Caver solution for injection 25 mg/ml in ampoules 2 ml No. 5x2


Composition and release form

Caver belongs to the anti-inflammatory non-steroidal drugs and is a derivative of propionic acid.

The drug is available in two dosage forms - tablets and injection solution. Next - in more detail about the Caver injection solution.

The drug substance is a clear, colorless liquid. Caver solution is packaged in 2 ml ampoules. Each package of the medicine contains two blisters of 5 ampoules.

The active ingredient in the parenteral form of the drug is dexketoprofen trometamol, which contains 0.025 grams per milliliter of solution.

The drug also contains additional ingredients, such as injection water, 96 percent ethyl alcohol, saline sodium chloride solution and sodium hydroxide, which potentiate the effects of the main component and act as preservatives.

Pharmacological properties

According to the anatomical-therapeutic-chemical classification, the drug is assigned the code M01AE17.

Caver injection solution has three main effects, namely:

  • painkillers;
  • anti-inflammatory;
  • antipyretic.

Dexketoprofen is a metabolic product of propionic acid. Its mechanism of action is based on reducing the production of prostaglandins by blocking the enzyme cyclooxygenase.

Prostaglandins are the most powerful provocateur of inflammation, increase the sensitivity of pain receptors to pain mediators and make the receptors of the thermoregulation center of the brain more susceptible to endogenous pyrogens. Therefore, by blocking cyclooxygenase, the drug has three therapeutic effects - anti-inflammatory, analgesic and antipyretic.

This drug also disrupts the transformation of arachidonic acid into endoperoxides, which are precursors of pro-inflammatory proteins such as kinins, prostacyclins and thromboxanes. All these processes are interconnected. In addition, prostaglandins are formed from cyclic endoperoxides, and inhibition of prostaglandin synthesis, in turn, affects other inflammatory mediators, such as kinins.

Clinical trials of the drug were carried out on patients with severe pain caused by surgical interventions and injuries, as well as diseases of the musculoskeletal system and urolithiasis. Based on the results of these tests, it became known that the drug effectively eliminates pain within 40 minutes after injection, and the effect lasts up to eight hours.

According to experts, Caver makes it possible to alleviate the condition of patients in the postoperative period with minimal use of narcotic analgesics, which have an impressive range of side effects. Thus, as a result of clinical trials, it was revealed that the use of drugs based on dexketoprofen trometamol can reduce the dose of morphine in operated patients by 35-45%.

After administration into the body, the drug is distributed to all tissues and organs. The maximum concentration in the blood plasma is achieved on average 20 minutes after the intramuscular injection (indicator range - from 10 to 45 minutes). After a single injection of one or two doses of the drug, the concentration of the active substance is proportional to time. There is no accumulation of the drug, as evidenced by measurements of the content of the active substance in the blood after single and repeated injections.

Metabolism of the drug occurs in hepatocytes. Metabolites are excreted by the kidneys and urine. The half-life of Caver is short - from 60 to 180 minutes, but in elderly patients this time increases.

Caver tablets p/o 25 mg No. 10x1

Name

Caver tab. p/o 25 mg in blister pack. in pack №10x1

Description

Tablets are round in shape with a biconvex surface, white or almost white in color with a score on one side, coated.

Main active ingredient

dexketoprofen

Release form

Pills

Dosage

25mg

Pharmacological properties
Pharmacodynamics

Dexketoprofen trometamol is a salt of propionic acid that has analgesic, anti-inflammatory and antipyretic effects and belongs to the class of non-steroidal anti-inflammatory drugs (NSAIDs). The mechanism of its action is based on a decrease in the synthesis of prostaglandins due to inhibition of cyclooxygenase. In particular, the conversion of arachidonic acid into the cyclic endoperoxides PGG2 and PGH2, from which prostaglandins PGE1, PGE2, PGF2a, PGD2 are formed, as well as prostacyclin PGI2 and thromboxanes TxA2 and TxB2, is inhibited. In addition, inhibition of prostaglandin synthesis may affect other inflammatory mediators, such as kinins, which may also indirectly affect the main effect of the drug. The inhibitory effect of dexketoprofen trometamol on the cyclooxygenase isoenzymes COX-1 and COX-2 has been identified in animals and humans. Clinical studies have shown that dexketoprofen trometamol has an effective analgesic effect, which develops 30 minutes after use of the drug and lasts 4-6 hours.

Pharmacokinetics

After oral administration of dexketoprofen trometamol, the maximum plasma concentration (Cmax) is achieved on average after 30 minutes (15-60 minutes). The distribution time and half-life of dexketoprofen trometamol are 0.35 and 1.65 hours, respectively. Due to the high degree of binding to plasma proteins (99%), the average volume of distribution of dexketoprofen trometamol is less than 0.25 l/kg. Elimination of dexketoprofen trometamol occurs mainly through glucuronidation and subsequent excretion by the kidneys. After administration of dexketoprofen trometamol, only the S-(+)-enantiomer is detected in the urine, which proves the absence of its inversion to the R-(+)-enantiomer in the human body. When studying the pharmacokinetics of multiple doses, it was shown that after the last use of dexketoprofen trometamol, the area under the bioavailability curve (AUC) was no higher than after its single use, which proves the absence of drug accumulation. When dexketoprofen trometamol is administered with food, the AUC values ​​do not change, but the Cmax value decreases and the rate of absorption decreases (tmax increases).

Indications for use

Symptomatic treatment of mild to moderate pain, such as musculoskeletal pain, painful menstruation (dysmenorrhea), toothache.

Directions for use and doses

The tablet can be divided into equal halves. Adults Depending on the type and intensity of pain, the recommended dose is 12.5 mg (½ film-coated tablet) every 4-6 hours or 25 mg (1 film-coated tablet) every 8 hours. The daily dose should not exceed 75 mg. Adverse effects can be minimized by using the lowest effective dose for the shortest possible period of time necessary to relieve symptoms. Caver® is not intended for long-term therapy; treatment continues as long as symptoms persist. Concomitant food intake reduces the rate of absorption of the active substance, so it is recommended to take the drug at least 30 minutes before meals with a sufficient amount of liquid (for example, a glass of water). Elderly patients are recommended to start treatment with low doses. The daily dose is 50 mg. If the drug is well tolerated, the dose can be increased to the usual dose. For mild to moderate liver dysfunction, treatment should begin with the minimum recommended dose and under strict medical supervision. The daily dose is 50 mg. For mild renal impairment For patients with mild renal impairment (creatinine clearance 50-80 ml/min), the initial daily dose should be reduced to 50 mg. Caver® tablets should not be used by patients with moderate to severe renal impairment (creatinine clearance

Precautionary measures

Caver® should be used with caution in patients with a history of allergic reactions. The simultaneous use of the drug with other NSAIDs, including cyclooxygenase-2 inhibitors, should be avoided. Adverse effects of the drug can be minimized by using the minimum effective dose for the shortest possible period of time necessary to eliminate symptoms. Gastrointestinal Disorders When using drugs of the NSAID class, peptic ulcers with or without perforation and bleeding (even death) may develop in the digestive tract. These adverse events can occur during any period of treatment, both with and without warning symptoms, regardless of the presence of a history of severe disorders of the digestive tract. If gastrointestinal bleeding or a peptic ulcer develops while using dexketoprofen, therapy with the drug should be stopped immediately. The risk of developing the above-mentioned adverse events increases in proportion to the increase in the dose of NSAIDs, as well as in patients with a history of gastric or duodenal ulcers and in the elderly. While using the drug, the doctor should carefully monitor the patient's condition, taking into account the possible occurrence of gastrointestinal bleeding. Before starting the use of dexketoprofen trometamol if the patient has a history of esophagitis, gastritis and/or peptic ulcer, you should, as in the case of other NSAIDs, make sure that these diseases are in remission. Patients with symptoms of pathology of the digestive tract and with a history of diseases of the digestive tract require observation to identify possible disorders of the digestive tract, especially bleeding. To reduce the risk of developing adverse reactions from the digestive tract, the doctor may prescribe medications that have a protective effect on the mucous membrane of the digestive tract (misoprostol, proton pump inhibitors). This also applies to patients who require concomitant administration of low doses of acetylsalicylic acid or other drugs that increase the risk of developing complications from the digestive system. Patients should be informed that in case of any discomfort in the abdominal area (primarily gastrointestinal bleeding), especially at the beginning of treatment, they should inform the doctor. Renal Impairment Use with caution in patients with renal impairment. In these patients, the use of NSAIDs may lead to deterioration of renal function, fluid retention and edema. Caution should be exercised when using dexketoprofen in patients using diuretics and prone to hypovolemia, since there is an increased risk of nephrotoxicity of the drug. During treatment, it is necessary to ensure adequate fluid intake to prevent dehydration and possibly associated increased renal toxicity. Like all NSAIDs, dexketoprofen may increase blood urea nitrogen and creatinine levels. As with other prostaglandin synthesis inhibitors, this may be associated with adverse effects on the renal system, which may lead to glomerular nephritis, interstitial nephritis, renal papillary necrosis, nephrotic syndrome and acute renal failure. Elderly patients are more likely to suffer from impaired renal function. Hepatic impairment: Use with caution in patients with impaired liver function. As with the use of other NSAIDs, taking dexketoprofen may cause a short-term slight increase in some liver parameters, as well as a significant increase in ALT and AST levels. If these indicators increase appropriately, therapy should be discontinued. Elderly patients are more likely to suffer from liver dysfunction. Cardiovascular system and cerebral circulation Appropriate monitoring and advice are required in patients with a history of hypertension and/or mild to moderate heart failure. Particular caution is required when prescribing the drug to patients with a history of heart disease, in particular, those who have had previous episodes of heart failure. These patients are at increased risk of developing heart failure, as fluid retention and edema associated with NSAID use have been reported. Clinical and epidemiological data indicate that the use of some NSAIDs (especially in high doses and with long-term treatment) slightly increases the risk of arterial thromboembolism (for example, myocardial infarction, stroke). There is not enough data to exclude such a risk when taking dexketoprofen. For patients with uncontrolled arterial hypertension, decompensated heart failure, manifesting coronary heart disease, obliterating endarteritis, cerebrovascular disorders, dexketoprofen should be prescribed only after a thorough assessment of the ratio of expected benefits and possible risks of such therapy. Using the same principle, evaluate the advisability of prescribing long-term therapy with dexketoprofen in patients with risk factors for cardiovascular diseases, such as hyperlipidemia, arterial hypertension, diabetes mellitus, and if the patient smokes. All non-selective NSAIDs can inhibit platelet aggregation and prolong bleeding time through inhibition of prostaglandin synthesis. Therefore, the use of dexketoprofen in patients receiving other therapies that interfere with hemostasis, such as warfarin or other coumarins or heparins, is not recommended. Elderly patients are more likely to suffer from impaired cardiovascular function. Skin reactions The use of NSAIDs has, in rare cases, been associated with serious skin reactions, sometimes fatal, including reactions such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. The risk of developing these conditions is greatest in the initial phase of therapy; in most cases, the onset of reactions occurred during the first month of treatment. At the first signs of skin rash, mucosal lesions or other indications of hypersensitivity, the drug should be discontinued immediately. Additional information Particular caution is required in patients with: an inborn error of porphyrin metabolism (for example, acute intermittent porphyria) dehydration immediately after major surgery. If your doctor believes that long-term therapy with dexketoprofen is necessary, your liver and kidney function, as well as your blood, should be checked regularly. Severe acute hypersensitivity reactions (eg, anaphylactic shock) have been observed in very rare cases. Treatment should be discontinued at the first sign of severe hypersensitivity reactions after taking dexketoprofen. Depending on the symptoms, any medical procedures should be initiated by healthcare professionals. Patients with asthma combined with chronic rhinitis, chronic sinusitis and/or nasal polyposis have a higher risk of developing an allergy to acetylsalicylic acid and/or NSAIDs than the rest of the population. Administration of this drug may cause asthma attacks or bronchospasm, especially in patients who are allergic to acetylsalicylic acid or NSAIDs. Chickenpox can cause serious infectious complications of the skin and soft tissues. To date, the role of NSAIDs in worsening the course of these infections cannot be ruled out. Therefore, it is advisable to avoid the use of dexketoprofen for chickenpox. Dexketoprofen should be used with caution in patients suffering from hematopoietic disorders, systemic lupus erythematosus or mixed connective tissue disease. Like other NSAIDs, dexketoprofen may mask the symptoms of infectious diseases. Use in children and adolescents The use of the drug in children and adolescents has not been studied, therefore it is not recommended to prescribe dexketoprofen to patients in this age group. Use during pregnancy or breastfeeding Caver® is contraindicated in the third trimester of pregnancy and during breastfeeding. The drug can be used during the first and second trimesters of pregnancy in case of urgent need, only if the potential benefit outweighs the potential risk to the fetus. Reduce the dose and duration of treatment to the minimum possible level. Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or the development of the embryo and fetus. In accordance with epidemiological studies, the use of drugs that inhibit prostaglandin synthesis in the early stages of pregnancy increases the risk of miscarriage, heart disease, and gastroschisis. If it is necessary to use dexketoprofen trometamol in women planning pregnancy, the minimum possible dose should be prescribed for the minimum duration of therapy. During the use of prostaglandin synthesis inhibitors in the third trimester of pregnancy, the following abnormalities may occur in the fetus: cardiovascular toxicity, for example, premature closure of the ductus arteriosus and hypertension in the pulmonary artery system; renal dysfunction, which can progress and develop into renal failure with the development of oligohydramnios. The following phenomena are possible in the mother at the end of pregnancy and in the infant: an increase in bleeding time due to suppression of platelet aggregation, even when using the drug in low doses; inhibition of contractile activity of the uterus, which leads to delay and delay of labor. There is no data on penetration into breast milk. The ability to influence the reaction rate when driving vehicles or operating other mechanisms When using dexketoprofen, dizziness and increased fatigue are possible, which may affect the ability to drive vehicles and operate other mechanisms.

Interaction with other drugs

The following drug interactions generally characterize drugs of the NSAID class. Combinations that are not recommended for use with Caver® Other NSAIDs, including salicylates in high doses (more than 3 g/day): the risk of peptic ulcers increases due to a synergistic effect. Heparin and indirect anticoagulants (for example, warfarin): the effect of anticoagulants is enhanced, which can lead to increased bleeding time; if it is not possible to avoid such a combination, close monitoring of the patient’s condition with appropriate monitoring of laboratory parameters is necessary. Corticosteroids: Increases the risk of peptic ulcers and bleeding in the digestive tract. Lithium preparations: the level of lithium in the blood increases up to toxic levels due to a decrease in its excretion by the kidneys. Methotrexate when used in high doses (15 mg/week or more): the level of methotrexate in the blood increases due to a decrease in its excretion by the kidneys, which leads to toxic effects on the blood system. Hydantoin and sulfonamides: the toxicity of these substances increases. Combinations requiring careful use with the drug Caver® Diuretics, ACE inhibitors, aminoglycoside antibiotics and angiotensin II receptor antagonists. Dexketoprofen weakens the effect of diuretics and other antihypertensive drugs. In some patients with impaired renal function (for example, those with dehydration or in elderly patients with impaired renal function), the condition may worsen when cyclooxygenase inhibitors are co-administered with ACE inhibitors, angiotensin II receptor antagonists and aminoglycoside antibiotics. As a rule, this deterioration is reversible. When using dexketoprofen concomitantly with any diuretic, ensure that the patient is adequately hydrated and monitor renal function during treatment. Methotrexate when used in small doses (less than 15 mg/week): it is possible to increase the toxic effect on the blood system due to a decrease in its excretion by the kidneys; If it is necessary to use such a combination, weekly monitoring of the blood picture is necessary, especially in the presence of even a slight decrease in renal function, as well as in elderly patients. Pentoxifylline: The risk of bleeding increases, so it is necessary to monitor the patient and monitor bleeding time. Zidovudine: There is a risk of increased toxic effects of zidovudine on erythropoiesis (toxic effects on reticulocytes), up to the development of severe anemia, a week after using NSAIDs, therefore, in the first 1-2 weeks after starting NSAID therapy, a blood test with a reticulocyte count should be performed. Sulfonylurea derivatives: NSAIDs can enhance the hypoglycemic effect of sulfonylurea drugs by displacing them from binding to blood proteins. Combinations that require attention when used with the drug Caver® Beta-blockers: their antihypertensive effect may be reduced due to inhibition of prostaglandin synthesis. Cyclosporine and tacrolimus: increased toxic effect of these drugs on the kidneys due to the effect of NSAIDs on the synthesis of prostaglandins; When using this combination, renal function should be regularly monitored. Thrombolytic drugs: increased risk of bleeding. Platelet aggregation inhibitors and selective serotonin reuptake inhibitors: increased risk of developing peptic ulcers and bleeding in the digestive tract. Probenecid: increasing the concentration of dexketoprofen in the blood plasma by reducing the level of its renal tubular secretion and glucuronidation; in this case, it is necessary to adjust the dose of dexketoprofen. Cardiac glycosides: their concentration in blood plasma may increase. Mifepristone: a decrease in its effectiveness due to a decrease in the synthesis of prostaglandins, therefore NSAIDs should not be used for 8-12 days after using mifepristone. Quinolines: their use in high doses in combination with NSAIDs increases the risk of developing seizures.

Contraindications

Hypersensitivity to dexketoprofen, any other non-steroidal anti-inflammatory drug or to the excipients of the drug. Use in patients in whom substances with a similar mechanism of action, for example, acetylsalicylic acid and other NSAIDs, cause attacks of bronchial asthma, bronchospasm, acute rhinitis or lead to the development of nasal polyps, urticaria or angioedema. Active phase of peptic ulcer/bleeding in the digestive tract or suspicion of their presence, recurrent course of peptic ulcer/bleeding in the digestive tract in the anamnesis (at least 2 confirmed cases of ulcer or bleeding), as well as chronic dyspepsia. History of bleeding or perforation in the digestive tract associated with the use of NSAIDs. Bleeding in the digestive tract, other active bleeding or increased bleeding. Crohn's disease or ulcerative colitis. History of bronchial asthma. Severe heart failure. Moderate or severe renal impairment (creatinine clearance

Compound

active ingredient: 1 tablet contains dexketoprofen (in the form of dexketoprofen trometamol) 25 mg; excipients: microcrystalline cellulose, pregelatinized starch, corn starch, sodium starch glycolate, glycerol distearate; composition of the Aquarius Prime BAP218010 white shell: hypromellose, titanium dioxide (E 171), polyethylene glycol.

Overdose

Overdose symptoms are unknown. Similar drugs cause disorders of the digestive tract (vomiting, anorexia, abdominal pain) and the nervous system (drowsiness, vertigo, disorientation, headache). Treatment In case of accidental overdose, symptomatic treatment should be started immediately according to the clinical condition of the patient. If an adult patient or child has taken a dose of more than 5 mg/kg body weight, activated charcoal should be used within 1 hour. Hemodialysis can be used to remove dexketoprofen.

Storage conditions

Store in a place protected from light at a temperature not exceeding 25 °C. Keep out of the reach of children. Best before date. 2 years. Do not use the drug after the expiration date indicated on the package.

Buy Caver tablet. p/o 25 mg in blister pack. in pack No. 10x1 in the pharmacy

Price for Caver table. p/o 25 mg in blister pack. in pack №10x1

Instructions for use for Caver tablet. p/o 25 mg in blister pack. in pack №10x1

Indications and contraindications for use

The injectable drug Caver is widely used to relieve pain of moderate and severe intensity. This dosage form is preferred in postoperative patients, as well as in emergency cases, for example, during attacks of renal or hepatic colic, injuries, and so on.

At the same time, there are a number of restrictions on the use of the drug. These include the following:

  • allergy to the drug or its individual components;
  • allergy to any other non-hormonal anti-inflammatory drugs;
  • exacerbation of peptic ulcer of the stomach or duodenum;
  • recurrent or acute gastrointestinal bleeding, including those caused by therapy with non-steroidal anti-inflammatory drugs;
  • intestinal pathology (nonspecific ulcerative colitis, Crohn's disease);
  • history of bronchial asthma, severe heart failure;
  • renal failure with creatinine clearance less than 50 ml per minute;
  • severe liver pathology with disruption of its functioning;
  • increased blood coagulation and tendency to bleeding;
  • childhood and adolescence;
  • gestation period.

Caver painkiller tablets 25 mg, 50 pcs.

Caver should be used with caution in patients with a history of allergic reactions.

The simultaneous use of the drug with other NSAIDs, including cyclooxygenase-2 inhibitors, should be avoided. Adverse effects of the drug can be minimized by using the minimum effective dose for the shortest possible period of time necessary to eliminate symptoms.

Safety regarding the gastrointestinal tract

When using drugs of the NSAID class, peptic ulcers with or without perforation and bleeding (even fatal) may develop in the digestive tract. These adverse events can occur during any period of treatment, both with and without warning symptoms, regardless of the presence of a history of severe disorders of the digestive tract. If gastrointestinal bleeding or a peptic ulcer develops while using dexketoprofen, therapy with the drug should be stopped immediately.

The risk of developing the above-mentioned adverse events increases in proportion to the increase in the dose of NSAIDs, as well as in patients with a history of gastric or duodenal ulcers and in the elderly. While using the drug, the doctor should carefully monitor the patient's condition, taking into account the possible occurrence of gastrointestinal bleeding. Before starting the use of dexketoprofen trometamol and if you have a history of esophagitis, gastritis and/or peptic ulcer, you should, as with other NSAIDs, make sure that these diseases are in remission. Patients with obvious symptoms of pathology of the digestive tract and with a history of diseases of the digestive tract should be monitored for disorders of the digestive tract, especially bleeding in the digestive tract.

NSAIDs should be prescribed with caution to patients with a history of diseases of the digestive tract (ulcerative colitis, Crohn's disease), since there is a risk of exacerbation.

To reduce the risk of developing unwanted side effects from the digestive tract, the doctor may prescribe medications that have a protective effect on the mucous membrane of the digestive tract (misoprostol, proton pump inhibitors). This also applies to patients requiring concomitant administration of low doses of acetylsalicylic acid or other drugs that increase the risk of developing complications from the digestive system.

Patients should be informed that in case of any discomfort in the abdominal area (primarily gastrointestinal bleeding), especially at the beginning of treatment, they should inform the doctor.

Kidney safety

In patients with impaired renal function, the drug should be prescribed with caution, since the use of NSAIDs may cause deterioration in renal function, fluid retention in the body, and edema. Due to the increased risk of nephrotoxicity, the drug should be prescribed with caution during treatment with diuretics, as well as in those patients who may develop hypovolemia. During treatment, the patient's body must receive a sufficient amount of fluid to avoid dehydration, which can lead to increased toxic effects on the kidneys.

Just like all NSAIDs, the drug can increase the concentration of urea nitrogen and creatinine in the blood plasma. Like other prostaglandin synthesis inhibitors, its use may be accompanied by side effects from the kidneys, which lead to glomerulonephritis, interstitial nephritis, papillary necrosis, nephrotic syndrome and acute renal failure. Most renal dysfunction occurs in elderly patients.

Liver safety

In patients with impaired liver function, the drug should be prescribed with caution. Like other NSAIDs, the drug can cause a temporary and slight increase in the values ​​of some liver parameters, as well as a pronounced increase in the activity of AST and ALT. If these indicators increase appropriately, therapy should be discontinued.

Most liver dysfunction occurs in elderly patients.

Safety regarding the cardiovascular system and cerebral circulation

Patients with arterial hypertension and/or mild to moderate heart failure require monitoring and counseling. Particular caution should be taken when treating patients with a history of heart disease, in particular with previous episodes of heart failure - while using the drug, the risk of developing heart failure increases, since fluid retention in the tissues and the formation of edema occurred during treatment with NSAIDs. Clinical studies and epidemiological data suggest that the use of certain NSAIDs (especially in high doses and for long periods of time) may slightly increase the risk of arterial thrombosis (for example, myocardial infarction or stroke). There is insufficient data to exclude such a danger when using dexketoprofen. Therefore, in cases of uncontrolled arterial hypertension, congestive heart failure, coronary heart disease, peripheral arterial and/or cerebrovascular disease, dexketoprofen should be prescribed only after a thorough assessment of the patient's condition. An equally careful consideration of the condition should be carried out before initiating long-term treatment in patients with risk factors for cardiovascular disease (for example, hypertension, hyperlipidemia, diabetes mellitus, smoking).

All non-selective NSAIDs can reduce platelet aggregation and increase bleeding time by suppressing prostaglandin synthesis. Therefore, it is not recommended to prescribe dexketoprofen trometamol to patients taking drugs that affect hemostasis, such as warfarin, other indirect drugs or heparins. Most dysfunctions of the cardiovascular system occur in elderly patients.

Skin reactions

There have been very rare case reports of serious skin reactions (some fatal) with the use of NSAIDs, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. The greatest risk of their occurrence is probably observed in patients at the beginning of treatment; in most patients they occurred during the first month of treatment.

At the first signs of skin rashes, damage to the mucous membranes or other symptoms of hypersensitivity, the drug Caver should be discontinued.

Other information

Particular caution should be exercised when prescribing the drug to patients with:

  • hereditary disorder of porphyrin metabolism (for example, in acute intermittent porphyria);
  • dehydration;
  • immediately after major surgical interventions.

If your doctor believes that long-term use of dexketoprofen is necessary, liver and kidney function should be regularly monitored.

In very rare cases, severe acute hypersensitivity reactions (eg anaphylactic shock) have been observed. At the first signs of severe hypersensitivity reactions after taking Caver, treatment should be discontinued. Depending on the symptoms, the treatment necessary in such cases should be carried out under the supervision of a doctor.

Patients suffering from asthma in combination with chronic rhinitis, chronic sinusitis and/or nasal polyps are at higher risk of allergies to acetylsalicylic acid and/or NSAIDs than the general population. The administration of this drug may cause asthma attacks or bronchospasm, especially in patients with an allergy to acetylsalicylic acid or NSAIDs.

In special cases, it is possible to develop severe infectious complications of the skin and soft tissues against the background of chickenpox. To date, no data have been obtained to completely exclude the role of NSAIDs in enhancing this infectious process. Therefore, in case of chickenpox, the use of the drug Caver should be avoided.

Caver should be used with caution in patients with hematopoietic disorders, systemic lupus erythematosus and mixed connective tissue diseases.

Like other NSAIDs, dexketoprofen can mask the symptoms of infectious diseases.

Instructions for using Caver injections

Injection Caver is used for acute attacks of pain. The dose of the drug is 50 mg every eight hours for two days, after which they switch to the tablet form of the drug.

The ampoule solution of the drug is intended for parenteral administration into the body, namely:

  • intramuscular injections - the medicine is injected undiluted into large muscles, such as the gluteal or quadriceps femoris. Before injection, shake the syringe with suspension;
  • intravenous jet injections - the drug is administered slowly into a vein undiluted or pre-diluted with 5-10 ml of physiological sodium chloride solution;
  • intravenous drip infusions - for droppers use Caver, diluted with 50-100 ml of 0.9% sodium chloride, 5% glucose and Ringer's solution. Since the drug deteriorates under ultraviolet light, it is recommended to put dark polyethylene on the bottle.

It is strictly forbidden to carry out intrathecal and epidural injections of Caver.

Side effects and overdose

Self-medication with the drug is unacceptable, since, although rare, adverse reactions may develop. Therefore, Caver is used exclusively as prescribed by the treating doctor.

Manufacturers warn about the following side effects of the drug:

  • on the part of the skin - itching, hyperemia, swelling of the skin, urticarial rash, dermatitis, Quincke's edema;
  • from the immune system – anaphylactic shock, hyperthermia;
  • from the digestive tract - loss of appetite, nausea, vomiting, abdominal pain, bloating, stool disorders, heartburn, sour belching, the appearance of erosions and ulcers on the mucous membrane of the digestive tube;
  • from the nervous system - sleep disturbance, irritability, headaches, vertigo, tinnitus, general weakness, asthenia, apathy, depression;
  • from the cardiovascular system - rapid heartbeat, surges in blood pressure, fluid retention in the body;
  • from the hepatobiliary system – hepatitis, acute liver failure;
  • from the genitourinary system - nephrotic syndrome, acute kidney dysfunction, dysmenorrhea, deterioration in sperm quality.

Caver therapy can also provoke changes in key indicators in blood tests, in particular a decrease in the number of platelets and neutrophils, an increase in the activity of liver transaminases and bilirubin.

As for drug overdose, no such cases have been registered. But other drugs from the group of non-hormonal anti-inflammatory drugs are known to cause vomiting, loss of appetite, epigastric pain, drowsiness, dizziness and headache. Therefore, it can be assumed that if Caver dosages are exceeded, and over a long period of time, similar symptoms may develop.

Treatment of overdose consists of discontinuing the drug, taking enterosorbents, detoxification and symptomatic therapy. In severe cases, extracorporeal hemodialysis is indicated.

Caver® (tablets)

Features of application

Caver should be used with caution in patients with a history of allergic reactions.
The simultaneous use of the drug with other NSAIDs, including cyclooxygenase-2 inhibitors, should be avoided. Adverse effects of the drug can be minimized by using the minimum effective dose for the shortest possible period of time necessary to eliminate symptoms.

Safety regarding the gastrointestinal tract

When using drugs of the NSAID class, peptic ulcers with or without perforation and bleeding (even fatal) may develop in the digestive tract. These adverse events can occur during any period of treatment, both with and without warning symptoms, regardless of the presence of a history of severe disorders of the digestive tract. If gastrointestinal bleeding or a peptic ulcer develops while using dexketoprofen, therapy with the drug should be stopped immediately.

The risk of developing the above-mentioned adverse events increases in proportion to the increase in the dose of NSAIDs, as well as in patients with a history of gastric or duodenal ulcers and in the elderly. While using the drug, the doctor should carefully monitor the patient's condition, taking into account the possible occurrence of gastrointestinal bleeding. Before starting the use of dexketoprofen trometamol and if you have a history of esophagitis, gastritis and/or peptic ulcer, you should, as with other NSAIDs, make sure that these diseases are in remission. Patients with obvious symptoms of pathology of the digestive tract and with a history of diseases of the digestive tract should be monitored for disorders of the digestive tract, especially bleeding in the digestive tract.

NSAIDs should be prescribed with caution to patients with a history of diseases of the digestive tract (ulcerative colitis, Crohn's disease), since there is a risk of exacerbation.

To reduce the risk of developing unwanted side effects from the digestive tract, the doctor may prescribe medications that have a protective effect on the mucous membrane of the digestive tract (misoprostol, proton pump inhibitors). This also applies to patients requiring concomitant administration of low doses of acetylsalicylic acid or other drugs that increase the risk of developing complications from the digestive system.

Patients should be informed that in case of any discomfort in the abdominal area (primarily gastrointestinal bleeding), especially at the beginning of treatment, they should inform the doctor.

Kidney safety

In patients with impaired renal function, the drug should be prescribed with caution, since the use of NSAIDs may cause deterioration in renal function, fluid retention in the body, and edema. Due to the increased risk of nephrotoxicity, the drug should be prescribed with caution during treatment with diuretics, as well as in those patients who may develop hypovolemia. During treatment, the patient's body must receive a sufficient amount of fluid to avoid dehydration, which can lead to increased toxic effects on the kidneys.

Just like all NSAIDs, the drug can increase the concentration of urea nitrogen and creatinine in the blood plasma. Like other prostaglandin synthesis inhibitors, its use may be accompanied by side effects from the kidneys, which lead to glomerulonephritis, interstitial nephritis, papillary necrosis, nephrotic syndrome and acute renal failure. Most renal dysfunction occurs in elderly patients.

Liver safety

In patients with impaired liver function, the drug should be prescribed with caution. Like other NSAIDs, the drug can cause a temporary and slight increase in the values ​​of some liver parameters, as well as a pronounced increase in the activity of AST and ALT. If these indicators increase appropriately, therapy should be discontinued.

Most liver dysfunction occurs in elderly patients.

Safety regarding the cardiovascular system and cerebral circulation

Patients with arterial hypertension and/or mild to moderate heart failure require monitoring and counseling. Particular caution should be taken when treating patients with a history of heart disease, in particular with previous episodes of heart failure - while using the drug, the risk of developing heart failure increases, since fluid retention in the tissues and the formation of edema occurred during treatment with NSAIDs. Clinical studies and epidemiological data suggest that the use of certain NSAIDs (especially in high doses and for long periods of time) may slightly increase the risk of arterial thrombosis (for example, myocardial infarction or stroke). There is insufficient data to exclude such a danger when using dexketoprofen. Therefore, in cases of uncontrolled arterial hypertension, congestive heart failure, coronary heart disease, peripheral arterial and/or cerebrovascular disease, dexketoprofen should be prescribed only after a thorough assessment of the patient's condition. An equally careful consideration of the condition should be carried out before initiating long-term treatment in patients with risk factors for cardiovascular disease (for example, hypertension, hyperlipidemia, diabetes mellitus, smoking).

All non-selective NSAIDs can reduce platelet aggregation and increase bleeding time by suppressing prostaglandin synthesis. Therefore, it is not recommended to prescribe dexketoprofen trometamol to patients taking drugs that affect hemostasis, such as warfarin, other indirect drugs or heparins. Most dysfunctions of the cardiovascular system occur in elderly patients.

Skin reactions

There have been very rare case reports of serious skin reactions (some fatal) with the use of NSAIDs, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. The greatest risk of their occurrence is probably observed in patients at the beginning of treatment; in most patients they occurred during the first month of treatment.

At the first signs of skin rashes, damage to the mucous membranes or other symptoms of hypersensitivity, the drug Caver should be discontinued.

Other information

Particular caution should be exercised when prescribing the drug to patients with:

- hereditary disorder of porphyrin metabolism (for example, in acute intermittent porphyria);

- dehydration;

— immediately after extensive surgical interventions.

If your doctor believes that long-term use of dexketoprofen is necessary, liver and kidney function should be regularly monitored.

In very rare cases, severe acute hypersensitivity reactions (eg anaphylactic shock) have been observed. At the first signs of severe hypersensitivity reactions after taking Caver, treatment should be discontinued. Depending on the symptoms, the treatment necessary in such cases should be carried out under the supervision of a doctor.

Patients suffering from asthma in combination with chronic rhinitis, chronic sinusitis and/or nasal polyps are at higher risk of allergies to acetylsalicylic acid and/or NSAIDs than the general population. The administration of this drug may cause asthma attacks or bronchospasm, especially in patients with an allergy to acetylsalicylic acid or NSAIDs.

In special cases, it is possible to develop severe infectious complications of the skin and soft tissues against the background of chickenpox. To date, no data have been obtained to completely exclude the role of NSAIDs in enhancing this infectious process. Therefore, in case of chickenpox, the use of the drug Caver should be avoided.

Caver should be used with caution in patients with hematopoietic disorders, systemic lupus erythematosus and mixed connective tissue diseases.

Like other NSAIDs, dexketoprofen can mask the symptoms of infectious diseases.

Use during pregnancy or breastfeeding.

Caver is contraindicated in the third trimester of pregnancy and during breastfeeding.

Pregnancy

Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or fetal development. In accordance with the results of epidemiological studies, the use of drugs that inhibit the synthesis of prostaglandins in early pregnancy increases the risk of miscarriage, fetal heart disease and patent anterior abdominal wall. Thus, the absolute risk of developing cardiovascular abnormalities increased from <1% to approximately 1.5%. It is believed that the risk of such events increases with increasing drug dose and duration of therapy. The use of prostaglandin synthesis inhibitors in animals caused an increase in pre- and postimplantation losses and an increase in embryofetal mortality. In addition, in animals that were treated with prostaglandin synthesis inhibitors during the period of organogenesis, the incidence of fetal malformations, including abnormalities of the cardiovascular system, increased. However, animal studies of dexketoprofen have not shown toxicity to the reproductive organs. Prescribing dexketoprofen in the first and second trimesters of pregnancy is possible only if absolutely necessary. When prescribing dexketoprofen to women planning pregnancy, or in the first and second trimesters of pregnancy, the lowest possible effective dose should be used for the shortest possible treatment period.

During the third trimester, all prostaglandin synthesis inhibitors cause the following:

risks to the fetus:

  • cardiovascular toxicity, such as premature closure of the ductus arteriosus and hypertension in the pulmonary artery system;
  • renal dysfunction, which can progress and develop into renal failure with the development of oligohydramnios:

The following phenomena are possible in the mother at the end of pregnancy and in the baby:

  • increased bleeding time due to inhibition of platelet aggregation, even when using the drug in low doses;
  • inhibition of contractile activity of the uterus, which leads to delay and delay of labor.

Breast-feeding

There is no data on the penetration of dexketoprofen into breast milk. Caver is contraindicated during breastfeeding.

Fertility.

Like all other NSAIDs, dexketoprofen trometamol can reduce female fertility and is therefore not recommended for women planning pregnancy. Women who have problems conceiving or are being evaluated for infertility should consider discontinuing the drug.

If dexketoprofen is used by a woman who is planning to become pregnant, or during the first or second trimester of pregnancy, the minimum effective dose should be used for the shortest possible period of time.

The ability to influence the reaction rate when driving vehicles or other mechanisms.

Side effects such as dizziness, blurred vision or drowsiness may occur when using Caver. In such cases, reaction speed and the ability to actively participate in traffic and operate machines may be reduced.

special instructions

Long-term therapy with Caver requires monitoring of blood counts. During this period, it is necessary to analyze the prescription of other medications to avoid negative effects from their interactions.

There is also clinical evidence that NSAIDs (non-steroidal anti-inflammatory drugs) worsen chickenpox, so they are not used during this disease. In addition, Caver is able to mask the manifestation of diseases of an infectious nature.

The drug contains a small amount of ethyl alcohol, so it should not be prescribed to persons suffering from alcoholism.

Impact on the ability to drive vehicles and complex mechanisms

Given the risk of side effects, in particular from the nervous system, it is recommended to be careful when driving a car or other complex machinery. It is also necessary to objectively assess the ability to perform professional duties that require increased concentration.

Interaction with other drugs

Caver may react with other medications, potentiating or reducing their effectiveness, as well as increasing their side effects.

The manufacturers of Caver have compiled a list of drugs with which it cannot be combined:

  • hormonal anti-inflammatory drugs - dangerous due to gastrointestinal bleeding, the appearance and intensification of side effects;
  • blood thinning medications – increases the risk of bleeding;
  • preparations of hormones of the adrenal cortex - adverse reactions from the digestive tract become more frequent, including the appearance of erosions and ulcers in the stomach and duodenum;
  • lithium preparations – NSAIDs (NSAIDs) increase the level of lithium in the blood serum, which can lead to poisoning;
  • cytostatics - will lead to significant neutropenia and thrombocytopenia;
  • sulfonamides - will cause side effects.

There are also a number of medications, the combination of which with Caver requires medical supervision of the patient and his indicators:

  • diuretics and blood pressure-lowering medications (beta blockers, ACE inhibitors, PAP blockers) – the effect decreases;
  • antiplatelet agents and thrombolytics – increases the risk of bleeding;
  • zidovudine – the level of reticulocytes in the blood decreases;
  • immunosuppressants – increase nephro- and hepatotoxicity;
  • digitalis preparations – dangerous due to digitalis intoxication;
  • quinolones – possible occurrence of convulsions.

Use in childhood

There is no reliable data on the effects of Caver on the children's body, so the drug is not used in pediatric practice.

In old age

In patients over 60 years of age, the frequency of adverse reactions increases, which is associated with an age-related decrease in renal function. Therefore, when treating elderly patients, the minimum dose of the drug is used - 2 ml (50 mg) per day.

For impaired renal and liver function

In case of decompensated liver failure, Caver is not prescribed. In patients with mild to moderate degree of organ dysfunction, the daily dose of the drug is reduced to 2 ml (50 mg).

For patients with renal dysfunction, when creatinine clearance is from 50 to 80 ml per minute, the dose is adjusted, reducing it to 50 mg per day. If organ performance deteriorates, Caver is discontinued.

Patients with liver or kidney failure during drug therapy must undergo a biochemical blood test to monitor indicators.

Caver solution for injection 25 mg/ml in ampoules 2 ml No. 5x2

Name

Caver solution for injection/conc. for other information solution 25 mg/ml in amp. 2ml per bl. in pack №5x2

Main active ingredient

1 ml of solution contains 25 mg of dexketoprofen (as dexketoprofen trometamol 36.9 mg)

Release form

Solution for injection/concentrate for the preparation of infusion solution.

Dosage

25mg/ml

Pharmacological properties
Pharmacodynamics

Dexketoprofen trometamol is a salt of propionic acid that has analgesic, anti-inflammatory and antipyretic effects and belongs to the class of non-steroidal anti-inflammatory drugs (NSAIDs). The mechanism of its action is based on a decrease in the synthesis of prostaglandins due to inhibition of cyclooxygenase. In particular, the conversion of arachidonic acid into the cyclic endoperoxides PGG2 and PGH2, from which prostaglandins PGE1, PGE2, PGF2a, PGD2 are formed, as well as prostacyclin PGI2 and thromboxanes TxA2 and TxB2, is inhibited. In addition, inhibition of prostaglandin synthesis may affect other inflammatory mediators, such as kinins, which may also indirectly affect the main effect of the drug. The inhibitory effect of dexketoprofen trometamol on the activity of cyclooxygenase-1 and cyclooxygenase-2 was revealed. Clinical studies for various types of pain have demonstrated that dexketoprofen trometamol has a pronounced analgesic effect. The analgesic effect of dexketoprofen trometamol when administered intramuscularly and intravenously to patients with pain of moderate and severe intensity has been studied for various types of pain during surgical interventions (orthopedic and gynecological operations, abdominal surgery), as well as for musculoskeletal pain (acute pain in the lower parts back) and renal colic. In the studies conducted, the analgesic effect of the drug began quickly and reached a maximum within the first 45 minutes. The duration of analgesic effect after using 50 mg of dexketoprofen trometamol is usually 8 hours. The use of the drug Caver allows you to significantly reduce the dose of opiates when used simultaneously to relieve postoperative pain. Patients prescribed morphine for postoperative pain using a patient-controlled analgesia device and also prescribed dexketoprofen trometamol required significantly less morphine (35-45%) than patients receiving placebo.

Pharmacokinetics

After intramuscular administration of dexketoprofen trometamol, the maximum concentration is reached after approximately 20 minutes (10-45 minutes). It has been proven that with a single intramuscular or intravenous administration of 25-50 mg of the drug, the area under the AUC curve (concentration-time) is proportional to the dose. Pharmacokinetic studies of repeated use of the drug have proven that AUC and Cmax (average maximum value) after the last intramuscular and intravenous administration do not differ from those after a single use, which indicates the absence of drug accumulation. Similar to other drugs with a high degree of binding to plasma proteins (99%), the volume of distribution of dexketoprofen averages 0.25 l/kg. The half-life of distribution is approximately 0.35 hours, and the half-life is 1-2.7 hours. The metabolism of dexketoprofen mainly occurs through conjugation with glucuronic acid and subsequent excretion by the kidneys. After administration of dexketoprofen trometamol, only the optical isomer S – (+) is detected in the urine, which indicates the absence of transformation of the drug into the optical isomer R – (-). After administration of single and multiple doses, the effect of the drug on healthy elderly volunteers (over 65 years of age) who took part in the study was significantly higher (up to 55%) than on young volunteers, but there was no statistically significant difference in the maximum concentration and time of its no achievement was observed. The average half-life increased (up to 48%), and the determined total clearance decreased.

Indications for use

Symptomatic treatment of acute pain of moderate to severe intensity in cases where oral administration of the drug is inappropriate, for example, with postoperative pain, renal colic and pain in the lower back.

Directions for use and doses

Adults. The recommended dose is 50 mg at intervals of 8-12 hours. If necessary, a repeat dose is administered after 6 hours. The maximum daily dose should not exceed 150 mg. The drug is intended for short-term use, so it should be used only during periods of acute pain (no more than 2 days). Patients should be switched to oral analgesics whenever possible. Adverse reactions can be reduced by using the minimum effective dose for the shortest possible time necessary to achieve improvement. For postoperative pain of moderate or severe severity, the drug can be used as indicated in the same recommended doses in combination with opioid analgesics. Elderly patients. Dose adjustment is usually not required. However, due to physiological decline in renal function, a lower dose is recommended, namely the maximum daily dose is 50 mg for mild renal impairment. Liver diseases. For patients with mild or moderate liver pathology (5-9 points on the Child-Pugh scale), the maximum daily dose should be reduced to 50 mg and liver function should be carefully monitored. In severe liver diseases, the drug is contraindicated (10-15 points on the Child-Pugh scale). Kidney dysfunction. For patients with mild renal impairment (creatinine clearance 50-80 ml/min), the maximum daily dose should be reduced to 50 mg. In case of moderate or severe renal impairment (creatinine clearance

Use during pregnancy and lactation

The use of the drug Caver is contraindicated in the third trimester of pregnancy and during breastfeeding. Suppression of prostaglandin synthesis may adversely affect pregnancy and/or fetal development. According to the results of epidemiological studies, the use of drugs that suppress the synthesis of prostaglandins in early pregnancy increases the risk of miscarriage, fetal heart defects and non-union of the anterior abdominal wall. Thus, the absolute risk of developing abnormalities of the cardiovascular system increased with

Precautionary measures

Use with caution in patients with a history of allergic conditions. Avoid using Caver in combination with other NSAIDs, including selective cyclooxygenase-2 inhibitors. Adverse reactions can be reduced by using the minimum effective dose for the shortest possible time necessary to achieve improvement. Gastrointestinal bleeding, ulceration or perforation, in some cases fatal, have been observed with the use of NSAIDs at various stages of treatment, regardless of the presence of warning symptoms or a history of serious pathology of the digestive tract. If gastrointestinal bleeding develops, use of the drug should be discontinued. The risk of gastrointestinal bleeding, ulceration or perforation increases with increasing dose of NSAIDs in patients with a history of ulcers, especially those complicated by bleeding or perforation, as well as in elderly patients. In elderly patients, the incidence of adverse reactions of NSAIDs is increased, especially gastrointestinal bleeding and perforation, sometimes with death. Treatment of such patients should begin with the lowest possible dose. NSAIDs should be prescribed with caution to patients with a history of diseases of the digestive tract (ulcerative colitis, Crohn's disease), since there is a risk of their exacerbation. Before starting the use of dexketoprofen trometamol in patients with a history of esophagitis, gastritis and/or peptic ulcer, you should make sure that these diseases are in remission. In patients with existing symptoms of pathology of the digestive tract and with a history of diseases of the digestive tract, during the use of the drug, it is necessary to monitor the condition of the digestive tract for the occurrence of possible disorders, especially with regard to gastrointestinal bleeding. For such patients and patients taking acetylsalicylic acid in small doses or other drugs that increase the risk of adverse reactions from the digestive tract, combination therapy with protective drugs, for example, misoprostol or proton pump inhibitors, should be considered. Patients, especially the elderly, who have a history of adverse reactions from the digestive tract, should inform the doctor about all unusual symptoms associated with the digestive system, in particular gastrointestinal bleeding, especially in the initial stages of treatment. Caution should be exercised when prescribing the drug to patients who are concomitantly taking medications that increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants (eg, warfarin), selective serotonin reuptake inhibitors, or antiplatelet agents such as aspirin. Non-selective NSAIDs can reduce platelet aggregation and increase bleeding time by suppressing prostaglandin synthesis. The simultaneous use of dexketoprofen trometamol and low molecular weight heparin in prophylactic doses in the postoperative period has been studied in clinical studies, and no effect on coagulation parameters was found. However, patients taking dexketoprofen trometamol concomitantly with drugs that affect hemostasis, such as warfarin, other coumarins or heparins, must be under close medical supervision. Patients with arterial hypertension and/or congestive heart failure of mild or moderate severity should be under close medical supervision due to possible fluid retention in the body and the appearance of peripheral edema. Available clinical and epidemiological data indicate that the use of some NSAIDs, especially in high doses and for long periods of time, slightly increases the risk of conditions caused by arterial thrombosis, such as myocardial infarction or stroke. There is insufficient data to exclude such a risk from the use of dexketoprofen trometamol. For uncontrolled arterial hypertension, congestive heart failure, confirmed coronary heart disease, peripheral arterial and/or cerebrovascular disease, dexketoprofen trometamol should be used only after a thorough assessment of the patient's condition. Such an assessment should also be made before starting long-term treatment of patients with risk factors for cardiovascular diseases, such as arterial hypertension, hyperlipidemia, diabetes mellitus, and smoking. There have been rare case reports of serious skin reactions (some fatal) with the use of NSAIDs, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. The greatest risk of their occurrence is observed in patients at the beginning of treatment; in most patients they occurred during the 1st month of therapy. If a skin rash, signs of damage to the mucous membranes or other symptoms of hypersensitivity appear, the drug Caver should be darkened. Like all NSAIDs, the drug is able to increase the level of urea nitrogen and creatinine in the blood plasma. Like other prostaglandin synthesis inhibitors, it may cause renal adverse reactions, which may lead to glomerulonephritis, interstitial nephritis, papillary necrosis, nephrotic syndrome and acute renal failure. Like other NSAIDs, the drug may cause a temporary slight increase in some liver function tests, as well as a significant increase in AST and ALT levels. If these indicators increase, treatment should be stopped. The drug should be prescribed with caution to patients with impaired liver and/or kidney function, as well as patients with arterial hypertension and/or congestive heart failure, since they may experience deterioration in renal function, fluid retention in the body and the appearance of peripheral edema while using NSAIDs. Due to the increased risk of nephrotoxicity, the drug should be used with caution during treatment with diuretics, as well as in patients who may develop hypovolemia. Particular caution should be exercised when treating patients with a history of heart disease, including previous episodes of heart failure, since the use of the drug increases the risk of heart failure. Elderly patients are more often susceptible to renal dysfunction, cardiovascular system and liver dysfunction occurs in elderly patients. Caver should be administered with caution to patients with hematopoietic disorders, systemic lupus erythematosus and mixed connective tissue diseases. Like other NSAIDs, dexketoprofen trometamol can mask the symptoms of infectious diseases during its use. When using NSAIDs, there have been reports of activation of infectious processes localized in soft tissues. Therefore, if symptoms of a bacterial infection appear or worsen during use, patients are advised to consult a doctor immediately. Like all other NSAIDs, dexketoprofen trometamol may reduce female fertility and is therefore not recommended for use in women planning pregnancy. If a woman has problems conceiving or is being examined for infertility, discontinuation of the drug should be considered. Prescription of the drug in the first and second trimesters of pregnancy is possible in cases of extreme necessity. Each ampoule of the drug Caver contains 200 mg of ethanol, which corresponds to 5 ml of beer or 2.08 wine per dose. The drug may have a negative effect on persons suffering from alcoholism. The ethanol content should be taken into account when using the drug for women in the first and second trimesters of pregnancy, children and patients at risk, for example, with liver diseases, as well as patients with epilepsy. The drug Caver contains less than 1 mmol/dose of sodium, i.e. practically free of sodium.

Interaction with other drugs

Concomitant use of the following drugs with NSAIDs is not recommended: - other NSAIDs, including salicylates in high doses (≥3 g/day). With the simultaneous use of several NSAIDs, the risk of ulcers in the digestive tract and gastrointestinal bleeding increases due to their mutual enhancement of action; anticoagulants: NSAIDs enhance the effect of anticoagulants, for example, warfarin, due to the high degree of binding of dexketoprofen to blood plasma proteins, as well as inhibition of platelet function and damage to the mucous membrane of the stomach and duodenum. If simultaneous use is necessary, it should be carried out under the close supervision of a physician with the monitoring of relevant laboratory parameters; – heparin: increases the risk of bleeding (due to inhibition of platelet function and damage to the mucous membrane of the stomach and duodenum). If simultaneous use is necessary, it should be carried out under close medical supervision with monitoring of appropriate laboratory parameters; – corticosteroids: increases the risk of developing ulcers in the digestive tract and gastrointestinal bleeding; – lithium (there have been reports regarding several NSAIDs): NSAIDs increase the level of lithium in the blood, which can lead to intoxication (reduced renal excretion of lithium). Therefore, when starting to use dexketoprofen, when adjusting the dose or discontinuing the drug, it is necessary to monitor the level of lithium in the blood; – methotrexate in high doses (more than 15 mg per week). Due to a decrease in the renal clearance of methotrexate during the use of NSAIDs, its negative effect on the blood system generally increases; hydantoin derivatives and sulfonamides: the toxicity of these substances may increase. The simultaneous use of the following drugs with NSAIDs requires caution: diuretics, angiotensin-converting enzyme (ACE) inhibitors, antibacterial drugs from the aminoglycoside group and angiotensin II receptor antagonists. Dexketoprofen reduces the effectiveness of diuretics and other antihypertensive drugs. In some patients with impaired renal function (for example, those with dehydration or the elderly), the use of cyclooxygenase inhibitors concomitantly with ACE inhibitors, angiotensin II receptor antagonists or aminoglycosides may worsen renal function, which is usually reversible. When using dexketoprofen together with any diuretic, you should ensure that the patient is not dehydrated, and renal function should be monitored at the beginning of treatment; – methotrexate in low doses (less than 15 mg per week): due to a decrease in the renal clearance of methotrexate during the use of NSAIDs, its negative effect on the blood system as a whole increases. Blood tests should be performed weekly during the first weeks of concomitant use. Even with slight impairment of renal function, as well as in elderly patients, treatment should be carried out under the strict supervision of a physician; – pentoxifylline: there is a risk of bleeding. It is necessary to strengthen control and check the bleeding time indicator more often; – zidovudine: there is a risk of increased toxic effects on red blood cells due to the effect on reticulocytes, which after the 1st week of NSAID use leads to severe anemia. Within 1-2 weeks after starting NSAID use, a blood test should be done to check the reticulocyte count; – sulfonylurea drugs: NSAIDs can enhance the hypoglycemic effect of these drugs by replacing them in compounds with blood plasma proteins. Possible interactions should be taken into account when using the following drugs: - beta blockers: NSAIDs can weaken their hypotensive effect by inhibiting the synthesis of prostaglandins; cyclosporine and tacrolimus: increased nephrotoxicity may occur due to the effect of NSAIDs on renal prostaglandins. During combination therapy, renal function should be monitored; thrombolytic agents: increased risk of bleeding; antiplatelet agents and selective serotonin reuptake inhibitors: increases the risk of gastrointestinal bleeding; probenecid: it is possible to increase the concentration of dexketoprofen in the blood plasma, which is probably due to inhibition of tubular secretion and conjugation of the drug with glucuronic acid and requires adjustment of the dose of dexketoprofen; cardiac glycosides: NSAIDs can increase the concentration of glycosides in the blood plasma; mifepristone: due to the theoretical likelihood of a decrease in the effectiveness of mifepristone under the influence of prostaglandin synthetase inhibitors, NSAIDs should be prescribed only 8-12 days after therapy with mifepristone; quinolone: ​​results from animal studies have shown that the use of quinolone derivatives in high doses in combination with NSAIDs increases the risk of developing seizures.

Contraindications

– Hypersensitivity to dexketoprofen, any other non-steroidal anti-inflammatory drug (NSAID) or to the excipients of the drug; – the drug is contraindicated if substances of similar action, for example, acetylsalicylic acid or other NSAIDs, provoke the development of asthma attacks, bronchospasm, acute rhinitis or cause the development of nasal polyps, urticaria or angioedema; – active phase of peptic ulcer or bleeding, suspicion of them, recurrent peptic ulcer or bleeding in history (at least two confirmed cases of ulcer or bleeding); – gastrointestinal bleeding, other bleeding in the active phase or increased bleeding; history of gastrointestinal bleeding or perforation associated with previous NSAID therapy; – Crohn's disease or ulcerative colitis; – history of bronchial asthma; – severe heart failure; – moderate to severe renal dysfunction (creatinine clearance

Compound

active ingredient: 1 ml of solution contains 25 mg of dexketoprofen (in the form of dexketoprofen trometamol 36.9 mg); excipients: ethanol 96%, sodium chloride, sodium hydroxide, water for injection.

Overdose

Overdose symptoms are unknown. Similar drugs cause disorders of the digestive tract (vomiting, anorexia, abdominal pain) and the nervous system (drowsiness, dizziness, disorientation, headache). In case of accidental overdose, symptomatic treatment should be started immediately in accordance with the patient's condition. Dexketoprofen trometamol is removed from the body by dialysis.

Side effect

The development of peptic ulcer, perforation or gastrointestinal bleeding is possible, sometimes with a fatal outcome, especially in elderly patients. According to available data, while using the drug, nausea, vomiting, diarrhea, flatulence, constipation, dyspeptic symptoms, abdominal pain, melena, vomiting with blood, ulcerative stomatitis, exacerbation of colitis and Crohn's disease may occur. Gastritis is less common. Edema, hypertension and heart failure, which may be caused by NSAIDs, have also been reported. As with the use of other NSAIDs, the following adverse reactions are possible: aseptic meningitis, which occurs in patients with systemic lupus erythematosus or mixed connective tissue diseases, and blood reactions (purpura, aplastic and hemolytic anemia, rarely - agranulocytosis and bone marrow hypoplasia) . Bullous reactions are possible, including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare). According to the results of clinical studies and epidemiological data, the use of some NSAIDs, especially in high doses and for a long time, slightly increases the risk of developing pathologies caused by arterial thrombosis, such as myocardial infarction and stroke.

Storage conditions

Store in original packaging to protect from light at temperatures not exceeding 25 °C. Keep out of the reach of children.

Buy Caver solution for injection/conc. for other information solution 25 mg/ml in amp. 2ml per bl. in pack No. 5x2 in the pharmacy

Price for Caver solution for injection/conc. for other information solution 25 mg/ml in amp. 2ml per bl. in pack №5x2

Instructions for use for Caver solution for injection/conc. for other information solution 25 mg/ml in amp. 2ml per bl. in pack №5x2

Analogs

The pharmaceutical market offers a lot of Caver analogues of domestic and foreign production, which differ only in manufacturer and price.

The most popular analogues of the drug:

  • Alfort Dexa;
  • De-Span;
  • Dekenor;
  • Dexalgin;
  • Sertofen.

The active ingredient of the listed drugs is dexketoprofen at a dosage of 50 mg in two milliliters of solution, so they have the same effects as Caver, that is, analgesic, antipyretic and anti-inflammatory. Indications, contraindications and side effects are similar to Caver.

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