CELECOXIB- celecoxib capsule

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Asclemed USA, Inc.

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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

Resumo do produto:

Celecoxib Capsules 100 mg Size '4', White opaque cap, white opaque body with 'C5' imprinted on the blue band on the cap and '100mg' imprinted on the blue band on the body and are available as follows: Bottles of 1 Capsule  NDC 76420-243-01 (repackaged from NDC 33342-156-XX) Bottles of 7 Capsules NDC 76420-243-07 (repackaged from NDC 33342-156-XX) Bottles of 30 Capsules NDC 76420-243-30 (repackaged from NDC 33342-156-XX) Bottles of 60 Capsules NDC 76420-243-60 (repackaged from NDC 33342-156-XX) Bottles of 90 Capsules NDC 76420-243-90 (repackaged from NDC 33342-156-XX) 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].

Status de autorização:

Abbreviated New Drug Application

Folheto informativo - Bula

CELECOXIB - CELECOXIB CAPSULE
Asclemed USA, Inc.
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.
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”, “antiplatelet
drugs”, “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 a

Características técnicas

CELECOXIB - CELECOXIB CAPSULE
ASCLEMED USA, INC.
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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
Warnings and Precautions, ( 5.1, 5.4) 6/2018
Warnings and Precautions ( 5.2) 5/2019
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 mg to 200 mg twice daily ( 2.3, 14.2)
• JRA: 50 mg twice daily in patients 10 kg to 25 kg. 100 mg twice
daily in patients more than 25