Description
Ketorol - gel for external use 2% homogeneous, transparent or translucent, with a characteristic odor.
Release form
Gel
Composition
Basis: Ketorolak tromethamine (Ketorolac trometamol) 20 mg. Additional substances: propylene glycol - 300 mg, dimethyl sulphoxide - 150 mg, carbomer 974P - 20 mg, methyl parahydroxybenzoate sodium - 1.8 mg, propyl parahydroxybenzoate sodium - 0.2 mg, tromethamine sodium nitrate - 1.8 mg, propyl parahydroxybenzoate sodium - 0.2 mg, tromethamine sodium nitrometer - 1.8 mg, propyl parahydroxybenzoate sodium - 0.2 mg, tromethamine sodium nitrate - 1.8 mg; - 390 mg, Drimon Indus fragrance (triethyl citrate - 0.09%, castor bean seed oil - 0.14%, isopropyl myristate - 0.3%, diethyl phthalate - 24.15%) - 3 mg, ethanol - 50 mg, glycerol - 50 mg.
Pharmacological effect
NSAIDs for external use. It has a pronounced analgesic effect and anti-inflammatory effect. The mechanism of action is associated with non-selective inhibition of the activity of COX (COX-1 and COX-2), catalyzing 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 the [-] S-form. When applied topically, it causes the pain to weaken or disappear, 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 in the following diseases: - injuries (soft tissue injuries, inflammation of soft tissues, including post-traumatic origin, damage to ligaments) - bursitis, tendonitis, epicondylitis, synovitis. - myalgia, arthralgia. - neuralgia, radiculitis. - rheumatic diseases. It is intended for symptomatic therapy, reducing the intensity of pain and inflammation at the time of use, it does not affect the progression of the disease.
Contraindications
There are CONTRAINDICATIONS. BEFORE USE IT IS REQUIRED TO READ THE INSTRUCTIONS
Use during pregnancy and lactation
Use of the drug in the III trimester of pregnancy and during lactation (breastfeeding) is contraindicated. With caution should use the drug in the I and II trimesters of pregnancy.
Dosage and administration
The drug is used externally.Wash and dry the skin before applying the gel. Apply a gel column of about 1-2 cm in length to a region of maximum pain 3-4 times / day in a uniform thin layer. The drug is applied by soft massaging movements, through which the gel is distributed over the skin over the affected area. The drug should be reused no earlier than 4 hours. The gel should be used no more than 4 times / day. Do not exceed the recommended 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, desquamation.
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 hepatic 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.
Treatment: in case of accidental ingestion of the gel, it is necessary to clean the stomach (induction of 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 possible. Care should be taken with simultaneous use of ketorolac with digoxin, phenytoin, lithium preparations, diuretics, cyclosporin, methotrexate, other NSAIDs, hypotensive and hypoglycemic agents. If the patient uses these agents is under the supervision of a doctor, it is necessary to consult 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.
Storage conditions
In a cool dry place. Keep out of the reach of children. Do not expose to direct sunlight. At room temperature
