INDOMETHACIN capsule, extended release

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Dispensing Solutions, Inc.

INN (nume internaţional):

INDOMETHACIN

Compoziție:

INDOMETHACIN 75 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Carefully consider the potential benefits and risks of Indomethacin Extended-Release Capsules, USP and other treatment options before deciding to use Indomethacin Extended-Release Capsules, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin Extended-Release Capsules, USP 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 sever osteoarthritis. 4. Acute painful shoulder (bursitis and/or tendonitis). 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 sever forms of rheumatoid arthritis. In such instances the steroid dosage should be reduced slowly and the patients followed very closely for any possible adverse effec

Rezumat produs:

Indomethacin Extended-Release Capsules, USP 75 mg are size “2” coni-snap, empty hard gelatin capsules with natural clear body imprinted “506” and blue translucent cap imprinted “AMNEAL” with black ink. They are available as follows: Bottles of 30:     NDC 65162-506-03 Bottles of 60:     NDC 65162-506-06 Bottles of 90:     NDC 65162-506-09 Bottles of 100:   NDC 65162-506-10 Bottles of 500:   NDC 65162-506-50 Bottles of 1000: NDC 65162-506-11

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

INDOMETHACIN - INDOMETHACIN CAPSULE, EXTENDED RELEASE
DISPENSING SOLUTIONS, INC.
----------
INDOMETHACIN EXTENDED – RELEASE CAPSULES, USP 75 MG
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 a 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 INDICATION AND USAGE.
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.
Indomethacin 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:
M.W. 357.80 C
H1 ClNO
Each extended-release capsule, for oral administration contains 75 mg
of indomethacin. In addition, each
capsule contains the following inactive ingredients: ammonia, black
iron oxide, butyl alcohol, corn
starch, dehydrated alcohol, FD&C Blue No. 1, FD&C Green No. 3, FD&C
Yellow No. 5, FD&C Red
19
6
4
No. 40, gelatin, isopropyl alcohol, lactose monohydrate, potassium
hydroxide, povidone, propylene
glycol, shellac, sucrose and talc.
This Product meets the USP Drug Release Test 2 Specifications.
CLINICAL PH