ZONISAMIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Wockhardt USA LLC.

INN (International Name):

ZONISAMIDE

Composition:

ZONISAMIDE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Zonisamide capsules 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 capsules 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. Zonisamide capsules is available in bottles of 100 with strengths and colors as follows: Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature], in a dry place and protected from light. Manufactured by: Wockhardt Limited Mumbai, India. Distributed by: Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA. Rev.190913

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ZONISAMIDE- ZONISAMIDE CAPSULE
Wockhardt USA LLC.
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Medication Guide
Zonisamide 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?
Zonisamide capsules may cause serious side effects, including:
1.
Serious skin rash that can cause death.
2.
Less sweating and increase in your body temperature (fever).
3.
Suicidal thoughts or actions in some people.
4.
Increased level of acid in your blood (metabolic acidosis).
5.
Problems with your concentration, attention, memory, thinking, speech,
or language.
6.
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 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 (ins

Summary of Product characteristics

ZONISAMIDE- ZONISAMIDE CAPSULE
WOCKHARDT USA LLC.
----------
PRODUCT INFORMATION
ZONISAMIDE CAPSULES
RX ONLY
DESCRIPTION
Zonisamide capsule 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
empirical 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 (0.80 mg/mL) and 0.1 N
HCl (0.50 mg/mL). The
chemical structure is:
Zonisamide capsules are supplied for oral administration as capsules
containing 25 mg, 50 mg and 100
mg zonisamide. Each capsule contains the labeled amount of zonisamide
plus the following inactive
ingredients: microcrystalline cellulose, sodium lauryl sulfate,
hydrogenated vegetable oil, colloidal
silicon dioxide, sodium starch glycolate, talc, gelatin, titanium
dioxide. For 100 mg D&C red # 28,
D&C yellow # 10, and FD&C # yellow 6 and for 50 mg contains FD&C red #
40, FD&C yellow # 5,
and FD&C Blue # 1.
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 so