ZONISAMIDE capsule

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Exelan Pharmaceuticals, Inc.

INN (mednarodno ime):

ZONISAMIDE

Sestava:

ZONISAMIDE 100 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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.

Povzetek izdelek:

Zonisamide, USP is available as 25mg, 50mg and 100 mg wth  two-piece hard gelatin capsules. The capsules imprinted with codes are printed in black ink. Zonisamide, USP is available in bottles with strengths and capsule description as follows: 25 mg 100 Count Size “1” white Opaque Cap and White Opaque Body imprinted with 25mg on the cap and IG226 on the body in black ink, filled with White to Off-white powder. 76282-226-01 50 mg 100 Count Size “2” Blue Opaque Cap and White Opaque Body imprinted with 50m g on the cap and IG227 on the body in black ink, filled with White to Off-white powder. 76282-227-01 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. Revised: 03/21

Status dovoljenje:

Abbreviated New Drug Application

Navodilo za uporabo

ZONISAMIDE- zonisamide capsule
Exelan Pharmaceuticals, 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 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 inc

Lastnosti izdelka

ZONISAMIDE- ZONISAMIDE CAPSULE
EXELAN PHARMACEUTICALS, INC.
----------
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. 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
25, 50 and 100 mg
of zonisamide.
Each capsule contains the labeled amount of zonisamide plus the
following inactive
ingredients: microcrystalline cellulose, hydrogenated vegetable oil,
gelatin and colorants.
Components of gelatin capsules,titanium dioxide, gelatin and Imprint
ink dye (Black SW-
9008/SW-9009). In addition, 100 mg capsule conatins: FDA/E172 red iron
oxide and 50
mg capsule contains: FD&C Blue No#2.
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
8
8
2
3
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 blo