INDOMETHACIN capsule

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

INDOMETHACIN (UNII: XXE1CET956) (INDOMETHACIN - UNII:XXE1CET956)

Dostopno od:

Bryant Ranch Prepack

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Indomethacin Capsules are indicated for: • Moderate to severe rheumatoid arthritis including acute flares of chronic disease • Moderate to severe ankylosing spondylitis • Moderate to severe osteoarthritis • Acute painful shoulder (bursitis and/or tendinitis) • Acute gouty arthritis Indomethacin Capsules are contraindicated in the following patients: • Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to indomethacin or any components of the drug product [see Warnings and Precautions (5.7, 5.9) ] • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.7, 5.8) ] • In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1) ] Risk Summary Use of NSAIDs, including indomethacin capsules, during the third trimester of pregnancy increases the risk of pre

Povzetek izdelek:

NDC: 63629-8066-1: 30 Capsules in a BOTTLE

Status dovoljenje:

Abbreviated New Drug Application

Navodilo za uporabo

Bryant Ranch Prepack
----------
INDOMETHACIN CAPSULES USP
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. NSAI

Lastnosti izdelka

INDOMETHACIN- INDOMETHACIN CAPSULE
BRYANT RANCH PREPACK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
INDOMETHACIN
CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
INDOMETHACIN
CAPSULES.
INDOMETHACIN CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1965
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 TREATMENT AND MAY INCREASE
WITH DURATION OF
USE (5.1)
• INDOMETHACIN CAPSULES ARE 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 05/2016
Warnings and Precautions, Cardiovascular Thrombotic Events (5.1)
05/2016
Warnings and Precautions, Heart Failure and Edema (5.5) 05/2016
INDICATIONS AND USAGE
Indomethacin Capsule is a nonsteroidal anti-inflammatory drug
indicated for:
• Moderate to severe rheumatoid arthritis including acute flares of
chronic disease
• Moderate to severe ankylosing spondylitis
• Moderate to severe osteoarthritis
• Acute painful shoulder (bursitis and/or tendinitis)
• Acute gouty arthritis (1)
DOSAGE AND ADMINISTRATION
• Use the lowest effective dosage for shortest duration consistent
with individual patient treatment goals
(2.1)
• The dosage for moderate to severe rheumatoid arthritis including
acute flares of chronic disease;
moderate to seve