Download XEFO® HIKMA PHARMACEUTICALS

09-15
XEFO®
HIKMA PHARMACEUTICALS
Lornoxicam
Action
Xefo is a potent new non-steroidal anti-inflammatory
drug (NSAID) with antirheumatic and strong analgesic properties originally developed by Nycomed
Pharmaceuticals. Xefo is rapidly and completely
absorbed from the gastrointestinal tract with peak
plasma levels occuring within half an hour after oral
administration. Unlike other oxicam drugs, Xefo is
characterized by its short half-life which is 4 hours.
Dosage in patients with impaired renal and hepatic
function: the recommended maximum daily dose is
12 mg to be given in divided doses.
Contraindications
Known hypersensitivity to Lornoxicam or any of the
excipients, peptic ulcer including those associated
with bleeding, and liver cirrhosis, haemorrhagic diathesis, blood coagulation disorders or at operations
bearing risks of bleeding or incomplete haemostasis, cerebral haemorrhage, severely impaired heart
function and moderately to severely impaired renal
function. Like other NSAIDs, Lornoxicam is contraindicated in asthmatic patients in whom attacks of
asthma, urticaria or acute rhinitis have been precipitated by aspirin or other NSAIDs.
Indications
Xefo Is indicated for the relief of mild to moderate
pain and inflammation in rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, painful post-traumatic and post-operative inflammation and swelling
(e.g. following dental surgery), painful syndromes Warnings
of vertebral column (e.g. low back pain) and acute There are no adequate and well-controlled studies
lumbo sciatica.
in pregnant women.
Dosage and administration
Safety of the use of Lornoxicam during pregnancy,
Mild to moderate pain associated with inflamma- lactation and in patients under 18 years has not yet
tion: the recommended dosage is 8-16 mg/day to be been established.
given in 2-3 divided doses.
Precautions
Rheumatic joint diseases: the recommended dosLornoxicam should be used cautiously in patients
age is 12-16 mg/day to be given in 2-3 divided
doses. In long-term therapy, Moderate postopera- with a history of gastrointestinal disease or bleetive pain: Xefo should be given either I.V. or I.M. in ding, patients with severe heart failure, patients with
doses of 8 mg, and the daily dose should not exceed severe hepatic or renal disease and in patients with
16 mg in general. In some patients a further 8 mg systemic lupus erythematosus.
given within the first 24 hours could be needed, Interactions
increasing the maximal allowed dose on the first Caution should be exercised in patients who are taktreatment day to 24 mg, a dose higher than doctor ing the following:
recommendation will not increase the effect of Xefo • Diuretics - as diuretic effect might be decreased
but may on the contrary cause side effects.
especially loop diuretics.
The solution for injection is prepared by dissolving • Anticoagulant - as the bleeding time might be prothe content of one vial in water for injection from the longed.
accompanying ampoule, immediately prior to use.
• Oral antidiabetic - as the hypoglycemic effect might
The time for injection should be at least over 15 sec- be increased.
onds and 5 seconds for I.V. and I.M., respectively.
• Beta blockers, lithium, cimetidine.
N.B: Lornoxicam has shown compatibility with 0.9% • ACE Inhibitors - as the effect of the ACE-inhibitor
might be decreased.
NaCI, 5% dextrose (glucose) and Ringer’s solution.
HIKMA-XEFO - p.1/2
HIKMA-XEFO - p.2/2
• Other NSAIDs - as the risk of adverse reactions
might be increased.
• Like other NSAIDs, Lornoxicam may elevate
Digoxin, Methotrexate, and Cyclosporine’s serum
levels, so caution should be exercised.
Side effects
Lornoxicam is generally well tolerated. The common side effects are GI upset, dyspepsia and injection site reactions (pain, redness, stinging, tension).
In rare cases, some adverse effects have been
reported such as headache, dizziness, GI disorders
like nausea and vomiting, hematological disorders
like anemia, dermatological disorders like itching
and allergic skin reactions, perception disorders like
tingling, visual disturbances and in isolated cases
hematological disturbances, weight gain and disturbances in urine output.
Overdosage
There is no specific antidote. In case of overdose,
discontinue the administration of the medicament
and emptying the stomach via induction of emesis
(in alert patients only) or gastric lavage should be
exercised followed by the administration of activated
charcoal and instituting symptomatic and other supportive treatment as necessary.
Presentation
Tablets
Xefo 4 mg:Lornoxicam 4 mg/ tablet
Xefo 8 mg:Lornoxicam 8 mg/ tablet
Vials
Xefo: Lornoxicam (lyophilized) 8 mg/ 2 ml*
*after reconstitution.