SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

Sumatriptan Succinate (UNII: J8BDZ68989) (Sumatriptan - UNII:8R78F6L9VO), Naproxen Sodium (UNII: 9TN87S3A3C) (Naproxen - UNII:57Y76R9ATQ)

Prieinama:

Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven

INN (Tarptautinis Pavadinimas):

Sumatriptan Succinate

Sudėtis:

SUMATRIPTAN 85 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Sumatriptan and Naproxen Sodium Tablets is indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older. Limitations of Use: - Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with Sumatriptan and Naproxen Sodium Tablets, reconsider the diagnosis of migraine before Sumatriptan and Naproxen Sodium Tablets is administered to treat any subsequent attacks. - Sumatriptan and Naproxen Sodium Tablets is not indicated for the prevention of migraine attacks. - Safety and effectiveness of Sumatriptan and Naproxen Sodium Tablets have not been established for cluster headache. Sumatriptan and Naproxen Sodium Tablets is contraindicated in the following patients: - 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 Precautio

Produkto santrauka:

Sumatriptan and Naproxen Sodium Tablets 85/500 mg contains 119 mg of sumatriptan succinate equivalent to 85 mg of sumatriptan and 500 mg of naproxen sodium and is supplied as blue film-coated tablets debossed on one side with TREXIMET in bottles of 9 tablets with desiccant (NDC 44183-850-09). Sumatriptan and Naproxen Sodium Tablets 10/60 mg contains 14 mg of sumatriptan succinate equivalent to 10 mg of sumatriptan and 60 mg of naproxen sodium and is supplied as light-blue film-coated tablets debossed on one side with TREXIMET and the other side with 10-60 in bottles of 9 tablets with desiccant (NDC 44183-860-09). Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Do not repackage; dispense and store in original container with desiccant.

Autorizacija statusas:

New Drug Application Authorized Generic

Pakuotės lapelis

sodium tablet
Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven
----------
This Medication Guide has been approved by the U.S. Food and
Drug Administration.
Revised: 10/2021
MEDICATION GUIDE
Sumatriptan and Naproxen Sodium Tablets
Read this Medication Guide before you start taking Sumatriptan and
Naproxen Sodium Tablets and each
time you get a refill. There may be new information. This Medication
Guide 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 Sumatriptan
and Naproxen Sodium Tablets?
Sumatriptan and Naproxen Sodium Tablets may increase your chance of a
heart attack or stroke that can lead
to death. Sumatriptan and Naproxen Sodium Tablets contains 2
medicines: sumatriptan and naproxen
sodium (a nonsteroidal anti-inflammatory drug [NSAID]).
•
This risk may happen early in treatment and may increase:
•
with increasing doses of NSAIDs
•
with longer use of NSAIDs
Do not take Sumatriptan and Naproxen Sodium Tablets right before or
after a heart surgery called a
"coronary artery bypass graft (CABG)."
Avoid taking Sumatriptan and Naproxen Sodium Tablets after a recent
heart attack, unless your healthcare
provider tells you to. You may have an increased risk of another heart
attack if you take NSAIDs after a
recent heart attack.
Stop taking Sumatriptan and Naproxen Sodium Tablets and get emergency
help right away if you have any
of the following symptoms of a heart attack or stroke:
•
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
•
weakness in one part or on one side of your body
•
slurred speech
Sumatriptan and Naproxen Sodium Tab

Prekės savybės

SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM- SUMATRIPTAN SUCCINATE
AND NAPROXEN SODIUM TABLET
CURRAX PHARMACEUTICALS LLC DBA CYPRESS, HAWTHORN, MACOVEN
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SUMATRIPTAN AND
NAPROXEN SODIUM TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
SUMATRIPTAN AND NAPROXEN SODIUM TABLETS.
SUMATRIPTAN AND NAPROXEN SODIUM TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2008
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) CAUSE AN INCREASED RISK
OF SERIOUS
CARDIOVASCULAR THROMBOTIC EVENTS, INCLUDING MYOCARDIAL INFARCTION AND
STROKE, WHICH
CAN BE FATAL. THIS RISK MAY OCCUR EARLY IN TREATMENT AND MAY INCREASE
WITH DURATION
OF USE. (5.1)
SUMATRIPTAN AND NAPROXEN SODIUM TABLETS IS CONTRAINDICATED IN THE
SETTING OF
CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY (4, 5.1)
NSAIDS CAUSE AN INCREASED RISK OF SERIOUS GASTROINTESTINAL (GI)
ADVERSE EVENTS
INCLUDING BLEEDING, ULCERATION, AND PERFORATION OF THE STOMACH OR
INTESTINES, WHICH
CAN BE FATAL. THESE EVENTS CAN OCCUR AT ANY TIME DURING USE AND
WITHOUT WARNING
SYMPTOMS. ELDERLY PATIENTS AND PATIENTS WITH A PRIOR HISTORY OF PEPTIC
ULCER DISEASE
AND/OR GI BLEEDING ARE AT GREATER RISK FOR SERIOUS GI EVENTS. (5.2)
RECENT MAJOR CHANGES
Contraindications, pregnancy removal (4)
4/2021
Warnings and Precautions (5.15, 5.16)
4/2021
INDICATIONS AND USAGE
Sumatriptan and Naproxen Sodium Tablets is a combination of
sumatriptan, a serotonin (5-HT) 1b/1d
receptor agonist (triptan), and naproxen sodium, a non-steroidal
anti-inflammatory drug, indicated for the
acute treatment of migraine with or without aura in adults and
pediatric patients 12 years of age and
older. (1)
Limitations of Use:
Use only if a clear diagnosis of migraine headache has been
established. (1)
Not indicated for the prophylactic therapy of migraine attacks. (1)
Not indicated for th