CELECOXIB capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aphena Pharma Solutions - Tennessee, LLC

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: Pregnancy Category C. Pregnancy Category D from 30 weeks of gestation onward. Use of NSAIDs, including celecoxib capsules, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including celecoxib capsules, in pregnant women starting at 30 weeks of gestation. There are no adequate and well-controlled studies of celecoxib capsules i

Product summary:

Celecoxib Capsules are available containing 50 mg, 100 mg, 200 mg or 400 mg of celecoxib, USP. The 50 mg capsules are hard-shell gelatin capsules, with a light orange opaque cap and a light orange opaque body filled with white to off-white powder. The capsule is axially printed with MYLAN over 7165 in black ink on both the cap and the body. They are available as follows: NDC 60429-459-60 bottles of 60 capsules The 100 mg capsules are hard-shell gelatin capsules, with a lavender opaque cap and a lavender opaque body filled with white to off-white powder. The capsule is axially printed with MYLAN over 7160 in black ink on both the cap and the body. They are available as follows: NDC 60429-460-01 bottles of 100 capsules NDC 60429-460-05 bottles of 500 capsules The 200 mg capsules are hard-shell gelatin capsules, with a light blue opaque cap and a light blue opaque body filled with white to off-white powder. The capsule is axially printed with MYLAN over 7150 in black ink on both the cap and the body. They are available as follows: NDC 60429-461-01 bottles of 100 capsules NDC 60429-461-05 bottles of 500 capsules The 400 mg capsules are hard-shell gelatin capsules, with a blue green opaque cap and a blue green opaque body filled with white to off-white powder. The capsule is axially printed with MYLAN over 7170 in black ink on both the cap and the body. They are available as follows: NDC 60429-462-91 bottles of 60 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Aphena Pharma Solutions - Tennessee, LLC
----------
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 o

Summary of Product characteristics

CELECOXIB- CELECOXIB CAPSULE
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
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._
•
•
•
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:
•
•
•
•
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
•
•
Hepatic Impairment: Reduce daily dose by 50% in patients with moderate
hepatic impairment (Child-Pugh Class B) (2.7,
8.6, 12.3).
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).
DOSAGE FORMS AND STRENGTHS
Celecoxib capsules: 50 mg, 100 mg, 200 mg and 400 mg (3)
CONTRAINDICATIONS
•
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)
Ost