Sefdene 20

Piroxicam.

Each film coated tablet contains: Piroxicam 20 mg.

Antirheumatic action: Piroxicam act via analgesic and anti-inflammatory mechanism. The therapeutic effects are not due to pituitary adrenal stimulation.

Piroxicam is use in the symptomatic relief of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
Piroxicam should be limited to a maximum of 20 mg a day.
Piroxicam should always be used with gastroprotective agent, such as Misoprostol or a proton-pump inhibitor.
Note: It should not be used as first-line treatment.
It should not be used in treatment of ACUTE PAINFUL and INFLAMMATORY conditions.
It should not be used with any other NSAIDs or an anticoagulant.
It should not be used in patients who are more likely to develop side effects, such as those with history of gastrointestinal disorders associated with bleeding, or those who have skin reactions to other medicines.

Usual adult dose: 20 mg once daily after meals.
OR AS PRESCRIBED BY THE PHYSICIAN.
SEFDENE 20 should be used at the lowest effective dose for shortest possible time.

Hypersensitivity to the drug, patients in whom Aspirin and other Non-Steroidal Anti-Inflammatory Drugs induce the symptoms of allergy.
SEFDENE 20 is contraindicated: in patients with severe heart failure and; for the treatment of peri-operative pain in the setting of coronary artery bypass graft surgery.
History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy; active, or history of recurrent peptic ulcer/haemorrhage.
The third trimester of pregnancy, because of risks of premature closure of the ductus arteriosus, and prolonged parturition.

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 a greater risk.
Gastrointestinal Risk: NSAIDs cause an increased risk of serious gastrointestinal adverse events including 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.
Renal Effects: Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been in patients in whom renal prostaglandin have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.
Advanced Renal Disease: No information is available from controlled clinical studies regarding the use of SEFDENE 20 in patients with advanced renal disease. Therefore, treatment with SEFDENE 20 is not recommended in these patients with advanced renal disease. If therapy must be initiated, close monitoring of patient's renal function is advisable.
Others: In rare cases, Piroxicam has been associated with serious liver injury.
Use in Pregnancy: SEFDENE 20 is contraindicated for use during the third trimester of pregnancy because of the risks of premature closure of the ductus arteriosus and the potential to prolong parturition. Caution is recommended in prescribing SEFDENE 20 during the first and second trimesters of pregnancy, particularly from the middle to end of the second trimester of pregnancy (onset at approximately 20 weeks) due to possible fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal impairment or failure.
SEFDENE 20 should not be used during the first two trimesters of pregnancy unless the expected benefits to the mother outweigh the risks to the fetus.
Published studies and postmarketing reports describe maternal Non-Steroidal Anti-Inflammatory Drug (NSAID) use at approximately 20 weeks gestation or later in pregnancy associated with fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment or failure. NSAIDs were shown to cause significant reduction in fetal urine production prior to reduction of amniotic fluid volume. There have also been a limited number of case reports of maternal NSAID use and neonatal renal dysfunction and renal impairment without oligohydramnios, some of which were irreversible, even after treatment discontinuation.
These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation.
Complications of prolonged oligohydramnios may for example, include limb contractures and delayed lung maturation. In some postmarketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required.
If after careful consideration of the benefit-risk, NSAID treatment is considered necessary to be administered anywhere from middle (onset at approximately 20 weeks) to the end of the second trimester of pregnancy, the use should be limited to the lowest effective dose and shortest duration possible. It is also recommended that ultrasound monitoring of amniotic fluid be considered if SEFDENE 20 treatment extends beyond 48 hours and that NSAIDs treatment be discontinued if oligohydramnios occurs, followed by appropriate medical follow up.

Use in Pregnancy: No impairment of fertility was demonstrated in animal reproduction studies, although studies in humans have not been done, use of NSAIDs during the second half of pregnancy and nursing mothers is not recommended.

Gastrointestinal symptoms are the most commonly side effects.
Dermal hypersensitivity side effects, usually in the form of skin rash, pruritus and swollen eyes.

Prolonged concurrent use of Acetaminophen with Piroxicam may increase the risk of adverse renal effects. Concurrent use of Piroxicam with Potassium supplements or alcohol may increase the risk of gastrointestinal side effects, including ulceration or hemorrhage. As NSAIDs may increase the hypoglycemic effect of antidiabetic agents or insulin, caution with concurrent use is recommended. Because Piroxicam reduces or reverses the effects of many antihypertensives, increased monitoring of the response to any antihypertensive agent may be advisable.

Store at temperature not more than 30°C.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M01AC01 - piroxicam ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, oxicams.

P₁S₁S₃