INDOMETHACIN capsule

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Preferred Pharmaceuticals Inc.

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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

ملخص المنتج:

Indomethacin capsules USP, 50 mg are size '1' hard gelatin capsules, with opaque light green cap imprinted with 'H' and opaque light green body imprinted with '104', containing white to off-white powder. They are supplied as follows: Bottles of Bottles of 30 capsules NDC 68788-6821-3 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

الوضع إذن:

Abbreviated New Drug Application

نشرة المعلومات

INDOMETHACIN- INDOMETHACIN CAPSULE
Preferred Pharmaceuticals Inc.
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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

خصائص المنتج

INDOMETHACIN- INDOMETHACIN CAPSULE
PREFERRED PHARMACEUTICALS INC.
----------
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
BOXED WARNING
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 severe
ankylosing spondylitis; and moderate to severe osteoarthritis is
indomethacin capsules 25 mg two or three times a day
(2.2)
• The dosage for acute painful shoulder (bursitis and/or tendinitis)
is 75 mg to 150 mg daily in 3 or 4 divided doses (2.3)
• The dosage for acute gouty arthritis is indomethacin capsules 50
mg three times a day (2.4)
DOSAGE FORMS AND STRENGTHS
Indomethacin Capsules: 25 mg and 50 mg (3)
CONTRAINDICATIONS
• Known hypersensitivity to indomethacin or any components of the
drug product (4)
• History of asthma, urticaria, or other allergic-type reactions
after taking aspirin or other NSAIDs (4)
• In the setting of CABG surgery (4)
WARNINGS AND PRECAUTIONS
• Hepatotoxicity: Inform patients of warning signs and symptoms of
hepatotoxicity. Discontinue if abnormal liver tests
persist or worsen or if clinical signs and symptoms of liver disease
devel