DICLOFENAC SODIUM- diclofenac sodium tablet, film coated, extended release

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Lake Erie Medical DBA Quality Care Products LLC

INN (Internationale Bezeichnung):

DICLOFENAC SODIUM

Zusammensetzung:

DICLOFENAC SODIUM 100 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Carefully consider the potential benefits and risks of diclofenac sodium extended-release tablets, USP and other treatment options before deciding to use diclofenac sodium extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Diclofenac sodium extended-release tablets are indicated: - For relief of the signs and symptoms of osteoarthritis - For relief of the signs and symptoms of rheumatoid arthritis Diclofenac sodium extended-release tablets, USP are contraindicated in patients with known hypersensitivity to diclofenac. Diclofenac sodium extended-release tablets 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-like reactions to NSAIDs have been reported in such patients (see WARNINGS, Anaphylactic Reactions , and PRECAUTIONS, General: Preexisting Asthma ). Diclofenac sodium extended-release ta

Produktbesonderheiten:

Diclofenac sodium extended-release tablets, USP 100 mg - Pink round convex film-coated tablet debossed with DX 41 on one side. 55700-246-30 55700-246-60 Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature). Protect from moisture.  Dispense in tight container (USP). Manufactured by: Dexcel® Ltd. 1 Dexcel Street Or-Akiva 30600, Israel  Distributed by: Watson Pharma, Inc. Parsippany, NJ  07054

Berechtigungsstatus:

Abbreviated New Drug Application

Gebrauchsinformation

Lake Erie Medical DBA Quality Care Products LLC
----------
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 bypass surgery
Tell your healthcare provider:
•
about all of your medical conditions.
•
about all of the medicines you take. NSAIDs and some other medicines
can interact with each
other and cause serious side effects. Keep a list of your medicines to
show to your
healthcare provider and pharmacist.
•
if you are p

Fachinformation

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED
RELEASE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS
_DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS, USP, TABLETS OF 100 MG_
_PRESCRIBING INFORMATION 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 greater risk
(see WARNINGS).
Diclofenac sodium extended-release tablets, USP are 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
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
Diclofenac sodium extended-release tablets, USP is a benzeneacetic
acid derivative. Diclofenac
sodium extended-release tablets of 100 mg (pink) are available 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 C
H Cl
NNaO and it has the following structural formula:
The inactive ingredients in diclofenac sodium extended-release tablets
include: carnauba wax,
14
10
2
2
cetostearyl alcohol, colloidal silicon dioxide, compressible sugar,
copovidone, gum acacia,
hydroxypropyl methylcellulose, iron oxide red, magnesium stearate,
polyethylene glycol, povidone,
sugar, talc, titanium dioxide.
Meets USP Dissolution Test 2.
CLINICAL PHARMACOLOGY
_PHARMACODYNAMICS_
Diclofenac sodium extended-release tablets, USP are a non-steroidal
anti-inflammatory drug (NSAID