ZONISAMIDE capsule

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

DirectRX

INN (International Adı):

ZONISAMIDE

Kompozisyon:

ZONISAMIDE 50 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Zonisamide is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy. Zonisamide is 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.

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

ZONISAMIDE- ZONISAMIDE CAPSULE
DIRECTRX
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ZONISAMIDE
DESCRIPTION SECTION
Zonisamide is an antiseizure drug chemically classified as a
sulfonamide and unrelated to other
antiseizure agents. The active ingredient is zonisamide,
1,2-benzisoxazole-3-methanesulfonamide. The
molecular formula is C8H8N2O3S with a molecular weight of 212.23.
Zonisamide is a 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:
spl-zonisamide-structure
Zonisamide 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 plus the following inactive
ingredients: microcrystalline cellulose, hydrogenated vegetable oil,
gelatin, and titanium dioxide.
In addition, individual empty hard gelatin capsule shell contains:
50 mg : Black iron oxide.
100 mg : FD&C Blue #1 and FD&C Red #40.
The imprinting ink contains black iron oxide, shellac glaze, propylene
glycol and also contains either
FD & C Blue No. 2, FD & C Red No. 40, FD & C Blue No. 1 and D & C
Yellow No.10 or strong
ammonia solution and potassium hydroxide.
CLINICAL PHARMACOLOGY SECTION
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 produ