Meloxicam

Registered South African indications:

• Symptomatic treatment of:
  - Rheumatoid arthritis
  - Painful osteoarthritis
  - Ankylosing spondylitis
  - Episodes of acute sciatica

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of the excipients
• Patients who have developed signs of asthma, urticaria, nasal polyps, angioedema or acute rhinitis following the administration of acetylsalicylic acid (aspirin) or other nonsteroidal anti-inflammatory drugs (NSAIDs) due to potential cross-sensitivity
• Active or history of recurrent gastrointestinal ulceration/perforation/haemorrhage
• Severe hepatic impairment
• Severe non-dialysed renal impairment
• Heart failure, established ischaemic heart disease, cerebrovascular disease (stroke), and peripheral arterial disease
• History of gastrointestinal perforation, ulceration, or bleeding related to previous NSAIDs, including meloxicam
• Pregnancy
• Breastfeeding
• Active inflammatory bowel disease (Crohn’s disease or ulcerative colitis)
• Overt gastrointestinal bleeding, recent cerebrovascular bleeding, or established systemic bleeding disorders
• Peri-operative analgesia in the context of coronary artery bypass graft (CABG) surgery
• Use in children under 12 years
• In cases of rare hereditary conditions that may be incompatible with an excipient, the use of meloxicam is contraindicated

• 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: tab

South African registered indications and dosages

Symptomatic treatment of:

- Episodes of acute sciatica

• Oral (tab): 7.5mg, once daily; If there is no improvement: Increase dose to 15mg/day, where necessary; Max: 15mg/24hrs

- Rheumatoid arthritis
- Ankylosing spondylitis

• Oral (tab): 15mg, once daily; According to the therapeutic response, the dose may be reduced to 7.5mg/day; Max: 15mg/24hrs

- Painful osteoarthritis

• Oral (tab): 7.5mg, once daily; Increase to 15mg/day, if necessary; Max: 15mg/24hrs

As the potential for adverse reactions increases with dose and duration of exposure, use the lowest effective dose for the shortest possible duration of treatment

The total daily dose of meloxicam tablets should be taken as a single dose and should be swallowed with water or other fluid in conjunction with food

Contraindicated in children below 12 years

Pregnancy

South African recommendations

• Contraindicated
• Meloxicam tablets are contraindicated during pregnancy
• Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or the embryo-foetal 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
• At the end of pregnancy, meloxicam may expose the mother and the neonate to the following:
  • 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
• Meloxicam is contraindicated during lactation. NSAIDs, such as meloxicam, are known to pass into mother’s milk

Fertility

South African recommendations

• Meloxicam can inhibit cyclooxygenase / prostaglandin synthesis, which may impair fertility and is not recommended in women attempting to conceive. Meloxicam may delay ovulation. In women who have difficulties conceiving, or who are undergoing investigation of infertility, meloxicam should be stopped

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; dose adjustment recommended 
  In patients with an increased risk of adverse reactions, such as the elderly, treatment should be started at a dosage of 7.5mg daily

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.

Tablet 7.5mg

• Adco-Meloxicam  7,5 (Adcock)
• Apex-Meloxicam 7.5mg (Camox)
• Arrow Meloxicam 7.5 (Arrow)
• Arthrocox 7.5 (Sandoz)
• Coxitec 7,5 mg (Activo)
• Coxflam 7.5 (Cipla Medpro)
• Flamaryx 7.5 mg (Aurobindo)
• Flexocam 7.5 (Pharma Dynamics)
• Loxiflam 7.5 mg (Pharmacare)
• Melflam 7.5 (Cipla Medpro)
• Meloxicam Unicorn 7.5 (Unicorn) 
• Medoxicam 7.5 (Specpharm)
• M-Cam 7.5 mg (Unichem)
• Mobic 7.5 mg (Ingelheim) originator
• Sandoz Meloxicam 7.5 (Sandoz)
• Zydus-Meloxicam 7.5 mg (Zydus)

Tablet 15mg

• Adco-Meloxicam (Adcock) 
• Apex-Meloxicam 15mg (Camox) 
• Arrow Meloxicam 15 (Arrow) 
• Arthrocox 15 (Sandoz)
• Coxitec 15 mg (Activo)
• Coxflam 15 (Cipla Medpro)
• Flamaryx 15 mg (Aurobindo)
• Flexocam 15 (Pharma Dynamics)
• Loxiflam 15 Mg (Pharmacare)
• Melflam 15 (Cipla Medpro)
• Meloxicam Unicorn 15 (Unicorn)
• Medoxicam 15 (Spechpharm)
• M-Cam 15 mg (Unichem)
• Mobic 15 mg (Ingelheim) originator
• Sandoz Meloxicam 15 (Sandoz) 
• Zydus-Meloxicam 15 mg (Zydus)