Isosorbide mononitrate oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Standard release formulations of isosorbide mononitrate.
Drugs List
Therapeutic Indications
Uses
Congestive heart failure (resistant to other treatment)
Prophylaxis of angina pectoris
Treatment of angina pectoris
Dosage
Adults
Those who have not previously received nitrates
The recommended initial dose is 10 to 40 mg twice daily.
Those who have previously received nitrates
Initially 10 to 40 mg 2 to 3 times daily. Up to 120 mg daily in divided doses if required.
Most patients will require 40 to 60 mg daily in divided doses.
Patients taking one tablet twice daily, the second dose should be taken 8 hours after the first dose. If the dose is one tablet three times a day, take one every 6 hours and ensure 12 hours treatment free interval every 24 hours.
Elderly
(See Dosage; Adult)
Additional Dosage Information
Patients being transferred from sustained release formulations should be initiated at half their previous dosage.
Contraindications
Children under 18 years
Low cardiac filling pressures
Systolic blood pressure < 90mmHg
Aortic stenosis
Cardiac tamponade
Cerebrovascular haemorrhage
Circulatory failure
Constrictive pericarditis
Head trauma
Hypertrophic obstructive cardiomyopathy
Hypotension
Hypovolaemia
Low filling pressure - if treating acute myocardial infarction
Mitral stenosis
Narrow angle glaucoma
Raised intracranial pressure
Severe anaemia
Toxic pulmonary oedema
Precautions and Warnings
Hypothermia
Predisposition to narrow angle glaucoma
Ventilation-perfusion mismatch
Breastfeeding
Galactosaemia
Glucose-galactose malabsorption syndrome
Hypothyroidism
Hypoxia
Lactose intolerance
Left ventricular failure
Malnutrition
Pregnancy
Recent myocardial infarction
Severe hepatic impairment
Severe renal impairment
Advise ability to drive/operate machinery may be affected by side effects
Not all available brands are licensed for all indications
Some formulations contain lactose
Assess patient's tolerance to treatment
Tolerance may occur with prolonged use of large doses
Avoid abrupt withdrawal
Maintain treatment at the lowest effective dose
Advise patient to moderate alcohol intake during treatment
Hypotensive effect enhanced by alcohol
Advise patient not to use for relief of acute attacks
Advise patient on possible rebound phenomena on withdrawal
After the first dose, symptoms of circulatory collapse may occur, particularly in patients with labile circulation.
Nitrates may induce hypotension which may be accompanied by paradoxical bradycardia and increased angina.
Pregnancy and Lactation
Pregnancy
Use isosorbide mononitrate with caution during pregnancy.
The manufacturer does not recommend using isosorbide mononitrate during pregnancy and notes that its use should only be considered if the possible benefits of treatment outweigh the risks. Some animal studies have shown teratogenic effects in doses up to 500mg/kg/day such as significant increases in prolonged gestation, prolonged parturition, still birth and neonatal death (Briggs, 2015). Human data is limited and as such a potential risk cannot be ruled out.
Lactation
Use isosorbide mononitrate with caution during breastfeeding.
The manufacturer advises caution if isosorbide mononitrate is used when breastfeeding. The presence of isosorbide mononitrate in human breast milk is unknown. Effects on exposed infants are unknown however, due to the short half-life of nitrates, toxic risk to the breastfed infant is not expected (Schaefer, 2015).
Side Effects
Allergic skin reactions
Angioedema
Asthenia
Bradyarrhythmias
Circulatory collapse
Dizziness
Drowsiness
Exfoliative dermatitis
Flushing
Headache
Heartburn
Hypotension
Hypoxaemia
Ischaemia
Methaemoglobinaemia
Nausea
Orthostatic hypotension
Pallor
Perspiration
Rash
Reflex tachycardia
Restlessness
Somnolence
Syncope
Transient hypoxaemia
Vomiting
Weakness
Worsening of angina
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: September 2013
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.
Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.
Summary of Product Characteristics: Ismo 10. Durbin Plc. Revised October 2007.
Summary of Product Characteristics: Ismo 20. Durbin Plc. Revised October 2007.
Summary of Product Characteristics: Ismo 40. Durbin Plc. Revised October 2007.
Summary of Product Characteristics: Isosorbide mononitrate 30mg tablets. Medreich PLC. Revised June 2021.
Summary of Product Characteristics: Isosorbide Mononitrate/Carmil/Monomil 20mg Tablets. Aurobindo Pharma - Milpharm Ltd. Revised March 2019.
Summary of Product Characteristics: Isosorbide Mononitrate/Carmil/Monomil 40mg Tablets. Aurobindo Pharma - Milpharm Ltd. Revised March 2019.
Summary of Product Characteristics: Elantan 10. UCB Pharma Ltd. Revised September 2008.
Summary of Product Characteristics: Elantan 20. UCB Pharma Ltd. Revised February 2008.
Summary of Product Characteristics: Elantan 40. UCB Pharma Ltd. Revised March 2009.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 09 November 2022
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