DICLOFENAC SODIUM tablet, delayed release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Carilion Materials Management

INN (International Name):

DICLOFENAC SODIUM

Sammensetning:

DICLOFENAC SODIUM 25 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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, are indicated: 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 and ). WARNINGS: Anaphylactic Reactions PRECAUTIONS: Preexisting Asthma Diclofenac sodium delayed-release tablets are contraindicated for the treatment of peri-operative pain in the setting o

Produkt oppsummering:

NDC:68151-2481-0 in a PACKAGE of 1 TABLET, DELAYED RELEASES Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container.

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, DELAYED RELEASE
Carilion Materials Management
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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)?
This chance increases: NSAID medicines may increase the chance of a
heart attack or stroke that can lead
to death.
•
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
to your healthcare

Preparatomtale

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, DELAYED RELEASE
CARILION MATERIALS MANAGEMENT
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DICLOFENAC SODIUM DELAYED-RELEASE TABLETS, USP
CARDIOVASCULAR RISK
•
•
GASTROINTESTINAL RISK
•
DESCRIPTION
Diclofenac sodium is a benzeneacetic acid derivative, designated
chemically as 2-[(2,6-
dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The
structural formula is:
Diclofenac sodium is a faintly yellowish white to light beige,
virtually odorless, slightly 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: Black
iron oxide, croscarmellose sodium, hydroxypropyl cellulose,
hydroxypropyl methylcellulose, lactose
(monohydrate), magnesium stearate, methacrylic acid copolymer,
microcrystalline cellulose,
polyethylene glycol, povidone, red iron oxide, and titanium dioxide.
The also contains: D & C Yellow
#10 Aluminum Lake and pharmaceutical glaze shellac. The also contains:
Pharmaceutical glaze shellac
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 delayed-release tablets 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 o