Prescription Drug Information: TOPIRAMATE

TOPIRAMATE- topiramate capsule, extended release
NorthStar RxLLC

1 INDICATIONS AND USAGE

1.1 Monotherapy Epilepsy

Topiramate extended-release capsules are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older.

1.2 Adjunctive Therapy Epilepsy

Topiramate extended-release capsules are indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut Syndrome in patients 2 years of age and older.

1.3 Migraine

Topiramate extended-release capsules are indicated for the preventive treatment of migraine in patients 12 years of age and older.

2 DOSAGE AND ADMINISTRATION

2.1 Dosing in Monotherapy Epilepsy

Adults and Pediatric Patients 10 Years of Age and Older

The recommended dose for topiramate extended-release capsules monotherapy in adults and pediatric patients 10 years of age and older is 400 mg orally once daily. Titrate topiramate extended-release capsules according to the following schedule (see Table 1).

Table 1: Monotherapy Titration Schedule for Adults and Pediatric Patients 10 Years of Age and Older

Topiramate Extended-Release Capsules Once Daily Dose

Week 1 Week 2 Week 3 Week 4 Week 5 Week 6

50 mg 100 mg 150 mg 200 mg 300 mg 400 mg

Pediatric Patients 2 to 9 Years of Age

Dosing in patients 2 to 9 years of age is based on weight. During the titration period, the initial dose of topiramate extended-release capsules is 25 mg/day nightly for the first week. Based upon tolerability, the dosage can be increased to 50 mg/day in the second week. Dosage can be increased by 25 mg to 50 mg once daily each subsequent week, as tolerated. Titration to the minimum maintenance dose should be attempted over 5 to 7 weeks. Based upon tolerability and clinical response, additional titration to a higher dose (up to the maximum maintenance dose) can be attempted at 25 mg to 50 mg once daily weekly increments. The total daily dose should not exceed the maximum maintenance dose for each range of body weight (see Table 2).

Table 2: Monotherapy Target Total Daily Maintenance Dosing for Patients 2 to 9 Years of Age

Weight (kg)

Total Daily Dose (mg/day) Minimum Maintenance Dose

Total Daily Dose (mg/day) Maximum Maintenance Dose

Up to 11

150

250

12 to 22

200

300

23 to 31

200

350

32 to 38

250

350

Greater than 38

250

400

2.2 Dosing in Adjunctive Therapy Epilepsy

Adults (17 Years of Age and Older)

The recommended total daily dose of topiramate extended-release capsules as adjunctive therapy in adults with partial-onset seizures or Lennox-Gastaut Syndrome is 200 mg to 400 mg orally once daily, and with primary generalized tonic-clonic seizures is 400 mg orally once daily. Initiate therapy at 25 mg to 50 mg once daily followed by titration to an effective dose in increments of 25 mg to 50 mg every week. Titrating in increments of 25 mg/day every week may delay the time to reach an effective dose. Doses above 400 mg/day have not been shown to improve responses in adults with partial-onset seizures.

Pediatric Patients 2 to 16 Years of Age

The recommended total daily dose of topiramate extended-release capsules as adjunctive therapy for pediatric patients 2 to 16 years of age with partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome is approximately 5 mg/kg to 9 mg/kg orally once daily. Begin titration at 25 mg once daily (or less, based on a range of 1 mg/kg/day to 3 mg/kg/day) given nightly for the first week. Subsequently, increase the dosage at 1- or 2-week intervals by increments of 1 mg/kg/day to 3 mg/kg/day to achieve optimal clinical response. Dose titration should be guided by clinical outcome. The total daily dose should not exceed 400 mg/day.

2.3 Dosing for the Preventive Treatment of Migraine

The recommended total daily dose of topiramate extended-release capsules as treatment for the preventive treatment of migraine in patients 12 years of age and older is 100 mg once daily. The recommended titration rate for topiramate extended-release capsules for the preventive treatment of migraine is as follows:

Table 3: Preventive Treatment of Migraine Titration Schedule for Patients 12 Years of Age and Older

Topiramate Extended-Release Capsules

Once Daily Dose

Week 1

25 mg

Week 2

50 mg

Week 3

75 mg

Week 4

100 mg

Dose and titration rate should be guided by clinical outcome. If required, longer intervals between dose adjustment can be used.

2.4 Dose Modifications in Patients With Renal Impairment

In patients with renal impairment (creatinine clearance less than 70 mL/min/1.73 m2), one-half of the usual adult dose of topiramate extended-release capsules is recommended [see Use in Specific Populations (8.5, 8.6), Clinical Pharmacology (12.3)].

2.5 Dosage in Patients Undergoing Hemodialysis

To avoid rapid drops in topiramate plasma concentration during hemodialysis, a supplemental dose of topiramate extended-release capsules 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 [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

2.6 Administration Instructions

Topiramate extended-release 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 or crushed. It should not be stored for further use. Topiramate extended-release capsules can be taken without regard to meals [see Clinical Pharmacology (12.3)].

3 DOSAGE FORMS AND STRENGTHS

Topiramate Extended-Release Capsules are available in the following strengths and colors:

25 mg: flesh colored cap printed with “G” in black ink and light grey body printed with “367” in black ink.
50 mg: light orange cap printed with “G” in black ink and light grey body printed with “368” in black ink.
100 mg: reddish orange cap printed with “G” in black ink and light grey body printed with “369” in black ink.
150 mg: grey cap printed with “G” in black ink and light grey body printed with “370” in black ink.
200 mg: brown cap printed with “G” in black ink and light grey body printed with “371” in black ink.

4 CONTRAINDICATIONS

None.

5 WARNINGS AND PRECAUTIONS

5.1 Acute Myopia and Secondary Angle Closure Glaucoma Syndrome

A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in patients receiving topiramate. Symptoms include acute onset of decreased visual acuity and/or ocular pain. Ophthalmologic findings can include some or all of the following: myopia, mydriasis, anterior chamber shallowing, ocular hyperemia (redness), choroidal detachments, retinal pigment epithelial detachments, macular striae, and increased intraocular pressure. This syndrome may be associated with supraciliary effusion resulting in anterior displacement of the lens and iris, with secondary angle closure glaucoma. Symptoms typically occur within 1 month of initiating topiramate therapy. In contrast to primary narrow angle glaucoma, which is rare under 40 years of age, secondary angle closure glaucoma associated with topiramate has been reported in pediatric patients as well as adults. The primary treatment to reverse symptoms is discontinuation of topiramate extended-release capsules as rapidly as possible, according to the judgment of the treating physician. Other measures, in conjunction with discontinuation of, topiramate extended-release capsules may be helpful.

Elevated intraocular pressure of any etiology, if left untreated, can lead to serious sequelae including permanent vision loss.

5.2 Visual Field Defects

Visual field defects (independent of elevated intraocular pressure) have been reported in patients receiving topiramate independent of elevated intraocular pressure. In clinical trials, most of these events were reversible after topiramate discontinuation. If visual problems occur at any time during treatment with topiramate, consideration should be given to discontinuing the drug.

5.3 Oligohydrosis and Hyperthermia

Oligohydrosis (decreased sweating), resulting in hospitalization in some cases, has been reported in association with topiramate use. Decreased sweating and an elevation in body temperature above normal characterized these cases. Some of the cases were reported after exposure to elevated environmental temperatures.

The majority of the reports have been in pediatric patients. Patients, especially pediatric patients, treated with topiramate extended-release capsules should be monitored closely for evidence of decreased sweating and increased body temperature, especially in hot weather. Caution should be used when topiramate extended-release capsules are prescribed with other drugs that predispose patients to heat-related disorders; these drugs include, but are not limited to, other carbonic anhydrase inhibitors and drugs with anticholinergic activity.

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