Topamax

[Topiramate]

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 m 2 ) is evident (see DOSAGE AND ADMINISTRATION: Patients with Renal Impairment and CLINICAL PHARMACOLOGY: Special Populations: Age, Gender, and Race).

Patients Undergoing Hemodialysis

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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 Ð bottles of 60 count with desiccant (NDC 0045-0640-65)
100 mg tablets Ð bottles of 60 count with desiccant (NDC 0045-0641-65)
200 mg tablets Ð 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 Ð bottles of 60 (NDC 0045-0647-65) 25 mg capsules Ð bottles of 60 (NDC 0045-0645-65)

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