INDOMETHACIN capsule

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Caraco Pharmaceutical Laboratories, Ltd.

INN (International Adı):

INDOMETHACIN

Kompozisyon:

INDOMETHACIN 25 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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 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 is contraindicated in patients with known hypersensitivity to indomethacin or the excipients (see DESCRIPTION ). Indomethacin 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 patients (see WARNINGS: Anaphylactic/Anaphylactoid Reactions , and

Ürün özeti:

Indomethacin Capsules, USP are available containing either 25 mg or 50 mg of indomethacin, USP. The 25 mg capsule is a hard-shell gelatin capsule, with a light green opaque colored cap and body with '119' imprinted in black ink on both cap and body. The capsule is filled with white to off-white colored granular powder blend. They are available as follows: NDC 57664-119-83   Bottles of 30     CRC NDC 57664-119-88   Bottles of 100   CRC NDC 57664-119-08   Bottles of 100    NDC 57664-119-13   Bottles of 500    NDC 57664-119-18   Bottles of 1000  The 50 mg capsule is a hard-shell gelatin capsule, with a light green opaque colored cap and body with '120' imprinted in black ink on both cap and body. The capsule is filled with white to off-white colored granular powder blend. They are available as follows: NDC 57664-120-83   Bottles of 30     CRC NDC 57664-120-88   Bottles of 100   CRC NDC 57664-120-08   Bottles of 100    NDC 57664-120-13   Bottles of 500    NDC 57664-120-18   Bottles of 1000  Store at 20-25°C (68-77°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. ATTENTION : Pharmacist dispense with a Medication Guide. Distributed by:      Caraco Pharmaceutical Laboratories, Ltd.                                Detroit, MI 48202 Manufactured by: Sun Pharmaceutical Industries, Inc.                                 Cranbury, NJ 08512 Iss. 3/2011 6356T01

Yetkilendirme durumu:

Abbreviated New Drug Application

Bilgilendirme broşürü

Caraco Pharmaceutical Laboratories, Ltd.
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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

Ürün özellikleri

INDOMETHACIN - INDOMETHACIN CAPSULE
CARACO PHARMACEUTICAL LABORATORIES, LTD.
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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:
C
H ClNO M.W.357.79
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: colloidal silicon dioxide, lactose monohydrate,
magnesium stearate, sodium lauryl
sulfate, sodium starch glycolate, titanium dioxide, D&C Yellow No. 10,
FD&C Green No. 3, and
gelatin.
The imprinting ink contains the following: black iron oxide, D&C
Yellow No. 10 Aluminum Lake,
FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red
No. 40 Aluminum
Lake, propylene glycol, N-Butyl alcohol, shellac glaze, ethanol and
methanol.
CLINICAL PHARMACOLOGY
In