Midodrine Hydrochloride (Midodrine Hcl)

Trade Name : Midodrine HCl

Eon Labs, Inc.

TABLET

Strength 2.5 mg/1

MIDODRINE HYDROCHLORIDE Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Midodrine Hydrochloride (Midodrine Hcl) which is also known as Midodrine HCl and Manufactured by Eon Labs, Inc.. It is available in strength of 2.5 mg/1 per ml. Read more

Midodrine Hydrochloride (Midodrine Hcl) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Rx Only
  • WARNING
  • Because midodrine hydrochloride tablets can cause marked elevation of supine blood pressure, it should be used in patients whose lives are considerably impaired despite standard clinical care. The indication for use of midodrine hydrochloride tablets in the treatment of symptomatic orthostatic hypotension is based primarily on a change in a surrogate marker of effectiveness, an increase in systolic blood pressure measured one minute after standing, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of midodrine hydrochloride tablets, principally improved ability to carry out activities of daily living, have not been verified.
  • Midodrine hydrochloride is a vasopressor/antihypotensive agent. Midodrine hydrochloride is an odorless, white, crystalline powder, soluble in water and sparingly soluble in methanol having a pKa of 7.8 (0.3% aqueous solution), a pH of 3.5 to 5.5 (5% aqueous solution) and a melting range of 200u00b0C to 203u00b0C. It is chemically described as: (1) Acetamide, 2-amino--[2-(2,5-dimethoxyphenyl)-2-hydroxyethyl]-monohydrochloride, (u00b1)-; or (2) (u00b1)-2-amino--(u00df-hydroxy-2,5-dimethoxyphenethyl)acetamide monohydrochloride. Midodrine hydrochlorideu2019s molecular formula is CHNOHCl, its molecular weight is 290.7 and its structural formula is:
  • Each tablet for oral administration contains 2.5 mg, 5 mg or 10 mg of midodrine hydrochloride and the following inactive ingredients: pregelatinized starch (corn starch), microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate. In addition, the 5 mg tablets contain FD&C yellow No. 6 aluminum lake and FD&C red No. 40 aluminum lake and the 10 mg tablets contain FD&C blue No. 2 aluminum lake.
  • No data
  • Midodrine hydrochloride tablets, USP are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablets, USP can cause marked elevation of supine blood pressure (BP > 200 mmHg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion and lifestyle alterations. The indication is based on midodrine hydrochloride tablet, USP's effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of midodrine hydrochloride tablets, USP principally improved ability to perform life activities, have not been established. Further clinical trials are underway to verify and describe the clinical benefits of midodrine hydrochloride tablets, USP.
  • After initiation of treatment, midodrine hydrochloride tablets, USP should be continued only for patients who report significant symptomatic improvement.
  • Midodrine hydrochloride is contraindicated in patients with severe organic heart disease, acute renal disease, urinary retention, pheochromocytoma or thyrotoxicosis. Midodrine hydrochloride should not be used in patients with persistent and excessive supine hypertension.
  • The most potentially serious adverse reaction associated with midodrine hydrochloride therapy is marked elevation of supine arterial blood pressure (supine hypertension). Systolic pressure of about 200 mmHg was seen overall in about 13.4% of patients given 10 mg of midodrine hydrochloride. 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 midodrine hydrochloride in such patients is not recommended. Sitting blood pressures were also elevated by midodrine hydrochloride therapy. It is essential to monitor supine and sitting blood pressures in patients maintained on midodrine hydrochloride. Uncontrolled hypertension increases the risk of cardiovascular events, particularly stroke.
  • No data
  • 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:
  • 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 midodrine hydrochloride 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.
  • Symptoms of overdose could include hypertension, piloerection (goosebumps), a sensation of coldness and urinary retention. There are 2 reported cases of overdosage with midodrine hydrochloride, both in young males. One patient ingested midodrine hydrochloride 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 midodrine hydrochloride (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 mg/kg to 50 mg/kg in rats, 675 mg/kg in mice and 125 mg/kg 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).
  • The recommended dose of midodrine hydrochloride tablets 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, midodrine hydrochloride tablets 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, midodrine hydrochloride tablets 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 midodrine hydrochloride tablets 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.
  • Midodrine Hydrochloride Tablets, USP, for oral administration, are available as
  • Arrayn- 2.5 mg
  • White, round, flat-faced, bevelled edge, debossed u201cu201d over u201c40u201d on one side and bisected on the other side and supplied as:
  • NDC 0185-0040-01 bottles of 100
  • NDC 0185-0040-05 bottles of 500
  • Arrayn- 5 mg
  • Reddish-orange, round, flat-faced, bevelled edge, debossed u201cu201d over u201c43u201d on one side and bisected on the other side and supplied as:
  • NDC 0185-0043-01 bottles of 100
  • NDC 0185-0043-05 bottles of 500
  • Arrayn- 10 mg
  • Blue-grey, round, flat-faced, bevelled edge, debossed, u201cu201d over u201c149u201d on one side and bisected on the other side and supplied as:
  • NDC 0185-0149-01 bottles of 100
  • NDC 0185-0149-05 bottles of 500
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature].
  • Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.
  • Protect from light and moisture.
  • KEEP TIGHTLY CLOSED.
  • To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Manufactured by
  • Sandoz Inc.
  • Princeton, NJ 08540
  • OS8009
  • Rev. March 2017
  • MF0040REV03/17
  • NDC 0185-0040-01
  • Midodrine Hydrochloride Tablets, USP
  • 2.5 mg
  • Rx only
  • 100 Tablets
  • Sandoz
  • NDC 0185-0043-01
  • Midodrine Hydrochloride Tablets, USP
  • 5 mg
  • Rx only
  • 100 Tablets
  • Sandoz
  • NDC 0185-0149-01
  • Midodrine Hydrochloride Tablets, USP
  • 10 mg
  • Rx only
  • 100 Tablets
  • Sandoz

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