DICLOFENAC SODIUM tablet, delayed release

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Blenheim Pharmacal, Inc.

INN (Medzinárodný Name):

DICLOFENAC SODIUM

Zloženie:

DICLOFENAC SODIUM 50 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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: - For relief of signs and symptoms of osteoarthritis - For relief of signs and symptoms of rheumatoid arthritis - For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis 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 WARNINGS, Anaphyla

Prehľad produktov:

Diclofenac Sodium Delayed-release Tablets, USP, for oral administration, are available as: 25 mg : round, Light brown, enteric-coated tablets P 25 imprinted on one side in black ink and plain on the reverse side are supplied as: Bottles of 100                     NDC 16571-203-10 50 mg : round, Light brown, enteric-coated tablets P 50 on one side in black ink and plain on the reverse side are supplied as: Bottles of 60                       NDC 16571-202-06 Bottles of 100                     NDC 16571-202-10 Bottles of 1000                   NDC 16571-202-11 75 mg : round, Light brown, enteric-coated tablets P 75 imprinted on one side in black ink and plain on the reverse side are supplied as: Bottles of 60                       NDC 16571-201-06 Bottles of 100                     NDC 16571-201-10 Bottles of 500                     NDC 16571-201-50 Bottles of 1000                   NDC 16571-201-11 Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container. Manufactured by: UNIQUE PHARMACEUTICAL LABORATORIES. (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) Mumbai 400 030, India. Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401 1-800-521-5340

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, DELAYED RELEASE
Blenheim Pharmacal, Inc.
----------
Diclofenac Sodium Delayed-Release Tablets, USP
MEDICATION GUIDE for Non-Steroidal 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:
•
anytime 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
•
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 A NSAIDS?
Do not take an 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 taking N

Súhrn charakteristických

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, DELAYED RELEASE
BLENHEIM PHARMACAL, INC.
----------
DICLOFENAC SODIUM DELAYED-RELEASE TABLETS USP, 25 MG, 50 MG AND 75 MG
Rx only
CARDIOVASCULAR THROMBOTIC EVENTS
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_ and _Precautions_].
Diclofenac sodium delayed-release tablets is contraindicated in the
setting of coronary artery
bypass graft (CABG) surgery [see _Contraindications_ and _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).
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Diclofenac Sodium Delayed-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 Delayed-release Tablets, like that of
other NSAIDs, is not completely
understood but may be related to prostaglandin synthetase inhibition.
PHARMACOKINETICS
ABS ORPTION
Diclofenac is 100% absorbed after oral administration compared to IV
administration as measured by
urine recovery. However, due to first-pass metabolism, only about 50%
of the absorbed dose is
systemically available (see Table 1). Food has no significant effect
on the extent of diclofenac
absorption. However, there is usually a delay in the onset of
absorption of 1 to 4.5 hours and a
reduction in peak plasma levels of <20%.
TABLE 1. PHARMACOKINETIC PARAMETERS FOR DICLOFENAC
NORMAL HEALTHY ADULTS (20-48 YRS.)
PK PARAMETER
MEAN
COEFFICIENT OF MEAN
VARIATION (%)
Absolute