ZONISAMIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

American Health Packaging

INN (International Name):

ZONISAMIDE

Composition:

ZONISAMIDE 100 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 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, USP is available as 100 mg two-piece hard gelatin capsules. The capsules imprinted with codes are printed in black ink. Zonisamide, USP is available in unit dose packages with strengths and capsule description as follows: Dosage Strength Capsule Description NDC# 100 mg Unit Dose Packages of 100 (10 x 10) Size "1" Brown Opaque Cap and White Opaque Body imprinted with 100 mg on the cap and IG228 on the body in black ink, filled with White to Off-white powder. 60687-230-01 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. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

American Health Packaging
----------
MEDICATION GUIDE
8423065/1120
Zonisamide Capsules, USP
(zoe nis' a mide)
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.
Serious allergic reactions that may affect different parts of the
body.
3.
Less sweating and increase in your body temperature (fever).
4.
Serious eye problems.
5.
Suicidal thoughts or actions in some people.
6.
Increased level of acid in your blood (metabolic acidosis).
7.
Problems with your concentration, attention, memory, thinking, speech,
or language.
8.
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 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 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.
Call your health care provider right away if you have:
•
high fever, recurring fever, or long lasting fever
•
less sweat than normal
4. Zonisamide may cause eye problems. Serious eye problems include:
•
sudden decreas

Summary of Product characteristics

ZONISAMIDE- ZONISAMIDE CAPSULE
AMERICAN HEALTH PACKAGING
----------
ZONISAMIDE CAPSULES, USP
8423065/1120
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.
Each 100 mg capsule contains the labeled amount of zonisamide 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.
8
8
2
3
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 C