Naproxen oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of naproxen.
Drugs List
Therapeutic Indications
Uses
Acute musculoskeletal disorders
Ankylosing spondylitis
Dysmenorrhoea
Gout - acute
Juvenile rheumatoid arthritis
Osteoarthritis
Rheumatoid arthritis
Dosage
Adults
Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis
500mg to 1g daily. This may be taken as a single daily dose or in 2 divided doses at 12 hour intervals.
A loading dose of 750mg or 1g per day is recommended for the acute phase in patients:
Reporting severe night-time pain or morning stiffness.
Switching from high doses of another anti-rheumatic medicinal product.
With pain as the predominant symptom in osteoarthritis.
Acute gout
750mg to be taken initially followed by 250mg every 8 hours until the attack has passed.
Acute musculoskeletal disorders and dysmenorrhoea
500mg to be taken initially followed by 250mg at 6 to 8 hour intervals as required.
The maximum dose after the first day is 1.25g daily.
Manufacturers of products on sale to the public for dysmenorrhoea without a prescription suggest a maximum dose after the first day of 750mg daily and a maximum duration of continuous treatment of three days in any one cycle.
Elderly
(See Dosage; Adult).
Although the total plasma concentration of naproxen is unchanged, the unbound fraction of naproxen is increased in the elderly.
Children
Acute musculoskeletal disorders
Children aged 16 to 18 years
(See Dosage; Adult).
Dysmenorrhoea
Children aged 15 to 18 years
(See Dosage; Adult).
Juvenile rheumatoid arthritis
Children aged 5 to 18 years
10mg/kg/day in 2 divided doses at 12 hour intervals.
The following alternate dosing schedule may be suitable:
Pain and inflammation in musculoskeletal disorders, dysmenorrhoea (unlicensed)
Children aged 1 month to 15 years: 5mg/kg twice daily (maximum 1 g daily).
Juvenile idiopathic arthritis (unlicensed in children under 5 years)
Children aged 2 to 18 years: 5mg/kg to 7.5mg/kg twice daily (maximum 1 g daily).
Patients with Renal Impairment
Creatinine clearance of 30 ml/minute and above
A reduced daily dose should be considered to avoid drug accumulation.
Treatment should be reviewed at regular intervals and discontinued if no benefit is seen.
The Renal Drug Handbook suggests the following doses:
Glomerular filtration rate (GFR)
GFR 20 to 50 ml/minute: Dose as in normal renal function, but avoid if possible.
GFR 10 to 20 ml/minute: Dose as in normal renal function, but avoid if possible.
GFR less than 10 ml/minute: Dose as in normal renal function, but only use if on dialysis.
Patients with Hepatic Impairment
The total plasma concentration of naproxen is reduced in patients with chronic alcoholic liver disease and other forms of cirrhosis. The plasma concentrations of unbound naproxen is increased in these patients.
Contraindications
Neonates under 1 month
Gastrointestinal haemorrhage
History of gastrointestinal haemorrhage
History of gastrointestinal perforation
History of peptic ulcer
Nasal polyps, angioedema, and bronchospastic reactivity to NSAIDs
Peptic ulcer
Renal impairment - creatinine clearance below 30 ml/minute
Severe cardiac failure
Severe hepatic impairment
Third trimester of pregnancy
Precautions and Warnings
Atopy
Children under 16 years
Debilitation
Elderly
Females attempting to conceive
Predisposition to haemorrhage
Restricted sodium intake
Risk factors for cardiovascular disorder
Asthma
Breastfeeding
Cardiac impairment
Cerebrovascular disorder
Coagulopathy
Congestive cardiac failure
Connective tissue disorder
Crohn's disease
Dehydration
Diabetes mellitus
First trimester of pregnancy
Galactosaemia
Glucose-galactose malabsorption syndrome
Hepatic cirrhosis
Hepatic impairment
Hereditary fructose intolerance
History of asthma
History of gastrointestinal disorder
Hypertension
Hypovolaemia
Ischaemic heart disease
Lactose intolerance
Menorrhagia
Peripheral arterial circulatory disorder
Renal impairment
Second trimester of pregnancy
Systemic lupus erythematosus
Thrombocytopenia
Ulcerative colitis
May mask fever
May mask signs of inflammation
May precipitate bronchospasm in patients with asthma or allergy
NSAIDs may provoke or exacerbate asthma
Reduce dose in patients with hepatic impairment
Reduce dose in patients with renal impairment
Some formulations contain more than 1mmol (23mg) sodium per dose
Advise ability to drive/operate machinery may be affected by side effects
Consider the need for combination therapy with gastroprotective agents
Not all available brands are licensed for all age groups
Not all available brands are licensed for all indications
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain lactose
Discontinue if signs of gastro-intestinal bleeding occur
Elderly: Monitor renal function and consider dose modification
If visual disturbances occur, perform ophthalmic evaluation
May inhibit platelet aggregation - observe for signs of bleeding
Monitor blood glucose closely in patients with diabetes mellitus
Monitor closely patient with pre-existing renal impairment
Monitor for signs of fluid retention
Monitor patients on prolonged therapy
Monitor renal function in patients with cardiac impairment
Monitor renal function in patients with hepatic impairment
Monitor serum creatinine in patients with renal impairment
Perform blood counts on prolonged use of this treatment
Advise patients to report lower gastrointestinal bleeding
Advise patients to report signs or symptoms of gastro-intestinal ulcer
Consider discontinuation if first occurrence/worsening of porphyria occurs
Discontinue if signs of gastro-intestinal ulceration occur
May prolong bleeding time
Risk of gastro-intestinal bleeding increased in the elderly
Severe gastro-intestinal side effects may occur without warning
May affect results of some laboratory tests
Discontinue if drug-related rash or other hypersensitivity reactions occur
Maintain treatment at the lowest effective dose
Maintain treatment for the shortest possible duration
Female: Reduced fertility (reversible) possible with long term use
Evidence on the relative safety of 7 non-selective NSAIDs indicates differences in the risks of serious upper gastrointestinal side effects. Naproxen is associated with intermediate risks.
The use of NSAIDs at high doses for long-term treatment may be associated with a small increased risk of arterial thrombotic events. The use of naproxen (1 g daily) may be associated with a lower risk.
Patients with connective tissue disorders such as systemic lupus erythematosus may be at increased risk of aseptic meningitis.
Mild peripheral oedema and fluid retention may occur with naproxen therapy. Sodium retention has not been reported but it is possible that patients with impaired cardiac function have a higher risk.
In patients whose renal blood flow is compromised, such as in extracellular volume depletion, cirrhosis of the liver, sodium restriction, congestive heart failure and pre-existing renal disease, should have their renal function assessed before and during naproxen therapy. Some elderly patients in whom impaired renal function may be expected, as well as patients using diuretics, may fall within this category. A reduction in daily dosage should be considered to avoid the possibility of excessive accumulation of naproxen metabolites in these patients.
Naproxen should not be taken, except on the advice of a doctor, by women who first experience period pain more than a year after starting menstruation.
Pregnancy and Lactation
Pregnancy
Naproxen is contraindicated during the third trimester.
During the first and second trimester of pregnancy, the dose of naproxen should be kept as low and duration of treatment as short as possible.
The manufacturer does not recommend the use of naproxen during the 1st or 2nd trimester of pregnancy unless the potential benefits outweigh the potential risks to the foetus.
Women planning a pregnancy should not take naproxen as NSAIDs have been shown to block blastocyst implantation. Exposure during the first trimester appears to increase risk for structural abnormalities and spontaneous abortions. Structural defects usually involve the heart but associations with oral clefts have been reported. Exposure during the third trimester can cause premature closure of the ductus arteriosus. There is the potential for newborn toxicity and naproxen should not be used late in the third trimester (Briggs, 2015).
Lactation
Use naproxen with caution during breastfeeding.
The manufacturer does not recommend the use of naproxen in breastfeeding.
Although only excreted in breast milk in small quantities, naproxen has a long half life and there have been reported serious adverse reactions including prolonged bleeding time, thrombocytopenia and acute anaemia in a neonate whose mother was taking naproxen. Therefore other agents may be the preferred choice for breastfeeding women (Lactmed, 2018).
If an NSAID is considered essential ibuprofen is considered the drug of choice. Levels of ibuprofen in breast milk are negligible.
Side Effects
Abnormal liver function tests
Aggravation of existing asthma
Agranulocytosis
Alopecia
Anaphylaxis
Angioedema
Aplastic anaemia
Arterial thrombosis
Aseptic meningitis
Asthma
Bronchospasm
Bullous reactions
Cognitive impairment
Colitis
Confusion
Congestive cardiac failure
Convulsions
Depression
Diarrhoea
Dizziness
Dream abnormalities
Drowsiness
Dyspnoea
Ecchymosis
Eosinophilia
Eosinophilic pneumonia
Epidermal necrolysis
Erythema multiforme
Erythema nodosum
Exacerbation of colitis
Exacerbation of Crohn's disease
Exfoliative dermatitis
Eye disorder
Fatal hepatitis
Fatigue
Fixed drug eruption
Fluid retention
Gastro-intestinal disturbances
Gastro-intestinal perforation
Gastro-intestinal ulceration and bleeding
Glomerulonephritis
Granulocytopenia
Haematemesis
Haematuria
Haemolytic anaemia
Hallucinations
Headache
Hearing disturbances
Hepatitis
Hyperkalaemia
Hypersensitivity reactions
Hypertension
Impaired concentration
Inhibition of platelet aggregation
Insomnia
Interstitial nephritis
Jaundice
Leucopenia
Lichen planus
Malaise
Melaena
Muscle weakness
Myalgia
Myocardial infarction
Nausea
Nephrotic syndrome
Nephrotoxicity
Neutropenia
Oedema
Oesophagitis
Palpitations
Pancreatitis
Paraesthesia
Peripheral oedema
Photosensitivity
Pruritus
Pseudoporphyria
Pulmonary alveolitis
Pulmonary oedema
Purpura
Pyrexia
Rash
Renal failure
Renal papillary necrosis
Serum creatinine increased
Stevens-Johnson syndrome
Stomatitis
Stroke
Suppressed female fertility
Sweating
Thirst
Thrombocytopenia
Tinnitus
Ulcerative stomatitis
Urticaria
Vasculitis
Vertigo
Visual disturbances
Effects on Laboratory Tests
Naproxen therapy should be temporarily discontinued 48 hours before adrenal function tests as it may interfere with some tests for 17-ketogenic steroids. Naproxen may interfere with some assays of urinary 5-hydroxyindoleacetic acid.
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: May 2016
Reference Sources
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Feminax Ultra 250mg Gastro-resistant Tablets. Bayer Plc. Revised August 2015.
Summary of Product Characteristics: Naprosyn 250mg tablets. Atnahs Pharma UK Ltd. Revised September 2015.
Summary of Product Characteristics: Naprosyn 500mg tablets. Atnahs Pharma UK Ltd. Revised September 2015.
Summary of Product Characteristics: Naprosyn EC 250mg Gastro-resistant Tablets. Atnahs Pharma UK Ltd. Revised September 2015.
Summary of Product Characteristics: Naprosyn EC 375mg Gastro-resistant Tablets. Atnahs Pharma UK Ltd. Revised September 2015.
Summary of Product Characteristics: Naprosyn EC 500mg Gastro-resistant Tablets. Atnahs Pharma UK Ltd. Revised September 2015.
Summary of Product Characteristics: Naproxen 250mg tablets. Accord healthcare Ltd. Revised January 2016.
Summary of Product Characteristics: Naproxen 500mg tablets. Accord healthcare Ltd. Revised January 2016.
Summary of Product Characteristics: Naproxen 250mg tablets. Actavis UK Ltd. Revised April 2014.
Summary of Product Characteristics: Naproxen 500mg tablets. Actavis UK Ltd. Revised April 2014.
Summary of Product Characteristics: Naproxen Gastro Resistant tablets 250mg. Actavis UK Ltd. Revised April 2014.
Summary of Product Characteristics: Naproxen Gastro Resistant tablets 375mg. Actavis UK Ltd. Revised April 2014.
Summary of Product Characteristics: Naproxen Gastro Resistant tablets 500mg. Actavis UK Ltd. Revised April 2014.
Summary of Product Characteristics: Naproxen Tablets 250mg. Aurobindo Pharma-Milpharm Ltd. Revised May 2016.
Summary of Product Characteristics: Naproxen Tablets 500mg. Aurobindo Pharma-Milpharm Ltd. Revised May 2016.
Summary of Product Characteristics: Naproxen Orion 25mg/ml oral solution. Orion Pharma (UK) Ltd. Revised January 2016.
Summary of Product Characteristics: Naproxen 50mg/ml oral suspension. Thornton & Ross Ltd. Revised June 2016.
Summary of Product Characteristics: Nexocin EC 250mg Gastro Resistant tablet. Noumed Life Sciences Ltd. Revised December 2020.
Summary of Product Characteristics: Nexocin EC 375mg Gastro Resistant tablet. Noumed Life Sciences Ltd. Revised December 2020.
Summary of Product Characteristics: Nexocin EC 500mg Gastro Resistant tablet. Noumed Life Sciences Ltd. Revised December 2020.
Summary of Product Characteristics: Period Pain Reliever 250mg Gastro-resistant Tablets. Accord Healthcare Limited. Revised December 2022
Summary of Product Characteristics: Stirlescent 250mg effervescent tablets. Stirling Anglian Pharmaceuticals Ltd. Revised December 2015.
The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Naproxen Last revised: 30 June 2019
Last accessed: 14 October 2022.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 18 October 2022.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.