ZOLMITRIPTAN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Direct_Rx

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Zolmitriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: Only use zolmitriptan tablets if a clear diagnosis of migraine has been established. If a patient has no response to zolmitriptan tablets treatment for the first migraine attack, reconsider the diagnosis of migraine before zolmitriptan tablets are administered to treat any subsequent attacks. Zolmitriptan tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of zolmitriptan tablets have not been established for cluster headache. Zolmitriptan 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 coronary artery vasospasm including Prinzmetal’s angina [see WARNINGS AND PRECAUTIONS (5.1)] . Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory co

Product summary:

2.5 mg Tablets - Pink, round, biconvex, film-coated tablets with "ZL 1" engraved on one side and break line on other side are supplied in bottles containing 6 tablets (NDC 27241-021-68). 5 mg Tablets - Yellow, round, biconvex, film-coated tablets with "ZL 2" engraved on one side and plain on other side are supplied in bottles containing 3 tablets (NDC 72189-435-03).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ZOLMITRIPTAN- ZOLMITRIPTAN TABLET
DIRECT_RX
----------
ZOLMITRIPTAN
Zolmitriptan tablets are indicated for the acute treatment of migraine
with or without
aura in adults.
Limitations of Use:
Only use zolmitriptan tablets if a clear diagnosis of migraine has
been established. If a
patient has no response to zolmitriptan tablets treatment for the
first migraine attack,
reconsider the diagnosis of migraine before zolmitriptan tablets are
administered to treat
any subsequent attacks.
Zolmitriptan tablets are not indicated for the prevention of migraine
attacks.
Safety and effectiveness of zolmitriptan tablets have not been
established for cluster
headache.
2.1 Dosing Information
The recommended starting dose of zolmitriptan tablets is 1.25 mg or
2.5 mg. The 1.25
mg dose can be achieved by manually breaking the functionally-scored
2.5 mg tablet in
half. The maximum recommended single dose of zolmitriptan tablets is 5
mg.
In controlled clinical trials, a greater proportion of patients had
headache response
following a 2.5 mg or 5 mg dose than following a 1 mg dose. There was
little added
benefit from the 5 mg dose compared to the 2.5 mg dose, but adverse
reactions were
more frequent with the 5 mg dose.
If the migraine has not resolved by 2 hours after taking zolmitriptan
tablets, or returns
after a transient improvement, a second dose may be administered at
least 2 hours
after the first dose. The maximum daily dose is 10 mg in any 24-hour
period.
The safety of zolmitriptan tablets in the treatment of an average of
more than three
migraines in a 30-day period has not been established.
2.3 Dosing in Patients with Hepatic Impairment
The recommended dose of zolmitriptan tablets in patients with moderate
to severe
hepatic impairment is 1.25 mg (one-half of one 2.5 mg zolmitriptan
tablets) because of
increased zolmitriptan blood levels in these patients and elevation of
blood pressure in
some of these patients. Limit the total daily dose in patients with
severe hepatic
impairment to no more than 5 mg per day.
2.4 Dosing in P