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PMS-PREDNISOLONE is a brand name for Prednisolone, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Management of conditions known to be responsive to prednisone or prednisolone where anti-inflammatory action or immunosuppression or adrenocortical supplementation and replacement is required. For most indications, glucocorticoid administration provides symptomatic relief, but has no effect on the underlying disease…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Standardized dosing is not available for oral corticosteroids. Therefore, any adjustments in consideration of age or renal function of the patient should be taken into account, along with the patient's weight and severity of the disease when the initial dosage is established.
2 Recommended Dose and Dosage Adjustment The initial dosage may vary from 5 mL to 60 mL (5 mg to 60 mg prednisolone base) per day, depending on the specific disease entity being treated. In situations of less severity, lower doses will generally suffice, while in selected patients, higher initial doses may be required.
The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, pms-PREDNISOLONE should be discontinued, and the patient transferred to other appropriate therapy.
pms-PREDNISOLONE Product Monograph Page 5 of 33 IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements, at appropriate time intervals, until the lowest dosage, which will maintain an adequate clinical response, is reached.
It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation, it may be necessary to increase the dosage of prednisolone for a period of time consistent with the patient's condition.
If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually, rather than abruptly, to avoid glucocorticoid withdrawal syndrome. 75 1 These dose relationships apply only to oral or intravenous administration of these compounds.
2 When these substances or their derivatives are injected intra-muscularly into joint spaces, their relative properties may be greatly altered. 4 Administration If on a once-daily therapy, pms-PREDNISOLONE should be administered in the morning to simulate the natural circadian rhythm of corticosteroid secretion.
). Due caution should be exercised when driving or operating a vehicle or potentially dangerous machinery. pms-PREDNISOLONE Product Monograph Page 8 of 33 Endocrine and Metabolism Electrolytes Average and large doses of corticosteroids can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium.
These effects are less likely to occur with the synthetic derivatives, except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion. Hypothyroidism There is an enhanced effect of corticosteroids in patients with hypothyroidism.
Pheochromocytoma Crisis Pheochromocytoma crisis, which can be fatal, has been reported after administration of corticosteroids. Corticosteroids should only be administered to patients with suspected or identified pheochromocytoma after an appropriate risk/benefit evaluation.
Secondary Adrenocortical Insufficiency Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstated.
Since mineralocorticoid secretion may be impaired, salt and/or mineralocorticoid should be administered concurrently. Steroid Withdrawal Syndrome When discontinuing long-term administration of corticosteroids, it should be done gradually.
The risks associated with sudden discontinuation are exacerbation or recurrence of the underlying disease, adrenocortical insufficiency or steroid withdrawal syndrome. Steroid withdrawal syndrome may present with a wide range of signs and symptoms, however typical symptoms include fever, anorexia, nausea, lethargy, malaise, arthralgias, desquamation of the skin, weakness, hypotension, and weight loss.
1 Pregnant Women 03/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
4 1 INDICATIONS ..................................................................................................................... 1 Pediatrics .....................................................................................................................
4 2 CONTRAINDICATIONS ........................................................................................................ 4 4 DOSAGE AND ADMINISTRATION ........................................................................................
1 Dosing Considerations ................................................................................................. 2 Recommended Dose and Dosage Adjustment ............................................................ 4 Administration.............................................................................................................
5 Missed Dose ................................................................................................................ 6 5 OVERDOSAGE ....................................................................................................................
6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING........................................ 6 7 WARNINGS AND PRECAUTIONS ......................................................................................... 1 Special Populations ...................................................................................................
1 Pregnant Women 03/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
4 1 INDICATIONS ..................................................................................................................... 1 Pediatrics .....................................................................................................................
4 2 CONTRAINDICATIONS ........................................................................................................ 4 4 DOSAGE AND ADMINISTRATION ........................................................................................
1 Dosing Considerations ................................................................................................. 2 Recommended Dose and Dosage Adjustment ............................................................ 4 Administration.............................................................................................................
5 Missed Dose ................................................................................................................ 6 5 OVERDOSAGE ....................................................................................................................
6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING........................................ 6 7 WARNINGS AND PRECAUTIONS ......................................................................................... 1 Special Populations ...................................................................................................
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5 Missed Dose The course of action will depend on the dosage regimen: One dose every other day: The missed dose should be taken as soon as possible the same morning, and the regular dosing schedule should be resumed. If it is later in the day, the missed dose should be taken the next morning, and the regular dosing schedule should be resumed after skipping a day.
One dose a day:
The missed dose should be taken as soon as possible, and the regular dosing schedule should be resumed. If the patient has missed a day, the missed dose should be skipped, and the regular dosing schedule should be resumed. The patient should be advised not to take a double dose to compensate for the missed one.
Several doses a day:
The missed dose should be taken as soon as possible, and the regular dosing schedule should be resumed. If it is time for the next dose, the dose should be doubled, and the regular dosing schedule should be resumed.
Suppression of HPA (Hypothalamic-Pituitary-Adrenal) Function Glucocorticoid-induced suppression of HPA function is dependent on dose and duration of treatment. Recovery occurs gradually as the steroid dose is reduced and withdrawn. Suppression persists for a period of time after withdrawal depending on dose and length of treatment time.
In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during and after the stressful situation is indicated. Tumor Lysis Syndrome In post-marketing experience, tumor lysis syndrome (TLS) has been reported in patients with hematological malignancies following the use of prednisolone alone or in combination with other chemotherapeutic agents.
Patients at high risk of TLS, such as patients with high pms-PREDNISOLONE Product Monograph Page 9 of 33 proliferative rate, high tumor burden, and high sensitivity to cytotoxic agents, should be monitored closely and appropriate precautions should be taken (see 8 ADVERSE REACTIONS).
Gastrointestinal In the case of a history of ulcers, corticotherapy may be prescribed, with clinical monitoring and after endoscopy when needed. Hematologic Acetylsalicylic acid (ASA) and other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia.
Hepatic/Biliary/Pancreatic There is an enhanced effect of corticosteroids in patients with cirrhosis of the liver. Corticosteroid use requires monitoring that is specifically adapted in patients with hepatic failure. Immune Infections Unless they have had varicella or measles, patients should avoid contact with subjects who have varicella, herpes zoster and measles.
If they are exposed to such infections whilst receiving pms-PREDNISOLONE, they must contact a physician immediately even if there are no symptoms. Patients who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals.
Immunosuppressed patients should be warned to avoid exposure to varicella or measles. Varicella and measles can have a more serious or even fatal course in non-immune children or adults who have not had these diseases, and particular care should be taken to avoid exposure.
It is not known whether the risk of developing serious cases of these infections is due to prior corticosteroid treatment, or to the contribution of the underlying disease which is being treated. If exposed to varicella, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated.
If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. If varicella develops, treatment with antiviral agents may be considered. The use of pms-PREDNISOLONE is contraindicated in patients with varicella, measles or uncontrolled active infections (see 2 CONTRAINDICATIONS).
While on corticosteroid therapy, patients should not be vaccinated with any live vaccine (see 2 CONTRAINDICATIONS). Other immunization procedures should not be undertaken in patients pms-PREDNISOLONE Product Monograph Page 10 of 33 who are on corticosteroids, especially on high doses, because of possible hazards of neurological complications and lack of antibody response.
Other people living with the patient should not receive oral polio vaccine, due to risk of passing on the polio virus. Corticosteroids may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance and inability to localize infection when corticosteroids are used.
If corticosteroids have to be used in the presence of fungal or bacterial infections, institute appropriate anti-infective therapy and closely monitor. In the case of known or suspected Strongyloides (threadworm) infestation, immunosuppression may lead to hyperinfection and dissemination, leading to severe enterocolitis and potentially fatal gram-negative septicemia (oral).
The use of corticosteroids in active tuberculosis should be restricted to those cases of fulminating or disseminated […]
1 Pregnant Women ...................................................................................................... 2 Breast-feeding ...........................................................................................................
3 Pediatrics ................................................................................................................... 4 Geriatrics ...................................................................................................................
13 8 ADVERSE REACTIONS ....................................................................................................... 1 Adverse Reaction Overview .......................................................................................
2 Clinical Trial Adverse Reactions ................................................................................. 5 Post-Market Adverse Reactions ................................................................................ 15 9 DRUG INTERACTIONS .......................................................................................................
2 Drug Interactions Overview ....................................................................................... 4 Drug-Drug Interactions ..............................................................................................
7 Drug-Laboratory Test Interactions ............................................................................ 20 10 CLINICAL PHARMACOLOGY ..............................................................................................
1 Mechanism of Action................................................................................................. 2 Pharmacodynamics ...................................................................................................
3 Pharmacokinetics ...................................................................................................... 22 11 STORAGE, STABILITY AND DISPOSAL ................................................................................
22 PART II: SCIENTIFIC INFORMATION ........................................................................................ 23 13 PHARMACEUTICAL INFORMATION...................................................................................
23 15 MICROBIOLOGY ............................................................................................................... 23 16 NON-CLINICAL TOXICOLOGY ............................................................................................
23 17 SUPPORTING PRODUCT MONOGRAPHS........................................................................... 24 PATIENT MEDICATION INFORMATION ................................................................................... 25 pms-PREDNISOLONE Product Monograph Page 4 of 24 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Management of conditions known to be responsive to prednisone or prednisolone where anti-inflammatory action or immunosuppression or adrenocortical supplementation and replacement is required.
For most indications, glucocorticoid administration provides symptomatic relief, but has no effect on the underlying disease processes. Use of these medications does not eliminate the need for other therapies that may be required. 1 Pediatrics pms-PREDNISOLONE oral solution is appropriate for pediatric usage and for those patients with difficulty swallowing solid oral dosage forms.
2 CONTRAINDICATIONS pms-PREDNISOLONE is contraindicated in patients with: • Untreated systemic fungal infections. • Known hypersensitivity to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, […]
1 Pregnant Women ...................................................................................................... 2 Breast-feeding ...........................................................................................................
3 Pediatrics ................................................................................................................... 4 Geriatrics ...................................................................................................................
13 8 ADVERSE REACTIONS ....................................................................................................... 1 Adverse Reaction Overview .......................................................................................
2 Clinical Trial Adverse Reactions ................................................................................. 5 Post-Market Adverse Reactions ................................................................................ 15 9 DRUG INTERACTIONS .......................................................................................................
2 Drug Interactions Overview ....................................................................................... 4 Drug-Drug Interactions ..............................................................................................
7 Drug-Laboratory Test Interactions ............................................................................ 20 10 CLINICAL PHARMACOLOGY ..............................................................................................
1 Mechanism of Action................................................................................................. 2 Pharmacodynamics ...................................................................................................
3 Pharmacokinetics ...................................................................................................... 22 11 STORAGE, STABILITY AND DISPOSAL ................................................................................
22 PART II: SCIENTIFIC INFORMATION ........................................................................................ 23 13 PHARMACEUTICAL INFORMATION...................................................................................
23 15 MICROBIOLOGY ............................................................................................................... 23 16 NON-CLINICAL TOXICOLOGY ............................................................................................
23 17 SUPPORTING PRODUCT MONOGRAPHS........................................................................... 24 PATIENT MEDICATION INFORMATION ................................................................................... 25 pms-PREDNISOLONE Product Monograph Page 4 of 24 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Management of conditions known to be responsive to prednisone or prednisolone where anti-inflammatory action or immunosuppression or adrenocortical supplementation and replacement is required.
For most indications, glucocorticoid administration provides symptomatic relief, but has no effect on the underlying disease processes. Use of these medications does not eliminate the need for other therapies that may be required. 1 Pediatrics pms-PREDNISOLONE oral solution is appropriate for pediatric usage and for those patients with difficulty swallowing solid oral dosage forms.
2 CONTRAINDICATIONS pms-PREDNISOLONE is contraindicated in patients with: • Untreated systemic fungal infections. • Known hypersensitivity to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 […]