COMPOSITION :
Each f/c tablet contains : Ketoprofen B.P. 100 mg.
DESCRIPTION :
Keto 100 (Ketoprofen) is a propionic acid derivative of non-steroidal anti-inflammatory drugs. It has anti-inflammatory, analgesic and antipyretic effects by inhibiting prostaglandin synthesis in the body tissues through inhibiting cyclo-oxygenase enzyme.It is readily absorbed from the gastrointestinal tract , peak plasma concentrations occur about 0.5 to 2 hours after a dose. It is 99% bound to plasma proteins.It is metabolized mainly by conjugation with glucouronic acid and excreted mainly in the urine.
INDICATIONS :
Keto 100 is indicated in case of :
- Rheumatoid arthritis, ankylosing spondylitis, spondyloarthritis and degenerative arthritis.
- Acute musculoskeletal disorders such as bursitis, tendinitis, synovitis, tenosynovitis and capsulitis.
- Fibrositis, cervical spondylitis, low back pain (strain, lumbago, sciatica, fibrositis) and shoulder pain.
- Painful inflammatory conditions in gynaecology e.g primary dysmenorrhoea or pelvic inflammatory disease.
- Microcrystalline arthritis such as gout and post operative pain.
DOSAGE AND ADMINISTRATION :
Keto 100 is indicated for adults and children more than 15 years, and should be taken with a large glass of water during meals.
- In short-term symptomatic treatment : The recommended dose is 100 mg Keto 100 three times daily.
- In long-term symptomatic treatment : The dose is 100 to 200 mg Keto 100 once daily.
- Patients with renal insufficiency and elderly patients : It is advisable to reduce the initial dose then to adjust it, if necessary, depending on renal tolerance.
RESTRICTIONS ON USE : Contraindications
- Hypersensitivity to Ketoprofen or other non-steroidal anti-inflammatory drugs.
- Pregnancy starting from the 6th months.
- Bronchial asthma, gastrointestinal hemorrhage, cerebrovascular hemorrhage or any hemorrhage in progress.
- Active stomach or intestinal ulcer, serious liver disease, serious kidney disease or serious heart disease. Precautions
Before use Ketoprofen inform your physician in case of history of asthma associated with chronic rhinitis, coagulation disorders, congenital galactosemia, glucose or galactose malabsorption syndrome or lactase deficiency. Effects on the capacity to drive vehicles or use machines
Ketoprofen may produce dizziness, drowsiness or visual disorders. If one of these symptoms occurs, avoid driving a vehicles or using machines. Use in Pregnancy and Lactation Ketoprofen can be prescribed by physician during the first five months of pregnancy, if necessary. As of the 6th month of pregnancy, it should not be used in any case. Also it is not recommended for lactating women.
DRUG INTERACTIONS :
Don’t use Ketoprofen with the following Drugs : other NSAIDs at high dose, oral anticoagulants, heparin, lithium, methotrexate, platelet aggregation inhibitors (e.g : clopidogrel), potassium salts, diuretics, ACE inhibitors, angiotensin II inhibitors, cyclosporin , tacrolimus, trimethoprim, beta-blocker, intrauterine device and pentoxyfilline.
ADVERSE EFFECTS :
Ketoprofen is well tolerated and its adverse effects usually mild and transient. The common adverse effects reported are : Dyspepsia, nausea, vomiting, abdominal pain, headache, dizziness, tinnitus, photosensitivity, visual disturbances and renal impairment.
STORAGE INSTRUCTIONS : Store below 25°C , in a dry place.
PRESENTATION :
Keto 100 : Pack of 30 Tablets and hospital packs of different sizes.
INSTRUCTIONS TO THE PATIENT
- Medicament is a product which affects your health, and its consumption contrary to instructions is dangerous for you.
- Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.
- The doctor and the pharmacist are experts in medicine, its benefits and risks.
- Do not by yourself interrupt the period of treatment prescribed for you.
- Do not repeat the same prescription without consulting your doctor.
Keep medicament out of reach of children Mfd. By
P.O. Box : 4265 Sana’a /Yemen.
Council of Arab Health Ministers Union of Arab Pharmacists
012-06-078 7/12