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ProAmatine

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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?

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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?

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What are the warnings of ProAmatine?

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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.

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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.

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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

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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.

Adverse Events
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?

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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