Lornoxicam

Registered South African indications:

• Pain - mild to moderate
• Osteoarthritis and rheumatoid arthritis
  - Symptomatic treatment of pain and inflammation

Contraindications

• Hypersensitivity to lornoxicam or to any excipients
• Patients who have suffered hypersensitivity reactions (bronchospasm, rhinitis, angioedema, or urticaria) to other non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid
• Patients with a history of gastrointestinal bleeding or perforation related to previous NSAID use (fct)
• Patients who suffer from cerebrovascular bleeding
• Patients with bleeding and coagulation disorders
• Patients with active peptic ulcer or a history of recurrent peptic ulceration/haemorrhage/perforations
• Severe liver impairment
• Severe renal impairment (serum creatinine >700μmol/L or creatinine clearance <30ml/min)
• Thrombocytopenia
• Heart failure
• The elderly (>65 years)
• Body weight less than 50kg (fct)
• Undergoing acute surgery (fct)
• Patients under 18 years of age
• Pregnancy
• Lactation
• Hypovolaemia or dehydration

Cautions

• Mild to moderate renal impairment
• Mild to moderate hepatic impairment
• History of gastrointestinal bleeding or perforation or ulcers
• History of gastrointestinal disease 
• Previous cerebrovascular haemorrhage 
• Systemic lupus erythematosus 
• Haematopoietic disorders 
• History of hypertension and/or heart failure/reduced cardiac function 
• Risk of serious skin reactions 

Forms avail. in SA and covered in this monograph: fct, rapid fct, inj

Pain - mild to moderate

• Oral (fct): 8-16mg/day in 2-3 divided doses; Max: 16mg/24hrs
• IM/IV/Oral (rapid fct): Given in doses of 8mg; In some patients a further 8mg given within the first 24hrs could be needed; Max: 16mg/24hrs (in general)

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Admin. slowly over not less than 15sec as an IV inj. and over not less than 5sec as an IM inj  

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The rapid film-coated tablet should be used for short term treatment of mild to moderate pain, where intra-muscular use is inappropriate (not exceeding 72 hours)

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Osteoarthritis
Rheumatoid arthritis
- Symptomatic treatment of pain and inflammation

• Oral (fct): Initial total daily dose: 12mg, in 2-3 divided doses; Max: 16mg/24hrs

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For all patients the appropriate dosing regimen should be based upon individual response to treatment. Use the lowest effective dose for the shortest possible duration of treatment

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Tablets are supplied for oral administration and should be taken before meals with a sufficient quantity of liquid

Not established for use in children below 18 years

Pregnancy 

• Contraindicated

Breastfeeding 

• Contraindicated
• There are no data on the excretion of lornoxicam in human breast milk. Lornoxicam is excreted in the milk of lactating rats in relatively high concentrations. Therefore lornoxicam should not be used, in breastfeeding women

Renal Impairment 

• Mild to moderate: Caution; dose adjustment recommended
• Severe: Contraindicated

Renal Impairment	Dose
Mild to Moderate	Max: 12mg/day, in 2-3 divided doses
Severe	Contraindicated

Hepatic Impairment 

• Moderate: Caution; dose adjustment recommended
• Severe: Contraindicated

Hepatic Impairment	Dose
Mild	No adjustment necessary
Moderate	Max: 12mg/day, in 2-3 divided doses
Severe	Contraindicated

Elderly 

• >65 years: Contraindicated

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings 

Central Nervous System Disorders

• Depression
• Insomnia
• Migraine
• Paraesthesia
• Tremor
• Dizziness
• Somnolence

Cardiovascular Disorders

• Palpitations
• Tachycardia
• Changes in blood pressure

Respiratory Disorders

• Dyspnoea
• Symptoms of irritation in upper respiratory tract

Gastrointestinal Disorders

• Abdominal pain
• Diarrhoea
• Dyspepsia
• Nausea and vomiting
• Flatulence
• Dysphagia
• Constipation
• Gastritis
• Dry mouth
• Stomatitis
• Gastro-esophageal reflux
• Peptic ulceration with or without bleeding
• Esophagitis
• Haemorrhoidal
• Rectal bleeding

Hepatobiliary Disorders

• Increased transaminases

Genitourinary Disorders

• Micturition disorders

Endocrine and Metabolic

• Changes in appetite
• Increased sweating
• Loss of weight
• Increased weight 

Musculoskeletal Disorders

• Cramps in leg
• Myalgia

Skin and Subcutaneous Tissue Disorders

• Allergic skin reactions 
• Loss of hair

Immune, Blood and Lymphatic Disorders

• Anaemia
• Ecchymosis
• Prolonged bleeding time
• Thrombocytopenia

Sensory Disorders

• Conjunctivitis
• Vision disorders
• Tinnitus
• Taste perversion

Others

• Oedema
• Debility

• Anticoagulants 
• Platelet aggregation inhibitors
• Selective serotonin reuptake inhibitors
• Sulphonylureas
• Non-steroidal anti-inflammatories 
• Aspirin
• Diuretics
• Angiotensin-converting enzyme inhibitors
• Lithium
• Methotrexate
• Cimetidine
• Digoxin
• Cyclosporin
• CYP2C9 inducers and inhibitors
• Corticosteroids

None routine. Specific cases may require

• Renal function  
• Hepatic function  
• Full blood count
• Coagulation profiles

Inhibits prostaglandin synthesis by inhibition of cyclooxygenase.

Tablet 4mg

• Xefo (Litha Pharma) originator

Tablet 8mg

• Xefo (Litha Pharma) originator

Tablet 8mg

• Xefo Rapid (Litha Pharma) originator

Injection (per 2ml) 8mg

• Xefo (Litha Pharma) originator