INDOMETHACIN capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

NuCare Pharmaceuticals, Inc.

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 Capsule, USP has been found effective in active stages of the following: - Moderate to severe rheumatoid arthritis including acute flares of chronic disease. - Moderate to severe ankylosing spondylitis. - Moderate to severe osteoarthritis. - Acute painful shoulder (bursitis and/or tendinitis). - Acute gouty arthritis. Indomethacin Capsule, USP is contraindicated in patients with known hypersensitivity to indomethacin or the excipients (see DESCRIPTION). Indomethacin Capsule, USP 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 pat

Produkt oppsummering:

Indomethacin Capsules, USP are available containing 50 mg of Indomethacin, USP. The 50 mg capsules are size ‘1’ hard gelatin capsules, with opaque light green cap imprinted with ‘H’ and opaque light green body imprinted with ‘104’, containing white to off-white powder. Bottles of 20 capsules NDC 66267-120-20 Bottles of 30 capsules NDC 66267-120-30 Store at 20° to 25°C (68° to 77°F) [see USP 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. Manufactured for: Camber Pharmaceuticals, Inc 2012729 Piscataway, NJ 08854 By: Hetero Labs Limited Jeedimetla, Hyderabad-500 055, India.

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

NuCare Pharmaceuticals, Inc.
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INDOMETHACIN 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 pregna

Preparatomtale

INDOMETHACIN- INDOMETHACIN CAPSULE
NUCARE PHARMACEUTICALS, INC.
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INDOMETHACIN CAPSULE, USP
RX ONLY
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: lactose monohydrate, sodium lauryl sulphate,
sodium starch glycolate, colloidal
silicon dioxide, magnesium stearate. The hard gelatin shell consists
of gelatin, titanium dioxide USP,
FD & C Blue 1, D & C Yellow 10. The capsules are printed with black
ink containing black iron oxide
E172 dye.
CLINICAL PHARMACOLOGY
Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) that
exhibits antipyretic and analgesic
properties. Its mode of action, like that of ot