DICLOFENAC SODIUM tablet, film coated, extended release

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

Diclofenac Sodium (UNII: QTG126297Q) (Diclofenac - UNII:144O8QL0L1)

Dostupné s:

Proficient Rx LP

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Carefully consider the potential benefits and risks of Diclofenac Sodium Extended-release Tablets 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 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 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, Anaphylactic Reactions, and PRECAUTIONS, Preexisting Asthma ). Diclofenac Sodium Extended-release Tablets are contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (see

Přehled produktů:

Diclofenac Sodium Extended-release Tablets 100 mg - unscored, pink, round film coated tablets, engraved with "93" on one side and "1041" on the other side. NDC 63187-994-15 Bottles of 15 NDC 63187-994-20 – Bottles of 20 NDC 63187-994-30 – Bottles of 30 NDC 63187-994-60 – Bottles of 60 NDC 63187-994-90 – Bottles of 90 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED
RELEASE
Proficient Rx LP
----------
MEDICATION GUIDE FOR NON-
STEROIDAL ANTI-INFLAMMATORY
DRUGS (NSAIDS)
DICLOFENAC (dye-KLOE-fen-ak)
(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 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
t

Charakteristika produktu

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED
RELEASE
PROFICIENT RX LP
----------
DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS
RX ONLY
CARDIOVASCULAR RISK
•
•
GASTROINTESTINAL RISK
•
DESCRIPTION
Diclofenac Sodium Extended-release Tablets are a benzeneacetic acid
derivative. The chemical name is
2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The
molecular weight is 318.13.
Its molecular formula is C
H Cl
NNaO , and it has the following structural formula:
Each extended-release tablet for oral administration contains 100 mg
of diclofenac sodium, USP. In
addition, each tablet contains the following inactive ingredients:
anhydrous lactose, colloidal silicon
dioxide, D & C Red # 27 (phloxine aluminum lake), hydroxyethyl
cellulose, hypromellose, isopropyl
alcohol, lactose monohydrate, magnesium stearate, polyethylene glycol,
povidone, talc, titanium
dioxide, and triacetin.
CLINICAL PHARMACOLOGY
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 are contraindicated for the
treatment of
perioperative 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
PHARMACODYNAMICS
Diclofenac Sodium Extended-release Tablets are a nonsteroidal
anti-inflammatory drug (NSAID) that
exhibits anti-inflammatory, analgesic, and antipyretic activities in
animal models. The mechanism of
action of Diclofenac Sodium Extended-release