Description

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Xloritom 8 mg powder and solvent for solution for injection.

QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 8 mg lornoxicam. Provides 4 mg lornoxicam per ml when reconstituted as recommended. For excipients, see section 6.1.
3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. Powder: Yellow solid substance. Solvent: Clear solution.
4. CLINICAL PARTICULARS 4.1 Therapeutic indications Short term treatment of moderate postoperative pain.

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Posology and method of administration

For all patients the appropriate dosing regimen should be based upon individual response to treatment. Xloritom 8 mg powder for injection has to be dissolved in 2 ml water for injection prior to injection. The pH of the reconstituted solution is about 8.7. The osmolarity of the reconstituted solution is about 328 mosmol/kg. The route of administration is intravenous (i.v.) or intramuscular injection. When given as i.v. injection, the time of injection should be at least 15 seconds, and for i.m. injection, at least 5 seconds. Lornoxicam should be given in doses of 8 mg, and the daily dose should in general not exceed 16 mg. Some patients may need a further 8 mg dose within 24 hours, increasing the maximal allowed dose on the first treatment day to 24 mg. The treatment should be limited to 2 days: if necessary treatment can be continued with tablets. After preparation of the solution, the needle should be changed. For i.m. injection a sufficiently long needle for a deep intramuscular injection. For further instructions on handling of the product before administration, see section 6.1. The medicinal product is for single use only. Additional information on special populations Children and adolescents Lornoxicam is not recommended for use in children and adolescents below age 18 due to a lack of data on safety and efficacy. Elderly No special dosage modification is required for elderly patients above age 65 unless renal or hepatic function is impaired. Lornoxicam should be administered with precaution as gastrointestinal adverse effects are less well tolerated in this group . –Renal impairment For patients with mild to moderate renal impairment dose reduction should be considered.
–Hepatic impairment For patients with moderate hepatic impairment dose reduction should be considered . Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.

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Contraindications

Xloritom must not be administered in the following groups of patients:
– Hypersensitivity to lornoxicam or any of the excipients
– Hypersensitivity (symptoms like asthma, rhinitis, angioedema or urticaria) to other NSAIDs including acetylsalicylic acid
– Thrombocytopenia
– Gastrointestinal bleeding, cerebrovascular bleeding or other bleeding disorders
– History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy
– Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding)
– Severe renal impairment (serum creatinine > 700 μmol/L)
– Severe hepatic impairment
– Severe heart failure
– The third trimester of pregnancy

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Special warnings and special precautions for use

For the following disorders, Xloritom should only be administered after careful risk-benefit assessment:
– Renal impairment: Lornoxicam should be administered with precaution in patients with mild (serum creatinine 150-300 μmol/L) to moderate (serum creatinine 300-700 μmol/L) renal impairment due to dependency on renal prostaglandins for maintenance of renal blood flow. Treatment with lornoxicam should be discontinued if renal function deteriorates during treatment. Renal functions should be monitored in patients who undergo major surgery, with cardiac failure, receiving treatment with diuretics, receiving concomitant treatment with drugs that are suspected to or known to be able to cause kidney damage.
– Hepatic impairment (e.g. liver cirrhosis): Clinical monitoring and laboratory assessments at regular intervals should be considered in patients with hepatic impairment as accumulation of lornoxicam (increase in AUC) may occur after treatment with daily doses of 12-16 mg. Apart from that, hepatic impairment does not seem to affect pharmacokinetic parameters of lornoxicam as compared to healthy subjects.
– Patients with blood coagulation disorders: Careful clinical monitoring and laboratory assessment is recommended (e.g. APTT). — Long-term treatment (longer than 3 months): Regular laboratory assessments of haematology (haemoglobin), renal functions (creatinine and liver enzymes are recommended.
— Elderly patients above 65 years: Monitoring of renal and hepatic function is recommended. Precaution is advised in elderly postoperative patients

. The use of lornoxicam with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided. Undesirable effects may be minimised by using lowest effective dose for the shortest duration necessary to control symptoms . Gastrointestinal bleeding, ulceration and perforation: GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events. The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation , and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose acetylsalicylic acid or other drugs likely to increase gastrointestinal risk . Clinical monitoring at regular intervals is recommended. Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the\initial stages of treatment. Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotoninreuptake inhibitors or anti-platelet agents such as acetylsalicylic acid . When GI bleeding or ulceration occurs in patients receiving lornoxicam, the treatment should be withdrawn. NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease) as their condition may be exacerbated ). The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal .
Caution is required in patients with a history of hypertension and/or heart failure as fluid retention and oedema have been reported in association with NSAID therapy. Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy. Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long-term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). There are insufficient data to exclude such a risk for lornoxicam. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with lornoxicam after careful consideration. Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular disease e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking). Concomitant treatment with NSAIDs and heparin in the context of a spinal or epidural anaesthesia increases the risk of spinal/epidural haematoma . Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs. Patients appear to be at highest risk of these reactions early in the course of therapy,the onset of the reaction occurring in the majority of cases within the first month of treatment. Lornoxicam should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Lornoxicam reduces platelet aggregation and prolongs bleeding time and consequently care should be taken when administering to patients with increased bleeding tendency. Concomitant treatment of NSAIDs and tacrolimus may increase the risk of nephrotoxicity owing to reduced synthesis of prostacyclin in the kidney. Renal function must therefore be monitored closely

in patients receiving combination therapy. As with most NSAIDs occasional increase in serum transaminase levels, increase in serum bilirubin or other liver function parameters, as well as increases in serum creatinine and blood urea nitrogen as well as other laboratory abnormalities have been reported. Should any such abnormality prove significant or persist the administration of lornoxicam should be stopped and appropriate investigations prescribed. The use of lornoxicam, as with any drug known to inhibit cyclooxygenase/prostaglandin synthesis, may impair fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of lornoxicam should be considered.
Interaction with other medicaments and other
forms of interaction Concomitant administration of lornoxicam and
-Cimetidine: Increased plasma concentrations of lornoxicam. (No interaction between lornoxicam and ranitidine, or lornoxicam and antacids has been demonstrated).
-Anticoagulants: NSAIDs may enhance the effects of anticoagulants, such as warfarin . Careful monitoring of INR should be undertaken.
-Phenprocoumon: Decreased effect of phenprocoumon treatment.
-Heparin: NSAIDs increase the risk of spinal or epidural haematoma when given concomitantly to heparin in the context of spinal or epidural anaesthesia.
-ACE inhibitors: The antihypertensive effect of the ACE inhibitor may decrease.
-Diuretics: Decreased diuretic and antihypertensive effect of loop diuretics and thiazide diuretics. -Beta-adrenergic blockers: Decreased antihypertensive efficacy.
-Digoxin: Decreased renal clearance of digoxin.
-Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding .
-Quinolone antibiotics: Increased risk of seizures.
-Anti-platelet agents: Increased risk of gastrointestinal bleeding .
-Other NSAIDs: Increased risk of gastrointestinal bleeding.
-Methotrexate: Increased serum concentration of methotrexate. Increased toxicity may result. When concomitant therapy has to be used careful monitoring should be undertaken.
-Selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding .
-Lithium: 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.
-Cyclosporine: Increased serum concentration of cyclosporine. Nephrotoxicity of cyclosporine may be enhanced via renal prostaglandin mediated effects. During combined treatment renal function should be monitored.
-Sulphonylureas: Increased risk of hypoglycaemia.
-Known inducers and inhibitors of CYP2C9 isoenzymes: Lornoxicam (as other NSAIDs depending on the cytochrome P450 2C9 (CYP2C9 isoenzyme)) has interactions with known inducers and inhibitors of CYP2C9 isoenzymes such as tranylcypromine and rifampicin (see section 5.2 Biotransformation).
-Tacrolimus: Increase the risk of nephrotoxicity owing to reduced synthesis of prostacyclin in the kidney. During combined treatment renal function should be monitored.

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Undesirable effects

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 longterm treatment) may be associated with an increased risk of arterial thrombotic events (for example myocardial infarction or stroke).
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 (³1/10); Common (³1/100, <1/10); Uncommon (³1/1,000, <1/100); rare (³1/10,000, <1/1,000); Very rare (<1/10,000). Infections and infestations Rare: Pharyngitis. Blood and the lymphatic system disorders Rare: Anaemia, thrombocytopenia, leukopenia, prolonged bleeding time. Very rare: Ecchymosis. Immune system disorders Rare: Hypersensitivity. Metabolism and nutritional disorders Uncommon: Anorexia, weight changes. Psychiatric disorders Uncommon: Insomnia, depression. Rare: Confusion, nervousness, agitation. preNervous system disorders Common: Mild and transient headache, dizziness. Rare: Somnolence, paraesthesia, dysgeusia, tremor, migraine. Eye disorders Uncommon: Conjunctivitis Rare: Visual disturbances. Ear and labyrinth disorders Uncommon: Vertigo, tinnitus. Cardiac disorders Uncommon: Palpitations, tachycardia, oedema, cardiac failure. Vascular disorders Uncommon: Flushing, oedema. Rare: Hypertension, hot flush, haemorrhage, haematoma. Respiratory, thoracic and mediastinal disorders Uncommon: Rhinitis. Rare: Dyspnoea, cough, bronchospasm. Gastrointestinal disorders 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. Hepatobiliary disorders

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Information for Health Care Professionals

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XLORITOM (Lomoxicam Lyophilized 8mg, Injection ) – TAJ PHARMA | Xloritom 8 mg powder and solvent for solution for injection.

XLORITOM (Lomoxicam Lyophilized 8mg, Injection ) – TAJ PHARMA INDIA

XLORITOM (Lomoxicam Lyophilized 8mg, Injection )