Ketanov - Instructions For The Use Of Tablets And Injections, Price, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Ketanov

Ketanov: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Ketanov

ATX code: M01AB15

Active ingredient: ketorolac (ketorolac)

Producer: SC Terapia SA (Romania), Sun Pharmaceutical Industries Ltd. (India), Ranbaxy (India)

Description and photo update: 2019-20-08

Prices in pharmacies: from 51 rubles.

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Ketanov is a drug with analgesic, antipyretic and anti-inflammatory effects.

Release form and composition

Ketans are produced in the following dosage forms:

• Solution for intramuscular administration: pale yellow or colorless, transparent (1 ml in ampoules, 5 or 10 ampoules in a cardboard box or 5, 10 ampoules in pallets, 1 pallet in a cardboard box);
• Coated or film-coated tablets: biconvex, round, almost white or white, on one side - engraved "KVT" (10 pcs. In blisters, 1-3, 10 packs in a cardboard box).

The composition of 1 ml of solution for intramuscular administration includes:

• Active ingredient: ketorolac tromethamine - 30 mg;
• Auxiliary components: sodium chloride, edetate disodium, ethanol, sodium hydroxide, water for injection.

The composition of 1 tablet includes:

• Active ingredient: ketorolac tromethamine - 10 mg;
• Auxiliary components: corn starch, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate.

The composition of the film shell: hydroxypropyl methylcellulose, polyethylene glycol 400 (macrogol 400), purified talc, titanium dioxide, purified water.

Pharmacological properties

Pharmacodynamics

Ketanov has a pronounced analgesic effect, and also has an anti-inflammatory and moderate antipyretic effect.

The mechanism of action of ketorolac is associated with non-selective inhibition of the activity of the enzyme COX-1 and -2 (cyclooxygenase), mainly in peripheral tissues, due to which the inhibition of the biosynthesis of PGs (prostaglandins), which are modulators of pain sensitivity, inflammation and thermoregulation, occurs. Ketorolac is a racemic mixture of [-] S- and [+] R-enantiomers, the analgesic effect is due to the [-] S form.

Ketanov does not inhibit respiration, does not affect opioid receptors, does not have anxiolytic and sedative effects, does not cause drug dependence.

In terms of the strength of the analgesic effect, it is significantly superior to other non-steroidal anti-inflammatory drugs (comparable to morphine).

The onset of the analgesic effect is noted 0.5 and 1 hour after intramuscular administration and oral administration, respectively. The time to achieve the maximum effect is 1–2 hours.

Pharmacokinetics

After oral administration of Ketanov tablets, ketorolac is well absorbed in the gastrointestinal tract. 40 minutes after taking 10 mg of the substance on an empty stomach, C _max (maximum concentration of the substance) in the blood plasma is reached, its value is 0.7-1.1 μg / ml. Fat-rich food lowers the C _{max of} ketorolac in the blood, and also lengthens the time to reach it by 1 hour. 99% of the dose binds to plasma proteins, with hypoalbuminemia the amount of free substance in the blood increases. Bioavailability ranges from 80% to 100%.

With the intramuscular injection of an injection of Ketanov, the absorption of ketorolac is fast and complete. C _max after using 30 mg of the drug is 1.74-3.1 μg / ml, the time to reach it is 15-73 minutes, C _max after using 60 mg of the drug is 3.23-5.77 μg / ml, the time to reach it is - 30-60 minutes.

The time to reach C _SS (equilibrium concentration), regardless of the method of administration of Ketanov, is 24 hours when applied 4 times a day. C _SS is: intramuscular injection of 15 mg and 30 mg - 0.65-1.13 μg / ml and 1.29-2.47 μg / ml, respectively; oral administration 10 mg - 0.39-0.79 mcg / ml.

V _d (volume of distribution) - from 0.15 to 0.33 l / kg. In renal failure, the V _d value of a substance can increase by 100%, and its R-enantiomer - by 20%.

Ketorolac passes into breast milk. After oral administration by the mother of the first and second doses of ketorolac (10 mg), C _max in breast milk is 7.3 and 7.9 ng / l, respectively, the time to reach it is 2 hours.

More than half of the administered dose of ketorolac is metabolized in the liver, resulting in the formation of pharmacologically inactive metabolites. The main metabolites are glucuronides (excreted through the kidneys) and p-hydroxyketorolac. Excretion occurs by the kidneys and intestines (91% and 6%, respectively).

With normal renal function, the average T _1/2 (half-life) is 5.3 hours (after intramuscular administration of 30 mg - from 3.5 to 9.2 hours; after oral administration of 10 mg - from 2.4 to 9 hours). In elderly patients, T _{1/2 is} lengthened, in young patients, it is shortened. Against the background of impaired renal function with a plasma concentration of creatinine in the blood of 19-50 mg / l, the T _1/2 value is in the range of 10.3-10.8 hours, in patients with more severe renal insufficiency, the indicator is more than 13.6 hours. Liver function does not affect the T _1/2 value.

When 30 mg of ketorolac is administered intramuscularly, the total clearance is 0.023 l / kg / h (in elderly patients, the value decreases to 0.019 l / kg / h), when taken orally 10 mg - 0.025 l / kg / h. In patients with renal insufficiency, with a plasma creatinine concentration of 19-50 mg / l, this figure is 0.015 l / kg / h (with intramuscular administration of 30 mg) or 0.016 l / kg / h (with oral administration of 10 mg).

Ketorolac is not excreted during hemodialysis.

Indications for use

According to the instructions, Ketanov is prescribed for pain syndrome of severe and moderate intensity of various origins (including with oncological diseases, in the postoperative period).

Contraindications

• Erosive and ulcerative lesions of the gastrointestinal tract (with exacerbation), hypocoagulation (including hemophilia), peptic ulcers;
• Renal and / or hepatic failure (with plasma creatinine above 50 mg / l);
• Violation of hematopoiesis, hemorrhagic diathesis, hemorrhagic stroke (suspected or confirmed), simultaneous use with other non-steroidal anti-inflammatory drugs, high risk of relapse or bleeding (including after surgery);
• Dehydration;
• Angioneurotic edema;
• Hypovolemia (regardless of the cause that caused it);
• "Aspirin asthma";
• Pain relief before and during surgery (high risk of bleeding);
• Chronic pain;
• Bronchospasm;
• Age up to 16 years (the effectiveness and safety of using Ketanov for this age group of patients have not been established);
• Pregnancy, childbirth and lactation;
• Hypersensitivity to the components of the drug or other nonsteroidal anti-inflammatory drugs.

Ketans should be used with caution in the presence of the following diseases / conditions:

• Bronchial asthma;
• Chronic heart failure;
• Cholecystitis;
• Cholestasis;
• Arterial hypertension;
• Functional renal disorders (with plasma creatinine below 50 mg / l);
• Active hepatitis;
• Systemic lupus erythematosus;
• Sepsis;
• Polyps of the mucous membrane of the nasopharynx and nose;
• Age over 65.

Instructions for use of Ketanov: method and dosage

Ketanov tablets are taken orally.

A single dose with a single dose is 10 mg (1 tablet). If necessary, the drug in the same dose can be taken up to 4 times a day (maximum 40 mg per day).

Ketanov's injections with injection solution are made deep intramuscularly. The drug should be administered in the minimum effective doses, which the doctor selects individually, depending on the intensity of pain and response to therapy. If necessary, it is possible to use it simultaneously with reduced doses of opioid analgesics.

With a single intramuscular injection, single doses of Ketanov are:

• Patients under 65 years of age - 10-30 mg (determined by the severity of the pain syndrome);
• Patients over 65 years old or patients with functional impairment of the kidneys - 10-15 mg.

With repeated intramuscular administration, the following are usually used:

• Patients under 65 years of age - 10-30 mg, then every 4-6 hours 10-30 mg;
• Patients over 65 years old or patients with functional impairment of the kidneys - every 4-6 hours, 10-15 mg.

The maximum daily doses of Ketanov with intramuscular administration are:

• Patients under 65 years of age - 90 mg;
• Patients over 65 years old or patients with functional impairment of the kidneys - 60 mg.

The same total daily doses should not be exceeded when switching from parenteral administration of Ketanov to taking the drug orally (on the day of transition, we can take 30 mg of Ketanov orally).

The duration of Ketanov's use in any dosage form should not exceed 5 days.

Side effects

During the use of Ketanov, the following side effects may develop, manifesting themselves with different frequency: (more than 3% - often; 1-3% - less often; less than 1% - rarely):

• Central nervous system: often - headache, drowsiness, dizziness; rarely - aseptic meningitis (severe headache, fever, cramps, stiff back and / or neck muscles), depression, hyperactivity (anxiety, mood swings), hallucinations, psychosis;
• Digestive system: often (especially in patients over 65 years of age with a history of erosive and ulcerative lesions of the gastrointestinal tract) - diarrhea, gastralgia; less often - flatulence, stomatitis, constipation, a feeling of fullness in the stomach, vomiting; rarely - nausea, erosive and ulcerative lesions of the gastrointestinal tract (possibly with bleeding and / or perforation: abdominal pain, cramps or burning sensation in the epigastric region, melena, nausea, vomiting like "coffee grounds", heartburn), cholestatic jaundice, hepatomegaly, hepatitis, acute pancreatitis;
• Respiratory system: rarely - rhinitis, dyspnea or bronchospasm, laryngeal edema (difficulty breathing, shortness of breath);
• Urinary system: rarely - acute renal failure, pain in the lumbar region with or without azotemia and / or hematuria, hemolytic uremic syndrome (purpura, renal failure, hemolytic anemia, thrombocytopenia), nephritis, frequent urination, increased or decreased urine volume, renal edema genesis;
• Cardiovascular system: less often - an increase in blood pressure; rarely - fainting, pulmonary edema;
• Hematopoietic organs: rarely - eosinophilia, anemia, leukopenia;
• Sense organs: rarely - ringing in the ears, hearing loss, visual impairment (including blurred vision);
• Hemostasis system: rarely - rectal, postoperative, nosebleeds;
• Skin: less common - purpura, skin rash (including maculopapular rash); rarely - exfoliative dermatitis (fever with or without chills, redness, Lyell's syndrome, Stevens-Johnson syndrome, urticaria, scaling or thickening of the skin, tenderness and / or swelling of the tonsils);
• Allergic reactions: rarely - anaphylactoid reactions (skin rash, discoloration of the face, urticaria, pruritus, tachypnea or dyspnea, eyelid edema, periorbital edema, wheezing, shortness of breath, shortness of breath, heaviness in the chest) or anaphylaxis;
• Local reactions: less often - pain or burning at the injection site;
• Others: often - swelling of the feet, legs, ankles, fingers, face, weight gain; less often - increased sweating; rarely - fever, swelling of the tongue.

Overdose

The main symptoms are metabolic acidosis, impaired renal function, abdominal pain, vomiting, nausea, the occurrence of erosive gastritis or peptic ulcers of the stomach.

Therapy: gastric lavage is prescribed, the use of activated charcoal or other adsorbents, symptomatic treatment is shown, aimed at maintaining the vital functions of the body. With the help of dialysis, it is excreted to a small extent.

special instructions

The effect of Ketanov on platelet aggregation stops after 24-48 hours.

If necessary, simultaneous use with narcotic analgesics is possible.

Hypovolemia increases the likelihood of kidney side effects.

The use of Ketanov for premedication, maintenance anesthesia and pain relief in obstetrics is not recommended.

You should not use Ketanov simultaneously with paracetamol for more than 5 days. In case of blood clotting disorders, Ketans are prescribed only with constant monitoring of the platelet count (especially important in the postoperative period if it is necessary to carefully monitor hemostasis).

Influence on the ability to drive vehicles and complex mechanisms

During therapy, it is recommended to avoid performing potentially hazardous types of work (driving vehicles, working with mechanisms) that require high attention and quick reactions, which is associated with a high probability of developing central nervous system disorders (dizziness, drowsiness, headache).

Application during pregnancy and lactation

Ketans are not prescribed during pregnancy, childbirth and lactation.

Pediatric use

Ketan therapy is contraindicated in patients under 16 years of age.

With impaired renal function

• renal failure (plasma creatinine from 50 mg / l): therapy is contraindicated;
• impaired renal function (plasma creatinine up to 50 mg / l): Ketanov should be used under medical supervision.

For violations of liver function

• liver failure: therapy is contraindicated;
• active hepatitis: Ketanov should be used under medical supervision.

Use in the elderly

Ketanov therapy in patients over 65 years of age should be carried out with caution.

Drug interactions

With the simultaneous use of Ketanov with some drugs, undesirable effects may occur:

• Paracetamol: increased nephrotoxicity;
• Glucocorticosteroids, calcium preparations, ethanol, acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, corticotropin: ulceration of the gastrointestinal tract and the occurrence of gastrointestinal bleeding;
• Probenecid: decrease in plasma clearance and volume of distribution of ketorolac, increase in its concentration in blood plasma and half-life;
• Methotrexate: increased nephro- and hepatotoxicity (simultaneous use only with low doses of methotrexate and under the control of its concentration in blood plasma is possible);
• Lithium, methotrexate: decrease in their clearance and increase in toxicity;
• Oral hypoglycemic drugs, insulin: increased hypoglycemic action (dose adjustment is necessary);
• Indirect anticoagulants, heparin, thrombolytics, antiplatelet agents, cefoperazone, cefotetan, pentoxifylline: increased risk of bleeding;
• Drugs that block tubular secretion: decrease in ketorolac clearance and increase in its concentration in blood plasma;
• Opioid analgesics: enhancement of their action (possibly a significant decrease in the doses used);
• Diuretic and antihypertensive drugs: reducing their effects;
• Nifedipine, verapamil: an increase in their concentration in blood plasma;
• Sodium valproate: violation of platelet aggregation;
• Nephrotoxic drugs (including drugs with gold content): increased risk of developing nephrotoxicity.

Due to the precipitation of a precipitate, the Ketanov solution cannot be mixed in the same syringe with morphine sulfate, hydroxyzine and promethazine.

Ketanov is pharmaceutically incompatible with lithium preparations and tramadol solution, compatible with Plazmalit solution, saline solution, Ringer's and Ringer's lactate solution, 5% dextrose solution, as well as infusion solutions containing aminophylline, sodium heparin, lidocaine hydrochloride, hydrochloride dopamine, short-acting human insulin.

Analogs

Ketanov's analogs are: Dolak, Ketorol, Ketorolac, Ketofril, Ketolak, Ketokam, Ketonal, Ketalgin.

Terms and conditions of storage

Store in a dark place, out of reach of children, at temperatures up to 25 ° C.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Ketanov

According to reviews, Ketanov quickly and for a long time relieves pain syndrome, including a very pronounced one. The disadvantages include a large list of contraindications and the inability to carry out therapy for more than 5 days. The cost of the drug is estimated as low.

Price for Ketans in pharmacies

The approximate price for Ketanov is: tablets (20 or 100 pcs. 10 mg each) - 45–69 or 217–255 rubles, solution for intramuscular injection (10 ampoules of 1 ml, 30 mg / ml) - 86–109 rubles.

Ketanov: prices in online pharmacies

Drug name Price Pharmacy

Ketanov 10 mg film-coated tablets 20 pcs. RUB 51 Buy

Ketanov tablets p.p. 10mg 20 pcs. RUB 57 Buy

Ketanov 10 mg film-coated tablets 10 pcs. RUB 57 Buy

Ketanov (for injection) 30 mg / ml solution for intramuscular administration 1 ml 10 pcs. 89 RUB Buy

Ketanov 10 mg film-coated tablets 100 pcs. 212 r 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!