INDOMETHACIN- indomethacin capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Jubilant Cadista Pharmaceuticals Inc.

INN (International Name):

INDOMETHACIN

Composition:

INDOMETHACIN 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Indomethacin capsules are indicated for: - Moderate to severe rheumatoid arthritis including acute flares of chronic disease. Moderate to severe rheumatoid arthritis including acute flares of chronic disease. - Moderate to severe ankylosing spondylitis. Moderate to severe ankylosing spondylitis. - Moderate to severe osteoarthritis. Moderate to severe osteoarthritis. - Acute painful shoulder (bursitis and/or tendinitis). Acute painful shoulder (bursitis and/or tendinitis). - Acute gouty arthritis. 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)] 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 react

Product summary:

Indomethacin Capsules, USP are available containing either 25 mg or 50 mg of Indomethacin, USP: The 25 mg capsule is a hard-shell gelatin capsule with green colored cap and body, size '3' hard gelatin capsules, axially printed in black ink with 'C 246' on cap and body containing off-white to yellow granular powder. They are available as follows:  NDC 59746-346-30            bottles of 30 capsules with child-resistant closure NDC 59746-346-01            bottles of 100 capsules with child-resistant closure NDC 59746-346-10            bottles of 1000 capsules The 50 mg capsule is a hard-shell gelatin capsule with a green colored cap and body, size '1' hard gelatin capsules, axially printed in black ink with 'C 247' on cap and body containing off-white to yellow granular powder. They are available as follows:   NDC 59746-347-30               bottles of 30 capsules with child-resistant closure NDC 59746-347-01               bottles of 100 capsules with child-resistant closure NDC 59746-347-05               bottles of 500 capsules Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°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. PHARMACIST: Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

INDOMETHACIN - INDOMETHACIN CAPSULE
Jubilant Cadista Pharmaceuticals Inc.
----------
MEDICATION GUIDE
FOR NONSTEROIDAL ANTI-INFLAMMATORY
DRUGS (NSAIDS)
What is the most important information I should know about medicines
called Nonsteroidal Anti-
inflammatory Drugs (NSAIDs)?
NSAIDs can cause serious side effects, including:
•
Increased risk of a heart attack or stroke that can lead to death.
This risk may happen early in
treatment and may increase:
•
with increasing doses of NSAIDs
•
with longer use of NSAIDs
Do not take NSAIDs right before or after a heart surgery called a
“coronary artery bypass graft (CABG).”
Avoid taking NSAIDs after a recent heart attack, unless your
healthcare provider tells you to. You may
have an increased risk of another heart attack if you take NSAIDs
after a recent heart attack.
•
Increased risk of bleeding, ulcers, and tears (perforation) of the
esophagus (tube leading from the
mouth to the stomach), stomach and intestines:
•
anytime during use
•
without warning symptoms
•
that may cause death
The risk of getting an ulcer or bleeding increases with:
•
past history of stomach ulcers, or stomach or intestinal bleeding with
use of NSAIDs
•
taking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs”, or “SNRIs”
•
increasing doses of NSAIDs
•
longer use of NSAIDs
•
smoking
•
drinking alcohol
•
older age
•
poor health
•
advanced liver disease
•
bleeding problems
NSAIDs should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
What are NSAIDs?
NSAIDs 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 NSAIDs?
Do not take NSAIDs:
•
if you have had an asthma attack, hives, or other allergic reaction
with aspirin or any other
NSAIDs.
•
right before or after heart bypass surgery.
Before taking NSAIDs, tell

Summary of Product characteristics

INDOMETHACIN - INDOMETHACIN CAPSULE
JUBILANT CADISTA 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
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)
INDICATIONS AND USAGE
Indomethacin capsules are 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: