Drugs List

Therapeutic Indications

Uses

Intermittent claudication

For the improvement of the maximal and pain-free walking distances in patients with intermittent claudication, who do not have rest pain and who do not have evidence of peripheral tissue necrosis.

Use is restricted to second line treatment where lifestyle modifications and other appropriate interventions have failed to improve symptoms.

Contraindications

Children under 18 years
Predisposition to haemorrhage
Breastfeeding
Congestive cardiac failure
Hereditary fructose intolerance
History of multifocal ventricular ectopics
History of severe tachyarrhythmia
History of ventricular fibrillation
History of ventricular tachycardia
Long QT syndrome
Moderate hepatic impairment
Peptic ulcer
Pregnancy
Proliferative diabetic retinopathy
Renal impairment - creatinine clearance below 25 ml/minute
Torsade de pointes
Uncontrolled hypertension
Unstable angina
Within 6 months of a myocardial infarction
Within 6 months of a percutaneous coronary intervention
Within 6 months of haemorrhagic cerebrovascular accident

Precautions and Warnings

Family history of long QT syndrome
Surgery
Atrial ectopy
Atrial fibrillation
Atrial flutter
Diabetes mellitus
Electrolyte imbalance
History of torsade de pointes
Ventricular ectopy

Correct electrolyte disorders before treatment
Advise ability to drive/operate machinery may be affected by side effects
Treatment to be initiated and supervised by a specialist
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Perform ECG before and during treatment
Monitor closely patient at risk of cardiovascular disorders
Monitor serum electrolytes
Perform blood counts if unexplained infection or fever develops
Review if an adequate response not obtained within 3 months
Advise patient to report unexplained fever, sore throat, bruising, bleeding
Predisposition QT prolongation: Counsel patient on symptoms of arrhythmias
Discontinue 5 days prior to surgery
Discontinue if blood dyscrasia develops
Discontinue if retinal haemorrhage occurs
Advise patient to avoid grapefruit products

There is a higher risk of intraocular bleeding in patients with diabetes mellitus.

Cilostazol is not recommended in patients receiving two or more other antiplatelet or anticoagulant treatments.

Pregnancy and Lactation

Pregnancy

Cilostazol is contraindicated in pregnancy.

At the time of writing there is no adequate data regarding the use of cilostazol during human pregnancy. Animal studies have shown reproductive toxicity. The potential risk for humans is unknown.

Lactation

Cilostazol is contraindicated in breastfeeding.

The transfer of cilostazol to breast milk has been reported in animal studies, however it is not known whether cilostazol is excreted in human milk. Due to the potential harmful effect to the newborn child breastfeeding is not recommended.

Side Effects

Abdominal pain
Abnormal faeces
Agranulocytosis
Allergic reaction
Anaemia
Angina pectoris
Anorexia
Anxiety
Aplastic anaemia
Arrhythmias
Asthenia
Atrial fibrillation
Cerebral haemorrhage
Chest pain
Chills
Congestive cardiac failure
Conjunctivitis
Cough
Diabetes mellitus
Diarrhoea
Dizziness
Dream abnormalities
Dyspepsia
Dyspnoea
Ecchymosis
Eczema
Epistaxis
Flatulence
Gastritis
Gastro-intestinal haemorrhage
Granulocytopenia
Haematuria
Haemorrhage
Headache
Hepatic impairment
Hepatitis
Hot flushes
Hypaesthesia
Hyperglycaemia
Hypertension
Hypotension
Impaired renal function
Increase in blood urea nitrogen
Increased bleeding tendency
Increased uric acid level
Insomnia
Interstitial pneumonia
Jaundice
Leucopenia
Malaise
Muscle haemorrhage
Myalgia
Myocardial infarction
Nausea
Ocular haemorrhage
Oedema
Orthostatic hypotension
Pain
Palpitations
Pancytopenia
Paresis
Peripheral oedema
Pharyngitis
Pneumonia
Pollakiuria
Prolongation of QT interval
Prolonged bleeding
Pruritus
Pulmonary haemorrhage
Pyrexia
Rash
Renal failure
Rhinitis
Serum creatinine increased
Skin eruption
Stevens-Johnson syndrome
Subcutaneous haemorrhage
Supraventricular tachycardia
Syncope
Tachycardia
Thrombocythaemia
Thrombocytopenia
Tinnitus
Toxic epidermal necrolysis
Urticaria
Ventricular extrasystoles
Ventricular tachycardia
Vomiting

Presentation

Oral formulations of cilostazol.

Drugs List

Therapeutic Indications

Uses

Intermittent claudication

For the improvement of the maximal and pain-free walking distances in patients with intermittent claudication, who do not have rest pain and who do not have evidence of peripheral tissue necrosis.

Use is restricted to second line treatment where lifestyle modifications and other appropriate interventions have failed to improve symptoms.

Dosage

Adults

Contraindications

Children under 18 years
Predisposition to haemorrhage
Breastfeeding
Congestive cardiac failure
Hereditary fructose intolerance
History of multifocal ventricular ectopics
History of severe tachyarrhythmia
History of ventricular fibrillation
History of ventricular tachycardia
Long QT syndrome
Moderate hepatic impairment
Peptic ulcer
Pregnancy
Proliferative diabetic retinopathy
Renal impairment - creatinine clearance below 25 ml/minute
Torsade de pointes
Uncontrolled hypertension
Unstable angina
Within 6 months of a myocardial infarction
Within 6 months of a percutaneous coronary intervention
Within 6 months of haemorrhagic cerebrovascular accident

Precautions and Warnings

Family history of long QT syndrome
Surgery
Atrial ectopy
Atrial fibrillation
Atrial flutter
Diabetes mellitus
Electrolyte imbalance
History of torsade de pointes
Ventricular ectopy

Correct electrolyte disorders before treatment
Advise ability to drive/operate machinery may be affected by side effects
Treatment to be initiated and supervised by a specialist
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Perform ECG before and during treatment
Monitor closely patient at risk of cardiovascular disorders
Monitor serum electrolytes
Perform blood counts if unexplained infection or fever develops
Review if an adequate response not obtained within 3 months
Advise patient to report unexplained fever, sore throat, bruising, bleeding
Predisposition QT prolongation: Counsel patient on symptoms of arrhythmias
Discontinue 5 days prior to surgery
Discontinue if blood dyscrasia develops
Discontinue if retinal haemorrhage occurs
Advise patient to avoid grapefruit products

There is a higher risk of intraocular bleeding in patients with diabetes mellitus.

Cilostazol is not recommended in patients receiving two or more other antiplatelet or anticoagulant treatments.

Pregnancy and Lactation

Pregnancy

Cilostazol is contraindicated in pregnancy.

At the time of writing there is no adequate data regarding the use of cilostazol during human pregnancy. Animal studies have shown reproductive toxicity. The potential risk for humans is unknown.

Lactation

Cilostazol is contraindicated in breastfeeding.

The transfer of cilostazol to breast milk has been reported in animal studies, however it is not known whether cilostazol is excreted in human milk. Due to the potential harmful effect to the newborn child breastfeeding is not recommended.

Side Effects

Abdominal pain
Abnormal faeces
Agranulocytosis
Allergic reaction
Anaemia
Angina pectoris
Anorexia
Anxiety
Aplastic anaemia
Arrhythmias
Asthenia
Atrial fibrillation
Cerebral haemorrhage
Chest pain
Chills
Congestive cardiac failure
Conjunctivitis
Cough
Diabetes mellitus
Diarrhoea
Dizziness
Dream abnormalities
Dyspepsia
Dyspnoea
Ecchymosis
Eczema
Epistaxis
Flatulence
Gastritis
Gastro-intestinal haemorrhage
Granulocytopenia
Haematuria
Haemorrhage
Headache
Hepatic impairment
Hepatitis
Hot flushes
Hypaesthesia
Hyperglycaemia
Hypertension
Hypotension
Impaired renal function
Increase in blood urea nitrogen
Increased bleeding tendency
Increased uric acid level
Insomnia
Interstitial pneumonia
Jaundice
Leucopenia
Malaise
Muscle haemorrhage
Myalgia
Myocardial infarction
Nausea
Ocular haemorrhage
Oedema
Orthostatic hypotension
Pain
Palpitations
Pancytopenia
Paresis
Peripheral oedema
Pharyngitis
Pneumonia
Pollakiuria
Prolongation of QT interval
Prolonged bleeding
Pruritus
Pulmonary haemorrhage
Pyrexia
Rash
Renal failure
Rhinitis
Serum creatinine increased
Skin eruption
Stevens-Johnson syndrome
Subcutaneous haemorrhage
Supraventricular tachycardia
Syncope
Tachycardia
Thrombocythaemia
Thrombocytopenia
Tinnitus
Toxic epidermal necrolysis
Urticaria
Ventricular extrasystoles
Ventricular tachycardia
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: January 2019

Reference Sources

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. Pletal 50mg tablets. Otsuka Pharmaceuticals (UK) Ltd. Revised January 2016.

Summary of Product characteristics. Pletal 100mg tablets. Otsuka Pharmaceuticals (UK) Ltd. Revised January 2016.

Summary of Product Characteristics. Cilostazol 100mg tablets. Advanz Pharma. Revised September 2016.

European Medicines Agency recommends restricting use of cilostazol-containing medicines.
European Medicines Agency (EMA) 22 March 2013
Available at: https://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/03/news_detail_001746.jsp&mid=WC0b01ac058004d5c1
Last accessed: 07 January 2019

MHRA Drug Safety Update April 2013
Available at: https://www.mhra.gov.uk
Last accessed: 07 January 2019