Verapamil hydrochloride modified release oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Modified release formulations of verapamil hydrochloride
Drugs List
Therapeutic Indications
Uses
Hypertension - mild to moderate
Prophylaxis of angina pectoris
Secondary prevention of reinfarction after MI in suitable pts. without CCF
Treatment of angina pectoris
Treatment and prophylaxis of angina pectoris.
Treatment of mild to moderate hypertension.
Secondary prevention of reinfarction after an acute myocardial infarction in patients without heart failure, and not receiving diuretics (apart from low-dose diuretics when used for indications other than heart failure), and where beta-blockers are not appropriate. Treatment is to be started at least one week after an acute myocardial infarction.
Dosage
Adults
Hypertension
240mg once daily.
For patients new to verapamil, an initial dose of 120mg should be considered.
If control is not achieved after one week, the dose may be increased up to a maximum of 480mg daily in divided doses, with a twelve hour dose interval (some brands recommend 480mg once daily).
Angina pectoris
360mg daily in one or two divided doses, increasing up to a maximum of 240mg twice daily or 480mg once daily if necessary. A small number of patients respond to a lower dose and where indicated adjustment down to 240mg once daily could be made.
Secondary prevention of reinfarction
For patients who have experienced an acute myocardial infarction, without heart failure and are not receiving diuretics (apart from low-dose diuretics when used for indications other than heart failure), and where beta blockers are not appropriate:
Start treatment at least 1 week after acute myocardial infarction using a dose of 360mg daily in divided doses either as:
120mg modified release tablet, three times daily
OR
240mg modified release tablet in the morning and 120mg modified release tablet in the evening.
Patients with Hepatic Impairment
The dosage may need to be adjusted in patients with hepatic impairment and initial doses should be low.
Verapamil hydrochloride is extensively metabolised by the liver and thus patients with hepatic impairment may experience delayed metabolism of the drug. This delay may be to a greater or lesser extent depending on the severity of hepatic impairment. Consequently, the effects of verapamil hydrochloride may be potentiated and/or prolonged.
Contraindications
Systolic blood pressure < 90mmHg
Bradycardia - if treating myocardial infarction
Bradycardia with pulse rate at rest < 50 beats per minute
Cardiogenic shock
Decompensated cardiac failure
First trimester of pregnancy
Galactosaemia
Hereditary fructose intolerance
History of cardiac failure
Hypotension - if treating myocardial infarction
Left ventricular dysfunction - if treating myocardial infarction
Lown-Ganong-Levine syndrome
Non paced second/third degree AV block
Non-paced sinus node dysfunction
Porphyria
Severe left ventricular failure
Sinoatrial exit block
Wolff-Parkinson-White syndrome
Precautions and Warnings
Children under 18 years
Bradycardia
Breastfeeding
Duchenne muscular dystrophy
First degree atrioventricular block
Glucose-galactose malabsorption syndrome
Hepatic impairment
Lactose intolerance
Myasthenia gravis
Myasthenic Eaton-Lambert syndrome
Myocardial infarction
Renal impairment
Second trimester of pregnancy
Third trimester of pregnancy
Control cardiac failure before starting treatment
Not removed via dialysis
Reduce dose in patients with hepatic 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
Monitor blood pressure regularly
May precipitate or aggravate cardiac failure even in controlled cases
Pregnancy: This medication may inhibit labour
Withdraw gradually after long-term use
Bioavailability differs with preparations;caution on changing formulations
Advise patient not to take aspirin unless advised by clinician
Advise patient not to take simvastatin unless advised by clinician
Advise patient not to take St John's wort concurrently
Advise patient that this medication may prolong the effects of alcohol
Advise patient grapefruit products may increase plasma level
Ventricular tachycardia may be precipitated in patients with atrial flutter or fibrillation in association with an accessory pathway (e.g. Wolff-Parkinson-White syndrome).
Pregnancy and Lactation
Pregnancy
Verapamil is contraindicated in the first trimester of pregnancy.
Use during the second and third trimesters of pregnancy only if essential and the benefits to the mother outweigh the potential risks to the foetus.
There is limited data available regarding the use of verapamil hydrochloride in pregnancy. Animal studies have not shown any teratogenic effects. Schaefer (2015) states that use can cause hyperprolactinaemia and galactorrhoea.
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 verapamil hydrochloride with caution in breastfeeding.
Verapamil hydrochloride is excreted in breast milk in small amounts and is unlikely to be harmful. Limited human data from the oral dose has shown the infant relative dose is low (0.1 to 1% of the mother's oral dose). LactMed states that verapamil would not be expected to cause any adverse effects in breastfed infants, especially if the infant is older than 2 months.
Due to the potential for serious adverse reactions in nursing infants, verapamil hydrochloride should only be used in breastfeeding if clearly necessary.
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
Abdominal pain
Aggravation of cardiac failure
Allergic reaction
Alopecia
Ankle oedema
Arthralgia
Asystole
Bradyarrhythmia in atrial fibrillation
Bradycardia
Cardiac failure
Constipation
Dizziness
Erythema
Erythema multiforme
Erythromelalgia
Extrapyramidal effects
Fatigue
Flushing
Galactorrhoea
Gingival hyperplasia
Gynaecomastia in older men
Headache
Hypotension
Ileus
Impotence
Increase in alkaline phosphatase
Increase in serum transaminases
Increased prolactin
Liver function disturbances
Muscle weakness
Myalgia
Nausea
Palpitations
Paraesthesia
Peripheral oedema
Pruritus
Purpura
Quincke's oedema
Second and third degree AV block
Sinus arrest with asystole
Sinus bradycardia
Stevens-Johnson syndrome
Tachycardia
Tinnitus
Tremor
Urticaria
Vertigo
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: August 2018
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: Half Securon SR. Mylan Ltd. Revised May 2017.
Summary of Product Characteristics: Securon SR. Mylan Products Ltd. Revised May 2017.
Summary of Product Characteristics: Vertab SR 240 Tablets. Dexcel-Pharma Ltd. Revised July 2013.
Summary of Product Characteristics: Vera-Til SR 120mg Tablets. Tillomed Laboratories Ltd. Revised January 2018.
Summary of Product Characteristics: Vera-Til SR 240mg Tablets. Tillomed Laboratories Ltd. Revised February 2018.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 16 August 2018
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
Verapamil. Last revised: 10 March, 2015
Last accessed: 16 August 2018
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