ZONISAMIDE- zonisamide capsule

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Eon Labs, Inc.

INN (इंटरनेशनल नाम):

ZONISAMIDE

रचना:

ZONISAMIDE 25 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Zonisamide capsules are 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 EventsCognitive 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.

उत्पाद समीक्षा:

Zonisamide Capsules, for oral administration, are available as: 25 mg: Light gray opaque body and reddish orange opaque cap, imprinted “E 193” in black ink on both cap and body, and filled with white to off-white powder and supplied as: NDC 0185-0193-01 bottles of 100 NDC 0185-0193-10 bottles of 1000 50 mg: Light gray opaque cap and body, imprinted “E 199” in black ink on both cap and body, and filled with white to off-white powder and supplied as: NDC 0185-0199-01 bottles of 100 NDC 0185-0199-10 bottles of 1000 100 mg: Reddish orange opaque cap and body, imprinted “E 200” in black ink on both cap and body, and filled with white to off-white powder and supplied as: NDC 0185-0200-01 bottles of 100 NDC 0185-0200-10 bottles of 1000 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature], in a dry place and protected from light.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

ZONISAMIDE- ZONISAMIDE CAPSULE
Eon Labs, Inc.
----------
MEDICATION GUIDE
Zonisamide (zoe nis’ a mide) 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?
Zonisamide Capsules may cause serious side effects, including:
1. Serious skin rash that can cause death.
2. Less sweating and increase in your body temperature (fever).
3. Suicidal thoughts or actions in some people.
4. Increased level of acid in your blood (metabolic acidosis).
5. Problems with your concentration, attention, memory, thinking,
speech, or language.
6. 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 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 healthcare 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
•
troubl

उत्पाद विशेषताएं

ZONISAMIDE- ZONISAMIDE CAPSULE
EON LABS, INC.
----------
ZONISAMIDE CAPSULES
RX ONLY
DESCRIPTION
Zonisamide capsules 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
empirical 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 (0.80 mg/mL) and 0.1 N
HCl (0.50 mg/mL).
The chemical structure is:
Zonisamide capsules are 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: hydrogenated castor oil, microcrystalline cellulose,
sodium lauryl sulfate, gelatin, and
titanium dioxide. In addition, the 25 mg and 50 mg capsules contain
black iron oxide and the 25 mg and
100 mg contain FD&C yellow No. 6 and FD&C red No. 40.
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 inward currents (T-typ