ZONISAMIDE capsule

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Direct_Rx

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Zonisamide capsules USP 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.

Bidhaa muhtasari:

Zonisamide USP is 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 25 mg White opaque body and light blue cap with ‘G 24’ printed on cap and ‘25’ printed on the body in black ink. 100 count 500 count 50 mg White opaque body and yellow gold cap with ‘G 24’ printed on cap and ‘50’ printed on the body in black ink. 100 count 500 count 100 mg White opaque body and light green cap with ‘G 24’ printed on cap and ‘100’ printed on the body in black ink. 100 count 500 count Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Store in a dry place and protect from light.

Idhini hali ya:

Abbreviated New Drug Application

Taarifa za kipeperushi

ZONISAMIDE- zonisamide capsule
Direct_Rx
----------
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.
Suicidal thoughts or actions in some people.
5.
Increased level of acid in your blood (metabolic acidosis).
6.
Problems with your concentration, attention, memory, thinking, speech,
or language.
7.
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.
fever
2.
severe muscle pain
3.
rash
4.
swollen lymph glands
5.
swelling of your face
6.
unusual bruising or bleeding
7.
weakness, fatigue
8.
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:
9.
high fever, recurring fever, or long lasting fever
10.
less sweat than normal
4.
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 away if you have any of these
symptoms, espec

Tabia za bidhaa

ZONISAMIDE- ZONISAMIDE CAPSULE
DIRECT_RX
----------
ZONISAMIDE
Rx Only
Manufactured by:
Glenmark Pharmaceuticals Ltd.
Colvale-Bardez, Goa 403 513, India
Manufactured for:
[logo]
Glenmark Pharmaceuticals Inc., USA
Mahwah, NJ 07430
Questions? 1 [phone]
www.glenmarkpharma.com/usa
April 2016
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 C8H8N2O3S
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:
[structure]
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
plus the following inactive ingredients: microcrystalline cellulose,
hydrogenated vegetable
oil 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 aluminium lake and iron oxide black. Additionally, the
printing ink also
contains n-butyl alcohol, ethanol, propylene glycol and shellac.
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 t