NARATRIPTAN tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

NARATRIPTAN HYDROCHLORIDE (UNII: 10X8X4P12Z) (NARATRIPTAN - UNII:QX3KXL1ZA2)

متاح من:

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

INN (الاسم الدولي):

NARATRIPTAN HYDROCHLORIDE

تركيب:

NARATRIPTAN 1 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: - Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks. - Naratriptan tablets are not indicated for the prevention of migraine attacks. - Safety and effectiveness of naratriptan tablets have not been established for cluster headache. Naratriptan tablets are 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 d

ملخص المنتج:

Naratriptan tablets, USP containing 1 mg and 2.5 mg of naratriptan (base) as the hydrochloride. Naratriptan tablets, USP 1 mg, are yellow, round, biconvex film-coated tablets, debossed with 'I53' on one side and plain on the other side in blister packs of 9 tablets (NDC 23155-054-19), in HDPE container packs of 30 tablets (NDC 23155-054-03), and 500 tablets (23155-054-05). Naratriptan tablets, USP 2.5 mg, are white, 'D' shaped, biconvex film-coated tablets, debossed with 'I54' on one side and plain on the other side in blister packs of 9 tablets (23155-055-19), in HDPE container packs of 30 tablets (NDC 23155-055-03), and 500 tablets (NDC 23155-055-05). Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature].

الوضع إذن:

Abbreviated New Drug Application

نشرة المعلومات

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
----------
PATIENT INFORMATION
Dispense with Patient Information available at:
www.avetpharma.com/product
Patient Information
NARATRIPTAN TABLETS, USP
(NAR-a-TRIP-tan)
Read this Patient Information before you start taking naratriptan
tablets and each time you get a refill.
There may be new information. This information does not take the place
of talking with your healthcare
provider about your medical condition or treatment.
What is the most important information I should know about naratriptan
tablets?
Naratriptan tablets can cause serious side effects, including:
Heart attack and other heart problems. Heart problems may lead to
death.
Stop taking naratriptan tablets and get emergency medical help right
away if you have any of the
following symptoms of a heart attack:
• discomfort in the center of your chest that lasts for more than a
few minutes, or that goes away and
comes back
• severe tightness, pain, pressure, or heaviness in your chest,
throat, neck, or jaw
• pain or discomfort in your arms, back, neck, jaw, or stomach
• shortness of breath with or without chest discomfort
• breaking out in a cold sweat
• nausea or vomiting
• feeling lightheaded
Naratriptan tablets are not for people with risk factors for heart
disease unless a heart exam is done and
shows no problem. You have a higher risk for heart disease if you:
• have high blood pressure
• have high cholesterol levels
• smoke
• are overweight
• have diabetes
• have a family history of heart disease
What are naratriptan tablets?
Naratriptan tablets are prescription medicine used to treat acute
migraine headaches with or without aura
in adults who have been diagnosed with migraine headaches.
Naratriptan tablets are not used to prevent or decrease the number of
migraine headaches you have.
Naratriptan tablets are not used to treat other types of headaches
such as hemiplegic migraines (that make
you unable to move on one side of your body) or basilar migraines
(rare fo

خصائص المنتج

NARATRIPTAN- NARATRIPTAN TABLET
HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NARATRIPTAN TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
NARATRIPTAN TABLETS.
NARATRIPTAN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
Naratriptan Tablets are serotonin (5-HT
) receptor agonists (triptan) indicated for the acute treatment
of migraine with or without aura in adults. _(1)_
Limitations of Use:
Use only if a clear diagnosis of migraine has been established. _(1)_
Not indicated for the prophylactic therapy of migraine attacks. _(1)_
Not indicated for the treatment of cluster headache. _(1)_
DOSAGE AND ADMINISTRATION
Recommended dose: 1 mg or 2.5 mg. (2.1)
May repeat dose after 4 hours if needed; not to exceed 5 mg in any 24-
hour period. (2.1)
Mild or moderate renal or hepatic impairment: recommended starting
dose is 1 mg not to exceed 2.5
mg in any 24-hour period. (2.2,2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 1 mg and 2.5 mg _(3, 16)_
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 an ergotamine-
containing medication _(4)_
Hypersensitivity to naratriptan (angioedema and anaphylaxis seen)
_(4)_
Severe renal or hepatic impairment _(4)_
WARNINGS AND PRECAUTIONS
Myocardial ischemia/infarction and Prinzmetal's angina: Perform
cardiac evaluation in patients with
multiple cardiovascular risk factors. _(5.1)_
Arrhythmias: Discontinue naratriptan if occurs_. (5.2)_
Chest/throat/neck/jaw pain, tightness, pressure, or heaviness:
Generally not associated with myocardial