Naproxen

Registered South African indications:

• Pain - mild to moderate
• Inflammation

Contraindications

Suppository 500mg

• Hypersensitivity to the active ingredient or any of its excipients
• Patients sensitive to aspirin or other non-steroidal anti-inflammatory agents (NSAIDs), since the potential for cross-sensitivity exists
• History of or active gastrointestinal bleeding or peptic ulceration
• Pregnancy
• Breastfeeding

Tablet 250mg & 500mg

• Hypersensitivity or allergic reactions to medicines containing naproxen or naproxen sodium, aspirin, or other non-steroidal anti-inflammatory agents (NSAIDs)
• Patients in whom aspirin or other non-steroidal anti-inflammatory/analgesic medicines induce the syndrome of asthma, rhinitis, nasal polyps, or urticaria. These reactions have the potential to be fatal. Severe anaphylactic-like reactions to naproxen have been reported in such patients
• Pregnancy
• Breastfeeding
• Heart failure
• History of gastrointestinal perforation, ulceration, or bleeding (PUBs) related to previous NSAIDs
• Active or history of recurrent ulcer/haemorrhage/perforations
• Porphyria
• Naproxen is not recommended for use in children under the age of 16 years
• Severe renal function impairment
  - Naproxen is not recommended in patients with baseline creatinine clearance of less than 20ml/minute because accumulation of naproxen metabolites has been seen in such patients

Tablet 220mg

• Hypersensitivity to the active ingredient or any of its excipients
• History of asthma, urticaria, or allergic-type reactions after taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
• History of gastrointestinal bleeding or perforation related to previous NSAID therapy
• Active, or a history of, recurrent peptic ulcer or haemorrhage (two or more distinct episodes of proven ulceration or bleeding)
• Severe heart failure
• Pregnancy
• Breastfeeding

Cautions

• Renal impairment (500mg sup)
• Mild to moderate renal impairment (220mg, 250mg, 500mg tab)
• Hepatic impairment
• Elderly 
• Debilitated patients
• History of bronchial asthma
• Coagulation disorder
• Cardiac impairment
• History of ulcer
• Smoker
• History of gastrointestinal disease
• Hypertension
• Congestive heart failure
• Ischaemic heart disease
• Peripheral arterial disease
• Cerebrovascular disease
• Systemic lupus erythematosus 
• Mixed connective tissue disorders
• Women attempting to conceive
• Alcohol consumption
• Anticoagulant therapy
• Steroid therapy
• Patients on a low potassium diet (as product may contain potassium sorbate)
• Galactose intolerance
• Lapp lactase deficiency
• Glucose-galactose malabsorption

Forms avail. in SA and covered in this monograph: tab, cap, sup

Acute gout

• Oral (tab, cap): Initial: 750mg, then 250mg, 8hrly
• Rectal (sup): 1 sup (500mg) rectally at night

Pain - acute musculoskeletal disorders

• Oral (tab, cap): Initial: 500mg, then 250mg, 6-8hrly; Max: 1250mg/24hrs; Max duration: 7-14 days
• Rectal (sup): 1 sup (500mg) rectally at night

Dysmenorrhoea

• Oral (tab, cap): Initial: 500mg, then 250mg, 6-8hrly; Max: 1250mg/24hrs
• Rectal (sup): 1 sup (500mg) at night

Osteoarthritis
Ankylosing spondylitis
Rheumatoid arthritis

• Oral (tab, cap): 250-500mg, 12hrly; Max: 1500mg/24hrs
• Rectal (sup): 1 sup (500mg) rectally at night

Post-operative pain

• Oral (tab, cap): 500mg, then 250mg, 3-5 times daily; Max: 1375mg/24hrs on first day

Post-partum pain

• Oral (tab, cap): 500mg immediately

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Naproxen sodium 275mg = 250mg naproxen

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Suppository may be used to substitute for one oral dose in patients receiving  ≥ 1,000 mg/day  

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May increase to 1,500 mg/day for limited time period (<6 months) in patients who require higher level of anti-inflammatory/analgesic activity and have tolerated lower doses

Contraindicated: Not recommended for use in children under the age of 16 years (250mg & 500mg tab)
Not recommended for use in children under 12 years (220mg tab)
No information available (500mg sup)

Pregnancy

• Contraindicated

Breastfeeding

• Contraindicated

Fertility

• The use of naproxen may impair female fertility and is not recommended in women attempting to conceive

Renal Impairment

Suppository naproxen

• Caution; no dose adjustment recommended

Tablet 250mg, 500mg naproxen

• Mild to moderate: Caution; no dose adjustment recommended
• Severe: Contraindicated

Tablet 220mg naproxen sodium

• Mild to moderate: Caution; no dose adjustment recommended
• Severe: Caution; dose adjustment recommended

Hepatic Impairment

• Caution; no dose adjustment recommended
  Discontinue immediately if acute changes in liver function test are observed

Elderly

• Caution; no dose adjustment recommended 

Porphyria Information

South African recommendations

• Contraindicated (250mg, 500mg tab)

Recommendations in other jurisdictions

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Insomnia
• Dream abnormalities
• Depression
• Confusion
• Hallucinations
• Convulsions
• Dizziness
• Nervousness
• Euphoria
• Low temperature
• Drowsiness
• Lightheadedness
• Inability to concentrate 
• Cognitive dysfunction
• Retrobulbar optic neuritis
• Headaches
• Paraesthesia
• Exacerbation of Parkinson's disease
• Aseptic meningitis
• Fatigue

Cardiovascular Disorders

• Oedema
• Angioneurotic edema
• Peripheral odema
• Palpitations
• Cardiac failure
• Congestive heart failure
• Arterial thrombotic events 
• Hypertension
• Vasculitis

Respiratory Disorders

• Dyspnoea
• Asthma
• Rhinitis
• Eosinophilic pneumonitis
• Pulmonary oedema

Gastrointestinal Disorders

• Heartburn
• Nausea and vomiting
• Constipation
• Diarrhoea
• Flatulence
• Dyspepsia
• Abdominal discomfort
• Epigastric distress
• Gastro-intestinal bleeding
• Inflammation
• Ulceration
• Perforation
• Obstruction of the upper and lower gastrointestinal tract
• Melaena
• Haematemesis
• Stomatitis
• Abdominal pain
• Dry mouth
• Throat irritation
• Decreased appetite
• Exacerbation of ulcerative colitis
• Crohn's disease
• Oesophagitis
• Gastritis
• Pancreatitis

Hepatobiliary Disorders

• Abnormal liver function tests
• Hepatitis 
• Jaundice
• Elevated transaminases 
• Increased alkaline phosphatases
• Elevated bilirubin levels

Genitourinary Disorders

• Glomerular nephritis
• Interstitial nephritis
• Nephrotic syndrome
• Pollakiuria
• Proteinuria
• Haematuria
• Nephropathy
• Renal insufficiency
• Renal papillary necrosis
• Renal failure

Endocrine and Metabolic Disorders

• Hyperkalaemia
• Thirst
• Pyrexia
• Elevated serum creatinine

Musculoskeletal Disorders

• Myalgia
• Muscle weakness

Skin and Subcutaneous Tissue Disorders

• Skin rashes including fixed drug eruption
• Itching 
• Urticaria
• Ecchymoses
• Purpura
• Sweating
• Alopecia
• Erythema multiforme
• Skin eruption
• Stevens Johnson syndrome
• Erythema nodosum
• Lichen planus
• Pustular reaction
• Systemic lupus erythematosis
• Epidermal necrolysis
• Toxic epidermal necrolysis
• Photosensitivity reactions 
• Epidermolysis bullosa-like reactions 
• Blistering
• Mild peripheral oedema

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions
• Non-specific allergic reactions and anaphylaxis
• Respiratory tract reactivity comprising asthma
• Aggravated asthma
• Bronchospasm 
• Dyspnoea
• Skin disorders, including rashes of various types, pruritus, urticaria, purpura, and angioedema
• Exfoliative and bullous dermatoses 
• Decrease in hemoglobin levels and/or hematocrit
• Granulocytopenia  

Sensory Disorders

• Corneal opacity
• Blurred vision
• Visual disturbances
• Papillitis
• Papilloedema
• Hearing disturbances including impairment, tinnitus, vertigo

Others

• Female infertility

• Alcohol
• Antacids
• Colestyramine
• Angiotensin-converting enzyme inhibitors
• Angiotensin II receptor antagonists
• Diuretics
• Cardiac glycosides
• Lithium
• Methotrexate
• Ciclosporin
• Mifepristone and 8-12 days after mifepristone administration
• Steroid therapy
• Corticosteroids
• Antiplatelet agents
• Anticoagulant agents
• Selective serotonin reuptake inhibitors
• Sulphonamide
• Sulphonylurea
• Probenecid  
• Zidovudine
• Bisphosphonates
• Quinolone antibiotics
• Tacrolimus
• Beta blockers
• Non-steroidal anti-inflammatory drugs

 

 

None routine. Specific cases may require

• Renal function
• Hepatic function

Inhibits prostaglandin synthesis by inhibition of cyclooxygenase.

Capsule 200mg

• Aleve (Bayer) originator

Capsule 500mg

• Napflam (Pharmacare)

Tablet 220mg

• Aleve (Bayer) originator

Tablet 250mg

• Adco-Naproxen (Adcock)
• Be-Tabs Naproxen (Be-Tabs)
• Bio-Naproxen (Biotech)
• Napflam (Pharmacare)
• Naproscript (Medicine Dev)
• Nafasol Ec-250 (Pharmacare)
• Mylan Naproxen (Mylan)

Tablet 275mg

• Aspen Naproxen (Litha)
• Synflex 275 (Akacia) originator

Tablet 500mg

• Bio-Naproxen (Biotech)
• Napflam (Pharmacare)
• Nafasol Ec-500 (Pharmacare)

Tablet 550mg

• Synflex 550 (Akacia) originator

Suppository 500mg

• Nafasol Suppositories (Pharmacare)

COMBINATION PREPARATIONS

Naproxen/ Esomeprazole

Tablet 500mg/20mg

• Vimovo (AstraZeneca) originator