COMPOSITION :
Benoxicam®Caplet 20 mg, each caplet contains : Piroxicam 20 mg.
DESCRIPTIONS :
Benoxicam® with Piroxicam as active ingredient is available in caplet 20 mg.
INDICATIONS :
Symptomatic therapy on rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute musculoskeletal disorder and gout acute.
DOSAGE AND ADMINISTRATIONS :
Benoxicam® dose for adult :
- Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis :
The initial dose is 20 mg given as a single dose. The maintenance dose is 20 mg a day or if necessary can be given 10 mg – 30 mg in a single dose or divided. A dose more than 20 mg a day can improves gastrointestinal side effects.
- Acute Gout :
Initially 40 mg a day as a single dose, followed by 4 – 6 the next day, 40 mg daily dose single or divided.
- Acute Musculoskeletal Disorders :
Initial dose is 40 mg a day as a single dose or divided for 2 days, then 20 mg a day for 7 – 14 days.
OVERDOSAGE :
Overcome by supportive and symptomatic actions. Administration of activated charcoal to reduce absorption and reabsorption of Piroxicam so that reducing the number of existing active substances.
CONTRAINDICATIONS :
- Patients that have a history of peptic ulcers or stomach bleeding.
- Hypersensitive to Piroxicam.
- Patient who underwent nasal polyps, bronchospasm and urticaria or angioedema in a given Acetylsalicylic acid or the other non steroidal anti-inflammatory drugs.
- Treatment of peri-operative pain in Coronary Artery Bypass Graft (CABG) surgery.
- Patients with severe liver and kidney failure.
- Patients with severe heart failure.
WARNINGS AND PRECAUTIONS :
CARDIOVASCULAR EFFECTS
- Cardiovascular Thrombotic Events
Clinical trials of severe COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increase 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 similar risk. Patients with known CV disease or risk factor for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with 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 sign and/or symptoms of serious CV events and the steps to take if they occur.
There is no consistent evidence that concurrent use of Acetylsalicylic acid mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of Acetylsalicylic acid and an NSAID does increase the risk of serious GI events (see GI WARNINGS, gastrointestinal (GI) effect – risk of GI ulceration, bleeding and perforation).
Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain the first 10 – 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke (see CONTRAINDICATIONS).
- Hypertension
NSAIDs, including Piroxicam can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Patients taking Thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including Piroxicam, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment with Piroxicam and throughout the course of therapy.
- Congestive Heart Failure And Edema
Fluid retention and edema have been observed in some patients taking NSAIDs, including Piroxicam. Piroxicam should be used with caution in patients with fluid retention or hearts failure.
GASTROINTESTINAL (GI) EFFECTS
- Risk of GI Ulceration, Bleeding And Perforation
NSAIDs, including Piroxicam, can cause serious gastrointestinal events, including inflammation, bleeding, ulceration and perforation of the stomach, small intestine or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop serious upper GI adverse events of NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3 – 6 months and in about 2 – 4% of patients treated for one year. These trends with longer duration of use, increasing the like hood of developing a serious GI event at some time, during the course of therapy. However, even short-term therapy is not without risk.
NSAIDs should prescribe with extreme caution in patients with prior history of ulcer disease or gastrointestinal bleeding. Patients with prior history of ulcer disease and/or gastrointestinal bleeding and who use NSAIDs, have a greater than 10-fold higher risk for developing a GI bleed compared to patients with neither of these risk factor. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age and poor general health status. Most spontaneous reports of fatal GI events are in the elderly or debilitated patients, and therefore, special care should be taken in treating this population.
To minimize the potential risk for an adverse GI event, in patients treated with NSAIDs, the lowest effective dose should be used for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of the NSAID until a serious GI adverse event is ruled out. For high-risk patients, alternate therapies that do not involve NSAIDs should be considered.
OTHERS
- Piroxicam inhibits the biosynthesis of prostaglandin, so that can impact to the formation of platelets and patients using Piroxicam should be monitored, especially if the patient has the nature of predisposing against abnormality blood clotting.
- Can caused damage liver, increase SGPT/SGOT until jaundice.
- Careful administration in patients with indigestion, heart failure, hypertension and the state of predisposing retention water, kidneys and liver.
- Not recommended administrating on pregnant woman and lactation.
- The safety use at children does not know with certainty.
- In patients who have a vision problem for using Piroxicam, advisable to check the eyes.
DRUG INTERACTIONS :
- Concomitant administration of Piroxicam with oral anticoagulants Sulphonylurea or Hydantoin should be carefully monitored, since Piroxicam binds to plasma protein and replaces the site of albumin binding with other drugs.
- Acetylsalicylic acid and Piroxicam should not be administered together.
- Concomitant administration with Lithium will increase blood levels of Lithium.
ADVERSE REACTIONS :
- Commonly gastrointestinal disorders such as stomatitis, anorexia, epigastric distress, nausea, constipation, abdominal discomfort, bloating, diarrhea, abdominal pain.
- Have been reported occur : Gastric haemorrhage, perforations and peptic ulcers.
- Other side effects : Oedema, dizziness, headache, skin rash, pruritus, somnolence, decrease in hemoglobin and hematocrit.
PRESENTATION:
Benoxicam® Caplet 20 mg Box, 10 strips @ 10 caplets Reg. No. DKL9002315204A1
STORAGE :
STORE BELOW 30°C
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
