CELECOXIB capsule

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Proficient Rx LP

INN (Международно Name):

CELECOXIB

Композиция:

CELECOXIB 100 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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 is indicated for relief of the signs and symptoms of OA [see Clinical Studies (14.1)] Celecoxib Capsules is indicated for relief of the signs and symptoms of RA [see Clinical Studies (14.2)] Celecoxib Capsules is indicated for relief of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3)] Celecoxib Capsules is indicated for the relief of signs and symptoms of AS [see Clinical Studies (14.4)] Celecoxib Capsules is indicated for the management of AP in adults [see Clinical Studies (14.5)] Celecoxib Capsules is indicated for the treatment of PD [see Clinical Studies (14.5)] Celecoxib Capsules is contraindicated: Pregnancy Category C. Pregnancy category D from 30 weeks of ges

Каталог на резюме:

Celecoxib Capsules are available in the following strengths and configurations: Celecoxib Capsules 100 mg: White to off white colored granules filled in size 2 hard gelatin white capsule, axially printed with ‘Cipla’ on cap & ‘422’ over ‘100 mg’ on body in blue ink. Storage: Store at 25°C (77°F) [see USP Controlled Room Temperature]

Статус Оторизация:

Abbreviated New Drug Application

Листовка

CELECOXIB- CELECOXIB CAPSULE
Proficient Rx LP
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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 increasing doses of NSAID medicines
•
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:
•
increasing doses of NSAID medicines
•
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 medicin

Данни за продукта

CELECOXIB- CELECOXIB CAPSULE
PROFICIENT RX LP
----------
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
•
•
Gastrointestinal Risk
•
INDICATIONS AND USAGE
Celecoxib Capsule is a non-steroidal anti-inflammatory drug indicated
for:
•
•
•
•
•
•
DOSAGE AND ADMINISTRATION
Use lowest effective dose for the shortest duration consistent with
treatment goals for the individual patient. (1, 5.1, 5.4)
•
•
•
•
•
Reduce daily dose by 50% in patients with moderate hepatic impairment
(Child-Pugh Class B).
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).
DOSAGE FORMS AND STRENGTHS
Capsules: 50 mg, 100 mg, 200 mg and 400 mg (3)
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
•
ADVERSE REACTIONS
Most common adverse reactions in arthritis trials (>2% and >placebo):
abdominal pain, diarrhea, dyspepsia, flatulence,
peripheral edema, accidental injury, dizziness, pharyngitis, rhinitis,
sinusitis, upper respiratory tract infection, rash (6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT CIPLA LTD, AT
1-866-604-3268 OR FDA AT 1-800-FDA-
1088 OR WWW.FDA.GOV/MEDWATCH
DRUG INTERACTIONS
•
•
•
•
USE IN SPECIFIC POPULATIONS
•
SEE 17 FOR PATIENT COUNSELING INFORMATION AND MEDICATION GUIDE.
REVISED: 1/2021
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Osteoarthritis (OA)
1.2 Rheumatoid Arthritis (RA)
1.3 Juvenile Rheumatoid Arthritis (JRA)
1.4 Ankylosing Spondylitis (AS)
1.5 Acute Pain (AP)
1.6 Primary Dysmenorrhea (PD)
2 DOSAGE AND ADMINISTRATION
2.1 Osteoarthritis
2.2 Rheumatoid Arthritis
2.3