CELEBREX celecoxib capsule

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Unit Dose Services

INN (Международно Name):

CELECOXIB

Композиция:

CELECOXIB 100 mg

Вид предписание :

PRESCRIPTION DRUG

Статус Оторизация:

New Drug Application

Данни за продукта

CELEBREX- CELECOXIB CAPSULE
UNIT DOSE SERVICES
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CELEBREX SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR CELEBREX.
CELEBREX (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._
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)
CELEBREX IS 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)
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
CELEBREX is a nonsteroidal 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 the lowest effective dosage for shortest duration consistent with
individual patient treatment goals (2.1)
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 10–25 kg. 100 mg twice daily in
patients more than 25 kg (2.4, 14.3)
AS: 200 mg once d