BRANDS / TRADE NAMES OF PIROXICAM AVAILABLE IN KENYA
Caroxicam, Careplus Ltd
Pirocam, Laboratory & Allied Ltd
Piromed, CPSC OUYI Pharma Co. Ltd
Piroxicam, Crown Healthcare
Piroxy, National Pharmacy Ltd
Roxicam, Biodeal Laboratories Ltd.
PIROXICAM MODE OF ACTION
While its mode of action is not fully understood, independent studies in vitro as well as in vivo have shown that piroxicam interacts at several steps in the immune and inflammation responses through:
- Inhibition of prostanoid synthesis, including prostaglandins, through a reversible inhibition of the cyclo-oxygenase enzyme.
- Inhibition of neutrophil aggregation.
- Inhibition of polymorphonuclear cell and monocyte migration to the area of inflammation.
- Inhibition of lyosomal enzyme release from stimulated leucocytes.
- Reduction of both systemic and synovial fluid rheumatoid factor production in patients with seropositive rheumatoid arthritis.
It is established that piroxicam does not act by pituitary-adrenal axis stimulation. In-vitro studies have not revealed any negative effects on cartilage metabolism.
Piroxicam is indicated for symptomatic relief of osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis.
Due to its safety profile, piroxicam is not a first line option should an NSAID be indicated. The decision to prescribe piroxicam should be based on an assessment of the individual patient’s overall risks
DOSAGE AND ADMINISTRATION
Carefully consider the potential benefits and risks of piroxicam and other treatment options before deciding to use piroxicam. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
After observing the response to initial therapy with piroxicam , the dose and frequency should be adjusted to suit an individual patient’s needs.
For the relief of rheumatoid arthritis and osteoarthritis, the recommended dose is 20 mg given orally once per day. If desired, the daily dose may be divided. Because of the long half-life of piroxicam , steady-state blood levels are not reached for 7 to 12 days. Therefore, although the therapeutic effects of piroxicam are evident early in treatment, there is a progressive increase in response over several weeks and the effect of therapy should not be assessed for two weeks.
- Hypersensitivity to the active substance or to any of the excipients.
- 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.
- Patients with active peptic ulcer, inflammatory gastrointestinal disorder or gastrointestinal bleeding.
- Concomitant use with other NSAIDs, including COX-2 selective NSAIDs and acetylsalicylic acid at analgesic doses.
- Concomitant use with anticoagulants.
- History of previous serious allergic drug reaction of any type, especially cutaneous reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
- Previous skin reaction (regardless of severity) to piroxicam, other NSAIDs and other medications.
- Patients in whom aspirin and other non-steroidal anti-inflammatory drugs induce the symptoms of asthma, nasal polyps, angioedema or urticaria.
- Severe heart failure.
- During the last trimester of pregnancy.
Antacids: Concomitant administration of antacids had no effect on piroxicam plasma levels.
NSAIDs, including piroxicam, may enhance the effects of anticoagulants, such as warfarin. Therefore, the use of piroxicam with concomitant anticoagulant such as warfarin should be avoided.
Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding.
Aspirin and other Non-Steroidal Anti-Inflammatory Drugs:
Piroxicam, like other non-steroidal anti-inflammatory drugs decreases platelet aggregation and prolongs bleeding time. This effect should be kept in mind when bleeding times are determined.
As with other NSAIDs, the use of piroxicam together with acetylsalicylic acid or concomitant use with other NSAIDs, including other piroxicam formulations, must be avoided, since data are inadequate to show that combinations produce greater improvement than that achieved with piroxicam alone; moreover, the potential for adverse reactions is enhanced . Human studies have shown that concomitant use of piroxicam and acetylsalicylic acid reduces the plasma piroxicam concentration to about 80% of the usual value.
NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.
Possible increased risk of nephrotoxicity when NSAIDs are given with ciclosporin or tacrolimus.
Results of two separate studies indicate a slight but significant increase in absorption of piroxicam following cimetidine administration but no significant changes in elimination rate constants or half-life. The small increase in absorption is unlikely to be clinically significant.
Increased risk of gastrointestinal ulceration or bleeding.
Concurrent therapy with piroxicam and digoxin, or piroxicam and digitoxin, did not affect the plasma levels of either drug.
Non-steroidal anti-inflammatory drugs may cause sodium, potassium and fluid retention and may interfere with the natriuretic action of diuretic agents. These properties should be kept in mind when treating patients with compromised cardiac function or hypertension since they may be responsible for the worsening of those conditions.
Highly protein-bound drugs:
Piroxicam is highly protein-bound and therefore might be expected to displace other protein-bound drugs. The physician should closely monitor patients for change when administering Piroxicam to patients on highly protein-bound drugs.
Non-steroidal anti-inflammatory drugs, including Piroxicam, have been reported to increase steady state plasma lithium levels. It is recommended that these levels are monitored when initiating, adjusting and discontinuing Piroxicam.
Piroxicam, like other non-steroidal anti-inflammatory drugs, may interact with the following drugs / classes of therapeutic agents:
Antihypertensives -antagonism of the hypotensive effect
Methotrexate – Reduced excretion of methotrexate, possibly leading to acute toxicity
Quinolone antibiotics – possible increased risk of convulsions
Mifepristone – NSAIDs could interfere with mifepristone-mediated termination of pregnancy.
Cardiovascular System: Edema.
Digestive System: Anorexia, abdominal pain, constipation, diarrhea, dyspepsia, elevated liver enzymes, flatulence, gross bleeding/perforation, heartburn, nausea, ulcers (gastric/duodenal), vomiting.
Hemic and Lymphatic System: Anemia, increased bleeding time.
Nervous System: Dizziness, headache.
Skin and Appendages: Pruritus, rash.
Special Senses: Tinnitus.
Urogenital System: Abnormal renal function.
Additional adverse experiences reported occasionally include:
Body As a Whole: Fever, infection, sepsis.
Cardiovascular System: Congestive heart failure, hypertension, tachycardia, syncope.
Digestive System: Dry mouth, esophagitis, gastritis, glossitis, hematemesis, hepatitis, jaundice, melena, rectal bleeding, stomatitis.
Hemic and Lymphatic System: Ecchymosis, eosinophilia, epistaxis, leukopenia, purpura, petechial rash, thrombocytopenia.
Metabolic and Nutritional: Weight changes.
Nervous System: Anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, nervousness, paresthesia, somnolence, tremors, vertigo.
Respiratory System: Asthma, dyspnea.
Skin and Appendages: Alopecia, bruising, desquamation, erythema, photosensitivity, sweat.
Special Senses: Blurred vision.
Urogenital System: Cystitis, dysuria, hematuria, hyperkalemia, interstitial nephritis, nephrotic syndrome, oliguria/polyuria, proteinuria, renal failure.
Reporting of suspected adverse reactions:
The PPB Department of Pharmacovigilance was set up with a vision to develop, implement and continuously upgrade an appropriate system for detecting, reporting, and monitoring adverse drug reactions (ADRs) and other relevant problems with medicines in Kenya. The department strives to ensure the safety and efficacy of pharmaceutical products in Kenya.
Reporting suspected adverse reactions after authorization of the medicinal product are important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals/ Patients are encouraged to report any suspected adverse reactions via Pharmacovigilance Yellow Form, firstname.lastname@example.org or clicking below button:
Lornoxicam / Paracetamol
Piroxicam in Kenya
Piroxicam in Kenya
Piroxicam in Kenya
Piroxicam in Kenya
Clinical | Pharmacokinetic data
Pregnancy Category: C , D if used during 3rd Trimester
Routes of Administration: Oral
Bioavailability: Not Available
Protein Binding: 99%
Metabolosim: Liver-mediated hydroxylation and glucuronidation
Onset of Action: Not Available
Elimination Half life: 50 hours
Excretion: Urine, faeces
Legal Status | Dosage forms & Strengths
Narcotic Drugs and Psychotropic Substances (Control ) Act Schedule:
This Drug is not Subject to DDA drugs Act
Dosage Forms | Strengths:
|CompTox Dashboard (EPA)|
- PPB Drugs Retention Register
- Brogden, R. N., et al. “Piroxicam.” Drugs 28.4 (1984): 292-323.
- Schnitzer, Thomas J., et al. “Effect of piroxicam on gait in patients with osteoarthritis of the knee.” Arthritis & Rheumatism: Official Journal of the American College of Rheumatology 36.9 (1993): 1207-1213.
- HOBBS, DONALD C., and THOMAS M. TWOMEY. “Piroxicam pharmacokinetics in man: aspirin and antacid interaction studies.” The Journal of Clinical Pharmacology 19.5‐6 (1979): 270-281.
- Malizia, Tecla, et al. “Interaction between piroxicam and azithromycin during distribution to human periodontal tissues.” Journal of periodontology 72.9 (2001): 1151-1156.