ZONISAMIDE capsule

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

NuCare Pharmaceuticals,Inc.

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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.

Tuoteyhteenveto:

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: White opaque body and light green cap with ‘G 24’ printed on cap and ‘100’ printed on the body in black ink. NDC 68071-4152-3 Bottles of 30 NDC 68071-4152-5 Bottles of 56 NDC 68071-4152-6 Bottles of 60 NDC 68071-4152-9 Bottles of 90 Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Store in a dry place and protect from light.

Valtuutuksen tilan:

Abbreviated New Drug Application

Pakkausseloste

NuCare Pharmaceuticals,Inc.
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MEDICATION GUIDE
ZONISAMIDE CAPSULES USP
( ZOE NIS’ A MIDE )
What is the most important information I should know about zonisamide?
Zonisamide may cause serious side effects, including:
1.
Serious skin rash that can cause death.
2.
Serious allergic reactions that may affect different parts of the
body.
3.
Less sweating and increase in your body temperature (fever).
4.
Suicidal thoughts or actions in some people.
5.
Increased level of acid in your blood (metabolic acidosis).
6.
Problems with your concentration, attention, memory, thinking, speech,
or language.
7.
Blood cell changes such as reduced red and white blood cell counts.
These serious side effects are described below.
1.
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.
2.
Zonisamide can cause other types of allergic reactions or serious
problems that may affect
different parts of the body such as your liver, kidneys, heart, or
blood cells. You may or may not
have a rash with these types of reactions. These reactions can be very
serious and can cause death.
Call your health care provider right away if you have:
1.
fever
2.
severe muscle pain
3.
rash
4.
swollen lymph glands
5.
swelling of your face
6.
unusual bruising or bleeding
7.
weakness, fatigue
8.
yellowing of your skin or the white part of your eyes
3.
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:
1.
high fever, recurring fever, or long lasting fever
2.
less sweat than normal
4.
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 ri

Valmisteyhteenveto

ZONISAMIDE- ZONISAMIDE CAPSULE
NUCARE PHARMACEUTICALS,INC.
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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
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