ZONISAMIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aidarex Pharmaceuticals LLC

INN (International Name):

ZONISAMIDE

Composition:

ZONISAMIDE 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Zonisamide capsules USP are indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy. Zonisamide capsules are 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 is available as 100 mg two-piece hard gelatin capsules. The capsules imprinted with codes are printed in black ink. Zonisamide is available in bottles Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature], in a dry place and protected from light. Repackaged by Aidarex Pharmaceuticals, LLC Corona, CA 92880

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ZONISAMIDE- ZONISAMIDE CAPSULE
Aidarex Pharmaceuticals LLC
----------
MEDICATION GUIDE
Zonisamide Capsules, USP
(zoe nis' a mide)
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?
Zonisamide capsules may cause serious side effects, including:
•
Serious skin rash that can cause death.
•
Less sweating and increase in your body temperature (fever).
•
Suicidal thoughts or actions in some people.
•
Increased level of acid in your blood (metabolic acidosis).
•
Problems with your concentration, attention, memory, thinking, speech,
or language.
•
Blood cell changes such as reduced red and white blood cell counts.
These serious side effects are described below.
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 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 atta

Summary of Product characteristics

ZONISAMIDE- ZONISAMIDE CAPSULE
AIDAREX PHARMACEUTICALS LLC
----------
RX ONLY
DESCRIPTION
Zonisamide USP is an antiseizure drug chemically classified as a
sulfonamide and unrelated to other
antiseizure agents. The active ingredient is zonisamide USP,
1,2-benzisoxazole-3-methanesulfonamide.
The empirical formula is C H N O S with a molecular weight of 212.23.
Zonisamide USP is a white
powder, pKa = 10.2, and is moderately soluble in water (0.80 mg/mL)
and 0.1 N HCl (0.50 mg/mL).
The chemical structure is:
Zonisamide is supplied for oral administration as capsules containing
100 mg zonisamide USP. Each
capsule contains the labeled amount of zonisamide USP plus the
following inactive ingredients:
microcrystalline cellulose, hydrogenated vegetable oil, gelatin and
colorants. Components of gelatin
capsules (For 100 mg: titanium dioxide, gelatin and FDA/E172 red iron
oxide). Imprint ink dye (Black
SW- 9008/SW-9009).
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
calcium channels. _In vitro_
pharmacological studies suggest that zonisamide blocks sodium channels
and reduces voltage-
dependent, transient inward currents (T-type Ca
currents), consequently stabilizing neuron