Drugs List

Therapeutic Indications

Uses

Ankylosing spondylitis
Relief of pain and inflammation in osteoarthritis
Relief of pain and inflammation in rheumatoid arthritis

Contraindications

Children under 18 years
Haemorrhage
Varicella
Cerebrovascular disorder
Gastrointestinal haemorrhage
History of gastrointestinal bleeding
History of gastrointestinal perforation
History of peptic ulcer
Ischaemic heart disease
New York Heart Association class II failure
New York Heart Association class III failure
New York Heart Association class IV failure
Peptic ulcer
Peripheral arterial circulatory disorder
Porphyria
Severe hepatic impairment
Severe renal impairment
Third trimester of pregnancy

Precautions and Warnings

Elderly
Females attempting to conceive
Predisposition to haemorrhage
Risk factors for cardiovascular disorder
Asthma
Breastfeeding
Cardiac impairment
Connective tissue disorder
Crohn's disease
First trimester of pregnancy
Gastrointestinal disorder
Haematological disorder
Hepatic impairment
History of asthma
History of cerebrovascular haemorrhage
History of gastrointestinal ulceration
New York Heart Association class I failure
Renal impairment - glomerular filtration rate below 50ml/minute
Second trimester of pregnancy
Systemic lupus erythematosus
Ulcerative colitis

May precipitate bronchospasm in patients with asthma or allergy
Advise ability to drive/operate machinery may be affected by side effects
Discontinue if signs of gastro-intestinal bleeding occur
Elderly: Monitor for gastrointestinal bleeding
May inhibit platelet aggregation - observe for signs of bleeding
Monitor closely patient with a history of congestive cardiac failure
Monitor hepatic function on long term therapy
Monitor patients with pre-existing hypertension
Monitor renal function on long term therapy
Allergic reactions may occur without previous exposure to the drug
Discontinue if signs of gastro-intestinal ulceration occur
Severe gastro-intestinal side effects may occur without warning
Discontinue if liver function deteriorates
Discontinue if severe skin reaction occurs
Discontinue if symptoms of hepatic disease occur
Maintain treatment at the lowest effective dose
Start treatment at lowest recommended dose
Advise patient not to take NSAIDs unless advised by clinician
Female: May cause infertility

The importance of prostaglandins in maintaining renal blood flow should be taken into account in patients with impaired cardiac or renal functions, those being treated with diuretics or recovering from major surgery. Effects on renal function are usually reversible when treatment is withdrawn.

If abnormal liver function tests persist or worsen, clinical signs and symptoms consistent with liver disease develop or if other manifestations occur (eosinophilia, rash), treatment should be discontinued. Hepatitis may occur without prodromal symptoms.

Patients with a history of peptic ulcers, particularly those with haemorrhaging or perforation, are at a higher risk of GI bleeding, ulceration or perforation with increasing doses of NSAIDs. The lowest available dose should be administered initially; a protective agent (misoprostol/proton pump inhibitor) should be considered for concomitant therapy. Patients requiring low dose aspirin should also be considered for concomitant therapy along with other drugs that may increase gastrointestinal risk.

Pregnancy and Lactation

Pregnancy

Aceclofenac is contraindicated during the 3rd trimester of pregnancy but may be used with caution in the 1st and 2nd trimester.

The manufacturer does not recommend aceclofenac during pregnancy.

When an NSAID is considered essential in the first and second trimester, a more established drug such as ibuprofen may be considered (Schaefer, 2015).

Studies in animals have shown an increased pre- and post-implantation loss and embryo-foetal lethality when a prostaglandin synthesis inhibitor has been administered. Additionally, increased incidences of malformations, including cardiovascular, has been observed when a prostaglandin synthesis inhibitor is given during the organogenetic period.

Aceclofenac may have the following effects during the third trimester:
- Pulmonary and cardiac toxicity in the foetus/newborn (pulmonary hypertension and premature closure of the ductus arteriosus).
- Renal dysfunction in the foetus, which may progress to renal failure with oligo-hydroamniosis.
- Inhibition of uterine contractions with delayed onset and prolongation of labour.
- Increased possibility of bleeding in mother and neonate at the end of pregnancy.

Lactation

Use aceclofenac with caution during breastfeeding.

In limited studies so far available, NSAIDs can appear in breast milk in very low concentrations. The manufacturer recommends avoiding the use of aceclofenac unless the potential benefits to the mother outweigh the possible risks to the foetus.

When an NSAID is considered necessary during breastfeeding ibuprofen or flurbiprofen would be the drugs of choice (Briggs, 2015).

Side Effects

Abdominal pain
Abnormal liver function
Aggravation of existing asthma
Agranulocytosis
Anaemia
Anaphylactic reaction
Angioedema
Aplastic anaemia
Arterial thrombosis
Aseptic meningitis
Asthma
Blood urea increased
Bronchospasm
Bullous dermatoses
Cardiac failure
Confusion
Constipation
Depression
Dermatitis
Diarrhoea
Dizziness
Dream abnormalities
Dyspepsia
Dyspnoea
Eczema
Erythema multiforme
Exacerbation of colitis
Exacerbation of Crohn's disease
Exfoliative dermatitis
Facial oedema
Fatigue
Flatulence
Flushing
Gastric ulceration
Gastritis
Gastro-intestinal haemorrhage
Gastro-intestinal perforation
Granulocytopenia
Haematemesis
Haemolytic anaemia
Hallucinations
Headache
Hepatitis
Hot flushes
Hyperkalaemia
Hypersensitivity reactions
Hypertension
Increase in alkaline phosphatase
Increase in blood urea nitrogen
Increases in hepatic enzymes
Insomnia
Interstitial nephritis
Jaundice
Leg cramps
Malaise
Melaena
Mouth ulcers
Nausea
Nephrotic syndrome
Nephrotoxicity
Neutropenia
Non-specific allergic reactions
Oedema
Optic neuritis
Palpitations
Pancreatitis
Paraesthesia
Photosensitivity
Pruritus
Purpura
Rash
Renal failure
Renal impairment
Serum creatinine increased
Somnolence
Stevens-Johnson syndrome
Stomatitis
Stridor
Taste disturbances
Thrombocytopenia
Tinnitus
Toxic epidermal necrolysis
Tremor
Ulcerative stomatitis
Urticaria
Vertigo
Visual disturbances
Vomiting
Weight gain

Presentation

Oral formulations of aceclofenac.

Drugs List

Therapeutic Indications

Uses

Ankylosing spondylitis
Relief of pain and inflammation in osteoarthritis
Relief of pain and inflammation in rheumatoid arthritis

Dosage

Adults

Patients with Renal Impairment

Patients with Hepatic Impairment

Contraindications

Children under 18 years
Haemorrhage
Varicella
Cerebrovascular disorder
Gastrointestinal haemorrhage
History of gastrointestinal bleeding
History of gastrointestinal perforation
History of peptic ulcer
Ischaemic heart disease
New York Heart Association class II failure
New York Heart Association class III failure
New York Heart Association class IV failure
Peptic ulcer
Peripheral arterial circulatory disorder
Porphyria
Severe hepatic impairment
Severe renal impairment
Third trimester of pregnancy

Precautions and Warnings

Elderly
Females attempting to conceive
Predisposition to haemorrhage
Risk factors for cardiovascular disorder
Asthma
Breastfeeding
Cardiac impairment
Connective tissue disorder
Crohn's disease
First trimester of pregnancy
Gastrointestinal disorder
Haematological disorder
Hepatic impairment
History of asthma
History of cerebrovascular haemorrhage
History of gastrointestinal ulceration
New York Heart Association class I failure
Renal impairment - glomerular filtration rate below 50ml/minute
Second trimester of pregnancy
Systemic lupus erythematosus
Ulcerative colitis

May precipitate bronchospasm in patients with asthma or allergy
Advise ability to drive/operate machinery may be affected by side effects
Discontinue if signs of gastro-intestinal bleeding occur
Elderly: Monitor for gastrointestinal bleeding
May inhibit platelet aggregation - observe for signs of bleeding
Monitor closely patient with a history of congestive cardiac failure
Monitor hepatic function on long term therapy
Monitor patients with pre-existing hypertension
Monitor renal function on long term therapy
Allergic reactions may occur without previous exposure to the drug
Discontinue if signs of gastro-intestinal ulceration occur
Severe gastro-intestinal side effects may occur without warning
Discontinue if liver function deteriorates
Discontinue if severe skin reaction occurs
Discontinue if symptoms of hepatic disease occur
Maintain treatment at the lowest effective dose
Start treatment at lowest recommended dose
Advise patient not to take NSAIDs unless advised by clinician
Female: May cause infertility

The importance of prostaglandins in maintaining renal blood flow should be taken into account in patients with impaired cardiac or renal functions, those being treated with diuretics or recovering from major surgery. Effects on renal function are usually reversible when treatment is withdrawn.

If abnormal liver function tests persist or worsen, clinical signs and symptoms consistent with liver disease develop or if other manifestations occur (eosinophilia, rash), treatment should be discontinued. Hepatitis may occur without prodromal symptoms.

Patients with a history of peptic ulcers, particularly those with haemorrhaging or perforation, are at a higher risk of GI bleeding, ulceration or perforation with increasing doses of NSAIDs. The lowest available dose should be administered initially; a protective agent (misoprostol/proton pump inhibitor) should be considered for concomitant therapy. Patients requiring low dose aspirin should also be considered for concomitant therapy along with other drugs that may increase gastrointestinal risk.

Pregnancy and Lactation

Pregnancy

Aceclofenac is contraindicated during the 3rd trimester of pregnancy but may be used with caution in the 1st and 2nd trimester.

The manufacturer does not recommend aceclofenac during pregnancy.

When an NSAID is considered essential in the first and second trimester, a more established drug such as ibuprofen may be considered (Schaefer, 2015).

Studies in animals have shown an increased pre- and post-implantation loss and embryo-foetal lethality when a prostaglandin synthesis inhibitor has been administered. Additionally, increased incidences of malformations, including cardiovascular, has been observed when a prostaglandin synthesis inhibitor is given during the organogenetic period.

Aceclofenac may have the following effects during the third trimester:
- Pulmonary and cardiac toxicity in the foetus/newborn (pulmonary hypertension and premature closure of the ductus arteriosus).
- Renal dysfunction in the foetus, which may progress to renal failure with oligo-hydroamniosis.
- Inhibition of uterine contractions with delayed onset and prolongation of labour.
- Increased possibility of bleeding in mother and neonate at the end of pregnancy.

Lactation

Use aceclofenac with caution during breastfeeding.

In limited studies so far available, NSAIDs can appear in breast milk in very low concentrations. The manufacturer recommends avoiding the use of aceclofenac unless the potential benefits to the mother outweigh the possible risks to the foetus.

When an NSAID is considered necessary during breastfeeding ibuprofen or flurbiprofen would be the drugs of choice (Briggs, 2015).

Side Effects

Abdominal pain
Abnormal liver function
Aggravation of existing asthma
Agranulocytosis
Anaemia
Anaphylactic reaction
Angioedema
Aplastic anaemia
Arterial thrombosis
Aseptic meningitis
Asthma
Blood urea increased
Bronchospasm
Bullous dermatoses
Cardiac failure
Confusion
Constipation
Depression
Dermatitis
Diarrhoea
Dizziness
Dream abnormalities
Dyspepsia
Dyspnoea
Eczema
Erythema multiforme
Exacerbation of colitis
Exacerbation of Crohn's disease
Exfoliative dermatitis
Facial oedema
Fatigue
Flatulence
Flushing
Gastric ulceration
Gastritis
Gastro-intestinal haemorrhage
Gastro-intestinal perforation
Granulocytopenia
Haematemesis
Haemolytic anaemia
Hallucinations
Headache
Hepatitis
Hot flushes
Hyperkalaemia
Hypersensitivity reactions
Hypertension
Increase in alkaline phosphatase
Increase in blood urea nitrogen
Increases in hepatic enzymes
Insomnia
Interstitial nephritis
Jaundice
Leg cramps
Malaise
Melaena
Mouth ulcers
Nausea
Nephrotic syndrome
Nephrotoxicity
Neutropenia
Non-specific allergic reactions
Oedema
Optic neuritis
Palpitations
Pancreatitis
Paraesthesia
Photosensitivity
Pruritus
Purpura
Rash
Renal failure
Renal impairment
Serum creatinine increased
Somnolence
Stevens-Johnson syndrome
Stomatitis
Stridor
Taste disturbances
Thrombocytopenia
Tinnitus
Toxic epidermal necrolysis
Tremor
Ulcerative stomatitis
Urticaria
Vertigo
Visual disturbances
Vomiting
Weight gain

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: March 2021

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.

Summary of Product Characteristics: Aceclofenac 100mg film-coated tablets. Accord healthcare Limited. Revised March 2019.

Summary of Product Characteristics: Preservex film-coated tablets. Almirall Limited. Revised August 2020.

The Renal Drug Handbook. Fifth Edition (2019) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.

MHRA Drug Safety Update January 2015
Available at: https://www.mhra.gov.uk
Last accessed: 02 March 2021

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 02 March 2021