravis)
  • you have skin cancer (Kaposi’s sarcoma), or a tumor of the adrenal glands (Pheochromocytoma)
  • you have certain eye disease such as glaucoma, cataracts, herpes infection or any problems with the retina
  • you have liver disease such as cirrhosis
  • you have certain mental or mood conditions (such as depression)
  • you have or have had stomach or gut problems (ulcer, ulcerative colitis)
  • you have low potassium or calcium you have a weak immune response
  • you have Cushing’s disease (caused by an excess of cortisol hormone)
  • you are pregnant or trying to become pregnant
  • you are breast-feeding or planning to breast-feed

Before you have any operation, tell your doctor, dentist or anesthetist that you are taking CORTEF.

Children

Corticosteroids can affect growth in children.

Interactions With This Medication

Before taking CORTEF, please talk to your doctor or pharmacist about all your other medications including those you bought without prescription, herbal or natural product and especially if are taking the following:

  • drugs to treat glaucoma and epilepsy such as acetazolamide
  • drugs to ‘thin’ the blood (anticoagulant such as warfarin, coumadin)
  • drugs to treat myasthenia gravis ( a muscle condition) such as distigmine and neostigmine
  • antibiotics (erythromycin, clarithromycin and troleandomycin, Rifampicin and rifabutin)
  • aspirin and non steroidal anti-inflammatory drugs (such as ibuprofen)
  • drugs to treat inflammatory conditions (such as methylprednisolone)
  • drugs to treat epilepsy (such as barbiturates and phenytoin)
  • drugs for antifungal infections (such as ketoconazole)
  • cyclosporine
  • drugs for heart problems or high blood pressure as digoxin and diltiazem
  • drugs to treat high cholesterol (cholestyramine)
  • water pills (diuretics)
  • drugs to treat HIV infections such as indinavir or ritonavir
  • hormones, such as estrogen and somatropin drugs to treat diabetes
  • drugs to treat tuberculosis
  • vaccines – tell your doctor if you have recently had or are about to have any vaccination.

Proper Use of This Medication

Usual Adult Dose

Take CORTEF tablets exactly as directed by your doctor. When your condition has improved, your doctor will reduce your dose gradually. CORTEF should not be stopped abruptly. Do not stop taking CORTEF without talking to your doctor.

If you are being treated for diabetes, high blood pressure or water retention (oedema) tell your doctor as he/she may need to adjust the dose of the medicines used to treat these conditions.

Do not eat grapefruit or drink grapefruit juice while taking CORTEF.

Overdose

In case of drug overdose, contact your doctor, or a Poison Control Centre or go to emergency room of a hospital near you immediately, even if there are no symptoms

Missed Dose

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

Side Effects and What to Do About Them

The following is a list of side effects that may occur with CORTEF. This is not a complete list. Therefore, check with your doctor immediately ifyou notice or are bothered by any unusual symptoms.

CORTEF may hide symptoms of infections, may cause latent infections to become active, and may induce infections by normally inoffensive organisms due to lowered body resistance.

Potential Side Effects of CORTEF Include

Allergic Reactions

  • anaphylaxis (a severe, life-threatening allergic reaction)
  • cardiac arrest
  • bronchospasm (narrowing of the airway)

Cardiovascular

  • heart failure
  • heart attack
  • arrhythmia (irregular heartbeat)
  • high and low blood pressure
  • blood clots
  • thrombophlebitis (vein inflammation)
  • thrombosis (blood clot within a blood vessel)

Dermatologic

  • thin fragile skin
  • impaired wound healing
  • swelling
  • ecchymosis (spots caused by ruptured blood vessels)
  • petechiae (reddish spot containing blood that appears in skin)
  • stretch marks
  • dry, scaly skin
  • rash
  • redness
  • itching
  • acne
  • increased sweating
  • lightening or darkening of an area of skin
  • abscess
  • suppressed reactions to skin tests
  • thinning hair

Endocrine and Metabolism

  • development of Cushingoid state (abnormal bodily condition caused by excess corticosteroids)
  • moon face (enlargement of chin and forehead)
  • weight gain
  • abnormal fat deposits
  • suppression of pituitary-adrenal axis (a condition that could lead to disabling the body’s responses to physiological stress such as severe infections or trauma)
  • suppression of growth in children
  • abnormal hair growth
  • new symptoms of diabetes

Gastrointestinal

  • stomach ulcer
  • stomach bleeding
  • inflammation of the pancreas and esophagus
  • perforation of the bowel
  • nausea
  • vomiting or altered sense of taste (with rapid administration of large doses)
  • abdominal pain
  • bloating
  • diarrhea
  • indigestion
  • bowl/bladder dysfunction
  • increased appetite

Hepatic

  • enlarged liver

Musculoskeletal

  • loss of muscle mass
  • muscle weakness
  • muscle pain
  • malaise (feeling of general discomfort or uneasiness)
  • osteoporosis
  • pathological fractures
  • vertebral compression fractures
  • tendon rupture, (particularly of the Achilles tendon)
  • Charcot joint disease (neuropathic arthropathy)
  • joint pain

Neurologic

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

Ophthalmologic

  • cataracts
  • increased intraocular pressure
  • glaucoma

Psychiatric

  • anxiety
  • confusion
  • depression
  • hallucination
  • emotional instability
  • euphoria (intense feelings of well-being, elation, happiness, excitement and joy)
  • insomnia
  • mood swings
  • personality changes
  • suicidal ideation

Sexual Function/Reproduction

  • menstrual irregularities
  • increased or decreased motility and number of sperm

Hemotology

  • Above normal white blood cell count
  • Abnormal blood tests

Other

  • fatigue, hiccups

Serious Side Effects, how Often They Happen and What to Do About Them

Symptom / effectTalk with your doctor or pharmacistStop taking drug and call your doctor or pharmacist
Only if severeIn all cases
Congestive heart failure
Fluid retention, swelling
High blood pressure (symptoms of which are headaches or feeling unwell)
Muscle weakness
Stomach ulcers (burst or bleeding ulcers; symptoms of which are stomach pain, blood in stools and/or vomiting
blood)
Wounds that are slow to heal
Convulsions
Psychological disorders (feeling depressed including thinking about suicide, feeling anxious, insomnia)
Irregular menstrual periods
Diabetes (symptoms of which can be frequent urination and thirst)
Cramps and spasms
Visual problems, failing eyesight
Reactivation of tuberculosis (symptoms of which could be coughing blood or pain in the chest)
Infections (symptoms might include a raised temperature and feeling unwell)
Bone/joint pain
Bone thinning
Allergic reactions in the form of angioedema (a severe skin reaction with swelling, itching and large welts).

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

How to Store It

Store at room temperature (15°C to 30°C).

Keep 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:

  • 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 found at: http://www.pfizer.ca or by contacting the sponsor, Pfizer Canada Inc., at:
1-800-463-6001.