Indomethacin Extended-release Capsules, USP Rx Only

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AvPAK

INN (International Name):

INDOMETHACIN

Composition:

INDOMETHACIN 75 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks of indomethacin extended-release capsules and other treatment options before deciding to use indomethacin extended-release capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Indomethacin extended-release capsules have 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). Indomethacin extended-release capsules, USP are not recommended for the treatment of acute gouty arthritis. Indomethacin may enable the reduction of steroid dosage in patients receiving steroids for the more severe forms of rheumatoid arthritis. In such instances the steroid dosag

Product summary:

Extended – release capsules USP 75 mg are size ‘2’ hard gelatin capsules, with dark yellow cap imprinted with ‘H’ and clear transparent body imprinted with ‘105’containing cream spherical pellets. They are supplied as 10 capsules per card, 5 cards per carton          NDC 50268-432-15   Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture Manufactured for: AvKARE, Inc. Pulaski, TN  38478 Mfg. Rev. 2017702 AV 09/15 (P) AvPAK

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

AvPAK
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SPL MEDGUIDE
Indomethacin Extended-release 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 a

Summary of Product characteristics

INDOMETHACIN- INDOMETHACIN CAPSULE, EXTENDED RELEASE
AVPAK
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INDOMETHACIN EXTENDED-RELEASE CAPSULES, USP
RX ONLY
BOXED WARNING 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
peri-operative 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 cannot be considered a simple analgesic and should not be
used in
conditions other than those recommended under INDICATIONS AND USAGE.
Indomethacin is a non-steroidal anti-inflammatory indole derivative
designated chemically
as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid.
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.
The structural formula is:
C
H
ClNO
M.W. 357.80
Each extended-release capsule, for oral administration contains 75 mg
of indomethacin
and the following inactive ingredients: sugar spheres, povidone,
mannitol, isopropyl
alcohol, talc. The hard gelatin shell consists of gelatin, iron oxide
yellow, titanium dioxide,
sodium lauryl sulfate.
The imprinting ink contains the following: shellac, dehydrated
alcohol, isopropyl alcohol,
butyl alcohol, propylene glycol, strong ammonia solution, black iron
oxide E172 dye and
potassium hydroxide.
This product meets USP Drug