Xefocam Rapid, 12 pcs., 8 mg, film-coated tablets
The risk of the ulcerogenic effect of the drug can be reduced by the simultaneous administration of proton pump inhibitors and synthetic analogues of PG. If bleeding occurs in the gastrointestinal tract, the drug should be stopped immediately and appropriate emergency measures taken. It is especially necessary to carefully monitor the condition of those patients with gastrointestinal pathology who are receiving a course of treatment with Xefocam® for the first time.
Like other oxicams, it inhibits platelet aggregation and may therefore increase bleeding time. When using this drug, it is necessary to carefully monitor the condition of patients who require absolutely normal functioning of the blood coagulation system (for example, patients who are undergoing surgery), who have disorders of the blood coagulation system, or who are receiving drugs that inhibit coagulation (including low-dose heparin), for in order to promptly detect signs of bleeding.
If signs of liver damage appear (itching, yellowing of the skin, nausea, vomiting, abdominal pain, dark urine, increased levels of liver transaminases), you should stop taking the drug and consult your doctor.
The drug should not be used simultaneously with other NSAIDs.
The drug can change the properties of platelets, but does not replace the preventive effect of acetylsalicylic acid in cardiovascular diseases.
For patients with impaired renal function caused by large blood loss or severe dehydration, the drug Xefocam®, as an inhibitor of PG synthesis, can be prescribed only after hypovolemia and the associated risk of reducing renal perfusion have been eliminated. Like other NSAIDs, it can cause an increase in blood urea and creatinine concentrations, as well as water and sodium retention, peripheral edema, hypertension and other early signs of nephropathy. Long-term treatment of such patients with Xefocam® can lead to the following consequences: glomerulonephritis, papillary necrosis and nephrotic syndrome with transition to acute renal failure. The drug should not be prescribed to patients with a pronounced decrease in renal function (see “Contraindications”). In elderly patients, as well as in patients suffering from arterial hypertension and/or obesity, it is necessary to control blood pressure levels.
It is especially important to monitor renal function in elderly patients, as well as in patients simultaneously receiving diuretics and drugs that can cause kidney damage.
With long-term use of the drug Xefocam®, it is necessary to periodically monitor hematological parameters, as well as renal and liver function. The use of the drug may adversely affect female fertility and is not recommended for women planning pregnancy.
Patients using the drug must refrain from activities that require increased attention, rapid mental and motor reactions, and alcohol consumption.
Xefocam Rapid tablet p/o film 8mg 12 pcs
Hypersensitivity to lornoxicam or any of the excipients; complete or incomplete combination of bronchial asthma, recurrent nasal polyposis or paranasal sinuses, rhinitis, angioedema, urticaria and intolerance to acetylsalicylic acid and other NSAIDs (including a history); hemorrhagic diathesis or bleeding disorders, as well as those who have undergone operations associated with the risk of bleeding or incomplete hemostasis; decompensated heart failure; erosive and ulcerative changes in the mucous membrane of the stomach or duodenum, active gastrointestinal bleeding; cerebrovascular or other bleeding; a history of gastrointestinal bleeding or ulcer perforation associated with taking NSAIDs; active peptic ulcer or history of recurrent peptic ulcer; inflammatory bowel diseases (Crohn's disease, ulcerative colitis) in the acute phase; severe liver failure; 3 severe renal failure (serum creatinine level more than 300 µmol/l), progressive kidney disease, confirmed hyperkalemia; period after coronary artery bypass surgery; pregnancy, breastfeeding period; patients under the age of 18 years (due to insufficient clinical experience). With caution: for the following disorders, Xefocam Rapid should be prescribed only after a careful assessment of the expected benefits of therapy and the possible risks. Impaired renal function: mild (serum creatinine 150,300 µmol/l) and moderate (serum creatinine 300,700 µmol/l), since the maintenance of renal blood flow depends on the level of renal prostaglandins. Lornoxicam should be discontinued if renal function deteriorates during treatment; Monitoring of renal function should be carried out in patients who have undergone major surgery, patients with heart failure receiving diuretics, and also in the case of the use of drugs with proven or suspected nephrotoxicity. Coagulation disorders: Close clinical monitoring and evaluation of laboratory parameters, such as activated partial thrombin time (aPTT), are recommended. Impaired liver function (liver cirrhosis): regular clinical observation and assessment of laboratory parameters should be carried out, since when treated with lornoxicam at a daily dose of 1216 mg, drug accumulation is possible. Long-term treatment (more than 3 months): regular assessment of laboratory blood parameters (hemoglobin), kidney function (creatinine) and liver enzymes is recommended. Patients over 65 years of age: monitoring of liver and kidney function is recommended. Use with caution in elderly people in the postoperative period. Concomitant use with other NSAIDs, including selective cyclooxygenase inhibitors2, should be avoided. Gastrointestinal bleeding, ulcer, perforation, which have previously been noted with the use of all NSAIDs at any stage of treatment and can be fatal. Presence of Helicobacter pylori. History of gastrointestinal toxicity, particularly in old age. While taking medications such as oral glucocorticosteroids (for example, prednisolone), anticoagulants (for example, warfarin), selective serotonin reuptake inhibitors (for example, citalopram, fluoxetine, paroxetine, sertraline) and antiplatelet drugs (for example, acetylsalicylic acid, clopidogrel). With the simultaneous use of NSAIDs and heparin during spinal and epidural anesthesia, the risk of developing hematoma increases. History of gastrointestinal pathology (ulcerative colitis, Crohn's disease), as their condition may worsen. History of arterial hypertension and/or heart failure, as fluid retention and the development of edema were noted when using NSAIDs. In the presence of peripheral arterial disease or cerebrovascular disease, the presence of risk factors for the development of cardiovascular diseases such as arterial hypertension, hyperlipidemia, diabetes mellitus, smoking, Lornoxicam should be prescribed only after a careful assessment of the expected benefits of therapy and the possible risks. Severe skin reactions leading to death, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. Concomitant use of NSAIDs and tacrolimus may lead to an increased risk of nephrotoxicity due to inhibition of prostacyclin synthesis in the kidneys. The use of Lornoxicam, like any drug that inhibits the synthesis of prostaglandins, may impair the ability to fertilize, therefore it is not recommended for use by women wishing to become pregnant.
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.
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.
Dosage forms and composition
Xefocam contains one active component - lornoxicam, which affects the production of prostaglandins. The drug is produced:
- In tablet form: with a dosage of 4–8 mg. Formative components: silicon dioxide, starch, lactose, magnesium stearate. White oblong pills are packaged in paper cellular blisters of 10 pieces. On the surface they have an engraving Lo and a dose designation - the number 4 or 8. The cardboard packaging of the medicine contains from 10 to 50 tablets.
- In the form of a lyophilisate for the preparation of solutions. Yellow dense mass placed in glass bottles - 5 pieces per package. One container contains a medicine in a dose of 8 mg, auxiliary compounds: mannitol, tromethanol.
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.
When is Xefocam indicated: instructions
Among the indications for taking the medication: pain of various origins, subject to the action of non-steroidal analgesics. Including those caused by:
- rheumatoid arthritis;
- deforming arthrosis;
- gout;
- ankylosing spondylitis.
The medication effectively reduces pain to moderate and moderate-to-severe intensity. Xefocam does not affect the general course of diseases; it is used only for symptomatic therapy: in short courses.
The drug is used with caution for pathologies of the gastrointestinal tract, smoking, alcoholism, heart failure, and diabetes.
Instructions for use of XEFOCAM RAPID
For the following disorders, the drug should be prescribed with caution
and only after a thorough assessment of the expected benefits of therapy and the possible risks.
History of gastrointestinal ulcers and bleeding.
Clinical follow-up at regular intervals is recommended. If a patient develops a peptic ulcer and/or gastrointestinal bleeding while taking the drug, then it is necessary to discontinue the drug and carry out appropriate treatment.
Kidney failure.
Patients with mild renal failure (serum creatinine 150-300 µmol/l) require quarterly examination; in case of moderate renal failure (serum creatinine 300-700 µmol/l), examinations should be carried out at intervals of 1-2 months. If renal function deteriorates, the drug should be discontinued.
Patients with bleeding disorders.
Careful clinical observation and assessment of laboratory parameters (for example, prothrombin index) are recommended.
Liver diseases (for example, cirrhosis of the liver).
Clinical observation and evaluation of laboratory parameters at regular intervals (eg, liver enzyme activity) are recommended.
Long-term treatment (more than a month).
Regular blood tests (hemoglobin), kidney function (serum creatinine) and liver function (liver enzyme activity) are recommended.
Elderly patients (65 years and older),
because
a decrease in the clearance of lornoxicam is possible ,
as well as
in patients weighing less than 50 kg and after surgery.
Monitoring of renal and liver functions is recommended.
Monitoring of renal function is necessary in the following
patients:
- those who have undergone extensive surgery;
- with impaired renal function, for example, as a result of significant blood loss or severe dehydration;
- with heart failure;
- those receiving concomitant treatment with diuretics, as well as those receiving concomitant treatment with drugs that are suspected or known to cause kidney damage.
It should be borne in mind that the drug increases the risk of spinal/epidural hematoma during spinal or epidural anesthesia.
During the treatment period, patients should refrain from activities that require increased attention, rapid mental and motor reactions, and from drinking alcohol.
The simultaneous administration of histamine H2 receptor blockers, omeprazole, and synthetic prostaglandin analogues can reduce the risk of the ulcerogenic effect of lornoxicam. If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study.
Caution should be exercised when coadministering drugs that may increase the risk of GI ulceration or bleeding, such as oral corticosteroids, anticoagulants (eg, warfarin), selective serotonin reuptake inhibitors, or antiplatelet drugs such as acetylsalicylic acid.
Appropriate monitoring should be provided and recommendations given to patients with a history of hypertension and/or mild or moderate heart failure, because There are data on cases of fluid retention and edema in combination with NSAID therapy.
Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially in high doses and long-term use) may be associated with a small increased risk of arterial thrombosis (eg, myocardial infarction or stroke). There are insufficient data to exclude such a risk for lornoxicam.
In patients with uncontrolled hypertension, heart failure, coronary artery disease, peripheral arterial disease and/or cerebrovascular disease, lornoxicam should be prescribed only after a careful assessment of the risk-benefit ratio of therapy. Similar measures should be taken before initiating long-term treatment in patients with risk factors for cardiovascular disease (eg, hypertension, hyperlipidemia, diabetes mellitus, smoking).
Very rare serious skin reactions that can be fatal have been reported, incl. exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis with the use of NSAIDs. The risk of such reactions is higher at the beginning of treatment, because most skin reactions occur during the first month of treatment. Treatment with lornoxicam should be discontinued immediately at the first appearance of skin rash, damage to the mucous membranes, or other signs of hypersensitivity.
Patients with systemic lupus erythematosus and mixed connective tissue diseases may have an increased risk of aseptic meningitis.
Concomitant use of NSAIDs and tacrolimus may increase the risk of nephrotoxicity by reducing the synthesis of prostacyclin in the kidneys. In patients receiving combination treatment, close monitoring of renal function is necessary.
Chicken pox can extremely rarely cause severe infectious complications of the skin and soft tissues. To date, a role for NSAIDs in worsening the severity of these infections cannot be excluded. Therefore, lornoxicam should not be prescribed to patients with chickenpox.
Impact on the ability to drive vehicles and operate machinery
Patients experiencing dizziness and/or drowsiness during treatment with lornoxicam should refrain from driving or operating machinery.
Xefocam
The non-steroidal anti-inflammatory drug xefocam may not be as well known among a wide range of drug consumers as its more “promoted” “brothers” in the pharmacological group, but the strength of its analgesic effect, coupled with the reputation of the manufacturer - known in Europe and outside the pharmaceutical industry - makes this drug very competitive, especially when it is necessary to quickly suppress severe pain. The active ingredient of Xefocam is lornoxicam, which has, first of all, an analgesic and anti-inflammatory effect.
The mechanism of action of Xefocam for a person ignorant of the nuances of biochemistry and pharmacology will seem too complex. Meanwhile, everything can be explained in fairly accessible language. The drug inhibits the activity of the enzyme cyclooxygenase, which takes part in the synthesis of prostaglandins. For all their considerable benefits in the body, prostaglandins also bring a certain amount of costs, being the initiators of pain and inflammatory processes. By excluding cyclooxygenase from the biochemical chain, xefocam thereby suppresses the formation of these generators of pain and inflammation. Lack of cyclooxygenase makes peripheral pain receptors less sensitive, which in turn inhibits inflammation. It should be noted that the analgesic effect of Xefocam is in no way associated with an opiate-like effect on the central nervous system and, unlike narcotic analgesics, the drug does not depress breathing and is not addictive.
Another positive property of Xefocam is its “non-interference policy”: it does not affect body temperature, heart rate and respiration, blood pressure and ECG readings.
Xefocam is available in two dosage forms: tablets and lyophilized powder for the preparation of a solution for intravenous and intramuscular injections. The tablets should be taken before meals. For severe pain, it is recommended to take 8-16 mg of the drug per day, dividing this dose into 2-3 doses. The duration of treatment depends on the specific disease and the severity of its course. Considering the presence of a number of undesirable side effects of non-steroidal anti-inflammatory drugs, especially from the digestive tract, it is recommended not to exceed the minimum effective dosage of the drug and not to abuse the duration of therapy. The injection form of Xefocam is used, as a rule, in a hospital setting to relieve postoperative pain. Due to the need to prepare the solution yourself, this dosage form is not particularly popular for treatment at home, although in an acute attack of radiculitis it can be very effective.
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.
