Loading…
NB-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 NB-PREGABALIN (pregabalin capsules) is indicated for the management of neuropathic pain associated with: • Diabetic peripheral neuropathy; • Postherpetic neuralgia; • Spinal cord injury. NB-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 Discontinuing Treatment). Patients with Impaired Renal Function Pregabalin is primarily eliminated from the systemic circulation by renal excretion as unchanged drug. 2 Recommended Dose and Dosage Adjustment, Dosage Adjustment Based on Renal Function).
2 Recommended Dose and Dosage Adjustment Adults Neuropathic Pain Associated with Diabetic Peripheral Neuropathy The recommended starting dose for NB-PREGABALIN is 150 mg/day, given in two or three divided doses (75 mg BID or 50 mg TID), with or without food in patients with a creatinine clearance rate of at least 60 mL/min.
Efficacy of pregabalin has been demonstrated within the first week. Based on individual patient response and tolerability, the dose may be increased to 150 mg BID (300 mg/day) after one week. For patients who experience significant and ongoing pain and can tolerate pregabalin 300 mg/day well, maximum daily dose of 600 mg (300 mg twice a day, BID) can be used.
2 Clinical Trial Adverse Reactions, Table 6). Doses above 600 mg/day have not been studied and are not recommended. NB-PREGABALIN (pregabalin capsules) Page 6 of 75 Protected B / Protégé B Neuropathic Pain Associated with Postherpetic Neuralgia The recommended starting dose for NB-PREGABALIN is 150 mg/day, given in two or three divided doses (75 mg BID or 50 mg TID), with or without food in patients with a creatinine clearance rate of at least 60 mL/min.
Efficacy of pregabalin has been demonstrated within the first week. Based on individual patient response and tolerability, the dose may be increased to 150 mg BID (300 mg/day) after one week. For patients who experience significant and ongoing pain and can tolerate pregabalin 300 mg/day well, maximum daily dose of 600 mg (300 mg twice a day, BID) can be used.
2 Clinical Trial Adverse Reactions, Table 4 and Table 7). Doses above 600 mg/day have not been studied and are not recommended. Neuropathic Pain Associated with Spinal Cord Injury The recommended starting dose for NB-PREGABALIN is 150 mg/day, given in two divided doses (75 mg BID), with or without food in patients with a creatinine clearance rate of at least 60 mL/min.
Efficacy of pregabalin has been demonstrated within the first week. Based on individual patient response and tolerability, the dose may be increased to 150 mg BID (300 mg/day) after one week. For patients who experience significant and ongoing pain and can tolerate pregabalin 300 mg/day well, a maximum daily dose of 600 mg (300 mg twice a day, BID) may be considered.
, 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).
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.
2 Drug Interactions Overview). • Limit dosages and durations to the minimum required. • Follow patients for signs and symptoms of respiratory depression and sedation. 1 Discontinuing Treatment). Patients with Impaired Renal Function Pregabalin is primarily eliminated from the systemic circulation by renal excretion as unchanged drug.
2 Recommended Dose and Dosage Adjustment, Dosage Adjustment Based on Renal Function). 2 Recommended Dose and Dosage Adjustment Adults Neuropathic Pain Associated with Diabetic Peripheral Neuropathy The recommended starting dose for NB-PREGABALIN is 150 mg/day, given in two or three divided doses (75 mg BID or 50 mg TID), with or without food in patients with a creatinine clearance rate of at least 60 mL/min.
Efficacy of pregabalin has been demonstrated within the first week. Based on individual patient response and tolerability, the dose may be increased to 150 mg BID (300 mg/day) after one week. For patients who experience significant and ongoing pain and can tolerate pregabalin 300 mg/day well, maximum daily dose of 600 mg (300 mg twice a day, BID) can be used.
2 Clinical Trial Adverse Reactions, Table 6). Doses above 600 mg/day have not been studied and are not recommended. NB-PREGABALIN (pregabalin capsules) Page 6 of 75 Protected B / Protégé B Neuropathic Pain Associated with Postherpetic Neuralgia The recommended starting dose for NB-PREGABALIN is 150 mg/day, given in two or three divided doses (75 mg BID or 50 mg TID), with or without food in patients with a creatinine clearance rate of at least 60 mL/min.
Efficacy of pregabalin has been demonstrated within the first week. Based on individual patient response and tolerability, the dose may be increased to 150 mg BID (300 mg/day) after one week. For patients who experience significant and ongoing pain and can tolerate pregabalin 300 mg/day well, maximum daily dose of 600 mg (300 mg twice a day, BID) can be used.
NB-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.
NB-PREGABALIN (pregabalin capsules) Page 5 of 75 Protected B / Protégé B
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Pregabalin in Canada.
Know a brand we are missing in Canada? Suggest a brand →
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.
Doses above 600 mg/day have not been studied and are not recommended. Pain Associated with Fibromyalgia The recommended dosage is 300 to 450 mg/day, given in two divided doses. The recommended starting dose for NB-PREGABALIN is 150 mg/day, given in two divided doses (75 mg BID), with or without food in patients with a creatinine clearance rate of at least 60 mL/min.
Based on individual response and tolerability, the dose may be increased to 150 mg BID (300 mg/day) after one week. Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg BID (450 mg/day).
In some patients, efficacy of pregabalin has been demonstrated within the first week. For patients who experience significant and ongoing pain and can tolerate pregabalin 300 mg/day well, maximum daily dose of 600 mg (300 mg twice a day, BID) can be used.
2 Clinical Trial Adverse Reactions, Table 8 and Table 11). In view of the dose-related adverse events, the decision to treat patients with doses above 450 mg/day should be based on clinical judgment of the treating physician. Doses above 600 mg/day have not been studied and are not recommended.
NB-PREGABALIN (pregabalin capsules) Page 7 of 75 Protected B / Protégé B Dosage Adjustment Based on Renal Function Pregabalin is primarily eliminated by renal excretion. Therefore, the dose should be adjusted for patients with reduced renal function.
Pregabalin clearance is directly proportional to creatinine clearance. Therefore, dosing adjustment should be based on creatinine clearance (CLCr), as indicated in Table 1. To use this dosing table, an estimate of the patient's creatinine clearance (CLCr) in mL/min is needed.
CLCr in mL/min may be estimated from serum creatinine (mg/dL) determination using the Cockcroft and Gault equation: Pregabalin is effectively removed from plasma by hemodialysis. Over a 4-hour hemodialysis treatment, plasma pregabalin concentrations are reduced by approximately 50%.
For patients receiving hemodialysis, pregabalin daily dose should be adjusted based on renal function. In addition to the daily dose adjustment, a supplemental dose should be given immediately following every 4-hour hemodialysis treatment (see Table 1).
Table 1:
Pregabalin Dosage Adjustment Based on Renal Function Creatinine Clearance (CLcr) (mL∕min) Total Pregabalin Daily Dose (mg∕day) a Recommended Dose Escalation* Dose Regimen Starting Dose Up […]
In randomized controlled trials, pregabalin was not associated with an increase in bleeding related adverse events. Immune NB-PREGABALIN (pregabalin capsules) Page 16 of 75 Protected B / Protégé B • 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. NB-PREGABALIN should be immediately discontinued in patients with these symptoms. 5 Post-Market Adverse Reactions). Caution should be exercised when prescribing NB-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 malaise or fever.
Pregabalin treatment should be discontinued if myopathy is diagnosed or suspected or if markedly elevated creatine kinase levels occur. NB-PREGABALIN (pregabalin capsules) Page 17 of 75 Protected B / Protégé B Neurologic • Respiratory Depression Pregabalin has been associated with central […]
2 Clinical Trial Adverse Reactions, Table 4 and Table 7). Doses above 600 mg/day have not been studied and are not recommended. Neuropathic Pain Associated with Spinal Cord Injury The recommended starting dose for NB-PREGABALIN is 150 mg/day, given in two divided doses (75 mg BID), with or without food in patients with a creatinine clearance rate of at least 60 mL/min.
Efficacy of pregabalin has been demonstrated within the first week. Based on individual patient response and tolerability, the dose may be increased to 150 mg BID (300 mg/day) after one week. For patients who experience significant and ongoing pain and can tolerate pregabalin 300 mg/day well, a maximum daily dose of 600 mg (300 mg twice a day, BID) may be considered.
Doses above 600 mg/day have not been studied and are not recommended. Pain Associated with Fibromyalgia The recommended dosage is 300 to 450 mg/day, given in two divided doses. The recommended starting dose for NB-PREGABALIN is 150 mg/day, given in two divided doses (75 mg BID), with or without food in patients with a creatinine clearance rate of at least 60 mL/min.
Based on individual response and tolerability, the dose may be increased to 150 mg BID (300 mg/day) after one week. Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg BID (450 mg/day).
In some patients, efficacy of pregabalin has been demonstrated within the first week. For patients who experience significant and ongoing pain and can tolerate pregabalin 300 mg/day well, maximum daily dose of 600 mg (300 mg twice a day, BID) can be used.
2 Clinical Trial Adverse Reactions, Table 8 and Table 11). In view of the dose-related adverse events, the decision to treat patients with doses above 450 mg/day should be based on clinical judgment of the treating physician. Doses above 600 mg/day have not been studied and are not recommended.
NB-PREGABALIN (pregabalin capsules) Page 7 of 75 Protected B / Protégé B Dosage Adjustment Based on Renal Function Pregabalin is primarily eliminated by renal excretion. Therefore, the dose should be adjusted for patients with reduced renal function.
Pregabalin clearance is directly proportional to creatinine clearance. Therefore, dosing adjustment should be based on creatinine clearance (CLCr), as indicated in Table 1. To use this dosing table, an estimate of the patient's creatinine clearance (CLCr) in mL/min is needed.
CLCr in mL/min may be estimated from serum creatinine (mg/dL) determination using the Cockcroft and Gault equation: Pregabalin is effectively removed from plasma by hemodialysis. Over a 4-hour hemodialysis treatment, plasma pregabalin concentrations are reduced by approximately 50%.
For patients receiving hemodialysis, pregabalin daily dose should be adjusted based on renal function. In addition to the daily dose adjustment, a supplemental dose should be given immediately […]