CELECOXIB- celecoxib capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

PD-Rx Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks of celecoxib capsules 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 ( 14.5) ]. Celecoxib capsules are indicated for the treatment of PD [ see Clinical Studies ( 14.5) ]. Celecoxib capsules are contraindicated: - In patients with known hype

Product summary:

Celecoxib capsules are available as follows: 200 mg - hard gelatin capsules with an opaque-white body and yellow-opaque cap, filled with a white to off-white powder with small agglomerates, imprinting “TEVA” on the cap and “7166” on the body, in bottles of 14 and 30). Storage 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, with a child-resistant closure (as required).

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

PD-Rx Pharmaceuticals, Inc.
----------
MEDICATION GUIDE FOR NON-
STEROIDAL ANTI-INFLAMMATORY
DRUGS (NSAIDS)
(See the end of this Medication Guide for a list of prescription NSAID
medicines.)
Rx only
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. NS

Summary of Product characteristics

CELECOXIB- CELECOXIB CAPSULE
PD-RX PHARMACEUTICALS, 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: CARDIOVASCULAR AND GASTROINTESTINAL RISKS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
CARDIOVASCULAR RISK
CELECOXIB CAPSULES MAY CAUSE AN INCREASED RISK OF SERIOUS
CARDIOVASCULAR THROMBOTIC EVENTS,
MYOCARDIAL INFARCTION, AND STROKE, WHICH CAN BE FATAL. ALL NSAIDS MAY
HAVE A SIMILAR RISK. THIS RISK MAY
INCREASE WITH DURATION OF USE. PATIENTS WITH CARDIOVASCULAR DISEASE OR
RISK FACTORS FOR CARDIOVASCULAR
DISEASE MAY BE AT GREATER RISK. _(_5.1_, _14.6_)_
CELECOXIB CAPSULES ARE CONTRAINDICATED FOR THE TREATMENT OF
PERI-OPERATIVE PAIN IN THE SETTING OF
CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY. _(_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 capsules are a non-steroidal 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 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