ZOLMITRIPTAN tablet, orally disintegrating

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZOLMITRIPTAN (UNII: 2FS66TH3YW) (ZOLMITRIPTAN - UNII:2FS66TH3YW)

Available from:

Zydus Lifesciences Limited

INN (International Name):

ZOLMITRIPTAN

Composition:

ZOLMITRIPTAN 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Zolmitriptan orally disintegrating tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use - Only use zolmitriptan if a clear diagnosis of migraine has been established. If a patient has no response to zolmitriptan treatment for the first migraine attack, reconsider the diagnosis of migraine before zolmitriptan is administered to treat any subsequent attacks. - Zolmitriptan orally disintegrating tablets are not indicated for the prevention of migraine attacks. - Safety and effectiveness of zolmitriptan have not been established for cluster headache. Zolmitriptan orally disintegrating tablets are contraindicated in patients with: -   Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), other significant underlying cardiovascular disease, or c oronary artery vasospasm including Prinzmetal's angina [seeWarnings and Precautions (5.1) ]. -   Wolff-Parkinson-White syndrome or arrhythmias associa

Product summary:

Zolmitriptan Orally Disintegrating Tablets, 2.5 mg are white/mottled white to cream white, round, flat-faced, uncoated tablet, debossed with '715' on one side and plain on the other side and are supplied as follows: NDC 65841-767-06 in bottle of 30 tablets NDC 65841-767-16 in bottle of 90 tablets NDC 65841-767-01 in bottle of 100 tablets NDC 65841-767-10 in bottle of 1000 tablets NDC 65841-767-86 in unit-dose blister cartons of 6 (1 x 6) unit dose tablets NDC 65841-767-77 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Zolmitriptan Orally Disintegrating Tablets, 5 mg are white/mottled white to cream white, round, biconvex, beveled, uncoated tablet, debossed with '717' on one side and plain on the other side and are supplied as follows: NDC 65841-768-06 in bottle of 30 tablets NDC 65841-768-16 in bottle of 90 tablets NDC 65841-768-01 in bottle of 100 tablets NDC 65841-768-10 in bottle of 1000 tablets NDC 65841-768-82 in unit-dose blister cartons of 3 (1 x 3) unit dose tablets NDC 65841-768-77 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Storage and Handling Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant closed container.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ZOLMITRIPTAN - ZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING
ZYDUS LIFESCIENCES LIMITED
----------
ZOLMITRIPTAN ORALLY DISTRAGING TABLETS
NDC 65841-767-10 in bottle of 1000 Tablets
Zolmitriptan Orally Disintegrating Tablets, 2.5 mg
Rx only
1000 Tablets
NDC 65841-768-10 in bottle of 1000 Tablets
Zolmitriptan Orally Disintegrating Tablets, 5 mg
Rx only
1000 Tablets
ZOLMITRIPTAN
zolmitriptan tablet, orally disintegrating
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-767
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ZOLMITRIPTAN (UNII: 2FS66TH3YW) (ZOLMITRIPTAN - UNII:2FS66TH3YW)
Z OLMITRIPTAN
2.5 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ASPARTAME (UNII: Z0H242BBR1)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
GELATIN (UNII: 2G86QN327L)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
ORANGE (UNII: 5EVU04N5QU)
POLACRILIN POTASSIUM (UNII: 0BZ5A00FQU)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
PRODUCT CHARACTERISTICS
COLOR
WHITE (WHITE/MOTTLED WHITE TO CREAM WHITE)
SCORE
no score
SHAPE
ROUND (ROUND)
SIZE
6mm
FLAVOR
ORANGE (ORANGE)
IMPRINT CODE
715
CONTAINS
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-
767-06
30 in 1 BOTTLE; Type 0: Not a Combination
Product
05/16/2013
2
NDC:65841-
767-16
90 in 1 BOTTLE; Type 0: Not a Combination
Product
05/16/2013
3
NDC:65841-
767-01
100 in 1 BOTTLE; Type 0: Not a Combination
Product
05/16/2013
4
NDC:65841-
767-10
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
05/16/2013
5
NDC:65841-
767-86
1 in 1 CARTON
05/16/2013
5
NDC:65841-
767-69
6 in 1 BLISTER PACK; Type 0: Not a Combination
Product
6
NDC:65841-
767-77
10 in 1 CARTON
05/16/2013
6
NDC:65841-
767-30
10 in 1 BLISTER PACK; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
M