INDOMETHACIN- indomethacin capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Liberty Pharmaceuticals, Inc.

INN (International Name):

INDOMETHACIN

Composition:

INDOMETHACIN 25 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 has been found effective in active stages of the following: - 1.Moderate to severe rheumatoid arthritis including acute flares of chronic disease. - 2.Moderate to severe ankylosing spondylitis. - 3.Moderate to severe osteoarthritis. - 4.Acute painful shoulder (bursitis and/or tendinitis). - 5.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 Reactio

Product summary:

Indomethacin Capsules, USP are available containing 25 mg of Indomethacin, USP. The 25 mg capsule is a hard-shell gelatin capsule with a light green opaque cap and a light green opaque body axially printed with MYLAN over 143 in black ink on both the cap and body. The capsule is filled with a white powder blend. They are available as follows: NDC 00440-1652-30 bottles of 30 capsules Store at 20° to 25°C (68° to 77°F). [See USP for 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. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 Repackaged By : Aidarex Pharmaceuticals LLC, Corona, CA 92880 REVISED MARCH 2008 INDO:R26mc

Authorization status:

New Drug Application

Patient Information leaflet

Liberty Pharmaceuticals, Inc.
----------
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:
•
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:
•
The chance of a person getting an ulcer or bleeding increases with:
•
NSAID medicines should only be used:
•
•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 re

Summary of Product characteristics

INDOMETHACIN- INDOMETHACIN CAPSULE
LIBERTY PHARMACEUTICALS, INC.
----------
INDOMETHACIN 25 MG 30 CAPS FOR MYLAN
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:
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.
Each capsule for oral administration contains 25 mg or 50 mg of
indomethacin and the following
inactive ingredients: colloidal silicon dioxide, gelatin, FD&C Green
No. 3, magnesium stearate,
microcrystalline cellulose, powdered cellulose, sodium lauryl sulfate,
sodium starch glycolate,
titanium dioxide and D&C Yellow No. 10.
The imprinting ink contains the following: black iron oxide, D&C
Yellow No. 10 Aluminum Lake,
FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red
No. 40 Aluminum
FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum La