Xefocam Rapid, pills 8 mg, 12 pcs.

Composition

of 1 tab. :

– lornoxicam 8 mg

Auxiliary substances:

calcium stearate,

hydroxypropylcellulose,

sodium bicarbonate,

monosubstituted hydroxypropylcellulose,

microcrystalline cellulose,

calcium hydrophosphate.

Shell composition:

propylene glycol, talc, titanium dioxide, hypromellose.

Pharmacological action

Pharmaceutical Group:

NSAIDs.

Pharmaceutical action:

  Xefocam rapid is an NSAID. It has a pronounced analgesic and anti-inflammatory effect. Lornoxicam has a complex mechanism of action, which is based on the suppression of prostaglandin synthesis, due to the inhibition of the activity of COX-1 and COX-2 isoenzymes both in the focus of inflammation and in healthy tissues. In addition, lornoxicam inhibits the release of oxygen free radicals from activated white blood cells.

The analgesic effect of lornoxicam is not associated with opioid action. Xefocam Rapid does not have an opiate-like effect on the central nervous system and, unlike narcotic analgesics, does not depress breathing, does not cause drug dependence.

Pharmacokinetics: 

Suction

Lornoxicam is rapidly and almost completely absorbed from the gastrointestinal tract.

Cmax in plasma is reached 1-2 hours after oral administration. Cmax of lornoxicam in blood plasma when using Xefocam Rapid is higher than when using Xefocam tablets and is equivalent to Cmax for dosage forms of lornoxicam intended for parenteral administration. The absolute bioavailability for Xefocam Rapid tablets is 90-100% and is equivalent to the bioavailability of Xefocam tablets. The effect of “first pass” through the liver is not observed.

Concomitant administration of lornoxicam with food reduces plasma Cmax by 30%. The time to reach Cmax increases from 1.5 h to 2.3 h. The absorption of lornoxicam (calculated by AUC) may decrease by up to 20%. Distribution

The binding of lornoxicam to plasma proteins is 99% and does not depend on its concentration.

Lornoxicam does not accumulate after repeated administration at the recommended doses.

Metabolism

In plasma, lornoxicam is found unchanged and in the form of its hydroxylated metabolite. The hydroxylated metabolite shows no pharmacological activity. Lornoxicam is completely metabolized to form a pharmacologically inactive metabolite.

Lornoxicam (like diclofenac and other oxycams) is metabolized by the CYP2C9 isoenzyme. As a result of genetic polymorphism, there are individuals with slow and intensive metabolism, which can be expressed in a noticeable increase in the concentration of lornoxicam in blood plasma in individuals with slow metabolism. Lornoxicam does not induce liver enzymes.

T1/2 elimination is 3-4 hours.

About 2/3 of the dose is excreted through the liver and 1/3-by the kidneys.

Pharmacokinetics in special clinical cases

Concomitant administration with antacids has no effect on the pharmacokinetics of lornoxicam. In senile individuals, systemic clearance is reduced by 30-40%. In patients with impaired liver or kidney function, no significant changes in the pharmacokinetics of lornoxicam are observed.

Indications

Short-term treatment of pain syndrome during injuries and after surgical interventions; algodismenorrhea; lumboishialgia.

Symptomatic treatment of rheumatoid arthritis and osteoarthritis.

Contraindications

-gastrointestinal bleeding;— brain hemorrhage (including if suspected);- active peptic ulcer or a history of peptic ulcer recurrence;— severe hepatic insufficiency— – severe renal insufficiency (serum creatinine level >700 mmol / l);— severe thrombocytopenia— – severe heart failure and hypovolemia— – pregnancy; – lactation (breastfeeding);- children and adolescents under 18 years of age (due to insufficient clinical experience);- hypersensitivity to lornoxicam or other components of the drug; Hypersensitivity to other NSAIDs, including acetylsalicylic acid.

With caution and only after careful assessment of the expected benefit of therapy and the possible risk, the drug should be prescribed if there is a history of gastrointestinal ulcers and bleeding, with renal failure, blood clotting disorders, liver diseases (for example, cirrhosis of the liver), for a long time (more than a month), in elderly patients (65 years and older), as well as in patients with a body weight of less than 50 kg and after surgery.

Side effects

the Frequency of side effects frequently (≥1% and From the digestive system: often – abdominal pain, diarrhea, dyspepsia, nausea, vomiting; rarely – constipation, dysphagia, dry mouth, flatulence, gastritis, gastroesophageal reflux, peptic ulcers, gastrointestinal bleeding, stomatitis, hemorrhoidal bleeding, increase in liver transaminases and alkaline phosphatase, and loss of appetite.

About 16% of patients (in the case of long-term treatment,20-25% of patients) may experience adverse reactions associated with the gastrointestinal tract.

From the hematopoietic system: rarely-changes in the blood formula, pathological changes in the blood, leukopenia, thrombocytopenia, increased bleeding time, anemia, a decrease in the number of red blood cells, hemoglobin and white blood cells.

From the cardiovascular system: rarely-edema, increased or decreased blood pressure, palpitation, tachycardia.

From the central nervous system and peripheral nervous system: often – dizziness, headache; sometimes-insomnia, malaise, weakness, hot flashes; rarely-drowsiness, paresthesia, tremor, taste disorders, agitation, depression.

From the respiratory system: rarely-shortness of breath, bronchospasm, cough, rhinitis.

From the urinary system: rarely-increased urea nitrogen and creatinine in the blood, impaired urination, interstitial nephritis, glomerulonephritis, tubular necrosis of the kidneys or nephrotic syndrome.

Musculoskeletal disorders: rarely-myalgia, leg muscle cramps.

From the sensory organs: rarely-conjunctivitis, visual disturbances, tinnitus.

Dermatological reactions: rarely-skin rashes, bullous rashes, eczema, erythema polymorphic, erythroderma (exfoliative dermatitis), alopecia, photosensitization, purpura.

Allergic reactions: rarely-bronchospasm, urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), allergic purpura, systemic anaphylactic reactions (including shock).

Other: rarely-changes in body weight.

Interaction

Concomitant administration of Xefocam Rapid with anticoagulants and platelet aggregation inhibitors may increase the bleeding time (increased risk of bleeding); with sulfonylureas – may increase the hypoglycemic effect; with other NSAIDs-increase the risk of adverse reactions.

Concomitant use of Xefocam Rapid reduces the effectiveness of loop diuretics; it may reduce the effect of ACE inhibitors.

When used concomitantly with lithium preparations, it is possible to increase the maximum concentration of lithium and, therefore, it is possible to increase the undesirable effects caused by lithium.

Xefocam Rapid increases serum concentrations of methotrexate and cyclosporine.

When taken concomitantly with cimetidine, an increase in the concentration of lornoxicam in plasma is observed (there is no interaction between Xefocam Rapid and ranitidine or Xefocam Rapid and antacids).

Xefocam Rapid reduces the renal clearance of digoxin.

Inducers of microsomal enzymes (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) reduce the concentration of lornoxicam in blood plasma, inhibitors of microsomal enzymes can increase the severity of side effects.

How to take, course of administration and dosage

For oral administration and they should be taken with a sufficient amount of liquid.

Special dose adjustment for elderly patients is not required in the absence of renal or hepatic insufficiency, in which case the daily dose should be reduced.

For all patients, the appropriate dosage regimen should be based on the individual response to treatment.

For administration, lornoxicam should be prescribed in doses of 8 mg, and the daily dose should not exceed 16 mg.

Overdose

Symptoms: nausea and vomiting, cerebral symptoms (dizziness, ataxia leading to coma and convulsions), possible liver and kidney function disorders, blood clotting disorders.

Treatment: if an overdose is detected or suspected, the drug should be discontinued. Due to its small T1/2, lornoxicam is rapidly eliminated from the body.

Lornoxicam is not excreted during dialysis.

To date, no specific antidote is known.

Routine emergency measures, including gastric lavage, should be considered.

Based on general principles, it is possible to use activated carbon only if it is taken immediately after taking Xefocam Rapid, which may lead to a decrease in the absorption of lornoxicam.

Special instructions

Patients using the drug should refrain from types of actions that require increased attention, rapid mental and motor reactions, and alcohol consumption.

Concomitant administration of H2 blockers, omeprazole, and synthetic prostaglandin analogues reduces the risk of ulcerogenic effects of lornoxicam.

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

Form of production

Pills.

Storage conditions

At a temperature of 18° – 30°C

Expiration date

2 years old.

Active ingredient

Lornoxicam

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Weight

Weight: 16 gr.