Chemical formula: C₁₃H₁₀ClN₃O₄S₂ Molecular mass: 371.81 g/mol PubChem compound: 54690031
Lornoxicam interacts in the following cases:
In concomitant administration of lornoxicam and corticosteroids observed increased risk of gastrointestinal ulceration or bleeding.
Lornoxicam (as other NSAIDs depending on the cytochrome P450 2C9 (CYP2C9 isoenzyme)) has interactions with known inducers and inhibitors of CYP2C9 isoenzymes.
Lornoxicam is extensively metabolised in the liver, primarily to the inactive 5–hydroxylornoxicam by hydroxylation. CYP2C9 is involved in this biotransformation of lornoxicam. Due to genetic polymorphism, slow and extensive metabolisers exist for this enzyme, which could result in markedly, increased plasma levels of lornoxicam in slow metabolisers. The hydroxylated metabolite exhibits no pharmacological activity. Lornoxicam is metabolised completely, and approximately ⅔ is eliminated via the liver and ⅓ via the kidneys as inactive substance.
In concomitant administration of lornoxicam and selective serotonin reuptake inhibitors (SSRIs) observed increased risk of gastrointestinal bleeding.
For patients with mild to moderate renal impairment the maximum recommended daily dose is 12 mg divided in 2 or 3 doses.
For patients with moderate hepatic impairment the maximum recommended daily dose is 12 mg divided in 2 or 3 doses.
In concomitant administration of lornoxicam and sulphonylureas observed increased risk of hypoglycaemia.
NSAIDs may enhance the effects of anti-coagulants, such as warfarin. Careful monitoring of INR should be undertaken.
NSAIDs increase the risk of spinal or epidural haematoma when given concomitantly to heparin in the context of spinal or epidural anaesthesia.
In concomitant administration of lornoxicam and anti-platelet agents observed increased risk of gastrointestinal bleeding.
In concomitant administration of lornoxicam and loop diuretics, thiazide diuretics, and potassium sparing diuretics observed decreased diuretic and antihypertensive effect of loop diuretics, thiazide diuretics, and potassium sparing diuretics.
In concomitant administration of lornoxicam and beta-adrenergic blockers observed decreased antihypertensive efficacy.
In concomitant administration of lornoxicam and ACE inhibitors, the antihypertensive effect of the ACE inhibitor may decrease.
In concomitant administration of lornoxicam and angiotensin II receptor blocker observed decreased antihypertensive efficacy.
In concomitant administration of lornoxicam and quinolone antibiotics observed increased risk of seizures.
In concomitant administration of lornoxicam and NSAIDs observed increased risk of gastrointestinal bleeding.
In concomitant administration of lornoxicam and ciclosporine observed increased serum concentration of cyclosporine. Nephrotoxicity of cyclosporine may be enhanced via renal prostaglandin mediated effects. During combined treatment renal function should be monitored.
In concomitant administration of lornoxicam and cimetidine observed increased plasma concentrations of lornoxicam.
In concomitant administration of lornoxicam and digoxin observed decreased renal clearance of digoxin.
NSAIDs inhibit renal clearance of lithium, thus the serum concentration of lithium may increase above toxicity limits. Therefore serum lithium levels require monitoring, especially during initiation, adjustment and withdrawal of treatment.
In concomitant administration of lornoxicam and methotrexate observed increased serum concentration of methotrexate. Increased toxicity may result. When concomitant therapy has to be used careful monitoring should be undertaken.
NSAIDs may reduce renal clearance of pemetrexed resulting in increased renal and gastrointestinal toxicity, and myelosuppression.
In concomitant administration of lornoxicam and phenprocoumon observed decreased effect of phenprocoumon treatment.
In concomitant administration of lornoxicam and tacrolimus observed increase the risk of nephrotoxicity owing to reduced synthesis of prostacyclin in the kidney. During combined treatment renal function should be monitored.
Caution is required if administered to patients suffering from, or with a previous history of, bronchial asthma since NSAIDs have been reported to precipitate bronchospasm in such patients.
Exceptionally, varicella can be at the origin of serious cutaneous and soft tissues infectious complications. To date, the contributing role of NSAIDs in the worsening of these infections cannot be ruled out. Thus, it is advisable to avoid use of lornoxicam in case of varicella.
In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis.
Lornoxicam is contraindicated on the third trimester of pregnancy and should not be used during pregnancy in the first and second trimesters and delivery, as no clinical data on exposed pregnancies are available.
There are no adequate data from the use of lornoxicam in pregnant women. Studies in animals have shown reproductive toxicity.
Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation after use of a prostaglandin synthesis inhibitor in early pregnancy. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post implantation loss and embryo-foetal lethality. During the first and second trimester of pregnancy, prostaglandin synthesis inhibitors should not be given unless clearly necessary.
Prostaglandin synthesis inhibitors administered during the third trimester of pregnancy may expose the foetus to cardiopulmonary toxicity (premature closure of the ductus arteriosus and pulmonary hypertension) and renal dysfunction which may lead to renal failure and hence a reduced quantity of amniotic fluid. At the end of pregnancy, prostaglandin synthesis inhibitors may expose the mother and the foetus to increased bleeding time and inhibition of uterine contractions, which may delay or prolong the labour. Therefore, the use of lornoxicam is contraindicated during the third trimester of pregnancy.
There are no data on the excretion of lornoxicam in human breast milk. Lornoxicam is excreted in milk of lactating rats in relatively high concentrations. Therefore lornoxicam should not be used in breastfeeding women.
Patients showing dizziness and/or sleepiness under treatment with lornoxicam should refrain from driving or operation machinery.
The most commonly observed adverse events of NSAIDs are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease have been reported following administration of NSAIDs. Less frequently, gastritis has been observed.
Approximately 20% of patients treated with lornoxicam can be expected to experience adverse reactions. The most frequent adverse effects of lornoxicam include nausea, dyspepsia, indigestion, abdominal pain, vomiting, and diarrhoea. These symptoms have generally occurred in less than 10% of patients in available studies.
Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment.
Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with an increased risk of arterial thrombotic events (for example myocardial infarction or stroke).
Exceptionally, occurrence of serious cutaneous and soft tissues infectious complications during varicella.
Listed below are undesirable effects, which generally occurred in more than 0.05% of the 6,417 patients treated in clinical phase II, III and IV trials.
Very common (≥1/10); Common (≥1/100, <1/10); Uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); Very rare (<1/10,000), not known (cannot be estimated from the available data).
Rare: Pharyngitis.
Rare: Anaemia, thrombocytopenia, leucopoenia, prolonged bleeding time.
Very rare: Ecchymosis. NSAIDs have been reported to cause potentially severe hematological disorders like neutropenia, agranulocytosis, aplastic anaemia, and hemolytic anaemia as class effects.
Rare: Hypersensitivity, anaphylactoid reaction and anaphylaxis.
Uncommon: Anorexia, weight changes.
Uncommon: Insomnia, depression.
Rare: Confusion, nervousness, agitation.
Common: Mild and transient headache, dizziness.
Rare: Somnolence, paraesthesia, dysgeusia, tremor, migraine.
Very rare: Aseptic meningitis in patients with SLE and mixed connective tissue disorder.
Uncommon: Conjuctivitis.
Rare: Visual disturbances.
Uncommon: Vertigo, tinnitus.
Uncommon: Palpitations, tachycardia, oedema, cardiac failure.
Uncommon: Flushing, oedema.
Rare: Hypertension, hot flush, haemorrhage, haematoma.
Uncommon: Rhinitis.
Rare: Dyspnoea, cough, bronchospasm.
Common: Nausea, abdominal pain, dyspepsia, diarrhoea, vomiting.
Uncommon: Constipation, flatulence, eructation, dry mouth, gastritis, gastric ulcer, abdominal pain upper, duodenal ulcer, mouth ulceration.
Rare: Melaena, haematemesis, stomatitis, oesophagitis, gastrooesophageal reflux, dysphagia, aphthous stomatitis, glossitis, perforated peptic ulcer, gastrointestinal haemorrhage.
Uncommon: Increase in liver function tests, SGPT (ALT) or SGOT (AST).
Very rare: Hepatotoxicity resulting in e.g. hepatic failure, hepatitis, jaundice and cholestasis.
Uncommon: Rash, pruritus, hyperhidrosis, rash erythematous, urticaria and angioedema, alopecia.
Rare: Dermatitis and eczema, purpura.
Very rare: Oedema and bullous reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis
Uncommon: Arthralgia.
Rare: Bone pain, muscle spasms, myalgia.
Rare: Nocturia, micturition disorders, increase in blood urea nitrogen and creatinine levels.
Very rare: Lornoxicam may precipitate acute renal failure in patients with pre-existing renal impairment, who are dependent on renal prostaglandins for maintenance of renal blood flow. Nephrotoxicity in various forms including nephritis and nephrotic syndrome has been associated with NSAIDs as class effect.
Uncommon: Malaise, face oedema.
Rare: Asthenia.
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