KETODOL © is a ketoprofen-based drug
THERAPEUTIC GROUP: Non-steroidal anti-inflammatory and antirheumatic drugs
Indications KETODOL ® Ketoprofen
KETODOL ® is indicated in the symptomatic treatment of pain affections of various kinds on an inflammatory basis.
Mechanism of action KETODOL ® Ketoprofen
KETODOL ® is a drug based on ketoprofen, an active ingredient belonging to the category of non-steroidal anti-inflammatory drugs, and chemically derived from arylpropionic acid.
Taken orally, this active ingredient reaches the intestinal environment unaltered where it is rapidly absorbed, allowing the achievement of the maximum plasma peak in just 60 minutes, and distributed to various tissues, bound to plasma proteins.
The presence in KETODOL ® of sucralfate, a cytoprotective agent commonly used in the treatment of duodenal ulcers, makes the absorption of ketoprofen more gradual over time, lengthening the therapeutic action exerted by the drug.
The latter is essentially guaranteed by the ability of ketoprofen to inhibit the activity of cyclooxygenases, enzymes activated significantly following trauma or injurious stimuli, capable of increasing the concentrations of chemical mediators with pro-inflammatory activity known as prostaglandins.
The therapeutic activity of this active principle is also completed by the central analgesic action, carried out through the direct crossing of the blood-brain barrier, by the indirect antipyretic action and by the antioxidant action which contributes to the reduction of the injurious stimulus to the inflamed tissues.
After a half-life of approximately 1-4 hours, ketoprofen is eliminated mainly in the kidney in the form of inactive catabolites.
Studies carried out and clinical efficacy
1.EFFICACY AND SAFETY OF KETOPROFENE + OMEPRAZOLE
Clin Drug Investig. 2012 Apr 1; 32: 221-33.
Non-steroidal anti-inflammatory drugs and gastroprotection with proton pump inhibitors: a focus on ketoprofen / omeprazole.
Giant A, Tagarro I.
Very recent work that demonstrates how the appearance of side effects on the gastric mucosa induced by the administration of ketoprofen can be minimized by the simultaneous intake of proton pump inhibitors such as omeprazole, thus increasing adherence to anti-inflammatory therapy.
2.KETOPROPHEN IN THE POST-OPERATIVE PHASES
Methods Find Exp Clin Pharmacol. 2008 Nov; 30: 703-6.
Efficacy of oral paracetamol and ketoprofen for pain management after major orthopedic surgery.
Karvonen S, Salomäki, Olkkola KT.
Work that demonstrates how the intake of ketoprofen in the phases immediately following major orthopedic surgery, can alleviate post-operative pain by reducing the amount of opioid painkillers used in the post-operative phases.
3. KETOPROPHENE- SUCRALPHATE AND TOLERABILITY "
Boll Chim Farm.1991 Dec; 130: 1S-5S.
Evaluation of the analgesic activity of a new ketoprofen-sucralfatecombination.
Roveda S, Colombo P, Pulvirenti A, Pini G, Germogli R, Molteni R, Lattuada V.
A somewhat dated study that demonstrates how the assumption of ketoprofen-sucralfate while guaranteeing the same therapeutic effects of ketoprofen alone, in the treatment of painful symptoms, can present a better tolerability by reducing the incidence of gastro-intestinal diseases.
Method of use and dosage
KETODOL ®
Modified-release tablets consisting of a 25 mg ketoprofen core and a 200 mg sucralfate coating.
For the treatment of painful symptoms it is recommended to take one tablet 2 - 3 times a day with a glass of water.
Medical supervision and adjustment of the doses used should inevitably occur in elderly patients or patients with renal and hepatic diseases.
Warnings KETODOL ® Ketoprofen
Although KETODOL ® can be sold without a prescription, given the potential side effects associated with ketoprofen therapy, it would be advisable to consult your doctor before taking this medicine.
The treatments should be considered of short duration and useful to overcome the acute phase of pain, reducing the intake of ketoprofen as soon as possible and using the minimum effective dose.
Medical supervision becomes necessary in all those patients suffering from gastro-intestinal, hepatic, renal, cardiovascular and coagulative diseases, for which periodic monitoring of the functionality of the aforementioned organs is necessary to reduce the incidence of new adverse reactions or the aggravation of pre-existing pathologies.
The possible appearance of both systemic and cutaneous side effects should alarm the patient, who, after consulting his doctor, should suspend the therapy.
Some of the side effects, especially those affecting the gastrointestinal tract, could be minimized by taking KETODOL ® on a full stomach.
KETODOL ® is contraindicated in children due to the presence of sucralfate, whose efficacy and safety has never been evaluated in the pediatric population.
KETODOL ® contains lactose, therefore it is not recommended for use in patients with lactose intolerance, glucose-galactose malabsorption syndrome and lactase enzyme deficiency.
PREGNANCY AND BREASTFEEDING
The intake of ketoprofen during pregnancy is strongly discouraged in light of the various studies in the literature that show potential toxic effects on both the fetus and the mother.
More precisely, the significant reduction in the amount of prostaglandins, induced by the use of ketoprofen, could compromise normal embryonic and fetal development, facilitating the appearance of malformations, especially in the cardiovascular and respiratory systems, and unwanted abortions.
The contraindication is also extended to the subsequent phase of breastfeeding given the possibility that ketoprofen has to be secreted, albeit minimally, with breast milk.
It is also recalled that the use of NSAIDs in the final period of pregnancy can complicate childbirth, reducing myometric contractions and at the same time increasing the risk of bleeding.
Interactions
The pharmacological interactions documented between ketoprofen and other active ingredients are different.
However, those of greatest concern from a clinical point of view, due to the potential side effects and the significant variations in biological efficacy and pharmacokinetic properties, are those relating to the simultaneous use of:
- Oral anticoagulants and serotonin reuptake inhibitors, due to the increased risk of bleeding;
- Diuretics, ACE inhibitors, angiotensin II antagonists, methotrexate and cyclosporins, for potential nephrotoxic effects;
- Non-steroidal and cortisone anti-inflammatory drugs, capable of significantly increasing the damaging action on the gastro-intestinal system;
- Antibiotics, given the significant variations in terms of therapeutic efficacy and metabolism;
- Sulfonylureas, given the possible hypoglycemic action.
Contraindications KETODOL ® Ketoprofen
The intake of KETODOL ® is contraindicated in patients hypersensitive to the active substance or to one of its excipients, hypersensitive to acetylsalicylic acid and other analgesics, in patients with hepatic, renal and cardiac insufficiency, haemorrhagic diathesis, intestinal bleeding, ulcerative colitis, Crohn's disease or with a previous history of the same pathologies.
Undesirable Effects - Side Effects
Although the intake of KETODOL ®, when carried out according to the appropriate medical indications, is devoid of particularly serious side effects, it should be remembered that the prolonged use of non-steroidal anti-inflammatory drugs such as ketoprofen could cause the onset of dyspepsia, nausea , vomiting, diarrhea, constipation, gastralgia and in the most severe cases ulcers and bleeding from perforation, dizziness, headache, somnolence and depression, hives, skin rash, bullous reactions and photosensitivity.
Furthermore, different clinical trials show how the abuse of ketoprofen and NSAIDs in general can be associated with the onset or clinical aggravation of hepatic, renal and cardiovascular diseases.
Note
KETODOL © can be sold without a prescription.
The information on KETODOL ® Ketoprofen published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
