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 Warnings, Precautions, Pregnancy, Nursing, Abuse - Midodrine
Proamatine Warnings, Precautions, Pregnancy, Nursing, Abuse - Midodrine
WARNINGS
Supine Hypertension
The most potentially serious adverse reaction
associated with ProAmatine® therapy is marked elevation
of supine arterial
blood pressure
(supine hypertension). Systolic pressure
of about 200 mmHg were seen overall in about 13.4% of patients given
10 mg of ProAmatine®.
Systolic elevations of this degree were most likely to be observed
in patients with relatively elevated pre-treatment systolic blood
pressures (mean 170 mmHg). There is no experience
in patients with initial
supine systolic
pressure above 180
mmHg, as those patients were excluded from the clinical
trials. Use of ProAmatine® in such patients is not recommended.
Sitting blood pressures
were also elevated by ProAmatine® therapy. It is essential
to monitor supine
and sitting blood pressures in patients maintained on ProAmatine®.
PRECAUTIONS
General
The potential for
supine and sitting hypertension
should be evaluated at the beginning of ProAmatine® therapy.
Supine hypertension
can often be controlled by preventing the patient
from becoming fully supine, i.e., sleeping with the head
of the bed elevated. The
patient should be cautioned
to report symptoms of
supine hypertension
immediately. Symptoms may include cardiac awareness, pounding in
the ears, headache, blurred vision, etc. The patient
should be advised to discontinue the medication
immediately if supine
hypertension persists.
Blood pressure should
be monitored carefully when ProAmatine® is used concomitantly
with other agents that cause vasoconstriction, such as phenylephrine,
ephedrine, dihydroergotamine, phenylpropanolamine or pseudoephedrine.
A slight slowing of the heart
rate may occur after administration
of ProAmatine®, primarily due to vagal
reflex. Caution should be exercised when ProAmatine® is used
concomitantly with cardiac
glycosides (such as digitalis), psychopharmacologic agents, beta
blockers or other agents that directly or indirectly reduce
heart rate. Patients who
experience any signs or symptoms suggesting bradycardia
(pulse slowing increased dizziness, syncope, cardiac
awareness) should be advised to discontinue ProAmetine® and
should be re- evaluated.
ProAmatine® should be used cautiously in patients with urinary
retention problems, as desglymidodrine acts on the alpha- adrenergic
receptors of the bladder
neck.
ProAmatine® should be used with caution in orthostatic
hypotensive patients who are also diabetic, as well as those with
a history of visual problems who are also taking fludrocortisone
acetate, which is known to cause an increase in intraocular
pressure and glaucoma.
ProAmatine® use has not been studied in patients with renal
impairment. Because desglymidodrine is eliminated via
the kidneys, and higher blood levels would be expected in such patients,
ProAmati ne® should be used with caution in patients with renal
impairment, with a starting dose
of 2.5 mg (see DOSAGE
AND ADMINISTRATION). Renal function
should be assessed prior to initial
use of ProAmatine®.
ProAmatine® use has not been studied in patients with hepatic
impairment. ProAmatine® should be used with caution in patients
with hepatic impairment,
as the liver has a role
in the metabolism
of midodrine.
Laboratory Tests
Since desglymidodrine is eliminated by the kidneys and the liver
has a role in its metabolism,
evaluation of the
patient should include
assessment of renal and
hepatic function
prior to initiating therapy and subsequently, as appropriate.
Drug Interactions
See DRUG INTERACTIONS
section.
Carcinogenesis Mutagenesis, Impairment of Fertility
Long-term studies have been conducted in rats and mice at dosages
of 3 to 4 times the maximum
recommended daily human
dose on a mg/m2
basis with no indication
of carcinogenic
effects related to ProAmatine®. Studies investigating the mutagenic
potential of ProAmatine®
revealed no evidence
of mutagenicity. Other than the dominant
lethal assay in male
mice, where no impairment
of fertility was observed, there have been no studies on the effects
of ProAmatine® on fertility.
Pregnancy
Pregnancy Category C. ProAmatine® increased the
rate of embryo resorption,
reduced fetal body weight
in rats and rabbits, and decreased fetal
survival in rabbits
when given in doses 13 (rat) and 7 (rabbit) times the maximum
human dose
based on body surface
area (mg/m2).
There are no adequate and well-controlled studies in pregnant
women. ProAmatine® should be used during pregnancy only if the
potential benefit
justifies the potential
risk to the fetus. No teratogenic
effects have been observed in studies in rats and rabbits.
Nursing Mothers
It is not known whether this drug
is excreted in human milk.
Because many drugs are excreted in human
milk, caution should be exercised when ProAmatine® is administered
to a nursing woman.
Pediatric Use
Safety and effectiveness
in pediatric patients
have not been established.
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