ZONISAMIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AvPAK

INN (International Name):

ZONISAMIDE

Composition:

ZONISAMIDE 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Zonisamide is available as 100 mg two-piece hard gelatin capsules. The capsules imprinted with codes are printed in black ink. Zonisamide is available in bottles with strengths and capsule description as follows: Capsule Description Size "1" Brown Opaque Cap and White Opaque Body imprinted with 100 mg on the cap and IG228 on the body in black ink, filled with White to Off-white powder.  Dosage Strength 100 mg NDC  50268-816-15 10 capsules per card,  5 cards per carton Dispensed in Blister Punch Material. For Institutional Use Only. Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature], in a dry place and protected from light. Manufactured for: AvKARE, Inc. Pulaski, TN  38478 Mfg. Rev. 01/12 AV 07/14 (P) AvPAK

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

AvPAK
----------
Medication Guide
Zonisamide Capsules USP
Read this Medication Guide before you start taking zonisamide capsules
and each time you get a refill. There
may be new information. This information does not take the place of
talking to your healthcare provider
about your medical condition or treatment.
What is the most important information I should know about zonisamide
capsules?
Zonisamide capsules may cause serious side effects, including:
1.
Serious skin rash that can cause death.
2.
Less sweating and increase in your body temperature (fever).
3.
Suicidal thoughts or actions in some people.
4.
Increased level of acid in your blood (metabolic acidosis).
5.
Problems with your concentration, attention, memory, thinking, speech,
or language.
6.
Blood cell changes such as reduced red and white blood cell counts.
These serious side effects are described below.
1. Zonisamide capsules may cause a serious skin rash that can cause
death. These serious skin reactions are
more likely to happen when you begin taking zonisamide capsules within
the first 4 months of treatment but
may occur at later times.
2. Zonisamide capsules 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 capsules.
Call your health care provider right away if you have:
•
a skin rash
•
high fever, recurring fever, or long lasting fever
•
less sweat than normal
3. 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, especially if they are new, worse,
or worry you:
•
thoughts about suicide or dying
•
attempt to commit suicide
•
new or worse depression
•
new or worse anxiety
•
feeling agitated or restless
•
panic attacks
•
trouble sleeping (insomnia)
•
new or worse irritability
•
acting a

Summary of Product characteristics

ZONISAMIDE- ZONISAMIDE CAPSULE
AVPAK
----------
ZONISAMIDE CAPSULES USP
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. 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:
Zonisamide is supplied for oral administration as capsules containing
100 mg zonisamide
USP. Each capsule contains the labeled amount of zonisamide USP plus
the following
inactive ingredients: microcrystalline cellulose, hydrogenated
vegetable oil, gelatin and
colorants. Components of gelatin capsules (For 100 mg: titanium
dioxide, gelatin and
FDA/E172 red iron oxide). Imprint ink dye (Black SW- 9008/SW-9009).
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
8
8
2
3
2+
reduces voltage-dependent, transient inward currents (T-type Ca
currents),
consequently stabi