Symptoms
The clinical effects of acute overdose can involve pronounced hypotension possibly leading to collapse, sinus bradycardia with or without isorhythmic dissociation, and atrioventricular conduction disturbances.
Treatment
Treatment, in a hospital setting, will include gastric lavage and/or osmotic diuresis. Conduction disturbances may be managed by temporary cardiac pacing. Proposed corrective treatments: atropine, vasopressors, inotropic agents, glucagon and calcium gluconate infusion.
Three years from the date of manufacture.
- Sick sinus syndrome except in the presence of a functioning ventricular pacemaker
- pregnancy; women of child-bearing potential
- congestive heart failure
- severe aortic stenosis
- cardiogenic shock
- severe hypotension (systolic Blood Pressure less than 90mmHg)
- Second- or third-degree AV block except in the presence of a functioning ventricular pacemaker
- Severe bradycardia (below 40 bpm)
- Left ventricular failure with pulmonary congestion
- Concomitant use of dantrolene infusion.
- Combination with ivabradine
- Acute porphyria.
None known.
Also contains: castor oil, lactose, magnesium stearate, polyethylene glycol.
White uncoated modified-release tablets.
White circular, biconvex, uncoated, modified-release tablets impressed “C†on one face, and the identifying letters “DU†on the reverse.
The following CIOMS frequency rating is used, when applicable: Very common (>1/10); common (>1/100 to <1/10); uncommon (>1/1,000 to ≤1/100); rare (>1/10,000 to ≤1/1,000); very rare (≤1/10,000); not known (cannot be estimated from the available data).
Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
| Very common | Common | Uncommon | Rare | Not known | |
| Blood and lymphatic system disorders | Thrombocytopenia | ||||
| Psychiatric disorders | Nervousness, insomnia | Mood changes (including depression) | |||
| Nervous system disorders | Headache, dizziness | Extrapyramidal syndrome | |||
| Cardiac disorders | Atrioventricular block (may be of first, second or third degree; bundle branch block may occur), palpitations | Bradycardia | Sinoatrial block, congestive heart failure | ||
| Vascular disorders | Flushing | Orthostatic hypotension | Vasculitis (including leukocytoclastic vasculitis) | ||
| Gastrointestinal disorders | Constipation, dyspepsia, gastric pain, nausea | Vomiting, diarrhoea | Dry mouth | Gingival hyperplasia | |
| Hepatobiliary disorders | Hepatic enzymes increase (AST, ALT, LDH, ALP increase) | Hepatitis | |||
| Skin and subcutaneous tissue disorders | Erythema | Urticaria | Photosensitivity (including lichenoid keratosis at sun exposed skin areas), angioneurotic oedema, rash, erythema multiforme (including Steven-Johnson's syndrome and toxic epidermal necrolysis), sweating, exfoliative dermatitis, acute generalized exanthematous pustulosis, occasionally desquamative erythema with or without fever | ||
| Reproductive system and breast disorders | Gynecomastia | ||||
| General disorders and administration site conditions | Peripheral oedema | Malaise |
The current literature suggests that the effects of vasodilation particularly ankle oedema are dose dependent and are more frequent in the elderly.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
Not applicable.
1) Prevention and long term treatment of angina pectoris. NOT indicated for acute attacks of angina.
2) Treatment of mild to moderate arterial hypertension.
Pharmacotherapeutic group: selective calcium channel blocker with direct cardiac effects, benzothiazepine derivative.
ATC Code: C08DB01
Diltiazem selectively reduces calcium entry through voltage-dependent calcium channels into vascular smooth muscle cells and myocardial cells. This lowers the concentration of intracellular calcium which is available to activate contractile proteins. This action of Diltiazem results in dilation of coronary arteries causing an increase in myocardial oxygen supply. It reduces cardiac work by moderating the heart rate and reducing systemic vascular resistance thus reducing oxygen demand.
When Diltiazem is given alone or with a beta-blocking agent only slight negative inotropic effects have been reported in patients with preserved ventricular function.
Absorption
Diltiazem is rapidly and almost completely absorbed from the GI tract following oral administration, but undergoes extensive first-pass hepatic metabolism.
Distribution
The bioavailability has been reported to be about 40% although there is considerable inter-individual variation in plasma concentrations.
Diltiazem is about 80% bound to plasma proteins.
Biotransformation
Diltiazem is extensively metabolised in the liver; one of the metabolites, desacetyl diltiazem has been reported to have 25-50% of the activity of the parent compound.
Elimination
The half-life is reported to be about 3-5 hours. Approximately 2-4% of a dose is excreted in urine as unchanged Diltiazem and the remainder excreted as metabolites in bile and urine.
28/04/2016
DILTIAZEM HYDROCHLORIDE TABLETS 60mg
Actavis UK Limited
(Trading style: Actavis)
Whiddon Valley
BARNSTAPLE
N Devon EX32 8NS
Blister packs:
Do not store above 25°C.
Store in the original package.
Keep container in the outer carton
Polypropylene containers, polyethylene containers and amber glass bottles:
Do not store above 25°C.
Store in the original container.
Keep the container tightly closed
The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene containers with snap-on polyethylene lids; in case any supply difficulties should arise the alternative is amber glass containers with screw caps. An alternative closure for polyethylene containers is a polypropylene, twist on, push down and twist off child-resistant, tamper-evident lid.
The product may also be supplied in blister packs and cartons:
a) Carton: Printed carton manufactured from white folding box board.
b) Blister pack: (i) 250µm white rigid PVC. (ii) Surface printed 20µm hard temper aluminium foil with 5-6g/M² PVC and PVdC compatible heat seal lacquer on the reverse side.
Pack sizes: 28s, 30s, 56s, 60s, 84s, 90s, 100s
Not all pack sizes may be marketed
PL 0142/0390
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Close observation is necessary in patients with reduced left ventricular function, bradycardia (risk of exacerbation) prolonged PR interval, or with a first degree AV block detected on the electrocardiogram (risk of exacerbation and rarely, of complete block).
Prior to general anaesthesia, the anaesthesist must be informed of ongoing diltiazem treatment. Depression of cardiac contractility, conductivity and automaticity, as well as the vascular dilatation associated with anaesthetics may be potentiated by calcium channel blockers.
Increase of plasma concentrations of diltiazem may be observed in the elderly and in patients with renal or hepatic insufficiency. The contraindications and precautions should be carefully observed and close monitoring, particularly of heart rate, should be carried out at the beginning of treatment.
Calcium channel blocking agents, such as diltiazem, may be associated with mood changes, including depression.
Like other calcium channel antagonists, diltiazem has an inhibitory effect on intestinal motility. Therefore it should be used with caution in patients at risk to develop an intestinal obstruction. Tablet residues from slow release formulations of the product may pass into the patient's stools; however, this finding has no clinical relevance.
On the basis of reported adverse drug reactions, i.e. dizziness (common), malaise (common), the ability to drive and use machines could be altered. However, no studies have been performed.
Posology
Adults:
The usual maintenance dose is one tablet (60mg) three times daily. However, patient responses may vary and dosage requirements can differ significantly between individual patients. If necessary the dosage may be increased to 360mg/daily. Higher doses of up to 480mg/daily have been used with benefit in some patients, especially in unstable angina. There is no evidence of any decrease in efficacy at these high doses.
Elderly and patients with impaired renal function:
The recommended starting dose is one tablet (60mg) twice daily. The heart rate should be measured regularly in these groups of patients and the dose should not be increased if the heart rate falls below 50 beats/minute.
Paediatric population:
Not recommended.
Method of Administration
For oral administration. Tablets should be swallowed whole with a little water.
Not applicable.
Administrative dataDate of first authorisation: 09/01/1996
Date of latest renewal: 25/04/2001
