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PMS-PREGABALIN is a brand name for Pregabalin, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Adults pms-PREGABALIN (pregabalin capsules) is indicated for the management of neuropathic pain associated with: • Diabetic peripheral neuropathy; • Postherpetic neuralgia; • Spinal cord injury. pms-PREGABALIN is indicated for the management of pain associated with fibromyalgia. The efficacy of pregabalin in the…
Verbatim from this product's HC label. Tap a section to expand.
1. Pregnant Women 07/2023 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............................................................................................................. 8 5 OVERDOSAGE ....................................................................................................................
8
, Weight Gain). Pregabalin-associated weight gain was related to dose and duration of exposure. Pregabalin-associated weight gain did not appear to be associated with baseline BMI, gender, or age. Weight gain was not limited to patients with edema and was not necessarily due to edema-related events (see 7 WARNINGS AND PRECAUTIONS, Peripheral Edema).
pms-PREGABALIN (pregabalin capsules) Page 15 of 75 Although weight gain was not associated with clinically important changes in blood pressure in short-term controlled studies, the long-term cardiovascular effects of pregabalin- associated weight gain are unknown.
3 kg (range: -10 to 9 kg) weight gain in placebo patients. 2 kg. 9% of placebo-treated patients. 7 kg weight gain in placebo patients. While the effects of pregabalin-associated weight gain on glycemic control have not been systematically assessed, in controlled and longer-term open label clinical trials with diabetic patients, pregabalin treatment did not appear to be associated with loss of glycemic control (as measured by HbA1C).
, intestinal obstruction, paralytic ileus, and constipation) in patients, some without reported previous history/episode(s), during initial/acute and chronic treatment with pregabalin, primarily in combination with other medications that have the potential to produce constipation.
Some of these events were considered serious and required hospitalization. In a number of instances, patients were taking opioid analgesics including tramadol. 5 Post-Market Adverse Reactions, Gastrointestinal). Hematologic • Laboratory Changes, Decreased Platelet Count Pregabalin treatment was associated with a decrease in platelet count.
Pregabalin-treated subjects experienced a mean maximal decrease in platelet count of 20 x 103/mcL, compared to 11 x 103/mcL in placebo patients. In the overall database of controlled trials, 2% of placebo patients and 3% of pregabalin patients experienced a potentially clinically significant decrease in platelets, defined as 20% below baseline value and < 150 x 103/mcL.
1. Pregnant Women 07/2023 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............................................................................................................. 8 5 OVERDOSAGE ....................................................................................................................
8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING........................................ 9 7 WARNINGS AND PRECAUTIONS ....................................................................................... 1 Special Populations ...................................................................................................
pms-PREGABALIN is contraindicated in patients who are hypersensitive 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, COMPOSITION AND PACKAGING.
pms-PREGABALIN (pregabalin capsules) Page 5 of 75
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Pregabalin in Canada.
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In randomized controlled trials, pregabalin was not associated with an increase in bleeding related adverse events. pms-PREGABALIN (pregabalin capsules) Page 16 of 75 Immune • Angioedema There have been post-marketing reports of angioedema in patients, some without reported previous history/episode(s), during initial/acute and chronic treatment with pregabalin.
Specific symptoms included swelling of the face, mouth (tongue, lips, and gums), neck, throat, and larynx/upper airway. There have been reports of life-threatening angioedema with respiratory compromise requiring emergency treatment.
Some of these patients did not have reported previous history/episode(s) of angioedema. pms-PREGABALIN should be immediately discontinued in patients with these symptoms. 5 Post-Market Adverse Reactions). Caution should be exercised when prescribing pms-PREGABALIN to patients with previous history/episode(s) of angioedema and related events.
, ACE-inhibitors) may be at increased risk of developing this condition. , skin redness, blisters, hives, rash, dyspnea, and wheezing). 5 Post-Market Adverse Reactions). 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data).
Musculoskeletal • Creatine Kinase Elevations Pregabalin treatment was associated with creatine kinase elevations. Mean changes in creatine kinase from baseline to the maximum value were 60 U/L for pregabalin-treated patients and 28 U/L for the placebo patients.
In all controlled trials across multiple patient populations, 2% of patients on pregabalin and 1% of placebo patients had a value of creatine kinase at least three times the upper limit of normal. Three pregabalin-treated subjects had events reported as rhabdomyolysis in premarketing clinical trials.
The relationship between these myopathy events and pregabalin is not completely understood because the cases had documented factors that may have caused or contributed to these events. Prescribers should instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if these muscle symptoms are accompanied by pms-PREGABALIN (pregabalin capsules) Page 17 of 75 malaise or fever.
Pregabalin treatment should be discontinued if myopathy is diagnosed or suspected or if markedly elevated creatine kinase levels occur. Neurologic • Respiratory Depression Pregabalin has been associated with central nervous system (CNS) depression including sedation, somnolence, loss […]
1 Pregnant Women ...................................................................................................... 2 Breast-feeding ...........................................................................................................
3 Pediatrics ................................................................................................................... 4 Geriatrics ...................................................................................................................
22 8 ADVERSE REACTIONS ....................................................................................................... 2 Clinical Trial Adverse Reactions .................................................................................
3 Less Common Clinical Trial Adverse Reactions (< 2%) ............................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ......................................................................................................
5 Post-Market Adverse Reactions ................................................................................ 40 9 DRUG INTERACTIONS .......................................................................................................
2 Drug Interactions Overview ....................................................................................... 4 Drug-Drug Interactions ..............................................................................................
5 Drug-Food Interactions.............................................................................................. 6 Drug-Herb Interactions ..............................................................................................
7 Drug-Laboratory Test Interactions ............................................................................ 46 10 CLINICAL PHARMACOLOGY ..............................................................................................
1 Mechanism of Action................................................................................................. 2 Pharmacodynamics ...................................................................................................
3 Pharmacokinetics ...................................................................................................... 47 11 STORAGE, STABILITY AND DISPOSAL ................................................................................
50 12 SPECIAL HANDLING INSTRUCTIONS.................................................................................. 50 PART II: SCIENTIFIC INFORMATION ........................................................................................
51 13 PHARMACEUTICAL INFORMATION................................................................................... 51 14 CLINICAL TRIALS ...............................................................................................................
1 Clinical Trials by Indication ........................................................................................ 52 Diabetic Peripheral Neuropathy ............................................................................................
52 Postherpetic Neuralgia .......................................................................................................... 55 Spinal Cord Injury ..................................................................................................................
57 Fibromyalgia […]