ZONISAMIDE capsule

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Viona Pharmaceuticals Inc

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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.

Tóm tắt sản phẩm:

Zonisamide capsules USP, 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 72578-040-01 in bottles of 100's capsules with child-resistant closure NDC 72578-040-05 in bottles of 500's capsules Zonisamide capsules USP, 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 72578-041-01 in bottles of 100's capsules with child-resistant closure NDC 72578-041-05 in bottles of 500's capsules Zonisamide capsules USP, 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 72578--042-01 in bottles of 100's capsules with child-resistant closure NDC 72578-042-05 in bottles of 500's capsules NDC 72578-042-10 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.vionausa.com/medguides or call 1-888-304-5011. Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India Distributed by: Viona Pharmaceuticals Inc. Cranford, NJ 07016 Rev.: 12/22

Tình trạng ủy quyền:

Abbreviated New Drug Application

Tờ rơi thông tin

ZONISAMIDE- ZONISAMIDE CAPSULE
Viona Pharmaceuticals Inc
----------
MEDICATION GUIDE
Zonisamide (zoe nis' a mide) Capsules, USP
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 o

Đặc tính sản phẩm

ZONISAMIDE- ZONISAMIDE CAPSULE
VIONA PHARMACEUTICALS INC
----------
ZONISAMIDE CAPSULES, USP
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, USP 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, USP 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 imprinted with black pharmaceutical ink and contains
following inactive
ingredients: black iron oxide, potassium hydroxide, 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
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
8
8
2
3
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-typ