Laxico

Oval shape, white to yellowish oblong film-coated tablet with imprint "L8" on one side and plain on other side.
Each film-coated tablet contains: Lornoxicam 8 mg.
Excipients/Inactive Ingredients: Lactose, microcrystalline cellulose, povidone, croscarmellose sodium, magnesium stearate, opadry white 03F58750 and purified water.

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids. Oxicams. Lornoxicam. ATC code: M01AC05.
Pharmacology: Pharmacodynamics: Lornoxicam is a non-steroidal anti-inflammatory drug with analgesic properties and belongs to the class of oxicams. Lornoxicam's mode of action is partly based on inhibition of the prostaglandin synthesis (inhibition of the cyclooxygenase enzyme). The inhibition of cyclooxygenase does not result in an increase in leukotriene formation. The mechanism of the analgesic action of lornoxicam, as well as that of other NSAIDs, has not yet been fully determined.
Pharmacokinetics: Lornoxicam is absorbed rapidly and almost completely from the gastrointestinal tract. Maximum plasma concentrations are achieved after approximately 1 to 2 hours. The absolute bioavailability (calculated on AUC) of Lornoxicam (Laxico) Tablet is 90-100%. No first-pass effect was observed. The mean elimination half-life is 3 to 4 hours. Lornoxicam is found in the plasma in unchanged form and as its hydroxylated metabolite. The hydroxylated metabolite exhibits no pharmacological activity.
The plasma protein binding of lornoxicam is 99% and not concentration dependent. Lornoxicam is metabolized completely, and approximately ²/₃ is eliminated via the liver and ¹/₃ via the kidneys as inactive substance.
Lornoxicam is metabolized by cytochrome P450 2C9. Due to genetic polymorphism slow and rapid metabolisers exist for this drug, which could result in markedly increased plasma levels of lornoxicam in slow metabolisers.
Simultaneous intake of lornoxicam with meals reduced Cmax by approximately 30%. Tmax was increased from 1,5 to 2,3 hours. The absorption of lornoxicam (calculated on AUC) can be reduced up to 20%.
Simultaneous intake with antacids has no effect on the pharmacokinetics of lornoxicam. In elderly subjects, the clearance is reduced by 30 to 40%. Apart from this reduced clearance there is no significant change in the kinetic profile of lornoxicam in elderly patients, or in patients with mild hepatic or kidney dysfunction.

Lornoxicam (Laxico) tablet is indicated for short-term relief of acute mild to moderate pain.
Also indicated in symptomatic relief of pain and inflammation in osteoarthritis & rheumatoid arthritis.

Dosage: With a moderate or significant pain syndrome, a dose of 8-16 mg per day, divided into 2-3 doses, is recommended.
In inflammatory and degenerative rheumatic diseases, an initial dose of 12 mg is recommended, divided into 2-3 doses.
The maximum daily dose should not exceed 16 mg per day.
The daily dose and duration of therapy are determined individually, depending on the nature and course of the disease.
In elderly patients (over 65 years of age), dose adjustment is not required, but caution should be used with Lornoxicam (Laxico) Tablet because of the likelihood of side effects of gastrointestinal tract.
For patients with moderate to severe renal failure, severe hepatic insufficiency, the recommended daily dose is 12 mg, which is divided into 2-3 doses.
Mode of administration: Oral.

Convulsions, change in liver and kidney function, maybe coagulation disorders.
Treatment: Symptomatic.
Lornoxicam is not dialyzable. There is no specific antidote. Gastric lavage is recommended. The use of activated charcoal, provided it is taken immediately after an overdose of Lornoxicam (Laxico) Tablet, can reduce the absorption of the drug.

Hypersensitivity to the active substance or to any of the excipients.
Pregnancy and lactation.
Under 18 years of age.
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/hemorrhage (two or more distinct episodes of proven ulceration or bleeding).
Severe hepatic impairment.
Severe renal impairment (Serum creatinine > 700 μmol/l).

Care should be taken and after careful analysis, the drug should be used for patients with hypertension and/or heart failure, because due to NSAID use, edema and fluid retention in the body are possible.
Patients with uncontrolled arterial hypertension, congestive heart failure, coronary heart disease, cerebrovascular disorders, as well as patients with elevated risk factors for cardiovascular disease (hypertension, hyperlipidemia, diabetes, smoking) should be treated after careful analysis.
Concomitant use of NSAIDs and heparin increases the risk of spinal/epidural hematoma with spinal or epidural anesthesia.
Due to intake of NSAIDs, especially at the beginning of treatment, in rare cases serious skin adverse reactions, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, were noted. Treatment with the drug should be discontinued at the first appearance of symptoms (skin rashes, lesions of the mucous membranes and other sign of hypersensitivity).
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.
In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis.
Lornoxicam inhibits platelet aggregation, increasing clotting time. The drug should be administered with caution to patients who are prone to bleeding.
Co-administration of NSAIDs and tacrolimus may increase the risk of nephrotoxicity due to impaired prostacyclin synthesis in the kidneys. With this combination therapy, it is a need to carefully monitor the kidney function.
Like other NSAIDs, lornoxicam can cause occasional increases in transaminases, serum bilirubin, and an increase in the concentration of urea and creatinine in the blood. Should any such abnormality prove significant or persist the administration of Lornoxicam (Laxico) Tablet should be stopped and appropriate investigations prescribed.
Patients who have a rare hereditary intolerance to galactose, lactase deficiency, or impaired absorption of glucose-galactose should not use the drug.
It is advisable to avoid use of lornoxicam in case of varicella.
Patients with blood coagulation disorders: Careful clinical monitoring and laboratory assessment is recommended (e.g. APTT), as lornoxicam decreases aggregation of thrombocytes, increasing bleeding time.
Long term treatment (longer than 3 months): Regular laboratory assessments of haematology (haemoglobin), renal functions (creatinine) and liver enzymes are recommended.
Effects on ability to drive and use machines: Patients who experience dizziness or other central nervous disturbances while taking NSAIDs should refrain from driving or operating machinery.
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.
Use in Pregnancy & Lactation: Lornoxicam, like other drugs that inhibit the synthesis of cyclooxygenase, can weaken fertility. It is not recommended in women attempting to conceive.
Use in the Elderly: 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 minimized by using lowest effective dose. GI bleeding, ulceration or perforation, which can be fatal, during treatment with NSAIDs.
Care should be taken to use Lornoxicam tablets to treat patients taking drugs that increase the risk of ulcers and bleeding (see Interactions).
For patients who need co-therapy, treatment can be performed against a background of simultaneous administration of proton pump inhibitors and close monitoring.
In elderly patients, the risk of adverse reactions increases during the administration of NSAIDs, in particular gastrointestinal bleeding and perforation. If any adverse reactions occur on the part of the digestive tract, stop taking the medication and consult a doctor.

Pregnancy: Lornoxicam should not be used as clinical experience is lacking. The safety of Lornoxicam during pregnancy and lactation has not been established and the drug should therefore not be given in these conditions.
Lactation: No clinical data is currently available on the possible passage of lornoxicam into mother's milk. However preclinical data has shown that lornoxicam was found in animal's milk (in rat lornoxicam levels are approx. 30% of those in the maternal circulation).

It is estimated that about 20% of patients may experience side effects. The most frequent adverse reactions that are common to all other non-steroidal anti-inflammatory drugs are associated with gastrointestinal disorders: gastrointestinal ulcers with intestinal perforation that can be severe, nausea, vomiting with blood, diarrhea, flatulence, constipation, dyspepsia, pain abdomen, melena, ulcerative stomatitis, exacerbation of colitis and Crohn's disease. Gastritis was less common.
The following adverse effects may occur with lornoxicam tablets: Common (≥1/100, 1/10): Mild short-term headache, dizziness, nausea, abdominal pain, indigestion, diarrhea, vomiting.
Uncommon (≥1/1,000, 1/100): Loss of appetite, weight changes, insomnia, depression, conjunctivitis, vertigo, tinnitus, palpitations, tachycardia, swelling, fluid retention, heart failure, redness of the face, rhinitis, constipation, flatulence, belching, dry mouth, gastritis, stomach and duodenal ulcers, abdominal pain, gum bleeding, ulcerative stomatitis, increase in serum transaminase levels (ALT, AST), rashes, itching, increased sweating, erythematous rashes, urticaria and angioedema, al petsiya, arthralgia, malaise, swelling of the face.
Rare (≥1/10,000, 1/1,000): Pharyngitis, anemia, thrombocytopenia, eosinophilia, leukopenia, coagulation disorder, pancytopenia, hypersensitivity reactions, fever, chills, anaphylactoid reactions, anaphylaxis, hyponatremia, anxiety, impaired consciousness, increased excitability, impaired ability to concentrate, changes in attention, cognitive disorders, drowsiness, paresthesia, dysgeusia, tremor, migraine, hyperkinesia, hypoesthesia, visual impairment, including blurring of vision, changes of color perception, visual field defects, scotoma, amblyopia, diplopia, iridocyclitis, arterial hypertension, hot flashes, venostasis, vasculitis, hematomas, dyspnoea, cough, bronchospasm, melena, vomiting with blood, stomatitis, esophagitis, gastroesophageal reflux disease, dysphagia, aphthous stomatitis, glossitis, perforation of peptic ulcers, hemorrhoids, gastrointestinal bleeding, dermatitis, eczema, maculopapular rash, purpura, pain sensation in the bones and back, muscle spasms, muscle weakness, myalgia, synovitis, nocturia, urinary disorders, increased urea and creatinine in the blood, asthenia.
Very rare (˂1/10,000): Ecchymosis, aseptic meningitis in patients with systemic lupus erythematosus and mixed connective tissue diseases, toxic effects on the liver, resulting in the development of hepatic insufficiency, hepatitis, jaundice, cholestasis, edema and bullous reactions, nail changes, psoriasis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, lornoxicam can cause acute renal failure in patients with pre-existing kidney disease.
Seek medical attention immediately at the first sign of any adverse drug reaction shall appear.

Cimetidine: Increased plasma concentrations of lornoxicam. (No interaction between lornoxicam and ranitidine, or lornoxicam and antacids has been demonstrated).
Anti-coagulants: NSAIDs may enhance the effects of anti-coagulants, 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, 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.
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 (e.g. glibenclamide): 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.
Tacrolimus: Increase the risk of nephrotoxicity owing to reduced synthesis of prostacyclin in the kidney. During combined treatment renal function should be monitored.
Pemetrexed: NSAIDs may reduce renal clearance of pemetrexed resulting in increased renal and gastrointestinal toxicity, and myelosuppression.

Store at temperatures not exceeding 30°C.
Shelf Life: 36 months.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M01AC05 - lornoxicam ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, oxicams.

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