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 Side Effects, and Drug Interactions - Midodrine
Proamatine Side Effects, and Drug Interactions - Midodrine
SIDE EFFECTS
The most frequent adverse reactions seen in controlled trials were
supine and sitting hypertension; paresthesia
and pruritus, mainly of the scalp; goosebumps; chills; urinary urge;
urinary retention
and urinary frequency. The frequency of these events in a 3-week
placebo-controlled trial is shown in the following table:
Adverse Events
|
|
Placebo
n= 88
|
Midodrine
n= 82
|
|
Event
|
# of reports
|
% of patients
|
# of reports
|
% of patients
|
| Total # of reports
|
22
|
|
77
|
|
| Paresthesia1
|
4
|
4.5
|
15
|
18.3
|
| Piloerection |
0
|
0
|
11
|
13. 4
|
| Dysuria2 |
0
|
0
|
11
|
13.4
|
| Pruritus3
|
2
|
2.3
|
10
|
12.2
|
|
Supine hypertension4
|
0
|
0
|
6
|
7.3
|
| Chills |
0
|
0
|
4
|
4.9
|
| Pain5
|
0
|
0
|
4
|
4.9
|
| Rash |
1
|
1.1
|
2
|
2.4
|
- 1 Includes hyperesthesia
and scalp paresthesia
- 2 Includes dysuria
(1) increased urinary frequency (2), impaired urination
(1), urinary retention
(5), urinary urgency (2)
- 3 Includes scalp
pruritus
- 4 Includes patients who experienced an increase
in supine hypertension
- 5 Includes abdominal
pain and pain
increase
Less frequent adverse reactions were headache; feeling
of pressure/ fullness in the head; vasodilation/flushing face; confusion/thinking
abnormality, dry mouth; nervousness/anxiety and rash. Other adverse
reactions that occurred rarely were visual
field defect; dizziness;
skin hyperesthesia; insomnia;
somnolence; erythema
multiforme; canker sore; dry skin; dysuria; impaired urination;
asthenia; backache; pyrosis; nausea; gastrointestinal
distress; flatulence and leg
cramps.
The most potentially serious adverse reaction
associated with ProAmatine® therapy is supine
hypertension. The feelings of paresthesia, pruritus, piloerection
and chills are pilomotor
reactions associated with the action of midodrine on the alpha-adrenergic
receptors of the hair follicles.
Feelings of urinary urgency retention
and frequency are associated with the action of midodrine on the
alpha-receptors of the bladder
neck.
DRUG INTERACTIONS
When administered concomitantly with ProAmatine®, cardiac
glycosides may enhance or precipitate
bradycardia, A.V. block
or arrhythmia. The use of drugs that stimulate
alpha-adrenergic receptors (e.g., phenylephrine, pseudoephedrine,
ephedrine, phenylpropanolamine or dihydroergotamine) may enhance
or potentiate the
pressor effects of ProAmatine®.
Therefore, caution should be used when ProAmatine® is administered
concomitantly with agents that cause
vasoconstriction.
ProAmatine® has been used in patients concomitantly treated
with salt-retaining steroid
therapy (i.e., fludrocortisone
acetate), with or without salt
supplementation. The potential
for supine hypertension
should be carefully monitored in these patients and may be minimized
by either reducing the dose
of fludrocortisone
acetate or decreasing
the salt intake prior to
initiation of treatment
with. ProAmatine®. Alpha-adrenergic blocking agents, such as
prazosin, terazosin, and doxazosin, can antagonize the effects of
ProAmatine®.
Potential for Drug Interactions: It appears possible, although
there is no supporting experimental evidence, that the high renal
clearance of desglymidodrine (a base) is due to active tubular
secretion by the base-secreting
system also responsible for the secretion
of such drugs as metformin, cimetidine, ranitidine, procainamide,
triamterene, flecainide, and quinidine. Thus there may be a potential
for drug-drug interactions with these drugs.
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