ZONISAMIDE capsule

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Quality Care Products LLC

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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.

Descriptif du produit:

Zonisamide capsules are available as 25 mg, 50 mg and 100 mg two-piece hard gelatin capsules. The capsules are printed in black with product code on cap and body “258”, “259” and “260”, respectively. Zonisamide capsules are available in bottles of 30, 100, 500 and 1000 with strengths and colors as follows: Dosage strength Capsule color Pack NDC # 25 mg White opaque body with white opaque cap 50 mg White opaque body with light gray opaque cap 100 mg White opaque body with light swedish orange opaque cap Store at 25°C (77°F), excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature], in a dry place and protected from light. Distributed by: Caraco Pharmaceutical Laboratories, Ltd. 1150 Elijah McCoy Drive, Detroit, MI 48202 Manufactured by: Sun Pharmaceutical Industries Ltd. Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai - 400 059, India. PJPI0192B ISS. 07/2010

Statut de autorisation:

Abbreviated New Drug Application

Notice patient

ZONISAMIDE- zonisamide capsule
Quality Care Products LLC
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MEDICATION GUIDE
Zonisamide Capsules
Read this Medication Guide before you start taking zonisamide capsules
and each time you get a refill. There
may be new information. This information does not take the place of
talking to your healthcare provider
about your medical condition or treatment.
What is the most important information I should know about Zonisamide
Capsules?
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 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:
•
a skin rash
•
high fever, recurring fever, or long lasting fever
•
less sweat than normal
3.
Like other antiepileptic drugs, zonisamide capsules may cause suicidal
thoughts or actions in a very
small number of people, about 1 in 500.
Call a healthcare provider right away if you have any of these
symptoms, especially if they are new,
worse, or worry you:
•
thoughts about suicide or dying
•
attempt to commit suicide
•
new or worse depression
•
new or worse anxiety
•
feeling agitated or restless
•
panic attacks
•
trouble sleeping (insomnia)
•
new or worse irritability
•
acting aggressive, being angry, or violent
•
acting on dangerous impulses
•
an extreme increase in activity and talking (mania)
•
other unusual changes in behavior or mood
•
Suicidal thoughts or actions can be caused by things other than
medicines. If you have suicidal
thoughts or actions, your healthcare provider may check for other
causes.
How can I watch for early symptoms of suicidal thoughts and actions?
•
Pay attention

Résumé des caractéristiques du produit

ZONISAMIDE- ZONISAMIDE CAPSULE
QUALITY CARE PRODUCTS LLC
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ZONISAMIDE CAPSULES
DESCRIPTION
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 C H N O S 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:
Zonisamide is supplied for oral administration as capsules containing
25 mg, 50 mg or
100 mg zonisamide. 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 and C Blue #1 and FD and C Red #40.
The imprinting ink contains black iron oxide, shellac glaze, propylene
glycol and also
contains either FD and C Blue No. 2, FD and C Red No. 40, FD and C
Blue No. 1 and D
and C Yellow No.10 or strong ammonia solution and potassium hydroxide.
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 the