CELECOXIB 200 MG- celecoxib capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals Inc.

INN (International Name):

CELECOXIB

Composition:

CELECOXIB 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks of celecoxib and other treatment options before deciding to use celecoxib. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)] Celecoxib is inCelecoxib is indicated for relief of the signs and symptoms of OA [see Clinical Studies (14.1)] Celecoxib is indicated for relief of the signs and symptoms of RA [see Clinical Studies (14.2)] Celecoxib is indicated for relief of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3)] Celecoxib is indicated for the relief of signs and symptoms of AS [see Clinical Studies (14.4)] Celecoxib is indicated for the management of AP in adults [see Clinical Studies (14.5)] Celecoxib is indicated for the treatment of PD [see Clinical Studies (14.5)] Celecoxib is contraindicated: • In patients with known hypersensitivity to celecoxib, aspirin, or other NSAIDs. • In patients who have demonstrated allergic

Product summary:

Celecoxib capsules 200 mg are opaque white/opaque white hard gelatin capsules size “1” having imprinting “136” on body with golden yellow ink and “A” on cap with golden yellow ink filled with white to off-white colored granular powder Storage: Store at 20°-25°C (68°-77°F) excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Preferred Pharmaceuticals Inc.
----------
MEDICATION GUIDE
Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
(See the end of this Medication Guide for a list of prescription NSAID
medicines.)
What is the most important information I should know about medicines
called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs)?
NSAID medicines may increase the chance of a heart attack or stroke
that can lead to death
This chance increases:
• with longer use of NSAID medicines
• in people who have heart disease
NSAID medicines should never be used right before or after a heart
surgery called a "coronary artery
bypass graft (CABG)."
NSAID medicines can cause ulcers and bleeding in the stomach and
intestines at any time during
treatment. Ulcers and bleeding:
• can happen without warning symptoms
• may cause death
The chance of a person getting an ulcer or bleeding increases with:
• taking medicines called corticosteroids and anticoagulants
• longer use
• smoking
• drinking alcohol
• older age
• having poor health
NSAID medicines should only be used:
• exactly as prescribed
• at the lowest dose possible for your treatment
• for the shortest time needed
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines 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 a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine:
• if you had an asthma attack, hives, or other allergic reaction
with aspirin or any other NSAID medicine
• for pain right before or after heart bypass surgery
Tell your healthcare provider:
• about all of your medical conditions.
• about all of the medicines you take. NSAIDs and some other
medicines can interact with each other and
cause serious side effects. Keep a list of your medicines to show to
your healthcare provider and
pharmacist.
• if you are pregnant. NSAID me

Summary of Product characteristics

CELECOXIB 200 MG- CELECOXIB CAPSULE
PREFERRED PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
CELECOXIB 200 MG
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CELECOXIB SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR CELECOXIB.
CELECOXIB CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISKS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
CARDIO VASC ULARRISK
•
•
GASTROINTESTINAL RISK
•
INDICATIONS AND USAGE
Celecoxib is a nonsteroidal anti-inflammatory drug indicated for: (1)
• Osteoarthritis (OA) (1.1)R
• heumatoid 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) (1)
DOSAGE AND ADMINISTRATION
USE LOWEST EFFECTIVE DOSE FOR THE SHORTEST DURATION CONSISTENT WITH
TREATMENT GOALS FOR THE INDIVIDUAL PATIENT.
(1, 5.1, 5.4) (2)
• 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 trial of 400 mg (single
or divided doses) may be of benefit (2.4, 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 (2.5, 14.5) (2)
Reduce daily dose by 50% in patients with moderate hepatic impairment
(Child-Pugh Class B). (2)
Consider a dose reduction by 50% (or alternative management for JRA)
in patients who are known or suspected to be
CYP2C9 poor metabolizers, (2.6, 8.4, 8.8, 12.3). (2)
DOSAGE FORMS AND STRENGTHS
Capsules: 50 mg, 100 mg, 200 mg and 400 mg (3) (3)
CONTRAINDICATIONS
• Known hypersensitivity to celecoxib or sulfonamides (4)
• History of asthma, urticaria, or other allergic-type reactions
after taking aspirin or