TOPIRAMATE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391)

Available from:

Proficient Rx LP

INN (International Name):

TOPIRAMATE

Composition:

TOPIRAMATE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Topiramate tablets are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures. Effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than 2 seizures in the 3 months prior to enrollment. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials. Topiramate tablets are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 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. Topiramate tablets are contraindicated in patients with a history of hypersensitivity to any component of this product. The abuse and dependence potential of topiramate has not been evaluated in human studies.

Product summary:

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) They are supplied as follows: 25 mg tablets    Bottles of 30's with Child Resistant Cap… …………NDC 63187-077-30 Bottles of 60's with Child Resistant Cap… …………NDC 63187-077-60 50 mg tablets    Bottles of 30's with Child Resistant Cap… …………NDC 63187-059-30                           Bottles of 90's with Child Resistant Cap… …………NDC 63187-059-90 100 mg tablets  Bottles of 30's with Child Resistant Cap… …………NDC 63187-060-30                                                         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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TOPIRAMATE- TOPIRAMATE TABLET, FILM COATED
Proficient Rx LP
----------
MEDICATION GUIDE
TOPIRAMATE TABLETS
Read this Medication Guide before you start taking topiramate tablets
and each time you get a refill. There
may be new information. This information does not take the place of
talking to your healthcare provider
about your medical condition or treatment. If you have any questions
about topiramate tablets, talk to your
healthcare provider or pharmacist.
What is the most important information I should know about topiramate
tablets?
•
Topiramate tablets may cause eye problems. Serious eye problems
include:
o
any sudden decrease in vision with or without eye pain and redness
o
a blockage of fluid in the eye causing increased pressure in the eye
(secondary angle closure
glaucoma).
o
These eye problems can lead to permanent loss of vision if not
treated. You should call your
healthcare provider right away if you have any new eye symptoms.
•
Topiramate tablets may cause decreased sweating and increased body
temperature (fever). People,
especially children, should be watched for signs of decreased sweating
and fever, especially in hot
temperatures. Some people may need to be hospitalized for this
condition.
•
Like other antiepileptic drugs, topiramate tablets may cause suicidal
thoughts or actions in a very small
number of people, about 1 in 500.
Call a healthcare provider right away if you have any of these
symptoms, especially if they are new, worse,
or worry you:
•
thoughts about suicide or dying
•
attempts to commit suicide
•
new or worse depression
•
new or worse anxiety
•
feeling agitated or restless
•
panic attacks
•
trouble sleeping (insomnia)
•
new or worse irritability
•
acting aggressive, being angry, or violent
•
acting on dangerous impulses
•
an extreme increase in activity and talking (mania)
•
other unusual changes in behavior or mood
Do not stop topiramate tablets without first talking to a healthcare
provider.
•
Stopping topiramate tablets suddenly can cause serious p

Summary of Product characteristics

TOPIRAMATE- TOPIRAMATE TABLET, FILM COATED
PROFICIENT RX LP
----------
TOPIRAMATE TABLETS
DESCRIPTION
Topiramate is a sulfamate-substituted monosaccharide. Topiramate
tablets are available
as 25 mg, 50 mg, and 100 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 C
H
NO S 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
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION:
The precise mechanisms by which topiramate exerts its anticonvulsant
effects are
unknown; however, preclinical studies have revealed four properties
that may contribute
to topiramate's efficacy for epilepsy. Electrophysiological and
biochemical evidence
suggests that topiramate, at pharmacologically relevant
concentrations, blocks voltage-
dependent sodium channels, augments the activity of the
neurotransmitter gamma-
12
21
8
aminobutyrate at some subtypes of the GABA-A receptor, antagonizes the
AMPA/kainate subtype of the glutamate receptor, and inhibits the
carbonic anhydrase
enzyme, particularly isozymes II and IV.
PHARMACODYNAMICS:
Topiramate has anticonvulsant activity in rat and mouse maximal
electroshock seizure
(MES) tests. Topiramate is only weakly effecti