INDOMETHACIN capsule, extended release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Blenheim Pharmacal, Inc.

INN (International Name):

INDOMETHACIN

Sammensetning:

INDOMETHACIN 75 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 dosage should be reduced slowly and the patients followed very closely for an

Produkt oppsummering:

Indomethacin 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 Bottles of 30 capsules    NDC 31722-565-30 Bottles of 60 capsules    NDC 31722-565-60 Bottles of 100 capsules  NDC 31722-565-01 Bottles of 500 capsules  NDC 31722-565-05 Bottles of 1000 capsules NDC 31722-565-10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

Blenheim Pharmacal, Inc.
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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 are pregnant. NSAID medicines should not be used by pregnant
wo

Preparatomtale

INDOMETHACIN - INDOMETHACIN CAPSULE, EXTENDED RELEASE
BLENHEIM PHARMACAL, INC.
----------
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 p