Drugs List

Therapeutic Indications

Uses

Ankylosing spondylitis
Musculo-skeletal conditions
Osteoarthritis
Rheumatoid arthritis
Treatment of post-operative pain

Contraindications

Children under 18 years
Bladder disorder
History of gastrointestinal haemorrhage secondary to NSAID
History of peptic ulcer
Peptic ulcer
Prostate disorder
Renal impairment - creatinine clearance below 10ml/minute
Severe cardiac failure
Severe hepatic impairment
Third trimester of pregnancy
Urinary system disorder

Precautions and Warnings

Elderly
Haemorrhagic diathesis
Risk factors for cardiovascular disorder
Asthma
Breastfeeding
Cardiac impairment
Cerebrovascular disorder
Congestive cardiac failure
Connective tissue disorder
Crohn's disease
First trimester of pregnancy
Hepatic impairment
History of asthma
History of gastrointestinal disorder
History of hepatic impairment
Hypertension
Intracranial haemorrhage
Ischaemic heart disease
Peripheral arterial circulatory disorder
Renal impairment
Second trimester of pregnancy
Systemic lupus erythematosus
Ulcerative colitis

NSAIDs may provoke or exacerbate asthma
Reduce dose in patients with renal impairment
Advise patient ability to drive or operate machinery may be impaired
Consider other first line treatment options in the elderly
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
Monitor patients on prolonged therapy
Monitor urine output & renal function in patients at risk of renal failure
Severe gastro-intestinal side effects may occur without warning
Discontinue if drug-related rash or other hypersensitivity reactions occur
Discontinue if urinary tract symptoms develop & report promptly to doctor
Maintain treatment at the lowest effective dose
Start treatment at lowest recommended dose
May cause impaired fertility

Pregnancy and Lactation

Pregnancy

Tiaprofenic acid is contraindicated in the third trimester of pregnancy.

In common with other NSAIDs, administration during the first and second trimester should be avoided unless the potential benefit to the patient outweighs the risk to the foetus. Although animal studies have not revealed evidence of teratogenicity, tiaprofenic acid crosses the placenta therefore safety in human pregnancy cannot be assumed. Congenital defects have been reported in association with NSAIDs, however these are of low frequency and follow no discernible pattern.

Schaefer (2015) recommends that the more established NSAIDs like ibuprofen and diclofenac should be considered in the first two trimesters. Use in late pregnancy should be avoided in view of the known effects of NSAIDS on the foetal cardiovascular system (a closure of ductus arteriosus). The onset of labour might be delayed and duration may increase as well as a risk of bleeding tendency in both mother and child. If treatment is unavoidable in the third trimester, foetal circulation should be monitored regularly (once or twice a week) as well as ductal flow and amniotic fluid volume evaluated by sonography.

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 tiaprofenic acid with caution in breastfeeding.

The level of tiaprofenic acid in mother's milk has been studied and the total daily exposure is very small, approximately 0.2% of the administered dose, and is unlikely to be of pharmacological significance. Breastfeeding or treatment of the mother should be stopped as necessary, Schaefer (2015) recommends that ibuprofen is the drugs of choice 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 tests
Acute interstitial nephritis
Agranulocytosis
Alopecia
Alveolitis
Anaemia
Anaphylactic shock
Angioedema
Anorexia
Aplastic anaemia
Arterial thrombosis
Aseptic meningitis
Asthma
Bladder irritation
Bronchospasm
Bullous dermatoses
Bullous eruption
Cardiac failure
Confusion
Constipation
Cystitis
Depression
Diarrhoea
Dizziness
Drowsiness
Dyspepsia
Dyspnoea
Dysuria
Erythema multiforme
Exacerbation of colitis
Exacerbation of Crohn's disease
Fatigue
Flatulence
Fluid retention
Gastritis
Gastro-intestinal haemorrhage
Gastro-intestinal perforation
Gastro-intestinal symptoms
Gastro-intestinal ulceration
Haematemesis
Haematuria
Haemolytic anaemia
Hallucinations
Headache
Heartburn
Hepatic damage
Hepatitis
Hypersensitivity reactions
Hypertension
Indigestion
Insomnia
Interstitial fibrosis
Jaundice
Malaise
Melaena
Nausea
Nephrotic syndrome
Nephrotoxicity
Nervousness
Neutropenia
Non-specific allergic reactions
Oedema
Optic neuritis
Pancreatitis
Papillary necrosis
Paraesthesia
Photosensitivity
Pruritus
Pulmonary eosinophilia
Purpura
Rash
Renal failure
Renal impairment
Sodium/water retention
Stevens-Johnson syndrome
Thrombocytopenia
Tinnitus
Toxic epidermal necrolysis
Ulcerative stomatitis
Upper abdominal pain
Urinary abnormalities
Urticaria
Vertigo
Visual disturbances
Vomiting

Presentation

Oral formulations of tiaprofenic acid

Drugs List

Therapeutic Indications

Uses

Ankylosing spondylitis
Musculo-skeletal conditions
Osteoarthritis
Rheumatoid arthritis
Treatment of post-operative pain

Dosage

Adults

Elderly

Contraindications

Children under 18 years
Bladder disorder
History of gastrointestinal haemorrhage secondary to NSAID
History of peptic ulcer
Peptic ulcer
Prostate disorder
Renal impairment - creatinine clearance below 10ml/minute
Severe cardiac failure
Severe hepatic impairment
Third trimester of pregnancy
Urinary system disorder

Precautions and Warnings

Elderly
Haemorrhagic diathesis
Risk factors for cardiovascular disorder
Asthma
Breastfeeding
Cardiac impairment
Cerebrovascular disorder
Congestive cardiac failure
Connective tissue disorder
Crohn's disease
First trimester of pregnancy
Hepatic impairment
History of asthma
History of gastrointestinal disorder
History of hepatic impairment
Hypertension
Intracranial haemorrhage
Ischaemic heart disease
Peripheral arterial circulatory disorder
Renal impairment
Second trimester of pregnancy
Systemic lupus erythematosus
Ulcerative colitis

NSAIDs may provoke or exacerbate asthma
Reduce dose in patients with renal impairment
Advise patient ability to drive or operate machinery may be impaired
Consider other first line treatment options in the elderly
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
Monitor patients on prolonged therapy
Monitor urine output & renal function in patients at risk of renal failure
Severe gastro-intestinal side effects may occur without warning
Discontinue if drug-related rash or other hypersensitivity reactions occur
Discontinue if urinary tract symptoms develop & report promptly to doctor
Maintain treatment at the lowest effective dose
Start treatment at lowest recommended dose
May cause impaired fertility

Pregnancy and Lactation

Pregnancy

Tiaprofenic acid is contraindicated in the third trimester of pregnancy.

In common with other NSAIDs, administration during the first and second trimester should be avoided unless the potential benefit to the patient outweighs the risk to the foetus. Although animal studies have not revealed evidence of teratogenicity, tiaprofenic acid crosses the placenta therefore safety in human pregnancy cannot be assumed. Congenital defects have been reported in association with NSAIDs, however these are of low frequency and follow no discernible pattern.

Schaefer (2015) recommends that the more established NSAIDs like ibuprofen and diclofenac should be considered in the first two trimesters. Use in late pregnancy should be avoided in view of the known effects of NSAIDS on the foetal cardiovascular system (a closure of ductus arteriosus). The onset of labour might be delayed and duration may increase as well as a risk of bleeding tendency in both mother and child. If treatment is unavoidable in the third trimester, foetal circulation should be monitored regularly (once or twice a week) as well as ductal flow and amniotic fluid volume evaluated by sonography.

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 tiaprofenic acid with caution in breastfeeding.

The level of tiaprofenic acid in mother's milk has been studied and the total daily exposure is very small, approximately 0.2% of the administered dose, and is unlikely to be of pharmacological significance. Breastfeeding or treatment of the mother should be stopped as necessary, Schaefer (2015) recommends that ibuprofen is the drugs of choice 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 tests
Acute interstitial nephritis
Agranulocytosis
Alopecia
Alveolitis
Anaemia
Anaphylactic shock
Angioedema
Anorexia
Aplastic anaemia
Arterial thrombosis
Aseptic meningitis
Asthma
Bladder irritation
Bronchospasm
Bullous dermatoses
Bullous eruption
Cardiac failure
Confusion
Constipation
Cystitis
Depression
Diarrhoea
Dizziness
Drowsiness
Dyspepsia
Dyspnoea
Dysuria
Erythema multiforme
Exacerbation of colitis
Exacerbation of Crohn's disease
Fatigue
Flatulence
Fluid retention
Gastritis
Gastro-intestinal haemorrhage
Gastro-intestinal perforation
Gastro-intestinal symptoms
Gastro-intestinal ulceration
Haematemesis
Haematuria
Haemolytic anaemia
Hallucinations
Headache
Heartburn
Hepatic damage
Hepatitis
Hypersensitivity reactions
Hypertension
Indigestion
Insomnia
Interstitial fibrosis
Jaundice
Malaise
Melaena
Nausea
Nephrotic syndrome
Nephrotoxicity
Nervousness
Neutropenia
Non-specific allergic reactions
Oedema
Optic neuritis
Pancreatitis
Papillary necrosis
Paraesthesia
Photosensitivity
Pruritus
Pulmonary eosinophilia
Purpura
Rash
Renal failure
Renal impairment
Sodium/water retention
Stevens-Johnson syndrome
Thrombocytopenia
Tinnitus
Toxic epidermal necrolysis
Ulcerative stomatitis
Upper abdominal pain
Urinary abnormalities
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: November 2016

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.

Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press. Accessed on 21 October 2016.

Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications. Accessed on 21 October 2016.

Summary of Product Characteristics: Surgam 300 mg. Sanofi-aventis. Revised November 2013.