DICLOFENAC SODIUM D/R tablet, delayed release

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Direct RX

INN (mednarodno ime):

DICLOFENAC SODIUM

Sestava:

DICLOFENAC SODIUM 50 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

INDICATIONS AND USAGE Carefully consider the potential bene ts and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Diclofenac is indicated: - For relief of the signs and symptoms of osteoarthritis - For relief of the 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 is 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 is contraindicated for the tr

Povzetek izdelek:

Diclofenac sodium delayed-release tablets 50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted on one side), supplied in bottles of 60, 100 and 1000. 75 mg -– white to off-white, biconvex, round shaped, unscored (imprinted on one side), supplied in bottles of 60, 100, 500 and 1000. 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 as defined in the USP. Manufactured and Distributed by: Carlsbad Technology, Inc. Carlsbad, CA 92008 USA Revised: February 2010 CTI-11 Rev. C Printed in USA 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: 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: The chance of a person getting an ulcer or bleeding increases with: 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: Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine: Tell your healthcare provider: What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? Get emergency help right away if you have any of the following symptoms: Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms: These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) NSAID medicines that need a prescription * Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke. This Medication Guide has been approved by the U.S. Food and Drug Administration.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

DICLOFENAC SODIUM D/R- DICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE
DIRECT RX
----------
DICLOFENAC SODIUM D/R
BOXED WARNING
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 is 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 14H 10Cl 2NNaO 2, and it
has the following
structural formula:
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;
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
PHARMACODYNAMICS
Diclofenac sodium delayed-release tablets is a nonsteroidal
anti-inflammatory drug
(NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic
activities in animal
models. The mechanism of action of diclofenac, like that of other
NSAIDs, is not
completely understood but may be related to