ZONISAMIDE capsule

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

NCS HealthCare of KY, LLC dba Vangard Labs

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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.

Dettagli prodotto:

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 bingo cards with strengths and capsule description as follows: 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. 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: 05/2017

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

ZONISAMIDE- ZONISAMIDE CAPSULE
NCS HealthCare of KY, LLC dba Vangard Labs
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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. Suicidal thoughts or actions in some people.
5. Increased level of acid in your blood (metabolic acidosis).
6. Problems with your concentration, attention, memory, thinking,
speech, or language.
7. 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 you 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. Like other antiepileptic drugs, zonisamide may cause suicidal
thoughts or

Scheda tecnica

ZONISAMIDE- ZONISAMIDE CAPSULE
NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS
----------
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
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.
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 inwar