Topiramate Tablets

DESCRIPTION

id: 7d8af6d9-03cd-40e1-ab3c-57a804c139ff
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg circular tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C₁₂H₂₁NO₈S and a molecular weight of 339.37. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula: Topiramate tablets contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, magnesium stearate, purified water, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, individual tablets contain: 50 mg tablets: iron oxide yellow
100 mg tablets: iron oxide yellow, and D&C Yellow # 10 Aluminum Lake
200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black

CLINICAL PHARMACOLOGY

id: 62d33ac4-ef3c-412f-b354-a08c2bce069d
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

CLINICAL STUDIES

id: a4902006-d2a3-400e-976d-0ec7ffa8f087
displayName: CLINICAL STUDIES SECTION
FDA Article Code: 34092-7

The studies described in the following sections were conducted using topiramate tablets.

CONTRAINDICATIONS

id: 87bf4da0-c265-49a4-b459-568915cd55e8
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Topiramate tablets are contraindicated in patients with a history of hypersensitivity to any component of this product.

ADVERSE REACTIONS

id: a36b94d1-4eb9-46d3-8eed-de197e9caaa0
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

The data described in the following section were obtained using topiramate tablets.

DRUG ABUSE AND DEPENDENCE

id: 7024b6c0-7d53-40dc-a550-4d8506ac1f6e
displayName: DRUG ABUSE AND DEPENDENCE SECTION
FDA Article Code: 42227-9

The abuse and dependence potential of topiramate has not been evaluated in human studies.

OVERDOSAGE

id: 1d642377-5563-4a58-b813-90c99a26ca7f
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

Overdoses of topiramate have been reported. Signs and symptoms included convulsions, drowsiness, speech disturbance, blurred vision, diplopia, mentation impaired, lethargy, abnormal coordination, stupor, hypotension, abdominal pain, agitation, dizziness and depression. The clinical consequences were not severe in most cases, but deaths have been reported after poly-drug overdoses involving topiramate. Topiramate overdose has resulted in severe metabolic acidosis (see
WARNINGS
). A patient who ingested a dose between 96 and 110 g topiramate was admitted to hospital with coma lasting 20 to 24 hours followed by full recovery after 3 to 4 days. In acute topiramate overdose, if the ingestion is recent, the stomach should be emptied immediately by lavage or by induction of emesis. Activated charcoal has been shown to adsorb topiramate in vitro. Treatment should be appropriately supportive. Hemodialysis is an effective means of removing topiramate from the body.

HOW SUPPLIED

id: 9a7511d7-9b5b-45d5-be69-614c793b2499
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Topiramate tablets are available as debossed, film-coated, circular tablets in the following strengths and colors: 25 mg white (coded “S” on one side; “707” on the other)
50 mg yellow (coded “S” on one side; “710” on the other)
100 mg yellow (coded “S” on one side; “711” on the other)
200 mg brown (coded “S” on one side; “712” on the other) They are supplied as follows:
25 mg tablets     Bottles of 30’s with Child Resistant Cap… …………NDC 21695-162-30
                            Bottles of 60’s with Child Resistant Cap… …………NDC 21695-162-60 50 mg tablets    Bottles of 30’s with Child Resistant Cap… ……… …NDC 21695-205-30                            Bottles of 60’s with Child Resistant Cap… ……… NDC 21695-205-60
                            Bottles of 90’s with Child Resistant Cap… … … …NDC 21695-205-90
                           
100 mg tablets  Bottles of 30’s with Child Resistant Cap… ………… NDC 21695-348-30
                            Bottles of 60’s with Child Resistant Cap… …………NDC 21695-348-60
                            Bottles of 90’s with Child Resistant Cap… … … … NDC 21695-348-90
                           

200 mg tablets  Bottles of 30’s with Child Resistant Cap… …………NDC 21695-349-30
                            Bottles of 60’s with Child Resistant Cap… …………NDC 21695-349-60
                            Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container.

MEDICATION GUIDE

id: 04862854-9d49-4cc5-b475-b829dc1727b7
displayName: SPL MEDGUIDE SECTION
FDA Article Code: 42231-1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL – Label – 25 mg

id: cf96d924-6c99-4bcb-b176-2b05acc475d9
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

NDC 21695-162-90
Topiramate Tablets
25 mg
Rx only
90 TABLETS
REBEL DISTRIBUTORS CORP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL – Label – 50 mg

id: 894b5b86-9a8f-4688-bf79-111cdee7e0f4
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

NDC 21695-205-90
Topiramate Tablets
50 mg
Rx only
90 TABLETS
REBEL DISTRIBUTORS CORP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL – Label – 100 mg

id: 9f6d3437-d28b-42eb-8d76-86af08a6288d
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

NDC 21695-348-90
Topiramate Tablets
100 mg
Rx only
90 TABLETS
REBEL DISTRIBUTORS CORP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL – Label – 200 mg

id: 6f89b836-a269-4582-a0f6-a795e7ea4a4c
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

NDC 21695-349-60 Topiramate Tablets
200 mg
Rx only
60 TABLETS
REBEL DISTRIBUTORS CORP