Xefocam tabs 8mg #30

Xefocam tabs user manual

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Composition

    1 tablet Xefocam can include 4 or 8 mg lornoxicam. Auxiliary components: povidone K25, magnesium stearate, cellulose, talc, croscarmellose sodium, lactose monohydrate, titanium dioxide, macrogol 6000, hypromellose.
    One vial with lyophilizate Xefocam includes 8 mg of lornoxicam. Auxiliary components: edetate disodium, trometamol, mannitol.

Form of issue

White oblong tablets (dosage 8 mg) with an engraved inscription "LO8".
    10 pieces in a blister - 10, 1, 2, 3 or 5 blisters in a pack of paper.

pharmachologic effect

Anti-inflammatory and analgesic effect.

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

Anti-inflammatory non-steroid drug. 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. The blocking of cyclooxygenase leads to the suppression of peripheral pain receptors and to the cessation 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 the emergence of drug dependence.
Does not affect important vital signs: respiratory rate, ECG parameters, body temperature, heart rate, blood pressure, spirometry.

Pharmacokinetics of tablets

After oral administration, lornoxicam is rapidly and completely adsorbed from the intestine. The greatest concentration in the blood occurs in an hour and a half. The intake of food reduces the maximum concentration by 30% and increases the half-life to 2.3 hours. 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 participates in the transformation. In plasma, the drug is predominantly unchanged and, to a small extent, in the form of a hydroxylated metabolite, which does not possess pharmacological activity.
The elimination half-life is close to 4 hours. About a third of the metabolites are excreted in the urine and the remainder is excreted in the bile.
In elderly people, as well as in patients with impaired hepatic and renal function, no changes in the pharmacokinetics of the drug have been detected.

Indications for use Xefocam in the form of tablets:

    short-term therapy of pain syndrome regardless of origin;
    symptomatic treatment of rheumatic diseases (ankylosing spondylitis, osteoarthrosis, articular syndrome in acute gout, rheumatoid arthritis, rheumatic damage of the periarticular soft tissues).

Contraindications

    A combination (complete or incomplete) of polyposis of paranasal sinuses or nose, bronchial asthma and intolerance of non-steroidal anti-inflammatory drugs (including in anamnesis).
    Thrombocytopenia.
    Hemorrhagic diathesis or blood clotting disorders, including conditions after surgery, associated with a bleeding or insufficient hemostasis.
    The period after aortocoronary bypass surgery.
    Changes in mucous duodenal ulcers or gastric erosive-ulcerative type, active bleeding from the organs of the gastrointestinal tract, as well as cerebrovascular or other bleeding.
    Previous bleeding from the digestive system associated with the use of non-steroidal anti-inflammatory drugs.
    Recurrent gastric ulcer or recurring bleeding from the digestive system.
    Exacerbation of inflammatory bowel diseases (Crohn's disease).
    Decompensated heart failure.
    Lack of liver function or liver disease in the active phase.
    Severe renal failure, progressive kidney disease, hyperkalemia, dehydration or hypovolemia.
    Pregnancy and lactation.
    Age is less than 18 years.
    Allergy to the components of the medication.
Care should be taken when prescribing at least one of the following conditions: damage to the organs of the digestive tract of an erosive and ulcerative nature and bleeding of said localization, renal failure of moderate severity, postoperative state, arterial hypertension, age over 65 years, coronary heart disease, cerebrovascular disease , chronic heart failure, dyslipidemia, peripheral arterial disease, diabetes, smoking, creatinine clearance up to 60 m l / min, the presence of Helicobacter pylori, the ulcerative lesions of the digestive system in the past, the long-term use of anti-inflammatory non-steroid drugs, severe somatic diseases, alcoholism, joint intake of oral forms of glucocorticosteroids, anticoagulants, antiplatelet agents, diuretics, selective serotonin uptake blockers or drugs with nephrotoxic action .
Joint therapy with anti-inflammatory non-steroid drugs and Tacrolimus can increase the risk of nephrotoxicity.
Simultaneous reception of anti-inflammatory non-steroid drugs and Heparin on the background of epidural or spinal anesthesia increases the likelihood of epidural and spinal hematomas.

Side effects

The most frequent adverse reactions to the use of anti-inflammatory non-steroid drugs are: the appearance of peptic ulcers, perforation of the hollow organ or bleeding of the gastrointestinal localization. There are also abdominal pains, vomiting, nausea, diarrhea, constipation, flatulence, dyspepsia, bloody vomiting, melena, exacerbation of colitis, ulcerative stomatitis, exacerbation of Crohn's disease, gastritis. Approximately 20% of patients taking the drug described can develop unwanted reactions.
    Reactions from hematopoiesis: anemia, leukopenia, thrombocytopenia, increased duration of bleeding, ecchymosis.
    Reactions from the immune system: allergies.
    Reactions from the metabolism: anorexia, increase or decrease in weight.
    Reactions from the psyche: depression, sleep disturbance, nervousness, confusion, anxiety.
    Reactions from the nervous activity: temporary weak headaches, dizziness, paresthesia, somnolentia, tremor, taste disorder, migraine.
    Reactions from vision: conjunctivitis, visual impairment.
    Reactions from the side of the vestibular apparatus: tinnitus, dizziness.
    Reactions from the circulation: tachycardia, palpitation, heart failure, edema, hot flashes, hemorrhages, arterial hypertension, hematoma.
    Response from the respiratory organs: rhinitis, dyspnoea, pharyngitis, bronchospasm, cough.
    Digestive reactions: abdominal pain, nausea, dyspepsia, vomiting, diarrhea, flatulence, constipation, dry mouth, belching, peptic ulcer, gastritis, ulceration in the oral mucosa, bloody vomiting, 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.
    Reactions from the skin: 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: impaired urination, nocturia, an increase in the concentration of urea or creatinine in the blood.
    General reactions: swelling of the face, malaise, asthenia.

Tablets Xefocam, instructions for use

The medicine is taken orally before meals, with 100 ml of water.
With a moderately severe pain syndrome, the drug is taken in a dose of 8-16 mg per day, which is 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 choice of the dose is performed by the doctor based on the patient's condition, and the duration of treatment depends on the clinic and the course of the illness.
With lesions of the digestive system, persons with impaired renal or liver function, elderly patients or after volume operations - the maximum daily dose is set at the rate of 12 mg of the drug per day, divided into 3 divided doses.
To reduce the likelihood of adverse events, the minimum effective dose size should be given by the least short course.

Overdose

In case of an overdose, 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 not excluded.
Treatment of an overdose: stop taking or taking the medicine. Lornoxicam is rapidly evacuated from the body. The use of dialysis is ineffective. The selective antidote is not known. When poisoning with tablets, it is necessary to carry out urgent measures, including taking enterosorbents and washing the stomach. To treat digestive disorders, Ranitidine or prostaglandin analogs are allowed.

Interaction

When combined with cimetidine, the concentration of lornoxicam in the blood increases.
When used simultaneously with anticoagulants or blockers of platelet aggregation, an increase in the duration of bleeding and an increase in the probability of bleeding may be excluded.
Joint use with Fentprokumon reduces its therapeutic effectiveness.
When taking anti-inflammatory non-steroid drugs with Heparin during spinal or epidural anesthesia, the risk of spinal and epidural hematomas increases.
When combined with ACE blockers and beta-adrenoblockers, their hypotensive effect decreases.
The drug weakens the hypotensive and diuretic effect of diuretics, and also lowers the clearance of digoxin.
When combined with other anti-inflammatory non-steroidal drugs or glucocorticosteroids, the risk of bleeding from the digestive system increases.
When combined with quinoline antibiotics, the risk of convulsive syndrome increases.
The drug raises the content of Methotrexate in the blood when they are used together.
When used simultaneously with selective blockers, seizure of serotonin increases the risk of bleeding from the digestive system.
Xefocam is able to cause an increase in the concentration of lithium in the blood, increasing the side effects of the latter when they are taken together.
Xefocam stimulates the nephrotoxic effects of Cyclosporine and the hypoglycemic effect of sulfonylurea preparations.
When combined with potassium, corticotropin, alcohol, the risk of undesirable effects on the part of digestion increases.
When used concomitantly with cefotetan, cefoperazone, cefamandol, valproic acid increases the likelihood of bleeding.
With a joint admission with Tacrolimus, the threat of nephrotoxicity increases.

Storage conditions

Store at room temperature. The lyophilisate must be stored in the dark. The prepared solution is stored for no more than a day. Keep away from children.
Shelf life - Five years.

special instructions

The likelihood of ulcerogenic action of the drug can be reduced by simultaneous administration of proton pump inhibitors and artificial prostaglandin analogues. When bleeding occurs from the digestive organs, the medication should be stopped immediately and emergency measures taken. It is especially necessary to observe patients with pathology of the gastrointestinal tract, who first take the drug.
Like any other oxicam, the described drug inhibits platelet aggregation, which causes an increase in the duration of bleeding. When using the drug, you need to closely monitor the condition of patients who need a normal physiological functioning of the coagulation system (including those who are scheduled to undergo a surgical operation) who have blood coagulation disorders or who take anti-clotting medications in order to identify signs of bleeding in time .
If signs of liver damage are found (jaundice of the skin, itching, vomiting, nausea, darkening of the urine, abdominal pain, increased liver transaminases), stop the use of the medicine immediately and consult a doctor.
It is forbidden to apply the drug at the same time as other anti-inflammatory non-steroid drugs.
Xefocam is able to change the properties of platelets, but it does not replace the prophylactic effect of Aspirin in cardiovascular disorders.
Patients with impaired renal function, triggered 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 reducing renal perfusion.
The described drug can cause an increase in urea and creatinine in the blood, as well as sodium, water, arterial hypertension, peripheral edema and some other initial symptoms of nephropathy. Long-term therapy of such patients Xefocam can cause glomerulonephritis, nephrotic syndrome and even acute kidney failure.
In the elderly, as well as those suffering from arterial hypertension or obesity, it is necessary to monitor blood pressure.
It is especially important to observe the function of the kidneys in elderly patients, as well as in people taking diuretics or drugs potentially damaging kidney tissue.
With long-term use of the drug, hematologic parameters, as well as renal and liver parameters, should be regularly monitored.
Persons receiving the drug are strongly advised to refrain from driving and drinking alcohol.

Children

Injections and Xefocam tablets are not prescribed for patients under 18 years of age.

With alcohol

Joint intake of alcohol and Xefocam can enhance the toxic effects of the drug. It is recommended to avoid the use of alcohol-containing drinks during the period of treatment with the drug.

In pregnancy and lactation

It is forbidden to take the drug during the periods indicated.

Reviews of Xefocam

Reviews about Xefocam pricks are identical to reviews on the eponymous tablets and highly appreciate their analgesic effect. However, the drug is quite toxic and can cause severe damage to the liver, kidneys and stomach, which is confirmed by the reviews of doctors and patients, so it is unsuitable for systematic use to relieve chronic pain syndrome.