Ketoprofen, 5 pcs., 2 ml, 50 mg/ml, solution for intravenous and intramuscular administration


Ketoprofen

Directions for use and doses

Intravenously (drip), intramuscularly.

To achieve the frequency of adverse reactions, it is recommended to use the minimum effective dose of the drug. The maximum daily dose is 200 mg.

It is necessary to carefully evaluate the ratio of expected benefits and risks before starting to take Ketoprofen at a dose of 200 mg/day.

Intramuscular administration.

Intramuscularly 100 mg 1-2 times a day. Ketoprofen is injected deeply, slowly into the upper outer square of the buttock, under strictly aseptic conditions. Subsequent injections are administered alternately into both buttocks.

Intravenous administration. Intravenous infusion of Ketoprofen should be carried out only in a hospital setting.

Short intravenous infusion: 100 to 200 mg of Ketoprofen is diluted in 100 ml of 0.9% sodium chloride solution and administered over 0.5-1 hour; administration can be repeated every 8 hours for no more than 48 hours.

Continuous intravenous infusion: from 100 to 200 mg of Ketoprofen is diluted in 500 ml of solution for infusion (0.9% sodium chloride solution, lactated Ringer's solution, 5% dextrose solution); administered within 8 hours; administration can be repeated every 8 hours for no more than 24 hours.

Treatment with the drug should not exceed 2-3 days.

Parenteral administration of the drug, if necessary, can be combined with the use of oral forms (tablets, capsules) or rectal suppositories.

Ketoprofen can be combined with centrally acting analgesics: it can be mixed with opioids (for example, morphine) in the same vial; it is pharmaceutically incompatible with tramadol solution due to precipitation.

Elderly patients:

The minimum effective dose is recommended. Patients should be monitored regularly because... Gastrointestinal bleeding is possible during therapy with NSAIDs.

For patients with renal impairment, the minimum effective dose is recommended and then adjusted based on renal tolerability.

Due to the fact that Ketoprofen is sensitive to light, the bottle or infusion bag should be covered with black paper or aluminum foil.

Side effect

According to the World Health Organization (WHO), undesirable effects are classified according to their frequency of development as follows: very often (?1/10) often (?1/100, <1/10), infrequently (?1/1000, <1 /100), rare (?1/10000, <1/1000) and very rare (<1/10000), frequency unknown (the frequency of events cannot be determined based on the available data).

From the hematopoietic and lymphatic systems:

rarely: hemorrhagic anemia, hemolytic anemia, leukopenia;

frequency unknown: agranulocytosis, thrombocytopenia, bone marrow dysfunction.

From the immune system:

frequency unknown: anaphylactic reactions (including anaphylactic shock).

From the nervous system:

often: insomnia, depression, asthenia;

uncommon: headache, dizziness, drowsiness;

rarely: paresthesia, confusion or loss of consciousness, peripheral polyneuropathy; frequency unknown: convulsions, taste disturbances, emotional lability.

From the senses:

rarely: blurred vision, tinnitus, conjunctivitis, dry mucous membrane of the eye, eye pain, hearing loss;

frequency unknown: optic neuritis.

From the cardiovascular system:

uncommon: tachycardia;

frequency unknown: heart failure, increased blood pressure, vasodilation.

From the respiratory system:

rarely: exacerbation of bronchial asthma, nosebleeds, laryngeal edema;

frequency unknown: bronchospasm (especially in patients with hypersensitivity to NSAIDs), rhinitis.

From the gastrointestinal tract:

often: nausea, vomiting, dyspepsia, abdominal pain, NSAID gastropathy;

uncommon: constipation, diarrhea, bloating, gastritis;

rarely: peptic ulcer, stomatitis;

very rarely: exacerbation of ulcerative colitis, Crohn's disease, gingival, gastrointestinal, hemorrhoidal bleeding, melena, perforation of the gastrointestinal tract;

frequency unknown: gastrointestinal discomfort, stomach pain.

From the liver and biliary tract:

rarely: hepatitis, increased activity of liver enzymes and bilirubin.

From the skin:

uncommon: skin rash, itching;

frequency unknown: photosensitivity, alopecia, urticaria, exacerbation of chronic urticaria, angioedema, erythema, bullous rash, including Stevens-Johnson syndrome, toxic epidermal necrolysis, purpura.

From the urinary system:

rarely: cystitis, urethritis, hematuria;

very rarely: acute renal failure, interstitial nephritis, nephrotic syndrome, abnormal values ​​of renal function indicators;

frequency unknown: fluid retention in the body and, as a result, weight gain, hyperkalemia.

Other:

uncommon: peripheral edema, fatigue;

rarely: hemoptysis, menometrorrhagia, shortness of breath, thirst, muscle twitching.

Overdose

An overdose was detected in doses greater than 2.5 g of Ketoprofen.

Symptoms

Manifest as an increase in dose-dependent side effects: convulsions, feeling of heaviness in the legs, high blood pressure, ringing in the ears, blurred vision, rash, nausea, vomiting, epigastric pain, diarrhea, gastrointestinal bleeding, headache, dizziness, incoherence (incoherence), confusion, drowsiness, convulsions, coma, respiratory depression.

Treatment

Symptomatic, no specific antidote for Ketoprofen is known. Provide appropriate hydration, monitor renal clearance, and correct acidosis. If necessary, hemofiltration is used.

Interaction with other drugs

Undesirable combinations of drugs.

The combined use of ketoprofen with other NSAIDs (including selective cyclooxygenase-2 inhibitors), salicylates in high doses is not recommended, due to the increased risk of gastrointestinal bleeding and ulceration of the gastrointestinal mucosa.

Simultaneous use with anticoagulants (heparin, warfarin), antiplatelet agents (ticlopidine, clopidogrel) increases the risk of bleeding. If the use of such a combination is unavoidable, the patient's condition should be carefully monitored.

When used simultaneously with lithium preparations, it is possible to increase the concentration of lithium in the blood plasma up to toxic values. The concentration of lithium in the blood plasma should be carefully monitored and the dose of lithium preparations should be promptly adjusted during and after treatment with NSAIDs.

Increases the hematological toxicity of methotrexate, especially when used in high doses (more than 15 mg per week). The time interval between stopping or starting therapy with ketoprofen while taking methotrexate should be at least 12 hours.

Combinations that must be used with caution.

During therapy with ketoprofen, patients taking diuretics, especially if dehydration develops, have a higher risk of developing renal failure due to a decrease in renal blood flow caused by inhibition of prostaglandin synthesis. Before starting to use ketoprofen in such patients, rehydration measures should be carried out. After starting treatment, it is necessary to monitor kidney function.

Combined use of the drug with ACE inhibitors and angiotensin II receptor blockers in patients with impaired renal function (with dehydration, elderly patients) can lead to worsening deterioration of renal function, incl. to the development of acute renal failure.

During the first weeks of simultaneous use of ketoprofen and methotrexate at a dose not exceeding 15 mg/week, blood tests should be monitored weekly. In elderly patients or if there are any signs of renal impairment, the study should be performed more frequently.

Combinations to take into account.

Ketoprofen may weaken the effect of antihypertensive drugs (beta blockers, angiotensin-converting enzyme inhibitors, diuretics).

Concomitant use with selective serotonin reuptake inhibitors (SSRIs) increases the risk of gastrointestinal bleeding.

Concomitant use with thrombolytics increases the risk of bleeding.

Concomitant use with potassium salts, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor blockers, NSAIDs, low molecular weight heparins, cyclosporine, tacrolimus and trimethoprim increases the risk of developing hyperkalemia.

When used simultaneously with cyclosporine and tacrolimus, there may be a risk of additive nephrotoxicity, especially in elderly patients.

The use of several antiplatelet drugs (tirofiban, eptifibarid, abciximab, iloprost) increases the risk of bleeding.

Increases the plasma concentration of cardiac glycosides, slow calcium channel blockers, cyclosporine, methotrexate and digoxin.

Ketoprofen may enhance the effect of oral hypoglycemic and some anticonvulsants (phenytoin).

Concomitant use with probenecid significantly reduces the plasma clearance of ketoprofen.

Nonsteroidal anti-inflammatory drugs may reduce the effectiveness of mifepristone. Taking NSAIDs should be started no earlier than 8-12 days after stopping mifepristone.

Pharmaceutically incompatible with tramadol solution due to precipitation.

special instructions

With long-term use of NSAIDs, it is necessary to periodically evaluate a clinical blood test, as well as monitor renal and liver function, especially in elderly patients (over 65 years), and conduct a stool test for occult blood. It is necessary to be careful and monitor blood pressure more often when using ketoprofen to treat patients suffering from arterial hypertension and cardiovascular diseases that lead to fluid retention in the body.

If visual disturbances occur, treatment should be stopped immediately.

Like other NSAIDs, ketoprofen can mask the symptoms of infectious and inflammatory diseases. If you notice signs of infection or deterioration in health while using the drug, you should immediately consult a doctor.

If there is a history of contraindications from the gastrointestinal tract (bleeding, perforation, peptic ulcer), long-term therapy and the use of high dosages of ketoprofen, the patient should be under close medical supervision.

Because of the important role of prostaglandins in maintaining renal blood flow, particular caution should be exercised when prescribing ketoprofen to patients with cardiac or renal insufficiency, as well as when treating elderly patients taking diuretics and patients who, for any reason, have a decrease in circulating volume. blood (for example, after surgery). The use of ketoprofen can affect female fertility, therefore, patients with infertility (including those undergoing examination) are not recommended to use the drug.

The influence of a medicinal product for medical use on the ability to drive vehicles and machinery

During the period of use of the drug, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions, since the drug can cause dizziness and other side effects that can affect these abilities.

Ketoprofen, 5 pcs., 2 ml, 50 mg/ml, solution for intravenous and intramuscular administration

Definition of categories of frequency of undesirable effects (according to WHO): very often (≥1/10), often (≥1/100, <1/10), infrequently (≥1/1000, <1/100), rarely (≥ 1/10,000, <1/1000) and very rarely (<1/10,000); frequency unknown (the incidence of adverse events cannot be determined based on available data).

From the hematopoietic and lymphatic systems: rarely - hemorrhagic anemia, hemolytic anemia, leukopenia; frequency unknown - agranulocytosis, thrombocytopenia, impaired bone marrow hematopoiesis.

From the immune system: frequency unknown - anaphylactic reactions (including anaphylactic shock).

From the nervous system: often - insomnia, depression, asthenia; infrequently - headache, dizziness, drowsiness; rarely - paresthesia, confusion or loss of consciousness, peripheral polyneuropathy; frequency unknown - convulsions, taste disturbances, emotional lability.

From the senses: rarely - blurred vision, tinnitus, conjunctivitis, dry mucous membrane of the eye, pain in the eyes, hearing loss; frequency unknown - optic neuritis.

From the cardiovascular system: infrequently - tachycardia; frequency unknown - heart failure, arterial hypertension, vasodilation.

From the respiratory system: rarely - exacerbation of bronchial asthma, nosebleeds, laryngeal edema; frequency unknown - bronchospasm (especially in patients with hypersensitivity to NSAIDs), rhinitis.

From the digestive system: often - nausea, vomiting, dyspepsia, abdominal pain NSAID gastropathy; uncommon - constipation, diarrhea, bloating, gastritis; rarely - peptic ulcer, stomatitis; very rarely - exacerbation of UC Crohn's disease, gingival, gastrointestinal, hemorrhoidal bleeding, melena, perforation of the gastrointestinal tract; frequency unknown - gastrointestinal discomfort, stomach pain.

From the liver and biliary tract: rarely - hepatitis, increased activity of liver enzymes and bilirubin concentration.

From the skin: infrequently - skin rash, itching; frequency unknown - photosensitivity, alopecia, urticaria, exacerbation of chronic urticaria, angioedema, erythema, bullous rash, including Stevens-Johnson syndrome, toxic epidermal necrolysis, purpura.

From the urinary system: rarely - cystitis, urethritis, hematuria; very rarely - acute renal failure, interstitial nephritis, nephrotic syndrome, abnormal values ​​of renal function indicators; frequency unknown - fluid retention in the body and, as a result, weight gain, hyperkalemia.

Other: infrequently - peripheral edema, fatigue; rarely - hemoptysis, menometrorrhagia, shortness of breath, thirst, muscle twitching.

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