ZONISAMIDE capsule

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Proficient Rx LP

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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.

Toote kokkuvõte:

Zonisamide USP is available as 100 mg two-piece hard gelatin capsules. Zonisamide capsules USP are available in bottles of 30, 60 and 90 as follows: Dosage Strength Capsule Description Pack NDC # 100 mg White opaque body and light green cap with ‘G 24’ printed on cap and ‘100’ printed on the body in black ink. 30 count 63187-583-30 30 count 100 mg White opaque body and light green cap with ‘G 24’ printed on cap and ‘100’ printed on the body in black ink. 60 count 63187-583-60 60 count 100 mg White opaque body and light green cap with ‘G 24’ printed on cap and ‘100’ printed on the body in black ink. 90 count 63187-583-90 90 count

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

ZONISAMIDE- ZONISAMIDE CAPSULE
Proficient Rx LP
----------
MEDICATION GUIDE
ZONISAMIDE CAPSULES USP
( 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 irritab

Toote omadused

ZONISAMIDE- ZONISAMIDE CAPSULE
PROFICIENT RX LP
----------
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, pK =
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 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
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
8
8
2
3
a
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 int