ZONISAMIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

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 Capsules USP, 100 mg are white to off-white powder filled in hard gelatin capsule with opaque flesh colored cap and opaque white colored body imprinted ‘ZNS’ on cap and ‘100’ on body with black ink. NDC: 70518-3224-00 NDC: 70518-3224-01 PACKAGING: 100 in 1 BOX PACKAGING: 1 in 1 POUCH Store at 20° to  25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] in a dry place and protected from light. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ZONISAMIDE- ZONISAMIDE CAPSULE
REMEDYREPACK INC.
----------
MEDICATION GUIDE
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 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. Zonisamide capsules may cause eye problems. Se

Summary of Product characteristics

ZONISAMIDE- ZONISAMIDE CAPSULE
REMEDYREPACK INC.
----------
ZONISAMIDE CAPSULES USP
RX ONLY
DESCRIPTION
Zonisamide capsules, 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 molecular formula is C
H
N
O
S with a
molecular weight of 212.23. Zonisamide is a white to off-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:
Zonisamide capsules, USP are supplied for oral administration as
capsules containing 25
mg, 50 mg or 100 mg zonisamide USP.
Each 25 mg, 50 mg and 100 mg capsule contains the labeled amount of
zonisamide USP
plus the following inactive ingredients: hydrogenated vegetable oil
and microcrystalline
cellulose. The capsule shell contains gelatin and titanium dioxide.
Imprinting ink contains
black iron oxide E172, butyl alcohol, dehydrated alcohol, isopropyl
alcohol, potassium
hydroxide, propylene glycol, purified water, shellac and strong
ammonia solution. In
addition 100 mg zonisamide capsule shell contains black iron oxide
E172 and red iron
oxide E172.
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.
Zon