SUMATRIPTAN injection, solution

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

SUMATRIPTAN SUCCINATE (UNII: J8BDZ68989) (SUMATRIPTAN - UNII:8R78F6L9VO)

Sẵn có từ:

AuroMedics Pharma LLC

INN (Tên quốc tế):

SUMATRIPTAN SUCCINATE

Thành phần:

SUMATRIPTAN 6 mg in 0.5 mL

Tuyến hành chính:

SUBCUTANEOUS

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Sumatriptan injection is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache. Limitations of Use: - Use only if a clear diagnosis of migraine or cluster headache has been established. If a patient has no response to the first migraine or cluster headache attack treated with sumatriptan injection, reconsider the diagnosis before sumatriptan injection is administered to treat any subsequent attacks. - Sumatriptan injection is not indicated for the prevention of migraine or cluster headache attacks. Sumatriptan injection is contraindicated in patients with: - Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) 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 conduction pathway disorders [see Warnings and Precautions (5.2)]. -

Tóm tắt sản phẩm:

Sumatriptan Injection USP contains sumatriptan as sumatriptan succinate USP and is supplied as a clear, colorless to pale yellow, sterile, nonpyrogenic solution as follows: Sumatriptan Injection USP, 6 mg per 0.5 mL Single-Dose Vials in a Carton of 5                                                                                   NDC 55150-173-05 Store between 2° and 30°C (36° and 86°F). Protect from light. The vial stopper is not made with natural rubber latex.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

SUMATRIPTAN - SUMATRIPTAN INJECTION, SOLUTION
AUROMEDICS PHARMA LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SUMATRIPTAN INJECTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
SUMATRIPTAN INJECTION.
SUMATRIPTAN INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1992
RECENT MAJOR CHANGES
Dosage and Administration, Dosing Information (2.1)
12/2021
INDICATIONS AND USAGE
Sumatriptan injection is a serotonin (5-HT
) receptor agonist (triptan) indicated for:
Acute treatment of migraine with or without aura in adults. (1)
Acute treatment of cluster headache in adults. (1)
Limitations of Use:
Use only if a clear diagnosis of migraine or cluster headache has been
established. (1)
Not indicated for the prophylactic therapy of migraine or cluster
headache attacks. (1)
DOSAGE AND ADMINISTRATION
For subcutaneous use only. (2.1)
Acute treatment of migraine: single-dose of 1 to 6 mg. (2.1)
Acute treatment of cluster headache: single-dose of 6 mg. (2.1)
Maximum dose in a 24-hour period: 12 mg, separate doses by at least 1
hour. (2.1)
Patients receiving doses other than 4 or 6 mg: Use the 6 mg
single-dose vial. (2.3)
DOSAGE FORMS AND STRENGTHS
Injection: 6 mg single-dose vial. (3)
CONTRAINDICATIONS
History of coronary artery disease or coronary artery vasospasm (4)
Wolff-Parkinson-White syndrome or other cardiac accessory conduction
pathway disorders (4)
History of stroke, transient ischemic attack, or hemiplegic or basilar
migraine (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)
Concurrent or recent (past 2 weeks) use of monoamine oxidase-A
inhibitor (4)
Hypersensitivity to sumatriptan (angioedema and anaphylaxis seen) (4)
Severe hepatic impairment (4)
WARNINGS AND PRECAUTIONS
Myocardial ischemia/infarction and Prinzmetal’s angina: Perform
cardiac evaluation in patient