ZONISAMIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Direct_Rx

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 1,000 with strengths and colors as follows: Dosage strength Capsule color Pack 25 mg White opaque body with white opaque cap. Bottle of 30’s with Child Resistant Cap. Bottle of 100’s with Child Resistant Cap. Bottle of 100’s with Non Child Resistant Cap Bottle of 1,000’s with Non Child Resistant Cap. 50 mg White opaque body with light gray opaque cap. Bottle of 30’s with Child Resistant Cap. Bottle of 100’s with Child Resistant Cap. Bottle of 100’s with Non Child Resistant Cap Bottle of 1,000’s with Non Child Resistant Cap. 100 mg White opaque body with light swedish orange opaque cap. Bottle of 30’s with Child Resistant Cap. Bottle of 100’s with Child Resistant Cap. Bottle of 100’s with Non Child Resistant Cap Bottle of 1,000’s with Non Child Resistant Cap. Bottle of 500’s with Non Child Resistant Cap. 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ZONISAMIDE- ZONISAMIDE CAPSULE
Direct_Rx
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Zonisamide (zoe nis’ a mide) Capsules
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.
Serious allergic reactions that may affect different parts of the
body.
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.
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.
Zonisamide capsules can cause other types of allergic reactions or
serious problems that may affect
different parts of the body such as your liver, kidneys, heart, or
blood cells. You may or may not have a
rash with these types of reactions. These reactions can be very
serious and can cause death. Call your
health care provider right away if you have:
fever
severe muscle pain
rash
swollen lymph glands
swelling of your face
unusual bruising or bleeding
weakness, fatigue
yellowing of your skin or the white part of your eyes
3. 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:
high fever, recurring fever, or long lasting fever
less sweat than normal
4. 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 provid

Summary of Product characteristics

ZONISAMIDE- ZONISAMIDE CAPSULE
DIRECT_RX
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ZONISAMIDE
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 C8H8N2O3S 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:
[spl-zonisamide-structure]
Zonisamide is supplied for oral administration as capsules containing
25 mg, 50 mg or
100 mg zonisamide, USP. 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.
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