ZONISAMIDE capsule

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Zydus Pharmaceuticals (USA) Inc.

INN (Internationale Bezeichnung):

ZONISAMIDE

Zusammensetzung:

ZONISAMIDE 25 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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.

Produktbesonderheiten:

Zonisamide capsules, 25 mg are white to off white granular powder filled in size '4' hard gelatin capsules with pink colored cap printed with "ZA-31" in black ink and white colored body printed with "25 mg" in black ink, which are supplied as follows. NDC 68382-212-01 in bottles of 100's capsules NDC 68382-212-05 in bottles of 500's capsules Zonisamide capsules, 50 mg are white to off white granular powder filled in size '3' hard gelatin capsules with pink colored cap printed with "ZA-32" in black ink and white colored body printed with "50 mg" in black ink, which are supplied as follows. NDC 68382-213-01 in bottles of 100's capsules NDC 68382-213-05 in bottles of 500's capsules Zonisamide capsules, 100 mg are white to off white granular powder filled in size '1' hard gelatin capsules with pink colored cap printed with "ZA-33" in black ink and white colored body printed with "100 mg" in black ink, which are supplied as follows. NDC 68382-214-01 in bottles of 100's capsules NDC 68382-214-05 in bottles of 500's capsules NDC 68382-214-10 in bottles of 1,000's capsules Store at 20o C to 25o C (68o F to 77o F) [see USP Controlled Room Temperature]. Keep in dry place and protect from light. Medication Guide available at www.zydususa.com/medguides or call 1-877-993-8779. Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 Rev.: 09/20

Berechtigungsstatus:

Abbreviated New Drug Application

Gebrauchsinformation

ZONISAMIDE- ZONISAMIDE CAPSULE
Zydus Pharmaceuticals (USA) Inc.
----------
MEDICATION GUIDE
Zonisamide (zoe nis' a mide) Capsules
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.
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 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:
•
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:
•
sudden decrease in vision with

Fachinformation

ZONISAMIDE- ZONISAMIDE CAPSULE
ZYDUS PHARMACEUTICALS (USA) INC.
----------
ZONISAMIDE CAPSULES
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 to off
white crystalline 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 capsules contain 25 mg or 50 mg or 100 mg zonisamide. Each
capsule contains the inactive
ingredients FD&C Blue #1, FD&C Red #4, gelatin, hydrogenated vegetable
oil, microcrystalline
cellulose, sodium lauryl sulfate, and titanium dioxide. The capsule is
printed with black pharmaceutical
ink.
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), consequently stabilizing neuronal
membranes and suppressing neuronal hypersynchronization. _In vitro
_binding studi