Pharmacodynamics. Ketorolac tromethamine is an NSAID with a pronounced analgesic, antipyretic and anti-inflammatory effect. the mechanism of pharmacological action is associated with the blockade of the cyclic enzyme in peripheral tissues, resulting in inhibition of the biosynthesis of prostaglandins - modulators of pain sensitivity, thermoregulation and inflammation. due to this, the therapeutic effect develops directly at the site of the lesion.
The preparation contains dimethyl sulfoxide, the transporting ability of which enhances the penetration of ketorolac tromethamine through the skin directly to the affected tissues.
Pharmacokinetics. When using Ketorol gel, Cmax is in the range of 0.18-0.82 μg / ml. AUC, respectively, 6.6-9.7 hours. NSAIDs directly penetrate through the skin to a depth of 3-4 mm, then the circulatory system is transported to the subcutaneous tissue.
Post-traumatic inflammation and pain in muscles, ligaments, joints, soft tissue damage, stretch marks, dislocations, bursitis, tendonitis, epicondylitis; inflammation of the synovium; osteoarthritis of superficial joints.
Apply externally 3-4 times a day. before applying ketorol gel, wash and wipe dry the affected area. extract the gel from the tube onto the tip of the finger and apply it to the skin with light massage movements, covering the areas around the affected area. it is advisable not to cover this place with clothes.
The duration of therapy depends on the indications and the effectiveness of the treatment.
Hypersensitivity to ketorolac, acetylsalicylic acid or other NSAIDs and / or other components of the preparation; exacerbation of gastric ulcer or duodenal ulcer, bleeding in the gastrointestinal tract, perforation; patients with nasal polyposis syndrome, bronchospasm and angioedema due to the use of acetylsalicylic acid.
Sometimes skin reactions (irritation, erythema, dermatitis) may occur at the site of application.
Do not apply the gel around the eyes, mucous membranes or open wounds. wash hands before and after use. do not exceed the recommended dose.
As with any NSAID, there is a risk of bleeding and bruising. If they occur, further use of the preparation should be avoided.
Care should be taken when starting the use of Ketorol gel in patients prone to allergic reactions. In case of irritation, treatment should be discontinued.
Elderly people (over 65 years old) are more sensitive to the action of preparations. Therefore, Ketorol gel should be used with caution in patients of this age category.
It is also recommended to use Ketorol gel with caution in persons with impaired renal and / or liver function, with cardiovascular diseases, with hypertension and if the previous intake of ketorolac was accompanied by fluid accumulation and edema. Before the start of use and during the treatment of Ketorol gel, it is recommended to monitor the indicators of liver function tests. In case of an increase in liver enzymes in comparison with their indicators at the beginning of treatment, use should be discontinued.
Use during pregnancy and lactation. The preparation is not used during pregnancy and lactation.
Children. The preparation is not prescribed for children under the age of 16.
The ability to influence the reaction rate when driving or working with other mechanisms. The possibility of drowsiness, dizziness, depression, insomnia should be taken into account, which leads to a decrease in concentration of attention, as a result of which the body's ability to react quickly when driving or working with other mechanisms may deteriorate.
No clinically significant interaction with other preparations was reported with the topical application of ketorol gel, but it should be borne in mind that if it is likely to enter the systemic circulation, interactions are possible that have been studied with oral administration of ketorolac tromethamine. it is known about a slight decrease in the binding of warfarin to blood plasma proteins. In vitro studies have shown that at therapeutic concentrations of salicylate, the binding of ketorolac to blood plasma proteins decreases from 99.2 to 97.5%, which can lead to an increase in the content of free ketorolac. ketorolac reduces the diuretic effect of furosemide by about 20%. with the combined appointment of probenicide and ketorolac, an increase in the concentration of ketorolac in the blood plasma and an increase in its t½ from the body are noted. with simultaneous use with lithium preparations, it is possible to inhibit the renal clearance of lithium, therefore, the lithium content in the blood plasma may increase. ketorolac can interact with non-depolarizing muscle relaxants, which can lead to respiratory failure. the simultaneous use of ketorolac with APF inhibitors may increase the risk of developing renal dysfunction, especially in patients with hypovolemia (reduced volume of intercellular fluid). the simultaneous use of ketorolac with anticoagulants may increase the risk of bleeding. do not use with other NSAIDs due to increased severity of side effects.
There are no cases of overdose of ketorolac tromethamine in the form of a gel when applied externally to small areas of the skin.
The development of systemic adverse reactions is possible with the use of the preparation for a long time, in high doses or on large areas of the skin. The specific antidote is unknown. Treatment is symptomatic.
At a temperature not higher than 25 ° C.
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