INDOMETHACIN capsule, extended release

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Denton Pharma, Inc. DBA Northwind Pharmaceuticals

INN (Tarptautinis Pavadinimas):

INDOMETHACIN

Sudėtis:

INDOMETHACIN 75 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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

Produkto santrauka:

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 14 capsules NDC 70934-031-14 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: HETEROTM Hetero Labs Limited Jeedimetla, Hyderabad – 500 055, India. Revised: August 2015

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

Denton Pharma, Inc. DBA Northwind Pharmaceuticals
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SPL MEDGUIDE
Indomethacin Extended-release Capsules, USP
Medication Guide for Non steroidal 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 heart attack or stroke that can lead to death.
This risk may happen early in treatment
and may increase:
o with increasing doses of NSAIDs
o 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:
o anytime during use
o without warning symptoms
o that may cause death
The risk of getting an ulcer or bleeding increases with:
o past history of stomach ulcers, or stomach or intestinal bleeding
with use of NSAIDs
o taking medicines called "corticosteroids", "anticoagulants",
"SSRIs", or "SNRIs"
o increasing doses of NSAIDs o older age
o longer use of NSAIDs o poor health
o smoking o advanced liver disease
o drinking alcohol o bleeding problems
NSAIDs should only be used:
o exactly as prescribed
o at the lowest dose possible for your treatment
o 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 a NSAIDs?
Do not take an NSAIDs:
• if you 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 your healthcare prov

Prekės savybės

INDOMETHACIN- INDOMETHACIN CAPSULE, EXTENDED RELEASE
DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS
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INDOMETHACIN EXTENDED RELEASE CAPSULES, USP
BOXED WARNING CARDIOVASCULAR THROMBOTIC EVENTS
• 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 [see Warnings and
Precautions].
• Indomethacin extended-release capsules are contraindicated in the
setting of coronary artery
bypass graft (CABG) surgery [see Contraindications and 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
19
16
4
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 d