TENOXICAM

2 Recommended Dose and Dosage Adjustment  A single daily dose of 20 mg TENOXICAM should be taken orally at the same time each day. Higher doses should be avoided as they do not usually achieve a significantly greater therapeutic effect, but may be associated with a higher risk of adverse events.

 In some patients, a 10 mg (1/2 tablet) daily dose may be sufficient. The smallest effective dose should be prescribed.  Use in Elderly: As with other NSAIDs, TENOXICAM should be used with special caution in elderly patients since they may be less able to tolerate side effects than younger patients.

They are also more likely to be receiving concomitant medication or to have impaired hepatic, renal or cardiovascular function. 5 Missed Dose If you miss a dose, take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take your medicine and skip the missed dose.

Do not take two doses at the same time.

1 Adverse Reaction Overview The most common adverse reactions encountered with nonsteroidal anti-inflammatory drugs are gastrointestinal, of which peptic ulcer, with or without bleeding, is the most severe. Fatalities have occurred on occasion, particularly in the elderly.

2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.

Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. 6%. 3%). 1% of the patients. 4%). 1% or less of the patients. One case of angioedema was also reported.

2%). 1% of the patients. 2%). 1% of the patients. 4%). 1% or less of the patients. 1%). 1% of the patients. Isolated cases of abnormal renal function and one case of renal failure were reported. 3%). 1% of the patients. Hepatitis, hepatic coma and hepatic failure were each reported once.

1%). 3%). 1% or less of the patients.

Skin Serious skin reactions:

Use of some NSAIDs, such as TENOXICAM, have been associated with rare post-market cases of serious, fatal or otherwise life-threatening skin reactions, including: • drug reaction with eosinophilia and systemic symptoms (DRESS) • Stevens-Johnson syndrome • toxic epidermal necrolysis (or Lyell’s Syndrome), • exfoliative dermatitis • erythema multiforme

Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. General Caution should be exercised when a NSAID such as tenoxicam is used in patients with a history suggestive of peptic ulcer, melena or any gastrointestinal disease. In these cases, the physician must weigh the benefits of treatment against the possible hazards.

Infection In common with other anti-inflammatory drugs, TENOXICAM may mask the usual signs of infection. Gastrointestinal If peptic ulceration or gastrointestinal bleeding occur in patients under treatment with TENOXICAM (tenoxicam), the drug should be immediately withdrawn.

There is no definitive evidence that the concomitant administration of histamine H2-receptor antagonists and/or antacids will either prevent the occurrence of gastrointestinal side effects or a llow continuation of TENOXICAM therapy when and if these adverse reactions appear.

Hematologic Drugs inhibiting prostaglandin biosynthesis do interfere with platelet function to some degree; therefore, patients who may be adversely affected by such an action should be carefully observed when TENOXICAM is administered.

Blood dyscrasias associated with the use of nonsteroidal anti-inflammatory drugs are rare, but could be with severe consequences. Hepatic/Biliary/Pancreatic As with other nonsteroidal anti-inflammatory drugs, borderline elevations of one or more liver tests may occur.

These abnormalities may progress, may remain essentially unchanged, or may be transient with continued therapy. A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver test has occurred, should be evaluated for evidence of the development of more Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Tablet 20 mg Colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, titanium dioxide, yellow ferric oxide and carnauba wax.

 TENOXICAM is contraindicated during the third trimester of pregnancy, because of risks of premature closure of the ductus arteriosus, and prolonged parturition.  TENOXICAM should not be administered to patients with active peptic ulcer or active inflammatory diseases of the gastrointestinal tract.

TENOXICAM is contraindicated in patients who have shown hypersensitivity to the drug.  Tenoxicam should not be used in patients in whom acute asthmatic attacks, urticaria, rhinitis or other allergic manifestations are precipitated by acetylsalicylic acid (ASA) or other nonsteroidal anti-inflammatory agents.

Fatal anaphylactoid reactions have occurred in such individuals.  Before anesthesia or surgery, TENOXICAM should not be given to elderly patients, to patients at risk of renal failure, or to patients with increased risk of bleeding, because of an increased risk of acute renal failure and possibility of impaired hemostasis.