KETODOL ® Ketoprofen

KETODOL © is a ketoprofen based drug

THERAPEUTIC GROUP: Non-steroidal anti-inflammatory and antirheumatic drugs

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications KETODOL ® Ketoprofen

KETODOL ® is indicated in the symptomatic treatment of various types of pain affections 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 where it is rapidly absorbed, allowing the maximum plasma peak to be reached 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 ketoprofen absorption more gradual over time, extending the therapeutic action exercised by the medicinal product.

The latter is essentially guaranteed by the ability of ketoprofen to inhibit the activity of cyclooxygenases, enzymes activated significantly following traumas or harmful stimuli, capable of increasing the concentrations of chemical mediators endowed 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 and by the antioxidant that contributes to the reduction of the damaging stimulus of inflamed tissues.

Ketoprofen after a half-life of about 1-4 hours is eliminated mainly at the renal level in the form of inactive catabolites.

Studies carried out and clinical efficacy

1. EFFECTIVENESS AND SAFETY OF KETOPROPHENES + OMEPRAZOLE

Clin Drug Investig. 2012 Apr 1; 32 (4): 221-33.

Recent work that shows how the appearance of the 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. THE KETOPROPHENE IN POST-OPERATIVE PHASES

Methods Find Exp Clin Pharmacol. 2008 Nov; 30 (9): 703-6.

Work that demonstrates how the intake of ketoprofen in the phases immediately following major orthopedic surgery can mitigate post-operative pain by reducing the amount of opioid painkillers used in the post-operative phases.

3. KETOPROPHENES- SUCRALFATE AND TOLERABILITY

Boll Chim Farm. 1991 Dec; 130 (11): 1S-5S.

A somewhat dated study that shows how the intake of ketoprofen-sucralfate while guaranteeing the same therapeutic effects of ketoprofen alone, in the treatment of pain symptomatology, may present a better tolerability by reducing the incidence of gastro-intestinal affections.

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 we recommend taking one tablet 2 - 3 times a day with a glass of water.

Medical supervision and adaptation of the doses used should inevitably occur in elderly patients or those suffering from kidney and liver disease.

Warnings KETODOL ® Ketoprofen

Although KETODOL ® can be sold without a prescription, given the potential side effects of ketoprofen therapy, it would be advisable to consult your doctor before taking this medicine.

Treatments should be considered short-term and useful to overcome the acute phase of pain, reducing ketoprofen intake 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 aggravation of pre-existing pathologies.

The possible occurrence of side effects, both systemic and cutaneous, should alarm the patient, who, after having heard his doctor, should stop the therapy.

Some of the side effects, especially those affecting the gastro-intestinal 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 its use in patients with lactose intolerance, glucose-galactose malabsorption syndrome and lactase enzyme deficiency is not recommended.

PREGNANCY AND BREASTFEEDING

We strongly advise against taking ketoprofen during pregnancy in light of 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 the normal embryonic and fetal development, facilitating the appearance of malformations, especially against the cardiovascular and respiratory system, and unwanted abortions.

The contraindication is also extended to the next stage of breastfeeding given the possibility that ketoprofen has to be secreted, even if minimally, with breast milk.

It is also recalled that the use of NSAIDs in the final period of pregnancy can complicate childbirth, reducing myometrial 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 that are of major concern from the clinical point of view, due to the potential side effects and the significant variations in biological efficacy and pharmacokinetic properties, are those related to the contextual use of:

Oral anticoagulants and inhibitors of serotonin reuptake, due to the increased risk of bleeding;
Diuretics, ACE inhibitors, angiotensin II antagonists, methotrexate and cyclosporine, due to potential nephrotoxic effects;
Non-steroidal anti-inflammatory and corticosteroids, able to significantly increase the damaging action on the gastro-intestinal tract;
Antibiotics, given the significant variations in terms of therapeutic efficacy and metabolism;
Sulfonylureas, given the possible hypoglycemic action.

Contraindications KETODOL ® Ketoprofen

The use of KETODOL ® is contraindicated in patients who are 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, bleeding diathesis, intestinal bleeding, ulcerative colitis, Crohn's disease or history with the same conditions.

Undesirable effects - Side effects

Despite taking KETODOL ®, when carried out according to the appropriate medical indications, it is free of particularly serious side effects, it should be remembered that the prolonged use of non-steroidal anti-inflammatory drugs such as ketoprofen could determine the appearance of dyspepsia, nausea, vomiting, diarrhea, constipation, gastralgia and in severe cases perforation ulcers and bleeding, dizziness, headache, drowsiness and depression, hives, skin rash, bullous reactions and photosensitivity.

Different clinical trials also demonstrate how the abuse of ketoprofen and NSAIDs in general can be associated with the onset or clinical aggravation of hepatic, renal and cardiovascular diseases.