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:

Rebel Distributors Corp

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) 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TOPIRAMATE- TOPIRAMATE TABLET, FILM COATED
Rebel Distributors Corp
----------
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:
•
.
•
any sudden decrease in vision with or without eye pain and redness
•
a blockage of fluid in the eye causing increased pressure in the eye
(secondary angle
closure glaucoma).
•
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

Summary of Product characteristics

TOPIRAMATE- TOPIRAMATE TABLET, FILM COATED
REBEL DISTRIBUTORS CORP
----------
TOPIRAMATE TABLETS
DESCRIPTION
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 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
200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black
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-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 :
12
21
8
Topiramate has anticonvulsant activity in rat