Ketorolac Reneval, 10 mg 28 pcs.

Indications

Pain syndrome of severe and moderate intensity:

• trauma;
• dental pain;
• pain in the postpartum and postoperative period;
• oncological diseases;
• myalgia;
• arthralgia;
• neuralgia;
• radiculitis;
• sprains,
• rheumatic diseases.

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Active ingredient

Ketorolac

Composition

Active ingredients:

Ketorolac (Ketorolaca tromethamine) – 10.00 mg

Excipients:

microcrystalline cellulose – 122.41 mg

corn starch – 44.76 mg

Colloidal silica (aerosil) – 1.83 mg

Magnesium stearate – 1.00 mg

Contents of the shell:

Hypromellose – 2.91 mg

titanium dioxide – 1.25 mg

macrogol 400 (polyethylene glycol 400) – 0.68 mg

talc – 0.16 mg.

How to take, the dosage

One time or repeatedly, depending on the severity of the pain syndrome.

A single dose of 10 mg (1 tablet), with repeated dosing it is recommended to take 10 mg up to 4 times a day depending on the severity of the pain.

The maximum daily dose should not exceed 40 mg.

The duration of the course should not exceed 5 days.

In order to reduce the risk of adverse events, the lowest effective dose of ketorolac should be used for the shortest possible course.

Interaction

Concomitant use of ketorolac with acetylsalicylic acid or other NSAIDs, calcium preparations, glucocorticosteroids, ethanol, corticotropin may lead to a significantly increased risk of adverse reactions, including formation of gastrointestinal ulcers and development of gastrointestinal bleeding.

Concomitant use of ketorolac with anticoagulants (including warfarin, heparin), other NSAIDs, pentoxifylline and probenecid is contraindicated.

Concomitant use of ketorolac with other NSAIDs (including cyclooxygenase-2 inhibitors) may result in fluid retention, decompensation of cardiac function, and increased blood pressure.

The concomitant use of ketorolac with indirect anticoagulants, thrombolytics, antiaggregants, cefoperazone, cefotetan and pentoxifylline increases the risk of bleeding.

Probenecid decreases plasma clearance and volume of distribution of ketorolac, increases its plasma concentration and prolongs its half-life.

The co-administration of ketorolac with sodium valproate causes impairment of platelet aggregation.

The use of ketorolac with other nephrotoxic drugs (including gold drugs) increases the risk of nephrotoxicity. Concomitant use with paracetamol increases the nephrotoxicity of ketorolac. Drugs that block tubular secretion reduce ketorolac clearance and increase its plasma concentrations.

The co-administration of ketorolac with methotrexate increases hepato- and nephrotoxicity of methotrexate. Co-administration of ketorolac and methotrexate is possible only when using low doses of the latter. Methotrexate clearance may decrease (plasma concentration of methotrexate should be monitored).

Ketorolac may decrease lithium clearance and increase its plasma concentration, and increase the toxic effects of lithium. Simultaneous use with lithium salts is contraindicated.

Ketorolac reduces the effect of hypotensive and diuretic drugs (reduces the synthesis of prostaglandins in the kidneys).

Ketorolac increases the effect of narcotic analgesics. When combined with opioid analgesics, doses of the latter may be significantly reduced.

Ketorolac increases hypoglycemic effect of insulin and oral hypoglycemic agents; therefore the doses of these drugs should be recalculated.

Ketorolac increases plasma concentrations of verapamil and nifedipine.

The concomitant use of NSAIDs and mifepristone may decrease the effectiveness of mifepristone. NSAIDs should not be used for 8-12 days after mifepristone.

The concomitant use of NSAIDs and cyclosporine increases the risk of nephrotoxicity.

The concomitant use of NSAIDs and quinolone antibiotics increases the risk of seizures.

The concomitant use of NSAIDs and tacrolimus increases the risk of nephrotoxicity.

The concomitant use of NSAIDs and zidovudine increases the risk of hematological toxicity.

In concomitant use with digoxin, ketorolac does not impair the binding of digoxin to plasma proteins. Therapeutic concentrations of digoxin do not affect the binding of ketorolac to plasma proteins.

Antacids do not affect absorption of ketorolac.

Myelotoxic drugs increase ketorolac hematotoxicity.

Special Instructions

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Contraindications

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Side effects

The incidence of adverse events (AEs) is classified according to the World Health Organization guidelines as: very common – at least 10%; common – at least 1%, but less than 10%; infrequent – at least 0.1%, but less than 1%; rare – less than 0.01%, but less than 0.1%; very rare, including single cases – less than 0.01%; frequency is unknown (frequency cannot be determined based on available data).

Digestive system disorders

Often (especially in elderly patients older than 65 years with a history of gastrointestinal erosive ulcers) – gastralgia, diarrhea;

infrequently – stomatitis, flatulence, constipation, vomiting, feeling of fullness of stomach;

rare – nausea, gastrointestinal erosive-ulcerative lesions (including those with perforation and/or bleeding – abdominal pain, epigastric spasm or burning, melena, “coffee grounds” type vomiting, nausea, heartburn), cholestatic jaundice, hepatitis, hepatomegaly, acute pancreatitis.

Urinary system disorders

. Rarely – acute renal failure, low back pain, hematuria, azotemia, hemolytic-uremic syndrome (hemolytic anemia, renal failure, thrombocytopenia, purpura), frequent urination, oliguria, polyuria, interstitial nephritis, edema of renal genesis;

frequency unknown – urinary retention.

Sensory organs

Rarely – decreased hearing, tinnitus, visual impairment (including blurred vision);

frequency unknown – impaired taste.

Respiratory system disorders

Rarely – bronchospasm or dyspnea, rhinitis, laryngeal edema (shortness of breath, difficulty in breathing).

Central nervous system disorders

Often – headache, dizziness, somnolence;

Rarely – aseptic meningitis (fever, severe headache, cramps, neck and/or back muscle stiffness), hyperactivity (mood changes, anxiety), hallucinations, depression, psychosis.

Cardiovascular system disorders

Infrequent – increased blood pressure;

rarely – pulmonary edema, syncope.

Hematopoietic disorders

Seldom – anemia, eosinophilia, leukopenia.

Hemostatic system disorders

Seldom – bleeding from the postoperative wound, nasal bleeding, rectal bleeding.

Skin disorders

Infrequent – skin rash (including maculopapular rash), purpura;

rare – exfoliative dermatitis (fever with or without chills, redness, thickening or peeling of the skin, swelling and/or pain of the palatine tonsils), urticaria, Stevens-Johnson syndrome, Lyell syndrome.

Allergic reactions

. Rarely, anaphylaxis or anaphylactoid reactions (changes in complexion, skin rash, urticaria, pruritus, tachypnea or dyspnea, edema of the eyelids, swelling of the tongue, periorbital edema, shortness of breath, difficulty in breathing, heaviness in the chest, wheezing).

Others

Often – edema (of face, shins, ankles, fingers, feet, weight gain);

infrequent – increased sweating;

rarely – fever;

frequency unknown – hyperkalemia, hyponatremia.

Overdose

Symptoms: abdominal pain, nausea, vomiting, occurrence of peptic ulcers of the stomach or erosive gastritis, impaired renal function, metabolic acidosis.

Treatment: gastric lavage, administration of adsorbents (activated charcoal) and symptomatic therapy (maintenance of vital functions in the body). Ketorolac is not eliminated sufficiently by hemodialysis.

Similarities

Dolac, Ketorol, Ketonov, Ketorolac, Ketorolac Rompharm