DICLOFENAC SODIUM tablet, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

H.J. Harkins Company, Inc.

INN (International Name):

Diclofenac Sodium

Composition:

Diclofenac Sodium 75 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 , and PRE

Product summary:

Diclofenac sodium delayed-release tablets, USP, for oral administration, are available as: 25 mg : round, Light brown, enteric-coated tablets imprinted P 25 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 imprinted 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 imprinted P 75 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

H.J. Harkins Company, 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 medicines

Summary of Product characteristics

DICLOFENAC SODIUM - DICLOFENAC SODIUM TABLET, DELAYED RELEASE
H.J. HARKINS COMPANY, INC.
----------
DICLOFENAC SODIUM DELAYED-RELEASE TABLETS USP, 25 MG, 50 MG AND 75 MG
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
perioperative 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 delayed-release tablets are a benzene-acetic acid
derivative. Diclofenac sodium
delayed-release tablets are available as delayed-release tablets of 75
mg for oral administration. The
chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid,
monosodium salt. The molecular
weight is 318.14. Its molecular formula is C
H Cl
NNaO , and it has the following structural
formula
The inactive ingredients in Diclofenac sodium delayed-release tablets
include: lactose (monohydrate),
microcrystalline cellulose, croscarmellose sodium, povidone, talc,
magnesium stearate, methacrylic
acid copolymer, polyethylene glycol, opadry brown (Titanium dioxide,
hypromellose, polyethylene
glycol, iron oxide red, iron oxide yellow) and purified water.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
14
10
2
2
Diclofenac sodium delayed-release tablets, are a nonsteroidal
anti-inflammatory drug (NSAID) that
exhibits anti-inflammatory, analgesic, and antipyreti