Meloxicam

Registered South African indications:

Short term symptomatic treatment of acute exacerbation of:
- Rheumatoid arthritis
- Painful osteoarthritis
- Ankylosing spondylitis
- Sciatica

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of the excipients
• Use in patients who have developed signs of asthma, nasal polyps, angioedema or urticaria following the administration of acetylsalicylic acid (aspirin) or other nonsteroidal anti-inflammatory drugs (NSAIDs), because of a potential cross-sensitivity
• Coadministration with anticoagulants as haematomas may occur
• Peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery
• Active or history of recurrent gastrointestinal ulceration/perforation/haemorrhage
• Active inflammatory bowel disease (Crohn’s disease or ulcerative colitis)
• Non-dialysed severe renal impairment
• Severe hepatic impairment
• Overt gastrointestinal bleeding, recent cerebrovascular bleeding or established systemic bleeding disorders
• Heart failure
• History of gastrointestinal perforation, ulceration or bleeding (PUBs) related to previous NSAIDs including meloxicam
• Pregnancy
• Lactation
• Children below 18 years

• Elderly
• Women of childbearing potential
• Hypertension
• Heart failure
• History of ulcers or gastrointestinal disease
• Risk of serious skin reactions
• Asthma
• Established ischaemic heart disease
• Dehydration
• Hypovolaemia
• Females trying to conceive

Forms available in SA and covered in this monograph: inj

South African registered indications and dosages

Short term symptomatic treatment of acute exacerbation of:
- Rheumatoid arthritis
- Painful osteoarthritis
- Ankylosing spondylitis

• IM: 7.5-15mg, once daily depending on the pain intensity and severity of inflammation; Treatment duration: IM admin. should only be used for up to 3 days, for continuation of treatment, the oral formulations should be used; Max: 15mg/24hrs

- Episodes of acute sciatica

• IM: 7.5mg, once daily; In the absence of improvement: Increase dose to 15mg/day, where necessary; Treatment duration: IM admin. should only be used for up to 3 days, for continuation of treatment, the oral formulations should be used; Max: 15mg/24hrs

As the potential for adverse reactions increases with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used

Method of administration
The total daily dose of meloxicam should be administered as a single dose. The liquid in the ampoule must be aspirated very slowly to avoid foaming of the solution. Meloxicam injection should be administered by deep intramuscular injection. It should not be administered intravenously

Contraindicated in children and adolescents below 18 years

Pregnancy

South African recommendations

• Contraindicated
• Meloxicam is contra-indicated during pregnancy
• Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or the embryofoetal development
• Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy
• During the third trimester of pregnancy, prostaglandin synthesis inhibition may expose the foetus to:
  • Cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension)
  • Renal dysfunction, which may progress to renal failure with oligohydramnios
• The mother and the neonate, at the end of pregnancy, may be exposed to:
  • Prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses
  • Inhibition of uterine contractions resulting in delayed or prolonged labour

Breastfeeding

South African recommendations

• Contraindicated
• While no specific experience exists for meloxicam in humans, NSAIDs are known to pass into mother’s milk. Administration therefore is contraindicated in women who are breastfeeding

Fertility

South African recommendations

• The use of meloxicam may impair fertility and is not recommended in women attempting to conceive
• Meloxicam may delay ovulation. Therefore, in women who have difficulties conceiving, or who are undergoing investigation of infertility, withdrawal of meloxicam should be considered

South African recommendations

• Mild to moderate: No dose adjustment recommended 
• Severe: Contraindicated

South African recommendations

• Mild to moderate: No dose adjustment recommended
• Severe: Contraindicated

South African recommendations

• Caution; no dose adjustment recommended 
  Caution should be used in the treatment of elderly patients who are more likely to be suffering from impaired renal, hepatic or cardiac function

Central Nervous System Disorders

• Headache
• Dizziness
• Light-headedness
• Vertigo
• Confusion
• Drowsiness
• Insomnia
• Nightmares

Cardiovascular Disorders

• Oedema
• Palpitation
• Elevated blood pressure 

Respiratory Disorders

• Bronchospasm 

Gastrointestinal Disorders

• Dyspepsia
• Nausea and vomiting
• Diarrhoea
• Flatulence
• Constipation 
• Abdominal pain
• Gastrointestinal bleeding
• Perforation or ulceration 
• Induction or exacerbation of colitis
• Gastritis

Hepatobiliary Disorders

• Hepatitis

Genitourinary Disorders  

• Nephrotic syndrome
• Glomerulonephritis
• Interstitial nephritis 
• Papillary necrosis
• Renal failure

Skin and Subcutaneous Tissue Disorders

• Pruritus
• Rash
• Flushing
• Urticaria
• Stomatitis
• Photosensitivity
• Bullous dermatoses
• Stevens-Johnson syndrome
• Toxic epidermal necrolysis

Immune, Blood and Lymphatic System Disorders

• Anaemia
• Thrombocytopenia 
• Neutropenia 
• Eosinophilia
• Agranulocytosis
• Leukopenia 
• Hypersensitivity reactions 
• Bronchospasm

Sensory Disorders

• Visual disturbances 
• Conjunctivitis 
• Tinnitus

• Non steroidal anti-inflammatory drugs
• Acetylsalicylic acid
• Corticosteroids
• Anticoagulants  
• Thrombolytics agents
• Antiplatelet agents
• Antihypertensives
• Tacrolimus
• Lithium
• Methotrexate
• Cholestyramine
• Intrauterine devices
• CYP2C9 inhibitors
• CYP3A4 inhibitors
• Alcohol
• Cardiac glycosides
• Quinolone
• Phenytoin
• Sulphonylurea antidiabetics
• Potassium supplements
• Ciclosporin

None routine. Specific cases may require

• Renal function
• Hepatic function
• Serum sodium and potassium

Inhibits prostaglandin synthesis by inhibition of cyclooxygenase.

Injection (per 1.5ml) 15mg

• Mobic (Ingelheim) originator