A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Proamatine Indications, Dosage, Storage, Stability - Midodrine
Proamatine Indications, Dosage, Storage, Stability - Midodrine
INDICATIONS
ProAmatine® is indicated for the treatment
of symptomatic orthostatic
hypotension (OH). Because ProAmatine® can cause
marked elevation of
supine blood pressure
(BP> 200 mmHg systolic), it should be used in patients whose
lives are considerably impaired despite standard
clinical care, including non- pharmacologic treatment
(such as support stockings),
fluid expansion, and lifestyle
alterations. The indication
is based on ProAmatine® 's effect
on increases in 1-minute standing systolic
blood pressure, a surrogate
marker considered likely
to correspond to a clinical benefit. At
present, however, clinical
benefits of ProAmatine®, principally improved ability to perform
life activities, have not
been established. Further clinical
trials are underway to verify and describe the clinical benefits
of ProAmatine®. After initiation of treatment, ProAmatine®
should be continued only for patients who report
significant symptomatic
improvement.
DOSAGE AND ADMINISTRATION
The recommended dose of
ProAmatine® is 10 mg, 3 times daily. Dosing should take
place during the daytime hours when the patient
needs to be upright, pursuing the activities of daily life. A suggested
dosing schedule of approximately 4-hour intervals is as follows:
shortly before or upon arising in the morning, midday, and late
afternoon (not later than 6 P. M.). Doses may be given in 3-hour
intervals, if required, to control
symptoms, but not more frequently. Single doses as high as 20 mg
have been given to patients, but severe and persistent systolic
supine hypertension
occurs at a high rate (about
45%) at this dose. In order
to reduce the potential
for supine hypertension
during sleep, ProAmatine® should not be given after the evening
meal or less than 4 hours
before bedtime. Total daily doses greater than 30 mg
have been tolerated by some patients, but their safety and usefulness
have not been studied systematically or established. Because of
the risk of supine
hypertension, ProAmatine® should be continued only in patients
who appear to attain symptomatic
improvement during initial treatment.
The supine and standing
blood pressure
should be monitored regularly, and the administration
of ProAmatine® should be stopped if supine
blood pressure increases excessively. Because desglymidodrine is
excreted renally, dosing in patients with abnormal
renal function
should be cautious; although this has not been systematically studied,
it is recommended that treatment of these patients be, initiated
using 2.5-mg doses. Dosing in children has not been adequately studied.
Blood levels of midodrine and desglymidodrine were similar when
comparing levels in patients 65 or older vs. younger than 65 and
when comparing males vs. females, suggesting dose
modifications for these groups are not necessary.
HOW SUPPLIED
ProAmatine® is supplied as 2.5-mg and 5-mg tablets for oral
administration.
The 2.5-mg tablet is
white, round, and biplanar, with a bevelled edge, and is scored
on one side with ''RPC''
above and ''2.5" below the score and "003'' on the other
side.
The 5- mg tablet
is orange, round, and biplanar, with a bevelled edge, and is scored
on one side with ''RPC"
above and ''5" below the score, and "004" on the
other side
2.5-milligram Tablets:
5-milligram Tablets:
Store from 15° C to 25° C (59° F to 77° F).
CAUTION: Keep this and all medication
out of the reach of children.
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