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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
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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
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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
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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
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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
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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
.
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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