Drugs List

Therapeutic Indications

Uses

Osteoarthritis
Rheumatoid arthritis

Contraindications

Children under 18 years
Haemorrhage
Breastfeeding
Cerebrovascular haemorrhage
Gastrointestinal haemorrhage
Gastrointestinal perforation
History of gastrointestinal bleeding
History of gastrointestinal perforation
History of peptic ulcer
Peptic ulcer
Pregnancy
Severe cardiac dysfunction
Severe hepatic impairment
Severe renal impairment

Precautions and Warnings

Elderly
Females attempting to conceive
Fluid retention
Infection
Risk factors for cardiovascular disorder
Asthma
Cardiac failure
Cardiovascular disorder
Cerebrovascular disorder
Congestive cardiac failure
Connective tissue disorder
Gastrointestinal disorder
Hepatic impairment
History of asthma
History of gastrointestinal disorder
Hypertension
Hypotension
Ischaemic heart disease
Renal impairment - creatinine clearance below 30 ml/minute
Systemic lupus erythematosus

Consider reducing dose if creatinine clearance is < or equal to 30ml/min
May mask symptoms or signs of infections
May precipitate bronchospasm in patients with asthma or allergy
NSAIDs may provoke or exacerbate asthma
Discontinue if signs of gastro-intestinal bleeding occur
Elderly - monitor for gastro-intestinal bleeding over initial 4 weeks
Monitor hepatic function in patients with hepatic impairment
Discontinue if signs of gastro-intestinal ulceration occur
Increased risk of venous thromboembolism
Severe gastro-intestinal side effects may occur without warning
May affect thyroid function tests
Discontinue if any kind of visual disturbance occurs
Discontinue treatment if skin rash or other allergic reaction occurs
Maintain treatment at the lowest effective dose
Start treatment at lowest recommended dose
May cause impaired fertility
Advise patient to take after food to reduce gastro-intestinal disturbances

In patients with Systemic Lupus Erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis.

Pregnancy and Lactation

Pregnancy

Nabumetone is contraindicated in pregnancy.

Constriction of the ductus arteriosus in utero is a pharmacologic consequence arising from the use of prostaglandin synthesis inhibitors during pregnancy, as is inhibition of labour, prolongation of pregnancy, and suppression of foetal renal function. Persistent pulmonary hypertension of the newborn may occur if these agents are used in the 3rd trimester close to delivery. NSAIDs have been associated with spontaneous abortions and congenital malformations.

If a NSAID is considered essential in pregnancy, a more established drug such as ibuprofen or flurbiprofen may be considered.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Lactation

Nabumetone is contraindicated in breastfeeding.

In limited studies so far available, NSAIDs can appear in breast milk in very low concentrations. The manufacturer recommends avoiding the use of nabumetone when breast-feeding.

When an NSAID is considered necessary during breast feeding ibuprofen or flurbiprofen would be the drugs of choice.

Nabumetone is known to be secreted into animal milk. Because of its long half life and low molecular weight its passage into human milk it to be expected.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal pain
Abnormal vision
Acute interstitial nephritis
Aggravation of existing asthma
Agranulocytosis
Alopecia
Altered liver function tests
Alveolitis
Anaphylactoid reaction
Anaphylaxis
Angioedema
Aplastic anaemia
Aseptic meningitis
Asthma
Blood dyscrasias
Bronchospasm
Cardiac failure
Colitis
Confusion
Constipation
Depression
Diarrhoea
Disorientation
Dizziness
Drowsiness
Dry mouth
Dyspepsia
Dyspnoea
Erythema multiforme
Exacerbation of acne
Exacerbation of Crohn's disease
Exacerbation of psoriasis
Fatigue
Fever
Flatulence
Gastritis
Gastro-intestinal perforation
Gastro-intestinal ulceration and bleeding
Haematemesis
Haematuria
Haemolytic anaemia
Hallucinations
Headache
Hepatitis
Hypertension
Impaired fertility
Insomnia
Jaundice
Leucopenia
Liver damage
Malaise
Melaena
Menorrhagia
Nausea
Neck stiffness
Nephrotic syndrome
Nephrotoxicity
Nervousness
Neutropenia
Non-specific allergic reactions
Occult blood in faeces
Ocular discomfort
Ocular irritation
Oedema
Oesophageal erosions
Oesophageal perforation
Oesophageal stricture
Oesophageal ulceration
Optic neuritis
Pancreatitis
Papillary necrosis
Papilloedema
Paraesthesia
Peritonitis
Photosensitivity
Pruritus
Pseudoporphyria
Pulmonary eosinophilia
Pulmonary fibrosis
Rash
Renal failure
Renal impairment
Retrobulbar optic neuritis
Rhinitis
Sedation
Skin eruption
Skin reactions
Stevens-Johnson syndrome
Thrombocytopenia
Thrombosis
Tinnitus
Toxic epidermal necrolysis
Ulcerative stomatitis
Urticaria
Vertigo
Vomiting

Presentation

Oral formulations of nabumetone

Drugs List

Therapeutic Indications

Uses

Osteoarthritis
Rheumatoid arthritis

Dosage

Adults

Elderly

Contraindications

Children under 18 years
Haemorrhage
Breastfeeding
Cerebrovascular haemorrhage
Gastrointestinal haemorrhage
Gastrointestinal perforation
History of gastrointestinal bleeding
History of gastrointestinal perforation
History of peptic ulcer
Peptic ulcer
Pregnancy
Severe cardiac dysfunction
Severe hepatic impairment
Severe renal impairment

Precautions and Warnings

Elderly
Females attempting to conceive
Fluid retention
Infection
Risk factors for cardiovascular disorder
Asthma
Cardiac failure
Cardiovascular disorder
Cerebrovascular disorder
Congestive cardiac failure
Connective tissue disorder
Gastrointestinal disorder
Hepatic impairment
History of asthma
History of gastrointestinal disorder
Hypertension
Hypotension
Ischaemic heart disease
Renal impairment - creatinine clearance below 30 ml/minute
Systemic lupus erythematosus

Consider reducing dose if creatinine clearance is < or equal to 30ml/min
May mask symptoms or signs of infections
May precipitate bronchospasm in patients with asthma or allergy
NSAIDs may provoke or exacerbate asthma
Discontinue if signs of gastro-intestinal bleeding occur
Elderly - monitor for gastro-intestinal bleeding over initial 4 weeks
Monitor hepatic function in patients with hepatic impairment
Discontinue if signs of gastro-intestinal ulceration occur
Increased risk of venous thromboembolism
Severe gastro-intestinal side effects may occur without warning
May affect thyroid function tests
Discontinue if any kind of visual disturbance occurs
Discontinue treatment if skin rash or other allergic reaction occurs
Maintain treatment at the lowest effective dose
Start treatment at lowest recommended dose
May cause impaired fertility
Advise patient to take after food to reduce gastro-intestinal disturbances

In patients with Systemic Lupus Erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis.

Pregnancy and Lactation

Pregnancy

Nabumetone is contraindicated in pregnancy.

Constriction of the ductus arteriosus in utero is a pharmacologic consequence arising from the use of prostaglandin synthesis inhibitors during pregnancy, as is inhibition of labour, prolongation of pregnancy, and suppression of foetal renal function. Persistent pulmonary hypertension of the newborn may occur if these agents are used in the 3rd trimester close to delivery. NSAIDs have been associated with spontaneous abortions and congenital malformations.

If a NSAID is considered essential in pregnancy, a more established drug such as ibuprofen or flurbiprofen may be considered.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Lactation

Nabumetone is contraindicated in breastfeeding.

In limited studies so far available, NSAIDs can appear in breast milk in very low concentrations. The manufacturer recommends avoiding the use of nabumetone when breast-feeding.

When an NSAID is considered necessary during breast feeding ibuprofen or flurbiprofen would be the drugs of choice.

Nabumetone is known to be secreted into animal milk. Because of its long half life and low molecular weight its passage into human milk it to be expected.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal pain
Abnormal vision
Acute interstitial nephritis
Aggravation of existing asthma
Agranulocytosis
Alopecia
Altered liver function tests
Alveolitis
Anaphylactoid reaction
Anaphylaxis
Angioedema
Aplastic anaemia
Aseptic meningitis
Asthma
Blood dyscrasias
Bronchospasm
Cardiac failure
Colitis
Confusion
Constipation
Depression
Diarrhoea
Disorientation
Dizziness
Drowsiness
Dry mouth
Dyspepsia
Dyspnoea
Erythema multiforme
Exacerbation of acne
Exacerbation of Crohn's disease
Exacerbation of psoriasis
Fatigue
Fever
Flatulence
Gastritis
Gastro-intestinal perforation
Gastro-intestinal ulceration and bleeding
Haematemesis
Haematuria
Haemolytic anaemia
Hallucinations
Headache
Hepatitis
Hypertension
Impaired fertility
Insomnia
Jaundice
Leucopenia
Liver damage
Malaise
Melaena
Menorrhagia
Nausea
Neck stiffness
Nephrotic syndrome
Nephrotoxicity
Nervousness
Neutropenia
Non-specific allergic reactions
Occult blood in faeces
Ocular discomfort
Ocular irritation
Oedema
Oesophageal erosions
Oesophageal perforation
Oesophageal stricture
Oesophageal ulceration
Optic neuritis
Pancreatitis
Papillary necrosis
Papilloedema
Paraesthesia
Peritonitis
Photosensitivity
Pruritus
Pseudoporphyria
Pulmonary eosinophilia
Pulmonary fibrosis
Rash
Renal failure
Renal impairment
Retrobulbar optic neuritis
Rhinitis
Sedation
Skin eruption
Skin reactions
Stevens-Johnson syndrome
Thrombocytopenia
Thrombosis
Tinnitus
Toxic epidermal necrolysis
Ulcerative stomatitis
Urticaria
Vertigo
Vomiting

Effects on Laboratory Tests

Administration of nabumetone can lower serum thyroid hormone levels and can effect the interpretation of thyroid function tests.

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: July 2014

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press https://www.medicinescomplete.com Accessed on July 21, 2014.

Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

Summary of Product Characteristics: Nabumetone Tablets 500mg. Actavis UK Ltd. Revised November 2012.

Summary of Product Characteristics: Nabumetone Tablets 500mg. Meda Pharmaceuticals. Revised June 2013.

Summary of Product Characteristics: Relifex 500mg. Meda Pharmaceuticals. Revised January 2014.

Summary of Product Characteristics: Relifex Suspension. Meda Pharmaceuticals. Revised July 2013.