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GD-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: GD-diclofenac/misoprostol (diclofenac sodium and misoprostol) 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 inhibitor NSAIDs, unless…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Use of GD-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). g. hypertension, hyperlipidemia, diabetes mellitus and smoking). These patients should be treated with GD-diclofenac/misoprostol only after careful consideration (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX). • Renal Insufficiency: In patients with mild to moderate renal insufficiency, the lowest dose of GD- 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 GD-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).
GD-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). g. antibiotics, anti-epileptics). 2 Recommended Dose and Dosage Adjustment • Use of GD-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 GD-diclofenac/misoprostol (diclofenac sodium plus 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 GD-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 GD-diclofenac/misoprostol is missed, the next dose should be taken at the regular time.
The dose should not be doubled.
1 Adverse Reaction Overview The most common adverse reactions encountered with nonsteroidal anti-inflammatory drugs are gastrointestinal, of which peptic ulcer, with or without bleeding, is the most severe. Fatalities have occurred, particularly in the elderly.
Most fatal gastrointestinal events occur in the elderly or debilitated patients. Gastrointestinal adverse events can develop at any time in the course of the therapy. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
In clinical trials, 3549 arthritic patients have been treated with diclofenac sodium plus misoprostol, 506 of whom received diclofenac sodium plus misoprostol for more than one year. A total of 285 patients have been treated with diclofenac sodium plus misoprostol 75 in clinical trials for a duration of up to 12 weeks.
0 1 A50 = diclofenac sodium plus misoprostol 50 2 D50 = Diclofenac 50mg 3 A75 = diclofenac sodium plus misoprostol 75 4 D75 = Diclofenac 75 mg *Patients must have experienced ulceration in order to enter study. 1 Clinical Trial Adverse Reactions – Pediatrics At the time of authorization, no clinical trials in the pediatric population have been conducted.
3 Less Common Clinical Trial Adverse Reactions The following adverse events were reported by 1% or less of the subjects receiving diclofenac sodium plus misoprostol. Causal relationships between diclofenac sodium plus misoprostol and these events have not been established but cannot be excluded.
1 pregnant women 02/2022 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 .................................................................................................................. 4 2 CONTRAINDICATIONS ................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................... 5 4 DOSAGE AND ADMINISTRATION................................................................................ 1 Dosing Considerations .............................................................................................
2 Recommended Dose and Dosage Adjustment ........................................................ 4 Administration ......................................................................................................... 5 Missed Dose .............................................................................................................
7 5 OVERDOSAGE............................................................................................................ 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 8 7 WARNINGS AND PRECAUTIONS .................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Misoprostol in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Body as a Whole: hot flushes, malaise, rigors Product Monograph GD-diclofenac/misoprostol (diclofenac sodium and misoprostol) Page 21 of 47 Blood and lymphatic system disorders: leukopenia and thrombocytopenia Cardiovascular: palpitation and syncope Female reproductive disorders: menstrual disorder, intermenstrual bleeding, dysmenorrhea, leukorrhea, vaginal bleeding, breast pain and uterine cramping.
(Post-menopausal vaginal bleeding may be related to GD-diclofenac/misoprostol administration. ) Gastrointestinal: mouth dry, abdomen enlarged, esophageal ulceration, glossitis, hematemesis, hiccup and melena Hepatobiliary disorders: gall bladder disorder, bilirubinemia, abnormal hepatic function, LDH increased, and alkaline phosphatase increased, hepatitis.
1 Less Common Clinical Trial Adverse Reactions – Pediatrics At the time of authorization, no clinical trials in the pediatric population have been conducted. […]
1 Special Populations ................................................................................................ 1 Pregnant Women ...................................................................................................
3 Pediatrics ................................................................................................................ 4 Geriatrics ..........................................................................................................
18 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.............................................................................
21 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......................................................................... 26 10 CLINICAL PHARMACOLOGY ...................................................................................... 1 Mechanism of Action .......................................................................................
2 Pharmacodynamics .......................................................................................... 3 Pharmacokinetics ............................................................................................. 26 11 STORAGE, STABILITY AND DISPOSAL ........................................................................
29 12 SPECIAL HANDLING INSTRUCTIONS.......................................................................... 29 PART II: SCIENTIFIC INFORMATION ..................................................................................... 30 13 PHARMACEUTICAL INFORMATION ..........................................................................
30 14 CLINICAL TRIALS ...................................................................................................... 1 Clinical Trials by Indications .............................................................................
31 15 MICROBIOLOGY ...................................................................................................... 32 16 NON-CLINICAL TOXICOLOGY ....................................................................................
32 PATIENT MEDICATION INFORMATION […]