DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS ADMINISTRATION ONLY
The dose in hypertension is 1.25 mg every six hours administered intravenously over a five minute period. A clinical response is usually seen within 15 minutes. Peak effects after the first dose may not occur for up to four hours after dosing. The peak effects of the second and subsequent doses may exceed those of the first.
No dosage regimen for VASOTEC I.V. has been clearly demonstrated to be more effective in treating hypertension than 1.25 mg every six hours. However, in controlled clinical studies in hypertension, doses as high as 5 mg every six hours were well tolerated for up to 36 hours. There has been inadequate experience with doses greater than 20 mg per day.
In studies of patients with hypertension, VASOTEC I.V. has not been administered for periods longer than 48 hours. In other studies, patients have received VASOTEC I.V. for as long as seven days.
The dose for patients being converted to VASOTEC I.V. from oral therapy for hypertension with enalapril maleate is 1.25 mg every six hours. For conversion from intravenous to oral therapy, the recommended initial dose of Tablets VASOTEC (Enalapril Maleate) is 5 mg once a day with subsequent dosage adjustments as necessary.
PATIENTS ON DIURETIC THERAPY
For patients on diuretic therapy the recommended starting dose for hypertension is 0.625 mg administered intravenously over a five minute period. A clinical response is usually seen within 15 minutes. Peak effects after the first dose may not occur for up to four hours after dosing, although most of the effect is usually apparent within the first hour. If after one hour there is an inadequate clinical response, the 0.625 mg dose may be repeated. Additional doses of 1.25 mg may be administered at six hour intervals.
For conversion from intravenous to oral therapy, the recommended initial dose of Tablets VASOTEC (Enalapril Maleate) for patients who have responded to 0.625 mg of enalaprilat every six hours is 2.5 mg once a day with subsequent dosage adjustment as necessary.
DOSAGE ADJUSTMENT IN RENAL IMPAIRMENT
The usual dose of 1.25 mg of enalaprilat every six hours 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 /=3 mg/dL), the initial dose is 0.625 mg. (See WARNINGS.)
If after one hour there is an inadequate clinical response, the 0.625 mg dose may be repeated. Additional doses of 1.25 mg may be administered at six hour intervals.
For dialysis patients, see below, Patients at Risk of Excessive Hypotension.
For conversion from intravenous to oral therapy, the recommended initial dose of Tablets VASOTEC (Enalapril Maleate) is 5 mg once a day for patients with creatinine clearance >30 mL/min and 2.5 mg once daily for patients with creatinine clearance
PATIENTS AT RISK OF EXCESSIVE HYPOTENSION
Hypertensive patients at risk of excessive hypotension include those with the following concurrent conditions or characteristics: heart failure, hyponatremia, high dose diuretic therapy, recent intensive diuresis or increase in diuretic dose, renal dialysis, or severe volume and/or salt depletion of any etiology (see WARNINGS). Single doses of enalaprilat as low as 0.2 mg have produced excessive hypotension in normotensive patients with these diagnoses. Because of the potential for an extreme hypotensive response in these patients, therapy should be started under very close medical supervision. The starting dose should be no greater than 0.625 mg administered intravenously over a period of no less than five minutes and preferably longer (up to one hour).
Patients should be followed closely whenever the dose of enalaprilat is adjusted and/or diuretic is increased.
ADMINISTRATION
VASOTEC I.V. should be administered as a slow intravenous infusion, as indicated above, over at least five minutes. It may be administered as provided or diluted with up to 50 mL of a compatible diluent.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use whenever solution and container permit.
COMPATIBILITY AND STABILITY
VASOTEC I.V. as supplied and mixed with the following intravenous diluents has been found to maintain full activity for 24 hours at room temperature:
5 percent Dextrose Injection
0.9 percent Sodium Chloride Injection
0.9 percent Sodium Chloride Injection in 5 percent Dextrose
5 percent Dextrose in Lactated Ringer's Injection
McGaw ISOLYTE * E.
*Registered trademark of American Hospital Supply Corporation.
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