ZONISAMIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

BluePoint Laboratories

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 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 USP are available as 25 mg, 50 mg and 100 mg two-piece hard gelatin capsules. Zonisamide capsules USP are available in bottles of 100 and 500 with strengths and colors as follows: Dosage Strength Capsule Description Pack NDC # 25 mg White opaque body and light blue cap with ‘G 24’ printed on cap and ‘25’ printed on the body in black ink. 100 count with child-resistant closure 68001-242-00 50 mg White opaque body and yellow gold cap with ‘G 24’ printed on cap and ‘50’ printed on the body in black ink. 100 count with child-resistant closure 68001-243-00 100 mg White opaque body and light green cap with ‘G 24’ printed on cap and ‘100’ printed on the body in black ink. 100 count with child-resistant closure 68001-244-00 500 count 68001-244-03

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ZONISAMIDE- ZONISAMIDE CAPSULE
BluePoint Laboratories
----------
MEDICATION GUIDE
ZONISAMIDE CAPSULES USP
(ZOE NIS’ A MIDE)
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT
ZONISAMIDE?
Zonisamide 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 may cause a serious skin rash that can cause death. These
serious skin reactions are
more likely to happen when you begin taking zonisamide 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 decrease in vision with or

Summary of Product characteristics

ZONISAMIDE- ZONISAMIDE CAPSULE
BLUEPOINT LABORATORIES
----------
ZONISAMIDE CAPSULES USP FOR ORAL ADMINISTRATION
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
g/mol. Zonisamide, USP is a
white powder, pK = 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, USP 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, USP plus the following
inactive ingredients: hydrogenated vegetable oil, microcrystalline
cellulose, and sodium lauryl sulfate.
The printed capsule shell of the different strengths is made from the
following ingredients:
25 mg – D&C Red #28, FD&C Blue #1, gelatin and titanium dioxide
50 mg – D&C Yellow #10, FD&C Blue #1, FD&C Red #40, gelatin and
titanium dioxide
100 mg - D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, gelatin and
titanium dioxide
The dyes used in the printing ink are FD&C Blue #1, FD&C Blue #2, FD&C
Red #40, D&C Yellow
#10 aluminum lake and iron oxide black. Additionally, the printing ink
also contains propylene glycol
and shellac.
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 t