ZONISAMIDE capsule

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Glenmark Pharmaceuticals Inc., USA

INN (mednarodno ime):

ZONISAMIDE

Sestava:

ZONISAMIDE 25 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 capsules USP are 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: Dosage Strength Capsule Description Pack NDC # 25 mg White opaque body and light blue cap with ‘G 24’ printed on the cap and ‘25’ printed on the body in black ink. 100 count with child-resistant closure 68462-128-01 500 count 68462-128-05 50 mg White opaque body and yellow gold cap with ‘G 24’ printed on the cap and ‘50’ printed on the body in black ink. 100 count with child-resistant closure 68462-129-01 500 count 68462-129-05 100 mg White opaque body and light green cap with ‘G 24’ printed on the cap and ‘100’ printed on the body in black ink. 100 count with child-resistant closure 68462-130-01 500 count 68462-130-05 Store at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store in a dry place and protect from light. Medication Guide available at www.glenmarkpharma-us.com/medguides Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 [phone] www.glenmarkpharma-us.com October 2020

Status dovoljenje:

Abbreviated New Drug Application

Navodilo za uporabo

ZONISAMIDE- ZONISAMIDE CAPSULE
Glenmark Pharmaceuticals Inc., USA
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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:
1.2.
fever
2.2.
severe muscle pain
3.2.
rash
4.2.
swollen lymph glands
5.2.
swelling of your face
6.2.
unusual bruising or bleeding
7.2.
weakness, fatigue
8.2.
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.
NaN
Call your health care provider right away if you have:
5 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 right

Lastnosti izdelka

ZONISAMIDE- ZONISAMIDE CAPSULE
GLENMARK PHARMACEUTICALS INC., USA
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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 g/mol. 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,
USP plus the following inactive ingredients: hydrogenated vegetable
oil, microcrystalline
cellulose, 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 aluminum lake and iron oxide black. Additionally, the
printing ink also contains
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
bot