DICLOFENAC SODIUM- 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:

Preferred Pharmaceuticals Inc.

INN (International Name):

DICLOFENAC SODIUM

Sammensetning:

DICLOFENAC SODIUM 75 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: Gastrointestinal Bleeding, Ulceration, and Perforation ). Diclofenac sodium delayed-release tablets are indicated: Diclofenac sodium delayed-release tablets are contraindicated in the following patients.

Produkt oppsummering:

Diclofenac sodium delayed-release tablets, USP, for oral administration, are available as: 75 mg: round, pink, enteric-coated tablets imprinted GG 739 on one side in black ink and plain on the reverse side are supplied as: NDC 68788-6952-2 bottles of 20 tablets NDC 68788-6952-3 bottles of 30 tablets NDC 68788-6952-6 bottles of 60 tablets NDC 68788-6952-9 bottles of 90 tablets NDC 68788-6952-1 bottles of 100 tablets NDC 68788-6952-8 bottles of 120 tablets 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.

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, DELAYED RELEASE
Preferred Pharmaceuticals Inc.
----------
MEDICATION GUIDE FOR NONSTEROIDAL ANTI-
INFLAMMATORY DRUGS (NSAIDS)
What is the most important information I should know about medicines
called Nonsteroidal Anti-
inflammatory Drugs (NSAIDs)?
NSAIDs can cause serious side effects, including:
•
Increased risk of a heart attack or stroke that can lead to death.
This risk may happen early in treatment
and may increase:
•
with increasing doses of NSAIDs
•
with longer use of NSAIDs
Do not take NSAIDs right before or after a heart surgery called a
“coronary artery bypass graft
(CABG).”
Avoid taking NSAIDs after a recent heart attack, unless your
healthcare provider tells you to. You may
have an increased risk of another heart attack if you take NSAIDs
after a recent heart attack.
•
Increased risk of bleeding, ulcers, and tears (perforation) of the
esophagus (tube leading from the
mouth to the stomach), stomach and intestines:
•
any time during use
•
without warning symptoms
•
that may cause death
The risk of getting an ulcer or bleeding increases with:
•
past history of stomach ulcers, or stomach or intestinal bleeding with
use of NSAIDs
•
taking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs”, or “SNRIs”
•
increasing doses of NSAIDs
•
longer use of NSAIDs
•
smoking
•
drinking alcohol
•
older age
•
poor health
•
advanced liver disease
•
bleeding problems
NSAIDs should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
What are NSAIDs?
NSAIDs 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 NSAIDs?
Do not take NSAIDs:
•
if you had an asthma attack, hives, or other allergic reaction with
aspirin or any other NSAIDs.
•
right before or after heart bypass surgery.
Before takin

Preparatomtale

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, DELAYED RELEASE
PREFERRED PHARMACEUTICALS INC.
----------
DICLOFENAC SODIUM DELAYED-RELEASE TABLETS, USP
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:
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.
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).
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,
hypromellose