INDOMETHACIN capsule, extended release

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Direct RX

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 slowly and the patients followed very closely for any possible adver

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

Direct RX
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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.
•

Prekės savybės

INDOMETHACIN- INDOMETHACIN CAPSULE, EXTENDED RELEASE
DIRECT RX
----------
INDOMETHACIN
BOXED WARNING
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 19H 16ClNO 4 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 Release Test