Xefokam - instructions for use, dose, side effects, contraindications

Active substanceLornoxicamLornoxicam

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Zornika

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Micro Labs Limited India

Xefokam®

lyophilizate w / m in / in

Takeda Austria GmbH Austria

Xefokam®

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Takeda Austria GmbH Austria

Xefokam® Rapid

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Takeda Pharma A / S Denmark

Dosage form: & nbsplyophilizate for the preparation of solution for intravenous and intramuscular administration

Composition:

Lyophilizate

1 bottle contains:

Active substance: lornoxicam 8.0 mg

Excipients: mannitol E-421 100.0 mg, trometamol 12.0 mg. edetate 0.20 mg.

Description:

Dense weight of yellow color.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID)

ATX: & nbsp

M.01.A.C Oksikamy

M.01.A. C.05 Lornoxicam

Pharmacodynamics:

Has a pronounced analgesic and anti-inflammatory effect. Lornoxicam has a complex mechanism of action, which is based on. suppression of prostaglandin synthesis, due to inhibition of cyclooxygenase isoenzymes activity. Inhibition of cyclooxygenase leads to desensitization of peripheral pain receptors and, accordingly, to inhibition of inflammation. Besides, lornoxicam inhibits the release of free oxygen radicals from activated leukocytes.The analgesic effect of lornoxicam is not associated with an opiate-like effect on the central nervous system and, unlike narcotic analgesics, lornoxicam Do not depress respiration, do not cause drug dependence.

Lornoxicam does not affect vital signs: body temperature, respiratory rate, heart rate, blood pressure, ECG parameters, spirometry.

Pharmacokinetics:The maximum concentration of lornoxicam in plasma with intramuscular injection is reached after approximately 0.4 hours. Absolute bioavailability (calculated, based on the value of the indicator "area under the concentration time curve") after intramuscular injection is 97%. The half-life period is on average 3-4 hours. Lornoxicam present in plasma in unmodified form, as well as in the form of hydroxylated metabolite, which does not possess pharmacological activity. The degree of binding to plasma proteins is 99% and does not depend on the concentration. Lornoxicam completely metabolized, about 1/3 of the metabolites are excreted through the kidneys and 2/3 through the liver. The elderly and patients with impaired liver and kidney function showed no significant changes in the pharmacokinetics of lornoxicam.

Indications:

Short-term therapy of acute pain from mild to moderately strong.

Contraindications:

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

- Complete or incomplete combination of bronchial asthma, recurrent nasal polyposis or paranasal sinuses and intolerance to acetylsalicylic acid and other NSAIDs (including in anamnesis);

- thrombocytopenia;

- hemorrhagic diathesis or bleeding disorders; as well as those who have undergone surgery associated with a risk of bleeding or incomplete hemostasis;

- period after aortocoronary shunting;

- erosive and ulcerative changes gastric mucosa or duodenum, active gastrointestinal bleeding; cerebrovascular or other bleeding;

- recurrent gastric ulcer or repeated gastrointestinal bleeding;

- data on previous gastrointestinal bleeding associated with the intake of NSAIDs; inflammatory bowel disease (Crohn's disease, nonspecificulcerative colitis) in the phase of exacerbation;

- Decompensated heart failure;

- hepatic insufficiency or active liver disease;

- severe renal failure (level of serum creatinine more than 300 μmol / l, progressive kidney disease, confirmed hyperkalemia, hypovolemia or dehydration;

- pregnancy, the period of breastfeeding;

- children under 18 years of age, due to the lack of clinical data on his use in this age group.

Carefully:

Erosive-ulcerative lesions and bleeding from the gastrointestinal tract (in the anamnesis), moderately pronounced renal failure, conditions after surgery, age over 65, hypertension, ischemic heart disease (CHD), chronic heart failure (CHF), cerebrovascular disease, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, creatinine clearance less than 60 ml / min, history of gastrointestinal lesions, infection Helicobacter pylori, long-term use of NSAIDs, alcoholism, severe somatic diseases, simultaneous administration of oral glucocorticosteroids (including GCT) (including prednisolone), anticoagulants, (incl. warfarin), antiaggregants (incl. clopidogrel), selective serotonin reuptake inhibitors (incl. citalopram, fluoxetine, paroxetine, sertraline), diuretics, drugs with known or presumptive nephrotoxic action.

Simultaneous treatment with NSAIDs and Tacrolimus may increase the risk of nephrotoxicity.

The simultaneous use of NSAIDs and heparin in combination with spinal or epidural anesthesia increases risk the occurrence of spinal / epidural hematomas.

Dosing and Administration:

Parenteral.

The solution for injection is prepared directly before use by dissolving the contents of one vial (8 mg of KSEFOKAM powder) with water for injections (2ml).

After the solution is prepared, the needle is replaced. Intramuscular injections are made with a long needle.

The solution thus prepared is administered intravenously or intramuscularly in postoperative pain and intramuscularly with an acute attack of lumbago / isalgia. The duration of intravenous administration of the solution should be at least 15 seconds, intramuscular for at least 5 seconds.

The initial dose may be 8 or 16 mg. If the analgesic effect of the dose of 8 mg is insufficient, an additional dose can be added.

Maintenance therapy: 8 mg twice a day.

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

The minimum effective dose should be used as short as possible course.

Side effects:

The most common adverse reactions to NSAIDs are from the gastrointestinal tract (GI tract). There may be edema, hypertension and heart failure in the treatment of NSAIDs. When this group of drugs is used, it is possible that there is a slight increase in the risk of arterial thrombotic events.

When applying XEPHOCAMA, the following undesirable effects may occur:

Infections and parasitic diseases

Rarely: pharyngitis

Diseases of the blood and lymphatic system

Rarely: anemia, thrombocytopenia, leukopenia, increased bleeding time Very rarely: hemorrhagic rash.

Diseases of the immune system

Rarely: hypersensitivity.

Metabolic and nutritional disorders

Sometimes: anorexia, weight change

Psychiatric diseases

Sometimes: insomnia, depression

Rarely: confused consciousness, nervousness, agitation

Diseases of the nervous system

Often: light and coming headaches, dizziness

Rarely: drowsiness, paresthesia, taste disturbance, distortion of taste perception, tremor, tremor, migraine

Eye Diseases

Sometimes: conjunctivitis

Rarely: a vision disorder

Diseases of ears and labyrinth

Sometimes: dizziness, tinnitus

Heart Disease

Sometimes: heart palpitations, tachycardia, swelling, heart failure

Diseases of blood vessels

Sometimes: hot flashes, swelling

Rarely: hypertension, bleeding, bruising

Diseases of the respiratory tract, thoracic cavity, mediastinum

Occasionally: rhinitis

Rarely: shortness of breath, cough, bronchospasm

Diseases of the gastrointestinal tract:

Often (≥1% and <10%): abdominal pain, diarrhea, nausea, vomiting, indigestion.

Sometimes (≥1 / 1 000, <1/100) constipation, flatulence, belching, dry mouth, gastritis, ulcer, stomach, epigastric pain, ulcer of the duodenum, ulceration of the oral cavity.

Rarely (<1%): dysphagia, esophagitis, stomatitis, tarry stool, bloody vomiting, reflux, aphthous stomatitis, glossitis, peptic ulcer with perforation.

Diseases of the liver and gallbladder

Sometimes: an increase in liver function

Rarely: abnormal liver function

Very rarely: hepatocellular disorders

Diseases of the skin and subcutaneous tissue:

Sometimes: skin rash, itchy skin, hyperhidrosis, erythematous rash, hives, alopecia

Rarely: dermatitis, hemorrhagic rash

Very rarely (<1/10 000): edema and bullous reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Diseases of skeletal musculature, connective tissue and bones

Sometimes: arthralgia

Rarely: pain in the bones, muscle spasms, myalgia

Diseases of the kidneys and urinary tract

Rarely: nocturia, impaired urination, increased indices of blood urea nitrogen and creatine.

Local Reactions:

hyperemia, tenderness at the injection site.

Common diseases and complaints about the introduction of a medicine

Sometimes: malaise, swelling of the face

Rarely: asthenia

Overdose:

At present, there is no evidence of an overdose of XEPHOCAM, which would allow to determine its consequences or to propose specific measures for their elimination. Nevertheless, it can be assumed that in the case of an overdose of XEPHOCAM, side effects from the gastrointestinal tract, central nervous system and signs of kidney failure will be more frequent and severe.Serious symptoms are ataxia, convulsions, liver and kidney damage, possibly a coagulation disorder.

Treatment: when suspicion of an overdose, the introduction of XEPHOCAM should be discontinued. Due to the fact that the half-life of lornoxicam is about 4 hours, it is rapidly excreted from the body. This substance can not be removed from the body by dialysis. At present, there is no specific antidote. You should use usual emergency measures and perform symptomatic treatment.

Interaction:

The simultaneous use of the drug KSEFOKAM and

- Cimetidine - increases the concentration of lornoxicam in plasma.

- Interactions with ranitidine and antacids have not been identified;

- anticoagulants or platelet aggregation inhibitors - bleeding time may be longer (increased risk of bleeding, monitoring of the international normalized relationship (INR) is necessary;

- fenprokumone - reduction of the effect of treatment with fenprocumone;

- while concurrent administration of NSAIDs and heparin in combination with spinal / epidural anesthesia increases risk of spinal or epidural hematomas.

- beta-blockers and angiotensin-converting enzyme inhibitors can reduce their hypotensive effect;

- diuretics - reduces the diuretic effect and hypotensive effect;

- digoxin - reduces renal clearance of digoxin.

- quinolone antibiotics - the risk of development of convulsive syndrome;

- other NSAIDs or glucocorticoids - the risk of GI tract bleeding;

- selective serotonin reuptake inhibitors (eg, citalopram, fluoxetine, paroxetine, sertraline) increases the risk of gastrointestinal bleeding.

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

- cyclosporine - increases the nephrotoxicity of cyclosporine

- derivatives of sulfonylureas - may increase hypoglycemic effect of the latter;

- alcohol, corticotropin, potassium drugs increase the risk of effects from the gastrointestinal tract;

- cefamandol, cefoperazone, cefotetan, valproic acid increase the risk of bleeding.

- Tacrolimus: increases the risk of nephrotoxicity

Special instructions:

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

Like other oxicams, the drug KSEFOCAM inhibits platelet aggregation and therefore may increase bleeding time. When using this drug, it is necessary to closely monitor the condition of patients who need the absolutely normal functioning of the blood clotting system (for example, patients who are undergoing surgery) who have disorders of the blood coagulation system, or who receive medications that depress coagulation (including heparin at low doses ), in order to timely detect signs of bleeding.

If there are signs of liver damage (skin itching, yellowing of the skin, nausea, vomiting, abdominal pain, darkening of urine, increased level of "liver" transaminases), stop taking the drug and consult a doctor.

Do not use the drug simultaneously with other NSAIDs.

The drug can alter the properties of platelets, but does not replace the preventive effect of acetylsalicylic acid in cardiovascular diseases.

Patients with impaired renal function caused by large blood loss or severe dehydration, XSEHOKAM, as an inhibitor of prostaglandin synthesis, can be prescribed only after elimination of hypovolemia and the associated danger of reducing renal perfusion. Like other NSAIDs, XEFOCAM can cause an increase in the concentration of urea and creatinine in the blood, as well as water and sodium retention, peripheral edema, arterial hypertension, and others. early signs of nephropathy. Long-term treatment of such patients with the drug KSEFOKAM can lead to the following consequences: glomerulonephritis, papillary necrosis and nephrotic syndrome with transition to acute renal failure. Patients with a marked decrease in kidney function drug KSEFOKAM can not be appointed (see "Contraindications"). 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;

- simultaneously receiving medicines that can cause kidney damage.

With prolonged use of the drug KSEFOKAM it is necessary 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 pregnancy.

Effect on the ability to drive transp. cf. and fur:Patients using the drug should refrain from types of action that require increased attention, rapid mental and motor reactions, alcohol consumption.

Form release / dosage:

Liofilizate for the preparation of solution for intravenous and intramuscular injection.

Packaging:

The amount of the preparation containing 8 mg of the active substance is placed in a vial of dark glass (1 Eur Eur.) With a volume of 10 ml or 6 ml, sealed with a rubber stopper, rolled with an aluminum cap and closed with a plastic cover that provides control of the first opening.

5 vials with lyophilizate in a plastic pallet or without a pallet are placed together with instructions for medical use in a cardboard pack.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children!

Shelf life:3 years.

The prepared solution must be used within 24 hours!
Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N011189

Date of registration:12.09.2011

The owner of the registration certificate:Takeda Austria GmbHTakeda Austria GmbH Austria

Manufacturer: & nbsp

WASSERBURGER ARZNEIMITTELWERK, GmbH Germany

Representation: & nbspTakeda Pharmaceuticals Ltd.Takeda Pharmaceuticals Ltd.

Information update date: & nbsp26.09.2015

Illustrated instructions

Instructions

Xefokam® (Xefocam®)