Oxira Tablets / Film-coated
Lornoxicam
8mg
SAUDI PHARMACEUTICAL INDUSTRIES & MEDICAL APPLIANCES CORPORATION (SPIMACO ADDWAEH)
| Pack size | 20's (10's Blister x 2) |
|---|---|
| Dispensing mode | POM |
| Source | SAUDI ARABIA |
| Agent | CITY MEDICAL STORE |
| Retail Price | 9.50 AED |
Indications
Oxira Tablets / Film-coated is used for:
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
Adult Dose
Adverse effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms. Adjust dose based on the individual response to treatment
Mild to moderate pain associated with inflammation, by mouth, ADULT, 8-16 mg daily to be given in 2-3 divided doses. Maximum recommended daily dose is 16 mg.
Osteoarthritis and Rheumatoid arthritis, by mouth, ADULT, initially 12 mg daily in 2 or 3 divided doses; may increase up to a max. 16 mg daily based on individual response and tolerance.
ELDERLY: No special dosage modification but caution as they are more likely to suffer gastrointestinal and other adverse effects.
Moderate hepatic impairment: Maximum recommended daily dose is 12 mg divided in 2 or 3 doses
Child Dose
Children and adolescents (<18 years): Not recommended due to a lack of data on safety and efficacy
Renal Dose
Mild to moderate renal impairment: Maximum recommended daily dose is 12 mg divided in 2 or 3 doses.
Moderate hepatic impairment: Maximum recommended daily dose is 12 mg divided in 2 or 3 doses.
Administration
For Oral use.
Administer whole, do not crush nor split tablet; may give with food or milk to minimize GI distress.
Give with a full glass of water to enhance absorption, keep patient upright for 30 mins
Contra Indications
Hypersensitivity to lornoxicam or to any of the excipients, to aspirin or other NSAIDs
History of attacks of asthma, angioedema, urticaria, or acute rhinitis precipitated by acetylsalicylic acid or other NSAIDs
Thrombocytopenia
Severe heart failure.
Active gastric or intestinal ulcer, bleeding or perforation
Severe hepatic impairment
Severe renal impairment (Serum creatinine >700 µmoL/L)
The third trimester of pregnancy
Precautions
History of peptic ulcer, unexplained GI disorders, asthma, seasonal allergic rhinitis, chronic pulmonary diseases, elderly, impaired renal or hepatic function (including porphyria), ulcerative colitis or Crohn’s disease;
Avoid use with other systemic NSAIDs including COX-2 inhibitors;
Risks of GI bleeding, perforation or serious allergic reactions (Discontinue immediately at the earliest signs or symptoms);
Increased risk of bleeding when used concomitantly with corticosteroids, anticoagulants, anti-platelets agents or SSRIs;
Consider co-administration with gastro-protective agents (e.g. PPI, H2RA) in patients with history of ulcer, elderly, and those requiring low-dose aspirin;
First and second trimesters of pregnancy, breastfeeding;
Liver function tests, blood counts recommended during prolonged therapy;
Renal function tests recommended in patients with history of hypertension, impaired cardiac or renal function, extracellular volume depletion, the elderly, patients treated with diuretics or drugs that impact renal function; Monitor for fluid retention and oedema;
Lornoxicam reduces platelet aggregation and prolongs bleeding time. Caution when used in patients with increased bleeding tendency.
May impair female fertility as with other NSAIDs; consider discontinuing in women who have difficulties conceiving
Advise patients who experience visual disturbances, dizziness, vertigo, somnolence, CNS disturbances, drowsiness, or fatigue while taking NSAIDs to avoid driving or operating machinery
Pregnancy-Lactation
Recommendations on the use of Lornoxicam in Pregnancy & Lactation:
Exposure to NSAIDs after 30 weeks' gestation is associated with an increased risk of premature closure of the fetal ductus arteriosus, oligohydramnios, and other fetal and neonatal adverse effects. NSAIDs should be given in pregnancy only if the maternal benefits outweigh the potential fetal risks, at the lowest effective dose and for the shortest duration possible (Antonucci et al., 2012). There is limited experience with the use of Lornoxicam during pregnancy and lactation. It should be used if benefit outweighs the risk but should be avoided in the 3rd trimester because of the risk of premature closure of the ductus arteriosus (Schaefer et al., 2015).
References:
1. Antonucci, R., Zaffanello, M., Puxeddu, E., Porcella, A., Cuzzolin, L., Pilloni, M. D., & Fanos, V. (2012). Use of non-steroidal anti-inflammatory drugs in pregnancy: Impact on the fetus and newborn. Current Drug Metabolism, 13(4), 474–490. https://doi.org/10.2174/138920012800166607
2. Schaefer, C., Peters, P., & Miller, R. K. (2015). Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment (Third Edition). Academic Press
Interactions
Other NSAIDs, corticosteroids, anticoagulants & antiplatelet agents, SSRIs: Co-administration of NSAIDs including lornoxicam with any of these drugs can increase the risk of GI bleeding;
Diuretics or antihypertensive agents (e.g. beta-blockers, ACE inhibitors): Concomitant use of NSAIDs including lornoxicam may cause a decrease in their antihypertensive effect;
Potent CYP2C9 inhibitors (e.g. sulfinpyrazone, voriconazole): Significant increase in peak plasma levels and exposure to lornoxicam due to inhibition of its metabolism;
CYP2C9 inducers (e.g. rifampicin): Significant decrease in plasma levels and exposure to lornoxicam.
Digoxin, Lithium and Phenytoin: Lornoxicam may raise plasma levels of these drugs
Methotrexate: Administration of NSAIDs less than 24 hours before or after treatment with methotrexate may cause increased plasma levels and risk of toxicity of MTX;
Cyclosporin and Tacrolimus: Concomitant use of NSAIDs may increase the nephrotoxicity of cyclosporin and tacrolimus due to the effect on renal prostaglandins;
Oral antidiabetic agents: Concomitant use of lornoxicam may cause hypoglycaemia or hyperglycaemia; monitor blood sugar levels and adjust antidiabetic dosages as needed
Adverse Effects
Side effects of Lornoxicam :
Common side effects are mainly gastrointestinal including nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, decreased appetite; Headache, dizziness, vertigo, rash.
Rarely gastritis, GI ulcer with or without bleeding, haematemesis, melaena, haemorrhagic diarrhoea; Asthma (including dyspnoea); Ulcerative stomatitis, exacerbation of colitis and Crohn’s disease; Oedema; Myocardial infarction, cardiac failure, palpitations, chest pain (risk is greater with prolonged use and at high doses); Hypersensitivity, anaphylactic and anaphylactoid reactions (including hypotension and shock)
Mechanism of Action
Note
Oxira 8mg Tablets / Film-coated manufactured by SAUDI PHARMACEUTICAL INDUSTRIES & MEDICAL APPLIANCES CORPORATION (SPIMACO ADDWAEH). Its generic name is Lornoxicam. Oxira is availble in United Arab Emirates.
Farmaco UAE drug index information on Oxira Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.