Hypertension

VASOTEC is indicated for the treatment of hypertension.

VASOTEC is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of VASOTEC and thiazides are approximately additive.

Heart Failure

VASOTEC is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients VASOTEC improves symptoms, increases survival, and decreases the frequency of hospitalization (see CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials for details and limitations of survival trials).

Asymptomatic Left Ventricular Dysfunction

In clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction =35 percent), VASOTEC decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure (see CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials for details and limitations of survival trials).

In using VASOTEC consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that VASOTEC does not have a similar risk (see WARNINGS).

In considering use of VASOTEC, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks (see WARNINGS, Head and Neck Angioedema).

Hypertension

In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally may occur following the initial dose of VASOTEC. The diuretic should, if possible, be discontinued for two to three days before beginning therapy with VASOTEC to reduce the likelihood of hypotension (see WARNINGS). If the patient's blood pressure is not controlled with VASOTEC alone, diuretic therapy may be resumed.

If the diuretic cannot be discontinued an initial dose of 2.5 mg should be used under medical supervision for at least two hours and until blood pressure has stabilized for at least an

additional hour (see WARNINGS and PRECAUTIONS: DRUG INTERACTIONS).

The recommended initial dose in patients not on diuretics is 5 mg once a day. Dosage should be adjusted according to blood pressure response. The usual dosage range is 10 to 40 mg per day administered in a single dose or two divided doses. In some patients treated once daily, the antihypertensive effect may diminish toward the end of the dosing interval. In such patients, an increase in dosage or twice daily administration should be considered. If blood pressure is not controlled with VASOTEC alone, a diuretic may be added.

Concomitant administration of VASOTEC with potassium supplements, potassium salt substitutes, or potassium-sparing diuretics may lead to increases of serum potassium (see PRECAUTIONS).

Dosage Adjustment in Hypertensive Patients with Renal Impairment

The usual dose of enalapril is recommended for patients with a creatinine clearance > 30 mL/min (serum creatinine of up to approximately 3 mg/dL). For patients with creatinine clearance =30 mL/min (serum creatinine =3 mg/dL), the first dose is 2.5 mg once daily. The dosage may be titrated upward until blood pressure is controlled or to a maximum of 40 mg daily.

Heart Failure

VASOTEC is indicated for the treatment of symptomatic heart failure, usually in combination with diuretics and digitalis. In the placebo-controlled studies that demonstrated improved survival, patients were titrated as tolerated up to 40 mg, administered in two divided doses.

The recommended initial dose is 2.5 mg. The recommended dosing range is 2.5 to 20 mg given twice a day. Doses should be titrated upward, as tolerated, over a period of a few days or weeks. The maximum daily dose administered in clinical trials was 40 mg in divided doses.

After the initial dose of VASOTEC, the patient should be observed under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour (see WARNINGS and PRECAUTIONS: DRUG INTERACTIONS). If possible, the dose of any concomitant diuretic should be reduced which may diminish the likelihood of hypotension. The appearance of hypotension after the initial dose of VASOTEC does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.

Asymptomatic Left Ventricular Dysfunction

In the trial that demonstrated efficacy, patients were started on 2.5 mg twice daily and were titrated as tolerated to the targeted daily dose of 20 mg (in divided doses).

After the initial dose of VASOTEC, the patient should be observed under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour (see WARNINGS and PRECAUTIONS: DRUG INTERACTIONS). If possible, the dose of any concomitant diuretic should be reduced which may diminish the likelihood of hypotension. The appearance of hypotension after the initial dose of VASOTEC does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.

Dosage Adjustment in Patients with Heart Failure and Renal Impairment or Hyponatremia

In patients with heart failure who have hyponatremia (serum sodium less than 130 mEq/L) or with serum creatinine greater than 1.6 mg/dL, therapy should be initiated at 2.5 mg daily under close medical supervision (see DOSAGE AND ADMINISTRATION, Heart Failure, WARNINGS and PRECAUTIONS: DRUG INTERACTIONS). The dose may be increased to 2.5 mg b.i.d., then 5 mg b.i.d. and higher as needed, usually at intervals of four days or more if at the time of dosage adjustment there is not excessive hypotension or significant deterioration of renal function. The maximum daily dose is 40 mg.

Pediatric Hypertensive Patients

The usual recommended starting dose is 0.08 mg/kg (up to 5 mg) once daily. Dosage should be adjusted according to blood pressure response. Doses above 0.58 mg/kg (or in excess of 40 mg) have not been studied in pediatric patients (see CLINICAL PHARMACOLOGY, Clinical Pharmacology in Pediatric Patients).

VASOTEC is not recommended in neonates and in pediatric patients with glomerular filtration rate < 30 mL/min/1.73 m², as no data are available.

Preparation of Suspension (for 200 mL of a 1.0 mg/mL suspension)

Add 50 mL of Bicitra®¹ to a polyethylene terephthalate (PET) bottle containing ten 20 mg tablets of VASOTEC and shake for at least 2 minutes. Let concentrate stand for 60 minutes. Following the 60-minute hold time, shake the concentrate for an additional minute. Add 150 mL of Ora-Sweet SF™² to the concentrate in the PET bottle and shake the suspension to disperse the ingredients. The suspension should be refrigerated at 2-8°C (36-46°F) and can be stored for up to 30 days. Shake the suspension before each use.

¹Registered trademark
²Trademark of Paddock

VASOTEC Tablets, 2.5 mg, are white, oval shaped tablet with "MSD14" and scored on one side and scored on the other. They are supplied as follows:

NDC 64455-140-30 bottles of 30 (with desiccant)
NDC 64455-140-90 unit of use bottles of 90 (with desiccant)

VASOTEC Tablets, 5 mg, are white, rounded triangle shaped tablet with "MSD712" on one side and scored on the other. They are supplied as follows:

NDC 64455-141-30 bottles of 30 (with desiccant)
NDC 64455-141-90 unit of use bottles of 90 (with desiccant)
NDC 64455-141-10 bottles of 1,000 (with desiccant)

VASOTEC Tablets, 10 mg, are rust red, rounded triangle shaped tablet with "MSD713" on one side and scored on the other. They are supplied as follows:

NDC 64455-142-30 bottles of 30 (with desiccant)
NDC 64455-142-90 unit of use bottles of 90 (with desiccant)
NDC 64455-142-10 bottles of 1,000 (with desiccant)

VASOTEC Tablets, 20 mg, are peach, rounded triangle shaped tablet with "MSD714" on one side and scored on the other. They are supplied as follows:

NDC 64455-143-30 bottles of 30 (with desiccant)
NDC 64455-143-90 unit of use bottles of 90 (with desiccant)
NDC 64455-143-10 bottles of 1,000 (with desiccant)

Storage

Store at 25°C (77°F); excursions permitted to 15-30°C (59- 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from moisture.

Dispense in a tight container as per USP, if product package is subdivided.

Vasotec® is a registered trademark of Biovail Laboratories International SRL

Manufactured by: Merck Sharp & Dohme Ltd. Cramlington, Northumberland, UK. NE23 3JU. Distributed by: Biovail Pharmaceuticals, Inc. (BPI) Bridgewater, NJ 08807, USA. Tablets made in the United Kingdom Rev. 07/07. FDA Rev date: 10/31/2007

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