Ketorol gel 2%, 30g

Composition

Each 1 g of gel contains: Active ingredient: ketorolac trometamine – ketorolac trometamol) – 20 mg; Excipients: propylene glycol 300 mg,150 mg of dimethyl sulfoxide, karbomer 974 R 20 mg, methyl parahydroxybenzoate sodium 1.8 mg, parahydroxybenzoate sodium 0.2 mg, trometamin (trometamol) 15 mg, purified water 390 mg, flavor “”Drymon the Indus”” (triethylcitrate 0.09 percent, the common castor bean seed oil 0,14%, methyl ethyl ketone 0,30%, diethyl 24,15%) 3 mg,50 mg ethanol, glycerol 50 mg.

Pharmacological action

Nonsteroidal anti-inflammatory drug (NSAID), has a pronounced analgesic and anti-inflammatory effect. The mechanism of action is associated with non-selective inhibition of cyclooxygenase (COX) activity – 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, and the analgesic effect is due to the [-]S form. When applied topically, it relieves or disappears pain at the site of application of the gel, including joint pain at rest and during movement, reduces morning stiffness and swelling of the joints. Helps to increase the volume of movement.

Indications

Topical application for pain relief:  – for injuries (soft tissue contusion, soft tissue inflammation, including post-traumatic origin, ligament damage, bursitis, tendinitis, epicondylitis, synovitis); – for muscle pain (myalgia) and joints (arthralgia), neuralgia, sciatica, rheumatic diseases. It is intended for symptomatic therapy, reducing the intensity of pain and inflammation at the time of use, and does not affect the progression of the disease.

Contraindications

• Hypersensitivity to ketorolac or other components of the drug; 
• weeping dermatitis, eczema, infected or open wounds (in the application of the gel);
• complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose or paranasal sinuses and intolerance of acetylsalicylic acid and other NSAIDs (specifying a history of bronchospasm, urticaria or rhinitis, caused by taking aspirin);
• pregnancy (III trimester);
• lactation (lactation);
• children up to age 16 years.

With caution:Exacerbation of hepatic porphyria, erosive and ulcerative lesions of the gastrointestinal tract, severe renal / hepatic insufficiency, chronic heart failure, bronchial asthma, old age, pregnancy (I and II trimester).

Side effects

Local reactions: itching, hives, and flaking. If you experience any adverse reactions, you should stop using the drug and consult your doctor. When applying the gel to large areas of the skin, the development of systemic adverse reactions is not excluded: 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.

Interaction

Pharmacokinetic interaction with drugs competing for binding to plasma proteins is not excluded.

Caution should be exercised when ketorolac is co-administered with digoxin, phenytoin, lithium preparations, diuretics, cyclosporine, methotrexate, other NSAIDs, antihypertensive and antidiabetic agents. Before using the gel, you should consult your doctor if the patient uses these products or is under medical supervision.

How to take, course of use and dosage

For external use only. Before applying the gel, wash and dry the skin surface. Apply a uniform thin layer of gel about 1-2 cm long to the area of maximum soreness 3-4 times a day. Application of the drug is carried out with gentle massaging movements, through which the gel is distributed over the skin over the affected area. Re-use the drug should not be earlier than 4 hours. Use the drug no more than 4 times a day. Do not exceed the specified dose. If 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.

Overdose

Cases of gel overdose are not described.

Treatment:  in case of accidental ingestion of the gel, it is necessary to clear the stomach (induction of vomiting, taking activated charcoal) and consult a doctor. Further treatment, if necessary, is symptomatic.

Description

Homogeneous transparent or semi-transparent gel with a characteristic smell.

Special instructions

The drug is recommended to be applied only to undamaged areas of the skin, avoiding contact with open wounds. Avoid contact with the gel in the eyes and other mucous membranes. Do not use the gel under airtight bandages. After applying the gel, wash your hands with soap and water. Close the tube tightly after using the gel.

Storage conditions

At a temperature not exceeding 25 °C. Do not freeze!Keep out of reach of children!

Shelf

life is 2 years.

Active ingredient

Ketorolac

Dosage form

gel for external use