Drugs List

Therapeutic Indications

Uses

Ankylosing spondylitis
Osteoarthritis
Rheumatoid arthritis

Unlicensed Uses

Juvenile idiopathic arthritis

Contraindications

Children under 6 years
History of serious hypersensitivity reactions
Recent anticoagulant therapy
Crohn's disease
Diverticulitis
Galactosaemia
Gastrointestinal haemorrhage
Gastrointestinal perforation
History of erythema multiforme
History of gastrointestinal bleeding
History of gastrointestinal perforation
History of gastrointestinal ulceration
History of Stevens-Johnson syndrome
History of toxic epidermal necrolysis
History of ulcerative colitis
Nasal polyps, angioedema, and bronchospastic reactivity to NSAIDs
Non-dialysed severe renal failure
Peptic ulcer
Severe cardiac failure
Severe hepatic impairment
Third trimester of pregnancy
Ulcerative colitis

Precautions and Warnings

Children under 18 years
Elderly
Risk factors for cardiovascular disorder
Asthma
Breastfeeding
Cardiac impairment
Cerebrovascular disorder
Congestive cardiac failure
First trimester of pregnancy
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of asthma
Hypertension
Ischaemic heart disease
Kidney transplantation
Lactose intolerance
Nephrotic syndrome
Peripheral vascular disease
Phenylketonuria
Renal impairment
Second trimester of pregnancy

NSAIDs may provoke or exacerbate asthma
Some formulations contain aspartame - caution in phenylketonuria
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
Treatment to be prescribed under the supervision of a specialist
Some formulations contain lactose
Advise patient to take with or after food
If visual disturbances occur, perform ophthalmic evaluation
May inhibit platelet aggregation - observe for signs of bleeding
Monitor for gastrointestinal toxicity
Monitor renal function in patients with cardiac impairment
Monitor renal function in patients with hepatic impairment
Monitor renal function in patients with renal impairment
Monitor serum creatinine in patients with renal impairment
Review treatment after 14 days, and frequently thereafter
Risk of gastrointestinal haemorrhage
Advise patients to report signs or symptoms of gastro-intestinal ulcer
Avoid concomitant drugs which may increase risk of gastrotoxicity/bleeding
Contact doctor immediately with any signs of hypersensitivity reactions
Discontinue treatment if Stevens-Johnson Syndrome suspected
Discontinue treatment if toxic epidermal necrolysis is suspected
High dose/long term use may increase risk of arterial thrombotic events
Risk of gastro-intestinal bleeding increased in the elderly
Severe gastro-intestinal side effects may occur without warning
Discontinue at first signs of skin erythema
Discontinue if liver function deteriorates
Maintain treatment at the lowest effective dose
Start treatment at lowest recommended dose
Maintain treatment for the shortest possible duration
Advise patient to avoid excess of alcohol
May cause impaired fertility

Pregnancy and Lactation

Pregnancy

Piroxicam is contraindicated in the last trimester of pregnancy.

Animal studies have not shown any teratogenic effects when using piroxicam during pregnancy (Briggs et al, 2015), however congenital abnormalities associated with NSAID use have been reported. Piroxicam inhibits prostaglandin synthesis which may expose the foetus to cardiopulmonary toxicity, renal dysfunction, possible prolongation of bleeding time and inhibition the contraction of the uterus if used in late pregnancy. Evidence indicates that NSAIDS use may lead to a higher risk of spontaneous abortions and impaired fertility (Briggs et al, 2015). The manufacturer suggests to avoid use of piroxicam in the first two trimesters of pregnancy and labour 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 piroxicam with caution in breastfeeding.

Schaefer (2015) states that piroxicam is not the first NSAID of choice in breastfeeding due to its relatively long half-life. However, if necessary, it is compatible with breastfeeding as NSAIDs are known to be excreted into breast milk at low concentrations, therefore it is unlikely to cause harm to the infant. Hale (2015) and Briggs (2015) also support piroxicam to be considered safe to use in breastfeeding. The manufacturer suggests to avoid the use of piroxicam in breastfeeding as it appears in breast milk 1% to 3% of maternal plasma concentrations.

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 discomfort
Abdominal pain
Alopecia
Anaemia
Anaphylaxis
Angioedema
Anorexia
Aplastic anaemia
Arterial thrombosis
Blurred vision
Bronchospasm
Cardiac failure
Confusion
Constipation
Convulsions
Decrease in haemoglobin and haematocrit
Depression
Diarrhoea
Dizziness
Dream abnormalities
Drowsiness
Drug rash with eosinophilia and systemic symptoms (DRESS)
Dyspepsia
Dyspnoea
Elevated serum potassium
Eosinophilia
Epigastric distress
Epistaxis
Exacerbation of colitis
Exacerbation of Crohn's disease
Exacerbation of pre-existing asthma
Exfoliative dermatitis
Eye irritation
Flatulence
Fluid retention
Gastritis
Gastro-intestinal perforation
Gastro-intestinal ulceration
Gastrointestinal bleeding
Glomerulonephritis
Haematemesis
Haemolytic anaemia
Hallucinations
Headache
Hearing disturbances
Hepatitis
Hyperglycaemia
Hypersensitivity reactions
Hypertension
Hypoglycaemia
Increase in antinuclear antibodies (ANA)
Increase in serum transaminases
Indigestion
Insomnia
Interstitial nephritis
Jaundice
Leucopenia
Malaise
Melaena
Metabolic changes
Mood changes
Myocardial infarction
Nausea
Nephrotic syndrome
Nervousness
Non-thrombocytopenic purpura
Oedema
Onycholysis
Palpitations
Pancreatitis
Paraesthesia
Photosensitivity
Prolonged bleeding
Pruritus
Psychosis
Rash
Renal failure
Renal papillary necrosis
Serum sickness
Skin reactions
Sodium retention
Somnolence
Stevens-Johnson syndrome
Stomatitis
Stroke
Swollen eyes
Thrombocytopenia
Tinnitus
Toxic epidermal necrolysis
Urticaria
Vasculitis
Vertigo
Vesiculo-bullous reactions
Visual disturbances
Vomiting
Weight changes

Presentation

Oral formulations of piroxicam.

Drugs List

Therapeutic Indications

Uses

Ankylosing spondylitis
Osteoarthritis
Rheumatoid arthritis

Unlicensed Uses

Juvenile idiopathic arthritis

Dosage

Adults

Children

Contraindications

Children under 6 years
History of serious hypersensitivity reactions
Recent anticoagulant therapy
Crohn's disease
Diverticulitis
Galactosaemia
Gastrointestinal haemorrhage
Gastrointestinal perforation
History of erythema multiforme
History of gastrointestinal bleeding
History of gastrointestinal perforation
History of gastrointestinal ulceration
History of Stevens-Johnson syndrome
History of toxic epidermal necrolysis
History of ulcerative colitis
Nasal polyps, angioedema, and bronchospastic reactivity to NSAIDs
Non-dialysed severe renal failure
Peptic ulcer
Severe cardiac failure
Severe hepatic impairment
Third trimester of pregnancy
Ulcerative colitis

Precautions and Warnings

Children under 18 years
Elderly
Risk factors for cardiovascular disorder
Asthma
Breastfeeding
Cardiac impairment
Cerebrovascular disorder
Congestive cardiac failure
First trimester of pregnancy
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of asthma
Hypertension
Ischaemic heart disease
Kidney transplantation
Lactose intolerance
Nephrotic syndrome
Peripheral vascular disease
Phenylketonuria
Renal impairment
Second trimester of pregnancy

NSAIDs may provoke or exacerbate asthma
Some formulations contain aspartame - caution in phenylketonuria
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
Treatment to be prescribed under the supervision of a specialist
Some formulations contain lactose
Advise patient to take with or after food
If visual disturbances occur, perform ophthalmic evaluation
May inhibit platelet aggregation - observe for signs of bleeding
Monitor for gastrointestinal toxicity
Monitor renal function in patients with cardiac impairment
Monitor renal function in patients with hepatic impairment
Monitor renal function in patients with renal impairment
Monitor serum creatinine in patients with renal impairment
Review treatment after 14 days, and frequently thereafter
Risk of gastrointestinal haemorrhage
Advise patients to report signs or symptoms of gastro-intestinal ulcer
Avoid concomitant drugs which may increase risk of gastrotoxicity/bleeding
Contact doctor immediately with any signs of hypersensitivity reactions
Discontinue treatment if Stevens-Johnson Syndrome suspected
Discontinue treatment if toxic epidermal necrolysis is suspected
High dose/long term use may increase risk of arterial thrombotic events
Risk of gastro-intestinal bleeding increased in the elderly
Severe gastro-intestinal side effects may occur without warning
Discontinue at first signs of skin erythema
Discontinue if liver function deteriorates
Maintain treatment at the lowest effective dose
Start treatment at lowest recommended dose
Maintain treatment for the shortest possible duration
Advise patient to avoid excess of alcohol
May cause impaired fertility

Pregnancy and Lactation

Pregnancy

Piroxicam is contraindicated in the last trimester of pregnancy.

Animal studies have not shown any teratogenic effects when using piroxicam during pregnancy (Briggs et al, 2015), however congenital abnormalities associated with NSAID use have been reported. Piroxicam inhibits prostaglandin synthesis which may expose the foetus to cardiopulmonary toxicity, renal dysfunction, possible prolongation of bleeding time and inhibition the contraction of the uterus if used in late pregnancy. Evidence indicates that NSAIDS use may lead to a higher risk of spontaneous abortions and impaired fertility (Briggs et al, 2015). The manufacturer suggests to avoid use of piroxicam in the first two trimesters of pregnancy and labour 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 piroxicam with caution in breastfeeding.

Schaefer (2015) states that piroxicam is not the first NSAID of choice in breastfeeding due to its relatively long half-life. However, if necessary, it is compatible with breastfeeding as NSAIDs are known to be excreted into breast milk at low concentrations, therefore it is unlikely to cause harm to the infant. Hale (2015) and Briggs (2015) also support piroxicam to be considered safe to use in breastfeeding. The manufacturer suggests to avoid the use of piroxicam in breastfeeding as it appears in breast milk 1% to 3% of maternal plasma concentrations.

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 discomfort
Abdominal pain
Alopecia
Anaemia
Anaphylaxis
Angioedema
Anorexia
Aplastic anaemia
Arterial thrombosis
Blurred vision
Bronchospasm
Cardiac failure
Confusion
Constipation
Convulsions
Decrease in haemoglobin and haematocrit
Depression
Diarrhoea
Dizziness
Dream abnormalities
Drowsiness
Drug rash with eosinophilia and systemic symptoms (DRESS)
Dyspepsia
Dyspnoea
Elevated serum potassium
Eosinophilia
Epigastric distress
Epistaxis
Exacerbation of colitis
Exacerbation of Crohn's disease
Exacerbation of pre-existing asthma
Exfoliative dermatitis
Eye irritation
Flatulence
Fluid retention
Gastritis
Gastro-intestinal perforation
Gastro-intestinal ulceration
Gastrointestinal bleeding
Glomerulonephritis
Haematemesis
Haemolytic anaemia
Hallucinations
Headache
Hearing disturbances
Hepatitis
Hyperglycaemia
Hypersensitivity reactions
Hypertension
Hypoglycaemia
Increase in antinuclear antibodies (ANA)
Increase in serum transaminases
Indigestion
Insomnia
Interstitial nephritis
Jaundice
Leucopenia
Malaise
Melaena
Metabolic changes
Mood changes
Myocardial infarction
Nausea
Nephrotic syndrome
Nervousness
Non-thrombocytopenic purpura
Oedema
Onycholysis
Palpitations
Pancreatitis
Paraesthesia
Photosensitivity
Prolonged bleeding
Pruritus
Psychosis
Rash
Renal failure
Renal papillary necrosis
Serum sickness
Skin reactions
Sodium retention
Somnolence
Stevens-Johnson syndrome
Stomatitis
Stroke
Swollen eyes
Thrombocytopenia
Tinnitus
Toxic epidermal necrolysis
Urticaria
Vasculitis
Vertigo
Vesiculo-bullous reactions
Visual disturbances
Vomiting
Weight changes

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.

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

Summary of Product Characteristics: Feldene 10 mg capsules. Pfizer Ltd. Revised October 2020.

Summary of Product Characteristics: Feldene 20 mg capsules. Pfizer Ltd. Revised October 2020.

Summary of Product Characteristics: Feldene Melt 20 mg. Pfizer Ltd. Revised February 2020.

Summary of Product Characteristics: Piroxicam 10 mg capsules. Actavis UK Ltd. Revised July 2016.

Summary of Product Characteristics: Piroxicam 20 mg capsules. Actavis UK Ltd. Revised July 2016.

The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 11 September 2017