TORADOL ® Ketorolac

TORADOL ® is a drug based on Ketorolac trometamine

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

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

Indications TORADOL ® Ketorolac

TORADOL ® is indicated, as an alternative or in combination with opioid therapy, for the treatment of pain of a medium to severe post-operative level.

Mechanism of action TORADOL ® Ketorolac

TORADOL ® is a drug based on ketorolac tromethamine, an active ingredient derived from arylacetic acid and belonging to the category of non-steroidal anti-inflammatory drugs, commonly used in the treatment of painful states on an inflammatory basis.

Its particular therapeutic efficacy is mainly due to its marked analgesic power, which has proved to be decidedly superior compared to that of other anti-inflammatories such as salicylates, carried out essentially through the inhibition of prostaglandin synthesis, especially PGE2, responsible among other activities, including activation of some peripheral receptors involved in pain transmission.

The biological activity of ketorolac however is represented by the inhibition exercised against cyclooxygenases, enzymes expressed following injurious stimuli of various kinds, capable of catalyzing the transformation of a membrane phospholipid such as arachidonic acid into a class of mediators chemicals, known as prostaglandins, with vasopermeabilization, chemotactic, algogenic and pyrogenic activity.

It is therefore evident that the control of the expression of these substances can contribute to the remission of the pain symptomatology present during inflammatory diseases of significant importance.

Studies carried out and clinical efficacy

1. THE EFFECTIVENESS OF KETOROLAC IN THE EYE CLINIC

Eye (Lond). 2011 Feb; 25 (2): 154-60. Epub 2010 Nov 19.

Recent clinical study that demonstrates how intravenous administration of ketorolac can be effective in reducing post-operative pain following surgery necessary in the treatment of strabismus.

2. INTRANASAL ADMINISTRATION OF KETOROLAC

Curr Med Res Opin. 2010 Aug; 26 (8): 1915-23.

Very interesting work that demonstrates how the intranasal intake of ketorolac can be effective and well tolerated, guaranteeing an improvement in symptoms even after only 20 minutes from the active ingredient.

3. KETOROLAC IN PEDIATRIC AGE

Intensive Care Med. 2009 Sep; 35 (9): 1584-92. Epub 2009 Jun 27.

Study demonstrating the efficacy and relative safety of using ketorolac following cardiac surgery even in pediatric patients. No clinically relevant case of nephrotoxicity has been observed in this trial.

Method of use and dosage

TORADOL ®

10 mg ketorolac tromethamine-coated tablets;

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

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

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

For the treatment of moderate pain, we recommend taking oral ketorolac, at the maximum daily dose of 40 mg, possibly divided into several 10 mg administrations spaced by a period of at least 4-6 hours.

The aforementioned treatment must absolutely not exceed the maximum duration of 5 days.

On the other hand, severe pain should be treated acutely as parenteral ketorolac, taking care not to exceed the maximum dose of 90 mg daily for a maximum period of two days.

Intravenous administration is instead reserved for hospital use.

In all cases it is always necessary to consult your doctor.

Warning TORADOL ® Ketorolac

TORADOL ® therapy should be understood as a symptom therapy useful in overcoming an acute phase of moderate to severe pain.

The use of TORADOL ® must necessarily take place under strict medical supervision, given the numerous side effects associated with ketorolac therapy and the known contraindications.

For this reason the use of ketorolac should be done with particular care in all those patients suffering from

hepatic, renal, gastro-intestinal and cardiovascular pathologies, in which this therapy could aggravate the possible clinical picture or determine the appearance of new side effects.

In order to minimize the development of adverse reactions it would be advisable to use the minimum effective dose for the shortest time necessary to guarantee a remission of symptoms.

Should unexpected reactions appear or any exacerbations of the pathologies already present, the patient, after having contacted his doctor, should evaluate the possibility of suspending the therapy in progress.

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

TORADOL ® 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

Taking TORADOL ® during pregnancy is strictly contraindicated, given the potential toxic effects of non-steroidal anti-inflammatory drugs on fetal health.

Different studies show that high blood concentrations of non-steroidal anti-inflammatory drugs can induce kidney and lung malformations in the fetus, compromising their vitality and at the same time increasing the frequency of unwanted spontaneous abortions.

The use of NSAIDs in this period could damage the health of the pregnant woman, given the increased risk of bleeding related to childbirth.

Interactions

Different pharmacokinetic studies demonstrate how the therapeutic efficacy and safety profile of ketorolac can be compromised by the simultaneous intake of other active ingredients such as:

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.

It is therefore recommended to consult your doctor, should the need arise to combine further pharmacological therapies with that already in place with ketorolac.

Contraindications TORADOL ® Ketorolac

The use of TORADOL ® 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

The use of ketorolac, especially when continued for prolonged periods of time or carried out at particularly high dosages, is often associated with the appearance of widespread side effects between various organs and systems.

Among the most frequently documented adverse reactions it is possible to describe: nausea, constipation, diarrhea, epigastric pain, gastritis, ulcers and in the most serious cases haemorrhages, hepatotoxicity and hepatic insufficiency, pulmonary edema and dyspnea, hypertension, vasodilation, increase in cerebral and cardiovascular accidents, angioedema, rash, increased sweating, urticaria and bullous reactions, alterations in renal function, headache, dizziness, vertigo, hyperkinesia and taste changes.

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