HomeNDC LookupIngredientsMidodrine Hydrochloride › 00245-0211-01
Midodrine Hydrochloride 2.5 mg Tablet, 100-count — NDC 00245-0211-01 package photo

Midodrine Hydrochloride 2.5 mg Tablet, 100-count

by Upsher-Smith laboratories, LLC · 100 BLISTER PACK in 1 CARTON (0245-0211-01) / 1 TABLET in 1 BLISTER PACK (0245-0211-89)
NDC 00245-0211-01
🏷️ FDA NDC (as labeled) 0245-0211-01 billing pads the labeler segment with a zero
This package
Contains100-count Pack sizes2 compare ↓
Also priced by: Part D plans $0.2074/unit — full pricing hub ↓
Also comes in: 100 tablets 00245-0211-11
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Midodrine Hydrochloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Feb 17, 2026 — Defective container; inadequately sealed blister packaging. (The Harvard Drug Group LLC) · FDA recall D-0383-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 0245-0211-01
Product NDC 0245-0211
11-digit billing NDC 00245021101
RxCUI 993462, 993466, 993470
UNII 59JV96YTXV
Application # ANDA076725
SPL Set ID 4c3517f3-1c68-4ade-b5f1-c488a3a335c1
Established class (EPC) alpha-Adrenergic Agonist
Mechanism of action Adrenergic alpha-Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2004-11-03
Route ORAL
Dosage form TABLET
Substance MIDODRINE HYDROCHLORIDE
GPI-14 38000083100320
GPI class Midodrine HCl
GCN Seq No 017118
GCN 28322
HICL code 015908
Ingredient (HICL) Midodrine Hcl
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J5
Therapeutic class — intermediate (HIC2) Adrenergics
HIC3 code J5H
Therapeutic class — specific (HIC3) Adrenergic Vasopressor Agents
AHFS code 12:12.04.00
AHFS class Alpha-Adrenergic Agonists (12:12)
FDB label name MIDODRINE HCL 2.5 MG TABLET
FDB brand name Midodrine Hcl
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 0245-0211-01 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00245-0211-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the alpha-Adrenergic Agonist class.

Pharmacologic class alpha-Adrenergic Agonist
Drug family (ATC) Adrenergic and dopaminergic agents
How it works Adrenergic alpha-Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerUpsher-Smith laboratories, LLC
Application holderBEIJING YILING BIO-ENGINEERING TECHNOLOGY CO LTD
FDA applicationANDA076725 (ANDA)
Labeler code00245
First marketedNov 2004
Product typeHuman Prescription Drug
Portfolio227 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name MIDODRINE HCL 2.5 MG TABLET Ingredient Midodrine Hcl
📖 What it is MedlinePlus · NLM

Midodrine is used to treat orthostatic hypotension (sudden fall in blood pressure that occurs when a person assumes a standing position). Midodrine is in a class of medications called alpha-adrenergic agonists. It works by causing blood vessels to tighten, which increases blood pressure.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Midodrine raises your blood pressure in all positions — including when you're lying down. If you take it too late in the day and then lie flat to sleep, your blood pressure can sho...
  • Why do I have to take this medication so early in the day and not close to bedtime?
  • If you feel a severe headache, vision changes, chest discomfort, or just feel like something is off while lying or sitting down, take your blood pressure right away if you can. A v...
  • What should I do if my blood pressure feels too high while I'm resting?
📖 Read our full Midodrine guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color White / Pink / Purple
ShapeRound
ImprintUS;10;213
Size9 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.2074 $20.74 / 100 tablet
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Midodrine Hydrochloride 2.5 mg 00378-1901-01 Mylan 100 tablets $0.073 AB Availability likely
Midodrine Hydrochloride 2.5 mg 00904-6817-06 Major 50 tablets $0.073 AB Availability likely
Midodrine Hydrochloride 2.5 mg 49884-0814-01 Par 100 tablets $0.073 AB Availability likely
Midodrine Hydrochloride 2.5 mg 50268-0561-15 AvPAK 50 tablets $0.073 AB Availability likely
Midodrine Hydrochloride 2.5 mg 52817-0323-10 TruPharma, 100 tablets $0.073 AB Availability likely
Midodrine Hydrochloride 2.5 mg 59651-0246-01 Aurobindo 100 tablets $0.073 AB Availability likely
Midodrine Hydrochloride 2.5 mg 60505-1320-01 Apotex 100 tablets $0.073 AB Availability likely
Midodrine Hydrochloride 2.5 mg 60687-0387-01 American 100 tablets $0.073 AB Availability likely
Midodrine Hydrochloride 2.5 mg 62332-0338-31 Alembic 100 tablets $0.073 AB Availability likely
Midodrine Hydrochloride 2.5 mg 64980-0433-01 Rising 100 tablets $0.073 AB Availability likely
Midodrine hydrochloride 2.5 mg 68382-0737-01 Zydus 100 tablets $0.073 AB Availability likely
Midodrine Hydrochloride 2.5 mg 70700-0157-01 Xiromed, 100 tablets $0.073 AB Availability likely
Midodrine Hydrochloride 2.5 mg 70756-0010-11 Lifestar 100 tablets $0.073 AB Availability likely
Midodrine Hydrochloride 2.5 mg 72603-0605-01 NorthStar 100 tablets $0.073 AB Availability likely
Midodrine Hydrochloride 2.5 mg 72888-0112-01 Advagen 100 tablets $0.073 AB Availability likely
Midodrine Hydrochloride 2.5 mg 82293-0003-10 Novugen 100 tablets $0.073 AB Availability likely
Midodrine Hydrochloride 2.5 mgthis 00245-0211-01 Upsher-Smith 100 tablets AB FDA listed
Midodrine Hydrochloride 2.5 mg 00615-8382-39 NCS 30 tablets AB FDA listed
Midodrine Hydrochloride 2.5 mg 23155-0969-01 Avet 100 tablets AB FDA listed
Midodrine Hydrochloride 2.5 mg 42291-0560-90 AvKARE 90 tablets AB FDA listed
Midodrine Hydrochloride 2.5 mg 46708-0338-31 Alembic 100 tablets AB FDA listed
Midodrine Hydrochloride 2.5 mg 51407-0388-90 Golden 90 tablets AB FDA listed
Midodrine Hydrochloride 2.5 mg 63629-2227-01 Bryant 100 tablets AB FDA listed
Midodrine Hydrochloride 2.5 mg 63629-2348-01 Bryant 100 tablets AB FDA listed
Midodrine hydrochloride 2.5 mg 70771-1595-01 Zydus 100 tablets AB FDA listed
Midodrine Hydrochloride 2.5 mg 71205-0904-00 Proficient 100 tablets AB FDA listed
Midodrine Hydrochloride 2.5 mg 71335-3037-01 Bryant 100 tablets AB FDA listed
Midodrine Hydrochloride 2.5 mg 72162-1517-01 Bryant 100 tablets AB FDA listed
Midodrine Hydrochloride 2.5 mg 72162-1973-01 Bryant 100 tablets AB FDA listed
Midodrine Hydrochloride 2.5 mg 72162-2560-01 Bryant 100 tablets AB FDA listed
Midodrine Hydrochloride 2.5 mg 72603-0906-05 NorthStar 50 tablets AB FDA listed
Midodrine Hydrochloride 2.5 mg 72789-0465-01 PD-Rx 100 tablets AB FDA listed
Midodrine Hydrochloride 2.5 mg 81469-0139-90 First 90 tablets AB FDA listed
Midodrine Hydrochloride 2.5 mg 85293-0005-01 Umasuto, 100 tablets AB FDA listed
Midodrine Hydrochloride 2.5 mg 00904-7640-06 Major 50 tablets AB FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2004
On the market since
Nov 2004
📍
2026
Currently FDA-listed
22 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 tablets00245-0211-11 9,249 Rx · $148,925
Drug total (last 4 qtrs): 9,249 Rx · 725,778 units · $148,925 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Midodrine Hydrochloride — the ingredient across all brands.

Top reported reactions

Hypotension375
Nausea373
Headache358
Dyspnoea357
Death335
Diarrhoea327
Fatigue308

Age at onset

Neonate2
Infant3
Adolescent9
Adult254
Elderly336

Reporter sex

4,209 reports
Male · 39%
Female · 61%

Serious outcomes

Hospitalization1,789
Death607
Life-threatening148
Disabling50
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 934 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
00245-0211-01 You're viewing this 100 BLISTER PACK in 1 CARTON (0245-0211-01) / 1 TABLET in 1 BLISTER PACK (0245-0211-89) 2004-11-03 Active
00245-0211-11 100 TABLET in 1 BOTTLE (0245-0211-11) $0.0728 / ea $7.28 2004-11-03 Active

This pack shows little to no recent Medicaid volume — the 100 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 00245-0211-01?
NDC 00245-0211-01 is a 100-count package — 100 blister pack in 1 carton / 1 tablet in 1 blister pack.
What is the difference between NDC 00245-0211-01 and NDC 00245-0211-11?
Both are Midodrine Hydrochloride 2.5 mg Tablet — the drug itself is identical. NDC 00245-0211-01 is the 100-count package, while NDC 00245-0211-11 is the 100 tablets package.
What NDC number is used to bill for this package of Midodrine Hydrochloride 2.5 mg Tablet?
Bill NDC 00245-0211-01 — the 11-digit billing format is 00245021101. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 0245-0211-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00245-0211-01, written without dashes as 00245021101. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00245-0211-01, the first segment (00245) is the labeler code FDA assigned to Upsher-Smith laboratories, LLC; the middle segment (0211) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Upsher-Smith laboratories, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 100 tablets (00245-0211-11). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Upsher-Smith laboratories, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 95 words

WARNING : Because midodrine 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 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, principally improved ability to carry out activities of daily living, have not been verified.

🎯 Indications and Usage 136 words

INDICATIONS AND USAGE Midodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablets 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'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, 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. After initiation of treatment, midodrine hydrochloride tablets should be continued only for patients who report significant symptomatic improvement.

⏱️ Dosage and Administration ~1 min read

DOSAGE AND ADMINISTRATION 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.

Contraindications 34 words

CONTRAINDICATIONS Midodrine hydrochloride tablets are contraindicated in patients with severe organic heart disease, acute renal disease, urinary retention, pheochromocytoma or thyrotoxicosis. Midodrine should not be used in patients with persistent and excessive supine hypertension.

⚠️ Warnings 131 words

WARNINGS Supine Hypertension: The most potentially serious adverse reaction associated with midodrine 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 midodrine. 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 in such patients is not recommended. Sitting blood pressures were also elevated by midodrine therapy.

It is essential to monitor supine and sitting blood pressures in patients maintained on midodrine. Uncontrolled hypertension increased the risk of cardiovascular events, particularly stroke.

🤒 Adverse Reactions ~1 min read

ADVERSE REACTIONS 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: Adverse Events 1 Includes hyperesthesia and scalp paresthesia 2 Includes dysuria (1), increased urinary frequency (2), impaired urination (1), urinary retention (5), urinary urgency (2) 3 Includes scalp pruritus 4 Includes patients who experienced an increase in supine hypertension 5 Includes abdominal pain and pain increase Placebo n=88 Midodrine n=82 Event # of reports % of patients # of reports % of patients Total # of reports 22 77 Paresthesia 1 4 4.5 15

18.3 Piloerection 0 0 11

13.4 Dysuria 2 0 0 11

13.4Pruritis 3 2 2.3 10

12.2 Supine hypertension 4 0 0 6

7.3 Chills 0 0 4

4.9 Pain 5 0 0 4

4.9Rash 1 1.1 2

2.4Less 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 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.

🔄 Drug Interactions 141 words

Drug Interactions: When administered concomitantly with midodrine hydrochloride tablets, cardiac glycosides may enhance or precipitate bradycardia, A.V. block or arrhythmia. The risk of hypertension increases with concomitant administration of drugs that increase blood pressure (phenylephrine, pseudoephedrine, ephedrine, dihydroergotamine, thyroid hormones or droxidopa). Avoid concomitant use of drugs that increase blood pressure.

If concomitant use cannot be avoided, monitor blood pressure closely. Avoid use of MAO inhibitors or linezolid with midodrine. Midodrine has been used in patients concomitantly treated with salt-retaining steroid therapy (i.e., fludrocortisone acetate), with or without salt supplementation.

The potential for supine hypertension should be carefully monitored in these patients and may be minimized by either reducing the dose of fludrocortisone acetate or decreasing the salt intake prior to initiation of treatment with midodrine. Alpha-adrenergic blocking agents, such as prazosin, terazosin, and doxazosin, can antagonize the effects of midodrine.

🤰 Pregnancy 84 words

Pregnancy: Midodrine 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/m 2 ). There are no adequate and well-controlled studies in pregnant women. Midodrine 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.

🧒 Pediatric Use 12 words

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

🆘 Overdosage 176 words

OVERDOSAGE Symptoms of overdose could include hypertension, piloerection (goosebumps), a sensation of coldness and urinary retention. There are 2 reported cases of overdosage with midodrine, 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 50 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).

🧬 Clinical Pharmacology ~3 min read

CLINICAL PHARMACOLOGY Mechanism of Action: Midodrine forms an active metabolite, desglymidodrine, that is an alpha 1 -agonist, and exerts its actions via activation of the alpha-adrenergic receptors of the arteriolar and venous vasculature, producing an increase in vascular tone and elevation of blood pressure. Desglymidodrine does not stimulate cardiac beta-adrenergic receptors. Desglymidodrine diffuses poorly across the blood-brain barrier, and is therefore not associated with effects on the central nervous system.

Administration of midodrine 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. Midodrine has no clinically significant effect on standing or supine pulse rates in patients with autonomic failure.

Pharmacokinetics: Midodrine is a prodrug, i.e., the therapeutic effect of orally administered midodrine is due to the major metabolite desglymidodrine, formed by deglycination of midodrine. After oral administration, midodrine is rapidly absorbed. The plasma levels of the prodrug peak after about half an hour, and decline with a half-life of approximately 25 minutes, while the metabolite reaches peak blood concentrations about 1 to 2 hours after a dose of midodrine and has a half-life of about 3 to 4 hours.

The absolute bioavailability of midodrine (measured as desglymidodrine) is 93%. The bioavailability of desglymidodrine is not affected by food. Approximately the same amount of desglymidodrine is formed after intravenous and oral administration of midodrine.

Neither midodrine nor desglymidodrine is bound to plasma proteins to any significant extent. Metabolism and Excretion: Thorough metabolic studies have not been conducted, but it appears that deglycination of midodrine to desglymidodrine takes place in many tissues, and both compounds are metabolized in part by the liver. Neither midodrine nor desglymidodrine is a substrate for monoamine oxidase.

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 Potential for Drug Interactions ].

Clinical Studies 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 12 mmHg;…

🧬 Mechanism of Action 141 words

Mechanism of Action: Midodrine forms an active metabolite, desglymidodrine, that is an alpha 1 -agonist, and exerts its actions via activation of the alpha-adrenergic receptors of the arteriolar and venous vasculature, producing an increase in vascular tone and elevation of blood pressure. Desglymidodrine does not stimulate cardiac beta-adrenergic receptors. Desglymidodrine diffuses poorly across the blood-brain barrier, and is therefore not associated with effects on the central nervous system.

Administration of midodrine 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. Midodrine has no clinically significant effect on standing or supine pulse rates in patients with autonomic failure.

📦 How Supplied / Storage and Handling 213 words

HOW SUPPLIED Midodrine hydrochloride tablets, USP are supplied as 2.5 mg, 5 mg and 10 mg tablets for oral administration. The 2.5 mg tablet is a white, round, uncoated tablet, scored on one side with "US" above and "2.5" below the score and "211" on the other side. They are supplied as follows: Bottles of 100 with child-resistant closure NDC 0245-0211-11 Unit-Dose Cartons of 100 tablets (10 cards containing 10 tablets each) NDC 0245-0211-01 The 5 mg tablet is a pink, round, uncoated tablet, scored on one side with "US" above and "5" below the score and "212" on the other side.

They are supplied as follows: Bottles of 100, with child-resistant closure NDC 0245-0212-11 Unit-Dose Cartons of 100 tablets (10 cards containing 10 tablets each) NDC 0245-0212-01 The 10 mg tablet is a purple, round, uncoated tablet, scored on one side with "US" above and "10" below the score and "213" on the other side. They are supplied as follows: Bottles of 100 tablets NDC 0245-0213-11 Unit-Dose Cartons of 100 tablets (10 cards containing 10 tablets each) NDC 0245-0213-01 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Manufactured by UPSHER-SMITH LABORATORIES, LLC Maple Grove, MN 55369 Revised: 6/2024

📋 Description 131 words

DESCRIPTION Name: Midodrine hydrochloride tablets, USP Dosage Form: 2.5 mg, 5 mg and 10 mg tablets for oral administration Active Ingredient: Midodrine hydrochloride, USP 2.5 mg, 5 mg and 10 mg Inactive Ingredients: colloidal silicon dioxide, corn starch, FD&C Blue No. 1 Lake (10 mg tablets), FD&C Red No. 40 Lake (5 mg and 10 mg tablets), magnesium stearate, microcrystalline cellulose and talc.

Pharmacological Classification: Vasopressor/Antihypotensive 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: C 12 H 18 N 2 O 4 HCl; Molecular Weight: 290.7 Organoleptic Properties: Odorless, white, crystalline powder Solubility: Water: Soluble Methanol: Sparingly soluble pKa: 7.8 (0.3% aqueous solution) pH: 3.5 to 5.5 (5% aqueous solution) Melting Range: 200° to 203°C chemical structure

💬 Information for Patients 101 words

Information for Patients: 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 midodrine, as they may enhance or potentiate the pressor effects of midodrine [ see Drug Interactions ]. 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 midodrine 3 to 4 hours before bedtime to minimize nighttime supine hypertension.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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