ZONISAMIDE capsule

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Cipla USA Inc.

INN (mednarodno ime):

ZONISAMIDE

Sestava:

ZONISAMIDE 100 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Zonisamide capsules 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 100 mg two-piece hard gelatin capsules. The capsules imprinted with codes are printed in black ink. Zonisamide, USP is available in bottles with strengths and capsule description as follows: Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature], in a dry place and protected from light. Revised: 07/2020

Status dovoljenje:

Abbreviated New Drug Application

Navodilo za uporabo

ZONISAMIDE- ZONISAMIDE CAPSULE
Cipla USA Inc.
----------
Medication Guide
Zonisamide Capsules, USP
(zoe nis’ a mide)
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 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 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:
•
high fever, recurring fever, or long lasting fever
•
less sweat than normal
4. Zonisamide may cause eye problems. Serious eye problems include:
•
sudd

Lastnosti izdelka

ZONISAMIDE- ZONISAMIDE CAPSULE
CIPLA USA INC.
----------
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, 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 is supplied for oral administration as capsules containing
100 mg zonisamide.
Each 100 mg capsule contains the labeled amount of zonisamide plus the
following inactive ingredients:
microcrystalline cellulose, hydrogenated vegetable oil, gelatin and
colorants. Components of gelatin
capsules (For 100 mg: titanium dioxide, gelatin and FDA/E172 red iron
oxide). Imprint ink dye (Black
SW- 9008/SW-9009).
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-type Ca
currents