CELECOXIB capsule

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Alembic Pharmaceuticals Limited

INN (Tên quốc tế):

CELECOXIB

Thành phần:

CELECOXIB 50 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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 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-type rea

Tóm tắt sản phẩm:

Celecoxib capsules 50 mg are opaque white/opaque white hard gelatin capsules size “5” having imprinting “134” on body with red ink and “A” on cap with red ink filled with white to off-white colored granular powder.  NDC 46708-267-30    bottle of 30 capsules  NDC 46708-267-60    bottle of 60 capsules NDC 46708-267-91    bottle of 1000 capsules NDC 46708-267-12    carton of 80 (10 x 8) unit-dose capsules NDC 46708-267-10    carton of 100 (10 x 10) unit-dose capsules Celecoxib capsules 100 mg are opaque white/opaque white hard gelatin capsules size “3” having imprinting “135” on body with blue ink and “A” on cap with blue ink filled with white to off-white colored granular powder.  NDC 46708-268-30    bottle of 30 capsules NDC 46708-268-60    bottle of 60 capsules NDC 46708-268-31    bottle of 100 capsules NDC 46708-268-71    bottle of 500 capsules NDC 46708-268-91    bottle of 1000 capsules NDC 46708-268-12    carton of 80 (10 x 8) unit-dose capsules NDC 46708-268-10    carton of 100 (10 x 10) unit-dose capsules 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.   NDC 46708-269-30    bottle of 30 capsules NDC 46708-269-60    bottle of 60 capsules NDC 46708-269-31    bottle of 100 capsules NDC 46708-269-71    bottle of 500 capsules NDC 46708-269-91    bottle of 1000 capsules NDC 46708-269-12    carton of 80 (10 x 8) unit-dose capsules NDC 46708-269-10    carton of 100 (10 x 10) unit-dose capsules Celecoxib capsules 400 mg are opaque white/opaque white hard gelatin capsules size “00” having imprinting “137” on body with green ink and “A” on cap with green ink filled with white to off-white colored granular powder.         NDC 46708-270-30    bottle of 30 capsules  NDC 46708-270-60    bottle of 60 capsules  NDC 46708-270-71    bottle of 500 capsules NDC 46708-270-10    carton of 100 (10 x 10) unit-dose capsules NDC 46708-270-14    carton of 126 (9 x 14) unit-dose capsules Storage : Store at 20°-25°C (68°-77°F) excursions permitted to 15°-30°C (59°- 86°F) [see USP Controlled Room Temperature].

Tình trạng ủy quyền:

Abbreviated New Drug Application

Tờ rơi thông tin

Alembic Pharmaceuticals Limited
----------
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 p

Đặc tính sản phẩm

CELECOXIB - CELECOXIB CAPSULE
ALEMBIC PHARMACEUTICALS LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
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_
CARDIOVASCULARRISK
CELECOXIB 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 IS 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 GASTRO
INTESTINAL
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 WITH
OUT WARNING SYMPTOMS. ELDERLY PATIENTS ARE AT GREATER RISK FOR SERIOUS
GASTRO INTESTINAL
(GI) EVENTS. _(5.4)_
INDICATIONS AND USAGE
Celecoxib is a non steroidal 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 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 100mg twice daily. If no e