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Basic Drug Info
Drug Name:Diclofenac Sodium
Manufacturer:UNIQUE PHARMACEUTICAL LABORATORIES
Other Info:

Serious side effects include:heart attack stroke high blood pressure heart failure from body swelling (fluid retention) kidney problems including kidney failure bleeding and ulcers in the stomach and intestine low red blood cells (anemia) life-threatening skin reactions life-threatening allergic reactions liver problems including liver failure asthma attacks in people who have asthma Other side effects include:stomach pain constipation diarrhea gas heartburn nausea vomiting dizziness Get emergency help right away if you have any of the following symptoms:shortness of breath or trouble breathingchest painweakness in one part or side of your bodyslurred speechswelling of the face or throatStop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:nauseamore tired or weaker than usualitchingyour skin or eyes look yellowstomach painflu-like symptomsvomit bloodthere is blood in your bowel movement or it is black and sticky like tarunusual weight gainskin rash or blisters with feverswelling of the arms and legs, hands and feetThese are not all the side effects with NSAID medicines.

Talk to your healthcare provider or pharmacist for more information about NSAID medicines.Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)Aspirin is an NSAID medicine but it does not increase the chance of a heart attack.

Aspirin can cause bleeding in the brain, stomach, and intestines.

Aspirin can also cause ulcers in the stomach and intestines.Some of these NSAID medicines are sold in lower doses without a prescription (over-the-counter).

Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.NSAID medicines that need a prescription Generic Name Tradename Celecoxib Celebrex Diclofenac Cataflam, Voltaren, Arthrotec (combined with misoprostol) Diflunisal Dolobid Etodolac Lodine, Lodine XL Fenoprofen Nalfon, Nalfon 200 Flurbirofen Ansaid Ibuprofen             Motrin, Tab-Profen, Vicoprofen (combined with hydrocodone), Combunox (combined with oxycodone) Indomethacin Indocin, Indocin SR, Indo-Lemmon, Indomethagan Ketoprofen Oruvail Ketorolac Toradol Mefenamic Acid Ponstel Meloxicam Mobic Nabumetone Relafen Naproxen Naprosyn, Anaprox, Anaprox DS, EC-Naproxyn, Naprelan, Naprapac (copackaged with lansoprazole) Oxaprozin Daypro Piroxicam Feldene Sulindac Clinoril Tolmetin Tolectin, Tolectin DS, Tolectin 600 This medication guide has been approved by U.S.

Food and Drug Administration



Clinical Trials:


Indications and Usage

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 osteoarthritisFor relief of signs and symptoms of rheumatoid arthritisFor acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis
Physical findings -- Objective evidence of disease perceptible to the examining physician.

Symptoms -- An indication that a person has a condition or disease. Some examples of symptoms are headache, fever, fatigue, nausea, vomiting, and pain.

Ankylosing spondylitis -- A chronic inflammatory condition affecting the axial joints, such as the SACROILIAC JOINT and other intervertebral or costovertebral joints. It occurs predominantly in young males and is characterized by pain and stiffness of joints (ANKYLOSIS) with inflammation at tendon insertions.

Contraindications

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 PRECAUTIONS, Preexisting Asthma).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).
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Asthma -- A form of bronchial disorder with three distinct components: airway hyper-responsiveness (RESPIRATORY HYPERSENSITIVITY), airway INFLAMMATION, and intermittent AIRWAY OBSTRUCTION. It is characterized by spasmodic contraction of airway smooth muscle, WHEEZING, and dyspnea (DYSPNEA, PAROXYSMAL).

Urticaria -- A vascular reaction of the skin characterized by erythema and wheal formation due to localized increase of vascular permeability. The causative mechanism may be allergy, infection, or stress.

Allergic Reaction --

ANAPHYLACTOID REACTION --

Pain -- An unpleasant sensation induced by noxious stimuli which are detected by NERVE ENDINGS of NOCICEPTIVE NEURONS.

Warnings

Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal.

All NSAIDs, both COX-2 selective and nonselective, may have a similar risk.

Patients with known CV disease or risk factors for CV disease may be at greater risk.

To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible.Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms.

Patients should be informed about the signs and/or symptoms of serious CV events and the steps to take if they occur.There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use.

The concurrent use of aspirin and an NSAID does increase the risk of serious GI events (see GI WARNINGS).Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke (see CONTRAINDICATIONS).
Branded Drugs
The following US Branded drugs contain Diclofenac Sodium


SOLARAZE -- NYCOMED US INC

VOLTAREN -- NOVARTIS CONSUMER HEALTH INC

VOLTAREN -- NOVARTIS PHARMACEUTICALS CORP

VOLTAREN-XR -- NOVARTIS PHARMACEUTICALS CORP

ARTHROTEC -- GD SEARLE LLC


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