Ketanov is a nonsteroidal anti-inflammatory agent (NSAID) with antipyretic and pronounced analgesic effect.
Release form and composition
Forms of Ketanov:
- Coated tablets - 10 pcs. in blisters, in a carton pack of 1, 2, 3 or 10 blisters;
- Solution for intramuscular (v / m) administration - 1 ml in ampoules, in a cardboard bundle of 5 or 10 ampoules.
The active ingredient of the drug is ketorolac tromethamine: in 1 tablet - 10 mg, in 1 ml of solution - 30 mg.
Auxiliary components of tablets: microcrystalline cellulose, corn starch, magnesium stearate, colloidal silicon dioxide.
The composition of the film shell of the tablets: polyethylene glycol 400, titanium dioxide, hydroxypropylmethylcellulose, talc and purified water, which is lost during the production process.
Additional components of the solution: disodium edetate, sodium chloride, sodium hydroxide, ethanol, and injectable water.
Indications for use
Ketans are intended for the relief of pain of various origins of medium and strong intensity, including in case of cancer and in the postoperative period.
- Chronic pain;
- Peptic ulcers, aggravation of erosive-ulcerative lesions of the gastrointestinal tract (GIT), hypocoagulation (including hemophilia);
- Hemorrhagic stroke or suspicion of its presence, hemorrhagic diathesis, impaired blood formation, high risk of developing or recurrent bleeding (including in the postoperative period);
- Hepatic / renal failure (with plasma creatinine greater than 50 mg / l);
- Anesthesia before surgery and during surgery (due to the high risk of bleeding);
- Simultaneous reception of other NSAIDs;
- Children's age up to 16 years (due to the lack of data on the effectiveness and safety of use);
- Pregnancy, childbirth and the period of breastfeeding;
- Dehydration, hypovolemia (regardless of the cause);
- Hypersensitivity to ketorolac, excipients or other NSAIDs, angioedema, bronchospasm, aspirin asthma.
Special supervision during treatment is required in the following cases:
- Age over 65 years;
- Active hepatitis;
- Arterial hypertension;
- Chronic heart failure;
- Impaired renal function (if plasma creatinine is less than 50 mg / l);
- Polyps of the nasal mucosa and nasopharynx;
- Systemic lupus erythematosus;
- Bronchial asthma;
Dosing and Administration
In the form of tablets, the drug is taken orally. A single dose is 10 mg (1 tablet). If necessary, repeat doses appoint 1 tablet up to 4 times a day, depending on the severity of pain. The maximum duration of admission - 5 days.
The solution is injected deep intramuscularly in the minimum effective doses, which are selected individually, taking into account the intensity of pain and the effectiveness of the drug.
Recommended single doses:
- Patients under 65 years old - 10-30 mg;
- Patients older than 65 years and patients with impaired renal function - 10-15 mg.
If necessary, repeated use of the drug between injections comply with 4-6-hour intervals.
The course of treatment is not more than 5 days.
The maximum permissible daily dose for i / m injection: for patients under 65 years old - 90 mg, patients over 65 years of age and patients with impaired renal function - 60 mg.
When transferring a patient from parenteral administration of the drug to oral administration, the total daily dose of both dosage forms should be considered. On the day of transition, the dose in tablets should not exceed 30 mg.
Adverse reactions are classified as follows:
- Often in more than 3% of patients;
- Less often - 1-3%;
- Rarely - less than 1%.
Possible side effects:
- The digestive system: often (especially in people over the age of 65, with a history of erosive and ulcerative lesions of the gastrointestinal tract) - diarrhea, gastralgia; less often - flatulence, feeling of fullness in the stomach, vomiting, constipation, stomatitis; rarely - erosive and ulcerative lesions of the gastrointestinal tract (including bleeding and / or perforation - burning or spasm in the epigastric region, abdominal pain, heartburn, nausea, vomiting like coffee grounds, melena, etc.), nausea, hepatitis, acute pancreatitis, cholestatic jaundice, hepatomegaly;
- Urinary system: rarely - frequent urination, edema of renal genesis, nephritis, increase or decrease in urine volume, hemolytic uremic syndrome (hemolytic anemia, purpura, thrombocytopenia, renal failure,), back pain (including with hematuria and / or azotemia) acute renal failure;
- Central nervous system: often - drowsiness, dizziness and headache; rarely, hyperactivity (anxiety, mood changes), hallucinations, psychosis, depression, aseptic meningitis (severe headache, fever, stiff muscles of the back and / or neck, convulsions);
- Cardiovascular system: less often - increase in blood pressure; rarely - fainting, pulmonary edema;
- Respiratory system: rarely - rhinitis, dyspnea or bronchospasm, laryngeal edema, manifested by shortness of breath and difficulty breathing;
- Sense organs: rarely - tinnitus, hearing loss and visual impairment (including blurred vision);
- Hematopoiesis: rarely - eosinophilia, anemia, leukopenia;
- Hemostasis system: rarely - nasal or rectal bleeding, bleeding from a postoperative wound;
- Skin: less often - purpura, skin rash (including maculopapulla); rarely - urticaria, exfoliative dermatitis (fever, sometimes with chills, peeling, redness and / or hardening of the skin, soreness and / or swelling of the tonsils), Lyell and Stevens-Johnson syndromes;
- Allergic reactions: rarely - anaphylaxis or anaphylactoid reactions (skin itching, rash, urticaria, discoloration of the skin, eyelid edema, shortness of breath, chest tightness, tachypnea or dyspnea, difficulty breathing, periorbital edema, wheezing);
- Other: often - edema (feet, fingers, ankles, legs, face), weight gain; less often, excessive sweating; rarely fever, swelling of the tongue.
Overdose symptoms: nausea, vomiting, abdominal pain, metabolic acidosis, impaired kidney function, peptic ulcers of the stomach or erosive gastritis. Treatment involves gastric lavage, the introduction of adsorbents and symptomatic therapy aimed at maintaining the vital functions of the body. Dialysis is ineffective.
Ketans are not recommended as an anesthetic in obstetric practice, as well as for sedation and supportive anesthesia.
In patients with hypovolemia, the likelihood of adverse reactions from the kidneys increases.
The drug can be prescribed in combination with narcotic analgesics (in reduced doses).
Ketans should not be taken simultaneously with paracetamol for longer than 5 days.
Patients with impaired blood coagulation in the period of treatment requires constant monitoring of the number of platelets, especially in the postoperative period.
Drowsiness, dizziness and headache are quite frequent side effects from the central nervous system with potentially dangerous consequences. Therefore, at the time of treatment, it is recommended to refrain from performing work that requires reaction speed and increased attention (including from driving vehicles).
With the combined use of ketorolac with ethanol, glucocorticosteroids, corticotropin, calcium supplements, acetylsalicylic acid or other NSAIDs, gastrointestinal ulcers may form and gastrointestinal bleeding may develop.
The risk of bleeding is also increased by indirect anticoagulants, antiplatelet agents, thrombolytics, heparin, pentoxifylline, cefotetan and cefoperazone.
When used simultaneously with paracetamol and other nephrotoxic drugs (including gold medications), nephrotoxicity increases, with lithium and methotrexate, nephrotoxicity and nephrotoxicity. The combination of ketorolac with methotrexate is possible only with the appointment of lower doses of the latter, while in the process of treatment it is necessary to monitor its concentration in the blood plasma.
The combination of Ketanova with sodium valproate leads to disruption of platelet aggregation.
Probenicid and preparations blocking tubular secretion, reduce the plasma clearance of ketorolac and increase its concentration in plasma.
The drug enhances the action of oral hypoglycemic agents and insulin, therefore, it is necessary to recalculate their doses.
Ketorolac reduces the effectiveness of diuretic and antihypertensive drugs, increases plasma concentration of nifedipine and verapamil.
Antacids do not affect the absorption of Ketanov.
The injection solution should not be mixed in the same syringe with hydroxyzine, promethazine and morphine sulfate, since precipitate falls.
Ketorolac is pharmaceutically incompatible with lithium preparations and tramadol solution.
Ketanov injection solution is compatible with solutions of dextrose 5%, Plasmalite, Ringer, Ringer-lactate, as well as with infusion solutions containing heparin sodium salt, dopamine hydrochloride, lidocaine hydrochloride, aminophylline and short-acting human insulin.
Terms and conditions of storage
Store at a temperature up to 25 ºС in a dark place, dry and out of reach of children.
Shelf life - 3 years.