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Chemical Name: Nisoldipine
Sular 24 Hour Tablets Information:
Sular (Nisoldipine) TABLETS SHOULD NOT BE CUT, CHEWED, OR BROKEN UNDER ANY CIRCUMSTANCE.
Sular (Nisoldipine) for oral administration, the tablets should be swallowed whole with a little liquid. The tablets should be taken once-daily at approximately 24-hour intervals, i.e. at the same time each day, preferably during the morning. Sular (Nisoldipine) tablets must be swallowed whole, under no circumstances should they be bitten, chewed or broken up. Sular (Nisoldipine) tablets should not be taken with grapefruit juice.
A food interaction has been observed with Sular (Nisoldipine), with an increase in peak plasma concentration and decrease in the area under the plasma concentration/time curve (AUC). It is therefore preferable to administer Sular (Nisoldipine) in the fasting state, i.e. before breakfast.
The recommended initial dose in angina pectoris is 10mg once daily. The usual maintenance dose is 20-40mg once daily. The maximum recommended dose is 40mg once daily.
In hypertension, the recommended initial dose is one 10mg tablet once daily. If necessary, the dosage can be increased according to individual requirements up to a maximum of 40mg once daily.
Patients should be assessed at least one week after starting on any dosage before titration to a higher dosage.
Patients with renal impairment should not require adjustment of dosage. Nisoldipine is highly protein-bound > 99%) and is not dialysable. Therefore, dose adjustment is not usually required in patients on dialysis.
An alteration of the pharmacokinetics of nisoldipine may be seen in the elderly with peak plasma concentrations and area under the plasma concentration/time curve being increased in some individuals, although there is no alteration of peak : trough fluctuation in plasma levels. Therefore, therapeutic plasma concentrations can be achieved with lower doses without compromising efficacy and safety. Therapy in the elderly with either angina pectoris or hypertension should commence with 10mg once daily, titration to higher doses being possible if clinically warranted and according to tolerability.
Treatment may be continued indefinitely.
Sular (Nisoldipine) tablets must be swallowed whole, under no circumstances should they be bitten, chewed or broken up.
Caution should be exercised in patients with symptomatic heart failure (NYHA Class III-IV). The safety of Sular (Nisoldipine) in patients with symptomatic heart failure has not been established.
There are no data to support the use of Sular (Nisoldipine) as monotherapy for the treatment of hypertension and chronic stable angina pectoris during or within one month of a myocardial infarction.
Caution should be exercised in patients with hypotension as there is a risk of further reduction in blood pressure.
Sular 24 Hour Tablets Side Effects:
Gravitational oedema, headache, flushing, tachycardia and palpitation may occur, particularly on commencement of treatment. Gravitational oedema is caused by peripheral dilatation and is not associated with heart failure or weight gain. Most vasodilatory side-effects improve or regress after a few weeks with continuation of therapy. Gravitational oedema may take longer to develop and may remain for longer than other acute vasodilatory side-effects.
Dizziness, asthenia, chest pain, dyspnoea and nausea may also occur. Other less frequently reported side-effects include: paraesthesia, hypotension, myalgia, nervousness, tremor, increased urinary frequency, allergic skin reactions (rash, urticaria, pruritus), gastrointestinal disorders such as dyspepsia, abdominal pain, constipation, diarrhoea and vomiting.
As with other sustained release dihydropyridines, exacerbation of angina pectoris may rarely occur at the start of treatment with nisoldipine. The occurrence of myocardial infarction has been described although it is not possible to distinguish such an event from the natural course of ischaemic heart disease.
Disturbances of the enzymes AST (SGOT), ALT (SGPT) and CPK may occur on Syscor MR. The abnormalities are usually slight increases in enzyme levels, which tend to return to normal with continuation of therapy. If these abnormalities do not regress, or increase within a few weeks, treatment should be discontinued. Enzyme elevations usually regress on discontinuation of the drug.
Abnormal vision, liver function test abnormalities, gynaecomastia and gum hyperplasia have also been observed rarely.
Syscor MR has a mild hypouricaemic effect.
Increased diuresis has been observed in isolated cases.
Anaphylactic reactions including angioedema may occur very rarely.
Sular (Nisoldipine) should not be administered to patients with known hypersensitivity to nisoldipine or other dihydropyridines because of the theoretical risk of cross-reactivity, or hypersensitivity to any components of the tablets.
Sular (Nisoldipine) should not be administered to pregnant women, to nursing mothers or to children (aged less than 12 years).
Sular (Nisoldipine) should not be used in cardiogenic shock, unstable angina or during or within one week of a myocardial infarction.
Sular (Nisoldipine) should not be used for the treatment of acute attacks of angina.
The safety of Sular (Nisoldipine) in malignant hypertension has not been established.
Sular (Nisoldipine) should not be used for secondary prevention of myocardial infarction.
Sular (Nisoldipine) is contra-indicated in cases where there is a fixed cardiac output obstruction, such as aortic stenosis, as the decrease in peripheral resistance cannot be compensated by an increase in cardiac output, with ensuing risk of severe hypotension.
Sular (Nisoldipine) should not be used in patients receiving rifampicin or long-term treatment with phenytoin.
Sular (Nisoldipine) should not be administered to patients receiving ketoconazole or its congeners itraconazole and fluconazole.
Owing to the duration of action of the formulation, Sular (Nisoldipine) should not be administered to patients with hepatic impairment.
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