ZONISAMIDE- zonisamide capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical DBA Quality Care Products LLC

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). 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 Capsules, USP are available as 25 mg, 50 mg or 100 mg capsules. The 25 mg capsule is a violet opaque cap/lavender opaque body, hard-shell gelatin capsule filled with white to off-white powder. The capsule is axially printed with MYLAN over 6725 in black ink on both the cap and body. They are available as follows: The 50 mg capsule is a violet opaque cap/white opaque body, hard-shell gelatin capsule filled with white to off-white powder. The capsule is axially printed with MYLAN over 6726 in black ink on both the cap and body. They are available as follows: The 100 mg capsule is a violet opaque cap/light blue opaque body, hard-shell gelatin capsule filled with white to off-white powder. The capsule is axially printed with MYLAN over 6727 in black ink on both the cap and body. They are available as follows: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture and light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ZONISAMIDE- ZONISAMIDE CAPSULE
Lake Erie Medical DBA Quality Care Products LLC
----------
MEDICATION GUIDE
ZONISAMIDE CAPSULES, USP
(zoe nis′ a mide)
25 mg, 50 mg and 100 mg
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 healthcare 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 capsules 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

Summary of Product characteristics

ZONISAMIDE- ZONISAMIDE CAPSULE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
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 or
almost white crystalline 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 capsules, USP are 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: anhydrous lactose, colloidal silicon dioxide,
magnesium stearate, microcrystalline
cellulose and sodium lauryl sulfate. The empty gelatin capsule shells
contain D&C Red No. 28, FD&C
Blue No. 1, gelatin and titanium dioxide. In addition, the 100 mg
empty gelatin capsule contains FD&C
Red No. 3.
The imprinting ink contains the following: black iron oxide, D&C
Yellow No. 10 Aluminum Lake,
FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red
No. 40 Aluminum
Lake, propylene glycol and shellac glaze.
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