Lornoliof (Lyophilisate) Instructions for Use

Marketing Authorization Holder

S.C. Rompharm Company S.R.L. (Romania)

ATC Code

M01AC05 (Lornoxicam)

Active Substance

Lornoxicam (Rec.INN registered by WHO)

Dosage Form

Lornoliof

Lyophilisate for preparation of solution for intravenous and intramuscular administration 8 mg: vial 1, 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilisate for preparation of solution for intravenous and intramuscular administration in the form of a dense mass of yellow color.

Excipients: mannitol – 100 mg, disodium edetate – 0.22 mg, trometamol – 24 mg, water for injections – 2 ml.

Vials – blister packs in a set with solvent: amp. 2 ml-1 pc. – cardboard boxes.
Vials (5) – blister packs in a set with solvent: amp. 2 ml-5 pcs. – cardboard boxes.
Vials (10) – blister packs in a set with solvent: amp. 2 ml-10 pcs. – cardboard boxes.

Clinical-Pharmacological Group

NSAID

Pharmacotherapeutic Group

NSAID

Pharmacological Action

NSAID, belongs to the oxicam class. It has a pronounced anti-inflammatory and analgesic effect, and also has antipyretic and antiplatelet action.

The mechanism of action is associated with the suppression of inflammatory factors; inhibition of prostaglandin synthesis due to inhibition of COX-1 and COX-2, which leads to disruption of arachidonic acid metabolism and inhibition of prostaglandin synthesis both at the site of inflammation and in healthy tissues. It suppresses the exudative and proliferative phases of inflammation.

Pharmacokinetics

Lornoxicam is rapidly and completely absorbed from the gastrointestinal tract after oral administration and from the injection site after intramuscular injection. C_max in plasma is reached approximately 1-2 hours after oral administration and 15 minutes after intramuscular administration.

The absolute bioavailability is 90-100%.

Plasma protein binding is 99% and does not depend on the concentration of the active substance.

Lornoxicam is completely metabolized. It is present in the blood plasma mainly in unchanged form and, to a lesser extent, as a hydroxylated metabolite, which has no pharmacological activity.

T_1/2 averages 4 hours and does not depend on the concentration of lornoxicam. Approximately one third of its metabolites are excreted by the kidneys and two thirds through the liver.

No significant changes in the pharmacokinetic parameters of lornoxicam were found in the elderly, or in patients with renal or hepatic insufficiency.

Indications

Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, joint syndrome in acute gout, bursitis, tenosynovitis.

Moderate and severe pain syndrome (including arthralgia, myalgia, neuralgia, lumbago, sciatica, migraine, toothache and headache, algodysmenorrhea, pain from injuries, burns). Febrile syndrome (in colds and infectious diseases).

ICD codes

Dosage Regimen

When taken orally – 4 mg 2-3 times/day or 8 mg 2 times/day.

Intravenous or intramuscular initial dose – 8-16 mg. If the analgesic effect is insufficient at a dose of 8 mg, an additional 8 mg can be administered again.

Maximum daily doses when taken orally – 16 mg; for concomitant gastrointestinal diseases, impaired renal or liver function, elderly patients (over 65 years), with body weight less than 50 kg, as well as after extensive surgery – 12 mg in 3 divided doses.

Adverse Reactions

From the digestive system: abdominal pain, diarrhea, dyspepsia, nausea, vomiting, heartburn, diarrhea; rarely – flatulence, dry mouth, gastritis, esophagitis, erosive and ulcerative lesions of the gastric and intestinal mucosa, gastrointestinal bleeding (including rectal), impaired liver function.

From the central nervous system: rarely – dizziness, headache, drowsiness, agitation, sleep disorders, depression, tremor, aseptic meningitis.

From the hematopoietic system: rarely – leukopenia, thrombocytopenia, agranulocytosis.

From the blood coagulation system: with long-term use in high doses – bleeding (gastrointestinal, gingival, uterine, nasal, rectal, hemorrhoidal), anemia.

From the metabolism: rarely – increased sweating, chills, change in body weight.

From the cardiovascular system: rarely – arterial hypertension, tachycardia, development or worsening of heart failure.

From the urinary system: rarely – dysuria, decreased glomerular filtration, interstitial nephritis, glomerulonephritis, papillary necrosis, nephrotic syndrome, peripheral edema, acute renal failure.

Allergic reactions: skin rash, itching, urticaria, angioedema, bronchospasm.

Other: edematous syndrome, tinnitus, change in body weight.

Contraindications

Acute gastrointestinal bleeding, gastric and duodenal ulcer in the acute phase, ulcerative colitis in the acute phase, bronchial asthma, severe chronic heart failure, hypovolemia, blood coagulation disorders (including hemophilia, hemorrhagic diathesis, thrombocytopenia), severe hepatic and/or renal failure, glucose-6-phosphate dehydrogenase deficiency, cerebral hemorrhage (including suspected), pregnancy, lactation period, children and adolescents under 18 years of age, hypersensitivity to lornoxicam, acetylsalicylic acid or other NSAIDs.

Use in Pregnancy and Lactation

Lornoxicam is contraindicated for use during pregnancy and during the lactation (breastfeeding) period.

Use in Hepatic Impairment

Contraindicated in severe hepatic failure.

In case of liver function impairment, Lornoxicam should be used only after careful assessment of the expected benefit of therapy and the possible risk.

Use in Renal Impairment

Contraindicated in severe renal failure.

In case of mild degree of renal impairment (serum creatinine level 150-300 µmol/l), Lornoxicam should be used only after careful assessment of the expected benefit of therapy and the possible risk. Use with caution in moderate renal failure.

In patients with impaired renal function, regular monitoring of their function is necessary during treatment.

Pediatric Use

Contraindicated in children and adolescents under 18 years of age.

Geriatric Use

Use with caution in elderly patients (over 65 years).

Elderly patients should have their blood pressure monitored when using lornoxicam.

Special Precautions

Use with caution in erosive and ulcerative lesions and gastrointestinal bleeding (in history), moderate renal failure, conditions after surgical interventions, in elderly patients (over 65 years), in patients with body weight less than 50 kg.

Lornoxicam should be used only after careful assessment of the expected benefit of therapy and the possible risk in the following cases: mild degree of renal impairment (serum creatinine level 150-300 µmol/l); heart failure and other conditions accompanied by a decrease in circulating blood volume and renal blood flow; impaired liver function; arterial hypertension and conditions accompanied by fluid retention, edema; patients who have undergone extensive surgery.

In patients with impaired renal function, regular monitoring of renal function is necessary during treatment.

Elderly patients, as well as patients with arterial hypertension, should have their blood pressure monitored when using lornoxicam.

For gastric peptic ulcer and duodenal ulcer disease, therapy should be carried out against the background of simultaneous administration of histamine H₂-receptor blockers or omeprazole.

With long-term use, it is necessary to periodically monitor the peripheral blood picture, as well as indicators of liver and kidney function.

Effect on ability to drive vehicles and machinery

Since Lornoxicam reduces the speed of psychomotor reactions, special care should be taken when driving a car and other potentially hazardous activities during the period of use.

Drug Interactions

With simultaneous use with anticoagulants, platelet aggregation inhibitors, an increase in bleeding time and an increased risk of bleeding are possible.

With simultaneous use, the hypotensive effect of beta-blockers and ACE inhibitors is reduced.

With simultaneous use, the hypoglycemic effect of sulfonylurea derivatives is enhanced.

With simultaneous use, the diuretic and hypotensive effect of diuretics is reduced.

With simultaneous use with NSAIDs, the risk of side effects increases; with digoxin – the renal clearance of digoxin decreases; with methotrexate – the concentration of methotrexate in blood plasma increases; with cimetidine – the concentration of lornoxicam in blood plasma increases; with lithium salts – an increase in C_max of lithium in blood plasma is possible, which leads to an increase in the manifestations of side effects of lithium preparations.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.