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PMS-DICLOFENAC-MISOPROSTOL is a brand name for Misoprostol, supplied as a tablet (delayed-release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: pms-DICLOFENAC-MISOPROSTOL (Diclofenac Sodium and Misoprostol Delayed-Release Tablets) is indicated for: • Acute and chronic use in the relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Throughout this document, the term NSAIDs refers to both non-selective NSAIDs and selective COX-2…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Use of pms-DICLOFENAC-MISOPROSTOL should be limited to the lowest effective dose for the shortest possible duration of treatment in order to minimize the potential risk for cardiovascular or gastrointestinal adverse events (see 2 CONTRAINDICATIONS; and 7 WARNINGS AND PRECAUTIONS).
4 Geriatrics). , hypertension, hyperlipidemia, diabetes mellitus and smoking). These patients should be treated with pms-DICLOFENAC-MISOPROSTOL only after careful consideration (see 3 WARNINGS AND PRECAUTIONS BOX). pms-DICLOFENAC-MISOPROSTOL (Diclofenac Sodium and Misoprostol Delayed-Release Tablets) Page 8 of 56 • Renal Insufficiency: In patients with mild to moderate renal insufficiency, the lowest dose of pms-DICLOFENAC-MISOPROSTOL should be considered, and patients should be monitored closely (see 7 WARNINGS AND PRECAUTIONS, Renal).
5mL/sec) (see 2 CONTRAINDICATIONS). • Hepatic Insufficiency: If pms-DICLOFENAC-MISOPROSTOL must be used in patients with mild to moderate hepatic impairment, these patients must be closely monitored (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic).
pms-DICLOFENAC-MISOPROSTOL is contraindicated in patients with significant hepatic impairment or active liver disease (see 2 CONTRAINDICATIONS). Diclofenac metabolism is predominantly mediated via cytochrome P450 CYP 2C9 in the liver.
2 Drug Interactions, Overview). , antibiotics, anti-epileptics). 2 Recommended Dose and Dosage Adjustment • Use of pms-DICLOFENAC-MISOPROSTOL should be limited to the lowest effective dose and the shortest possible duration of treatment in every patient (see 7 WARNINGS AND PRECAUTIONS).
• The recommended daily oral dose of pms-DICLOFENAC-MISOPROSTOL for treating the signs and symptoms of rheumatoid arthritis and osteoarthritis is 100 mg administered as two divided doses (50 mg twice per day) (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular).
• The recommended maximum daily dose is 100 mg. 4 Administration pms-DICLOFENAC-MISOPROSTOL should be taken immediately after a meal or with food or milk and the tablets should be swallowed whole. 5 Missed Dose If a dose of pms-DICLOFENAC-MISOPROSTOL is missed, the next dose should be taken at the regular time.
The dose should not be doubled. pms-DICLOFENAC-MISOPROSTOL (Diclofenac Sodium and Misoprostol Delayed-Release Tablets) Page 9 of 56
). pms-DICLOFENAC-MISOPROSTOL (Diclofenac Sodium and Misoprostol Delayed-Release Tablets) Page 14 of 56 Hematologic NSAIDs inhibiting prostaglandin biosynthesis interfere with platelet function to varying degrees; patients who may be adversely affected by such an action, such as those on anti-coagulants or suffering from haemophilia or platelet disorders should be carefully monitored when pms-DICLOFENAC-MISOPROSTOL is administered.
Anti-coagulants:
The concomitant use of NSAIDs, including diclofenac/misoprostol, with anticoagulants increases the risk of GI and non-GI bleeding and should be given with caution. Concurrent therapy of pms-DICLOFENAC-MISOPROSTOL with anticoagulants requires close monitoring of the international normalized ratio (INR) (see
, Skin 08/2024 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 ...........................................................................................................................
2 Geriatrics............................................................................................................................ 5 2 CONTRAINDICATIONS ...........................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ...................................................................... 6 4 DOSAGE AND ADMINISTRATION ...........................................................................................
1 Dosing Considerations ....................................................................................................... 2 Recommended Dose and Dosage Adjustment ..................................................................
4 Administration ................................................................................................................... 5 Missed Dose .......................................................................................................................
8 5 OVERDOSAGE ....................................................................................................................... 9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ...........................................
9 7 WARNINGS AND PRECAUTIONS .......................................................................................... 1 Special Populations ..........................................................................................................
1 Pregnant Women ............................................................................................................. 2 Breast-feeding .................................................................................................................
3 Pediatrics ......................................................................................................................... 4 Geriatrics..........................................................................................................................
21 8 ADVERSE REACTIONS.......................................................................................................... 1 Adverse Reaction Overview .............................................................................................
2 Clinical Trial Adverse Reactions ....................................................................................... 1 Clinical Trial Adverse Reactions – Pediatrics ...................................................................
3 Less Common Clinical Trial Adverse Reactions................................................................ 1 Less Common Clinical Trial Adverse Reactions – Pediatrics ............................................ 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data..................................................................................................................................
5 Post-Market Adverse Reactions ...................................................................................... 25 pms-DICLOFENAC-MISOPROSTOL (Diclofenac Sodium and Misoprostol Delayed-Release Tablets) Page 3 of 56 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 ..................................................................................
30 10 CLINICAL PHARMACOLOGY ................................................................................................. 1 Mechanism of Action .......................................................................................................
2 Pharmacodynamics.......................................................................................................... 3 Pharmacokinetics.............................................................................................................
31 11 STORAGE, STABILITY AND DISPOSAL ................................................................................... 33 12 SPECIAL HANDLING INSTRUCTIONS .....................................................................................
33 PART II: SCIENTIFIC INFORMATION ........................................................................................... 34 13 PHARMACEUTICAL INFORMATION......................................................................................
34 14 CLINICAL TRIALS […]
; and 7 WARNINGS AND PRECAUTIONS). For patients with increased risk of developing GI adverse events other management strategies that do not include NSAIDs should be considered first (see 2 CONTRAINDICATIONS; and 7 WARNINGS AND PRECAUTIONS).
Use of pms-DICLOFENAC-MISOPROSTOL should be limited to the lowest effective dose for the shortest possible duration of treatment in order to minimize the potential risk for cardiovascular or gastrointestinal adverse events (see 2 CONTRAINDICATIONS; and 7 WARNINGS AND PRECAUTIONS).
pms-DICLOFENAC-MISOPROSTOL, as a NSAID, does NOT treat clinical disease or prevent its progression. pms-DICLOFENAC-MISOPROSTOL, as a NSAID, only relieves symptoms and decreases inflammation for as long as the patient continues to take it.
3 Pediatrics). 4 Geriatrics). 2 CONTRAINDICATIONS pms-DICLOFENAC-MISOPROSTOL is contraindicated in: • The peri-operative setting of coronary artery bypass graft surgery (CABG). Although Diclofenac Sodium and Misoprostol Delayed-Release Tablets has NOT been studied in this patient population, a selective COX-2 inhibitor NSAID studied in such a setting has led to an increased incidence of cardiovascular/thromboembolic events, deep surgical infections and sternal wound complications.
• The women who are pregnant, or in whom pregnancy has not been excluded. Women of childbearing potential should be fully counseled about misoprostol’s abortifacient potential and the importance of effective contraception (oral contraceptive or intrauterine device) and prevention of pregnancy while undergoing treatment (see
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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