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APO-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 APO-PREGABALIN CAPSULES (pregabalin capsules) is indicated for the management of neuropathic pain associated with: • Diabetic peripheral neuropathy; • Postherpetic neuralgia; • Spinal cord injury APO-PREGABALIN CAPSULES is indicated for the management of pain associated with fibromyalgia. The efficacy of…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations In accordance with current clinical practice, if APO-PREGABALIN CAPSULES (pregabalin capsules) has to be discontinued, it is recommended this should be done gradually over a minimum of 1 week (see 7 WARNINGS AND PRECAUTIONS, Abrupt or Rapid Discontinuation).
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 APO-PREGABALIN CAPSULES 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 capsules 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.
However, in clinical trials, pregabalin capsules 600 mg/day did not provide additional significant efficacy and patients treated with this dose experienced markedly higher rates of adverse events and discontinued the trial more frequently (see 8 ADVERSE REACTIONS, Table 2 and Table 6).
Doses above 600 mg/day have not been studied and are not recommended. Neuropathic Pain Associated with Postherpetic Neuralgia APO- PREGABALIN CAPSULES (Pregabalin capsules) Page 6 of 75 The recommended starting dose for APO-PREGABALIN CAPSULES 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 capsules 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.
However, in clinical trials, pregabalin capsules 600 mg/day did not provide additional significant efficacy and patients treated with this dose experienced markedly higher rates of adverse events and discontinued the trial more frequently (see 8 ADVERSE REACTIONS, Table 4 and Table 7).
, Table 2 and Table 6). Doses above 600 mg/day have not been studied and are not recommended. Neuropathic Pain Associated with Postherpetic Neuralgia APO- PREGABALIN CAPSULES (Pregabalin capsules) Page 6 of 75 The recommended starting dose for APO-PREGABALIN CAPSULES 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 capsules 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.
However, in clinical trials, pregabalin capsules 600 mg/day did not provide additional significant efficacy and patients treated with this dose experienced markedly higher rates of adverse events and discontinued the trial more frequently (see 8 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 APO-PREGABALIN CAPSULES 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 capsules 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 APO-PREGABALIN CAPSULES 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.
1. Pregnant Women 01/2024 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 ..................................................................................................................... 4 2 CONTRAINDICATIONS ......................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ................................................................. 4 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 ....................................................................................................
APO-PREGABALIN CAPSULES 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 APO-PREGABALIN CAPSULES 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 capsules 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 APO-PREGABALIN CAPSULES 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 capsules 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.
However, in clinical trials of fibromyalgia, pregabalin capsules 600 mg/day did not provide additional significant efficacy and patients treated with this dose experienced significantly higher rates of adverse events and discontinued the trial more frequently (see 8 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.
APO- PREGABALIN CAPSULES (Pregabalin capsules) Page 7 of 75 Dosage Adjustment Based on Renal Function APO-PREGABALIN CAPSULES 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.
85 for female patients) 72 x serum creatinine (mg/dL) 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, APO-PREGABALIN CAPSULES daily dose should be adjusted based on renal function.
In addition to the daily dose adjustment, a supplemental dose should be given […]
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 capsules 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.
However, in clinical trials of fibromyalgia, pregabalin capsules 600 mg/day did not provide additional significant efficacy and patients treated with this dose experienced significantly higher rates of adverse events and discontinued the trial more frequently (see 8 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.
APO- PREGABALIN CAPSULES (Pregabalin capsules) Page 7 of 75 Dosage Adjustment Based on Renal Function APO-PREGABALIN CAPSULES 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.
85 for female patients) 72 x serum creatinine (mg/dL) 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, APO-PREGABALIN CAPSULES 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 APO-PREGABALIN CAPSULES Daily Dose (mg/day)a Recommended Dose Escalation* Dose Regimen Starting Dose up to Maximum daily dose ≥60 150 300 450 600 BID or TID 30-60 75 150 225 300 BID or TID 15-30 25-50 75 100-150 150 QD or BID <15 25 25-50 50-75 75 QD Supplementary dosage following hemodialysis (mg)b Patients on the 25 mg QD regimen: take one supplemental dose of 25 mg or 50 mg Patients on the 25-50 mg QD regimen: take one supplemental dose of 50 mg or 75 mg Patients on the 50-75 mg QD regimen: take one supplemental dose of 75 mg or 100 mg Patients on the 75 mg QD regimen: take one supplemental dose of 100 mg or 150 mg TID = Three divided doses; BID = Two divided doses; QD = Single daily dose.
* Based on individual patient response and tolerability. a Total daily dose (mg/day) should be divided as indicated by dose regimen to provide mg/dose. APO- PREGABALIN CAPSULES (Pregabalin capsules) Page 8 of 75 b Supplementary dose is a single additional dose.
Geriatrics (> 65 years):
Pregabalin oral clearance tended to decrease with increasing age. This decrease in pregabalin oral clearance is consistent with age-related decreases in creatinine clearance. Reduction of pregabalin dose may be required in patients who have age-related compromised renal function.
Pediatrics (< 18 years of age):
The safety and efficacy of pregabalin in pediatric patients (< 18 years of age) have not been established and its use in this patient population is […]
1 Pregnant Women ....................................................................................................... 2 Breast-feeding ............................................................................................................
3 Pediatrics ................................................................................................................... 4 Geriatrics ...................................................................................................................
23 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 ................................................................................. 42 9 DRUG INTERACTIONS .....................................................................................................
2 Drug Interactions Overview ....................................................................................... 4 Drug-Drug Interactions ..............................................................................................
5 Drug-Food Interactions .............................................................................................. 6 Drug-Herb Interactions ..............................................................................................
7 Drug-Laboratory Test Interactions.............................................................................. 48 10 CLINICAL PHARMACOLOGY ............................................................................................
1 Mechanism of Action ................................................................................................. 2 Pharmacodynamics ....................................................................................................
3 Pharmacokinetics ....................................................................................................... 49 11 STORAGE, STABILITY AND DISPOSAL ..............................................................................
51 12 SPECIAL HANDLING INSTRUCTIONS................................................................................ 52 PART II: SCIENTIFIC INFORMATION .......................................................................................
53 13 PHARMACEUTICAL INFORMATION ................................................................................. 53 14 CLINICAL TRIALS .............................................................................................................
1 Clinical Trials by Indication ......................................................................................... 53 Diabetic Peripheral Neuropathy .........................................................................................
53 Postherpetic Neuralgia ....................................................................................................... 57 Spinal Cord Injury ................................................................................................................
59 Fibromyalgia ........................................................................................................................ 2 Comparative Bioavailability Studies […]