Product Data
Composition:
Active ingredient: Each suppository contains Ketoprofen 100 mg Excipients: Hydrophobic silica and Hard fat 2.2. Pharmacological Properties Ketoprofen overall has the properties of a potent non-steroidal anti-inflammatory agent. It has the following pharmacological effects:
Properties:
The bioavailability of ketoprofen from the suppository formulation (1 x 100 mg suppositories) has been compared with that from the capsule formulation (2 x 50 mg capsules). The results indicated that there was no significant difference between the bioavailability of the two dosage forms.
Indications And Usage:
Ketolgin is a potent non steroidal anti-inflammatory analgesic agent and strong inhibitor of prostaglandin synthetase. Ketolgin is recommended in the management of rheumatoid arthritis, osteoarthritis, ankylosing spondilitis, acute articular and peri-articular disorders (bursitis, capsulitis, synovitis, tendinitis), cervical spondylitis, low back pain (strain, lumbago, sciatica, fibrositis), painful musculo-skeletal conditions, acute gout and control of pain and inflammation following orthopaedic surgery. Ketolgin reduces joint pain and inflammation and facilitates increase in mobility and functional independence. As with other non-steroidal anti-inflammatory agents, it does not cure the underlying disease.
Contraindications:
Ketoprofen is contraindicated in patients who have a history of hypersensitivity reactions such as bronchospasm, asthmatic attacks, rhinitis, angioedema, urticaria or other allergic-type reactions to ketoprofen, or other NSAIDs. Ketoprofen is contraindicated in patients with hypersensitivity to any of the excipients of the drug. Ketoprofen is also contraindicated in the third trimester of pregnancy. Ketoprofen is contraindicated in the following cases: - Severe heart failure - Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding) - History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy - haemorrhagic diathesis - Severe hepatic insufficiency - Severe renal insufficiency - Rectitis or history of proctorrhagia (rectal administration) Disease in children (safety/dosage during long term treatment has not been established).
Adverse Reactions:
The following adverse reactions have been reported with Ketoprofen in adults: Blood and lymphatic system disorders - haemorrhagic anaemia, anaemia due to bleeding - agranulocytosis, thrombocytopenia, bone marrow failure, neutropenia Immune system disorders - anaphylactic reactions (including shock) Psychiatric disorders - mood altered Nervous system disorders - headache, dizziness, somnolence - paraesthesia - convulsions, dysgeusia, depression, confusion, hallucinations, vertigo, malaise, drowsiness, reports of aseptic meningitis (especially in patients with existing auto-immune disorders such as systemic lupus erythematosis, mixed connective tissue disease) with symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation. Eye disorders - visual disturbances such as blurred vision. - optic neuritis Ear and labyrinth disorders - tinnitus Cardiac disorders - heart failure, oedema Vascular disorders - hypertension, vasodilatation Respiratory, thoracic and mediastinal disorders - asthma, asthmatic attack - bronchospasm (particularly in patients with known hypersensitivity to ASA and other NSAIDs), rhinitis, non-specific allergic reactions, dyspnoea Gastrointestinal disorders - dyspepsia, nausea, abdominal pain, vomiting - constipation, diarrhoea, flatulence, gastritis - stomatitis, peptic ulcer - pancreatitis (very rare reports of pancreatitis have been noted with NSAIDs) - exacerbation of colitis and Crohn's disease, gastrointestinal haemorrhage and perforation, gastralgia, melaena, haematemesis Gastrointestinal bleeding may sometimes be fatal, particularly in the elderly. Hepatobiliary disorders - hepatitis, transaminases increased, elevated serum bilirubin due to hepatitis disorders - abnormal liver function, jaundice Skin and subcutaneous disorders - rash, pruritis - photosensitivity reactions, alopecia, urticaria, angioedema, bullous eruption including Stevens-Johnson syndrome and toxic epidermal necrolysis, exfoliative and bullous dermatoses (including epidermal necrolysis, erythema multiforme), purpura Renal and urinary disorders - renal failure acute, tubulointerstitial nephritis, nephritic syndrome, renal function tests abnormal General disorders and administration site conditions - oedema, fatigue - headache, taste perversion In all cases of major adverse effects Ketolgin should be withdrawn at once.
Dosage & Administration:
-Rectal dosage is one suppository (100 mg) late at night supplemented as required with Ketolgin capsules during daytime. -Elderly: The elderly are at increased risk of serious adverse reactions from NSAIDs. If an NSAID is considered necessary, it is generally advisable to begin ketoprofen therapy at the lower end of the dose range and to maintain such patients on the lowest effective dosage, for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy. -Paediatric dosage is not established. -Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.
Drug Interactions:
- Anticoagulants (heparin and warfarin) and platelet aggregation inhibitors (i.e. ticlopidine, clopidogrel) increase risk of bleeding. If coadministration is unavoidable, patient should be closely monitored. - Lithium: Risk of elevation of lithium plasma levels, sometimes reaching toxic levels due to decreased lithium renal excretion. Where necessary, plasma lithium levels should be closely monitored and the lithium dosage levels adjusted during and after NSAIDs therapy. - Other analgesics/NSAIDs (including cyclooxygenase-2 selective inhibitors) and high dose salicylates: Avoid concomitant use of two or more NSAIDs (including aspirin) as this may increase the risk of adverse effects, particularly gastrointestinal ulceration and bleeding. - Methotrexate: Serious interactions have been recorded after the use of high dose methotrexate with NSAIDs, including ketoprofen, due to decreased elimination of methotrexate. Increased risk of haematologic toxicity of methotrexate, particularly if administered at high doses (> 15 mg/week), possibly related to displacement of protein-bound methotrexate and to its decreased renal clearance. At doses lower than 15mg/week, during the first weeks of combination treatment, full blood count should be monitored weekly. If there is any alteration of the renal function or if the patient is elderly, monitoring should be done more frequently. - Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone. - Pentoxifylline: There is an increased risk of bleeding. More frequent clinical monitoring and monitoring of bleeding time is required. - Antihypertensive agents (beta-blockers, angiotensin converting enzyme inhibitors, diuretics): Risk of decreased antihypertensive potency (inhibition of vasodilator prostaglandins by NSAIDs). - Diuretics: Risk of reduced diuretic effect. Patients and particularly dehydrated patients taking diuretics are at a greater risk of developing renal failure secondary to a decrease in renal blood flow caused by prostaglandin inhibition. Such patients should be rehydrated before initiating coadministration therapy and renal function monitored when the treatment is started. - Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels. - Ciclosporin: Increased risk of nephrotoxicity, particularly in elderly subjects. - Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding. - Quinolone antibiotics: Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions. - Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus, particularly in elderly subjects. - Thrombolytics: Increased risk of bleeding. - Probenecid: Concomitant administration of probenecid may markedly reduce the plasma clearance of ketoprofen. - Anti-platelet agents and Selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding. - ACE inhibitors and Angiotensin II Antagonists: In patients with compromised renal function (e.g. dehydrated patients or elderly patients the co-administration of an ACE inhibitor or Angiotensin II antagonist and agents that inhibit cyclooxygenase may result in further deterioration of renal function, including possible acute renal failure. - Zidovudine: Increased risk of haematological toxicity when NSAlDs are given with zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV(+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.
How Supplied:
Packs of 5 suppositories Keep all medicaments out of reach of children
Storage:
Store in a dry place below 25°C
Pregnancy & Lactation:
Pregnancy Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. Lactation No data are available on excretion of ketoprofen in human milk. Ketoprofen is not recommended in nursing mothers.
Overdosage:
Symptoms Cases of overdose have been reported with doses up to 2.5g of ketoprofen. In most instances, the symptoms observed have been benign and limited to lethargy, drowsiness, nausea, vomiting and epigastric pain. Headache, rarely diarrhoea, disorientation, excitation, coma, dizziness, tinnitus, fainting, occasionally convulsions may also occur. Adverse effects seen after overdosage with propionic acid derivatives such as hypotension, bronchospasm and gastro-intestinal haemorrhage should be anticipated. 13. Shelf life 36 months
