Ketorolol, gel 2% 30 g

Non-steroidal 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, 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, with analgesic effect due to the [-]S form. When applied topically, it alleviates or disappears pain at the gel application site, including joint pain at rest and on movement, reduces morning stiffness and joint swelling.

Helps to increase the volume of movement.

Indications

Local application for pain relief:
– for injuries (soft tissue bruise, soft tissue inflammation, including post-traumatic origin, ligament damage, bursitis, tendonitis, epicondylitis, synovitis);
– for pain in muscles (myalgia) and joints (arthralgia), neuralgia, radiculitis, rheumatic diseases.
Intended for symptomatic therapy, reducing the intensity of pain and inflammation at the time of use, does not affect the progression of the disease.

Pharmacological effect

A nonsteroidal anti-inflammatory drug (NSAID) 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, and the analgesic effect is due to the [-]S form. When applied topically, it causes a weakening or disappearance of pain at the site of application of the gel, including pain in the joints at rest and during movement, reduces morning stiffness and swelling of the joints.

Helps increase range of motion.

Special instructions

It is recommended to apply the drug only to intact areas of the skin, avoiding contact with open wounds.

Active ingredient

Ketorolac

Composition

Each 1 g of gel contains:

Active ingredient:

ketorolac tromethamine (ketorolac trometamol) – 20 mg;

Excipients:

propylene glycol 300 mg,

dimethyl sulfoxide 150 mg,

carbomer 974Р 20 mg,

sodium methyl parahydroxybenzoate 1.8 mg,

sodium propyl parahydroxybenzoate 0.2 mg,

tromethamine (trometamol) 15 mg,

purified water 390 mg,

flavoring “Drimon Inde” (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.

Contraindications

Hypersensitivity to ketorolac or other components of the drug;
weeping dermatoses, eczema, infected or open wounds (at the site of application of the gel);
complete or incomplete combination of bronchial asthma, recurrent nasal polyposis or paranasal sinuses and intolerance to acetylsalicylic acid and other NSAIDs (history of bronchospasm, urticaria or rhinitis caused by taking acetylsalicylic acid);
pregnancy (III trimester);
period of breastfeeding (lactation);
children under 16 years of age.
With caution:

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

Side Effects

Local reactions: itching, urticaria, peeling.

If any adverse reactions occur, 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 cannot be ruled out: 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

A pharmacokinetic interaction with drugs that compete for binding to plasma proteins is possible.

Caution should be exercised when using ketorolac simultaneously with digoxin, phenytoin, lithium preparations, diuretics, cyclosporine, methotrexate, other NSAIDs, antihypertensive and antidiabetic drugs. Before using the gel, you should consult a doctor if the patient is using these drugs or is under medical supervision.

Overdose

Cases of gel overdose have not been described.

Treatment: if you accidentally ingest the gel, you must empty your stomach (induce vomiting, take activated charcoal) and consult a doctor. Further treatment, if necessary, is symptomatic.

Storage conditions

At a temperature not exceeding 25 °C. Do not freeze!

Shelf life

2 years.

Manufacturer

Dr. Reddy’s Laboratories Ltd, India