Skip to Content

The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content.

DILTIAZEM HYDROCHLORIDE MODIFIED RELEASE TABLETS 60MG

PDF options:  View Fullscreen   Download PDF

PDF Transcript

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Diltiazem Hydrochloride Modified Release Tablets 60mg

2.

Qualitative and Quantitative Composition
Active ingredient
Diltiazem Hydrochloride

3.

HSE 60mg per tablet.

Pharmaceutical Form
Modified release tablets

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Prophylaxis and treatment of angina pectoris

4.2.

Posology and Method of Administration
Adults:
60mg three times daily. As patient response may vary, the dose can be
increased to a maximum of 360mg daily in divided doses. Higher doses up to
480mg/day have been used with benefit in some patients especially in unstable
angina.
Elderly patients with impaired hepatic or renal function: Initially 60mg twice
daily.
Monitoring of the heart rate should be carried out. The dose should not be
increased if the rate falls below 50 beats per minute
Children: not recommended.
Route of administration: Oral

4.3.

Contra-indications
Marked Bradycardia, second or third degree heart blocks except in the
presence of a functioning pacemaker, uncontrolled left ventricular failure with
statis, sick sinus syndrome. Also contraindicated in pregnancy and in women
of child-bearing potential. This medicine is contra-indicated in patients with
hypersensitivity to Diltiazem or any of it’s ingredients.

4.4.

Special Warnings and Special Precautions for Use
The product should be used with caution in patients with reduced ventricular
function. Patients with mild bradycardia, first degree AV block or prolonged
PR interval should be observed closely.

4.5.
Interaction with Other Medicinal Products and Other Forms of
Interaction
The doses of both diltiazem and beta-blockers, diuretics, ACE inhibitors and
other antihypertensive agents should be monitored regularly when both drugs
are used concurrently. Diltiazem may increase the levels of beta-blockers
which have a low bioavailability. Diltiazem may cause small increases in the
plasma levels of digitalis. The blood levels of carbamazepine, cyclosporin and
theophylline may be increased when given concurrently with diltiazem
hydrochloride. Concurrent administration of H2 antagonists may increase the
blood level of diltiazem. Concurrent use of diltiazem with alpha blockers such
as prazosin should be strictly monitored because of the possible synergistic
hypotensive effect of this combination.
In common with other calcium antagonists when Diltiazem is used with drugs
which may induce bradycardia or with antiarrhythmic or antihypertensive
drugs the possibility of an additive effect should be borne in mind.
Diltiazem hydrochloride treatment has been continued without problem during
anaesthesia, but the anaesthetist should be informed that the patient is
receiving a calcium antagonist. Diltiazem, like any calcium antagonist, should
not be administered concurrently with dantrolene infusion because of the risk
of ventricular fibrillation.
There is an risk of decrease of diltiazem plasma levels after initiating therapy
with rifampicin and patients should be carefully monitored when initiating or
have the therapy discontinued. There is also a risk of increase in lithiuminduced neurotoxicity when patients are concurrently treated with lithium.

4.6.

Pregnancy and Lactation
Diltiazem hydrochloride is teratogenic in some animal species and therefore
should not be used in pregnancy or in women of child bearing potential.
Diltiazem hydrochloride is excreted in breast milk and therefore should not be
used in nursing mothers until an alternative method of infant feeding has been
instituted.

4.7.

Effects on Ability to Drive and Use Machines
None known.

4.8.

Undesirable Effects
Diltiazem is generally well tolerated. Occasional undesirable effects are
nausea, headache, skin rashes, oedema of the lower limbs, flushing/hot
flushes, hypotension and fatigue/asthenia, palpitations, malaise, minor
gastrointestinal disorders, (dyspepsia, abdominal pain, dry mouth) which
disappear on cessation of treatment. Diltiazem may cause depression of
atrioventricular nodal conduction bradycardia and sina-atrial block.
Some instances of skin rashes have occurred such as pruritus, and
erythematosus rash which regress when treatment is discontinued. There have
been rare cases of Stevens Johnson Syndrome and erythema multiforme with
diltiazem.
Isolated cases of changes in liver function tests i.e. clinical hepatitis and
increase in liver transaminases have been observed which regressed on
cessation of treatment.
Changes in renal function have been reported in a few cases i.e. anuria and
metabolic acidosis but again levels returned to baseline on cessation of
treatment.
Isolated cases of gingival hyperplasia have also been observed.
As with some other calcium channel blockers, exceptional cases of
extrapyramidal symptoms and gynaecomastia have been reported, reversible
after discontinuation of calcium antagonists.

4.9.

Overdose

The clinical symptoms of acute intoxication may include pronounced
hypotension or even collapse, and sinus bradycardia with or without
atrioventricular conduction defects.
The patient should be closely monitored in hospital to exclude arrhythmias or
atrioventricular conduction defects. Gastric lavage and osmotic diuresis
should be undertaken when considered appropriate. Symptomatic bradycardia
and high grade atrioventricular block may respond to atropine, isoprenaline or
occasionally temporary cardiac pacing. Hypotension may require correction
with plasma volume expanders, intravenous calcium gluconate and positive
inotropic agents.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Diltiazem is a calcium antagonist. It restricts the slow channel entry of
calcium ions into the cell and so reduces the liberation of calcium from stores
in the sarcoplasmic reticulum. This results in a reduction in the amount of
available intracellular calcium and consequently a (1) reduction of myocardial
oxygen consumption (2) dilation of small and large coronary arteries (3) mild
peripheral vasodilation (4) negative dromotropic effects (5) reflex positive
chronotropic and inotropic effects due to reflex sympathetic activity are
partially inhibited and result in a slight reduction or no change in heart rate.
The antianginal effect is due to reduction in cardiac oxygen demand with
maintenance of coronary blood flow. Cardiac contractility and ventricular
ejection fraction are unchanged. Diltiazem increases exercise capacity and
improves indices of myocardial ischaemia in the angina patient. Diltiazem
relieves the spasm of vasospastic (Prinzmetals) angina.

5.2.

Pharmacokinetic Properties
Diltiazem is rapidly and almost completely absorbed from gastro-intestinal
tract following oral administration, but undergoes extensive first-pass hepatic
metabolism. The bioavailability has been reported to be about 40%, although
there is considerable inter-individual variation in plasma concentration.
Diltiazem is about 80% bound to plasma proteins. It is extensively
metabolised in the liver; one of the metabolites, desacetyldiltiazem has been
reported to have 25 to 50% of the activity of the parent compound. The half
life is reported to be about 3 to 5 hours. Approximately 2 to 4% of a dose is
excreted in urine as unchanged diltiazem with the remainder excreted as
metabolites in bile and urine.

5.3.

Preclinical Safety Data
There are no pre-clinical data of relevance to the prescriber which are
additional to that already included in other sections of the SPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Lactose Monohydrate Ph.Eur.
Hydrogenated Castor Oil
USNF
Polyethylene Glycol 6000
USNF
Magnesium Stearate Ph.Eur.

6.2.

Incompatibilities
None known.

6.3.

Shelf Life
3 years.

6.4.

Special Precautions for Storage
Store below 25°C, in a dry place.
Keep out of the reach of children.

6.5.

Nature and Contents of Container
The product is blister packed (10’s) in 250μ PVC film faced with 48 gins
PVDC and sealed with hard tempered aluminium lidding foil. The blister
strips are subsequently packed in printed boxboard cartons, in pack sizes of
60, 100 and 500 tablets.

6.6.

Instructions for Use/Handling
No special precautions.

7

MARKETING AUTHORISATION HOLDER
Niche Generics Limited
1 The Cam Centre
Wilbury Way
Hitchin
Hertfordshire
SG4 0TW
United Kingdom

8.

Marketing Authorisation Number
PL 19611/0007

9.

Date of First Authorisation/Renewal of Authorisation

23 January 2003

10

DATE OF REVISION OF THE TEXT
22/02/2004

+ Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide