DICLOFENAC SODIUM tablet, delayed release

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Physicians Total Care, Inc.

INN（国际名称）:

DICLOFENAC SODIUM

组成:

DICLOFENAC SODIUM 25 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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: Anaphylactoid Reactions

產品總結:

Diclofenac sodium delayed-release tablets, USP, for oral administration, are available as: 25 mg: round, yellow, enteric-coated tablets imprinted GG 737 on one side in black ink and plain on the reverse side are supplied as: 50 mg: round, brown, enteric-coated tablets imprinted GG 738 on one side in black ink and plain on the reverse side are supplied 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: Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container. Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK      74146

授权状态:

Abbreviated New Drug Application

资料单张

Physicians Total Care, Inc.
----------
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 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
provider and pharmacist.
•
if you are pregnant. NSAID medicine

产品特点

DICLOFENAC SODIUM - DICLOFENAC SODIUM TABLET, DELAYED RELEASE
PHYSICIANS TOTAL CARE, INC.
----------
REVISED – MARCH 2009
RX ONLY
PRESCRIBING INFORMATION
CARDIOVASCULAR RISK
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).
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).
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,
polyethyl