CELECOXIB capsule

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

RxChange Co.

INN (International Name):

CELECOXIB

Sammensætning:

CELECOXIB 200 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Carefully consider the potential benefits and risks of celecoxib and other treatment options before deciding to use celecoxib capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions (5) ] Celecoxib capsules are indicated for relief of the signs and symptoms of OA [ see Clinical Studies (14.1) ] Celecoxib capsules are indicated for relief of the signs and symptoms of RA [ see Clinical Studies (14.2) ] Celecoxib capsules are indicated for relief of the signs and symptoms of JRA in patients 2 years and older [ see Clinical Studies (14.3) ] Celecoxib capsules are indicated for the relief of signs and symptoms of AS [ see Clinical Studies (14.4) ] Celecoxib capsules are indicated for the management of AP in adults [ see Clinical Studies (1

Produkt oversigt:

Celecoxib capsules 50 mg are available for oral administration as hard gelatin capsules with a white opaque body and a white opaque cap. “APO C50” is imprinted on each capsule in red ink. They are supplied as follows: Bottles of 30s                      NDC 60505-3847-3 Bottles of 60s                      NDC 60505-3847-6 Bottles of 100s                    NDC 60505-3847-1   Bottles of 1000                    NDC 60505-3847-8                          Unit Dose Blisters of 100      NDC 60505-3847-0                             Celecoxib capsules 100 mg are available for oral administration as hard gelatin capsules with a white opaque body and a white opaque cap. “APO C100” is imprinted on each capsule in blue ink.  They are supplied as follows: Bottles of 30s                      NDC 60505-3848-3 Bottles of 100s                    NDC 60505-3848-1      Bottles of 500s                    NDC 60505-3848-5                          Bottles of 1000                    NDC 60505-3848-8                          Unit Dose Blisters of 100      NDC 60505-3848-0                            Celecoxib capsules 200 mg are available for oral administration as hard gelatin capsules with a white opaque body and a white opaque cap. “APO C200” is imprinted on each capsule in yellow ink.  They are supplied as follows: Bottles of 30s                      NDC 60505-3849-3 Bottles of 100s                    NDC 60505-3849-1   Bottles of 500s                    NDC 60505-3849-5                         Bottles of 1000                    NDC 60505-3849-8                          Unit Dose Blisters of 100      NDC 60505-3849-0                          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].

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

CELECOXIB- CELECOXIB CAPSULE
RxChange Co.
----------
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:
•
with increasing doses of NSAIDs
•
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:
•
anytime during use
•
without warning symptoms
•
that may cause death
The risk of getting an ulcer or bleeding increases with:
•
past history of stomach ulcers, or stomach or intestinal bleeding with
use of NSAIDs
•
taking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs”, or “SNRIs”
•
increasing doses of NSAIDs
•
longer use of NSAIDs
•
smoking
•
drinking alcohol
•
older age
•
poor health
•
advanced liver disease
•
bleeding problems
NSAIDs should only be used: :
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
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 yo

Produktets egenskaber

CELECOXIB- CELECOXIB CAPSULE
RXCHANGE CO.
----------
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: CARDIOVASCULAR AND GASTROINTESTINAL RISKS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
CARDIOVASCULAR THROMBOTIC EVENTS
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. (SEE _WARNINGS AND_
_PRECAUTIONS_) (_5.1_)
CELECOXIB IS CONTRAINDICATED IN THE SETTING OF CORONARY ARTERY BYPASS
GRAFT (CABG) SURGERY (SEE
_CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS_). _( 4, 5.1)_
GASTROINTESTINAL RISK
NSAIDS, INCLUDING CELECOXIB, CAUSE AN INCREASED RISK OF SERIOUS
GASTROINTESTINAL 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 ARE AT GREATER
RISK FOR SERIOUS GASTROINTESTINAL (GI) EVENTS. _( 5.4)_
INDICATIONS AND USAGE
Celecoxib is a nonsteroidal anti-inflammatory drug indicated for:
Osteoarthritis ( 1.1)
Rheumatoid Arthritis ( 1.2)
Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (
1.3)
Ankylosing Spondylitis ( 1.4)
Acute Pain ( 1.5)
Primary Dysmenorrhea ( 1.6)
DOSAGE AND ADMINISTRATION
USE LOWEST EFFECTIVE DOSE FOR THE SHORTEST DURATION CONSISTENT WITH
TREATMENT GOALS FOR THE INDIVIDUAL PATIENT. (
1, 5.1, 5.4)
OA: 200 mg once daily or 100 mg twice daily ( 2.1, 14.1)
RA: 100 to 200 mg twice daily ( 2.2, 14.2)
JRA: 50 mg twice daily in patients 10 to 25 kg. 100 mg twice daily in
patients more than 25 kg ( 2.3, 14.3)
AS: 200 mg once daily single dose or 100 mg twice daily. If no effect
is observed after 6 weeks, a