Enalaprilat
Vasotec ® |
| Usual
Diluents |
| D5W,
NS |
| Standard
Dilutions [Amount of drug]
[Infusion volume] [Infusion rate] |
| [0 -
2.5 mg] [50 ml] [15-20 min] |
|
| Stability
/ Miscellaneous |
EXP: 1
DAY (RT).
The dose for pt's being converted from oral to IV
is the same.
May also be given IV push over 5 minutes.
Ace inhibitor conversion:
[Captopril 12.5mg] =
[lisinopril,fosinopril,quinapril, benazepril 5 mg]
=
[enalapril,ramipril 2.5mg]
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 enalaprilat injection 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,
enalaprilat injection has not been administered
for periods longer than 48 hours. In other
studies, patients have received enalaprilat
injection for as long as seven days.
The dose for patients being converted to
enalaprilat injection 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
Enalapril Maleate Tablets 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; also see below, Patients at Risk of
Excessive Hypotension. 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 Enalapril Maleate
Tablets 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 ≤30 mL/min
(serum creatinine ≥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 Enalapril Maleate
Tablets 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
≤30 mL/min. Dosage should then be adjusted
according to blood pressure response.
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
Enalaprilat Injection should be administered as a
slow intravenous infusion, as indicated above. 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
Enalaprilat Injection 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
B. Braun ISOLYTE***E.
HOW SUPPLIED
Enalaprilat Injection, 1.25 mg per mL, is a clear,
colorless solution and is supplied as follows:
Vial - 1.25 mg/mL - 1 mL
Vial - 1.25 mg/mL - 2 mL
Store at 20 to 25°C (68 to 77°F). [See USP
Controlled Room Temperature.]
***Registered trademark of B. Braun
December, 2004
©Hospira 2004 EN-0765 Printed in USA
HOSPIRA, INC., LAKE FOREST, IL 60045 USA |
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