Xefocam: effective pain relief for injuries and diseases

Compound

1 tablet of Xefocam may contain 4 or 8 mg of the active ingredient lornoxicam and auxiliary components: povidone K25, magnesium stearate, cellulose, talc, croscarmellose sodium, lactose monohydrate, titanium dioxide, macrogol 6000 , hypromellose.
One bottle of Xefocam lyophilisate contains 8 mg of the active ingredient lornoxicam and auxiliary components: disodium edetate, trometamol, mannitol.

Release form

White oblong tablets (4 mg dosage) engraved with “LO4”.

• 10 pieces in a blister - 10, 1, 2, 3 or 5 blisters in a pack of paper.

White oblong tablets (dosage 8 mg) engraved with the inscription “LO8”.

• 10 pieces in a blister - 10, 1, 2, 3 or 5 blisters in a pack of paper.

The lyophilisate for making the solution is a dense yellow mass.

• 5 glass bottles in a paper pack.
• 5 glass bottles in a plastic tray; 1 pallet in a pack of paper.

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

Anti-inflammatory non-steroidal drug. It has a pronounced analgesic and anti-inflammatory effect. Lornoxicam has a rather complex mechanism of action, which includes inhibition of prostaglandin synthesis caused by inhibition of cyclooxygenase activity. Blocking cyclooxygenase leads to suppression of peripheral pain receptors and relief of signs of inflammation.

Lornoxicam also reduces the production of oxygen radicals by leukocytes that have undergone activation. The analgesic effect of the drug is not associated with an opiate-like effect on the nervous system and is not accompanied by respiratory depression or drug dependence.

Does not affect important vital signs: respiratory rate, ECG readings, body temperature, heart rate, blood pressure, spirometry .

Pharmacokinetics of tablets

After oral administration, lornoxicam is quickly and completely absorbed from the intestine. In this case, the highest concentration in the blood occurs after an hour and a half. Eating reduces the maximum concentration by 30% and increases the half-life to 2.3 hours. The bioavailability of lornoxicam reaches 92-100%. Binding to blood proteins is 99% and does not depend on its content.

The active substance is completely transformed in the liver. The enzyme CYP2C9 is involved in the transformation . In plasma, the drug is present predominantly unchanged and, only to a small extent, in the form of a hydroxylated metabolite that does not have pharmacological activity.

The half-life is approximately 4 hours. About a third of the metabolites are excreted in the urine and the remainder in the bile.

In elderly people, as well as in patients with impaired liver and kidney function, no changes in the pharmacokinetics of the drug were detected.

Pharmacokinetics of solution for parenteral administration

When administered intramuscularly, the highest content of lornoxicam in the blood is achieved after 25 minutes. Bioavailability in this case reaches 97%, and the reaction with blood proteins is 99%.

Lornoxicam is found in plasma in unchanged form and also in the form of a hydroxylated metabolite that has no pharmacological activity.

The half-life is approximately 3.5 hours. Completely metabolized. About a third of the metabolites are excreted in the urine and the remainder in the bile.

In elderly people, as well as in patients with impaired liver and kidney function, no changes in the pharmacokinetics of the drug were detected.

Mechanism of action

Lornoxicam belongs to the category of non-opioid analgesics. In the body, it inhibits the activity of the enzyme cyclooxygenase, which is responsible for the synthesis of neurotransmitters of pain and inflammation. It also slows down oxidation reactions. The substance does not affect the thermoregulation center, breathing, the functioning of the cardiovascular system, and does not cause drug dependence.

Xefocam in tablets and solution is quickly absorbed into the blood, binding to its proteins. The analgesic effect is observed after 15–20 minutes, reaching its maximum after 1.5–2 hours. Within 3.5–4 hours, the substance is filtered by liver cells and gradually eliminated from the body through the kidneys and intestines. During its activity and elimination, the drug produces almost no metabolites.

If the instructions are followed, Xefocam does not have a pronounced toxic effect on internal organs. Its components do not accumulate in tissues. The product is approved for use by physical parameters in weakened people, with insufficient liver function and excretory system.

Indications for use

Indications for use of Xefocam in tablet form:

• short-term therapy of pain syndrome, regardless of origin;
• symptomatic treatment of rheumatic diseases: nylosing spondylitis , osteoarthritis , articular syndrome in acute gout , rheumatoid arthritis , rheumatic lesions of periarticular soft tissues.

The drug is used in the form of injections for short-term treatment of acute pain of a moderate, mild and moderately severe nature.

Ksefokam analogues and prices

With caution: arterial hypertension; anemia. Special instructions During the treatment period, it is necessary to monitor the condition of the gastrointestinal tract in order to prevent ulcerogenic effects or gastrointestinal bleeding. The risk of ulcerogenic effects can be reduced by the simultaneous administration of omeprazole or H2-histamine receptor blockers, synthetic analogs of Pg (misoprostol). During treatment, monitoring of the peripheral blood picture and the functional state of the liver and kidneys is necessary. In patients with renal failure (plasma creatinine concentration 150-300 µmol/l), dosage adjustment and regular monitoring of renal function are required. If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study. Retains Na+, K+, Li+ and water in the body, which can worsen the course of arterial hypertension and heart failure, and in people taking Li+ drugs, increase the severity of the side effects of Li+ salts. Elderly patients, as well as those with arterial hypertension, require regular blood pressure monitoring. During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions. Composition: 1 tablet contains lornoxicam 8 mg.

Method of administration and dosage Xefocam tablets are taken orally, before meals, with a glass of water. For moderate and severe pain: the recommended dose is 8-16 mg/day, divided into 2-3 doses; the maximum daily dose is 16 mg. For inflammatory and degenerative rheumatic diseases: the recommended initial dose is 12 mg; standard dose is 8-16 mg/day, depending on the patient’s condition. The duration of therapy depends on the nature and course of the disease.

Side effects From the gastrointestinal tract and liver: abdominal pain, diarrhea, dyspepsia, nausea, vomiting; in rare cases - flatulence, dry mouth, gastritis, esophagitis, the formation of peptic ulcers and/or bleeding in the gastrointestinal tract (including rectal), stomatitis, glossitis, colitis, dysphagia, hepatitis, pancreatitis, liver dysfunction. Allergic reactions: possible skin rashes, hypersensitivity reactions accompanied by shortness of breath, tachycardia, bronchospasm, Stevens-Johnson syndrome, exfoliative dermatitis, angitis, fever, allergic rhinitis, lymphadenopathy. From the central nervous system: rarely - dizziness, headache, drowsiness, agitation, sleep disturbances, tinnitus, hearing loss, dysarthria, hallucinations, migraine, peripheral neuropathy, syncope, aseptic meningitis. From the senses: blurred vision, conjunctivitis. From the peripheral blood and coagulation system: rarely - leukopenia, thrombocytopenia. Metabolism: rarely - increased sweating, chills, change in body weight. From the cardiovascular system: rarely - arterial hypertension, tachycardia, peripheral edema. From the urinary system: rarely - dysuria, in some cases - glomerulonephritis, papillary necrosis and nephrotic syndrome with transition to acute renal failure, interstitial nephritis, crystalluria, polyuria.

Drug interactions Reduces the effectiveness of uricosuric drugs, enhances the effect of anticoagulants, antiplatelet agents, fibrinolytics, side effects of MCS and GCS, estrogens; reduces the effect of antihypertensive drugs and diuretics; enhances the hypoglycemic effect of sulfonylurea derivatives. Increases the concentration of Li+ and methotrexate in the blood. Reduces the renal clearance of digoxin. Cimetidine increases plasma concentrations of lornoxicam. Antacids and cholestyramine reduce absorption. Myelotoxic drugs increase the manifestations of hematotoxicity of the drug.

Contraindications

• combination (complete or incomplete) of polyposis of the paranasal sinuses or nose, bronchial asthma and intolerance to non-steroidal anti-inflammatory drugs (including a history);
• thrombocytopenia;
• bleeding diathesis or bleeding disorders, including conditions after surgical interventions associated with the likelihood of bleeding or insufficient hemostasis;
• the period after undergoing coronary artery bypass surgery ;
• changes in the mucous membranes of the duodenum or stomach of the erosive-ulcerative type, active bleeding from the gastrointestinal tract, as well as cerebrovascular or other bleeding;
• previous bleeding from the digestive organs associated with taking non-steroidal anti-inflammatory drugs;
• recurrent stomach ulcers or repeated bleeding from the digestive system;
• exacerbation of inflammatory bowel disease ( Crohn's disease );
• decompensated heart failure;
• liver failure or active liver disease;
• severe renal failure , progressive kidney disease, hyperkalemia , dehydration or hypovolemia ;
• pregnancy and lactation;
• age less than 18 years;
• allergy to the components of the drug.

Caution should be exercised in prescribing the medicine in the presence of at least one of the following conditions: lesions of the digestive tract of an erosive-ulcerative nature and bleeding of the specified localization, moderate renal failure, conditions after surgery, arterial hypertension , age over 65 years, coronary heart disease , cerebrovascular diseases , chronic cardiac failure, dyslipidemia , peripheral arterial disease, diabetes mellitus , smoking, creatinine clearance up to 60 ml/min, the presence of Helicobacter pylori, ulcerative lesions of the digestive tract in the past, long-term use of anti-inflammatory non-steroidal drugs, severe somatic diseases, alcoholism , joint taking oral forms of glucocorticosteroids, anticoagulants, antiplatelet agents, diuretics, selective serotonin uptake blockers or drugs with nephrotoxic effects.

Concomitant therapy with anti-inflammatory nonsteroidal drugs and Tacrolimus may increase the risk of nephrotoxicity.

The simultaneous use of anti-inflammatory non-steroidal drugs and Heparin against the background of epidural or spinal anesthesia increases the likelihood of epidural and spinal hematomas .

To whom is Xefocam contraindicated?

It is necessary to stop using an analgesic:

• with bronchial asthma complicated by polyposis;
• for erosive and ulcerative lesions of the mucous membranes of the stomach and intestines;
• internal bleeding, suspicion of its presence;
• decreased blood clotting, impaired hematopoietic functions;
• Crohn's disease;
• in the period after heart surgery;
• in case of severe liver dysfunction: cirrhosis, acute hepatosis, hepatitis;
• in case of individual intolerance or allergic reactions to the drug.

Contraindications also include: all stages of pregnancy, children under 18 years of age.

Side effects

The most common adverse reactions to taking non-steroidal anti-inflammatory drugs are: the appearance of peptic ulcers , perforation of a hollow organ or bleeding of the gastrointestinal localization. Also noted are abdominal pain, vomiting, nausea, diarrhea, constipation, flatulence , dyspepsia , hematemesis , melena , exacerbation of colitis , ulcerative stomatitis , exacerbation of Crohn's disease , gastritis . Approximately 20% of patients taking this medication may develop adverse reactions.

• reactions from hematopoiesis: anemia , leukopenia , thrombocytopenia , increased duration of bleeding, ecchymosis ;
• reactions from the immune system: allergies;
• metabolic reactions: anorexia , weight gain or loss;
• mental reactions: depression , sleep disturbance, nervousness, confusion, anxious agitation;
• reactions from nervous activity: temporary mild headaches, dizziness, paresthesia , somnolence , tremor , taste disturbance, migraine ;
• reactions from vision: conjunctivitis , blurred vision;
• reactions from the vestibular apparatus: tinnitus, dizziness ;
• reactions from the circulation: tachycardia , palpitations, heart failure , edema, hot flashes , hemorrhages, arterial hypertension , hematoma ;
• reactions from the respiratory organs: rhinitis , dyspnea , pharyngitis , bronchospasm , cough;
• digestive reactions: abdominal pain, nausea, dyspepsia , vomiting , , flatulence , constipation, dry mouth, belching, peptic ulcer , gastritis , ulcerations in the oral mucosa, hematemesis, glossitis , melena , stomatitis , gastroesophageal reflux , esophagitis , aphthous stomatitis , dysphagia , perforated ulcer ;
• reactions from the hepatobiliary system: increased concentrations of glutamate-pyruvate transaminase and glutamate-oxaloacetate transaminase, damage to hepatocytes, impaired liver function;
• skin reactions: itching, rash, sweating, urticaria , dermatitis , alopecia , purpura , bullous reactions, edema, epidermal toxic necrolysis , Stevens-Johnson syndrome ;
• reactions from the musculoskeletal system: arthralgia , muscle spasms, bone pain, myalgia ;
• reactions from the urinary system: urinary disorders, nocturia , increased concentration of urea or creatinine in the blood;
• general reactions: facial swelling , malaise, asthenia .

Side effects of the drug

Occasionally, while using Xefocam, nausea, dry mouth, decreased appetite, abdominal cramps, and swelling occur. In isolated cases, it is also possible:

• physical weakness, drowsiness;
• weight loss;
• increased irritability;
• the appearance of stomatitis;
• exacerbation of gastritis.

Overdose increases the risk of internal bleeding and perforation of a stomach ulcer.

Instructions for use of Xefocam (Method and dosage)

Xefocam tablets, instructions for use

The medicine is taken orally before meals with 100 ml of water.

For moderate to severe pain, the drug is taken in a dose of 8-16 mg per day, divided into 2-3 doses. The maximum daily dose is 16 mg.

For rheumatic diseases of an inflammatory-degenerative nature, 12 mg is recommended as the initial dose. The usual daily dose is 8-16 mg.

The exact dose selection is carried out by the doctor based on the patient’s condition, and the duration of treatment depends on the clinic and the course of the disease.

For damage to the digestive organs, for persons with impaired kidney or liver function, for elderly patients or after major operations, the maximum daily dose is set at 12 mg of the drug per day, divided into 3 doses.

To reduce the likelihood of adverse events, the minimum effective dose should be prescribed for the shortest course.

Xefocam injections, instructions for use

Injections are used only parenterally.

When treating pain after surgery, Xefocam injections are given intravenously or intramuscularly, when treating acute lumbago or ischalgia - only intramuscularly.

The initial injection dose may be 8 or 16 mg. If the analgesic effect is weak after administration of 8 mg of the drug, it is allowed to additionally administer another identical dose.

Injections of medication used as maintenance therapy are prescribed at a dose of 8 mg twice a day. The maximum daily dosage is 16 mg.

Injections should be administered at the minimum effective dose in the shortest possible course.

A solution for parenteral administration is prepared before use by dissolving the contents of the bottle with 2 ml of water for injection. The needle is then replaced. Intramuscular injections are made only with a long needle. The drug solution prepared in the described manner is administered intramuscularly or intravenously. The duration of the injection with the intravenous method should be more than 15 seconds, with the intramuscular method - more than 5 seconds.

How to use Xefocam

The medication in tablets is prescribed to adults at 4–8 mg per day. The maximum dose per day is 16 mg. The pills should be swallowed without chewing, with 50–100 ml of water. It is important to follow the regimen, taking the medicine orally before meals - 30–40 minutes. Food slows down absorption and reduces the activity of the analgesic in severe pain.

Xefocam injections are given intramuscularly or intravenously. A single dose of the drug is 8 mg. Before administration, the lyophilisate from the bottle is diluted with distilled water in a volume of 2 ml. If necessary, the injection of the drug is repeated after 4–6 hours.

Overdose

In case of an overdose of the drug, the following symptoms are possible: dizziness, nausea and vomiting, ataxia , visual disturbances, convulsions , coma . Changes in the liver and kidneys, as well as blood clotting disorders, are possible.

Treatment of overdose: Stop administering or taking the medication. Lornoxicam is quickly evacuated from the body. Dialysis is ineffective. A selective antidote is not known. In case of poisoning with tablets, emergency measures must be taken, including taking enterosorbents and gastric lavage. Ranitidine or prostaglandin are allowed to be used for the treatment of digestive disorders .

Interactions of the drug Xefocam

Interactions of the drug Xefocam with the following drugs have been noted:

• anticoagulants or platelet aggregation inhibitors - may increase bleeding time (increased risk of bleeding);
• sulfonylurea derivatives - the hypoglycemic effect of the latter may be enhanced;
• other NSAIDs or corticosteroids - increases the risk of side effects from the gastrointestinal tract;
• diuretics - reduces the severity of the diuretic and hypotensive effect;
• β-adrenergic receptor blockers and ACE inhibitors - their hypotensive effect may decrease.

Enhances the effect of fibrinolytics. Paracetamol, cyclosporine, gold preparations and other nephrotoxic drugs increase the risk of side effects from the kidneys; alcohol, corticotropin, potassium preparations increase the risk of developing side effects from the gastrointestinal tract; cefamandole, cefoperazone, cefotetan, valproic acid increase the risk of bleeding; when used simultaneously with lithium salts, the maximum concentration of lithium in the blood plasma may increase and the toxic effects of lithium may appear; increases the concentration of methotrexate in the blood serum; reduces the renal clearance of digoxin.

Interaction

When used together with Cimetidine, the concentration of lornoxicam in the blood increases.

When used simultaneously with anticoagulants or platelet aggregation blockers, it is possible that the duration of bleeding may increase and the likelihood of bleeding may increase.

Combined use with Phenprocoumon reduces its therapeutic effectiveness.

When taking anti-inflammatory nonsteroidal drugs along with Heparin during spinal or epidural anesthesia, the risk of spinal and epidural hematomas increases.

When used together with ACE blockers and beta-blockers, their hypotensive effect is reduced.

The drug weakens the hypotensive and diuretic effect of diuretics, and also reduces the clearance of Digoxin .

When used together with other anti-inflammatory non-steroidal drugs or glucocorticosteroids, the risk of bleeding from the digestive organs increases.

When used together with quinoline antibiotics, the risk of seizure syndrome increases.

The drug increases the level of methotrexate in the blood when used together.

When used simultaneously with selective serotonin uptake blockers, the risk of bleeding from the digestive organs increases.

Xefocam can cause an increase in the concentration of lithium in the blood, increasing the side effects of the latter when taken together.

Xefocam stimulates the nephrotoxic effects of Cyclosporine and the hypoglycemic effect of sulfonylurea drugs.

When taken together with potassium supplements, corticotropin , alcohol, the risk of undesirable effects on the digestive system increases.

When used simultaneously with Cefotetan , Cefoperazone , Cefamandole , and valproic acid, the likelihood of bleeding increases.

When taken together with Tacrolimus , the risk of nephrotoxicity increases.

Compatibility of the drug with alcohol and other medications

During the period of use of the medication, alcohol should be avoided, since ethanol greatly enhances its toxic effect. Caution is necessary when using Xefocam simultaneously with Cimetidine, Heparin, Methotrexate, Corticotropin, diuretics, antihypertensive drugs from the group of beta blockers and ACE inhibitors. As a result of their combination, a mutual increase in toxicity is likely.

Xefocam is not recommended to be combined with other non-steroidal analgesics, since all of them are characterized by an anticoagulant effect - a decrease in blood clotting.

During the treatment period, you should also refrain from driving a car or operating complex equipment. Xefocam affects the speed of motor skills and mental reactions, which increases the risk of accidents.

special instructions

The likelihood of an ulcerogenic effect of the drug can be reduced by simultaneous use of proton pump inhibitors and artificial prostaglandin analogues. If bleeding from the digestive organs occurs, the medication must be stopped immediately and emergency measures must be taken. It is especially necessary to carefully monitor patients with pathologies of the gastrointestinal tract who are taking the drug for the first time.

Like any other oxicams, the described drug inhibits platelet aggregation, which causes an increase in the duration of bleeding. When using the drug, the condition of patients who require normal physiological functioning of the coagulation system (including those who are planning to undergo surgery), who have blood clotting disorders, or who are taking medications that suppress coagulation, should be carefully monitored in order to promptly identify signs of bleeding .

If signs of liver damage are detected (yellowness of the skin, itching, vomiting, nausea, dark urine, abdominal pain, increased levels of liver transaminases), you should immediately stop using the medication and consult a doctor.

It is prohibited to use the medicine simultaneously with other anti-inflammatory non-steroidal drugs.

Xefocam is able to change the properties of platelets, but it does not replace the preventive effect of Aspirin for cardiovascular disorders.

For patients with impaired renal function caused by severe blood loss or dehydration, the drug, as an inhibitor of prostaglandin biosynthesis, is allowed to be prescribed only after relief of hypovolemia and the resulting risk of decreased renal perfusion.

The described medicine can cause an increase in urea and creatinine in the blood, as well as sodium and water retention, arterial hypertension , peripheral edema and some other initial symptoms of nephropathy . Long-term therapy of such patients with Xefocam can cause glomerulonephritis , nephrotic syndrome and even acute kidney failure.

In elderly people, as well as those suffering from arterial hypertension or obesity , blood pressure should be monitored.

It is especially important to monitor renal function in elderly patients, as well as in persons concomitantly taking diuretics or drugs that potentially cause damage to kidney tissue.

With long-term use of the drug, it is necessary to regularly monitor hematological parameters, as well as kidney and liver parameters.

Persons receiving the drug are strongly advised to refrain from driving and drinking alcohol.

Xefocam tablets p/o 8 mg No. 10x1

Product description

Xefocam.

Release form

Film-coated tablets.

Dosage

8 mg. Quantity per package: 10 pcs.

Manufacturer

Takeda GmbH.

INN

Lornoxicam.

FTG

Npvp.

Qualitative and quantitative composition

One film-coated tablet contains 4.00 mg or 8.00 mg of lornoxicam. Excipients with known effect: Each 4 mg tablet contains 94.00 mg of lactose monohydrate. Each 8 mg tablet contains 90.00 mg of lactose monohydrate. For a complete list of excipients, see the “List of excipients” section.

Description

White to off-white with a yellowish tint, oblong film-coated tablets with indentation “L04” (4 mg dosage) and “L08” (8 mg dosage).

Indications for use

— Short-term symptomatic treatment of acute pain syndrome of mild to moderate intensity in adults. — Symptomatic treatment of pain and inflammation in osteoarthritis in adults. — Symptomatic treatment of pain and inflammation in rheumatoid arthritis in adults.

Directions for use and doses

Dosage Regimen For all patients, the appropriate dosage regimen should be based on the individual response to treatment. The risk of adverse effects can be minimized by using the lowest effective dose for the shortest course necessary to control symptoms (see Precautions). Pain syndrome The daily dose of lornoxicam is 8-16 mg, divided into 2-3 doses. The maximum recommended daily dose is 16 mg. Osteoarthritis and rheumatoid arthritis The recommended initial daily dose is 12 mg of lornoxicam, divided into 2-3 doses. The maintenance dose should not exceed 16 mg of lornoxicam per day.

Special patient groups

Pediatric patients Lornoxicam is not recommended for use in children and adolescents under 18 years of age due to the lack of data on safety and effectiveness. Elderly patients For elderly patients over 65 years of age, no special dose adjustment is required, except in cases of existing renal or hepatic impairment. Lornoxicam should be prescribed with caution, since this group of patients is more susceptible to adverse reactions from the gastrointestinal tract (see section "Precautions"). Renal impairment In patients with mild to moderate renal impairment, the maximum recommended daily dose is 12 mg divided into 2 or 3 divided doses (see Precautions). Lornoxicam is contraindicated in patients with severe renal impairment (see section "Contraindications"). Hepatic impairment: In patients with moderate hepatic impairment, the maximum recommended daily dose is 12 mg divided into 2 or 3 divided doses (see section "Precautions"). Lornoxicam is contraindicated in patients with severe liver dysfunction (see section "Contraindications").

Mode of application

Xefocam film-coated tablets are intended for oral administration and should be taken with a sufficient amount of liquid. Contraindications - hypersensitivity to the active substance or to any of the excipients listed in the section “List of excipients”; - thrombocytopenia; - hypersensitivity (symptoms such as asthma, rhinitis, angioedema or urticaria) to other non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid; - severe heart failure; - gastrointestinal bleeding, cerebrovascular hemorrhage or other bleeding; - a history of gastrointestinal bleeding or perforation associated with previous NSAID therapy; - history of acute peptic ulcer/bleeding or recurrent peptic ulcer/bleeding (2 or more clear episodes of confirmed ulceration or bleeding); - severe liver failure; - severe renal failure (serum creatinine >700 µmol/l); third trimester of pregnancy (see section “Period of pregnancy and breastfeeding”).

Precautionary measures

Lornoxicam reduces platelet aggregation and prolongs bleeding time; therefore, caution should be used when prescribing to patients with a tendency to bleed. For the following disorders, lornoxicam should be prescribed only after a careful benefit-risk assessment: - Renal impairment: lornoxicam should be used with caution in patients with mild (serum creatinine 150-300 µmol/l) and moderate (serum creatinine 300-700 µmol/l) renal impairment failure due to the dependence of the maintenance of renal blood flow on the level of renal prostaglandins (see section “Dosage and Administration”). If renal function deteriorates during treatment, treatment with lornoxicam should be discontinued. — Monitoring of renal function is necessary in patients: • undergoing major surgery, • with heart failure, • during concomitant treatment with diuretics or drugs with known or suspected nephrotoxic effects (see section “Interaction with other drugs and other forms of interaction”) . - Patients with bleeding disorders: Close clinical observation and laboratory monitoring (eg, aPTT) is recommended. - Liver failure (for example, with cirrhosis of the liver): in patients with impaired liver function, careful clinical observation and laboratory monitoring should be considered, since after the use of daily doses of 12-16 mg, accumulation of lornoxicam may occur (increase in AUC) (see section " Pharmacokinetics"). In other cases, impaired liver function is unlikely to affect the pharmacokinetics of lornoxicam compared to healthy individuals. - Patients receiving long-term treatment (more than 3 months): when taking NSAIDs, it is recommended to regularly assess renal and liver function, as well as hematological parameters. — Elderly patients over 65 years of age: monitoring of kidney and liver function is recommended. It is recommended to use with caution in elderly patients after surgery. Concomitant use with other NSAIDs Avoid simultaneous use of lornoxicam with NSAIDs, including selective cyclooxygenase-2 inhibitors (see section "Interaction with other medicinal products and other forms of interaction").

Minimizing the risk of unwanted effects

The risk of adverse effects can be minimized by using the lowest effective dose for the shortest course necessary to control symptoms (see Dosage and Administration), and taking into account the gastrointestinal and cardiovascular risks listed below ). Gastrointestinal bleeding, ulceration and perforation Gastrointestinal bleeding, ulceration and perforation: Gastrointestinal bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs. They occurred with or without warning symptoms or a history of serious gastrointestinal complications at any time during therapy. The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing doses of NSAIDs, in patients with a history of ulcers, especially if they were complicated by bleeding or perforation (see section "Contraindications"), and in elderly patients. In these patients, treatment should be started with the lowest dose possible (see section "Dosage and Administration"). For these patients and for patients requiring concomitant treatment with low-dose acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal adverse reactions, combination therapy with gastroprotective agents (eg, misoprostol or proton pump inhibitors) should be considered (see information below, as well as the section “Interaction with other medicinal products and other forms of interaction”). Regular monitoring by a doctor is recommended. Patients with a history of gastrointestinal toxicity, especially the elderly, should be instructed to report all unusual abdominal symptoms (especially signs of gastrointestinal bleeding); especially at the beginning of treatment. Caution should be exercised in patients concomitantly taking medications that increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants (such as warfarin), selective serotonin reuptake inhibitors, or antiplatelet agents (such as acetylsalicylic acid) (see Interactions with Others). drugs and other forms of interaction"). If gastrointestinal bleeding or ulceration occurs in patients taking lornoxicam, treatment should be interrupted. NSAIDs should be used with caution in patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease), as their use may cause an exacerbation of the disease (see section "Side effects"). Elderly patients Elderly patients have an increased incidence of adverse reactions to NSAIDs, primarily gastrointestinal bleeding and perforation, which can be fatal (see section "Dosage and Administration"). Cardiovascular and Cerebrovascular Effects Adequate monitoring and instruction are required in patients with a history of or active hypertension and/or heart failure, as fluid retention and edema have been described in association with NSAID therapy. Clinical studies and epidemiological data indicate that the use of some NSAIDs, particularly at high dosages and during long-term treatment, may be associated with an increased risk of arterial thrombotic complications (eg, myocardial infarction and stroke). The available data are insufficient to exclude such a risk for lornoxicam. The use of lornoxicam in patients with uncontrolled hypertension, chronic heart failure, established coronary artery disease, peripheral arterial disease and/or cerebrovascular disease should only be undertaken after a careful assessment of the benefits and risks. Such an assessment should be made before initiating long-term treatment in patients with risk factors for cardiovascular disease (eg, hypertension, hyperlipidemia, diabetes mellitus, smoking). Concomitant treatment of NSAIDs and heparin in connection with spinal or epidural anesthesia increases the risk of spinal/epidural hematomas (see section "Interaction with other medicinal products and other forms of interaction"). Skin and subcutaneous tissue disorders Severe, sometimes fatal skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, have been very rarely reported in association with the use of NSAIDs (see section "Side effects"). The highest risk for such reactions exists at the beginning of therapy, in most cases in the first month of treatment. At the first appearance of a skin rash, damage to the mucous membranes or other signs of increased individual sensitivity, lornoxicam should be discontinued. Respiratory system disorders: Caution should be used in patients suffering from bronchial asthma or with a history of asthma, as it has been reported that NSAIDs may cause bronchospasm in such patients. Systemic lupus erythematosus and mixed connective tissue disease Caution should be exercised in patients with systemic lupus erythematosus (SLE) and mixed connective tissue disease due to the increased risk of aseptic meningitis. Nephrotoxicity Concomitant use of NSAIDs and tacrolimus may increase the risk of nephrotoxicity due to decreased renal prostacyclin synthesis. In patients receiving such combination therapy, renal function should be carefully monitored (see section "Interaction with other medicinal products and other forms of interaction"). Laboratory Abnormalities As with most other NSAIDs, increases in serum concentrations of transaminases, bilirubin, or other liver function tests, as well as increases in creatinine, blood urea nitrogen, and other laboratory changes have been reported. If these abnormalities become significant or persist, use of lornoxicam should be discontinued and appropriate evaluation performed. Lactose This medicine contains lactose. Patients with rare hereditary galactose intolerance, lactase intolerance and glucose-galactose malabsorption should not take this medicinal product. Fertility The use of lornoxicam, like any other medicinal product known to inhibit cyclooxygenase/prostaglandin synthesis, may have a negative effect on fertility and is therefore not recommended for use in women planning pregnancy. For women experiencing difficulty becoming pregnant or undergoing evaluation for infertility, discontinuation of lornoxicam should be considered (see section "Pregnancy and Breastfeeding"). Chickenpox In exceptional cases, chickenpox can lead to serious infectious complications of the skin and soft tissues. It still cannot be ruled out that NSAIDs may worsen the course of these infections. Therefore, it is advisable to avoid the use of lornoxicam for chickenpox.

Interaction with other drugs and other forms of interaction

Concomitant use of lornoxicam with: - cimetidine: leads to increased plasma concentrations of lornoxicam, which may increase the risk of side effects of lornoxicam (no interactions have been detected between lornoxicam and ranitidine or between lornoxicam and antacids). - anticoagulants: NSAIDs may enhance the effect of anticoagulants such as warfarin (see section "Precautions"). INR control is indicated. - phenprocoumon: decreased effectiveness of treatment with phenprocoumon. - heparin: NSAIDs, when used simultaneously with heparin in connection with spinal or epidural anesthesia, increase the risk of bleeding, as well as spinal or epidural hematomas (see section "Precautions"). - ACE inhibitors: the antihypertensive effect of ACE inhibitors may be reduced. - diuretics: decreased diuretic and antihypertensive effects of loop, thiazide and potassium-sparing diuretics (increased risk of hyperkalemia and nephrotoxicity). - beta blockers: decreased antihypertensive effect. - angiotensin II receptor blockers: decreased antihypertensive effect; - digoxin: decreased renal clearance of digoxin, which increases the risk of digoxin toxicity. - corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section "Precautions"). - quinolone antibiotics (for example, levofloxacin, ofloxacin): increased risk of seizures. - antiplatelet agents (for example, clopidogrel): increased risk of bleeding (see section "Precautions"). - other NSAIDs: increased risk of gastrointestinal bleeding and ulceration. - methotrexate: increased serum methotrexate levels. This may lead to increased toxicity. If concomitant therapy is necessary, careful monitoring should be considered. - selective serotonin reuptake inhibitors: increased risk of bleeding (see section "Precautions"). - Lithium: NSAIDs inhibit the renal clearance of lithium and thus may increase serum lithium concentrations beyond toxic limits. Therefore, it is necessary to monitor serum lithium levels, especially during initiation of treatment, when adjusting the dose or discontinuing treatment. - cyclosporine: increased concentration of cyclosporine in the blood serum. The renal toxicity of cyclosporine may be enhanced by effects that are mediated by renal prostaglandins. When combined therapy, it is necessary to monitor renal function. - sulfonylureas (for example, glibenclamide): increased risk of hypoglycemia. - known inducers and inhibitors of CYP2C9 isoenzymes: lornoxicam (like other NSAIDs dependent on cytochrome P450 2C9 (CYP2C9 isoenzyme) interacts with known inducers and inhibitors of CYP2C9 isoenzymes (see section "Pharmacokinetics" Biotransformation). - tacrolimus: increases the risk of renal toxicity in connection with a decrease in the synthesis of prostacyclin in the kidneys. When used together, it is necessary to monitor renal function (see section "Precautions") - pemetrexed: NSAIDs may reduce the renal clearance of pemetrexed and thus increase renal and gastrointestinal toxicity and lead to myelosuppression. When taking Xefocam with food, the absorption of lornoxicam slows down. As a result, Xefocam should not be taken with food if a rapid onset of analgesic effect is required. Food can reduce the absorption of the drug by approximately 20% and increase Tmax (see section “Pharmacokinetics” Biotransformation)

Pregnancy and breastfeeding period

Pregnancy Lornoxicam is contraindicated in the third trimester of pregnancy (see section "Contraindications"), it should also not be used in the first and second trimester of pregnancy and during childbirth, since there are no clinical data on treatment during pregnancy. There are no sufficient data on the use of lornoxicam in pregnant women. Experimental studies in animals have demonstrated reproductive toxicity of the drug (see section "Preclinical safety data"). Inhibition of prostaglandin synthesis may have a negative effect on pregnancy and/or embryonic/fetal development. Data from epidemiological studies indicate an increased risk of miscarriage and cardiac malformations after the use of prostaglandin synthesis inhibitors in early pregnancy. It is assumed that the risk increases with increasing dose and duration of treatment. In animals, administration of a prostaglandin synthesis inhibitor resulted in increased pre- and postimplantation loss and increased embryofetal mortality. Prostaglandin synthesis inhibitors should not be used during the first and second trimesters of pregnancy, unless clearly necessary. During the third trimester of pregnancy, prostaglandin synthesis inhibitors can cause fetal cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension) and cause renal dysfunction, which can progress to renal failure with oligohydramnios. During late pregnancy in both mother and newborn, prostaglandin synthesis inhibitors may prolong bleeding time and inhibit uterine contractions, which may delay or prolong labor. Therefore, the use of lornoxicam is contraindicated in the third trimester of pregnancy (see section “Contraindications”). Breastfeeding There are no data on the excretion of lornoxicam into human milk. In rats during lactation, lornoxicam passes into mother's milk in relatively high concentrations. Lornoxicam should not be used by breastfeeding women. Fertility The use of lornoxicam, like any other medicinal product known to inhibit cyclooxygenase/prostaglandin synthesis, may have a negative effect on fertility and is therefore not recommended for use in women planning pregnancy. For women experiencing difficulty becoming pregnant or undergoing evaluation for infertility, discontinuation of lornoxicam should be considered.

Impact on the ability to drive vehicles or other machinery

Patients who experience dizziness and/or drowsiness during treatment with lornoxicam should refrain from driving or using other machinery.

Side effect

The most common adverse reactions of NSAIDs are reactions from the gastrointestinal tract. Peptic ulcers, perforation or gastrointestinal bleeding may develop, in some cases life-threatening, especially in elderly patients (see section "Precautions"). After using NSAIDs, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease were observed (see section "Precautions"). In more rare cases, gastritis developed. About 20% of patients taking lornoxicam may experience adverse reactions. The most common adverse reactions when taking lornoxicam were nausea, dyspepsia, indigestion, abdominal pain, vomiting and diarrhea. In general, available clinical trial results indicate the development of these symptoms in less than 10% of patients. During treatment with NSAIDs, cases of edema, arterial hypertension, and heart failure have been reported. Clinical studies and epidemiological data indicate that the use of some NSAIDs (especially in high doses and during long-term treatment) may increase the risk of arterial thrombosis (for example, myocardial infarction or stroke) (see section "Precautions"). Severe infectious complications of the skin and soft tissues can occur extremely rarely due to chickenpox. Below are data on adverse reactions that were detected in more than 0.05% of 6417 patients after taking the drug lornoxicam during phases II, III and IV clinical trials. Adverse reactions are classified depending on the frequency of occurrence: very often (≥1/10); often (≥1/100,

Overdose

There are currently no data on acute overdose of lornoxicam to describe the consequences of overdose or to recommend specific treatments. However, with an overdose of lornoxicam, the following symptoms may be observed: nausea, vomiting, cerebral symptoms (dizziness, blurred vision). Severe symptoms may also occur, such as ataxia to the point of coma and seizures, liver and kidney damage, and possibly coagulation disorders. In case of actual or suspected overdose, the drug should be discontinued. Lornoxicam is rapidly eliminated from the body due to its short half-life. Lornoxicam is not eliminated by dialysis. A specific antidote is still unknown. Routine emergency measures, including gastric lavage, should be considered. Based on general principles, the use of activated carbon only when taken immediately after taking lornoxicam may lead to a decrease in the absorption of the drug. Gastrointestinal disorders, for example, can be treated with prostaglandin analogues or ranitidine.

Pharmacotherapeutic group

Nonsteroidal anti-inflammatory and antirheumatic drugs, oxicams. ATX code: M01AC05

Pharmacological properties

Pharmacodynamics

Mechanism of action Lornoxicam belongs to the oxicam class of NSAIDs with analgesic properties. The mechanism of action of lornoxicam is based on the suppression of prostaglandin synthesis (inhibition of the activity of cyclooxygenase isoenzymes), which leads to desensitization of peripheral pain receptors and, accordingly, to inhibition of inflammation. It also suggests a central effect on pain perception independent of anti-inflammatory effects. Pharmacodynamic properties Lornoxicam does not affect vital signs of the body (for example, body temperature, respiratory rate, heart rate, blood pressure, ECG, spirometry). Clinical efficacy and safety The analgesic effects of lornoxicam were successfully demonstrated in several clinical trials during drug development. When treated with lornoxicam, as with other NSAIDs, common adverse effects are gastrointestinal complications due to local gastrointestinal irritation and systemic ulcerogenic effects, which are mediated by inhibition of prostaglandin synthesis.

Pharmacokinetics

Absorption Lornoxicam is rapidly and almost completely absorbed from the gastrointestinal tract. Maximum plasma concentrations are reached after approximately 1-2 hours. The absolute bioavailability of lornoxicam is 90-100%. There is no first-pass effect of the drug through the liver. Concomitant use of lornoxicam with food reduces Cmax by approximately 30% and increases Tmax from 1.5 hours to 2.3 hours. Absorption of lornoxicam (calculated by AUC) may be reduced by 20%. Distribution Lornoxicam is present in plasma unchanged and also in the form of a hydroxylated metabolite. The degree of binding of lornoxicam to plasma proteins is 99% and does not depend on concentration. After repeated dosing, it is also found in the synovial fluid. Biotransformation Lornoxicam undergoes extensive metabolism in the liver, primarily through hydroxylation to the inactive metabolite 5-hydroxylornoxicam. The CYP2C9 isoenzyme is involved in the biotransformation of lornoxicam. Due to genetic polymorphism for this enzyme, there are slow and rapid metabolizers, so slow metabolizers may experience significantly increased levels of lornoxicam in the blood plasma. The hydroxylated metabolite does not exhibit pharmacological activity. Lornoxicam is completely metabolized, with approximately 2/3 excreted by the liver and approximately 1/3 by the kidneys in the form of an inactive substance. In animal studies, lornoxicam did not induce liver enzymes. In clinical studies, no accumulation of lornoxicam was observed after repeated use at recommended doses. This result was confirmed by drug monitoring data in one-year studies. Elimination The average half-life of the parent substance is 3-4 hours. After oral administration, approximately 50% is excreted in the feces and 42% by the kidneys, mainly in the form of 5-hydroxylornoxicam. The half-life of 5-hydroxylornoxicam after a single or twice daily parenteral dose is approximately 9 hours. There is no evidence of changes in the rate of elimination with repeated use. In elderly patients over 65 years of age, clearance is reduced by 30-40%. Apart from a reduction in clearance, no significant changes in the kinetic profile of lornoxicam were observed in elderly patients. There are no significant changes in the kinetic profile of lornoxicam in patients with renal or hepatic impairment, with the exception of accumulation in patients with chronic liver disease after 7 days of treatment with a daily dose of 12 mg and 16 mg.

Preclinical safety data

Preclinical data based on conventional safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential studies have not identified specific hazards to humans. Lornoxicam caused renal toxicity and gastrointestinal ulceration in single- and repeated-dose toxicity studies in several species. In rats, lornoxicam reduces fertility (affects ovulation and implantation) and affects pregnancy and childbirth. In rabbits and rats, lornoxicam causes premature closure of the ductus arteriosus due to inhibition of cyclooxygenase. It has been demonstrated that in animals, the administration of prostaglandin synthesis inhibitors leads to increased loss before and after implantation and death of the fetal embryo. In addition, an increase in the incidence of various malformations, including cardiovascular diseases, has been reported in animals treated with a prostaglandin synthesis inhibitor during the organogenetic period.

List of excipients

Core: Magnesium stearate Povidone (K 25) Sodium croscarmellose Cellulose Lactose monohydrate Shell: Macrogol (6000) Titanium dioxide E171 Talc Hypromellose

Incompatibility

Not applicable.

Best before date

3 years.

Storage conditions

Store at a temperature not exceeding 30°C. Keep out of the reach of children.

Release form

Film-coated tablets 4 mg and 8 mg. 10 tablets in a blister made of aluminum foil and PVC film. 1 blister with instructions for use is placed in a cardboard box.

Disposal precautions

No special requirements.

Conditions for dispensing from pharmacies

By doctor's prescription.

Buy Ksefokam tablet p/pl.ob. 8 mg per bl. in pack No. 10x1 in the pharmacy

Price for Ksefokam tablet p/pl.ob. 8 mg per bl. in pack №10x1

Instructions for use for Xefocam tablet p/pl.ob. 8 mg per bl. in pack №10x1

Analogues of Xefocam

Level 4 ATX code matches:
Mirlox

Revmoxicam

Xefocam Rapid

Movalis

Mesipol

Lem

Melbek

Movasin

Piroxicam

Lornoxicam

Arthrozan

Texamen

Amelotex

Meloxicam

• Zornica
• Xefocam Rapid
• Larfix
• Lorakam
• Aroxicam
• Aspikam
• Loxidol
• Melbek
• Meloxicam
• Revmalim
• Rekoksa

The price of Xefocam analogues, which are listed above, is in almost all cases higher than the price of Xefokam itself.

Xefocam price, where to buy

The price of Xefocam in tablets of 8 mg No. 10 in Russia is about 250 rubles. For comparison, the price of 5 ampoules with lyophilisate is approximately 800 rubles.

Buying Xefocam 8 mg No. 10 in Ukraine will cost an average of 100 hryvnia, and the price of Xefocam No. 5 injections reaches 450 hryvnia.

• Online pharmacies in RussiaRussia
• Online pharmacies in UkraineUkraine
• Online pharmacies in KazakhstanKazakhstan

ZdravCity

• Xefocam tablets p.p.o.
  8 mg 30 pcs. Takeda GmbH RUB 538 order
• Xefocam tablets p.p.o. 8 mg 10 pcs. Takeda GmbH

  RUB 261 order

• Xefocam liof. d/prig. solution for intravenous and intramuscular injection. 8mg vial. No.5Wasserburger Arzneumittelwerk GmbH

  RUR 742 order

Pharmacy Dialogue

• Xefocam (vial 8 mg No. 5)Wasserburger

  RUR 767 order

• Xefocam (tablet p/o 8 mg No. 10)Takeda

  RUB 235 order

• Xefocam (tab.p.pl/vol.8mg No. 30)Takeda

  516 RUR order

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Pharmacy24

• Xefocam 8 mg No. 10 tablets Nycomed Austria GmbH.Austria/Nycomed Austria GmbH.Austria,Nimechchina/Takeda GmbH, Nimechchina
  94 UAH.order
• Xefocam 4 mg N10 tablets Takeda GmbH, city of Vir-va Oranienburg, Germany

  59 UAH order

• Xefocam 8 mg No. 5 lyophilisate Nycomed Austria GmbH.Austria/Takeda Austria GmbH,Austria

  446 UAH. order

PaniPharmacy

• Xefocam tablets Xefokam tablets. p/o 8 mg No. 10 Germany, Takeda

  110 UAH order

• Ksefokam bottle Ksefokam por. d/in. 8ml fl. No.5 Austria, Takeda Austria

  481 UAH order

• Xefocam tablets Xefokam tablets. p/o 4 mg No. 10 Germany, Takeda

  75 UAH order

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