A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Topamax Indications, Dosage, Storage, Stability - Topiramate
Topamax Indications, Dosage, Storage, Stability - Topiramate
INDICATIONS AND USAGE
TOPAMAX® (topiramate) Tablets and TOPAMAX (topiramate
capsules) Sprinkle Capsules are indicated as adjunctive therapy for adults and
pediatric patients ages 2 -16 years with partial onset seizures, or primary
generalized tonic-clonic seizures, and in patients 2 years of age and older
with seizures associated with Lennox-Gastaut syndrome.
DOSAGE AND ADMINISTRATION
TOPAMAX® has been shown to be effective in adults
and pediatric patients ages 2-16 years with partial onset seizures or primary
generalized tonic-clonic seizures, and in patient 2 years of age and older with
seizures associated with Lennox-Gastaut syndrome. In the controlled add-on trials,
no correlation has been demonstrated between trough plasma concentrations of
topiramate and clinical efficacy. No evidence of tolerance has been demonstrated
in humans. Doses above 400 mg/day (600, 800, or 1,000 mg/day) have not been
shown to improve responses in dose-response studies in adults with partial onset
seizures.
It is not necessary to monitor topiramate plasma concentrations
to optimize TOPAMAX® therapy. On occasion, the addition of TOPAMAX®
to phenytoin may require an adjustment of the dose of phenytoin to achieve optimal
clinical outcome. Addition or withdrawal of phenytoin and/or carbamazepine during
adjunctive therapy with TOPAMAX® may require adjustment of the
dose of TOPAMAX®. Because of the bitter taste, tablets should
not be broken.
TOPAMAX® can be taken without regard to meals.
Adults (17 Years of Age and Over)
The recommended total daily dose of TOPAMAX®
as adjunctive therapy in adults with partial seizures is 200-400 mg/day in two
divided doses, and 400 mg/day in two divided doses as adjunctive treatment in
adults with primary generalized tonic-clonic seizures. It is recommended that
therapy be initiated at 25-50 mg/day followed by titration to an effective dose
in increments of 25-50 mg/week. Titrating in increments of 25 mg/week may delay
the time to reach an effective dose. Daily doses above 1,600 mg have not been
studied.
In the study of primary generalized tonic-clonic seizures the
initial titration rate was slower than in previous studies; the assigned dose
was reached at the end of 8 weeks (see CLINICAL STUDIES,
Controlled Trials in Patients With Primary Generalized Tonic-Clonic Seizures).
Pediatric Patients (Ages 2 - 16 Years) – Partial Seizures,
Primary Generalized Tonic-Clonic Seizures, or Lennox-Gastaut Syndrome
The recommended total daily dose of TOPAMAX®
(topiramate) as adjunctive therapy for patients with partial seizures, primary
generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut
syndrome is approximately 5 to 9 mg/kg/day in two divided doses. Titration should
begin at 25 mg (or less, based on a range of 1 to 3 mg/kg/day) nightly for the
first week. The dosage should then be increased at 1- or 2-week intervals by
increments of 1 to 3 mg/kg/day (administered in two divided doses), to achieve
optimal clinical response. Dose titration should be guided by clinical outcome.
In the study of primary generalized tonic-clonic seizures the
initial titration rate was slower than in previous studies; the assigned dose
of 6 mg/kg/day was reached at the end of 8 weeks (see CLINICAL
STUDIES, Controlled Trials in Patients With Primary Generalized Tonic-Clonic
Seizures).
Administration of TOPAMAX Sprinkle Capsules
TOPAMAX (topiramate capsules) Sprinkle Capsules may be swallowed
whole or may be administered by carefully opening the capsule and sprinkling
the entire contents on a small amount (teaspoon) of soft food. This drug/food
mixture should be swallowed immediately and not chewed. It should not be stored
for future use.
Patients with Renal Impairment:
In renally impaired subjects (creatinine clearance less than
70 mL/min/1.73m2), one half of the usual adult dose is recommended.
Such patients will require a longer time to reach steady-state at each dose.
Geriatric Patients (Ages 65 Years and Over):
Dosage adjustment may be indicated in the elderly patient when
impaired renal function (creatinine clearance rate <70 mL/min/1.73
m2) is evident. (See DOSAGE AND ADMINISTRATION:
Patients with Renal Impairment and CLINICAL
PHARMACOLOGY: Special Populations: Age, Gender, and Race).
Patients Undergoing Hemodialysis:
Topiramate is cleared by hemodialysis at a rate that is 4 to
6 times greater than a normal individual. Accordingly, a prolonged period of
dialysis may cause topiramate concentration to fall below that required to maintain
an anti-seizure effect. To avoid rapid drops in topiramate plasma concentration
during hemodialysis, a supplemental dose of topiramate may be required. The
actual adjustment should take into account 1) the duration of dialysis period,
2) the clearance rate of the dialysis system being used, and 3) the effective
renal clearance of topiramate in the patient being dialyzed.
Patients with Hepatic Disease:
In hepatically impaired patients topiramate plasma concentrations
may be increased. The mechanism is not well understood.
HOW SUPPLIED
TOPAMAX (topiramate) Tablets is available as debossed, coated,
round tablets in the following strengths and colors: 25 mg white (coded "TOP"
on one side; "25" on the other) 50 mg light-yellow (coded "TOPAMAX" on one side;
"50" on the other)
100 mg yellow (coded "TOPAMAX" on one side; "100" on the other)
200 mg salmon (coded "TOPAMAX" on one side; "200" on the other)
They are supplied as follows:
25 mg tablets – bottles of 60 count with desiccant (NDC 0045-0639-65)
50 mg tablets – bottles of 60 count with desiccant (NDC 0045-0640-65)
100 mg tablets – bottles of 60 count with desiccant (NDC 0045-0641-65)
200 mg tablets – bottles of 60 count with desiccant (NDC 0045-0642-65)
TOPAMAX (topiramate capsules) Sprinkle Capsules contain small,
white to off white spheres. The gelatin capsules are white and clear.
They are marked as follows:
15 mg capsule with "TOP" and "15 mg" on
the side 25 mg capsule with "TOP" and "25 mg" on the side
The capsules are supplied as follows:
15 mg capsules – bottles of 60 (NDC 0045-0647-65) 25 mg capsules
– bottles of 60 (NDC 0045-0645-65)
TOPAMAX (topiramate) Tablets should be stored in tightly-closed
containers at controlled room temperature, (59 to 86°F,
15 to 30°C). Protect from
moisture. TOPAMAX (topiramate capsules) Sprinkle Capsules should be stored in
tightly-closed containers at or below 25°C
(77°F). Protect from moisture.
TOPAMAX® (topiramate) and TOPAMAX (topiramate
capsules) are trademarks of Ortho-McNeil Pharmaceutical.
OMP Division ORTHO-McNEIL PHARMACEUTICAL, INC.
Raritan, New Jersey 08869, © OMP xxxx Revision Date December 2003 XXXXXXX
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