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PRO-GABAPENTIN is a brand name for Gabapentin, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Adults PRO-GABAPENTIN (gabapentin) is indicated as adjunctive therapy for the management of patients with epilepsy who are not satisfactorily controlled with conventional therapy. 1.1 Pediatrics Pediatrics (< 18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Because PRO-GABAPENTIN is eliminated solely by renal excretion, dosage adjustments are recommended for patients with renal impairment (including elderly patients with declining renal function) and patients undergoing hemodialysis.
2 Recommended Dose and Dosage Adjustment, Special Patient Populations, Geriatrics and Renal Impairment). Serious Warnings and Precautions Life-threatening Respiratory Depression Concomitant use of PRO-GABAPENTIN with opioids may result in respiratory depression, profound sedation, syncope, and death.
(see 7 WARNINGS AND PRECAUTIONS, Neurologic, Concomitant Use With Opioids) • Limit dosages and durations to the minimum required. • Follow patients for signs and symptoms of respiratory depression and sedation. 2 Recommended Dose and Dosage Adjustment Adults Initial dose: The starting dose is 300 mg three times a day.
Dose Range:
The dose may be increased, depending on the response and tolerance of the patient, using 300 or 400 mg capsules 3 times a day up to 1800 mg/ day. In clinical trials, the effective dosage range was 900 to 1800 mg/day, given 3 times a day using 300 mg or 400 mg capsules.
Dosages up to 2400 mg/day have been well tolerated in long-term open-label clinical studies. Doses of 3600 mg/day have also been administered to a small number of patients for a relatively short duration and have been well tolerated.
Although data from clinical trials suggest that doses higher than 1200 mg/day may have increased efficacy in some patients, higher doses may also increase the incidence of adverse events. (See 8 ADVERSE REACTIONS).
Maintenance:
Daily maintenance doses should be given in three equally divided doses, and the maximum time between doses in a three times daily schedule should not exceed 12 hours to prevent breakthrough convulsions. It is not necessary to monitor gabapentin plasma concentrations in order to optimize PRO-GABAPENTIN therapy.
Further, as there are no drug interactions with commonly used antiepileptic drugs, PRO-GABAPENTIN may be used in combination with these drugs without concern for alteration of plasma concentrations of either gabapentin or other antiepileptic drugs.
).
Maintenance:
Daily maintenance doses should be given in three equally divided doses, and the maximum time between doses in a three times daily schedule should not exceed 12 hours to prevent breakthrough convulsions. It is not necessary to monitor gabapentin plasma concentrations in order to optimize PRO-GABAPENTIN therapy.
Further, as there are no drug interactions with commonly used antiepileptic drugs, PRO-GABAPENTIN may be used in combination with these drugs without concern for alteration of plasma concentrations of either gabapentin or other antiepileptic drugs.
Discontinuation of Treatment, Dose Reduction or Initiation of Adjunctive Antiepileptic Therapy: If PRO-GABAPENTIN dose is reduced, discontinued or substituted with an alternate anticonvulsant or an alternate anticonvulsant is added to PRO-GABAPENTIN therapy, this should be done gradually over a minimum of 1 week (a longer period may be needed at the discretion of the prescriber.
(See 7 WARNINGS AND PRECAUTIONS, General, Discontinuation of Treatment with PRO-GABAPENTIN).
Special Patient Populations Geriatrics and Renal Impairment:
Due to the primarily renal excretion of PRO-GABAPENTIN, the following dosage adjustments are recommended for elderly patients with declining renal function, patients with renal impairment and patients undergoing hemodialysis. 3 Pharmacokinetics, Special Populations and Conditions).
Table 1 – Dosage of PRO-GABAPENTIN in Adults Based on Renal Function Renal Function Creatinine Clearance (mL/min) Total Daily Dose Range1 (mg/day) Dose Regimen2 ≥ 60 900 - 3600 Total daily dose (mg/day) should be divided by 3 and administered three times daily (TID) > 30 - 59 400 - 1400 Total daily dose (mg/day) should be divided by 2 and administered twice daily (BID) PRO-GABAPENTIN (gabapentin) page 6 of 37 Renal Function Creatinine Clearance (mL/min) Total Daily Dose Range1 (mg/day) Dose Regimen2 > 15 - 29 200 - 700 Total daily dose (mg/day) should be administered once daily (QD) 15 100 - 300 Total daily dose (mg/day) should be administered once daily (QD).
1 Pregnant Women, Teratogenic Potential 12/2024 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 ..................................................................................................................... 5 Missed Dose ........................................................................................................................
PRO-GABAPENTIN is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredients, 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.
Other brands of Gabapentin in Canada.
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Discontinuation of Treatment, Dose Reduction or Initiation of Adjunctive Antiepileptic Therapy: If PRO-GABAPENTIN dose is reduced, discontinued or substituted with an alternate anticonvulsant or an alternate anticonvulsant is added to PRO-GABAPENTIN therapy, this should be done gradually over a minimum of 1 week (a longer period may be needed at the discretion of the prescriber.
(See 7 WARNINGS AND PRECAUTIONS, General, Discontinuation of Treatment with PRO-GABAPENTIN).
Special Patient Populations Geriatrics and Renal Impairment:
Due to the primarily renal excretion of PRO-GABAPENTIN, the following dosage adjustments are recommended for elderly patients with declining renal function, patients with renal impairment and patients undergoing hemodialysis. 3 Pharmacokinetics, Special Populations and Conditions).
Table 1 – Dosage of PRO-GABAPENTIN in Adults Based on Renal Function Renal Function Creatinine Clearance (mL/min) Total Daily Dose Range1 (mg/day) Dose Regimen2 ≥ 60 900 - 3600 Total daily dose (mg/day) should be divided by 3 and administered three times daily (TID) > 30 - 59 400 - 1400 Total daily dose (mg/day) should be divided by 2 and administered twice daily (BID) PRO-GABAPENTIN (gabapentin) page 6 of 37 Renal Function Creatinine Clearance (mL/min) Total Daily Dose Range1 (mg/day) Dose Regimen2 > 15 - 29 200 - 700 Total daily dose (mg/day) should be administered once daily (QD) 15 100 - 300 Total daily dose (mg/day) should be administered once daily (QD).
5 mL/min should receive one-half the daily dose that patients with a creatinine clearance of 15 mL/min receive) Post-hemodialysis Supplemental Dose (mg) Hemodialysis 125 - 350 Patients on hemodialysis should receive maintenance doses as indicated and an additional post-hemodialysis dose administered after each 4 hours of hemodialysis.
1 The table lists the recommended dose to be administered. When the recommended dose is unobtainable with the available dosage strengths, in these cases, dose selection should be based on available dosage strengths, clinical judgement and tolerability.
2 Health professional should administer the dose regimen according to the response and tolerance of the patient.
Pediatrics:
PRO-GABAPENTIN is not indicated for use in children under 18 years of age. 3 Pediatrics).
Hepatic Impairment:
Because gabapentin is not metabolized to a significant extent in humans, no studies have been performed in patients with hepatic impairment. 4 Administration PRO-GABAPENTIN is given orally with or without food. 5 Missed Dose Health professionals should instruct their patients that if a dose is missed, the next one should be taken as soon as possible.
However, if it is within 4 hours of the next dose, the missed dose is not to be taken and the patient should return to the regular dosing schedule. To avoid breakthrough convulsions the maximum time between doses should not exceed 12 hours.
PRO-GABAPENTIN (gabapentin) page 7 of 37
5 mL/min should receive one-half the daily dose that patients with a creatinine clearance of 15 mL/min receive) Post-hemodialysis Supplemental Dose (mg) Hemodialysis 125 - 350 Patients on hemodialysis should receive maintenance doses as indicated and an additional post-hemodialysis dose administered after each 4 hours of hemodialysis.
1 The table lists the recommended dose to be administered. When the recommended dose is unobtainable with the available dosage strengths, in these cases, dose selection should be based on available dosage strengths, clinical judgement and tolerability.
2 Health professional should administer the dose regimen according to the response and tolerance of the patient.
Pediatrics:
PRO-GABAPENTIN is not indicated for use in children under 18 years of age. 3 Pediatrics).
Hepatic Impairment:
Because gabapentin is not metabolized to a significant extent in humans, no studies have been performed in patients with hepatic impairment. 4 Administration PRO-GABAPENTIN is given orally with or without food. 5 Missed Dose Health professionals should instruct their patients that if a dose is missed, the next one should be taken as soon as possible.
However, if it is within 4 hours of the next dose, the missed dose is not to be taken and the patient should return to the regular dosing schedule. To avoid breakthrough convulsions the maximum time between doses should not exceed 12 hours.
PRO-GABAPENTIN (gabapentin) page 7 of 37 5 OVERDOSAGE Symptoms of Overdosage Acute, life-threatening toxicity has not been observed with gabapentin overdoses of up to 49 grams ingested at one time. In these cases, dizziness, double vision, slurred speech, drowsiness, loss of consciousness, lethargy and mild diarrhea were observed.
All patients recovered with supportive care. Overdoses of gabapentin, particularly in combination with other CNS depressant medications, including opioids, can result in coma and death. An oral lethal dose of gabapentin was not identified in mice and rats given doses as high as 8000 mg/kg.
Signs of acute toxicity in animals included ataxia, laboured breathing, ptosis, hypoactivity, or excitation. Treatment of Overdosage Gabapentin can be removed by hemodialysis. Although hemodialysis has not been performed in the few overdose cases reported, it may be indicated by the patient’s clinical state or in patients with significant renal impairment.
Reduced absorption of gabapentin at higher doses may limit drug absorption at the time of overdosing and, hence, reduce toxicity from overdoses. In managing overdosage, consider the possibility of multiple drug involvement. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 2 – Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Capsules 100 mg, 300 mg, and 400 mg Corn Starch, Lactose Anhydrous, and Talc.
Capsule shells contain Gelatin, Red Iron Oxide (400 mg), Titanium Dioxide, and Yellow Iron Oxide (300 mg and 400 mg).
PRO-GABAPENTIN capsules are supplied as follows: 100 mg capsules:
Hard gelatin, white opaque body and cap. Printed “Gabapentin / 100 mg” on the cap in blue ink. Capsule filled with white powder. Bottles of 100, 500 and 1000 capsules. For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669).
PRO-GABAPENTIN (gabapentin) page 8 of 37 300 mg capsules:
Hard gelatin, yellow opaque, body and cap. Printed “Gabapentin / 300 mg” on the cap in blue ink. Capsule filled with white powder. Bottles of 100, 500 and 700 capsules. 400 mg capsules: Hard gelatin, […]
6 5 OVERDOSAGE ........................................................................................................................... 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ..............................................
7 7 WARNINGS AND PRECAUTIONS................................................................................................ 1 Special Populations ............................................................................................................
2 Breast-feeding ................................................................................................................... 3 Pediatrics ...........................................................................................................................
4 Geriatrics ........................................................................................................................... 12 8 ADVERSE REACTIONS..............................................................................................................
1 Adverse Reaction Overview .............................................................................................. 2 Clinical Trial Adverse Reactions .........................................................................................
3 Less Common Clinical Trial Adverse Reactions................................................................... 5 Post-Market Adverse Reactions .........................................................................................
17 PRO-GABAPENTIN (gabapentin) page 3 of 37 9 DRUG INTERACTIONS ............................................................................................................. 1 Serious Drug Interactions...................................................................................................
2 Drug Interactions Overview ............................................................................................... 4 Drug-Drug Interactions ......................................................................................................
5 Drug-Food Interactions ...................................................................................................... 6 Drug-Herb Interactions ......................................................................................................
7 Drug-Laboratory Test Interactions ..................................................................................... 21 10 CLINICAL PHARMACOLOGY .....................................................................................................
1 Mechanism of Action......................................................................................................... 3 Pharmacokinetics...............................................................................................................
22 11 STORAGE, STABILITY AND DISPOSAL ...................................................................................... 25 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................................
25 PART II: SCIENTIFIC INFORMATION .................................................................................................... 26 13 PHARMACEUTICAL INFORMATION .........................................................................................
26 14 CLINICAL TRIALS ..................................................................................................................... 2 Comparative Bioavailability Studies ......................................................................................
27 15 MICROBIOLOGY ...................................................................................................................... 28 16 NON-CLINICAL TOXICOLOGY […]