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:

Aphena Pharma Solutions - Tennessee, Inc.

INN (International Name):

Diclofenac Sodium

Composition:

Diclofenac Sodium 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks of diclofenac 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 is 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 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 PRECAUTIONS, Preexisting Asthma ). Diclofenac are contraindicated for the treatment of peri-operati

Product summary:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Diclofenac sodium delayed-release tablets 50 mg - white to off-white, biconvex, round-shaped, unscored (imprinted "CTI 102" on one side), supplied in bottles of 180   NDC 42291-230-18 1000 NDC 42291-230-10 75 mg - white to off-white, biconvex, round shaped, unscored (imprinted "CTI 103" on one side), supplied in bottles of 180   NDC 42291-231-18 1000 NDC 42291-231-10 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. Manufactured by: Carlsbad Technology, Inc. Carlsbad, CA 92008 USA   Distributed by: AvKARE Inc. Pulaski, TN 38478 Revised: February 2010 CTI-11 Rev. C AK02-11 Printed in USA

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Aphena Pharma Solutions - Tennessee, 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 use 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 of 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.

Summary of Product characteristics

DICLOFENAC SODIUM - DICLOFENAC SODIUM TABLET, DELAYED RELEASE
APHENA PHARMA SOLUTIONS - TENNESSEE, INC.
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DICLOFENAC SODIUM DELAYED-RELEASE TABLETS, USP 50 MG
OT230
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, as the sodium salt, is a benzene-acetic acid derivative..
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
Each enteric-coated tablet for oral administration contains 50 mg or
75 mg of diclofenac sodium. In
addition, each tablet contains the following inactive ingredients;
black iron oxide, hypromellose, lactose
monohydrate, magnesium stearate, methacrylic acid copolymer,
microcrystalline cellulose,
pharmaceutical glaze, polyethylene glycol, povidone, sodium starch
glycolate, talc, titanium dioxide,
triethyl citrate.
CLINICAL PHARMACOLOGY
14
10
2
2
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 diclofen