Diltiazem 8 hour modified release preparations
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
8 hour modified release oral formulations containing diltiazem hydrochloride.
Hypertension - mild to moderate
Prophylaxis of angina pectoris
Treatment of angina pectoris
60mg three times daily.
If necessary, the dose may be increased up to 360mg daily. Doses of up to 480mg daily have been used with benefit in some patients, especially in cases of unstable angina.
Plasma levels of diltiazem can be increased in elderly patients.
The recommended starting dose is 60mg twice daily. The heart rate should be monitored regularly and the dose should not be increased if heart rate falls below 50 beats per minute.
Children aged 12 to 18 years (unlicensed)
30mg to 60mg, given two to three times a day.
Patients with Renal Impairment
Plasma levels of diltiazem can be increased in patients with renal impairment.
In patients with renal impairment, the recommended starting dose is 60mg twice daily. The heart rate should be monitored regularly and the dose should not be increased if heart rate falls below 50 beats per minute.
Patients with Hepatic Impairment
Plasma levels of diltiazem can be increased in patients with hepatic impairment.
In patients with hepatic impairment, the recommended starting dose is 60mg twice daily. The heart rate should be monitored regularly and the dose should not be increased if heart rate falls below 50 beats per minute.
Children under 12 years
Systolic blood pressure < 90mmHg
Bradycardia with pulse rate at rest < 50 beats per minute
Congestive cardiac failure
Left ventricular failure with stasis
Non paced second/third degree AV block
Non-paced sinus node dysfunction
Severe aortic stenosis
Precautions and Warnings
Children aged 12 to 18 years
Females of childbearing potential
Predisposition to gastrointestinal obstruction
First degree atrioventricular block
Glucose-galactose malabsorption syndrome
Reduced left ventricular function
Anaesthetist should be made aware patient is taking this medication
Avoid concurrent use of beta blockers in patients with conduction defects
May exacerbate asthma
Reduce dose in patients with hepatic impairment
Reduce dose in patients with renal impairment
Advise ability to drive/operate machinery may be affected by side effects
Not all available brands are licensed for all indications
Exclude pregnancy prior to initiation of treatment
Monitor antidiabetic drug treatment
Monitor heart rate pre-treatment and periodically thereafter
Monitor patients with existing or tendency towards diabetes mellitus
Monitor respiratory function
Advise patient to report any new or worsening respiratory symptoms
Consider discontinuing if depression develops
May cause bronchospasm
Patient should be made aware of possible adverse effects on mood/behaviour
Abrupt withdrawal may be associated with exacerbation of angina
Reduce dose in elderly
Advise patient grapefruit products may increase plasma level
Female: Ensure adequate contraception during treatment
Advise patients that empty tablet/capsule may be observed in stools
Calcium channel blockers do not reduce the risk of myocardial infarction in unstable angina. The use of diltiazem should be reversed for patients resistant to treatment with beta-blockers. However, because of the risk of bradycardia, diltiazem should be used with caution in association with beta-blockers. Avoid concurrent use of beta blockers with diltiazem in patients with pre-existing conduction defects.
Acute renal failure secondary to decreased renal perfusion has been reported in patients with reduced left ventricular function, severe bradycardia or severe hypotension.
Pregnancy and Lactation
Diltiazem is contraindicated during pregnancy.
The limited available data on the use of diltiazem in pregnant patients suggests that reproductive risk is low. Diltiazem has resulted in reproductive toxicity in some animal species (rat, mice and rabbit) (Briggs, 2015).
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 ).
Use diltiazem with caution during breastfeeding.
Diltiazem is excreted in human breast milk with approximately equal concentration in maternal serum and the breast milk (Briggs, 2015). The quantities ingested by the infant are likely to be small and LactMed considers the quantity unlikely to be problematic.
Schaefer (2015) considers diltiazem to be one of the calcium channel blockers of choice for hypertension while 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
Acute generalised exanthematous pustulosis
Acute renal failure
Aggravation of existing asthma
Bundle branch block
Congestive cardiac failure
Increase in alkaline phosphatase
Increase in lactate dehydrogenase
Increase in serum ALT/AST
Toxic epidermal necrolysis
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 ).
Last Full Review Date: December 2016
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: Diltiazem Hydrochloride Tablets 60mg. Actavis UK Ltd. Revised April 2016.
Summary of Product Characteristics: Retalzem 60mg MR Tablets. Kent Pharmaceuticals Ltd. Revised June 2014.
Summary of Product Characteristics: Tildiem 60mg Modified-Release tablets. Sanofi. Revised May 2020.
NAPOS: The Norwegian Porphyria Centre
Available at: https://www.drugs-porphyria.org/languages/UnitedKingdom/selsearch.php?l=gbr
Drug: Diltiazem. Last accessed: December, 2016
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 22 August 2017
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Diltiazem. Last revised: March 10, 2015
Last accessed: December 7, 2016
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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