Ksefokam

1,173 5 minutes read

Active material: Lornoxicam
When ATH: M01AC05
CCF: NSAIDs
ICD-10 codes (testimony): M05, M15, M25.5, R52.0, R52.2
When CSF: 05.01.01.07
Manufacturer: NYCOMED AUSTRIA GmbH (Austria)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

Pills, coated white or yellowish, oblong, with sunken inscription “L04”.

	1 tab.
lornoxicam	4 mg

Excipients: magnesium stearate, polyvidone K25, sodium croscarmellose, cellulose, lactose, macrogol 6000, Titanium dioxide (E171), talc, gipromelloza.

10 PC. – blisters (1) – packs cardboard.
10 PC. – blisters (2) – packs cardboard.
10 PC. – blisters (3) – packs cardboard.
10 PC. – blisters (5) – packs cardboard.
10 PC. – blisters (10) – packs cardboard.

Pills, coated white or yellowish, oblong, with sunken inscription “L08”.

	1 tab.
lornoxicam	8 mg

Excipients: magnesium stearate, polyvidone K25, sodium croscarmellose, cellulose, lactose, macrogol 6000, Titanium dioxide (E171), talc, gipromelloza.

Pharmacological action

NSAIDs, It refers to the class of oxicams. It has a pronounced analgesic and anti-inflammatory effect.

The mechanism of action of lornoxicam is suppression of the synthesis of prostaglandins, due to inhibition of cyclooxygenase isoenzyme activity. Besides, lornoxicam inhibits the release of oxygen radicals from activated leukocytes.

Ksefokam has no opiate effect on the central nervous system, It does not suppress breathing, It does not cause drug dependence.

Pharmacokinetics

Absorption

Lornoxicam is rapidly and completely absorbed from the gastrointestinal tract after oral administration. C_max in plasma are reached after about 1-2 no.

The absolute bioavailability of lornoxicam 90-100%.

Distribution

The binding to plasma proteins lornoxicam, mainly to the albumin fraction, is 99% and does not depend on its concentration.

Metabolism

Lornoxicam completely metabolized. Lornoxicam is present in plasma mainly as unchanged and, less, in format gidroksilirovannogo metabolite, which has no pharmacological activity.

Deduction

T_1/2 averages 4 hours and is independent of the concentration of lornoxicam. About 1/3 its metabolites are excreted by the kidneys and 2/3 – through the liver.

Pharmacokinetics in special clinical situations

In the elderly, and in patients with renal or hepatic insufficiency have not found significant changes in pharmacokinetic parameters of lornoxicam.

Testimony

- Moderate and severe pain;

- Symptomatic treatment of pain and inflammation in inflammatory and degenerative rheumatic diseases.

Dosage regimen

At moderate to severe pain syndrome administered in a daily dose of 8-16 mg 2-3 admission, the maximum daily dose – 16 mg.

At inflammatory and degenerative rheumatic diseases dose starting dose is 12 mg / day. The average dose is 8-16 mg / day depending on the condition of the patient.

The duration of therapy depends on the nature and course of the disease.

The tablets are taken orally before a meal, with a glass of water.

Patients with diseases of the gastrointestinal tract, impaired renal function or liver, patients Seniors (senior 65 years) Ksefokam prescribe a maximum dose 12 mg / day (by 4 mg 3 times / day).

Side effect

From the digestive system: stomach ache, diarrhea, dyspepsia, nausea, vomiting; rarely – flatulence, dry mouth, gastritis, esophagitis, the formation of peptic ulcers and / or gastrointestinal bleeding (incl. rectal), stomatitis, glossitis, colitis, dysphagia, hepatitis, pancreatitis, abnormal liver function.

Allergic reactions: possible skin rashes, hypersensitivity reactions, accompanied by dyspnea and tachycardia, bronchospasm, Stevens-Johnson syndrome, exfoliative dermatitis, angiit, fever, nasal allergy, lymphadenopathy.

From the central and peripheral nervous system: rarely – dizziness, headache, drowsiness, state of excitement, sleep disorders, noise in ears, hearing loss, blurred vision, dysarthria, hallucinations, migraine, perifericheskaya neuropathy, syncope, aseptic meningitis.

From the hematopoietic system: rarely – leukopenia, thrombocytopenia.

From the blood coagulation system: rarely – nosebleeds, hemorrhoidal bleeding.

Metabolism: rarely – increased sweating, chills, weight change.

Cardio-vascular system: rarely – arterial hypertension, tachycardia, peripheral edema.

From the urinary system: rarely – dizurija; in some cases – glomerulonephritis, papillary necrosis and nephrotic syndrome, a transition to acute renal failure, interstitial nephritis, kristallurija, polyuria.

Other: conjunctivitis.

Contraindications

- Bleeding diathesis or coagulation disorders, and the state after the operation, with a risk of bleeding or incomplete hemostasis;

- Gastric ulcer and duodenal ulcer in the acute phase;

- Nespetsificheskiy yazvennыy colitis;

- Expressed human liver;

- Moderate or severe renal impairment (serum creatinine>300 mmol / l);

- Hypovolemia or dehydration;

- Confirmed or suspected brain haemorrhage;

- Bronchial asthma;

- Heart failure;

- Hearing loss;

- Deficiency of glucose-6-fosfatdegidrogenazы;

- Pregnancy;

- Lactation (breast-feeding);

- Childhood and adolescence up 18 years;

- Indicate a history of hypersensitivity to aspirin or other NSAIDs;

- Hypersensitivity to lornoxicam or other ingredients.

FROM caution should be prescribed the drug for hypertension and anemia.

Only after a thorough evaluation of benefit / risk ratio can be used on patients, with a history of bleeding indications from the gastrointestinal tract, ulcerative lesions of the gastrointestinal tract, as well as in patients with impaired kidney function and diabetes with impaired renal function.

Pregnancy and lactation

Ksefokam is contraindicated during pregnancy and lactation (breast-feeding).

Cautions

When peptic ulcer and duodenal ulcer therapy Ksefokamom should be against the background of the simultaneous reception of histamine H₂-receptors or omeprazole. It should be noted, that long-term treatment with Ksefokam may slow the healing process of peptic ulcers.

In case of bleeding in the gastrointestinal tract the drug is necessary at once the stop and take immediate action. Especially carefully it is necessary to monitor the state of those patients gastrointestinal diseases, for the first time receive a course of treatment Ksefokam.

Ksefokam inhibits aggregation platelet, so, may increase bleeding time. Therefore, to assign the drug to patients (which, eg, will have surgery or have coagulation disorders or are receiving medicinal products, suppress the blood coagulation / including heparin at low doses /) with caution and under close medical supervision, to timely detect signs of bleeding.

Patients with impaired renal function, It causes more blood loss or severe dehydration, Ksefokam, as an inhibitor of prostaglandin synthesis, You can assign only after the hypovolemia and the associated danger of reducing renal perfusion.

Like other NSAIDs, Ksefokam may cause an increase in blood concentrations of urea and creatinine, as well as sodium and water retention, peripheral edema, hypertension and other early signs of nephropathy.

In patients with impaired renal function during treatment requires regular monitoring of renal function. It is particularly important to monitor renal function in elderly patients, and in patients, concomitantly receiving diuretics and nephrotoxic drugs.

Elderly patients, as well as patients with hypertension when used Xefocam shown blood pressure control.

With long-term use of the drug must be monitored periodically Ksefokam peripheral blood picture, as well as indicators of liver and kidney function.

Effects on ability to drive vehicles and management mechanisms

Since Ksefokam reduces the speed of psychomotor reactions, during the use of the drug should refrain from activities, require increased attention and psychomotor speed reactions.

Overdose

Symptoms: may increase the side effects described Xefocam.

Treatment: symptomatic therapy. To reduce the intake expedient appointment of activated charcoal immediately after receiving Xefocam, to eliminate shock syndrome shows the assignment of anti-ulcer therapy.

Drug Interactions

In an application Ksefokama and anticoagulants or platelet aggregation inhibitors may increase bleeding time and increase the risk of bleeding.

In an application Ksefokam may enhance the hypoglycaemic effect of sulfonylureas.

In an application Ksefokam reduce diuretic effect of diuretics, thus their hypotensive action is reduced.

In an application Ksefokam may reduce the hypotensive effect of beta-blockers and ACE inhibitors.

In an application Xefocam with other NSAIDs or corticosteroids increases the risk of side effects from the gastrointestinal tract.

In an application Ksefokam enhances the action of fibrinolytic.

In an application with paracetamol Xefocam, cyclosporine, preparations of gold and other nephrotoxic agents increases the risk of side effects from the kidney.

In an application with corticotropin Ksefokama, potassium supplements, ethanol increases the risk of side effects from the gastrointestinal tract.

In an application with Ksefokama Tsefamandol, cefoperazone, tsefotetanom, valproic acid increases the risk of bleeding.

Pharmacokinetic interactions

In an application with lithium salts Ksefokam may cause an increase in peak plasma concentrations of lithium and, thereby, intensify the side effects of lithium.

In an application Ksefokam increases the concentration of methotrexate in plasma.

In an application Ksefokama and cimetidine increases the plasma concentration of lornoxicam.

In an application Ksefokam reduces renal clearance of digoxin.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. The drug should be stored out of reach of children at temperature from 15 ° to 25 ° C. Shelf life – 5 years.

Vladimir Andreevich Didenko

1,173 5 minutes read