DICLOFENAC SODIUM- diclofenac sodium tablet, delayed release

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Preferred Pharmaceuticals, Inc.

INN (Διεθνής Όνομα):

DICLOFENAC SODIUM

Σύνθεση:

DICLOFENAC SODIUM 50 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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: Gastrointestinal Bleeding, Ulceration and Perforation ). Diclofenac sodium delayed-release tablets are indicated: Diclofenac sodium delayed-release tablets are contraindicated in the following patients.

Περίληψη προϊόντος:

HOW SUPPLIED 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: Bottle of 20 - 68788-9175-2 Bottle of 30 - 68788-9175-3 Bottle of 60 - 68788-9175-6 Bottle of 90 - 68788-9175-9 Bottle of 100 - 68788-9175-1 Bottle of 120 - 68788-9175-8 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: Bottle of 20 - 68788-9231-2 Bottle of 30 - 68788-9231-3 Bottle of 60 - 68788-9231-6 Bottle of 90 - 68788-9231-9 Bottle of 100 - 68788-9231-1 Bottle of 120 - 68788-9231-8 Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container. Manufactured for: Rising® Rising Pharmaceuticals, Inc. Allendale, NJ 07401 1-800-521-5340 Manufactured by: UNIQUE PHARMACEUTICAL LABORATORIES (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) Mumbai 400 030, India. 121266 April 2017 Repackaged By: Preferred Pharmaceuticals Inc.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, DELAYED RELEASE
PREFERRED PHARMACEUTICALS, INC.
----------
DICLOFENAC SODIUM DELAYED-RELEASE TABLETS, USP 25 MG, 50 MG AND 75 MG
Rx only
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL
EVENTS
CARDIOVASCULAR THROMBOTIC EVENTS
•
•
GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION
•
DESCRIPTION
Diclofenac sodium is a benzeneacetic acid derivative, designated
chemically as 2-[(2,6-
dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The
structural formula is:
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).
Diclofenac sodium delayed-release tablets are contraindicated in the
setting of coronary
artery bypass graft (CABG) surgery (see CONTRAINDICATIONS and
WARNINGS).
NSAIDs cause an increased risk of serious gastrointestinal (GI)
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 and
patients with a prior history of peptic ulcer disease and/or GI
bleeding are at greater risk
for serious GI events (see WARNINGS).
C
H CL
NNAO M.W. 318.14
Diclofenac sodium is a white to off-white, hygroscopic crystalline
powder. It is freely soluble in
methanol, soluble in ethanol, sparingly soluble in water and
practically insoluble in chloroform and in
dilute acid. The n-octanol/water partition coefficient is 13.4 at pH
7.4 and 1545 at pH 5.2. Diclofenac
sodium has a dissociation constant (pKa) of 4.0 ± 0.2 at 25°C in
water.
Each enteric-coated tablet for oral administration contains 25 mg, 50
mg, or 75 mg of diclofenac
sodium. In addition, each tablet contains the following inactive
ingredients. Inactive ingredients: lactose
(monohydrate), microcrystalline cellulose, croscarmellose sodiu