Isosorbide mononitrate oral modified release
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Modified release formulations of isosorbide mononitrate.
Drugs List
Therapeutic Indications
Uses
Prophylaxis of angina pectoris
Dosage
Adults
Maintenance dosage:
25mg to 60mg modified release (MR) taken once daily in the morning, increasing if required to a maximum of 120mg MR once daily.
To minimise possibility of headache the treatment may be titrated starting at 25mg to 30mg MR for the first 2 to 4 days.
There is a risk of tolerance developing when nitrate therapy is given. For this reason it is important to maintain a once daily dosage regime to achieve an interval with low nitrate concentration, thereby reducing the risk of tolerance development. Two tablets or two capsules may be given together once daily.
Contraindications
Children under 18 years
Low cardiac filling pressures
Aortic stenosis
Cardiac tamponade
Cerebrovascular haemorrhage
Cerebrovascular insufficiency
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
Breastfeeding
Galactosaemia
Glucose-galactose malabsorption syndrome
Hepatic cirrhosis
Hereditary fructose intolerance
Hypothyroidism
Hypoxia
Lactose intolerance
Malnutrition
Pregnancy
Recent myocardial infarction
Severe hepatic impairment
Severe renal impairment
Hepatic cirrhosis: Decrease of effective renal plasma flow (ERPF)
Advise ability to drive/operate machinery may be affected by side effects
Some formulations contain lactose
Some formulations contain sucrose
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
Advise patients that empty tablet/capsule may be observed in stools
Pregnancy and Lactation
Pregnancy
Use isosorbide mononitrate with caution in pregnancy.
There is limited data regarding the use of isosorbide mononitrate in pregnancy. Animal studies have shown reproductive toxicity.
Some manufactures advise the product should not be used in pregnancy whilst others recommend the benefits and risks of therapy should be evaluated prior to treatment.
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 isosorbide mononitrate with caution in breastfeeding.
It is not known whether nitrates are excreted in human milk and safety has therefore not been established. The transfer of nitrates into human milk in general is quite poor. No paediatric concerns have been reported.
Some manufactures advise the product should not be used in breastfeeding whilst others recommend the benefits and risks of therapy should be evaluated prior to treatment.
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
Allergic skin reactions
Blurred vision
Bradyarrhythmias
Bradycardia-paradoxical
Collapse
Diarrhoea
Dizziness
Drowsiness
Dry skin
Exfoliative dermatitis
Fatigue
Flushing
Headache
Heartburn
Hypotension
Light-headedness
Myalgia
Nausea
Pallor
Perspiration
Postural hypotension
Pruritus
Rash
Reflex tachycardia
Restlessness
Syncope
Tachycardia
Transient hypoxaemia
Vomiting
Weakness
Withdrawal symptoms
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, 3nd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.
Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.
The Renal Drug Handbook. 3rd edition. (2009) ed. Ashley, C and Currie, Radcliffe Publishing Ltd, Abingdon.
Summary of Product Characteristics: Carmil XL 60mg Tablets. Aurobindo Pharma-Milpharm Ltd. Revised January 2016.
Summary of Product Characteristics: Chemydur 60XL. Amdipharm Mercury Company Ltd. Revised May 2013.
Summary of Product Characteristics: Elantan LA25. UCB Pharma Ltd. Revised February 2013.
Summary of Product Characteristics: Elantan LA50. UCB Pharma Ltd. Revised February 2013.
Summary of Product Characteristics: Imdur Tablets 60mg. AstraZeneca UK Ltd. Revised August 2007.
Summary of Product Characteristics: IMO LA 50mg capsules. Kent Pharmaceuticals Ltd. Revised July 2009.
Summary of Product Characteristics: Isotard XL. ProStrakan. Revised August 2012.
Summary of Product Characteristics: Modisal XL 40mg prolonged release tablets. Ennogen Pharma Ltd. Revised July 2012.
Summary of Product Characteristics: Monomax SR 40 & 60mg Prolonged Release Capsules. Chiesi Ltd. Revised December 2010.
Summary of Product Characteristics: Monomax XL 60mg Prolonged Release Tablets. Chiesi Ltd. Revised June 2012.
Summary of Product Characteristics: Monomil XL 60mg/Carmil 60mg tablets. Aurobindo Pharma - Milpharm Ltd. Revised February 2009.
Summary of Product Characteristics: Nyzamac SR 40mg modified-release capsules. Ethypharm. Revised April 2017.
Summary of Product Characteristics: Nyzamac SR 60mg modified-release capsules. Ethypharm. Revised April 2017.
Summary of Product Characteristics: Tardisc XL 60 Prolonged Release Tablets. Dexcel Pharma Ltd. Revised October 2009.
Summary of Product Characteristics: Trangina XL. Actavis UK Ltd. Revised September 2012.
Summary of Product Characteristics: Xismox 60XL Prolonged Release Tablets. Genus Pharmaceuticals. Revised October 2009.
Summary of Product Characteristics: Zemon 40XL Prolonged Release Tablets. Fannin (UK) Ltd. Revised May 2018.
NICE Evidence Services Available at: www.nice.org.uk
Last accessed: 10 October 2017
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