VASCACE Film-coated tablet Ref.[2653] Active ingredients: Cilazapril

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2012  Publisher: Roche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

Therapeutic indications

Vascace is indicated for the treatment of hypertension.

Vascace is indicated for the treatment of chronic heart failure.

Posology and method of administration

Posology

Hypertension

The initial dose is 1 mg/day. Blood pressure should be assessed, and dosage adjusted individually in accordance with the blood pressure response. The usual dose range of Vascace is 2.5 to 5.0 mg once daily.

Patients with a strongly activated renin-angiotensin-aldosterone system (in particular, salt and/or volume depletion, cardiac decompensation or severe hypertension) may experience an excessive drop in blood pressure following the initial dose. A lower starting dose of 0.5 mg once daily is recommended in such patients and the initiation of treatment should take place under medical supervision.

Hypertensive patients receiving diuretics

If possible, the diuretic should be discontinued 2 – 3 days before beginning therapy with Vascace to reduce the likelihood of symptomatic hypotension. It may be resumed later if required. The recommended starting dose in these patients is 0.5 mg once daily.

Chronic heart failure

Therapy with Vascace should be initiated at a recommended starting dose of 0.5 mg once daily under close medical supervision. This dose should be maintained for about 1 week. If this dose has been well tolerated it may be increased in weekly intervals and according to the clinical status of the patient to 1.0 mg or 2.5 mg. The maximum daily dose for these patients is 5.0 mg. The posology recommendation for cilazapril in chronic heart failure is based on effects on symptomatic improvement, rather than on data showing that cilazapril reduces morbidity and mortality in this patient group (see section 5.1).

Patients with renal impairment

Reduced dosages are required for patients with renal impairment, depending on their creatinine clearance (see section 4.4).

The following dosage schedules are recommended:

Table 1. Recommended dosage schedule for patients with renal impairment:

Creatinine clearanceInitial dose of VascaceMaximal dose of Vascace
>40 ml/min1 mg once daily5 mg once daily
10-40 ml/min0.5 mg once daily2.5 mg once daily
<10 ml/minNot recommended

If renovascular hypertension is also present there is an increased risk of severe hypotension and renal insufficiency. In these patients, treatment should be started under close medical supervision with low doses and careful dose titration. Since treatment with diuretics may be a contributory factor, they should be discontinued and renal function should be monitored during the first weeks of Vascace therapy.

Results from clinical trials showed that clearance of cilazapril was correlated with creatinine clearance in patients with chronic heart failure. The special dosage recommendation should thus be followed in chronic heart failure patients with impaired renal function.

Liver cirrhosis

In patients with liver cirrhosis (but without ascites) who require therapy for hypertension, cilazapril should be dosed with great caution not exceeding 0.5 mg/day accompanied by careful monitoring of the blood pressure, because significant hypotension may occur.

Elderly with hypertension

Treatment with Vascace should be initiated with a dose between 0.5 and 1.0 mg once daily. Thereafter, the maintenance dose must be adapted to individual tolerability, response and clinical status.

Elderly with chronic heart failure

The recommended starting dose of Vascace 0.5 mg must be strictly followed.

Paediatric population

Safety and efficacy in children have not been established. Therefore, there is no recommendation for administration of cilazapril to children.

Method of administration

Vascace should be administered once daily. As food intake has no clinically significant influence on absorption, Vascace can be administered before or after a meal. The dose should always be taken at about the same time of day.

Overdose

Limited data are available for overdosage in humans. Symptoms associated with overdosage of ACE inhibitors may include hypotension, circulatory shock, electrolyte disturbances, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety and cough.

The recommended treatment of overdosage is intravenous infusion of sodium chloride 9 mg/ml (0.9%) solution. If hypotension occurs, the patient should be placed in the shock position. If available, treatment with angiotensin II infusion and/or intravenous catecholamines may also be considered.

Pacemaker therapy is indicated for therapy-resistant bradycardia. Vital signs, serum electrolytes and creatinine concentrations should be monitored continuously.

If indicated, cilazaprilat, the active form of cilazapril, may be removed from the general circulation by haemodialysis (see section 4.4).

Shelf life

3 years.

Special precautions for storage

0.5 mg: Do not store above 25°C.

1 mg: Do not store above 25°C.

2.5 mg: Do not store above 25°C.

5 mg: This medicinal product does not require any special storage conditions.

Nature and contents of container

ALU/ALU blisters containing 14, 20, 28, 30, 50, 56, 60, 98 film-coated tablets.

Amber glass bottles containing 28, 100 film-coated tablets.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements.

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.