CELECOXIB capsule

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

CELECOXIB (UNII: JCX84Q7J1L) (CELECOXIB - UNII:JCX84Q7J1L)

Disponible desde:

Proficient Rx LP

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Celecoxib capsules are indicated For the management of the signs and symptoms of OA [see Clinical Studies (14.1) ] For the management of the signs and symptoms of RA [see Clinical Studies (14.2) ] For the management of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3) ] For the management of the signs and symptoms of AS [see Clinical Studies (14.4) ] For the management of acute pain in adults [see Clinical Studies (14.5) ] For the management of primary dysmenorrhea [see Clinical Studies (14.5) ] • Celecoxib capsules are contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to celecoxib, any components of the drug product [see Warnings and Precautions (5.7, 5.9) ]. • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs, have been reported in such patients [see Warnings and Precautions (5.7, 5.8) ]

Resumen del producto:

Celecoxib Capsules 200 mg Size '2', White opaque cap, white opaque body with 'C6' imprinted on the yellow band on the cap and '200mg' imprinted on the yellow band on the body and are available as follows: Bottles of 14 Capsules NDC 71205-027-14 Bottles of 30 Capsules NDC 71205-027-30 Bottles of 60 Capsules NDC 71205-027-60 Bottles of 90 Capsules NDC 71205-027-90 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

CELECOXIB- celecoxib capsule
Proficient Rx LP
----------
Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
What is the most important information I should know about medicines
called Nonsteroidal Anti-
inflammatory Drugs (NSAIDs)?
NSAIDs can cause serious side effects, including:
• Increased risk of a heart attack or stroke that can lead to death.
This risk may happen early in treatment and
may increase:
o with increasing doses of NSAIDs
o with longer use of NSAIDs
Do not take NSAIDs right before or after a heart surgery called a
“coronary artery bypass graft (CABG)."
Avoid taking NSAIDs 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.
• Increased risk of bleeding, ulcers, and tears (perforation) of the
esophagus (tube leading from the mouth to
the stomach), stomach and intestines:
o anytime during use
o without warning symptoms
o that may cause death
The risk of getting an ulcer or bleeding increases with:
o past history of stomach ulcers, or stomach or intestinal bleeding
with use of NSAIDs
o taking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs” or “SNRIs”
o increasing doses of NSAIDs o older age
o longer use of NSAIDs o poor health
o smoking o advanced liver disease
o drinking alcohol o bleeding problems
NSAIDs should only be used:
o exactly as prescribed
o at the lowest dose possible for your treatment
o for the shortest time needed
What are NSAIDs?
NSAIDs are used to treat pain and redness, swelling, and heat
(inflammation) from medical conditions such
as different types of arthritis, menstrual cramps, and other types of
short-term pain.
Who should not take NSAIDs?
Do not take NSAIDs:
• if you have had an asthma attack, hives, or other allergic
reaction with aspirin or any other NSAIDs.
• right before or after heart bypass surgery.
Before taking NSAIDS, tell your healthcare provider about all of your
medical conditions, incl

Ficha técnica

CELECOXIB- CELECOXIB CAPSULE
PROFICIENT RX LP
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CELECOXIB CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CELECOXIB
CAPSULES.
CELECOXIB CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
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 the treatment and may increase with duration of use. (5.1)
• Celecoxib capsules are
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
Boxed Warning 5/2016
Warnings and Precautions, Cardiovascular Thrombotic Events (5.1)
5/2016
Warnings and Precautions, Heart Failure and Edema (5.5) 5/2016
INDICATIONS AND USAGE
Celecoxib capsules are a nonsteroidal anti-inflammatory drug indicated
for:
• Osteoarthritis (OA) (1.1)
• Rheumatoid Arthritis (RA) (1.2)
• Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older
(1.3)
• Ankylosing Spondylitis (AS) (1.4)
• Acute Pain (AP) (1.5)
• Primary Dysmenorrhea (PD) (1.6)
DOSAGE AND ADMINISTRATION
• Use the lowest effective dosage for shortest duration consistent
with individual patient treatment goals
(2.1)
• OA: 200 mg once daily or 100 mg twice daily (2.2, 14.1)
• RA: 100 to 200 mg twice daily (2.3, 14.2)
• JRA: 50 mg twice daily in patients 10-25