Xefocam, lyophilizate 8 mg 5 pcs

Xefocam has a pronounced analgesic and anti-inflammatory effect.

Lornoxicam has a complex mechanism of action, which is based on inhibition of prostaglandin synthesis due to inhibition of cyclooxygenase isoenzymes activity. In addition, lornoxicam inhibits the release of free oxygen radicals from activated leukocytes.

The analgesic effect of lornoxicam is not associated with narcotic action.

The drug XEFOCAM has no opiate-like effect on the central nervous system (CNS) and unlike narcotic analgesics it does not inhibit respiration and does not cause drug dependence.

Pharmacokinetics:

Lornoxicam is rapidly and almost completely absorbed from the gastrointestinal tract (GIT) after oral administration.
With this maximum plasma concentrations are reached after about 1-2 hours. Food intake reduces the maximum concentration (C max) by 30% and increases the time to reach the maximum concentration (Ttax) up to 2.3 hours. Absolute bioavailability of lornoxicam is 90-100 %. Lornoxicam is present in plasma, mostly unchanged and, to a lesser extent, in the form of hydroxylated metabolite, which has no pharmacological activity. Binding of lornoxicam with plasma proteins, mainly albumin fraction, is 99 % and does not depend on its concentration.

The elimination half-life is on average 4 h and does not depend on the drug concentration. Lornoxicam is completely metabolized in the liver. CYP2C9 isoenzyme is involved in metabolism. Approximately 1/3 of metabolites are excreted by the kidneys and 2/3 – in the bile. No significant changes in lornoxicam pharmacokinetics were found in elderly patients and patients with renal or hepatic impairment.

Indications

Short-term treatment of pain syndrome of different origin.

Symptomatic therapy of rheumatic diseases (rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, joint syndrome with exacerbation of gout, rheumatic soft tissue lesions).

Active ingredient

Composition

Active substance:

Lornoxicam 8 mg;

Supplements:

Mannitol, 100 mg;

trometamol, 12 mg;

p>dinatrium edetate – 0.2 mg;

solvent (water for injection) – 2 ml.

How to take, the dosage

The duration of intravenous Xefocam solution administration should be at least 15 s, intravenous – at least 5 s. The initial dose may be 8 or 16 mg. If the analgesic effect of 8 mg dose is insufficient, the same dose may be administered additionally.

Supportive therapy is 8 mg twice daily.

The maximum daily dose should not be more than 16 mg.

Interaction

Simultaneous use of XEFOCAM and:

Xefocam increases the side effects of glucocorticosteroids and mineralocorticosteroids, estrogens. Inducers ( phenytoin , ethanol , barbiturates , rifampicin , phenylbutazone , tricyclic antidepressants) decrease the plasma concentration of lornoxicam, microsomal oxidation inhibitors may increase the severity of side effects.

Special Instructions

The gastrointestinal tract should be monitored during treatment to prevent ulcerogenic effects or gastrointestinal bleeding.

The simultaneous administration of omeprazole or H 2-histamine blockers, synthetic prostaglandin analogues (misoprostol) can reduce the risk of ulcerogenic effects.

The peripheral blood count and the functional state of the liver and kidneys should be monitored during treatment.

If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study.

It retains sodium, potassium, lithium, and water in the body, which can worsen arterial hypertension and heart failure, and in people taking lithium medications, increase the severity of side effects of lithium salts.

Patients who are elderly and also with arterial hypertension need regular monitoring of blood pressure.

The use in patients with renal impairment

In patients with renal impairment (plasma creatinine concentration of 150-300 µmol/L) regular monitoring of renal function is required.

Impact on driving and operating machinery

When taking this medicine, caution must be exercised while driving motor vehicles and engaging in other potentially dangerous activities requiring increased concentration and quick psychomotor reactions.

Contraindications

Side effects

Gastrointestinal tract and liver: abdominal pain, diarrhea, dyspepsia, nausea, vomiting; in rare cases – flatulence, dry mouth, gastritis, esophagitis, formation of peptic ulcers and/or bleeding in the GI (including rectal), stomatitis, glossitis, colitis, dysphagia, hepatitis, pancreatitis, liver function disorders.

Allergic reactions: skin rashes, hypersensitivity reactions accompanied by shortness of breath, tachycardia, bronchospasm, Stevens-Johnson syndrome, exfoliative dermatitis, angioitis, fever, allergic rhinitis, lymphadenopathy may occur.

CNS disorders: rarely – dizziness, headache, somnolence, agitation, sleep disturbances, tinnitus, hearing loss, dysarthria, hallucinations, migraine, peripheral neuropathy, syncopal states, aseptic meningitis.

Sensory organs: visual impairment, conjunctivitis.

Peripheral blood and coagulation system disorders: rarely – leukopenia, thrombocytopenia.

Metabolism disorders: rare – increased sweating, chills, weight changes.

Cardiovascular system disorders: rare – arterial hypertension, tachycardia, peripheral edema.

Urinary system disorders: rarely – dysuria, in single cases – glomerulonephritis, papillary necrosis and nephrotic syndrome with transition to acute renal failure, interstitial nephritis, crystalluria, polyuria.

Overdose

There are currently no data on XEFOCAM overdose to establish its effects or to suggest specific remedies. However, it can be assumed that gastrointestinal, central nervous system side effects and signs of renal failure, will be more frequent and severe in case of XEFOCAM overdose.

Treatment: if an overdose is suspected, the administration of XEFOCAM should be stopped. Due to the fact that the half-life of lornoxicam is about 4 hours, it is rapidly excreted from the body. The substance cannot be removed from the body by dialysis. There is currently no specific antidote. The usual emergency measures and symptomatic treatment should be used.

Pregnancy use

It is contraindicated in pregnancy and lactation.

Similarities