ZONISAMIDE- zonisamide capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

ZONISAMIDE

Composition:

ZONISAMIDE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 capsules have 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 containing 25 mg, 50 mg or 100 mg of zonisamide, USP. The 25 mg capsule is a violet opaque cap and 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: NDC 0378-6725-01 bottles of 100 capsules The 50 mg capsule is a violet opaque cap and 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: NDC 0378-6726-01 bottles of 100 capsules The 100 mg capsule is a violet opaque cap and 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: NDC 0378-6727-01 bottles of 100 capsules NDC 0378-6727-05 bottles of 500 capsules 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

Mylan Pharmaceuticals Inc.
----------
MEDICATION GUIDE
Zonisamide Capsules, USP
(zoe nis′ a mide)
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.
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 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 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.
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:
•
high fever, recurring fever, or long lasting fever
•
less sweat than normal
4.
Like other antiepileptic drugs, zonisamide capsules may cause suicidal
thoughts or actions

Summary of Product characteristics

ZONISAMIDE- ZONISAMIDE CAPSULE
MYLAN PHARMACEUTICALS INC.
----------
DESCRIPTION
Zonisamide capsules, USP are 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 are supplied for oral administration as capsules
containing 25 mg, 50 mg or 100
mg zonisamide. 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 freezing in ca