Drugs List

Therapeutic Indications

Uses

Ankylosing spondylitis
Dysmenorrhoea (adjunctive treatment)
Osteoarthritis
Pain - mild to moderate
Relief of migraine headache
Rheumatoid disease
Short term use in musculoskeletal disorders

Contraindications

Children under 12 years
Crohn's disease
Galactosaemia
Hereditary fructose intolerance
History of gastrointestinal bleeding
History of gastrointestinal perforation
History of peptic ulcer
History of ulcerative colitis
Peptic ulcer
Severe cardiac failure
Severe hepatic impairment
Severe renal impairment
Third trimester of pregnancy
Ulcerative colitis

Precautions and Warnings

Elderly
Females attempting to conceive
Risk factors for cardiovascular disorder
Asthma
Breastfeeding
Cardiac impairment
Cerebrovascular disorder
Coagulopathy
Congestive cardiac failure
Connective tissue disorder
First trimester of pregnancy
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of gastrointestinal disorder
Hypertension
Ischaemic heart disease
Lactose intolerance
Renal impairment
Second trimester of pregnancy
Severe dehydration
Systemic lupus erythematosus

NSAIDs may provoke or exacerbate asthma
Advise ability to drive/operate machinery may be affected by side effects
Consider other first line treatment options in the elderly
Consider the need for combination therapy with gastroprotective agents
Contains lactose
Preparation contains sucrose
Advise patient to take with or after food
Discontinue if signs of gastro-intestinal bleeding occur
Elderly - monitor for gastro-intestinal bleeding over initial 4 weeks
May inhibit platelet aggregation - observe for signs of bleeding
Monitor closely patient with a history of congestive cardiac failure
Monitor for gastrointestinal bleeding following discontinuation of therapy
Monitor renal function in patients with cardiac impairment
Monitor renal function in patients with hepatic impairment
Monitor renal function in patients with renal impairment
Advise patients to report lower gastrointestinal bleeding
Avoid concomitant drugs which may increase risk of gastrotoxicity/bleeding
Discontinue if signs of gastro-intestinal ulceration occur
High dose/long term use may increase risk of arterial thrombotic events
May prolong bleeding time
Risk of gastro-intestinal bleeding increased in the elderly
Severe gastro-intestinal side effects may occur without warning
Discontinue if drug-related rash or other hypersensitivity reactions occur
Discontinue if patient is attempting to conceive
Discontinue if severe skin reaction occurs
Dosage must be individualised for each patient, especially children
Maintain treatment at the lowest effective dose
Reduce dose in elderly
Start treatment at lowest recommended dose
Avoid long term use
Maintain treatment for the shortest possible duration
May cause impaired fertility

Pregnancy and Lactation

Pregnancy

Flurbiprofen is contraindicated in the third trimester of pregnancy.

At the time of writing there is limited published information regarding the use of flurbiprofen during human pregnancy (Briggs et al, 2015). Studies that have used flurbiprofen on pregnant rats have shown a decrease in foetal survival and prolonged gestation (Briggs et al, 2015). Similar findings to other NSAIDs that have also been associated with spontaneous abortion. However Briggs (2015) also states the risk of flurbiprofen causing defects when used in pregnancy appears to be low. The manufacturer states to avoid the use of flurbiprofen during the first two trimesters of pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use flurbiprofen with caution in breastfeeding.

At the time of writing there is limited published information regarding the use of flurbiprofen during breastfeeding. The Drugs and Lactation Database (LactMed) states that flurbiprofen has a short half-life and therefore any insignificant amounts of the drug that may be excreted in breast milk is unlikely to cause harm to the infant. Hale (2015) also supports LactMed stating any trace of flurbiprofen excreted into breast milk is likely to be clinically insignificant. Schaefer (2015) states that there has been no toxic affects reported on the use of flurbiprofen in breastfeeding, however the manufacturer still suggests to avoid using flurbiprofen during breastfeeding.

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 liver function
Aggravation of existing asthma
Agranulocytosis
Anaphylaxis
Angioedema
Aplastic anaemia
Arterial thrombosis
Aseptic meningitis
Asthma
Bronchospasm
Bullous dermatoses
Cardiac failure
Cerebrovascular accident
Confusion
Constipation
Depression
Diarrhoea
Dizziness
Dyspepsia
Dyspnoea
Epidermal necrolysis
Erythema multiforme
Exacerbation of colitis
Exacerbation of Crohn's disease
Exfoliative dermatitis
Fatigue
Fever
Flatulence
Gastritis
Gastro-intestinal perforation
Gastro-intestinal ulceration and bleeding
Haematemesis
Haemolytic anaemia
Hallucinations
Headache
Hepatitis
Hypersensitivity reactions
Hypertension
Interstitial nephritis
Jaundice
Malaise
Melaena
Myocardial infarction
Nausea
Nephrotic syndrome
Neutropenia
Non-specific allergic reactions
Oedema
Optic neuritis
Pancreatitis
Paraesthesia
Photosensitivity
Pruritus
Purpura
Rash
Renal failure
Somnolence
Stevens-Johnson syndrome
Stomatitis
Stroke
Systemic lupus erythematosus
Thrombocytopenia
Tinnitus
Toxic epidermal necrolysis
Ulcerative stomatitis
Urticaria
Vertigo
Visual disturbances
Vomiting

Presentation

Oral formulations of flurbiprofen

Drugs List

Therapeutic Indications

Uses

Ankylosing spondylitis
Dysmenorrhoea (adjunctive treatment)
Osteoarthritis
Pain - mild to moderate
Relief of migraine headache
Rheumatoid disease
Short term use in musculoskeletal disorders

Dosage

Adults

Elderly

Children

Contraindications

Children under 12 years
Crohn's disease
Galactosaemia
Hereditary fructose intolerance
History of gastrointestinal bleeding
History of gastrointestinal perforation
History of peptic ulcer
History of ulcerative colitis
Peptic ulcer
Severe cardiac failure
Severe hepatic impairment
Severe renal impairment
Third trimester of pregnancy
Ulcerative colitis

Precautions and Warnings

Elderly
Females attempting to conceive
Risk factors for cardiovascular disorder
Asthma
Breastfeeding
Cardiac impairment
Cerebrovascular disorder
Coagulopathy
Congestive cardiac failure
Connective tissue disorder
First trimester of pregnancy
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of gastrointestinal disorder
Hypertension
Ischaemic heart disease
Lactose intolerance
Renal impairment
Second trimester of pregnancy
Severe dehydration
Systemic lupus erythematosus

NSAIDs may provoke or exacerbate asthma
Advise ability to drive/operate machinery may be affected by side effects
Consider other first line treatment options in the elderly
Consider the need for combination therapy with gastroprotective agents
Contains lactose
Preparation contains sucrose
Advise patient to take with or after food
Discontinue if signs of gastro-intestinal bleeding occur
Elderly - monitor for gastro-intestinal bleeding over initial 4 weeks
May inhibit platelet aggregation - observe for signs of bleeding
Monitor closely patient with a history of congestive cardiac failure
Monitor for gastrointestinal bleeding following discontinuation of therapy
Monitor renal function in patients with cardiac impairment
Monitor renal function in patients with hepatic impairment
Monitor renal function in patients with renal impairment
Advise patients to report lower gastrointestinal bleeding
Avoid concomitant drugs which may increase risk of gastrotoxicity/bleeding
Discontinue if signs of gastro-intestinal ulceration occur
High dose/long term use may increase risk of arterial thrombotic events
May prolong bleeding time
Risk of gastro-intestinal bleeding increased in the elderly
Severe gastro-intestinal side effects may occur without warning
Discontinue if drug-related rash or other hypersensitivity reactions occur
Discontinue if patient is attempting to conceive
Discontinue if severe skin reaction occurs
Dosage must be individualised for each patient, especially children
Maintain treatment at the lowest effective dose
Reduce dose in elderly
Start treatment at lowest recommended dose
Avoid long term use
Maintain treatment for the shortest possible duration
May cause impaired fertility

Pregnancy and Lactation

Pregnancy

Flurbiprofen is contraindicated in the third trimester of pregnancy.

At the time of writing there is limited published information regarding the use of flurbiprofen during human pregnancy (Briggs et al, 2015). Studies that have used flurbiprofen on pregnant rats have shown a decrease in foetal survival and prolonged gestation (Briggs et al, 2015). Similar findings to other NSAIDs that have also been associated with spontaneous abortion. However Briggs (2015) also states the risk of flurbiprofen causing defects when used in pregnancy appears to be low. The manufacturer states to avoid the use of flurbiprofen during the first two trimesters of pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use flurbiprofen with caution in breastfeeding.

At the time of writing there is limited published information regarding the use of flurbiprofen during breastfeeding. The Drugs and Lactation Database (LactMed) states that flurbiprofen has a short half-life and therefore any insignificant amounts of the drug that may be excreted in breast milk is unlikely to cause harm to the infant. Hale (2015) also supports LactMed stating any trace of flurbiprofen excreted into breast milk is likely to be clinically insignificant. Schaefer (2015) states that there has been no toxic affects reported on the use of flurbiprofen in breastfeeding, however the manufacturer still suggests to avoid using flurbiprofen during breastfeeding.

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 liver function
Aggravation of existing asthma
Agranulocytosis
Anaphylaxis
Angioedema
Aplastic anaemia
Arterial thrombosis
Aseptic meningitis
Asthma
Bronchospasm
Bullous dermatoses
Cardiac failure
Cerebrovascular accident
Confusion
Constipation
Depression
Diarrhoea
Dizziness
Dyspepsia
Dyspnoea
Epidermal necrolysis
Erythema multiforme
Exacerbation of colitis
Exacerbation of Crohn's disease
Exfoliative dermatitis
Fatigue
Fever
Flatulence
Gastritis
Gastro-intestinal perforation
Gastro-intestinal ulceration and bleeding
Haematemesis
Haemolytic anaemia
Hallucinations
Headache
Hepatitis
Hypersensitivity reactions
Hypertension
Interstitial nephritis
Jaundice
Malaise
Melaena
Myocardial infarction
Nausea
Nephrotic syndrome
Neutropenia
Non-specific allergic reactions
Oedema
Optic neuritis
Pancreatitis
Paraesthesia
Photosensitivity
Pruritus
Purpura
Rash
Renal failure
Somnolence
Stevens-Johnson syndrome
Stomatitis
Stroke
Systemic lupus erythematosus
Thrombocytopenia
Tinnitus
Toxic epidermal necrolysis
Ulcerative stomatitis
Urticaria
Vertigo
Visual disturbances
Vomiting

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: February 2017

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

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.
Joint Formulary Committee. British National Formulary. 72nd ed. London: BMJ Group and Pharmaceutical Press; 2016.

Paediatric Formulary Committee. BNF for Children 2016-2017. London: BMJ Group, Pharmaceutical Press, and RCPCH Publications; 2016.

Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

Summary of Product Characteristics: Froben 50 mg Tablets. Mylan Products Limited. Revised September 2016.

Summary of Product Characteristics: Froben 100 mg Tablets. Mylan Products Limited. Revised September 2016.

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
Last revised: 03 October 2015
Last accessed: 11 January 2017