ZONISAMIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Zydus Lifesciences Limited

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 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 capsules, 25 mg are white to off white granular powder filled in size '4' hard gelatin capsules with pink colored cap printed with "ZA-31" in black ink and white colored body printed with "25 mg" in black ink, which are supplied as follows. NDC 70771-1142-1 in bottles of 100's capsules NDC 70771-1142-5 in bottles of 500's capsules Zonisamide capsules, 50 mg are white to off white granular powder filled in size '3' hard gelatin capsules with pink colored cap printed with "ZA-32" in black ink and white colored body printed with "50 mg" in black ink, which are supplied as follows. NDC 70771-1143-1 in bottles of 100's capsules NDC 70771-1143-5 in bottles of 500's capsules Zonisamide capsules, 100 mg are white to off white granular powder filled in size '1' hard gelatin capsules with pink colored cap printed with "ZA-33" in black ink and white colored body printed with "100 mg" in black ink, which are supplied as follows. NDC 70771-1144-1 in bottles of 100's capsules NDC 70771-1144-5 in bottles of 500's capsules NDC 70771-1144-0 in bottles of 1000's capsules Store at 20o – 25o C (68o – 77o F) [see USP Controlled Room Temperature]. Keep in dry place and protect from light. Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Rev.: 11/17

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Zydus Lifesciences Limited
----------
Manufactured by:
Cadila Healthcare Ltd.
India
SPL MEDGUIDE
Revised: 10/2023
Document Id: c4382248-d7f2-4082-8ee9-dc4bf53779f7
34391-3
Set id: 4a4de4ca-6e4a-4b62-b2b4-26cef6dafb2f
Version: 7
Effective Time: 20231004
Zydus Lifesciences Limited

Summary of Product characteristics

ZONISAMIDE- ZONISAMIDE CAPSULE
ZYDUS LIFESCIENCES LIMITED
----------
ZONISAMIDE CAPSULES
MANUFACTURED BY:
Cadila Healthcare Ltd.
India
SPL MEDGUIDE
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1142-1 in bottle of 100 Capsules
Zonisamide Capsules, 25 mg
R only
100 Capsules
NDC 70771-1143-1 in bottle of 100 Capsules
Zonisamide Capsules, 50 mg
x
R only
100 Capsules
NDC 70771-1144-1 in bottle of 100 Capsules
Zonisamide Capsules, 100 mg
R only
100 Capsules
x
x
ZONISAMIDE
zonisamide capsule
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1142
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ZONISAMIDE (UNII: 459384H98V) (ZONISAMIDE - UNII:459384H98V)
Z ONISAMIDE
25 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
GELATIN (UNII: 2G86QN327L)
HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PRODUCT CHARACTERISTICS
COLOR
PINK (PINK) , WHITE (WHITE)
SCORE
no score
SHAPE
CAPSULE (CAPSULE)
SIZE
14mm
FLAVOR
IMPRINT CODE
Z A;31;25;mg
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1142-1
100 in 1 BOTTLE; Type 0: Not a Combination
Product
11/22/2017
2
NDC:70771-
1142-5
500 in 1 BOTTLE; Type 0: Not a Combination
Product
11/22/2017
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA077625
11/22/2017
ZONISAMIDE
zonisamide capsule
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1143
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ZONISAMIDE (UNII: 459384H98V) (ZONISAMIDE - UNII:459384H98V)
Z ONISAMIDE
50 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
GELAT