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APO PREDNISONE TAB is a brand name for Prednisone, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: APO-PREDNISONE (prednisone) is indicated for: • Adrenocortical function abnormalities: Chronic primary adrenocortical insufficiency (Addison's disease) together with mineralocorticoid or sodium supplementation; secondary adrenocortical insufficiency; adrenogenital syndrome (congenital adrenal hyperplasia). • Allergic…
Verbatim from this product's HC label. Tap a section to expand.
3 Pediatrics 10/2025 TABLE OF CONTENTS Certain sections or subsections that are not applicable at the time of the preparation of the most recent authorized product monograph are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
5 1 INDICATIONS ................................................................................................................ 1 Pediatrics ...............................................................................................................
2 Geriatrics ............................................................................................................... 6 2 CONTRAINDICATIONS ..................................................................................................
6 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................. 7 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations ...........................................................................................
2 Recommended Dose and Dosage Adjustment ...................................................... 4 Administration ..................................................................................................... 5 Missed Dose ........................................................................................................
10 5 OVERDOSAGE............................................................................................................. 10
1 Adverse Reaction Overview The majority of adverse reactions from corticosteroids are those resulting from withdrawal or from prolonged use of high doses.
Note:
The following are typical for all systemic glucocorticoids. Their inclusion in this list does not necessarily indicate that the specific event has been observed with this particular formulation. Table 2 - Adverse Reactions System Organ Class Frequency Not Known (Cannot be estimated from available data) Blood and lymphatic system disorders Leukocytosis.
Cardiac disorders Cardiac failure congestive (in susceptible patients); Bradycardia; Cardiac arrest; APO-PREDNISONE (Prednisone Tablets) Page 21 of 55 System Organ Class Frequency Not Known (Cannot be estimated from available data) Arrhythmia; Cardiomegaly; Hypertrophic cardiomyopathy in premature infants; Myocardial rupture following recent myocardial infarction; Pulmonary oedema; Syncope; Tachycardia.
Endocrine disorders Cushingoid; Pituitary-adrenal axis suppression particularly at times of stress as in trauma, surgery or illness; Hirsutism; Moon face; Suppression of growth in children; Manifestations of latent diabetes mellitus; Antagonism occurs between the parathyroids and hypercorticism.
Latent hypoparathyroidism may be unmasked by administration of corticosteroids. The phosphate retention occurring in renal failure caused by adrenal insufficiency may also make hypoparathyroidism manifest. Eye disorders Cataract subcapsular (associated with prolonged, high dose systemic therapy); Exophthalmos; Glaucoma; Central serous chorioretinopathy; Corneal or scleral thinning; Exacerbation of ophthalmic viral or fungal disease.
Gastrointestinal disorders Peptic ulcer (with possible perforation and hemorrhage); Gastric hemorrhage; Pancreatitis; Oesophagitis ulcerative; APO-PREDNISONE (Prednisone Tablets) Page 22 of 55 System Organ Class Frequency Not Known (Cannot be estimated from available data) Intestinal perforation (of the small and large intestine, particularly in patients with inflammatory bowel disease); Abdominal distension; Nausea; Hiccups; Dyspepsia; Abdominal pain; Diarrhoea; Oesophageal candidiasis; Vomiting; Constipation; Gastric irritation.
3 Pediatrics 10/2025 TABLE OF CONTENTS Certain sections or subsections that are not applicable at the time of the preparation of the most recent authorized product monograph are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
5 1 INDICATIONS ................................................................................................................ 1 Pediatrics ...............................................................................................................
2 Geriatrics ............................................................................................................... 6 2 CONTRAINDICATIONS ..................................................................................................
6 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................. 7 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations ...........................................................................................
2 Recommended Dose and Dosage Adjustment ...................................................... 4 Administration ..................................................................................................... 5 Missed Dose ........................................................................................................
10 5 OVERDOSAGE............................................................................................................. 10 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 11 7 WARNINGS AND PRECAUTIONS .................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Prednisone in Canada.
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General disorders and administration site conditions Impaired healing (usually at high doses); Malaise; Abscess sterile; Fatigue. Hepatobiliary disorders Hepatomegaly. g. bronchospasm, laryngeal oedema, urticaria]); Angioedema. Infections and infestations Infection masked; Opportunistic infection (with any pathogen, in any location in the body, from mild to fatal); Infection (becoming active including reactivation of tuberculosis); Infection susceptibility increased.
Injury, poisoning and procedural complications Spinal compression fracture; Tendon rupture (particularly of the Achilles tendon); Pathological fracture; Vertebral and long bone fractures. APO-PREDNISONE (Prednisone Tablets) Page 23 of 55 System Organ Class Frequency Not Known (Cannot be estimated from available data) Investigations Intraocular pressure increased; Carbohydrate tolerance decreased; Increased insulin requirement (or oral hypoglycemic agents in diabetics); Blood potassium decreased which are correctable and largely preventable by restricting sodium intake to 500 mg per day and supplementing potassium intake; Nitrogen balance negative (due to protein catabolism); Negative calcium balance; Urine calcium increased; Alanine aminotransferase increased; Aspartate aminotransferase increased; Blood alkaline phosphatase increased; Abnormal fat deposits; Weight increased; Elevation in serum liver enzyme levels (usually reversible upon discontinuation); Spermatozoa progressive motility abnormal / sperm concentration abnormal.
EEG abnormalities. Metabolism and nutrition disorders Sodium retention; Fluid retention; Alkalosis hypokalemic; Glucose tolerance impaired; Increased appetite. Anorexia (which may result in weight loss); All glucocorticoids increase gluconeogenesis.
Glucose tolerance and sensitivity to insulin are decreased but provided pancreatic islet function is normal carbohydrate metabolism will not be noticeably deranged. Steroid diabetes, has been reported to develop in one fifth of patients treated with high glucocorticoid dosage; High dose corticosteroid therapy may induce marked APO-PREDNISONE (Prednisone Tablets) Page 24 of 55 System Organ Class Frequency Not Known (Cannot be estimated from available data) hypertriglyceridaemia with milky plasma.
Musculoskeletal and connective tissue disorders Myopathy; Muscular weakness; Osteonecrosis of femoral and humeral heads; Osteoporosis; Growth retardation; Neuropathic arthropathy; Muscle atrophy. Myalgia. Neoplasms benign, malignant and unspecified (including cysts and polyps) Kaposi’s sarcoma (has been reported to occur in patients receiving glucocorticoid therapy) Nervous system disorders Intracranial pressure increased with papilloedema (benign intracranial hypertension) usually following discontinuation of treatment; Convulsions; Aggravation of epilepsy; Dizziness; Headache; Neuritis; Neuropathy peripheral; Paraesthesia; Vertigo; Arachnoiditis; Meningitis; Paraparesis/paraplegia; Epidural lipomatosis.
Increased motor activity; Ischemic neuropathy; Restlessness. Psychiatric disorders Psychic derangements/psychotic manifestations (Euphoric mood, Insomnia, Mood swings, Personality change, Depression, Exacerbation of preexisting Affect APO-PREDNISONE (Prednisone Tablets) Page 25 of 55 System Organ Class Frequency Not Known (Cannot be estimated from available data) lability or Psychotic behaviour) Suicidal ideation; Mania; Delusions; Hallucinations; Irritability; Anxiety; Psychological dependence; Cognitive dysfunction; Nervousness; Paranoid states; Acute toxic psychoses; The absence of a history of psychiatric illness is no guarantee against the occurrence of psychosis during hormonal therapy.
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1 Special Populations.............................................................................................. 1 Pregnant Women ............................................................................................ 2 Breast-feeding .................................................................................................
3 Pediatrics ......................................................................................................... 4 Geriatrics .........................................................................................................
20 8 ADVERSE REACTIONS ................................................................................................. 1 Adverse Reaction Overview ................................................................................. 5 Post-Market Adverse Reactions ..........................................................................
26 9 DRUG INTERACTIONS ................................................................................................. 2 Drug Interactions Overview ................................................................................. 3 Drug-Behavioural Interactions.............................................................................
4 Drug-Drug Interactions ........................................................................................ 5 Drug-Food Interactions........................................................................................ 6 Drug-Herb Interactions ........................................................................................
7 Drug-Laboratory Test Interactions....................................................................... 36 10 CLINICAL PHARMACOLOGY ........................................................................................ 1 Mechanism of Action...........................................................................................
2 Pharmacodynamics ............................................................................................. 3 Pharmacokinetics ................................................................................................ 38 11 STORAGE, STABILITY AND DISPOSAL ..........................................................................
40 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................ 40 PART II: SCIENTIFIC INFORMATION ........................................................................................
41 13 PHARMACEUTICAL INFORMATION ............................................................................. 41 14 CLINICAL TRIALS .........................................................................................................
41 15 MICROBIOLOGY ......................................................................................................... 41 APO-PREDNISONE (Prednisone Tablets) Page 4 of 55 16 NON-CLINICAL TOXICOLOGY ......................................................................................
41 PATIENT MEDICATION INFORMATION ................................................................................... 43 APO-PREDNISONE (Prednisone […]