Ketorol gel 2% tube 30 g

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 COX 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 drug contains dimethyl sulfoxide, the transport ability of which enhances the penetration of ketorolac tromethamine through the skin directly to the affected tissues.

Pharmacokinetics. When using Ketorol gel, C _max is within 0.18-0.82 μg/ml. AUC, respectively, 6.6-9.7 h. NSAIDs directly penetrate the skin to a depth of 3-4 mm, then are transported by the circulatory system to the subcutaneous tissues.

Post-traumatic inflammation and pain in muscles, ligaments, joints, soft tissue injuries, sprains, dislocations, bursitis, tendonitis, epicondylitis; inflammation of the synovial membrane; osteoarthritis of superficial joints.

Apply externally 3-4 times a day. Before applying Ketorol gel, wash and dry the affected area. Remove the gel from the tube onto the tip of your finger and apply to the skin with light massage movements, covering the areas around the affected area. It is advisable not to cover this area with clothing.

The duration of therapy depends on the indications and effectiveness of treatment.

• Hypersensitivity to ketorolac, acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs and/or other components of the drug; exacerbation of gastric or duodenal ulcer, gastrointestinal bleeding, 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 to areas around the eyes, mucous membranes or open wounds. Wash hands before and after application. DO NOT exceed the recommended dose.

As with any non-steroidal anti-inflammatory drug, there is a risk of bleeding and bruising. If this occurs, further use of the drug should be avoided.

Ketorol gel should be used with caution in patients prone to allergic reactions. If irritation occurs, treatment should be discontinued.

Elderly people (over 65 years of age) are more sensitive to the effects of drugs. Therefore, Ketorol gel should be used with caution in patients of this age group.

It is also recommended to use Ketorol gel with caution in people with impaired renal and/or hepatic function, with cardiovascular diseases, with hypertension and in cases where previous ketorolac administration was accompanied by fluid retention and edema. Before starting use and during treatment with Ketorol gel, it is recommended to monitor liver function tests. In case of an increase in liver enzymes compared to their values ​​at the beginning of treatment, the use should be discontinued.

Use during pregnancy and breastfeeding. The drug is not used during pregnancy and breastfeeding.

Children. The drug is not prescribed to children under 16 years of age.

Ability to influence the reaction speed when driving vehicles or working with other mechanisms. It is necessary to take into account the possibility of drowsiness, dizziness, depression, insomnia, which leads to a decrease in concentration, as a result of which the body’s ability to react quickly when driving vehicles or working with other mechanisms may deteriorate.

No clinically significant interactions with other drugs have been reported with topical application of Ketorol gel, but it should be borne in mind that with probable systemic exposure, interactions are possible that have been studied with oral administration of ketorolac tromethamine. A slight decrease in the binding of warfarin to plasma proteins is known. In vitro studies have shown that at therapeutic concentrations of salicylate, the binding of ketorolac to plasma proteins decreases from 99.2 to 97.5%, which may lead to an increase in the content of free ketorolac. Ketorolac reduces the diuretic effect of furosemide by approximately 20%. With the combined administration of probenecid and ketorolac, an increase in the concentration of ketorolac in the blood plasma and a prolongation of its half-life from the body are noted. With simultaneous use with lithium preparations, inhibition of renal clearance of lithium is possible, so the content of lithium in the blood plasma may increase. Ketorolac may interact with non-depolarizing muscle relaxants, which may lead to respiratory failure. Concomitant use of ketorolac with ACE inhibitors may increase the risk of renal dysfunction, especially in patients with hypovolemia (decreased interstitial fluid volume). Concomitant 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 gel form when applied externally to small areas of skin.

The development of systemic adverse reactions is possible when using the drug for a long time, in high doses or on large areas of the skin. A specific antidote is not known. Treatment is symptomatic.

At a temperature not exceeding 25 °C.