Tradename

Lauro, Lauro

International non-proprietary name

Lornoxicam, Lornoxicam

Compound

Each tablet, covered film shell, contains

active substance: Lornoxicam 8 mg excipients: Q . S

Dosage form

Tablets.

Pharmacological properties

Lornoxicam is a non-steroidal anti-inflammatory drug (NSAID) belonging to the oxicam class. Like other NSAIDs, lornoxicam is a potent inhibitor of the cyclooxygenase enzymes that catalyze the formation of prostaglandins (acting as messenger molecules in inflammation) and thromboxane from arachidonic acid. Unlike some NSAIDs, inhibition cyclooxygenase does not result in lornoxicam to increase formation of leukotrienes, which means that arachidonic acid does not move into the 5-lipoxygenase cascade, which leads to to minimization risk side effects effects.

Pharmacokinetics

Lornoxicam is absorbed from gastrointestinal tract and characterized fast speed. Maximum concentration in blood achieved approximately through 1–2 hours. Absolute bioavailability (calculated as AUC ) tablets, covered film casing LAURO , is 90-100%. Lornoxicam is found in plasma in unchanged form and in the form hydroxylated metabolite. The hydroxylated metabolite does not show pharmacological activity. Lornoxicam is completely metabolized, approximately 2/3 output through liver and 1/3 through the kidneys in the form of an inactive substance. 5-hydroxylation is the major metabolic pathway, accounting for up to 95% of the total intrinsic clearance of lornoxicam, and cytochrome P 450 2 C 9 has been shown to be the major enzyme involved in education 5-hydroxylornoxicam in vitro . At lornoxicam has not been tested in animal models. induced liver enzymes. Clinical trial data showed no evidence of accumulation of lornoxicam after multiple doses according to With recommended dose. This conclusion was confirmed by drug monitoring data for 1 year. Co-administration of lornoxicam with meals reduced Cmax by approximately 30%. Tmax increased from 1.5 to 2.3 hours. Absorption of lornoxicam (calculated as AUC ) may be reduced by up to 20%. Co-administration with antacids does not affect the pharmacokinetics of lornoxicam. Bioavailability lornoxicam after oral administration is more than 90%. Maximum concentrations in plasma achieved about through 2 hours. Lornoxicam found in plasma in unchanged form and in the form of a hydroxylated form. The hydroxylated metabolite does not show pharmacological activity. With normal liver and kidney function, the plasma half-life is near four hours. He easily penetrates in synovial fluid, presumed site of action at chronic inflammatory arthropathies. In elderly patients clearance lornoxy- Kama declining about on the 30–40%; so thus, the half-life is somewhat longer. Even in the presence of impaired renal and hepatic function significant differences in pharmacokinetics were not observed. Due to the short half-life, cumulation does not occur even with repeated administration. Like others oxicam and diclofenac, lornoxicam is metabolized through cytochrome P450 2C9. because of genetic polymorphism, some people may be slowly metabolized and therefore have elevated levels lornoxicam. Max- new therapeutic level in blood, calling- analgesic activity, is 1 μg / ml. No speed change data accumulation or elimination upon repeated administration.

Mechanism of action

As with other NSAIDs, the anti-inflammatory and analgesic activity of lornoxicam is associated With his inhibitory action on the synthesis of prostaglandins and thromboxane through inhibition how COX-1, So and COX-2. it leads to decrease inflammation, pain, fever and swelling which mediated prostaglandins. However accurate mechanism actions lornoxicam, like and others NSAIDs before end not defined.

Indications for use

This medicine is a non-steroidal anti-inflammatory drug (NSAID) prescribed at moderate and strong pain, osteoarthritis and rheumatoid arthritis.

Contraindications

Contraindicated patients With ulcerative disease, severe renal failure and hypersensitivity.

Special instructions and precautions

Caution should be exercised in patients with a history of infections, asthma, any allergies, violations clotting blood, high blood pressure, impaired kidney, liver, heart function, during pregnancy and lactation breast.

It may cause drowsiness or dizziness, do not drive or work with mechanisms, taking this is medicine.

Side effect

•          Gastrointestinal tract: abdominal pain, diarrhea, disorder stomach, nausea, vomiting, inflammation pancreatic glands and ulcers in the mouth.

•         Central nervous system: head pain, drowsiness, insomnia and dizziness.

•         Eyes and ENT: Violation vision, ringing in ears and sensitivity to light.

•         Heart: high bloody pressure, increased heartbeat and fluid retention.

•         Urogenital: Defeat kidneys.

•         Skin: Skin necrosis and skin rash.

Interaction with other drugs

Lornoxicam maybe to interact With anticoagulants (warfarin, heparin, phenprocoumon), immunosuppressants (tacrolimus, cyclosporine), painkillers (aspirin), antacids (cimetidine), antirheumatoid (methotrexate), antipsychotics (lithium), cordial glycosides. (digoxin), antidiabetic (glibenclamide), antibiotic (rifampicin), antifungal (fluconazole), anticancer (pemetrexed), diuretics, ACE inhibitors, beta-blockers, antidepressants and corticosteroids.

Dosage and administration

Adults: PO -Pain: 8-16 mg/day. Max: 24 mg/day. Osteoarthritis, rheumatoid arthritis: 12 mg/day in 2-3 doses, up to 16 mg/day.

Overdose

Storage conditions

Store at 15-30° C . Keep away from the world.

Keep out of the reach of children!

Best before date

3 years. Do not use after the expiry date stated on the packaging.

Holiday conditions

Released by prescription

Release form

1 blister Alu - Alu 10 tablets packed in a cardboard box with a leaflet.