INDOMETHACIN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

INDOMETHACIN

Composition:

INDOMETHACIN 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Indomethacin capsules have been found effective in active stages of the following: - 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 is contraindicated in patients with known hypersensitivity to indomethacin or the excipients (see DESCRIPTION ). Indomethacin should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic/anaphylactoid reactions to NSAIDs have been reported in such patients (see WARNINGS: Anaphylactic/Anaphylactoid React

Product summary:

Indomethacin capsules USP are available containing either 25 mg or 50 mg of indomethacin, USP. The 50 mg capsule is a size ‘1’ two piece opaque green hard gelatin capsules imprinted with ‘G302’ on body and ‘G’ on cap filled with white to off-white granular powder. They are available as follows: Bottles of 15 capsules NDC 35356-697-15 Bottles of 21 capsules NDC 35356-697-21 Bottles of 30 capsules NDC 35356-697-30

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

INDOMETHACIN- INDOMETHACIN CAPSULE
Lake Erie Medical DBA Quality Care Products LLC
----------
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
phar

Summary of Product characteristics

INDOMETHACIN- INDOMETHACIN CAPSULE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
INDOMETHACIN CAPSULES USP, 25 MG AND 50 MG
RX ONLY
CARDIOVASCULAR RISK
NSAIDs may cause an increased risk of serious cardiovascular
thrombotic
events, myocardial infarction, and stroke, which can be fatal. This
risk may
increase with duration of use. Patients with cardiovascular disease or
risk
factors for cardiovascular disease may be at greater risk (see
WARNINGS).
Indomethacin is contraindicated for the treatment of perioperative
pain in the
setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
GASTROINTESTINAL RISK
NSAIDs cause an increased risk of serious gastrointestinal 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 are at greater risk for serious
gastrointestinal events (see WARNINGS).
DESCRIPTION
Indomethacin capsules, USP for oral administration are provided in two
dosage
strengths which contain either 25 mg or 50 mg of indomethacin.
Indomethacin is a non-
steroidal anti-inflammatory indole derivative designated chemically as
1-(4-
chlorobenzoyl)-5-methoxy-2-methyl-1_H_ -indole-3-acetic acid.
The structural formula is:
C
H
ClNO M.W. 357.79
Indomethacin, USP is practically insoluble in water and sparingly
soluble in alcohol. It has
a pKa of 4.5 and is stable in neutral or slightly acidic media and
decomposes in strong
alkali.
19
16
4
Each capsule for oral administration contains 25 mg or 50 mg of
indomethacin and the
following inactive ingredients: colloidal silicon dioxide, FD&C Blue
No. 1, D&C Yellow No.
10, gelatin, hypromellose, lactose monohydrate, magnesium stearate,
microcrystalline
cellulose, sodium lauryl sulfate, sodium starch glycolate and titanium
dioxide.
The imprinting ink contains the following: black iron oxide, butyl
alcohol, dehydrated
alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol,
shellac and strong
a