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

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Proficient Rx LP

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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: 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, Anaphylactoid Reactions , and PRECAUTIONS, General: Preexisting Asthma ). Diclofenac sodium extended-release tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG

Produkt oversigt:

Diclofenac Sodium Extended-release Tablets, USP 100 mg - Pink round convex film coated tablet debossed with DX 41 on one side. Bottles of: 15 (NDC 63187-475-15) 15 (NDC 63187-475-20) 30 (NDC 63187-475-30) 60 (NDC 63187-475-60) 90 (NDC 63187-475-90) Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature). Protect from moisture. Dispense in tight container (USP). Manufactured for: Watson Laboratories Inc. Corona, CA 92880 USA Manufactured by: Dexcel ® Ltd. 1 Dexcel Street Or-Akiva 30600, Israel Repackaged by: Proficient Rx LP Thousand Oaks CA, 91320

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED
RELEASE
Proficient Rx LP
----------
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
health

Produktets egenskaber

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED
RELEASE
PROFICIENT RX LP
----------
DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS
DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS,
USP, TABLETS OF 100 MG
_PRESCRIBING INFORMATION RX ONLY_
CARDIOVASCULAR RISK
•
•
GASTROINTESTINAL RISK
•
DESCRIPTION
Diclofenac sodium extended-release tablets, USP are 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:
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).
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).
14
10
2
2
The inactive ingredients in diclofenac sodium extended-release tablets
include: carnauba wax,
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)
that exhibits anti-