VOLTAREN- diclofenac sodium d/r tablet, delayed release

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1)

متاح من:

Direct_Rx

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of Diclofenac Sodium Delayed-Release Tablets and other treatment options before deciding to use Diclofenac Sodium Delayed-Release Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Diclofenac Sodium Delayed-Release Tablets, USP, are indicated: For relief of signs and symptoms of osteoarthritis For relief of signs and symptoms of rheumatoid arthritis For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis Diclofenac Sodium Delayed-Release Tablets are contraindicated in patients with known hypersensitivity to Diclofenac. Diclofenac Sodium Delayed-Release Tablets should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS,

ملخص المنتج:

HOW SUPPLIED Diclofenac Sodium Delayed-Release Tablets, USP, for oral administration, are available as: 25 mg: round, Light brown, enteric-coated tablets P 25 imprinted on one side in black ink and plain on the reverse side are supplied as: Bottles of 100.......................................NDC 16571-203-10 50 mg: round, Light brown, enteric-coated tablets P 50 imprinted on one side in black ink and plain on the reverse side are supplied as: Bottles of 60.........................................NDC 16571-202-06 Bottles of 100.......................................NDC 16571-202-10 Bottles of 1000.....................................NDC 16571-202-11 75 mg: round, Light brown, enteric-coated tablets P 75 imprinted on one side in black ink and plain on the reverse side are supplied as: Bottles of 60.........................................NDC 16571-201-06 Bottles of 100.......................................NDC 16571-201-10 Bottles of 500.......................................NDC 16571-201-50 Bottles of 1000.....................................NDC 16571-201-11 Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

VOLTAREN- DICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE
DIRECT_RX
----------
DICLOFENAC SODIUM D/R
BOXED WARNING
Cardiovascular Thrombotic Events
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk
of serious
cardiovascular thrombotic events, including myocardial infarction and
stroke, which
can be fatal. This risk may occur early in treatment and may increase
with duration
of use [see Warnings and Precautions].
Diclofenac sodium delayed-release tablets is contraindicated in the
setting of
coronary artery bypass graft (CABG) surgery [see Contraindications and
Warnings].
Gastrointestinal Risk
NSAIDs cause an increased risk of serious gastrointestinal adverse
events including
inflammation, 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
DESCRIPTION
Diclofenac Sodium Delayed-Release Tablets, USP are a benzene-acetic
acid derivative.
Diclofenac Sodium Delayed-Release Tablets are available as
delayed-release (delayed-
release) tablets of 25 mg, 50 mg and 75mg for oral administration. The
chemical name is
2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The
molecular
weight is 318.14. Its molecular formula is C14H10Cl2NNaO2, and it has
the following
structural formula
[structural formula]
The inactive ingredients in Diclofenac Sodium Delayed-Release Tablets
include: lactose
(monohydrate), microcrystalline cellulose, croscarmellose sodium,
povidone, talc,
magnesium stearate, methacrylic acid copolymer, polyethylene glycol,
opadry brown
(Titanium dioxide, hypromellose, polyethylene glycol, iron oxide red,
iron oxide yellow)
and purified water.
CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY
Pharmacodynamics
Diclofenac Sodium Delayed-Release Tablets, are a nonsteroidal
anti-inflammatory drug
(NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic
activities in anim