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Western Medicine Piroxicam Usp 20mg Pharmaceutical Capsules ( Non Steroidal Antiinflammatory Agent With Analgesic )

Wuhan uni-pharma bio-tech co.,ltd
Wuhan uni-pharma bio-tech co.,ltd
Province/State: Hubei
Country/Region: China
Tel: 86-27-82316816

Western Medicine Piroxicam Usp 20mg Pharmaceutical Capsules ( Non Steroidal Antiinflammatory Agent With Analgesic )

Brand Name : Uni-pharma
Model Number : 20mg
Certification : GMP
Place of Origin : China
Payment Terms : L/C, D/A, D/P, T/T
MOQ : 5000000Caps
Price : USD0.48/Box
Delivery Time : After packaging confirmed 30 days
Packaging Details : 10’s/blister×10blisters/ box ×200boxes/carton
Applications : Internal Medicine
Usage method : For oral administration
Applicable people : Adults/Children
Form : Solid
Shape : Capsule
Type : Organic chemicals
Pharmaceutical methods : Chemical Synthesis
Specification : 20mg
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Western Medicine Piroxicam Usp 20mg Pharmaceutical Capsules ( Non Steroidal Antiinflammatory Agent With Analgesic )

Formula: Each Capsule contains: Piroxicam U.S.P. 20mg

Picap is an effective anti-inflammatory drug.

Picap is completely absorbed after oral administration. It undergoes entherohepatic cyclling and is bound to plasma porteins.

[Therapeutic indications]

Piroxicam is a non-steroidal anti-inflammatory agent with analgesic and antipyretic activity.
Piroxicam is indicated for the symptomatic relief of rheumatoid arthritis, osteoarthritis or ankylosing spondylitis.

Onset of action :Analgesic action 1 hour,anti-rheumatic action 7-12 hours.

Duration of action :48-72 hours

Adverse Effects :Nausea,heartbum,vomiting,epigastic distress,tinnitus,skin rashes,odema

Contra-indications :History of recurrent ulcer,NSAID induced allergy. hypersensitivity,bronchial asthma.

Special Precaution :Sever impairment of hepatic or renal function,hypertension,surgery,hemorrhagic disorders,Prolonged use,Pregnancy and Post-Pregnancy

[Posology and method of administration]


The prescription of piroxicam should be initiated by physicians with experience in the diagnostic evaluation and treatment of patients with inflammatory or degenerative rheumatic diseases.

The maximum recommended daily dose is 20mg.

Undesirable effects may be minimised by using the minimum effective dose for the shortest duration necessary to control symptoms. The benefit and tolerability of treatment should be reviewed within 14 days. If continued treatment is considered necessary, this should be accompanied by frequent review.

Given that piroxicam has been shown to be associated with an increased risk of gastrointestinal complications, the possible need for combination therapy with gastroprotective agents (e.g. misoprostol or proton pump inhibitors) should be carefully considered, in particular for elderly patients.

Adults:Initially 20mg given as a single daily dose. The majority of patients may be maintained on 20mg a day, a relatively small group of patients may be maintained on 10mg daily.
Children:Not recommended for children under 12 years of age.
Elderly:There are no specific modifications required in the elderly, except where hepatic, renal or cardiac function is impaired, in which case dosage should be individually assessed.

The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.

[Method of Administration]

For oral administration. To be taken preferably with or after food.


• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, previous skin reaction (regardless of severity) to piroxicam, other NSAIDs and other medications.

• History of previous serious allergic drug reaction of any type, especially cutaneous reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

• Patients with active peptic ulcer, inflammatory gastrointestinal disorder or gastrointestinal bleeding.

• History of gastro-intestinal ulceration, bleeding or perforation.

• Patient history of gastrointestinal disorders that predispose to bleeding disorders such as ulcerative colitis, Crohn's disease, gastrointestinal cancers or diverticulitis.

• Concomitant use with other NSAIDs, including COX-2 selective NSAIDs and aspirin at analgesic doses.

• Concomitant use with anticoagulants.

• Piroxicam should not therefore be administered to patients in whom aspirin and other NSAIDs induce the symptoms of angioneurotic oedema, asthma, rhinitis, nasal polyps or urticaria.

• Patients with severe heart failure.

[Special warnings and precautions for use]

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2, and GI cardiovascular risks below). The clinical benefit and tolerability should be re-evaluated periodically and treatment should be immediately discontinued at the first appearance of cutaneous reactions or relevant gastrointestinal events.

Cardiovascular and cerebrovascular effects

Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.

Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). There are insufficient data to exclude such a risk for piroxicam.

Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with piroxicam after careful consideration. Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking).

Cardiovascular, Renal and Hepatic Impairment

The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly. Renal function should be monitored in these patients

In rare cases, NSAIDs may cause interstitial nephritis, glomerulonephritis, papillary necrosis and the nephrotic syndrome. Due to the renal excretion of piroxicam, patients with severely impaired renal function should be closely monitored.

ElderlyThe elderly have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation which may be fatal
Respiratory disorders

Caution is required if administered to patients suffering from or with a previous history of bronchial asthma since NSAIDs have been reported to precipitate bronchospasm in such patients.

Due to reports of adverse eye findings with NSAIDs, it is recommended that patients who develop visual complaints during treatment with piroxicam have ophthalmic evaluation.

Gastrointestinal bleeding, ulceration and perforation

NSAIDs, including piroxicam, can cause serious gastrointestinal events including 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.

NSAID exposures of both short and long duration have an increased risk of serious GI event. Evidence from observational studies suggests that piroxicam may be associated with a high risk of serious gastrointestinal toxicity, relative to other NSAIDs.

Patients with significant risk factors for serious GI events should be treated with piroxicam only after careful consideration

The possible need for combination therapy with gastro-protective agents (e.g. misoprostol or proton pump inhibitors) should be carefully considered and also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk

Serious GI Complications

Identification of at-risk subjects: The risk for developing serious GI complications increases with age. Age over 70 years is associated with high risk of complications. The administration to patients older than 80 years should be avoided.

The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, and in the elderly. These patients should commence treatment on the lowest dose available.

When GI bleeding or ulceration occurs in patients receiving piroxicam the treatment should be withdrawn.

NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated.

Patients taking concomitant oral corticosteroids, selective serotonin reuptake inhibitors (SSRls) or anti-platelet agents such as low-dose aspirin are at increased risk of serious GI complications . As with other NSAIDs, the use of piroxicam in combination with protective agents (e.g. misoprostil and proton pump inhibitors) must be considered for these at-risk patients.

Patients and physicians should remain alerted for signs and symptoms of GI ulceration and/or bleeding during piroxicam treatment. Patients should be asked to report any new or unusual abdominal symptom during treatment. If a gastrointestinal complication is suspected during treatment, piroxicam should be discontinued immediately and additional clinical evaluation and treatment should be considered.

SLE and mixed connective tissue diseaseIn patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Evidence from observational studies suggests that piroxicam may be associated with a higher risk of serious skin reactions than other NSAIDs.

Life-threatening cutaneous reactions Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with the use of piroxicam. Patients should be advised of the signs and symptoms and monitored closely for skin reactions. The highest risk for occurrence of SJS or TEN is within the first weeks of treatment. If symptoms or signs of SJS or TEN (e.g. progressive skin rash often with blisters or mucosal lesions) are present, piroxicam treatment should be discontinued. The best results in managing SJS and TEN come from early diagnosis and immediate discontinuation of any suspect drug. Early withdrawal is associated with a better prognosis. If the patient has developed SJS or TEN with the use of piroxicam, piroxicam must not be re-started in this patient at any time.

Patients appear to be at a highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Piroxicam should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Impaired female fertiltyThe use of piroxicam may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Piroxicam should be considered.
HeadacheWhere analgesics are used long-term (>3 months) with administration every two days or more frequently, headache may develop or worsen. Headache induced by overuse of analgesics (MOH medication-overuse headache) should not be treated by dose increase. In such cases, the use of analgesics should be discontinued in consultation with the doctor.
LactosePiroxicam contain lactose. Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.


Anticoagulants :May prolong prothrombin time.

B-Blockers :Anti-hypertensive effect may be increased.

Cyclosporines :Nephrotoxicity of both agents may be increased.

Lithium :Serum Lithium levels increased resulting in increased Pharmacologic and toxic effects.

Methotrexate :Risk of methotrexate toxicity (stomatitis,bone marrow Suppresion,nephrotoxicity) increased.

Probenecid :May increase the contentrations & toxicity

Aspirin :Displace Picap from serumbinding sites resulting in increased incifence of G.I.Effects

Indications :Rheumatioid arthritis,Osteoarthritis,Ankylosing spondylitis, Acute musculoskeletal disorders,Acute gout,Post-operative & post-traumatic pain.Primary dysmenorrhoea.

Dosage Adults :20mg daily as a single dose. Musculo-skeketal disorders: Initially 40mg daily for 2 days then 20mg daily for 7-14 days. Gout. Intially 40mg as s Single Dose then 40mg daily in a single or divided doses for next 4-6 days.Post-operative & post-traumatic pain:40mg daily as a single or divided doses for first two days.

Children :Not recommended.

Presentation :Blister pack of 10 capusles.

[Shelf life]
Three years

Store below 25°C in a dry place.

Protect from light.

Product Tags:

organic gelatin capsules


medical capsules

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