Expiration date: 04/2025

Form release 

gel

Composition

1 g contains tromethamine Ketorolac (Ketorolac trometamol) 20 mg.

Packaging

Tube 30 or 50 g

Pharmacological action

Ketorol is a non - steroidal anti-inflammatory drug (NSAID) with pronounced analgesic effect. 

Ketorolac has a marked analgesic effect, also has anti-inflammatory and mild antipyretic action.

The mechanism of action is nonselective inhibition of the activity of the enzyme COX-1 and COX-2, mainly in peripheral tissues, resulting in the inhibition of the biosynthesis of prostaglandins - modulators of pain sensitivity, thermoregulation and inflammation. Ketorolac is a racemic mixture of S - and R-enantiomers, while the analgesic effect is due to S-enantiomerom.

The drug does not affect opioid receptors, not oppressing breathing, does not cause drug dependence, does not possess sedative and anxiolytic effect.

Strength of the analgesic effect comparable to morphine, significantly superior to other NSAIDs.

Indications

Local application for the relief of pain under the following conditions and diseases:

• injuries (soft tissue injuries, inflammation of soft tissues, including post-traumatic origin, ligament damage, bursitis, tendonitis, epicondylitis, synovitis and osteoarthritis),
  
• pain in muscles and joints (myalgia, arthralgia),
  
• neuralgia,
  
• radiculitis,
  
• rheumatic diseases (articular syndrome with exacerbation of gout, psoriatic arthritis, ankylosing spondylitis).
  
• Intended for symptomatic therapy, reducing intensity of pain and inflammation at the point of use, on disease progression is not affected.
  

Contraindications

• hypersensitivity,
  
• weeping dermatitis, eczema, infected abrasion, the wound in the site of the proposed application,
  
• full or partial combination of bronchial asthma, recurrent polyposis of the nose or paranasal sinuses and intolerance of acetylsalicylic acid and other NSAIDs (including history),
  
• pregnancy (III trimester),
  
• lactation,
  
• children up to age 12 years.
  
• Caution: aggravation of hepatic porfirii, erosivno-azwenne defeat of the gastrointestinal tract, severe renal/hepatic insufficiency, chronic heart failure, bronchial asthma, old age, pregnancy (I and II trimester).
  

Method of application and doses

Outwardly.

Before applying the gel, wash and dry the surface of the skin. A uniform thin layer is applied to the column gel with a length of about 1-2 cm at the area of maximum pain 3-4 times a day. The application of the drug is carried out with gentle massaging movements, by which the distribution of the gel on the skin over the affected area.

The amount of gel, and the frequency of application (no more than 4 times a day) can vary depending on the size of the area being treated and patient response.

Do not apply the gel more than 10 days without consulting a doctor.

Side effect

Local reactions: itching, hives, flaking.

If you experience any adverse reactions, discontinue the drug and consult a doctor.

When applying the gel on large areas of skin can not be excluded the development of systemic adverse reactions: heartburn, nausea, vomiting, diarrhea, gastralgia, ulceration of the gastrointestinal mucosa, increase in liver transaminases, headache, dizziness, fluid retention, hematuria, allergic reactions (anaphylactic shock, skin rash), thrombocytopenia, leukopenia, anemia, agranulocytosis, prolongation of bleeding time.

Special instruction

The drug should be applied only to intact skin, avoiding open wounds. Avoid contact of gel with eyes and other mucous membranes. Do not use the gel under airtight dressings. After applying the gel wash hands with soap and water. Tightly close the tube after using the gel.

Drug interaction

It is not excluded pharmacokinetic interactions with drugs competing for the relationship with blood plasma proteins.

Caution should be exercised with simultaneous use of Ketorolac with digoxin, phenytoin, lithium drugs, diuretics, cyclosporine, methotrexate, other NSAIDs, anti-hypertensive and anti-diabetic agents.

Before using the gel you should consult your doctor if the patient uses those means, or is under the supervision of a physician.

Overdose

Cases of overdose not described gel.

Treatment: in case of accidental ingestion of the gel inside it is necessary to empty the stomach (induction of vomiting, administration of activated charcoal) and to go to the doctor. Further treatment, if necessary, symptomatic.

Storage conditions

At temperatures above 25 °C (do not freeze).

Shelf life

2 years.