ZONISAMIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZONISAMIDE (UNII: 459384H98V) (ZONISAMIDE - UNII:459384H98V)

Available from:

Physicians Total Care, Inc.

INN (International Name):

ZONISAMIDE

Composition:

ZONISAMIDE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Zonisamide is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy. Zonisamide is contraindicated in patients who have demonstrated hypersensitivity to sulfonamides or zonisamide. The abuse and dependence potential of zonisamide has not been evaluated in human studies (see WARNINGS, Cognitive/Neuropsychiatric Adverse Events subsection). In a series of animal studies, zonisamide did not demonstrate abuse liability and dependence potential. Monkeys did not self-administer zonisamide in a standard reinforcing paradigm. Rats exposed to zonisamide did not exhibit signs of physical dependence of the CNS-depressant type. Rats did not generalize the effects of diazepam to zonisamide in a standard discrimination paradigm after training, suggesting that zonisamide does not have abuse potential of the benzodiazepine-CNS depressant type.

Product summary:

Zonisamide capsules are available as 25 mg, 50 mg and 100 mg two-piece hard gelatin capsules. The capsules are printed in black with product code on cap and body “258”, “259” and “260”, respectively. Zonisamide capsules are available in bottles of 30, 100, 500 and 1000 with strengths and colors as follows: Store at 25°C (77°F), excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature], in a dry place and protected from light. Distributed by: Caraco Pharmaceutical Laboratories, Ltd. 1150 Elijah McCoy Drive, Detroit, MI 48202 Manufactured by: Sun Pharmaceutical Industries Ltd. Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai - 400 059, India. PJPI0192B ISS. 07/2010 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK       74146

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Physicians Total Care, Inc.
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MEDICATION GUIDEZonisamide Capsules
Read this Medication Guide before you start taking zonisamide capsules
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.
What is the most important information I should know about Zonisamide
Capsules?
1.
Zonisamide capsules may cause a serious skin rash that can cause
death. These serious skin
reactions are more likely to happen when you begin taking zonisamide
capsules within the first 4
months of treatment but may occur at later times.
2.
Zonisamide capsules may cause you to sweat less and to increase your
body temperature (fever).
You may need to be hospitalized for this. You should watch for
decreased sweating and fever,
especially when it is hot and especially in children taking zonisamide
capsules.
Call your health care provider right away if you have:
•
a skin rash
•
high fever, recurring fever, or long lasting fever
•
less sweat than normal
3.
Like other antiepileptic drugs, zonisamide capsules 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
•
attempt 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
•
Suicidal thoughts or actions can be caused by things other than
medicines. If you have
suicidal thoughts or actions, your healthcare provider may check for
other causes.
How can I watch for early symptoms of suicidal thoughts and actions?
•
Pay attention to any changes, especially sud

Summary of Product characteristics

ZONISAMIDE - ZONISAMIDE CAPSULE
PHYSICIANS TOTAL CARE, INC.
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DESCRIPTION
Zonisamide is an antiseizure drug chemically classified as a
sulfonamide and unrelated to other
antiseizure agents. The active ingredient is zonisamide,
1,2-benzisoxazole-3-methanesulfonamide. The
molecular formula is C H N O S with a molecular weight of 212.23.
Zonisamide is a white powder,
pKa = 10.2, and is moderately soluble in water (0.8 mg/mL) and 0.1 N
HCl (0.5 mg/mL).
The chemical structure is:
Zonisamide is supplied for oral administration as capsules containing
25 mg, 50 mg or 100 mg
zonisamide. Each capsule contains the labeled amount of zonisamide
plus the following inactive
ingredients: microcrystalline cellulose, hydrogenated vegetable oil,
gelatin, and titanium dioxide.
In addition, individual empty hard gelatin capsule shell contains:
50 mg: Black iron oxide.
100 mg: FD&C Blue #1 and FD&C Red #40.
The imprinting ink contains black iron oxide, shellac glaze, propylene
glycol and also contains either
FD&C Blue No. 2, FD&C Red No. 40, FD&C Blue No. 1 and D&C Yellow No.10
or strong ammonia
solution and potassium hydroxide.
CLINICAL PHARMACOLOGY
Mechanism of Action
The precise mechanism(s) by which zonisamide exerts its antiseizure
effect is unknown. Zonisamide
demonstrated anticonvulsant activity in several experimental models.
In animals, zonisamide was
effective against tonic extension seizures induced by maximal
electroshock but ineffective against
clonic seizures induced by subcutaneous pentylenetetrazol. Zonisamide
raised the threshold for
generalized seizures in the kindled rat model and reduced the duration
of cortical focal seizures
induced by electrical stimulation of the visual cortex in cats.
Furthermore, zonisamide suppressed both
interictal spikes and the secondarily generalized seizures produced by
cortical application of tungstic
acid gel in rats or by cortical freezing in cats. The relevance of
these models to human epilepsy is
unknown.
Zonisamide may produce these effects through action at sodium and
ca