Zestril 10 mg

Zestril 10 mg

1. Name drug

Zestril 2.5 mg, 5 mg, 10 mg, 20 mg tablets.
Zestril 10 mg

2. Qualitative and quantitative composition

Each tablet contains lisinopril dihydrate equivalent to 2.5 mg, 5 mg, 10 mg or 20 mg of anhydrous lisinopril.

For fillers, see List of 6.1 fillers.


3. PHARMACEUTICALS FORM

2.5 mg tablets are white, round and biconvex. They have a diameter of 6 mm.

5 mg tablets, pink, round and biconvex. They have a diameter of 6 mm.

10 mg tablets, pink, round and biconvex. They have a diameter of 8 mm.

20 mg tablets, pink, round and biconvex. They have a diameter of 8 mm.

All pills are marked on one side with a number denoting tablet strength.


4. CLINICAL PARTICULARS




4.1 Therapeutic indications

Hypertension

Treatment of hypertension.

Zestril 10 mg
Heart failure

The treatment of the symptoms of heart failure.


Acute myocardial infarction

Short-term (6 weeks) treatment of haemodynamically stable patients within 24 hours after acute myocardial infarction.


Renal complications of diabetes

Treatment of kidney disease in hypertensive patients with Type 2 diabetes and incipient nephropathy (see section 5.1).



Posology 4.2 and the method of administration

Zestril must be made orally in a single daily dose. Like all other drugs taken once a day, should take Zestril about the same time every day. Depreciation Zestril tablets is not affected by food.

The dose should be individualised according to the patient's profile and blood pressure response (see section 4.4).


Hypertension

Zestril may be used as monotherapy or in combination with other classes of antihypertensive therapy.


Starting dose

In patients with hypertension usual recommended starting dose is 10 mg. Patients with highly activated renin-angiotensin-aldosterone system (in particular, renovascular hypertension, salt and / or layer volume, cardiac decompensation or severe hypertension) may experience excessive pressure in autumn after the initial dose. A 2.5-5 mg starting dose is recommended for such patients and the initiation of treatment should be conducted under medical supervision. A lower starting dose is required if renal view (see Table 1 below).


The maintenance dose

Usually the effective maintenance dosage of 20 mg administered in a single daily dose. In general, if the desired therapeutic effect can not be achieved in the period of 2 to 4 weeks, at a dose level, the dose could be further increased. The maximum dose used in the long-term, controlled clinical trials with 80 mg per day.


Diuretic patients

Symptomatic hypotension may occur after the beginning of therapy with Zestril. This is more likely in patients who are being treated currently Diuretics. Attention is therefore recommended, as these patients can be the volume and / or salt depleted. If possible, the diuretic should be dispensed from 2 to 3 days before the start of therapy with Zestril. In hypertensive patients in the diuretic which can not be terminated, with Zestril therapy should begin with 5 mg dose. Renal function and serum potassium should be monitored. In subsequent Zestril doses should be adjusted according to blood pressure response. If required, diuretic therapy may be renewed (see section 4.4 and 4.5).
Zestril 10 mg

Dosage adjustment in violation of kidney

The dosage in patients with renal damage should be based on creatinine clearance as indicated in Table 1.


Table 1 Dosage adjustment in violation of kidney