Piroxicam

Registered South African indications:

• Pain - mild to moderate
• Inflammation

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy third trimester
• Previous skin reaction to piroxicam, other non-steroidal anti-inflammatory drugs 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
• Active peptic ulcer
• Inflammatory gastrointestinal disorder 
• Gastrointestinal bleeding
• Gastrointestinal perforation
• History of gastrointestinal disorders that predispose to bleeding disorders such as ulcerative colitis, Crohn's disease, gastrointestinal cancers or diverticulitis
• Patients in whom aspirin and other non-steroidal anti-inflammatory drugs induce the symptoms of asthma, nasal polyps, angioedema or urticarial
• Severe heart failure
• Coadministration with other non-steroidal anti-inflammatory drugs
• Coadministration with anticoagulants

Caution

• Pregnancy first and second trimester
• Breastfeeding
• Severe renal impairment
• Hepatic impairment
• Elderly
• Hypertension
• Congestive heart failure
• Established ischaemic heart disease
• Peripheral arterial disease
• Cerebrovascular disease
• Hyperlipidaemia
• Diabetes mellitus
• Asthma
• Smoking
• Cardiac impairment
• Systemic lupus erythematosus 
• Mixed connective tissue disorders
• Women attempting to conceive
• Galactose intolerance
• Lapp lactase deficiency
• Glucose-galactose malabsorption

Forms avail. in SA and covered in this monograph: tab, dsp, cap

Osteoarthritis 
Rheumatoid arthritis
Ankylosing spondylitis

• Oral (tab, dsp, cap): Initial: 20mg, dly; Maintenance:  10-20mg, dly; Max: 20mg/24hrs 

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Review treatment after 14 days for benefit and tolerability; Prolonged treatment requires frequent review

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Individualise dosage to lowest effective dose for the shortest duration to minimise adverse effects

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Dispersible tablet forms may either be taken whole with fluid or dispersed in a minimum of 50mL water and then swallowed

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May be taken with food to decrease gastrointestinal adverse effect

Not recommended for children below 12 years

Pregnancy

• Caution; first and second trimester
• Contraindicated; positive evidence of risk; third trimester
• Although no teratogenic effects were seen in animal testing, the safety of piroxicam during pregnancy has not yet been established
• Piroxicam inhibits prostaglandin synthesis and release through a reversible inhibition of the cyclo-oxygenase enzyme. This effect, as with other non-steroidal anti-inflammatory drugs, has been associated with an increased incidence of dystocia and delayed parturition in pregnant animals when drug administration was continued in late pregnancy
• In view of the known effects of NSAIDs on the foetal cardiovascular system (risk of closure of the ductus arteriosus), use in the last trimester of pregnancy is contraindicated. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child
• Inhibition of prostaglandin synthesis might adversely affect pregnancy. Data from epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss
• NSAIDs should not be used during the first two trimesters of pregnancy or labour unless the potential benefit to the patient outweighs the potential risk to the foetus

Breastfeeding 

• Caution; not recommended
• Piroxicam safety during breastfeeding has not yet been established. A study indicates that piroxicam appears in the breast milk at about 1% to 3% of the maternal plasma concentrations. No accumulation of piroxicam occurred in milk relative to that in plasma during treatment for up to 52 days. Piroxicam is not recommended for use in breastfeeding mothers as clinical safety has not been established

Fertility

• Based on the mechanism of action, the use of NSAIDs, including piroxicam, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women
• In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of NSAIDs, including piroxicam, should be considered

Renal Impairment

• Mild to moderate: No dose adjustment recommended
• Severe: Caution; no dose adjustment recommended
  Avoid use

Hepatic Impairment 

• Mild (Child-Pugh Class A): No dose adjustment recommended
  Limit daily intake to a maximum of 20mg/24hrs
• Moderate (Child-Pugh Class B): Caution; dose adjustment recommended
  Reduce the recommended daily dose by 50%. Limit maximum daily intake to 10mg/24hrs
• Severe (Child-Pugh Class C): Contraindicated

Elderly 

• Caution; no dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Optic neuritis 
• Dizziness 
• Headache 
• Vertigo 
• Malaise 
• Fatigue tiredness
• Anxiety 
• Convulsions 
• Confusion 
• Depression 
• Hallucinations 
• Disorientation
• Insomnia
• Irritability 
• Memory disturbance 
• Nightmares 
• Paraesthesia 
• Psychotic reactions 
• Tinnitus 
• Tremor
• Aseptic meningitis
• Malaise

Cardiovascular Disorders 

• Oedema
• Hypertension 
• Cardiac failure 
• Increased risk of arterial thrombotic events
• Palpitations

Respiratory Disorders 

• Dyspnoea

Gastrointestinal Disorders 

• Peptic ulcers 
• Perforation or gastrointestinal bleeding 
• Nausea and vomiting 
• Diarrhoea 
• Flatulence 
• Constipation 
• Dyspepsia 
• Abdominal pain 
• Melaena 
• Haematemesis 
• Ulcerative stomatitis 
• Exacerbation of colitis and Crohn's disease  
• Gastritis 
• Pancreatitis 
• Taste alteration disorders.  

Hepatobiliary Disorders 

• Changes in various liver function parameters
• Increased serum transaminase 
• Severe hepatic reactions 
• Including jaundice   
• Fatal hepatitis

Genitourinary Disorders

• Reversible elevations of blood urea nitrogen (BUN) and creatinine
• Nephrotoxicity 
• Including interstitial nephritis 
• Nephritic syndrome 
• Renal failure

Endocrine and Metabolic Disorders 

• Hypoglycaemia
• Increase weight 
• Decrease weight

Skin and Subcutaneous Tissue Disorders 

• Rash 
• Pruritus 
• Onycholysis  
• Alopecia 
• Photosensitivity reactions  
• Severe cutaneous adverse sections (SCARs: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN))

Immune, Blood and Lymphatic System Disorders 

• Non-specific allergic reactions 
• Anaphylaxis 
• Respiratory tract reactivity comprising asthma
• Aggravated asthma 
• Bronchospasm 
• Dyspnoea 
• Pruritus 
• Urticaria 
• Purpura
• Angiodema 
• Exfoliative and bullous dermatoses 
• Vasculitis  
• Serum sickness 
• Decreases in haemoglobin and haematocrit 
• Anaemia 
• Thrombocytopenia and non-thrombocytopenic purpura (Henoch-Schoenlein)
• Neutropenia 
• Agranulocytosis 
• Leucopenia 
• Eosinophilia  
• Aplastic anaemia
• Haemolytic anaemia  
• Epitaxis

Sensory Organs 

• Disturbance of vision
• Impaired hearing

Others

• Anecdotal cases of positive antinuclear antibosy test (ANA)

• Anticoagulants
• Antiplatelet agents
• Selective serotonin reuptake inhibitors
• Aspirin 
• Non-steroidal anti-inflammatory drugs
• Cardiac glycosides
• Ciclosporin
• Tacrolimus
• Cimetidine  
• Corticosteroids
• Diuretics
• Highly protein-bound agents
• Lithium
• Antihypertensives
• Methotrexate
• Quinolone antibiotics
• Mifepristone
• Zidovudine
• Pentoxifyline
• Penicillamine

None routine. Specific cases may require

• Renal function
• Hepatic function

None routine. Specific cases may require

• Renal function
• Hepatic function

Inhibits prostaglandin synthesis and release through a reversible inhibition of the cyclooxygenase enzyme.

Capsule 10mg

• Adco Piroxicam (Adcock)

Capsule 20mg

• Adco Piroxicam (Adcock)
• Cpl Alliance Piroxicam (Alliance)
• Pyrocaps (Be-Tabs)
• Roxifen (Gulf Drug)
• Xycam (Pharmacare)

Tablet 20mg  

• Brexecam (Adcock) originator
• Xycam (Pharmacare)

Tablet dispersible 20mg

• Piroxicam Actor Dt (Cipla)
• Pixicam 20 (Kiara Health)
• Rheugesic (Cipla)
• Sandoz Piroxicam (Sandoz)

Also available in the following forms: Gel