drugs

LIXIDOL ® Ketorolac

LIXIDOL ® is a drug based on Ketorolac tromethamine

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

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

Indications LIXIDOL ® Ketorolac

LIXIDOL ® is indicated as an alternative to opiate analgesic therapy in the treatment of post-operative pain, both moderate and severe.

Mechanism of action LIXIDOL ® Ketorolac

Keteroloac, the active ingredient of LIXIDOL ®, is a drug derived from arylacetic acid, included in the pharmaceutical category of non-steroidal anti-inflammatory drugs, also called NSAIDs.

Given its particular chemical structure, ketorolac is commonly used in the form of trometamol salt, resulting particularly stable both from a pharmacokinetic and pharmacodynamic point of view.

The analgesic and anti-inflammatory activity associated with this active ingredient is due to its role as an inhibitor of prostaglandinic synthesis, performed through the control of cyclooxygenase activity, enzymes involved in the transformation of arachidonic acid into molecules with vasopermeabilization, chemotactic and algogenic activity notes just like prostaglandins.

Different studies show that the analgesic activity induced by ketorolac can be significantly higher than that of salicylic acid, with a duration of action that is prolonged even up to 4 -6 hours after taking the drug.

Among the biological properties of ketorolac, in addition to the anti-inflammatory and pain-relieving action, we must not overlook the anti-aggregating, often responsible for some side effects, such as sudden bleeding, in patients already suffering from coagulative diathesis.

Studies carried out and clinical efficacy

1.KETOROLAC AND ENDOSCOPIC THERAPY

Int Forum Allergy Rhinol. 2012 Mar 12.

Recent study demonstrating that intravenous administration of ketorolac may be effective in reducing pain associated with endoscopic sinus surgical therapy, without significant risk of bleeding.

2 .KETOROLAC AND POST-OPERATIVE PAIN

Anesth Analg. 2012 Feb; 114 (2): 424-33. Epub 2011 Sep 29.

Further work in meta-analysis, which demonstrates how the use of a single dose of ketorolac can be effective in reducing post-operative pain, significantly improving convalescence and also reducing post-operative nausea and vomiting.

3. KETOROLAC IN ORTHOPEDIC CLINICAL PRACTICE

J Back Musculoskelet Rehabil. 2011; 24 (1): 31-8.

Clinical study demonstrating that the intra-articular injection of ketorolac is characterized by a great analgesic activity in the treatment of osteoarthritis, without clinically significant complications.

Method of use and dosage

LIXIDOL ®

10 mg ketorolac tromethamine-coated tablets;

30 mg solution for injection of ketorolac trometamine per ml of solution;

Oral drops of 20 mg of ketorolac trometamine per ml of solution;

Note the pharmacokinetic properties of ketorolac, and in particular its estimated duration of action between 4 and 6 hours, it is recommended to take 10 mg every 6 hours, orally, for a maximum daily dose of 40 mg .

In any case, in order to reduce the incidence of side effects, it would be preferable to use the minimum effective dose for a maximum duration of treatment of 5 days.

Sensitive dosage changes should be provided for elderly patients or those with liver and kidney disease.

The parenteral administration is reserved for the treatment of severe acute pain, for a maximum dose of 90 mg daily and for a period no longer than 2 days.

In all the aforementioned cases, supervision by your doctor is always necessary.

Warnings LIXIDOL ® Ketorolac

The use of LIXIDOL ® should be carried out under strict medical supervision, meaning a short-term therapy reserved for medium and severe painful episodes.

In order to reduce both the incidence and the severity of the side effects normally associated with ketorolac therapy, it would be indicated to use the minimum effective dose for the shortest possible time.

Particular caution is required for patients suffering from hepatic, renal, gastro-intestinal and cardiovascular diseases, in which the possible intake of ketorolac, could aggravate the clinical picture already present or determine the appearance of new side effects.

Consequently the appearance of side effects or the possible exacerbation of the already present symptomatology, should alarm the patient, who after having heard his own doctor, could evaluate the necessity to suspend the therapy in progress.

LIXIDOL ® in tablets contains lactose, therefore its use is not recommended in patients with lactase enzyme deficiency, lactose intolerance or glucose-galactose malabsorption syndromes.

LIXIDOL ® injectable instead contains alcohol, so it is not recommended for use in those who must guide in light of the ability to cause sleepiness.

PREGNANCY AND BREASTFEEDING

In light of the numerous studies published in the literature, which have clarified the key role of prostaglandins in the process of differentiation and proliferative induction of embryonic cells, it is logical to foresee the potential side effects on the correct fetal development linked to the assumption, during pregnancy, of drugs non-steroidal anti-inflammatory drugs, including ketorolac.

Spontaneous abortions, cardiopulmonary toxicity and renal dysfunction, are the most frequently observed consequences among NSAID users during pregnancy, whose state of health could be further compromised by the anti-aggregation action of these drugs, such as to increase the risk of bleeding at the moment of childbirth.

Interactions

As described for all the other non-steroidal anti-inflammatory drugs, ketorolac, especially when taken orally, is subject to different drug interactions, some of which are clinically relevant both for the variations due to the normal therapeutic activity and for the potential effects side.

Among the most significant interactions it is necessary to describe those provided with:

  • Oral anticoagulants and serotonin reuptake inhibitors, responsible for the increased risk of bleeding;
  • Diuretics, ACE inhibitors, angiotensin II antagonists, methotrexate and cyclosporine, associated with an increase in the toxic effects of flurbiprofen especially on kidney and liver;
  • Non-steroidal anti-inflammatory drugs and corticosteroids, responsible for significant damage to the gastric mucosa;
  • Antibiotics, whose intake is often linked to a significant variation in the therapeutic profile of both drugs;
  • Sulfonylureas, potentially dangerous for alterations affecting glucose homeostasis.

Contraindications LIXIDOL ® Ketorolac

Intake of LIXIDOL ® is contraindicated in case of hypersensitivity to the active ingredient or to one of its excipients, hypersensitivity to acetylsalicylic acid and other analgesics, nasal polyposis, asthma, bronchospasm, angioedema, peptic ulcer, history of intestinal bleeding, colitis ulcer, Crohn's disease or previous history for the same conditions, cerebrovascular bleeding, bleeding diathesis or concomitant anticoagulant therapy, renal failure and liver failure.

Undesirable effects - Side effects

Systemic therapy with non-steroidal anti-inflammatory drugs is often associated with the onset of numerous side effects, the severity and incidence of which is generally proportional to the doses used and the duration of treatment.

Among the numerous side effects described both in the literature and in common clinical practice, the most relevant are those related to:

  • Gastrointestinal system, with the onset of nausea, constipation, diarrhea, epigastric pain, gastritis, ulcers and in the most serious cases haemorrhages, hepatotoxicity and liver failure;
  • Respiratory system, suffering from pulmonary edema and dyspnea;
  • Cardiovascular system, subject to hypertension, vasodilation, increase in cerebral and cardiovascular accidents;
  • Integumentary system with the appearance of angioedema, rash, increased sweating, hives and bullous reactions;
  • Urinary system with urinary anomalies and in more serious cases alterations of renal function;
  • Nervous system with headache, dizziness, vertigo, hyperkinesia and taste alterations.

In addition, allergic reactions have been described, both local and systemic, with greater frequency in patients treated with ketorolac by injection.

Note

LIXIDOL ® can be sold only with a medical prescription.