Trokendi Xr Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Trokendi Xr Indications
Indications
Trokendi Xr Dosage and Administration
Adult
Children
Renal Impairment
-
The clearance of topiramate is reduced in patients with moderate (creatinine clearance 30 to 69 mL/min/1.73m2) and severe (creatinine clearance less than 30 mL/min/1.73m2) renal impairment. A dosage adjustment is recommended in patients with moderate or severe renal impairment.
-
Patients Undergoing Hemodialysis: Topiramate is cleared by hemodialysis at a rate that is 4 to 6 times greater than in a normal individual. A dosage adjustment may be required.
Other Modifications
Females and Males of Reproductive Potential
- Contraception: Advise women of childbearing potential who are not planning a pregnancy to use effective contraception due to risks of the fetus of oral clefts and of being small for gestational age.
Trokendi Xr Contraindications
Contraindications
Trokendi Xr Boxed Warnings
Not Applicable
Trokendi Xr Warnings/Precautions
Warnings/Precautions
Discontinue if acute myopia and secondary angle-closure glaucoma syndrome occur. Consider discontinuing if visual problems occur. Measure baseline and periodic serum bicarbonate during therapy; consider reducing dose or discontinuing if acidosis occurs. Inborn errors of metabolism, reduced hepatic mitochondrial activity: increased risk of hyperammonemia; measure ammonia levels if encephalopathic symptoms occur. Monitor on growth (during prolonged therapy), oligohidrosis, and hyperthermia esp. in children. Suicidal tendencies (monitor). Discontinue at the 1st sign of a rash. Kidney stones. Maintain adequate hydration; avoid ketogenic diets. Renal impairment; obtain CrCl prior to initiation. Avoid abrupt cessation. Fetal toxicity (eg, congenital malformations, oral clefts, small for gestational age). Labor & delivery. Pregnancy. Advise females of reproductive potential to use effective contraception during therapy. Nursing mothers.
Trokendi Xr Pharmacokinetics
Absorption
The peak plasma concentrations (Cmax) of topiramate occurred at approximately 24 hours following a single 200 mg oral dose of Trokendi XR. At steady-state, the (AUC0-24, Cmax, and Cmin) of topiramate from Trokendi XR administered once-daily and the immediate-release tablet administered twicedaily were shown to be bioequivalent. Fluctuation of topiramate plasma concentrations at steady-state for Trokendi XR administered once-daily was approximately 26% and 42% in healthy subjects and in epileptic patients, respectively, compared to approximately 40% and 51%, respectively, for immediate-release topiramate.
Distribution
Topiramate is 15% to 41% bound to human plasma proteins over the blood concentration range of 0.5 mcg/mL to 250 mcg/mL. The fraction bound decreased as blood concentration increased.
Elimination
Overall, oral plasma clearance (CL/F) is approximately 20 mL/min to 30 mL/min in adults following oral administration. The mean elimination half-life of topiramate was approximately 31 hours following repeat administration of Trokendi XR.
Trokendi Xr Interactions
Interactions
Trokendi Xr Adverse Reactions
Adverse Reactions
Paresthesia, anorexia, weight decrease, speech disorders/related speech problems, fatigue, dizziness, somnolence, nervousness, psychomotor slowing, abnormal vision, difficulty with memory/concentration/attention, fever, taste perversion, upper RTI, abdominal pain, diarrhea, hypoesthesia, nausea; metabolic acidosis, cognitive/neuropsychiatric reactions, serious skin reactions (eg, SJS, TEN), decrease in bone mineral density.
Trokendi Xr Clinical Trials
Trokendi Xr Note
Not Applicable
Trokendi Xr Patient Counseling
Cost Savings Program
Trokendi Xr Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Trokendi Xr Indications
Indications
Trokendi Xr Dosage and Administration
Adult
Children
Renal Impairment
-
The clearance of topiramate is reduced in patients with moderate (creatinine clearance 30 to 69 mL/min/1.73m2) and severe (creatinine clearance less than 30 mL/min/1.73m2) renal impairment. A dosage adjustment is recommended in patients with moderate or severe renal impairment.
-
Patients Undergoing Hemodialysis: Topiramate is cleared by hemodialysis at a rate that is 4 to 6 times greater than in a normal individual. A dosage adjustment may be required.
Other Modifications
Females and Males of Reproductive Potential
- Contraception: Advise women of childbearing potential who are not planning a pregnancy to use effective contraception due to risks of the fetus of oral clefts and of being small for gestational age.
Trokendi Xr Contraindications
Contraindications
Trokendi Xr Boxed Warnings
Not Applicable
Trokendi Xr Warnings/Precautions
Warnings/Precautions
Discontinue if acute myopia and secondary angle-closure glaucoma syndrome occur. Consider discontinuing if visual problems occur. Measure baseline and periodic serum bicarbonate during therapy; consider reducing dose or discontinuing if acidosis occurs. Inborn errors of metabolism, reduced hepatic mitochondrial activity: increased risk of hyperammonemia; measure ammonia levels if encephalopathic symptoms occur. Monitor on growth (during prolonged therapy), oligohidrosis, and hyperthermia esp. in children. Suicidal tendencies (monitor). Discontinue at the 1st sign of a rash. Kidney stones. Maintain adequate hydration; avoid ketogenic diets. Renal impairment; obtain CrCl prior to initiation. Avoid abrupt cessation. Fetal toxicity (eg, congenital malformations, oral clefts, small for gestational age). Labor & delivery. Pregnancy. Advise females of reproductive potential to use effective contraception during therapy. Nursing mothers.
Trokendi Xr Pharmacokinetics
Absorption
The peak plasma concentrations (Cmax) of topiramate occurred at approximately 24 hours following a single 200 mg oral dose of Trokendi XR. At steady-state, the (AUC0-24, Cmax, and Cmin) of topiramate from Trokendi XR administered once-daily and the immediate-release tablet administered twicedaily were shown to be bioequivalent. Fluctuation of topiramate plasma concentrations at steady-state for Trokendi XR administered once-daily was approximately 26% and 42% in healthy subjects and in epileptic patients, respectively, compared to approximately 40% and 51%, respectively, for immediate-release topiramate.
Distribution
Topiramate is 15% to 41% bound to human plasma proteins over the blood concentration range of 0.5 mcg/mL to 250 mcg/mL. The fraction bound decreased as blood concentration increased.
Elimination
Overall, oral plasma clearance (CL/F) is approximately 20 mL/min to 30 mL/min in adults following oral administration. The mean elimination half-life of topiramate was approximately 31 hours following repeat administration of Trokendi XR.
Trokendi Xr Interactions
Interactions
Trokendi Xr Adverse Reactions
Adverse Reactions
Paresthesia, anorexia, weight decrease, speech disorders/related speech problems, fatigue, dizziness, somnolence, nervousness, psychomotor slowing, abnormal vision, difficulty with memory/concentration/attention, fever, taste perversion, upper RTI, abdominal pain, diarrhea, hypoesthesia, nausea; metabolic acidosis, cognitive/neuropsychiatric reactions, serious skin reactions (eg, SJS, TEN), decrease in bone mineral density.
Trokendi Xr Clinical Trials
Trokendi Xr Note
Not Applicable