| Customization: | Available |
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| Application: | Internal Medicine |
| Usage Mode: | For oral administration |
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USP 20mg Piroxicam Capsules with Western Medicine GMP
Indications
Piroxicam is indicated for symptomatic relief of osteoarthritis, rheumatoid arthritis or ankylosing spondylitis.
Dosage and Administration
Usage: Oral.
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.
Precautions & Warning:
1.Gastrointestinal (GI) Effects, risk of GI ulceration, bleeding and perforation: NSAIDs can cause serious gastrointestinal events .
2.Serious GI complications: The administration to patients older than 80 years old should be avoided.
3.Poor Metabolisers of CYP2C9 Substrates
4.Skin reactions:Life-threatening cutaneous reactions (Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)) have been reported with the use of piroxicam.
5.Cardiovascular, Renal and Hepatic Impairment.
6.Eye disorders
7.Respiratory disorders; Impaired female fertility; Piroxicam Capsules contain lactose
8.Cardiovascular and cerebrovascular effects
Contraindications:
1.History of gastro-intestinal ulceration, bleeding or perforation.
2.Patient history of gastrointestinal disorders that predispose to bleeding disorders such as ulcerative colitis, Crohn's disease, gastrointestinal cancers or diverticulitis.
3.Patients with active peptic ulcer, inflammatory gastrointestinal disorder or gastrointestinal bleeding.
4.Concomitant use with other NSAIDs, including COX-2 selective NSAIDs and acetylsalicylic acid at analgesic doses.
5.Concomitant use with anticoagulants
6.History of previous serious allergic drug reaction of any type, especially cutaneous reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
7.Hypersensitivity to the active substance or any of the excipients, previous skin reaction (regardless of severity) to piroxicam, other NSAIDs and other medications.
8.NSAIDs are contraindicated in patients who have previously shown hypersensitivity reactions in response to ibuprofen, aspirin or other non-steroidal anti- inflammatory drugs.
9.During the last trimester of pregnancy
10.Patients with severe heart failure.
Adverse Reactions:
1.Blood and lymphatic system disorders:Anaemia; Eosinophilia; Leucopenia; Thrombocytopenia
2.Metabolism and nutrition disorders:Anorexia; Hyperglycaemia
3.Nervous system disorders:Dizziness; Headache; Somnolence; Vertigo
4.Ear and labyrinth disorders:Tinnitus
5.Gastrointestinal disorders:Abdominal discomfort; Abdominal pain; Constipation; Diarrhoea; Epigastric distress; Flatulence; Nausea; Vomiting; Indigestion
6.Skin and subcutaneous tissue disorders:Pruritis; Skin rash
7.General disorders and administration site conditions:Oedema (mainly of the ankle)
Storage instructions:
Do not store above 30° C
Drug Interactions:
Piroxicam may increase the blood levels of lithium (Eskalith, Lithobid) by reducing the excretion of lithium by the kidneys. Increased levels of lithium may lead to lithium toxicity.
Piroxicam may reduce the blood pressure lowering effects of blood pressure medications. This may occur because prostaglandins play a role in the regulation (reduction) of blood pressure.
Combining NSAIDs such as piroxicam with angiotensin receptor blockers (for example, valsartan [Diovan], losartan [Cozaar], irbesartan [Avapro]) or angiotensin converting enzyme ACE) inhibitors (for example, enalapril [Vasotec], captopril [Capoten]) in patients who are elderly, volume-depleted (including those on diuretic therapy), or with poor kidney function may result in reduced kidney function, including kidney failure. These effects usually are reversible.
When piroxicam is used in combination with (Rheumatrex, Trexall) or aminoglycoside antibiotics (for example, gentamicin) the blood levels of methotrexate or aminoglycoside may increase, presumably because the elimination of or aminoglycosides from the body is reduced. This may lead to more - or aminoglycoside- related side effects.
Individuals taking oral blood thinners or anticoagulants, for example, warfarin, (Coumadin), should avoid piroxicam because piroxicam also thins the blood, and excessive blood thinning may lead to bleeding.
Alcohol consumption may increase the risk of developing stomach ulcers when taking piroxicam or other NSAIDs.
Storage:
Piroxicam should be stored at room temperature in a sealed container that excludes moisture.
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