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ProAmatine
Overview
What is ProAmatine?
Name: ProAmatine
Dosage Form:
Active Ingredient:
Inactive Ingredients:
Pharmacological Classification:
Chemical Names (USAN: Midodrine Hydrochloride): (1) Acetamide,
2-amino-N-[2-(2,5-dimethoxyphenyl)-2-hydroxyethyl]-monohydrochloride, (±)-;
(2) (±)-2-amino-N-(β-hydroxy-2,5-dimethoxyphenethyl)acetamide
monohydrochloride
BAN, INN, JAN: Midodrine
Structural formula:
Molecular formula:
Molecular Weight:
Organoleptic Properties:
Solubility:
Methanol: Sparingly soluble
pKa:
pH:
Melting Range:
What does ProAmatine look like?
What are the available doses of ProAmatine?
Sorry No records found.
What should I talk to my health care provider before I take ProAmatine?
Sorry No records found
How should I use ProAmatine?
ProAmatine
ProAmatine
ProAmatine
ProAmatine
ProAmatine
After initiation of treatment,
should be continued only for patients who report significant
symptomatic improvement.
The recommended dose of 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 living. 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, 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,
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
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.
What interacts with ProAmatine?
ProAmatine
ProAmatine
®
What are the warnings of ProAmatine?
Array
What are the precautions of ProAmatine?
The potential for supine and sitting hypertension should be
evaluated at the beginning of
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
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
, primarily due to vagal
reflex. Caution should be exercised when
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
and should be
re-evaluated.
ProAmatine
ProAmatine
ProAmatine
ProAmatine
ProAmatine
ProAmatine
ProAmatine
Patients should be told that certain agents in over-the-counter
products, such as cold remedies and diet aids, can elevate blood pressure, and
therefore, should be used cautiously with
, as they may enhance or
potentiate the pressor effects of
(see ).
Patients should also be made aware of the possibility of supine hypertension.
They should be told to avoid taking their dose if they are to be supine for any
length of time, i.e., they should take their last daily dose of
3 to 4 hours before bedtime
to minimize nighttime supine hypertension.
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.
When administered concomitantly with
, 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
. Therefore, caution should
be used when
is
administered concomitantly with agents that cause vasoconstriction.
ProAmatine
ProAmatine
ProAmatine
It appears possible, although there is no supporting experimental
evidence, that the high renal clearance of desyglymidodrine (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.
Long-term studies have been conducted in rats and mice at dosages
3 to 4 times the maximum recommended daily human dose on a mg/m basis, with no indication of carcinogenic effects related to
. Studies
investigating the mutagenic potential of
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
on fertility.
Pregnancy Category C
ProAmatine
ProAmatine
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
is administered to a
nursing woman.
Safety and effectiveness in pediatric patients have not been
established.
What are the side effects of ProAmatine?
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:
1
2
3
4
5
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 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.
| Total # of reports | 22 | 77 | ||
| Paresthesia | 4 | 4.5 | 15 | 18.3 |
| Piloerection | 0 | 0 | 11 | 13.4 |
| Dysuria | 0 | 0 | 11 | 13.4 |
| Pruritis | 2 | 2.3 | 10 | 12.2 |
| Supine hypertension | 0 | 0 | 6 | 7.3 |
| Chills | 0 | 0 | 4 | 4.9 |
| Pain | 0 | 0 | 4 | 4.9 |
| Rash | 1 | 1.1 | 2 | 2.4 |
What should I look out for while using ProAmatine?
ProAmatine
ProAmatine
®
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
.
®
®
®
®
®
What might happen if I take too much ProAmatine?
Symptoms of overdose could include hypertension, piloerection
(goosebumps), a sensation of coldness and urinary retention. There are 2
reported cases of overdosage with , both in young males. One patient ingested drops, 250 mg, experienced
systolic blood pressure greater than 200 mmHg, was treated with an IV injection
of 20 mg of phentolamine, and was discharged the same night without any
complaints. The other patient ingested 205 mg of (41 5-mg tablets), and was
found lethargic and unable to talk, unresponsive to voice but responsive to
painful stimuli, hypertensive and bradycardic. Gastric lavage was performed, and
the patient recovered fully by the next day without sequelae.
The single doses that would be associated with symptoms of overdosage or
would be potentially life-threatening are unknown. The oral LD is approximately 30 to 50 mg/kg in rats, 675 mg/kg in mice,
and 125 to 160 mg/kg in dogs.
Desglymidodrine is dialyzable.
Recommended general treatment, based on the pharmacology of the drug,
includes induced emesis and administration of alpha-sympatholytic drugs (e.g.,
phentolamine).
How should I store and handle ProAmatine?
Store at 20° to 25ºC (68° to 77°F).[See USP Controlled Room Temperature]Dispense in a tight container as defined in the USP.Store at 20° to 25ºC (68° to 77°F).[See USP Controlled Room Temperature]Dispense in a tight container as defined in the USP.Store at 20° to 25ºC (68° to 77°F).[See USP Controlled Room Temperature]Dispense in a tight container as defined in the USP.ProAmatine 5.0-milligram Tablets: NDC 54868-5442-0 Bottle of 10 NDC 54868-5442-2 Bottle of 60 NDC 54868-5442-1 Bottle of 90Store at 25°C (77°F)Excursions permitted to 15-30 °C (59-86 °F)[see USP Controlled Room Temperature]Manufactured for Shire US Inc.by NYCOMED Austria GmbH© 2003 Shire US Inc.Rev. 10/03003 0107 006Rx onlyRepackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146 ProAmatine 5.0-milligram Tablets: NDC 54868-5442-0 Bottle of 10 NDC 54868-5442-2 Bottle of 60 NDC 54868-5442-1 Bottle of 90Store at 25°C (77°F)Excursions permitted to 15-30 °C (59-86 °F)[see USP Controlled Room Temperature]Manufactured for Shire US Inc.by NYCOMED Austria GmbH© 2003 Shire US Inc.Rev. 10/03003 0107 006Rx onlyRepackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146 ProAmatine 5.0-milligram Tablets: NDC 54868-5442-0 Bottle of 10 NDC 54868-5442-2 Bottle of 60 NDC 54868-5442-1 Bottle of 90Store at 25°C (77°F)Excursions permitted to 15-30 °C (59-86 °F)[see USP Controlled Room Temperature]Manufactured for Shire US Inc.by NYCOMED Austria GmbH© 2003 Shire US Inc.Rev. 10/03003 0107 006Rx onlyRepackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146 ProAmatine 5.0-milligram Tablets: NDC 54868-5442-0 Bottle of 10 NDC 54868-5442-2 Bottle of 60 NDC 54868-5442-1 Bottle of 90Store at 25°C (77°F)Excursions permitted to 15-30 °C (59-86 °F)[see USP Controlled Room Temperature]Manufactured for Shire US Inc.by NYCOMED Austria GmbH© 2003 Shire US Inc.Rev. 10/03003 0107 006Rx onlyRepackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146 ProAmatine 5.0-milligram Tablets: NDC 54868-5442-0 Bottle of 10 NDC 54868-5442-2 Bottle of 60 NDC 54868-5442-1 Bottle of 90Store at 25°C (77°F)Excursions permitted to 15-30 °C (59-86 °F)[see USP Controlled Room Temperature]Manufactured for Shire US Inc.by NYCOMED Austria GmbH© 2003 Shire US Inc.Rev. 10/03003 0107 006Rx onlyRepackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146 ProAmatine 5.0-milligram Tablets: NDC 54868-5442-0 Bottle of 10 NDC 54868-5442-2 Bottle of 60 NDC 54868-5442-1 Bottle of 90Store at 25°C (77°F)Excursions permitted to 15-30 °C (59-86 °F)[see USP Controlled Room Temperature]Manufactured for Shire US Inc.by NYCOMED Austria GmbH© 2003 Shire US Inc.Rev. 10/03003 0107 006Rx onlyRepackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146 ProAmatine 5.0-milligram Tablets: NDC 54868-5442-0 Bottle of 10 NDC 54868-5442-2 Bottle of 60 NDC 54868-5442-1 Bottle of 90Store at 25°C (77°F)Excursions permitted to 15-30 °C (59-86 °F)[see USP Controlled Room Temperature]Manufactured for Shire US Inc.by NYCOMED Austria GmbH© 2003 Shire US Inc.Rev. 10/03003 0107 006Rx onlyRepackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146 ProAmatine 5.0-milligram Tablets: NDC 54868-5442-0 Bottle of 10 NDC 54868-5442-2 Bottle of 60 NDC 54868-5442-1 Bottle of 90Store at 25°C (77°F)Excursions permitted to 15-30 °C (59-86 °F)[see USP Controlled Room Temperature]Manufactured for Shire US Inc.by NYCOMED Austria GmbH© 2003 Shire US Inc.Rev. 10/03003 0107 006Rx onlyRepackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146 ProAmatine 5.0-milligram Tablets: NDC 54868-5442-0 Bottle of 10 NDC 54868-5442-2 Bottle of 60 NDC 54868-5442-1 Bottle of 90Store at 25°C (77°F)Excursions permitted to 15-30 °C (59-86 °F)[see USP Controlled Room Temperature]Manufactured for Shire US Inc.by NYCOMED Austria GmbH© 2003 Shire US Inc.Rev. 10/03003 0107 006Rx onlyRepackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146 ProAmatine 5.0-milligram Tablets: NDC 54868-5442-0 Bottle of 10 NDC 54868-5442-2 Bottle of 60 NDC 54868-5442-1 Bottle of 90Store at 25°C (77°F)Excursions permitted to 15-30 °C (59-86 °F)[see USP Controlled Room Temperature]Manufactured for Shire US Inc.by NYCOMED Austria GmbH© 2003 Shire US Inc.Rev. 10/03003 0107 006Rx onlyRepackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146 ProAmatine 5.0-milligram Tablets: NDC 54868-5442-0 Bottle of 10 NDC 54868-5442-2 Bottle of 60 NDC 54868-5442-1 Bottle of 90Store at 25°C (77°F)Excursions permitted to 15-30 °C (59-86 °F)[see USP Controlled Room Temperature]Manufactured for Shire US Inc.by NYCOMED Austria GmbH© 2003 Shire US Inc.Rev. 10/03003 0107 006Rx onlyRepackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146 ProAmatine 5.0-milligram Tablets: NDC 54868-5442-0 Bottle of 10 NDC 54868-5442-2 Bottle of 60 NDC 54868-5442-1 Bottle of 90Store at 25°C (77°F)Excursions permitted to 15-30 °C (59-86 °F)[see USP Controlled Room Temperature]Manufactured for Shire US Inc.by NYCOMED Austria GmbH© 2003 Shire US Inc.Rev. 10/03003 0107 006Rx onlyRepackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146 ProAmatine 5.0-milligram Tablets: NDC 54868-5442-0 Bottle of 10 NDC 54868-5442-2 Bottle of 60 NDC 54868-5442-1 Bottle of 90Store at 25°C (77°F)Excursions permitted to 15-30 °C (59-86 °F)[see USP Controlled Room Temperature]Manufactured for Shire US Inc.by NYCOMED Austria GmbH© 2003 Shire US Inc.Rev. 10/03003 0107 006Rx onlyRepackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146 ProAmatine 5.0-milligram Tablets: NDC 54868-5442-0 Bottle of 10 NDC 54868-5442-2 Bottle of 60 NDC 54868-5442-1 Bottle of 90Store at 25°C (77°F)Excursions permitted to 15-30 °C (59-86 °F)[see USP Controlled Room Temperature]Manufactured for Shire US Inc.by NYCOMED Austria GmbH© 2003 Shire US Inc.Rev. 10/03003 0107 006Rx onlyRepackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146 ProAmatine 5.0-milligram Tablets: NDC 54868-5442-0 Bottle of 10 NDC 54868-5442-2 Bottle of 60 NDC 54868-5442-1 Bottle of 90Store at 25°C (77°F)Excursions permitted to 15-30 °C (59-86 °F)[see USP Controlled Room Temperature]Manufactured for Shire US Inc.by NYCOMED Austria GmbH© 2003 Shire US Inc.Rev. 10/03003 0107 006Rx onlyRepackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Mechanism of Action: ProAmatine
Administration of
results in a rise in standing, sitting, and supine systolic and diastolic blood
pressure in patients with orthostatic hypotension of various etiologies.
Standing systolic blood pressure is elevated by approximately 15 to 30 mmHg at 1
hour after a 10-mg dose of midodrine, with some effect persisting for 2 to 3
hours.
has no
clinically significant effect on standing or supine pulse rates in patients with
autonomic failure.
Pharmacokinetics:
ProAmatine
ProAmatine
Metabolism and Excretion:
Renal elimination of midodrine is insignificant. The renal clearance of
desglymidodrine is of the order of 385 mL/minute, most, about 80%, by active
renal secretion. The actual mechanism of active secretion has not been studied,
but it is possible that it occurs by the base-secreting pathway responsible for
the secretion of several other drugs that are bases (see also ).
Midodrine has been studied in 3 principal controlled trials, one
of 3-weeks duration and 2 of 1 to 2 days duration. All studies were randomized,
double-blind and parallel-design trials in patients with orthostatic hypotension
of any etiology and supine-to-standing fall of systolic blood pressure of at
least 15 mmHg accompanied by at least moderate dizziness/lightheadedness.
Patients with pre-existing sustained supine hypertension above 180/110 mmHg were
routinely excluded. In a 3-week study in 170 patients, most previously untreated
with midodrine, the midodrine-treated patients (10 mg t.i.d., with the last dose
not later than 6 P.M.) had significantly higher (by about 20 mmHg) 1-minute
standing systolic pressure 1 hour after dosing (blood pressures were not
measured at other times) for all 3 weeks. After week 1, midodrine-treated
patients had small improvements in dizziness/lightheadedness/unsteadiness scores
and global evaluations, but these effects were made difficult to interpret by a
high early drop-out rate (about 25% vs 5% on placebo). Supine and sitting blood
pressure rose 16/8 and 20/10 mmHg, respectively, on average.
In a 2-day study, after open-label midodrine, known midodrine responders
received midodrine 10 mg or placebo at 0, 3, and 6 hours. One-minute standing
systolic blood pressures were increased 1 hour after each dose by about 15 mmHg
and 3 hours after each dose by about 12mmHg; 3-minute standing pressures were
increased also at 1, but not 3, hours after dosing. There were increases in
standing time seen intermittently 1 hour after dosing, but not at 3 hours.
In a 1-day, dose-response trial, single doses of 0, 2.5, 10, and 20 mg of
midodrine were given to 25 patients. The 10- and 20-mg doses produced increases
in standing 1- minute systolic pressure of about 30 mmHg at 1 hour; the increase
was sustained in part for 2 hours after 10 mg and 4 hours after 20 mg. Supine
systolic pressure was =200 mmHg in 22% of patients on 10mg and 45% of patients
on 20 mg; elevated pressures often lasted 6 hours or more.
Special Populations
A study with 16 patients undergoing hemodialysis demonstrated that
is removed by dialysis.
Non-Clinical Toxicology
ProAmatineProAmatine
®
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
.
®
®
®
®
®
Anticoagulants (Oral): The activity of anticoagulants may be potentiated by anti-vitamin-K activity attributed to propylthiouracil.
β-Adrenergic Blocking Agents: Hyperthyroidism may cause an increased clearance of beta blockers with a high extraction ratio. A dose reduction of beta-adrenergic blockers may be needed when a hyperthyroid patient becomes euthyroid.
Digitalis Glycosides: Serum digitalis levels may be increased when hyperthyroid patients on a stable digitalis glycoside regimen become euthyroid; a reduced dosage of digitalis glycosides may be required.
Theophylline: Theophylline clearance may decrease when hyperthyroid patients on a stable theophylline regimen become euthyroid; a reduced dose of theophylline may be needed.
The potential for supine and sitting hypertension should be evaluated at the beginning of 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 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 , primarily due to vagal reflex. Caution should be exercised when 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 and should be re-evaluated.
ProAmatine
ProAmatine
ProAmatine
ProAmatine
ProAmatine
ProAmatine
ProAmatine
Patients should be told that certain agents in over-the-counter products, such as cold remedies and diet aids, can elevate blood pressure, and therefore, should be used cautiously with , as they may enhance or potentiate the pressor effects of (see ). Patients should also be made aware of the possibility of supine hypertension. They should be told to avoid taking their dose if they are to be supine for any length of time, i.e., they should take their last daily dose of 3 to 4 hours before bedtime to minimize nighttime supine hypertension.
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.
When administered concomitantly with , 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 . Therefore, caution should be used when is administered concomitantly with agents that cause vasoconstriction.
ProAmatine
ProAmatine
ProAmatine
It appears possible, although there is no supporting experimental evidence, that the high renal clearance of desyglymidodrine (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.
Long-term studies have been conducted in rats and mice at dosages 3 to 4 times the maximum recommended daily human dose on a mg/m basis, with no indication of carcinogenic effects related to . Studies investigating the mutagenic potential of 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 on fertility.
Pregnancy Category C
ProAmatine
ProAmatine
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 is administered to a nursing woman.
Safety and effectiveness in pediatric patients have not been established.
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:
1
2
3
4
5
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 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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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