MAXALT- rizatriptan benzoate tablet MAXALT-MLT- rizatriptan benzoate tablet, orally disintegrating

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

rizatriptan benzoate (UNII: WR978S7QHH) (rizatriptan - UNII:51086HBW8G)

Sẵn có từ:

Merck Sharp & Dohme Corp.

INN (Tên quốc tế):

rizatriptan benzoate

Thành phần:

rizatriptan 5 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

MAXALT® and MAXALT-MLT® are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use - MAXALT should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with MAXALT, the diagnosis of migraine should be reconsidered before MAXALT is administered to treat any subsequent attacks. - MAXALT is not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)] . - MAXALT is not indicated for the prevention of migraine attacks. - Safety and effectiveness of MAXALT have not been established for cluster headache. MAXALT is contraindicated in patients with: - Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), or other significant underlying cardiovascular disease [see Warnings and Precautions (5.1)] . - Coronary artery vasospasm including Prinzmetal's

Tóm tắt sản phẩm:

No. 3733 — MAXALT Tablets, 10 mg, are pale pink, capsule-shaped, compressed tablets coded MAXALT on one side and MRK 267 on the other: NDC 0006-0267-18, carton of 18 tablets. No. 3801 — MAXALT-MLT Orally Disintegrating Tablets, 10 mg, are white to off-white, round lyophilized orally disintegrating tablets debossed with a modified square on one side, and measuring 12.0-13.8 mm (side-to-side) with a peppermint flavor. Each orally disintegrating tablet is individually packaged in a blister inside an aluminum pouch (sachet). They are supplied as follows: NDC 0006-3801-18, 6 × unit of use carrying case of 3 orally disintegrating tablets (18 tablets total). Storage Store MAXALT Tablets at room temperature, 15°C-30°C (59°F-86°F). Store MAXALT-MLT Orally Disintegrating Tablets at room temperature, 15°C-30°C (59°F-86°F).

Tình trạng ủy quyền:

New Drug Application

Đặc tính sản phẩm

MAXALT- RIZATRIPTAN BENZOATE TABLET
MAXALT-MLT- RIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING
MERCK SHARP & DOHME CORP.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MAXALT AND MAXALT-MLT
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MAXALT
AND MAXALT-MLT.
MAXALT (RIZATRIPTAN BENZOATE) TABLETS, FOR ORAL USE
MAXALT-MLT (RIZATRIPTAN BENZOATE) ORALLY DISINTEGRATING TABLETS
INITIAL U.S. APPROVAL: 1998
RECENT MAJOR CHANGES
Dosage and Administration (2)
09/2020
INDICATIONS AND USAGE
MAXALT is a serotonin (5-HT) 1B/1D receptor agonist (triptan)
indicated for the acute treatment of
migraine with or without aura in adults and in pediatric patients 6 to
17 years of age (1)
Limitations of Use:
Use only after clear diagnosis of migraine has been established (1)
Not indicated for the prophylactic therapy of migraine (1)
Not indicated for the treatment of cluster headache (1)
DOSAGE AND ADMINISTRATION
Adults: 5 or 10 mg single dose; separate repeat doses by at least two
hours; maximum dose in a 24-
hour period: 30 mg (2.1)
Pediatric patients 6 to 17 years: 5 mg single dose in patients less
than 40 kg (88 lb); 10 mg single dose
in patients 40 kg (88 lb) or more (2.2)
Adjust dose if co-administered with propranolol (2.4)
DOSAGE FORMS AND STRENGTHS
MAXALT Tablets: 10 mg (3)
MAXALT-MLT Orally Disintegrating Tablets: 10 mg (3)
CONTRAINDICATIONS
History of ischemic heart disease or coronary artery vasospasm (4)
History of stroke or transient ischemic attack (4)
Peripheral vascular disease (4)
Ischemic bowel disease (4)
Uncontrolled hypertension (4)
Recent (within 24 hours) use of another 5-HT agonist (e.g., another
triptan), or of an ergotamine-
containing medication (4)
Hemiplegic or basilar migraine (4)
MAO-A inhibitor used in the past 2 weeks (4)
Hypersensitivity to rizatriptan or any of the excipients (4)
WARNINGS AND PRECAUTIONS
Myocardial ischemia, myocardial infarction, and Prinzmetal's angina:
Perform cardiac evaluation in
patients with