Ksefokam pills 8mg №30

Indications

- short-term treatment of pain syndrome of different origin;

- symptomatic therapy of rheumatic diseases (rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, articular syndrome with exacerbation of gout, rheumatic soft tissue damage).

Dosage and administration

The drug is taken orally before meals with a glass of water.

At severe pain syndrome The recommended dose of 8-16 mg / day, divided into 2-3 doses. The maximum daily dose is 16 mg.

At inflammatory and degenerative rheumatic diseases The recommended starting dose is 12 mg. The 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.

In diseases of the gastrointestinal tract, patients with impaired renal or hepatic function, to patients old age (over 65)After extensive operations - the maximum daily dose is 12 mg in 3 doses.

To reduce the risk of adverse events from the gastrointestinal tract, use the minimum effective dose of the shortest possible course.

Side effect

Gastrointestinal: dyspepsia, abdominal pain, dry mouth, stomatitis, nausea, vomiting, heartburn, diarrhea; esophagitis, gastritis, erosive and ulcerative lesions of the mucous membrane of the stomach and intestines including with perforation and bleeding, constipation, flatulence, melena, abnormal liver function, increased levels of liver transaminases.

Nervous system: headache, dizziness, drowsiness, sleep disorders, depression, agitation, tremor, aseptic meningitis, paresthesias.

Special senses: tinnitus, blurred vision.

Cardiovascular: development or aggravation of heart failure, tachycardia, increased blood pressure.

Respiratory: pharyngitis, rhinitis, dyspnea, cough, bronchospasm.

Urogenital: dysuria, reduction of glomerular filtration, interstitial nephritis, glomerulonephritis, papillary necrosis, nephrotic syndrome, peripheral edema, acute renal failure.

From the skin and subcutaneous fat: edematous syndrome, ecchymosis, skin rash, pruritus, urticaria, alopecia, Stevens-Johnson syndrome, Lyell's syndrome, angioedema.

From the side of blood-forming organs and hemostasis system: agranulocytosis, leukopenia, anemia, thrombocytopenia, increased bleeding time.

Other: anorexia, increased sweating, changes in body weight, arthralgia, myalgia.

Contraindications

- A complete or incomplete combination of asthma, recurrent nasal polyposis or paranasal sinuses and intolerance to Acetylsalicylic acid and other NSAIDs (including a history of);

- hemorrhagic diathesis or bleeding disorders;

- recent surgery with a risk of bleeding or incomplete hemostasis;

- the period after coronary artery bypass surgery;

- erosive and ulcerative changes of the gastric or duodenal mucosa, active Gastrointestinal bleeding;

- cerebrovascular or other bleeding;

- recurrent gastric ulcer or repeated gastrointestinal bleeding;

- Gastrointestinal bleeding associated with NSAID in history;

- inflammatory bowel disease (Crohn's disease, ulcerative colitis) in the acute phase;

- decompensated heart failure;

- severe liver failure or active liver disease;

- severe renal failure (serum creatinine level more than 300 mcmol / l), progressive kidney disease;

- confirmed hyperkalemia;

- hypovolemia or dehydration;

- pregnancy;

- lactation period (breastfeeding);

- children's and teenage age up to 18 years (due to the lack of clinical data on its use in this age group);

- hypersensitivity / allergy to lornoxicam or to one of the components of the drug.

Carefully: erosive and ulcerative lesions and bleeding from the gastrointestinal tract (in history); moderate renal failure, CC less than 60 ml / min; conditions after surgery; CHD, chronic heart failure; cerebrovascular diseases; dyslipidemia / hyperlipidemia; diabetes; peripheral arterial disease; the presence of Helicobacter pylori infection; long-term use of NSAIDs; severe somatic diseases; simultaneous use of oral corticosteroids (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including clopidogrel), selective serotonin reuptake inhibitors (includingcitalopram, Fluoxetine, paroxetine, sertraline); smoking, alcoholism; age over 65 years.

Use during pregnancy and lactation

The use of the drug is contraindicated in pregnancy and lactation.

Application for violations of the liver

Patients with impaired liver function - the maximum daily dose is 12 mg, for 3 doses.

Application for violations of kidney function

Patients with impaired renal function - the maximum daily dose is 12 mg, for 3 doses.

Use in children

Contraindication: age up to 18 years (due to the lack of clinical data on its use in this age group).

Use in elderly patients

Elderly patients (over 65 years) - the maximum daily dose is 12 mg, for 3 doses.

Special notes

The risk of an ulcerogenic effect of the drug reduces the simultaneous administration of proton pump inhibitors and synthetic analogues of prostaglandins. In the event of bleeding in the gastrointestinal tract, taking the drug should be immediately stopped and appropriate emergency measures should be taken. Especially carefully it is necessary to monitor the condition of those patients with gastrointestinal pathology, who for the first time receive a course of treatment with the drug Ksefokam.

Like other oxicam, Ksefokam inhibits platelet aggregation and therefore may increase bleeding time. When using this drug, it is necessary to carefully monitor the condition of patients in need of an absolutely normal functioning of the blood coagulation system (for example, patients who are to undergo surgery) who have violations of the blood coagulation system or who receive drugs that suppress coagulation (including low-dose heparin), in order to timely detect signs of bleeding.

If there are signs of liver damage (itching, yellowing of the skin, nausea, vomiting, abdominal pain, dark urine, elevated levels of liver transaminases), the patient should stop taking the drug and consult your doctor.

Do not use the drug at the same time as other NSAIDs.

The drug can change the properties of platelets, but does not replace the prophylactic action of acetylsalicylic acid in cardiovascular diseases.

Patients with impaired renal function caused by large blood loss or severe dehydration, Ksefokam, as an inhibitor of prostaglandin synthesis, can be appointed only after the elimination of hypovolemia and the associated risk of reducing renal perfusion. Like other NSAIDs, Ksefokam can cause an increase in blood concentration of urea and creatinine, as well as water and sodium retention, peripheral edema, arterial hypertension, and other early signs of nephropathy. Long-term treatment of such patients with Ksefokam can lead to the following consequences: glomerulonephritis, papillary necrosis and nephrotic syndrome with a transition to acute renal failure. Patients with a pronounced decrease in renal function should not prescribe Ksefokam. In elderly patients, as well as in patients suffering from hypertension and / or obesity, it is necessary to control the level of blood pressure.

It is especially important to monitor kidney function in elderly patients, as well as in patients:

- simultaneously receiving diuretics;

- At the same time receiving drugs that can cause kidney damage.

With prolonged use of the drug Ksefokam need to periodically monitor hematological parameters, as well as the function of the kidneys and liver.

The use of the drug may adversely affect female fertility and is not recommended for women planning a pregnancy.

Patients using the drug should refrain from drinking alcohol.

Influence on ability to drive motor transport and control mechanisms

Patients using the drug should refrain from work that requires increased attention and quickness of psychomotor reactions.

Overdose

Symptoms: may increase the above side effects of the drug.

Treatment: conducting symptomatic therapy. Taking Activated carbon immediately after taking Xefocam may help reduce the absorption of the drug. Anti-ulcer drugs can be used to prevent damage to the mucous membrane. Dialysis is ineffective.

Drug interaction

The simultaneous use of the drug Ksefokam and:

cimetidine - increases the concentration of lornoxicam in plasma; interactions with Ranitidine and antacid drugs have not been identified;

anticoagulants or platelet aggregation inhibitors - possible increase in bleeding time (increased risk of bleeding, control of MHO is necessary;

beta blockers and ACE inhibitors - can reduce their hypotensive effect;

diuretics - reduces the diuretic effect and hypotensive effect;

digoxin - reduces renal clearance of Digoxin;

quinolone antibiotics - increases the risk of convulsive disorders;

other NSAIDs or GKS - increases the risk of gastrointestinal bleeding;

methotrexate - increases the concentration of Methotrexate in serum;

selective serotonin reuptake inhibitors (for example, citalopram, fluoxetine, paroxetine, sertraline) - increases the risk of gastrointestinal bleeding;

lithium salts - may cause an increase in peak plasma lithium concentrations and, thereby, enhance the known side effects of lithium;

cyclosporine - increases nephrotoxicity of cyclosporine.

sulfonylurea derivatives - may enhance the hypoglycemic effect of the latter;

ethanol, corticotropin, potassium preparations - increases the risk of side effects from the gastrointestinal tract;

cefamendol, cefoperazone, cefotetan, valproic acid - increases the risk of bleeding.

Pharmacy sales terms

The drug is available on prescription.

Terms and conditions of storage

The drug should be stored out of the reach of children at a temperature not higher than 25 ° C.