Ketorol gel for external use 30 g
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Active ingredients
Ketorolac
Release form
Gel
Composition
Each 1 g of gel contains: Active substance: Ketorolaka tromethamine (Ketorolaka trometamol) - 20 mg; ; Excipients: propylene glycol 300 mg, dimethyl sulfoxide 150 mg, carbomer 974P 20 mg, methyl parahydroxybenzoate sodium 1.8 mg, propyl parahydroxybenzoate sodium 0.2 mg, tromethamine (trometamol) 15 mg, purified water 390 mg, flavoring "Drymon Indo" (triethyl citrate) 0.09%, castor bean seed oil 0.14%, isopropyl myristate 0.30%, diethyl phthalate 24.15%) 3 mg, ethanol 50 mg, glycerol 50 mg.
Pharmacological effect
Nonsteroidal anti-inflammatory drug (NSAIDs), has a pronounced analgesic and anti-inflammatory effect. The mechanism of action is associated with non-selective inhibition of the activity of cyclooxygenase (COX) - COX-1 and COX-2, which catalyzes the formation of prostaglandins from arachidonic acid, which play an important role in the pathogenesis of pain, inflammation and fever. Ketorolac is a racemic mixture of [-] S and [+] R enantiomers, while the analgesic effect is due to [-] S form.; When applied topically, it causes the pain to weaken or disappear at the site of gel application, including joint pain at rest and when moving, reduces morning stiffness and swelling of joints. Contributes to increased range of motion.
Indications
Local application for the relief of pain: - with injuries (soft tissue contusion, inflammation of soft tissues, including those of post-traumatic origin, damage to the ligaments, bursitis, tendonitis, epicondylitis, synovitis); - for pain in the muscles (myalgia) and joints (arthralgia), neuralgia, radiculitis, rheumatic diseases .; Designed for symptomatic therapy, reducing the intensity of pain and inflammation at the time of use, does not affect the progression of the disease.
Contraindications
- Hypersensitivity to ketorolac or other components of the drug; - weeping dermatosis, eczema, infected or open wounds (at the site of application of the gel); - A complete or incomplete combination of asthma, recurrent nasal polyposis or paranasal sinuses and intolerance to acetylsalicylic acid and other NSAIDs (a history of bronchospasm, urticaria or rhinitis caused by the intake of acetylsalicylic acid); - pregnancy (III trimester); - breastfeeding period (lactation); ; - children's age up to 16 years.
Use during pregnancy and lactation
Contraindicated: pregnancy (III trimester) and the period of breastfeeding (lactation). With care: pregnancy (I and II trimester).
Dosage and administration
For external use only.; Before applying the gel, wash and dry the skin surface. Apply with a uniform thin layer a gel column about 1-2 cm long on the area of maximum pain 3-4 times a day. The drug is applied by soft massaging movements, by means of which the gel is distributed over the skin over the affected area. The drug should be reused no earlier than after 4 hours. Use the drug no more than 4 times a day. Do not exceed the specified dose.; If the symptoms persist or worsen, or there is no improvement after 10 days of using the drug, you should stop treatment and consult a doctor. Do not use the gel for more than 10 days without consulting a doctor.
Side effects
Local reactions: itching, urticaria, peeling.; If any adverse reactions occur, discontinue use of the drug and consult a doctor .; When applying the gel on large areas of the skin, the development of systemic adverse reactions is possible: heartburn, nausea, vomiting, diarrhea, gastralgia, ulceration of the gastrointestinal mucosa, increased activity of liver transaminases headache, dizziness; fluid retention, hematuria; allergic reactions (anaphylactic shock, skin rash); thrombocytopenia, leukopenia, anemia, agranulocytosis, prolongation of bleeding time.
Overdose
Cases of gel overdose are not described. In case of accidental ingestion of the gel, it is necessary to clean the stomach (by causing vomiting, taking activated carbon) and consult a doctor. Further treatment, if necessary, symptomatic.
Interaction with other drugs
Pharmacokinetic interaction with drugs competing for binding to plasma proteins is not excluded; Care should be taken with simultaneous use of ketorolac with digoxin, phenytoin, lithium preparations, diuretics, cyclosporine, methotrexate, other NSAIDs, antihypertensive and antidiabetic drugs .; Before using the gel, you should consult with your doctor if you use these funds or are under the supervision of a doctor.
special instructions
The drug is recommended to be applied only to intact skin, avoiding contact with open wounds. Avoid getting the gel in the eyes and other mucous membranes. Do not use the gel under air-tight dressings. After applying the gel, wash your hands with soap and water. Close the tube tightly after using the gel.