VIAZEM XL

Dosage requirements may differ between patients with angina and patients with hypertension. In addition individual patients response may vary, necessitating careful titration. The range of strengths facilitates titration to the optimal dose.

One capsule of VIAZEM XL is to be taken before or during a meal. The dose should be taken at approximately the same time each day. The capsule should not be chewed but swallowed whole, with a glass of water. Due to the variability of release profile in individual patients, when changing from one type of sustained release diltiazem preparation to another, it may be necessary to adjust the dose.

Adults Hypertension:

The usual starting dose is 180 mg once daily. The dose may be increased after 2-4 weeks according to the patient’s response and the usual maintenance dose is 240mg-360mg once daily. The maximum daily dose is 360 mg. However, the single daily doses of 300 mg and 360 mg should only be administered to patients when no satisfactory therapeutic effect has been effected with lower doses and after the benefit risk-ratio has been carefully assessed by the doctor.

Angina:

Care should be taken when titrating patients with stable angina in order to establish the optimal dose. The usual starting dose is 180 mg once daily. The dose may be increased after 2-4 weeks according to the patient’s response. The maximum daily dose is 360 mg.

However, the single daily doses of 300 mg and 360 mg should only be administered to patients when no satisfactory therapeutic effect has been effected with lower doses and after the benefit risk-ratio has been carefully assessed by the doctor.

Elderly and patients with impaired hepatic or renal function:

Plasma levels of diltiazem can be increased in the elderly, and in patients with impaired hepatic renal or hepatic function. In these cases, the starting dose should be one 120mg VIAZEM XL capsule once daily. Heart rate should be monitored and if it falls below 50 beats per minute, the dose should not be increased.

Dose adjustment may be required to obtain a satisfactory clinical response.

Children:

Certain undesirable effects may lead to suspension of treatment: sinus bradycardia, sino-atrial heart block, 2nd and 3rd degree atrioventricular heart block, skin rash, oedema of the lower limbs. In hypertensive patients, adverse effects are generally mild and transient and are most commonly vasodilatory related events.

The following have been described in decreasing order of frequency: lower limb oedema, headache, hot flushes/flushing, asthenia/fatigue, palpitations, malaise, minor gastro-intestinal disorders (dyspepsia, abdominal pain, dry mouth, nausea, vomiting, diarrhoea, constipation) and skin rash.

Erythema multiform and Stevens Johnson syndrome have been reported infrequently in patients receiving diltiazem hydrochloride. Vasodilatory related events (in particular, oedema) are dose-dependent and appear to be more frequent in elderly subjects.

Rare cases of symptomatic bradycardia and exceptionally sino-atrial block and atrioventricular block, hypotension, syncope, reduced left ventricular function have also been recorded. Isolated cases of hallucinations, depression, insomnia, hyperglycaemia and impotence have been reported.

Experience with use in other indications and with other formulations has shown that skin rashes are usually localised and are limited to cases of erythemia, urticaria or occasionally desquamative erthema, with or without fever, which regress when treatment is discontinued.

Isolated cases of moderate and transient elevations of liver transaminases have been observed at the start of treatment. Isolated cases of clinical hepatitis have been reported which resolved with cessation of therapy. Dizziness, pruritis, lupus-like syndrome, nervousness, paraesthesia, articular/muscular pain, photo sensitisation, hypotension, gingival hyperplasia, and gynaecomastia, have also been observed.

Close observation is necessary in patients with reduced left ventricular function, bradycardia (risk of exacerbation) or with a 1st degree AV block or prolonged PR interval detected on the electrocardiogram (risk of exacerbation and rarely, of complete block).

Patients treated with beta-adrenoreceptor blocking drugs and patients with conduction disturbances (bradycardia, bundle branch block, first degree AV block, prolonged PR interval) should only be treated with VIAZEM XL after special consideration due to the risk of serious bradyarrhythmias.

Cases of acute renal failure secondary to decreased renal perfusion have been reported in patients with existing cardiac disease especially reduced left ventricular function, severe bradycardia or severe hypotension. Careful monitoring of renal function is advised.

This product should be used with caution in patients with hepatic dysfunction. Abnormalities of liver function may appear during therapy. The higher single daily doses of VIAZEM XL capsules 300mg and 360mg should not be administered to patients with impaired renal and/or hepatic function and to elderly patients (prolonged half life of elimination) because there is no experience on the use of such high dosages in these patient categories.

In patients undergoing long-term therapy with cyclosporin, plasma levels of cyclosporin should be monitored when concurrent administration of diltiazem is initiated, or discontinued or if the dose of diltiazem is changed. g. in chronic conditions with associated diarrhoea such as Crohns disease or ulcerative colitis.

Patients with rare heriditary problems of fructose intolerances, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicines.

Diltiazem depresses atrioventricular node conduction and is therefore contraindicated in patients with severe bradycardia (less than 50 bpm), sick sinus syndrome, congestive heart failure, and left ventricular failure with second or third degree AV or sino-atrial block, except in the presence of a functioning pacemaker.

Diltiazem is also contraindicated in left ventricular failure with pulmonary stasis as diltiazem may have mild negative effects on contractility. g. bradycardia hypotension, congestive heart failure/reduced LV function), pulmonary congestion, hypotension (<90 mmHg systolic) cerebrovascular accident, cardiac shock and unstable angina pectoris.

g. WPW) accompanied with atrial flutter, fibrillation and in digitalis intoxication, as diltiazem may precipitate ventricular tachycardia. 5). 5). Diltiazem should not be used in patients with known hypersensitivity to diltiazem. Diltiazem should not be used during pregnancy, by women of child-bearing potential, or by women who are breastfeeding.