Derm Piroxicam Capsule

DERM’S PIROXICAM
Piroxicam capsule 20mg

 

COMPOSITION

Each capsule contains: Piroxicam 20 mg

 

CLINICAL PHARMACOLOGY

Piroxicam has analgesic, anti-inflammatory and antipyretic properties. Piroxicam acts as an inhibitor of prostaglandin biosynthesis. Piroxicam is completely absorbed after oral administration, peak concentrations in plasma occur within two to four hours. Neither food nor antacids alter the rate or extent of absorption. After absorption, piroxicam is extensively (99%) bound to plasma proteins, and has a long plasma half-life of approximately forty eight hours. At steady state (e.g. after seven to ten days) concentrations of piroxicam in plasma and synovial fluid are approximately equal. Piroxicam is metabolised in the liver by hydroxylation of the pyridyl ring of the piroxicam side chain followed by conjugation with glucuronic acid and urinary elimination. Less than 5% of the medicine is excreted in the urine unchanged.

 

INDICATION AND USAGE

DERM’S PIROXICAM is indicated for a variety of conditions requiring anti-inflammatory and/or analgesic activity, such as rheumatoid arthritis, osteo-arthritis (arthrosis, degenerative joint disease), ankylosing spondylitis, acute musculoskeletal disorders and acute gout.

 

CONTRA-INDICATIONS

DERM’S PIROXICAM should not be used in those patients who have previously shown a sensitivity to piroxicam. The potential exists for cross sensitivity to aspirin and other non-steroidal anti inflammatory agents. Do not administer to patients sensitive to aspirin or other non-steroidal anti-inflammatory agents; patients who have hepatic dysfunction; patients with a history of gastrointestinal haemorrhage or ulcers.

 

INTERACTIONS

DERM’S PIROXICAM should not be used in patients on coumarin-type anticoagulants.

DERM’S PIROXICAM increases plasma lithium levels.

 

WARNINGS

Care should be exercised in patients with impairment of renal function. Used with caution in patients with cardiovascular disorders where oedema may worsen the condition. DERM’S PIROXICAM decreases platelet aggregation and prolongs bleeding time. Serious, skin reactions, which can be fatal, may occur. Caution is advised when DERM’S PIROXICAM is prescribed to patients with cardiovascular risk factors e.g. hypertension, diabetes, smoking and hypercholesterolaemia. Because of its lack of platelet effects, DERM’S PIROXICAM is not a substitute for aspirin for cardiovascular prophylaxis.

DERM’S PIROXICAM is not recommended for use in children.

Usage in Pregnancy and nursing mothers: The safety of DERM’S PIROXICAM use during pregnancy or during lactation has not yet been established. Regular use of NSAIDs during the third trimester of pregnancy may result in premature closure of the foetal ductus arteriosus in utero and possibly in persistent pulmonary hypertension of the newborn. The onset of labour may be delayed and its duration increased.

 

PRECAUTIONS

Due to inhibition of prostaglandin synthesis, fluid retention and oedema have been observed in patients taking DERM’S PIROXICAM, therefore it should be used with caution in patients with compromised cardiac function and other conditions predisposing to, or worsened by, fluid retention. Patients with pre-existing congestive heart failure or hypertension should be closely monitored.

 

ADVERSE REACTION

Gastrointestinal symptoms are the most commonly encountered side-effects. Long-term administration of doses higher than 30 mg daily carries an increased risk of gastrointestinal side effects. Peptic ulceration and gastrointestinal bleeding have been reported with DERM’S PIROXICAM, Other than the gastrointestinal symptoms, cardiac symptoms include peripheral oedema, aggravated hypertension, arrhythmia, hypertension, palpitations, tachycardia, congestive cardiac failure, myocardial infarction and cardiovascular thrombotic events. Neurological events include cerebrovascular events (stroke). Changes in different liver function parameters have been observed. Some patients may develop increased serum transaminase levels during treatment with DERM’S PIROXICAM. Blood-urea-nitrogen elevation has been observed in some patients. These elevations are not progressive over the course of treatment with DERM’S PIROXICAM, a plateau being reached which returns to or towards baseline levels if treatment is stopped. The rise in blood-urea-nitrogen is not associated with elevations in serum creatinine. Dermal sensitivity reactions, usually in the form of skin rash, have been reported. Stevens-Johnson syndrome may develop. Decreases in haemoglobin and haematocrit, independent of gastrointestinal bleeding, have occurred.

Thrombocytopenia and non-thrombocytopenic purpura (Henoch-Schonlein), aplastic anaemia, leucopenia and eosinophilia have been reported and constitute indications for immediate withdrawal of DERM’S PIROXICAM. It should be assumed that DERM’S PIROXICAM will precipitate bronchoconstriction in those patients who are hypersensitive to aspirin. Central nervous system effects such as dizziness, headache, somnolence and vertigo have been reported. In view of the product’s inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients.

 

DOSAGE AND ADMINISTRATION

Piroxicam should preferably be taken after meals or with food to reduce gastro-intestinal irritation.

Rheumatoid arthritis, osteo-arthritis (arthrosis, degenerative joint disease), ankylosing spondylltis: The usual daily dose for the relief of signs and symptoms of rheumatoid arthritis or osteroarthritis is 20 mg given in single or divided doses. Since steady state concentrations in plasma are not reached for seven to ten days, maximal therapeutic responses should not be expected for two weeks. Long-term administration of doses higher than 30 mg carries an increased risk of gastrointestinal side-effects.

Acute musculoskeletal disorders: Therapy should be initiated with 40 mg daily for the first two days, given in single or divided doses. For the remainder of the seven to fourteen day treatment period, the dose should be reduced to 20 mg daily.

Acute Gout: Therapy should be initiated by a single oral dose of 40 mg followed on the next four to six days by 40 mg given in a single or divided daily dosage. DERM’S PIROXICAM is not indicated for the long-term management of gout.

 

SYMPTOMS OF OVERDOSAGE AND ANTIDOTE

See Adverse reaction. In the event of overdosage with DERM’S PIROXICAM, supportive and symptomatic therapy is indicated.

 

IDENTIFICATION

Opaque hard gelatin self-locked capsules containing a white powder.

 

PRESENTATION

Carton containing 10 x 10 capsules in blister strips.

 

STORAGE INSTRUCTIONS

Store below 30oC. Protect from light. Keep Out of reach of children.

 

Manufactured by

Yangzhou NO. 3 Pharmaceutical Co., Ltd.

No. 51, Guotai Road, Jiangdu, Jiangsu, China.

 

Marketed by

Derm Pharmaceuticals Limited,

19 Alhaji Salami Street Aguda Surulere, Lagos, Nigeria.

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