Ketokam
Ketokam: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Ketokam
ATX code: M01AB15
Active ingredient: ketorolac (ketorolac)
Manufacturer: SIMPEX PHARMA, Pvt. Ltd. (India)
Description and photo update: 2018-21-11
Prices in pharmacies: from 47 rubles.
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Ketokam is a non-steroidal anti-inflammatory drug (NSAID) with a pronounced analgesic effect.
Release form and composition
Dosage form Ketokam - film-coated tablets: biconvex, round, almost white (in a blister of 10 pcs., In a cardboard box 1, 2, 10, 20 or 100 blisters).
Composition of one tablet:
- active substance: ketorolac trometamol - 10 mg;
- auxiliary components (core): microcrystalline cellulose, corn starch (dried), magnesium stearate, colloidal silicon dioxide;
- shell: universal shell (hypromellose, titanium dioxide, macrogol, talc).
Pharmacological properties
Pharmacodynamics
Ketorolac trometamol has a strong analgesic effect, as well as a moderate antipyretic and anti-inflammatory effect. Its mechanism of action consists in non-selective inhibition of the activity of the enzymes cyclooxygenase-1 and cyclooxygenase-2, which catalyze the formation of prostaglandins from arachidonic acid, as a result of which the biosynthesis of prostaglandins, which play an important role in modulating pain sensitivity, inflammation and fever, is inhibited.
Ketokam in terms of the severity of the analgesic effect is comparable to morphine and significantly exceeds other NSAIDs (non-steroidal anti-inflammatory drugs).
Ketorolac does not have a sedative and anxiolytic effect, does not depress respiration, does not affect opioid receptors, and does not cause drug dependence.
After oral administration of Ketokam, the analgesic effect is noted after 1 hour, the maximum effect is achieved after 2-3 hours.
Pharmacokinetics
Ketorolac trometamol when taken orally is well absorbed in the gastrointestinal tract. C max (maximum concentration) in plasma after ingestion fasting 10mg Ketokama is 0.7-1.1 ug / ml achieved after 40 minutes. 99% of the dose binds to plasma proteins. Bioavailability of ketorolac is 80-100%. C ss (equilibrium concentration) is achieved after 24 hours when administered four times a day and after oral administration of 10 mg is in the range from 0.39 to 0.79 μg / ml.
The volume of distribution (V d) is 0.15–0.33 l / kg. In patients with impaired renal function, Vd may increase: for the S-enantiomer - 2 times, for the R-enantiomer - by 20%.
Ketorolac has the ability to pass into breast milk. After the mother takes the first dose of the drug in the amount of 10 mg, C max in milk is 7.3 ng / ml and is achieved 2 hours later, 2 hours after taking the second dose of 10 mg (with four doses of Ketokam per day) C max is 7, 9 ng / ml.
More than 50% of the dose taken is metabolized in the liver, forming pharmacologically inactive metabolites. The main metabolites of ketorolac trometamol are glucuronides (excreted by the kidneys) and p-hydroxyketorolac.
The active substance is excreted mainly by the kidneys - 91%, as well as through the intestines - 6%. T 1/2 (half-life) in patients with normal renal function after oral administration of a dose of 10 mg is 2.4 to 9 hours. In elderly patients, it is lengthened, in young patients it is shortened. T 1/2 does not depend on liver function. In cases of renal failure with a concentration of creatinine in the blood plasma from 19 to 50 mg / l (from 168 to 442 μmol / l) T 1/2 is in the range of 10.3-10.8 hours, with more pronounced impaired renal function - more 13.6 hrs
With oral administration of 10 mg of ketorolac, the total clearance is 0.025 l / h / kg, and in case of renal failure with a plasma concentration of creatinine from 19 to 50 mg / l - 0.016 l / h / kg.
Ketorolac is not excreted by hemodialysis.
Indications for use
According to the instructions, Ketokam is used for short-term relief of pain syndrome of moderate and severe severity: toothache, trauma, postoperative and postpartum pain, cancer, arthralgia, myalgia, neuralgia, ligament damage, sciatica, rheumatic diseases.
Contraindications
Absolute:
- acute stage of erosive and ulcerative lesions of the gastrointestinal tract;
- bleeding and / or a high likelihood of their development;
- severe renal dysfunction (creatinine clearance below 30 ml / min);
- hypovolemia (regardless of the cause that caused it);
- hypocoagulation, including hemophilia;
- severe liver failure or active liver disease;
- inflammatory bowel disease;
- confirmed hyperkalemia;
- complete or incomplete combination (including a history) of recurrent polyposis of the nose and its paranasal sinuses, bronchial asthma and intolerance to NSAIDs, including acetylsalicylic acid;
- rhinitis, urticaria caused by the use of NSAIDs (in history);
- intolerance to drugs of the pyrazolone series;
- condition after coronary artery bypass grafting;
- III trimester of pregnancy;
- period of childbirth and lactation;
- age under 16;
- increased individual sensitivity to ketorolac or any auxiliary component of the drug.
The use of Ketokam requires caution in bronchial asthma, chronic heart failure, coronary heart disease, history of ulcerative lesions of the gastrointestinal tract, cholecystitis, renal dysfunction (plasma creatinine content less than 50 mg / l), chronic renal failure (creatinine clearance from 30 to 60 ml / min), arterial hypertension, cholestasis, edematous syndrome, active hepatitis, sepsis, systemic lupus erythematosus, cerebrovascular diseases, diabetes mellitus, peripheral arterial disease, the presence of factors that increase gastrointestinal toxicity (smoking, alcoholism), dyslipidemia / hyperlipidemia, the presence of Helicobacter pylori infection, severe somatic diseases, concomitant use with other NSAIDs, prolonged use of NSAIDs,coadministration with oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including clopidogrel), selective serotonin reuptake inhibitors (including citalopram, paroxetine, fluoxetine, sertraline), as well as in the elderly and (over 65 years old).
Instructions for the use of Ketokam: method and dosage
Ketokam tablets are taken orally, 30-60 minutes after meals.
Depending on the intensity of the pain syndrome, the drug is taken once or repeatedly.
Recommended dosage regimen:
- adults from 16 to 64 years old with a body weight of more than 50 kg: the first dose - 2 tablets (20 mg), then 1 tablet (10 mg) 4 times a day. The maximum daily dose is 40 mg;
- adults weighing up to 50 kg or patients with impaired renal function: first dose - 1 tablet (10 mg) and then 1 tablet 4 times a day. The maximum daily dose is 40 mg.
The duration of the course of treatment should not exceed 5 days.
Side effects
The incidence of side effects from systems and organs (often - more than 3% of cases, infrequently - from 1 to 3%, rarely - less than 1%):
- digestive system: often (especially in patients over 65 years of age with anamnestic data on erosive and ulcerative lesions of the gastrointestinal tract) - diarrhea, gastralgia; infrequently - flatulence, vomiting, constipation, stomatitis, a feeling of heaviness in the stomach; rarely - nausea, decreased appetite, erosive and ulcerative lesions of the gastrointestinal tract (including bleeding and / or perforation - nausea, heartburn, pain, burning or cramping in the epigastric region, melena or blood in the stool, vomiting with blood or vomiting "Coffee grounds" and others), hepatitis, cholestatic jaundice, hepatomegaly, acute pancreatitis;
- central nervous system: often - dizziness, headache, drowsiness; rarely - aseptic meningitis (severe headache, fever, stiff neck / back muscles, convulsions), hyperactivity (anxiety, mood changes), depression, hallucinations, psychosis, fainting;
- urinary system: rarely - back pain, azotemia, hematuria, acute renal failure, hemolytic uremic syndrome (renal failure, hemolytic anemia, purpura, thrombocytopenia), increase or decrease in urine volume, frequent urination, nephritis, renal edema;
- respiratory system: rarely - dyspnea or bronchospasm, rhinitis, laryngeal edema (shortness of breath, shortness of breath), pulmonary edema;
- sense organs: rarely - ringing in the ears, hearing impairment, visual impairment (including blurred vision);
- cardiovascular system: infrequently - increased blood pressure;
- hematopoietic organs: rarely - anemia, leukopenia, eosinophilia;
- hemostatic system: rarely - nosebleeds, bleeding from a postoperative wound, rectal bleeding;
- skin: infrequently - skin rash (including maculopapular rash), purpura; rarely - urticaria, exfoliative dermatitis (hyperemia, fever with or without chills, peeling or thickening of the skin, soreness and / or swelling of the palatine tonsils), Stevens-Johnson syndrome (malignant exudative erythema), Lyell's syndrome (toxic epidermal necrolysis);
- allergic reactions: rarely - anaphylactoid reactions (skin rash, itching, discoloration of the skin, urticaria, dyspnoea or tachypnea, swelling of the eyelids, shortness of breath, difficulty breathing, periorbital edema, wheezing, heaviness in the chest), anaphylaxis;
- others: often - edema (face, fingers, feet, ankles, legs), weight gain; infrequently - increased sweating; rarely - fever, swelling of the tongue.
Overdose
In case of an overdose of Ketokam, the following symptoms may develop: nausea, vomiting, pain in the epigastric region, erosive and ulcerative lesions of the gastrointestinal tract, impaired renal function, metabolic acidosis.
It is recommended in such cases to carry out symptomatic treatment to maintain vital body functions. Overdose dialysis is ineffective.
special instructions
Before using Ketokam, you should find out about a possible allergy to ketorolac or other NSAIDs. The first dose of the drug must be taken under medical supervision due to the risk of allergic reactions.
It is recommended to use the minimum effective dose of the drug and to carry out the shortest possible course of treatment to reduce the likelihood of side effects.
With an increase in the duration of Ketokam's use (especially in patients with chronic diseases) and taking a dose of more than 40 mg / day, the risk of developing drug complications increases.
The use of Ketokam in patients with blood clotting disorders requires constant monitoring of the platelet count, especially in postoperative patients, when a thorough analysis of hemostasis is required.
If necessary, a combined appointment of Ketokam with opioid analgesics is possible.
In the case of simultaneous use with other NSAIDs, cardiac decompensation, fluid retention, and increased blood pressure may be observed. The action on platelet aggregation lasts from 24 to 48 hours.
To reduce the risk of NSAID gastropathy, antacid drugs, omeprazole, and misoprostol are prescribed.
Ketokam is not recommended for use for premedication (preliminary drug preparation of the patient for general anesthesia) and maintenance of anesthesia.
With hypovolemia, the likelihood of developing nephrotoxic side effects increases.
It is not recommended to use Ketokam together with paracetamol for more than five days.
Influence on the ability to drive vehicles and complex mechanisms
During the period of treatment with Ketokam, caution should be exercised when driving vehicles and engaging in any potentially hazardous activities that require quick psychomotor reactions and high concentration of attention.
Application during pregnancy and lactation
Ketokam is contraindicated in the third trimester of pregnancy, during childbirth and during breastfeeding.
In the first and second trimesters of pregnancy, the drug should be prescribed with caution and in the case when the expected benefit to the mother is higher than the potential risk to the fetus.
In obstetric practice, Ketokam is contraindicated for use as a drug for premedication, basic anesthesia and pain relief, since it can lead to an increase in the duration of the first period of labor, as well as to inhibition of uterine contractility and fetal blood circulation.
Pediatric use
Since the efficacy and safety of using Ketokam in pediatrics has not been established, it is contraindicated in children and adolescents under 16 years of age.
With impaired renal function
It is prohibited to prescribe the drug to patients with severe impaired renal function (with a serum creatinine content of more than 50 mg / l), as well as in case of a risk of developing renal failure with dehydration and hypovolemia.
The use of Ketokam in patients with impaired renal function (with a plasma creatinine content of less than 50 mg / l) and chronic renal failure (with a creatinine clearance of 30-60 ml / min) requires caution.
For violations of liver function
Patients with impaired liver function must be taken with caution.
Use in the elderly
When prescribing the drug to elderly patients (over 65 years old), care should be taken, since its T 1/2 in such patients is lengthened, and plasma clearance decreases. In such cases, it is recommended to take Ketokam in the lowest doses of the therapeutic range.
Drug interactions
The use of ketorolac along with some drugs can lead to the development of the following effects:
- paracetamol: increased nephrotoxicity of ketorolac;
- glucocorticosteroids, ethanol, corticotropin, other NSAIDs, calcium preparations: an increased risk of ulceration of the gastrointestinal tract mucosa and the occurrence of gastrointestinal bleeding;
- anticoagulants (coumarin and indandione derivatives), heparin, thrombolytics (urokinase, streptokinase, alteplase), antiplatelet agents, cephalosporins, valproic acid and acetylsalicylic acid: increasing the likelihood of bleeding;
- antihypertensive and diuretic drugs: a decrease in their effect due to the effect of ketorolac on prostaglandin synthesis in the kidneys;
- methotrexate: increased hepatotoxicity and nephrotoxicity. Joint use with ketorolac is possible only with the use of low doses of methotrexate and control of its content in the blood plasma;
- nephrotoxic drugs (including gold preparations): increased risk of nephrotoxicity;
- drugs that block tubular secretion: a decrease in the clearance of ketorolac and an increase in its concentration in blood plasma;
- narcotic analgesics: enhancing their effect;
- myelotoxic drugs: increased hematotoxicity.
Analogs
Ketokam's analogs are: Dolak, Ketalgin, Ketanov, Ketolak, Ketorolac, Ketofril and others.
Terms and conditions of storage
Store in a dark, dry place at a temperature not exceeding 25 ° C.
Keep out of the reach of children.
Shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Ketokame
Reviews about Ketokam are mostly positive. It effectively helps to get rid of pain syndrome of various origins: with neuralgia, radiculitis, traumatic, muscle and toothache, as well as pain in cancer. The drug begins to act quickly enough - within one hour.
In some patients, however, while taking Ketokam, there are undesirable effects such as nausea, pain and burning sensation in the abdomen, and gastrointestinal upset.
Price for Ketokam in pharmacies
The price of Ketokam for a pack of 20 tablets is 50 rubles on average.
Ketokam: prices in online pharmacies
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Drug name Price Pharmacy |
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Ketokam tablets p.p. 10mg 20 pcs. RUB 47 Buy |
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Ketokam 10 mg film-coated tablets 20 pcs. RUB 47 Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
