|
|
Line 1: |
Line 1: |
| {{CMG}}
| | #REDIRECT [[Lisinopril#Adult Indications and Dosage]] |
| ==Instructions for administration==
| |
| <font size="4">[[Lisinopril instructions for administration#Initial Therapy|Initial Therapy]]</font>
| |
| <br>
| |
| <br>
| |
| <font size="4">[[Lisinopril instructions for administration#Diuretic Treated Patients|Diuretic Treated Patients]]</font>
| |
| <br>
| |
| <br>
| |
| <font size="4">[[Lisinopril instructions for administration#Dosage Adjustment in Renal Impairment|Dosage Adjustment in Renal Impairment]]</font>
| |
| <br>
| |
| <br>
| |
| <font size="4">[[Lisinopril instructions for administration#Heart Failure|Heart Failure]]</font>
| |
| <br>
| |
| <br>
| |
| <font size="4">[[Lisinopril instructions for administration#Acute Myocardial Infarction|Acute Myocardial Infarction]]</font>
| |
| <br>
| |
| <br>
| |
| <font size="4">[[Lisinopril instructions for administration#Dosage Adjustment in Patients With Myocardial Infarction with Renal Impairment|Dosage Adjustment in Patients With Myocardial Infarction with Renal Impairment]]</font>
| |
| <br>
| |
| <br>
| |
| <font size="4">[[Lisinopril instructions for administration#Use in Elderly|Use in Elderly]]</font>
| |
| <br>
| |
| <br>
| |
| <font size="4">[[Lisinopril instructions for administration#Preparation of Suspension (for 200 mL of a 1.0 mg/mL suspension)|Preparation of Suspension (for 200 mL of a 1.0 mg/mL suspension)]]</font>
| |
| <br>
| |
| ----
| |
| <br>
| |
| ===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 greater effect. If blood pressure is not controlled with ZESTRIL 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 ZESTRIL. ''[[Lisinopril instructions for administration#Instructions for administration|Return to top]]''
| |
| | |
| ===Diuretic Treated Patients===
| |
| In hypertensive patients who are currently being treated with a diuretic, symptomatic hypotension may occur
| |
| occasionally following the initial dose of ZESTRIL. The diuretic should be discontinued, if possible, for two to three days before beginning
| |
| therapy with ZESTRIL to reduce the likelihood of hypotension. (See WARNINGS.) The dosage of ZESTRIL should be adjusted according to
| |
| blood pressure response. If the patient’s blood pressure is not controlled with ZESTRIL 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 ZESTRIL with potassium supplements, potassium salt substitutes, or potassium-sparing diuretics may lead
| |
| to increases of serum potassium. ''[[Lisinopril instructions for administration#Instructions for administration|Return to top]]''
| |
| | |
| ===Dosage Adjustment in Renal Impairment===
| |
| The usual dose of ZESTRIL (10 mg) is recommended for patients with creatinine clearance
| |
| > 30 mL/min (serum creatinine of up to approximately 3 mg/dL). For patients with creatinine clearance ≥ 10 mL/min ≤ 30 mL/min (serum
| |
| creatinine ≥ 3 mg/dL), the first dose is 5 mg once daily. For patients with creatinine clearance < 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. ''[[Lisinopril instructions for administration#Instructions for administration|Return to top]]''
| |
| | |
| ===Heart Failure===
| |
| ZESTRIL 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 ZESTRIL does not preclude subsequent careful dose titration with the drug, following
| |
| effective management of the hypotension.
| |
| The usual effective dosage range is 5 to 40 mg per day administered as a single daily dose. The dose of ZESTRIL can be increased by increments
| |
| of no greater than 10 mg, at intervals of no less than 2 weeks to the highest tolerated dose, up to a maximum of 40 mg daily. Dose
| |
| adjustment should be based on the clinical response of individual patients.
| |
| Dosage Adjustment in Patients with Heart Failure and Renal Impairment or Hyponatremia: In patients with heart failure who have
| |
| hyponatremia (serum sodium < 130 mEq/L) or moderate to severe renal impairment (creatinine clearance ≤ 30 mL/min or serum
| |
| creatinine > 3 mg/dL), therapy with ZESTRIL should be initiated at a dose of 2.5 mg once a day under close medical supervision. ''[[Lisinopril instructions for administration#Instructions for administration|Return to top]]''
| |
| | |
| ===Acute Myocardial Infarction===
| |
| In hemodynamically stable patients within 24 hours of the onset of symptoms of acute myocardial infarction,
| |
| the first dose of ZESTRIL is 5 mg given orally, followed by 5 mg after 24 hours, 10 mg after 48 hours and then 10 mg of ZESTRIL 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 (≤ 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 ZESTRIL. If hypotension occurs (systolic blood pressure ≤ 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
| |
| < 90 mmHg for more than 1 hour) ZESTRIL should be withdrawn. ''[[Lisinopril instructions for administration#Instructions for administration|Return to top]]''
| |
| | |
| ===Dosage Adjustment in Patients With Myocardial Infarction with Renal Impairment===
| |
| In acute myocardial infarction, treatment with ZESTRIL
| |
| should be initiated with caution in patients with evidence of renal dysfunction, defined as serum creatinine concentration exceeding 2 mg/dL.
| |
| No evaluation of dosing adjustments in myocardial infarction patients with severe renal impairment has been performed. ''[[Lisinopril instructions for administration#Instructions for administration|Return to top]]''
| |
| | |
| ===Use in Elderly===
| |
| In general, the clinical response was similar in younger and older patients given similar doses of ZESTRIL. 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
| |
| 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.
| |
| ZESTRIL is not recommended in pediatric patients < 6 years or in pediatric patients with glomerular filtration rate < 30 mL/min/1.73m2. ''[[Lisinopril instructions for administration#Instructions for administration|Return to top]]''
| |
| | |
| ===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 ZESTRIL 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 25ºC (77ºF) and can be stored for up to four weeks.
| |
| Shake the suspension before each use. ''[[Lisinopril instructions for administration#Instructions for administration|Return to top]]''
| |
| <br>
| |
| <br>
| |
| ----
| |
| <br>
| |
| {{FDA}}
| |