ZONISAMIDE capsule

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Direct Rx

INN (mednarodno ime):

ZONISAMIDE

Sestava:

ZONISAMIDE 50 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Zonisamide capsules USP 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 25 mg, 50 mg and 100 mg two-piece hard gelatin capsules. Zonisamide capsules USP are available in bottles of 100 and 500 with strengths and colors as follows:

Status dovoljenje:

Abbreviated New Drug Application

Navodilo za uporabo

ZONISAMIDE- ZONISAMIDE CAPSULE
Direct Rx
----------
SPL MEDGUIDE SECTION
( zoe nis’ a mide )
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?
Zonisamide may cause serious side effects, including:
Serious skin rash that can cause death.
Less sweating and increase in your body temperature (fever).
Suicidal thoughts or actions in some people.
Increased level of acid in your blood (metabolic acidosis).
Problems with your concentration, attention, memory, thinking, speech,
or language.
Blood cell changes such as reduced red and white blood cell counts.
These serious side effects are described below.
Zonisamide may cause a serious skin rash that can cause death. These
serious skin reactions are more
likely to happen when you begin taking zonisamide within the first 4
months of treatment but may occur
at later times.
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:
a skin rash
high fever, recurring fever, or long lasting fever
less sweat than normal
3. Like other antiepileptic drugs, zonisamide 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 ac

Lastnosti izdelka

ZONISAMIDE- ZONISAMIDE CAPSULE
DIRECT RX
----------
ZONISAMIDE
SPL UNCLASSIFIED SECTION
Rx Only
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 C8H8N2O3S 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).
Zonisamide USP 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
USP plus the following
inactive ingredients: microcrystalline cellulose, hydrogenated
vegetable oil, and sodium lauryl sulfate.
The printed capsule shell of the different strengths is made from the
following ingredients:
25 mg – D&C Red #28, FD&C Blue #1, gelatin and titanium dioxide
50 mg – D&C Yellow #10, FD&C Blue #1, FD&C Red #40, gelatin and
titanium dioxide
100 mg - D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, gelatin and
titanium dioxide
The dyes used in the printing ink are FD&C Blue #1, FD&C Blue #2, FD&C
Red #40, D&C Yellow
#10 aluminium lake and iron oxide black. Additionally, the printing
ink also contains n-butyl alcohol,
ethanol, propylene glycol and shellac.
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 prod