ZONISAMIDE capsule

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Sun Pharmaceutical Industries, Inc.

INN (mednarodno ime):

ZONISAMIDE

Sestava:

ZONISAMIDE 25 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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.

Povzetek izdelek:

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 1,000 with strengths and colors as follows: 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.

Status dovoljenje:

Abbreviated New Drug Application

Navodilo za uporabo

Sun Pharmaceutical Industries, Inc.
----------
MEDICATION GUIDE
Zonisamide (zoe nis’ a mide) Capsules
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.
Serious allergic reactions that may affect different parts of the
body.
3.
Less sweating and increase in your body temperature (fever).
4.
Serious eye problems
5.
Suicidal thoughts or actions in some people.
6.
Increased level of acid in your blood (metabolic acidosis).
7.
Problems with your concentration, attention, memory, thinking, speech,
or language.
8.
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 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:
•
fever
•
severe muscle pain
•
rash
•
swollen lymph glands
•
swelling of your face
•
unusual bruising or bleeding
•
weakness, fatigue
•
yellowing of your skin or the white part of your eyes
3. 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:
•
high fever, recurring fever, or long lasting fever
•
less sweat than normal
4. Zonisamide capsules may cause eye problems. Serious eye proble

Lastnosti izdelka

ZONISAMIDE - ZONISAMIDE CAPSULE
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
ZONISAMIDE CAPSULES, FOR ORAL ADMINISTRATION
RX ONLY
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, USP. 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&C Blue #1 and FD&C Red #40.
The imprinting ink contains black iron oxide, shellac glaze, propylene
glycol and also contains either
FD & C Blue No. 2, FD & C Red No. 40, FD & C Blue No. 1 and D & 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