Loxodol8 mg

Short-term relief of acute mild to moderate pain Symptomatic relief of pain and inflammation in osteoarthritis Symptomatic relief of pain and inflammation in rheumatoid arthritis.

For all patients, the appropriate dosing regimen should be based upon individual response to treatment.Pain: 8-16 mg Loxodol 8 mg daily divided into 2 or 3 doses. The Maximum recommended daily dose is 16 mg.Osteoarthritis and Rheumatoid arthritis: Initial recommended dose is 12 mg Loxodol 8 mg daily divided into 2 or 3 doses. The maintenance dose should not exceed 16 mg Loxodol 8 mg daily. Loxodol 8 mg film-coated tablets are supplied for oral use and should be taken with a sufficient quantity of liquid.Children and adolescents: Loxodol 8 mg 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, but Loxodol 8 mg 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 the maximum recommended daily dose is 12 mg divided in 2 or 3 doses.Hepatic impairment: For patients with moderate hepatic impairment the maximum recommended daily dose is 12 mg divided in 2 or 3 doses.

Cimetidine: Increased plasma concentrations of Loxodol 8 mg. (No interaction between Loxodol 8 mg and ranitidine, or Loxodol 8 mg and antacids has been demonstrated). Anti-coagulants: NSAIDs may enhance the effects of anti-coagulants, such as warfarin (see section 4.4). 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 (see section 4.4). ACE inhibitors: The antihypertensive effect of the ACE inhibitor may decrease. Diuretics: Decreased diuretic and antihypertensive effect of loop diuretics, thiazide diuretics, and potassium sparing diuretics. Beta-adrenergic blockers: Decreased antihypertensive efficacy. Angiotensin II receptor blocker: Decreased antihypertensive efficacy. Digoxin: Decreased renal clearance of digoxin. Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding (see section 4.4). Quinolone antibiotics: Increased risk of seizures. Anti-platelet agents: Increased risk of gastrointestinal bleeding (see section 4.4). 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 (see section 4.4). 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 (e.g. glibenclamide): Increased risk of hypoglycaemia. Known inducers and inhibitors of CYP2C9 isoenzymes: Loxodol 8 mg (as other NSAIDs depending on the cytochrome P450 2C9 (CYP2C9 isoenzyme)) has interactions with known inducers and inhibitors of CYP2C9 isoenzymes (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 (see section 4.4). Pemetrexed: NSAIDs may reduce renal clearance of pemetrexed resulting in increased renal and gastrointestinal toxicity, and myelosuppression.

Hypersensitivity to Loxodol 8 mg or to any of the excipients Thrombocytopenia Hypersensitivity (symptoms like asthma, rhinitis, angioedema or urticaria) to other NSAIDs including acetylsalicylic acid Severe heart failure. Gastro-intestinal 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 hepatic impairment Severe renal impairment (Serum creatinine > 700 µmol/l) The third trimester of pregnancy

Renal impairment: Loxodol 8 mg 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 Loxodol 8 mg 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.Patients with blood coagulation disorders: Careful clinical monitoring and laboratory assessment is recommended (e.g. APTT).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 Loxodol 8 mg (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 Loxodol 8 mg as compared to healthy subjects.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.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Loxodol 8 mg is a non-steroidal anti-inflammatory drug (NSAID) that belongs to the oxicam class. As with other NSAIDS, Loxodol 8 mg is a potent inhibitor of the cyclooxgenase enzymes, which are responsible for catalyzing the formation of prostaglandins (act as messenger molecules in the process of inflammation) and thromboxane from arachidonic acid. Unlike some NSAIDS, Loxodol 8 mg's inhibition of cyclooxygenase does not lead to an increase in leukotriene formation, meaning that arachidonic acid is not moved to the 5-lipoxygenase cascade, resulting in the minimization of the risk of adverse events.Like other NSAIDS, Loxodol 8 mg's anti-inflammatory and analgesic activity is related to its inhibitory action on prostaglandin and thromboxane synthesis through the inhibition of both COX-1 and COX-2. This leads to the reduction of inflammation, pain, fever, and swelling, which are mediated by prostaglandins. However, the exact mechanism of Loxodol 8 mg, like that of the other NSAIDs, has not been fully determined.

Loxodol 8 mg 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 Loxodol 8 mg in pregnant women. Studies in animals have shown reproductive toxicity. There are no data on the excretion of Loxodol 8 mg in human breast milk. Loxodol 8 mg is excreted in milk of lactating rats in relatively high concentrations. Therefore Loxodol 8 mg should not be used in breastfeeding women.