Ketorol - instructions for use, dose, side effects, contraindications

Excipients: propylene glycol 300 mg, Dimethyl sulfoxide 150 mg, carbomer 974P 20 mg, methylparahydroxybenzoate sodium 1.8 mg, sodium propylparahydroxybenzoate 0.2 mg, tromethamine (trometamol) 15 mg, water purified 390 mg, flavoring "Dreamon Inde" (triethyl citrate 0.09%, castor oil ordinary seeds oil 0.14%, isopropyl myristate 0.3 0%, diethyl phthalate 24.15%) 3 mg, ethanol 50 mg, glycerol 50 mg.

Description:

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

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID)

ATX: & nbsp

M.01.A.B.15 Ketorolac

Pharmacodynamics:

Nonsteroidal anti-inflammatory drug (NSAID), has a pronounced analgesic and anti-inflammatory effect. The mechanism of action is associated with nonselective inhibition of cyclooxygenase (COX) -COG-1 and COX-2 activity 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 [-]S and [+]R enantiomers, while the analgesic effect is due to [-]S form.

When topical application causes the weakening or disappearance of pain in the place of application of the gel, including joint pain at rest and during movement, reduces morning stiffness and swelling of the joints. Promotes an increase in the volume of movements.

Indications:

Local application for relief of pain syndrome:

- Injuries (soft tissue injury, inflammation of soft tissues, including post-traumatic origin, ligament damage, bursitis, tendonitis, epicondylitis, synovitis);

- with pain in the muscles (myalgia) and joints (arthralgia), neuralgia, radiculitis, rheumatic diseases.

It is intended for symptomatic therapy, reducing the intensity of pain and inflammation at the time of use, the progression of the disease is not affected.

Contraindications:

- Hypersensitivity to ketorolac or other components of the drug;

- wet 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, hives, or rhinitis caused by acetylsalicylic acid);

- pregnancy (III trimester);

- the period of breastfeeding (lactation);

- Children's age till 16 years.

Carefully:

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

Dosing and Administration:

For external use only.

Before applying the gel, wash and dry the surface of the track. In a uniform thin layer, apply a gel column about 1-2 cm long to the area of maximum soreness 3-4 times a day. Application of the drug is carried out by soft massaging movements, through which the gel spreads over the skin over the affected area.

Re-use the drug should not be earlier than 4 hours later. Apply the drug no more than 4 times a day. Do not exceed the indicated dose.

If symptoms persist or worsen, or if there is no improvement after 10 days of use, stop treatment and consult a doctor.Do not apply gel for more than 10 days without consulting a doctor.

Side effects:

Local reactions: itching, hives, scaling.

If any adverse reactions occur, discontinue use and consult a physician.

When applying the gel to large areas of the skin, it is possible to develop systemic adverse reactions: 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 an overdose of gel are not described. If you accidentally take the gel inside, you need to clean the stomach (causing vomiting, taking activated charcoal) and contact your doctor. Further treatment, if necessary, symptomatic.

Interaction:

Pharmacokinetic interaction with drugs competing for binding to blood plasma proteins is not ruled out.

Caution should be exercised while using ketorolac with digoxin, phenytoin, lithium preparations, diuretics,cyclosporine, methotrexate, other NSAIDs, antihypertensive and anti-diabetic agents. Before using the gel, you should consult your doctor if you are using these drugs or are under medical supervision.

Special instructions:

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

Form release / dosage:Gel for external use 2%.

Packaging:

To 30 grams or 50 g in a tube of laminated aluminum, equipped with a membrane to control the first opening.

Tuba with instructions for use in a pack of cardboard.

Storage conditions:

At a temperature of no higher than 25 ° C. Do not freeze!

Keep out of the reach of children!

Shelf life:

2 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-001080

Date of registration:02.11.2011 / 18.04.2017

Expiration Date:Unlimited

The owner of the registration certificate:Dr. Reddy's Laboratories Ltd.Dr. Reddy's Laboratories Ltd. India

Manufacturer: & nbsp

DR. REDDY`S LABORATORIES, LTD. India

Representation: & nbspDr. Reddy`c Laboratoris Ltd.Dr. Reddy`c Laboratoris Ltd.

Information update date: & nbsp16.11.2017

Illustrated instructions

Instructions

Ketorol® (Ketorol®)