Geskaprofen Dexketoprofen 25 mg
Film coated tablets
Company Name :
Future Pharmaceutical Industries for Utopia phanma.
Generic Name :
Dexketoprofen trometamol 36.9mg
(equivalent to dexketoprofen 25mg).
Pharmaceutical Form :
Film-coated tablets.
Composition :
Each film coated tablet contains:
Active Ingredients: Dexketoprofen trometamol 36.9 mg (equivalent to dexketoprofen 25mg).
Inactive Ingredients: Lactose – Avicel PH – Povidone – Croscarmellose Sodium – Purified talc – Magnesium stearate – Colloidal Silicon Dioxide – Hypromellose -Titanium dioxide – PEG -Red ferric oxide.
Pharmacological Action :
Geskaprofen is a non-steroidal anti-inflammatory agent that possesses analgesic, anti-inflammatory and antipyretic activities. It is the active enantiomer of ketoprofen. Its mode of action like that of other NSAIDs, is related to the inhibition of the cyclooxygenase enzyme activity and prostaglandin synthesis.
Pharmacokinetics :
Dexketoprofen is the s-enantiomer of ketoprofen which has a more potent pharmacological action than ketoprofen.Dexketoprofen is readily absorbed from the gastrointestinal tract, peak plasma
concentrations occur about 0.5 to 2 hours after a dose.When Dexketoprofen is given with food, the bioavailability is not altered but the rate of absorption is slowed. Dexketoprofen is 99% bound to plasma proteins and substantial concentrations of the drug is found in the synovial fluid. The elimination half-life in plasma is about 1.5 to 4 hours. Dexketoprofen is metabolized mainly by conjugation with glucuronic acid, and is mainly excreted in the urine.
Indications :
Geskaprofen is an anti-inflammatory used in:
– The treatment of mild to moderate pain such as musculoskeletal pain, dysmenorrhea or dental pain
– Painful inflammatory and degenerative forms of rheumatism:
Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and spondyloarthritis.
– Non- articular rheumatism.
– Acute attacks of gout.
– As an adjuvant in painful infections of E.N.T.
– Pain of other origins such as sciatica, lumbago, neuralgia and cramps.
Dosage and Administration :
12.5 mg (1/2 tablet) every 4-6 hours or 25 mg (1 tablet) every 8 hours. The maximum dose is 75 mg (3 tablets) daily. In elderly, the maximum dose is 50 mg (2 tablets) daily.
Contraindications :
– Dexketoprofen is contraindicated in patients with a history of hypersensitivity to any other NSAIDs.
– It is contraindicated in severe heart failure and in patients with previous or active peptic ulcer or bleeding.
– Dexketoprofen is contraindicated in children.
Side Effects :
Dexketoprofen rarely causes nausea and/or vomiting, abdominal pain, diarrhea, dyspepsia, insomnia, anxiety, headache, dizziness, somnolence, gastritis, constipation, dry mouth, flatulence and rash.
Drug Interactions :
Administraion of dexketoprofen with the following drugs might lead to interactions:
– Other NSAIDs: The risk of gastrointestinal ulcers and bleeding may increase.
– Anti-coagulants, such as warfarin: The effects of warfarin may be
enhanced.
– Heparins: Risk of hemorrhage.
– Corticosteroids: Increased risk of gastrointestinal ulcers or bleeding.
– Lithium: Increases its blood levels which may reach toxic values.
– Methotrexate at high doses of 15 mg/week or more: May cause haematological toxicity
– Hydantoines and sulphonamides: Increases the toxic effects of these substances.
– Diuretics, ACE inhibitors and angiotensin 11 receptor antagonists:
May result in further deterioration of renal functions.deterioration of renal functions. – Pentoxyfilline: Increases risk of bleeding.
– Sulfonylureas: NSAIDs can increase the hypoglycaemic effect of
sulfonylureas.
– Beta-blockers: Diminishes its antihypertensive effects.
– Cyclosporin and tacrolimus: Enhances nephrotoxicity.
Pregnancy and Lactation :
It is advisable to avoid using Dexketoprofen during pregnancy unless the potential benefit outweighs the risk.
Precautions and Warnings :
– Undesirable events may be minimized by using the lowest effective dose for the shortest possible duration necessary to control symptoms.
– Safety of usage in children has not been established.
– Usage with concomitant other NSAIDs including cyciooxygenase-2 selective inhibitors should be avoided.
– Caution should be exercised in patients with impairment of hepatic and/or renal functions .
– Cardiovascular Risk: NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. NSAIDs are
contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
-Gastrointesfinal risk: NSAIDs cause an increased risk of serious gastrointestinal adverse events including inflammation, bleeding, ulceration and perforation of stomach or intestines, which can be fatal. These events can occur at any time during use and without waming symptoms. Elderly patients are at greater risk for serious
gastrointestinal events.
Package :
Carton box containing 1 or 2 PVDC tAL strips; each strip has 10 film-coated tablets with insert leaflet.
Storage :
– Keep at a temperature not exceeding 30’C in a dry place.
– Keep out of reach of children.
Instructions for Patients :
– Keep this leaflet. You may need to read it again.
– If you have any further questions, please refer to your doclor or pharmacisl.
– Do not use more than one oral NSAlo at a time.
– It Isrecornm-el1a~(no be tekert at least-30 rnrnutes Irefore meals.
Produced by :
Future Pharmaceutical Industries for Utopia pharma
