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:

Blenheim Pharmacal, 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

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
BLENHEIM PHARMACAL, INC.
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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.)
CLINICAL PHARMACOLOGY
Indomethacin is a non-steroidal drug with anti-inflammatory,
antipyretic and analgesic properties. Its
mode of action, like that of other anti-inflammatory drugs, is not
known. However, its therapeutic action
is not due to pituitary-adrenal stimulation.
Indomethacin is a potent inhibitor of prostaglandin synthesis _in
vitro_. Concentrations are reached during
therapy which have been demonstrated to have an effect _in vivo _as
well. Prostaglandins sensitize afferent
nerves and potentiate the action of bradykinin in inducing pain in
animal models. Moreover,
prostaglandins are known to be among the mediators of inflammation.
Since indomethacin is an inhibitor
of prostaglandin synthesis, its mode of action may be due to a
decrease of prostaglandins in peripheral
tissues.
Indomethacin has been shown to be an effective anti-inflammatory
agent, appropriate for long-term use
in rheumatoid arthritis, ankylosing spondylitis, and osteoarthritis.
Indomethacin affords relief of symptoms; it does not alter the
progressive course of the unde