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Prinivil

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Prinivil

Prinivil

INDICATIONS

Hypertension

PRINIVIL is indicated for the treatment of hypertension. It may be used alone as initial therapy or concomitantly with other classes of antihypertensive agents.

Heart Failure

PRINIVIL is indicated as adjunctive therapy in the management of heart failure in patients who are not responding adequately to diuretics and digitalis.

Acute Myocardial Infarction

PRINIVIL is indicated for the treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction, to improve survival. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta-blockers.

In using PRINIVIL, 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 PRINIVIL does not have a similar risk. (See WARNINGS.)

In considering use of PRINIVIL, 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, Anaphylactoid and Possibly Related Reactions, Head and Neck Angioedema).

DOSAGE AND ADMINISTRATION

Hypertension

Initial Therapy

In patients with uncomplicated essential hypertension not on diuretic therapy, the recommended initial dose is 10 mg once a day. Dosage should be adjusted according to blood pressure response. The usual dosage range is 20 to 40 mg per day administered in a single daily dose. The antihypertensive effect may diminish toward the end of the dosing interval regardless of the administered dose, but most commonly with a dose of 10 mg daily. This can be evaluated by measuring blood pressure just prior to dosing to determine whether satisfactory control is being maintained for 24 hours. If it is not, an increase in dose should be considered. Doses up to 80 mg have been used but do not appear to give a greater effect. If blood pressure is not controlled with PRINIVIL alone, a low dose of a diuretic may be added. Hydrochlorothiazide 12.5 mg has been shown to provide an additive effect. After the addition of a diuretic, it may be possible to reduce the dose of PRINIVIL.

Diuretic Treated Patients

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

If the diuretic cannot be discontinued, an initial dose of 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.)

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

Dosage Adjustment in Renal Impairment

The usual dose of PRINIVIL (10 mg) is recommended for patients with a creatinine clearance greater than 30 mL/min (serum creatinine of up to approximately 3 mg/dL). For patients with creatinine clearance greater than or equal to 10 mL/min and less than or equal to 30 mL/min (serum creatinine greater than or equal to 3 mg/dL), the first dose is 5 mg once daily. For patients with creatinine clearance less than 10 mL/min (usually on hemodialysis) the recommended initial dose is 2.5 mg. The dosage may be titrated upward until blood pressure is controlled or to a maximum of 40 mg daily.

Table 3

Renal Status Creatinine- Clearance mL/min Initial Dose mg/day
Normal Renal Function to Mild Impairment > 30 mL/min 10 mg
Moderate to Severe Impairment ≥ 10 ≤ 30 mL/min 5 mg
Dialysis Patients** < 10 mL/min 2.5 mg***
** See WARNINGS, Anaphylactoid reactions during membrane exposure.
*** Dosage or dosing interval should be adjusted depending on the blood pressure response.

Heart Failure

PRINIVIL is indicated as adjunctive therapy with diuretics and (usually) digitalis. The recommended starting dose is 5 mg once a day.

When initiating treatment with lisinopril in patients with heart failure, the initial dose should be administered under medical observation, especially in those patients with low blood pressure (systolic blood pressure below 100 mmHg). The mean peak blood pressure lowering occurs six to eight hours after dosing. Observation should continue until blood pressure is stable. The concomitant diuretic dose should be reduced, if possible, to help minimize hypovolemia which may contribute to hypotension. (See WARNINGS and PRECAUTIONS: DRUG INTERACTIONS.) The appearance of hypotension after the initial dose of PRINIVIL does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.

The usual effective dosage range is 5 to 20 mg per day administered as a single daily dose.

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 moderate to severe renal impairment (creatinine clearance less than or equal to 30 mL/min or serum creatinine greater than 3 mg/dL), therapy with PRINIVIL should be initiated at a dose of 2.5 mg once a day under close medical supervision. (See WARNINGS and PRECAUTIONS: DRUG INTERACTIONS.)

Acute Myocardial Infarction

In hemodynamically stable patients within 24 hours of the onset of symptoms of acute myocardial infarction, the first dose of PRINIVIL is 5 mg given orally, followed by 5 mg after 24 hours, 10 mg after 48 hours and then 10 mg of PRINIVIL once daily. Dosing should continue for six weeks. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta-blockers. Patients with a low systolic blood pressure (less than or equal to 120 mmHg) when treatment is started or during the first 3 days after the infarct should be given a lower 2.5 mg oral dose of PRINIVIL (see WARNINGS). If hypotension occurs (systolic blood pressure less than or equal to 100 mmHg) a daily maintenance dose of 5 mg may be given with temporary reductions to 2.5 mg if needed. If prolonged hypotension occurs (systolic blood pressure less than 90 mmHg for more than 1 hour) PRINIVIL should be withdrawn. For patients who develop symptoms of heart failure, see DOSAGE AND ADMINISTRATION, Heart Failure.

Dosage Adjustment in Patients with Myocardial Infarction with Renal Impairment

In acute myocardial infarction, treatment with PRINIVIL should be initiated with caution in patients with evidence of renal dysfunction, defined as serum creatinine concentration exceeding 2 mg/dL. No evaluation of dosage adjustment in myocardial infarction patients with severe renal impairment has been performed.

Use in Elderly

In general, blood pressure response and adverse experiences were similar in younger and older patients given similar doses of PRINIVIL. Pharmacokinetic studies, however, indicate that maximum blood levels and area under the plasma concentration time curve (AUC) are doubled in older patients, so that dosage adjustments should be made with particular caution.

Pediatric Hypertensive Patients 6 years of age and older

The usual recommended starting dose is 0.07 mg/kg once daily (up to 5 mg total). Dosage should be adjusted according to blood pressure response. Doses above 0.61 mg/kg (or in excess of 40 mg) have not been studied in pediatric patients. (See CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism and Pharmacodynamics and Clinical Effects.)

PRINIVIL is not recommended in pediatric patients younger than 6 years or in pediatric patients with glomerular filtration rate less than 30 mL/min/1.73 m² (see CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism, Pharmacodynamics and Clinical Effects and PRECAUTIONS). Preparation of Suspension (for 200 mL of a 1.0 mg/mL suspension)

Add 10 mL of Purified Water USP to a polyethylene terephthalate (PET) bottle containing ten 20-mg tablets of PRINIVIL and shake for at least one minute. Add 30 mL of Bicitra® diluent and 160 mL of Ora-Sweet SF± to the concentrate in the PET bottle and gently shake for several seconds to disperse the ingredients. The suspension should be stored at or below 25°C (77°F) and can be stored for up to four weeks. Shake the suspension before each use.

HOW SUPPLIED

No. 8110 — Tablets PRINIVIL, 5 mg, are white, oval shaped compressed tablets with code MSD 19 on one side and scored on the other side. They are supplied as follows:

NDC 0006-0019-54 unit of use bottles of 90.

No. 8111 — Tablets PRINIVIL, 10 mg, are light yellow, oval shaped compressed tablets with code MSD 106 on one side and scored on the other side. They are supplied as follows:

NDC 0006-0106-54 unit of use bottles of 90.

No. 8112 — Tablets PRINIVIL, 20 mg, are peach, oval shaped compressed tablets with code MSD 207 on one side and scored on the other side. They are supplied as follows:

NDC 0006-0207-54 unit of use bottles of 90.

Storage

Store at controlled room temperature, 15-30°C (59-86°F), and protect from moisture.

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

Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Manufactured by: Merck Sharp & Dohme Ltd. Cramlington, Northumberland, UK NE23 3JU. Revised: 02/2013

Last reviewed on RxList: 3/20/2013
This monograph has been modified to include the generic and brand name in many instances.

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