CELECOXIB capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mas Management Group, Inc.

INN (International Name):

CELECOXIB

Composition:

CELECOXIB 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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)]. - In the

Product summary:

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: NDC 69677-154-15 Bottles of 15 NDC 69677-154-30 Bottles of 30 NDC 69677-154-60 Bottles of 60 NDC 69677-154-90 Bottles of 90 NDC 69677-154-01 Bottles of 120 Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Mas Management Group, Inc.
----------
MEDICATION GUIDE FOR
NONSTEROIDAL ANTI-
INFLAMMATORY DRUGS (NSAIDS)
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

Summary of Product characteristics

CELECOXIB- CELECOXIB CAPSULE
MAS MANAGEMENT GROUP, INC.
----------
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
CARDIOVASCULAR THROMBOTIC EVENTS
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 is a nonsteroidal anti-inflammatory drug indicated for: (1)
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) (2)
(2)
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 to 25 kg. 100 mg twice daily in
patients more than 25 kg (2.4, 14.3)
AS: 200 mg once daily single dose or 100 mg twice daily. If no effect
is observed after 6 weeks, a trial of 400 mg (single
or divided doses) may be of benefit (2.5, 14.4)
AP and PD: 400 mg initially, followed by 200 mg dose if needed on
first day. On subsequent days, 200 mg twice daily as
needed (2.6, 14.5)
(2)
Hepatic Impairment: Reduce daily dose by 50% in patients with moderate
hepatic impairment (Child-Pugh Class B). (2.7,
8.6, 12.3) (2)
(2)
Poor Metabolizers of CYP2C9 Substrates: Consider a dose reduction by
50% (or alternative management for JRA) in
patients who are known or suspected to be CYP2C9 poor metabolizers,
(2.7, 8.8, 12.3). (2)
DOSAGE FORMS AND STRENGTHS
Capsules: 50 mg, 100 mg and 200 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to celecoxib, or an