ZONEGRAN- zonisamide capsule

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Concordia Pharmaceuticals Inc.

INN:

ZONISAMIDE

composition:

ZONISAMIDE 25 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

ZONEGRAN is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy. ZONEGRAN is contraindicated in patients who have demonstrated hypersensitivity to sulfonamides or zonisamide. The abuse and dependence potential of ZONEGRAN 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.

leaflet_short:

ZONEGRAN is available as 25 mg and 100 mg two-piece hard gelatin capsules. The capsules are printed in black with “ZONEGRAN 25” or “ZONEGRAN 100,” respectively. ZONEGRAN is available in bottles of 100 with strengths and colors as follows: Store at 25°C (77°F), excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature], in a dry place and protected from light. Mfd. for: Concordia Pharmaceuticals Distributed by: Amdipharm Limited 17 Northwood House Dublin 9, Ireland ZONEGRAN® is a registered trademark of Dainippon Pharmaceutical Co., Ltd. and licensed exclusively to Amdipharm Limited. © 2015 All rights reserved. Revised: 04/2020

authorization_status:

New Drug Application

PIL

Concordia Pharmaceuticals Inc.
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MEDICATION GUIDE
ZONEGRAN® (ZO-nuh-gran)
(zonisamide) capsules
What is the most important information I should know about ZONEGRAN?
ZONEGRAN 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.
ZONEGRAN may cause a serious skin rash that can cause death. These
serious skin reactions are
more likely to happen when you begin taking ZONEGRAN within the first
4 months of treatment
but may occur at later times.
2.
ZONEGRAN 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.
ZONEGRAN 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 ZONEGRAN.
Call your health care provider right away if you have:
•
high fever, recurring fever, or long lasting fever
•
less sweat than normal
4.
ZONEGRAN may cause eye problems. Serious eye problems include:
• sudden decrease in vision with or without eye pain and redness
• a b

SPC

ZONEGRAN - ZONISAMIDE CAPSULE
CONCORDIA PHARMACEUTICALS INC.
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ZONEGRAN (ZONISAMIDE) CAPSULES, FOR ORAL ADMINISTRATION
RX ONLY
DESCRIPTION
ZONEGRAN (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 empirical formula is C H N O S
with a
molecular weight of 212.23. Zonisamide 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:
ZONEGRAN is supplied for oral administration as capsules containing 25
mg or 100 mg
zonisamide.
Each 25 mg capsule contains the labeled amount of zonisamide plus the
following
inactive ingredients: microcrystalline cellulose, hydrogenated
vegetable oil, sodium lauryl
sulfate, gelatin, and titanium dioxide.
Each 100 mg capsule contains the labeled amount of zonisamide plus the
following
inactive ingredients: microcrystalline cellulose, hydrogenated
vegetable oil, sodium lauryl
sulfate, gelatin, titanium dioxide, FD&C Red No. 40 and FD&C Yellow
No. 6.
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 cha