HomeNDC LookupIngredientsMilrinone Lactate › 00143-9708-01
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Milrinone Lactate 1 mg/mL Injection, Solution, 50 mL

by Hikma Pharmaceuticals USA Inc. · 50 mL in 1 BOX (0143-9708-01)
NDC 00143-9708-01
🏷️ FDA NDC (as labeled) 0143-9708-01 billing pads the labeler segment with a zero
This package
Contains50 mL Medicaid pays$0.3823 / unit · 12 mo Per package$19.12 / 50 ml · Medicaid Pack sizes2 compare ↓
Also comes in: 10 vials 00143-9708-10
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 →

🆔 Identity & classification

FDA NDC (as labeled) 0143-9708-01
Product NDC 0143-9708
11-digit billing NDC 00143970801
NCPDP billing unit ML — per mL (volume)
UNII 9K8XR81MO8
UPC 0301439710103
Application # ANDA077966
SPL Set ID 88f78780-399f-4780-be19-205739db1682
Established class (EPC) Phosphodiesterase 3 Inhibitor
Mechanism of action Phosphodiesterase 3 Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2010-12-03
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance MILRINONE LACTATE
GPI-14 31350050102050
GPI class Milrinone Lactate
GCN Seq No 017051
GCN 05321
HICL code 006549
Ingredient (HICL) Milrinone Lactate
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A1
Therapeutic class — intermediate (HIC2) Cardiac Stimulants
HIC3 code A1C
Therapeutic class — specific (HIC3) Inotropic Drugs
AHFS code 24:04.08.00
AHFS class Cardiotonic Agents
FDB label name MILRINONE LACT 50 MG/50 ML VL
FDB brand name Milrinone Lactate
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 0143-9708-01 — 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 → 00143-9708-01. 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 Phosphodiesterase 3 Inhibitor class.

Pharmacologic class Phosphodiesterase 3 Inhibitor
Drug family (ATC) Phosphodiesterase inhibitors
How it works Phosphodiesterase 3 Inhibitors
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

LabelerHikma Pharmaceuticals USA Inc.
Application holderHIKMA FARMACEUTICA (PORTUGAL) SA
FDA applicationANDA077966 (ANDA)
Labeler code00143
First marketedDec 2010
Product typeHuman Prescription Drug
Portfolio724 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 MILRINONE LACT 50 MG/50 ML VL Ingredient Milrinone Lactate
📖 What it is MedlinePlus · NLM

Milrinone injection is used to treat heart failure. Milrinone is in a class of medications called cardiotonic agents. It works by helping the heart to pump better.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Milrinone is helping your heart pump more effectively during this acute episode. It works two ways: it makes your heart muscle contract with more force, and it relaxes your blood v...
  • Why am I getting milrinone — what is it actually doing for my heart?
  • Milrinone is only for short-term use — typically up to 48 hours based on controlled trial experience. Your care team will keep watching how your heart and blood pressure respond an...
  • The most important ones to flag immediately are a racing, pounding, or irregular heartbeat — milrinone can trigger serious heart rhythm problems in some patients. Also tell your te...
📖 Read our full Milrinone 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.

🧪 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.

  • 47 mg / 1 mL UNII 5SL0G7R0OK
    A simple sugar made from corn or other plants, used in medicines as a filler and sweetener. It helps create the right texture and taste in tablets, powders, and liquid formulations.
  • 1 mg / 1 mL UNII 33X04XA5AT
    Lactic acid is a naturally occurring organic acid derived from milk or plant sources. It lowers and maintains pH in formulations, helps preserve the product, and can enhance ingredient stability and absorption.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

4 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 mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $0.3823 $19.12 / 50 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J2260 $1.098 / J2260 unit
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.

🧾 Billing & reimbursement

FDA NDC (as labeled)0143-9708-01
11-digit billing NDC00143-9708-01
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ2260
DescriptorINJECTION, MILRINONE LACTATE, 5 MG
Billing units / pkg0.2 units
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Milrinone Lactate 1 mg/mLthis 00143-9708-01 Hikma 50 ml AP FDA listed
Milrinone Lactate 1 mg/mL 00409-0212-01 Hospira, 10 vials AP FDA listed
Milrinone Lactate 1 mg/mL 42677-0338-01 Shandong 1 vial AP FDA listed
Milrinone Lactate 1 mg/mL 63323-0617-10 Fresenius 10 vials AP FDA listed
Milrinone Lactate 1 mg/mL 65145-0122-01 Caplin 1 vial AP FDA listed
Milrinone Lactate 1 mg/mL 70069-0809-01 Somerset 1 vial AP FDA listed
Milrinone Lactate 1 mg/mL 71288-0200-11 Meitheal 10 vials AP FDA listed
Milrinone Lactate 1 mg/mL 72485-0503-01 Armas 1 vial AP FDA listed
Milrinone Lactate 1 mg/mL 00143-9326-10 Hikma 10 vials AP FDA listed
Milrinone Lactate 1 mg/mL 70069-0807-10 Somerset 10 vials AP FDA listed
Milrinone Lactate 1 mg/mL 70069-0808-10 Somerset 10 vials AP FDA listed
Milrinone Lactate 1 mg/mL 00143-9373-10 Hikma 10 vials AP FDA listed
Milrinone Lactate 1 mg/mL 00143-9374-10 Hikma 10 vials AP FDA listed
Milrinone Lactate 1 mg/mL 72485-0501-10 Armas 10 vials AP FDA listed
Milrinone Lactate 1 mg/mL 72485-0502-10 Armas 10 vials AP FDA listed
Milrinone Lactate 1 mg/mL 65145-0120-10 Caplin 10 vials AP FDA listed
Milrinone Lactate 1 mg/mL 65145-0121-10 Caplin 10 vials AP FDA listed
Milrinone Lactate 1 mg/mL 42677-0313-10 Shandong 10 vials AP FDA listed
Milrinone Lactate 1 mg/mL 00143-9710-25 Hikma 25 vials AP FDA listed
Milrinone Lactate 1 mg/mL 83301-0016-02 Mullan 10 vials AP FDA listed
Milrinone Lactate 1 mg/mL 83301-0017-02 Mullan 10 vials AP FDA listed
Milrinone Lactate 1 mg/mL 42677-0314-10 Shandong 10 vials AP FDA listed
Milrinone Lactate 1 mg/mL 00143-9709-10 Hikma 20 ml AP FDA listed
Milrinone Lactate 1 mg/mL 83301-0018-01 Mullan 1 vial AP 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

🏛️
2010
On the market since
Dec 2010
📍
2026
Currently FDA-listed
16 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 & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00143-9708-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
3.2K
Units reimbursed last 4 qtrs
817.6K
Gross reimbursed last 4 qtrs
$312.6K
Avg / prescription
$97.54
Avg / unit
$0.3823
Latest quarter Q4 2025
658Rx
Fee-for-service vs managed care
16% FFS 84% MCO
Fee-for-service · 514 Rx Managed care · 2,691 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: 1,318 units · 168 per 100k residents ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 5,450 units · 54.3 per 100k residents MI New York: 68,655 units · 351 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 90,411 units · 720 per 100k residents IL Indiana: 5,400 units · 78.7 per 100k residents IN Ohio: 56,300 units · 478 per 100k residents OH Pennsylvania: 90,670 units · 700 per 100k residents PA New Jersey: 11,707 units · 126 per 100k residents NJ Massachusetts: no data reported MA California: 5,502 units · 14.1 per 100k residents CA Utah: no data reported UT Colorado: 8,350 units · 142 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 106,030 units · 2,343 per 100k residents KY West Virginia: no data reported WV Virginia: 4,565 units · 52.4 per 100k residents VA Maryland: no data reported MD Connecticut: 13,250 units · 366 per 100k residents CT Rhode Island: no data reported RI Arizona: 7,820 units · 105 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 15,980 units · 224 per 100k residents TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: 56,285 units · 5,459 per 100k residents DE Oklahoma: no data reported OK Louisiana: 11,350 units · 248 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 29,555 units · 268 per 100k residents GA D.C.: 1,881 units · 277 per 100k residents DC Hawaii: no data reported HI Texas: 94,450 units · 310 per 100k residents TX Florida: 132,711 units · 587 per 100k residents FL
Units reimbursed · per 100k residents
14.15,459
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Delaware 5,459 /100k
2 Kentucky 2,343 /100k
3 Illinois 720 /100k
4 Pennsylvania 700 /100k
5 Florida 587 /100k
6 Ohio 478 /100k
7 Connecticut 366 /100k
8 New York 351 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 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.
50 ml this page00143-9708-01 3,094 Rx · $272,443
10 vials00143-9708-10 No Medicaid data
Drug total (last 4 qtrs): 3,094 Rx · 804,850 units · $272,443 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Milrinone Lactate — the program that covers self-administered drugs. 3 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Milrinone Lactate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$9K
Claims incl. refills
89
Beneficiaries
Spend / beneficiary
Spend / claim
$100.84
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 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 Milrinone Lactate — the ingredient across all brands.

Top reported reactions

Hypotension16
Renal Failure13
Cardiac Failure12
Dyspnoea11
Ventricular Tachycardia10
Cardiac Arrest9
Haemorrhage9

Age at onset

Neonate2
Infant2
Child5
Adolescent1
Adult8
Elderly6

Reporter sex

269 reports

Serious outcomes

Death47
Disabling6
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 45 1
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 Marketing startStatus
00143-9708-10 10 VIAL in 1 BOX (0143-9708-10) / 50 mL in 1 VIAL (0143-9708-01) 2010-12-03 Active
00143-9708-01 You're viewing this 50 mL in 1 BOX (0143-9708-01) 2010-12-03 Active

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 00143-9708-01?
NDC 00143-9708-01 contains 50 mL — 50 ml in 1 box.
What NDC number is used to bill for this package of Milrinone Lactate 1 mg/mL Injection, Solution?
Bill NDC 00143-9708-01 — the 11-digit billing format is 00143970801. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 — Not published for this NDC No photo available yet for this listing.
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 ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“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 0143-9708-01, 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: 00143-9708-01, written without dashes as 00143970801. 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 00143-9708-01, the first segment (00143) is the labeler code FDA assigned to Hikma Pharmaceuticals USA Inc.; the middle segment (9708) 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 Hikma Pharmaceuticals USA Inc.. 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 10 vials (00143-9708-10). 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?
Hikma Pharmaceuticals USA Inc. 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J2260 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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.
🎯 Indications and Usage 89 words

INDICATIONS AND USAGE Milrinone Lactate Injection, USP and Milrinone Lactate in 5% Dextrose Injection are indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. Patients receiving milrinone should be observed closely with appropriate electrocardiographic equipment. The facility for immediate treatment of potential cardiac events, which may include life threatening ventricular arrhythmias, must be available.

The majority of experience with intravenous milrinone has been in patients receiving digoxin and diuretics. There is no experience in controlled trials with infusions of milrinone for periods exceeding 48 hours.

⏱️ Dosage and Administration ~3 min read

DOSAGE AND ADMINISTRATION Milrinone Lactate in 5% Dextrose Injection should not be used for administering a loading dose. The information regarding loading doses for milrinone is for 1 mg/mL vial only. A loading dose of Milrinone Lactate Injection (1 mg [base]/mL) should be administered followed by a continuous infusion (maintenance dose) according to the following guidelines: LOADING DOSE — 50 mcg/kg: Administer slowly over 10 minutes The table below shows the loading dose in milliliters (mL) of milrinone (1 mg/mL) by patient body weight (kg).

Loading Dose (mL) Using 1 mg/mL Concentration Patient Body Weight (kg) kg 30 40 50 60 70 80 90 100 110 120 mL 1.5 2 2.5 3 3.5 4 4.5 5 5.5 6 The loading dose may be given undiluted, but diluting to a rounded total volume of 10 or 20 mL (see Maintenance Dose for diluents) may simplify the visualization of the injection rate. MAINTENANCE DOSE Infusion Rate Total Daily Dose (24 hours) Minimum 0.375 mcg/kg/min 0.59 mg/kg Administer as a continuous intravenous infusion Standard 0.50 mcg/kg/min 0.77 mg/kg Maximum 0.75 mcg/kg/min 1.13 mg/kg Milrinone drawn from vials should be diluted prior to maintenance dose administration.

The diluents that may be used are 0.45% Sodium Chloride Injection, USP; 0.9% Sodium Chloride Injection, USP; or 5% Dextrose Injection, USP. The table below shows the volume of diluent in milliliters (mL) that must be used to achieve 200 mcg/mL concentration for infusion, and the resultant total volumes. Desired Infusion Concentration mcg/mL Milrinone 1 mg/mL (mL) Diluent (mL) Total Volume (mL) 200 10 40 50 200 20 80 100 The infusion rate should be adjusted according to hemodynamic and clinical response.

Patients should be closely monitored. In controlled clinical studies, most patients showed an improvement in hemodynamic status as evidenced by increases in cardiac output and reductions in pulmonary capillary wedge pressure. Note : See " Dosage Adjustment in Renally Impaired Patients ." Dosage may be titrated to the maximum hemodynamic effect and should not exceed 1.13 mg/kg/day.

Duration of therapy should depend upon patient responsiveness. The maintenance dose in mL/hr by patient body weight (kg) may be determined by reference to the following table. Note : Milrinone Lactate in 5% Dextrose Injection supplied in 100 mL and 200 mL Flexible Containers (200 mcg/mL in 5% Dextrose Injection) need not be diluted prior to use.

Milrinone Infusion Rate(mL/hr) Using 200 mcg/mL Concentration Maintenance Dose (mcg/kg/min) Patient Body Weight (kg) 30 40 50 60 70 80 90 100 110 120 0.375 3.4 4.5 5.6 6.8 7.9 9 10.1 11.3 12.4 13.5 0.4 3.6 4.8 6 7.2 8.4 9.6 10.8 12 13.2 14.4 0.5 4.5 6 7.5 9 10.5 12 13.5 15 16.5 18 0.6 5.4 7.2 9 10.8 12.6 14.4 16.2 18 19.8 21.6 0.7 6.3 8.4 10.5 12.6 14.7 16.8 18.9 21 23.1 25.2 0.75 6.8 9 11.3 13.5 15.8 18 20.3 22.5 24.8 27 When administering milrinone lactate by continuous infusion, it is advisable to use a calibrated electronic infusion device.

The Flexible Container has a concentration of milrinone equivalent to 200 mcg/mL in 5% Dextrose Injection and is more convenient to use than dilutions prepared from the vials. To use the Flexible Container, tear the overwrap at the notch and remove the Pre-Mix solution container. Squeeze the container firmly to check for leaks.

Discard the container if leaks are found since the sterility of the product could be affected. Do not add supplementary medication. To prepare the container for administration of milrinone intravenously, use aseptic techniques.

1. The flow control clamp of the administration set is closed. 2.

The cover of the outlet port at the bottom of the container is removed. 3. Noting the full directions on the administration set carton, the piercing pin of the set is inserted into the port with a twisting motion until it is firmly sealed.

4. The container is suspended on the hanger. 5.

The drop chamber is squeezed and released to establish the fill level. 6. The flow control clamp is opened to expel air…

Contraindications 21 words

CONTRAINDICATIONS Milrinone Lactate Injection, USP and Milrinone Lactate in 5% Dextrose Injection are contraindicated in patients who are hypersensitive to it.

⚠️ Warnings 164 words

WARNINGS Whether given orally or by continuous or intermittent intravenous infusion, milrinone has not been shown to be safe or effective in the longer (greater than 48 hours) treatment of patients with heart failure. In a multicenter trial of 1088 patients with Class III and IV heart failure, long-term oral treatment with milrinone was associated with no improvement in symptoms and an increased risk of hospitalization and death. In this study, patients with Class IV symptoms appeared to be at particular risk of life-threatening cardiovascular reactions.

There is no evidence that milrinone given by long-term continuous or intermittent infusion does not carry a similar risk. The use of milrinone both intravenously and orally has been associated with increased frequency of ventricular arrhythmias, including nonsustained ventricular tachycardia. Long-term oral use has been associated with an increased risk of sudden death.

Hence, patients receiving milrinone should be observed closely with the use of continuous electrocardiographic monitoring to allow the prompt detection and management of ventricular arrhythmias.

🤒 Adverse Reactions ~1 min read

ADVERSE REACTIONS Cardiovascular Effects In patients receiving milrinone in Phase II and III clinical trials, ventricular arrhythmias were reported in 12.1%: Ventricular ectopic activity, 8.5%; nonsustained ventricular tachycardia, 2.8%; sustained ventricular tachycardia, 1% and ventricular fibrillation, 0.2% (2 patients experienced more than one type of arrhythmia). Holter recordings demonstrated that in some patients injection of milrinone increased ventricular ectopy, including nonsustained ventricular tachycardia.

Life-threatening arrhythmias were infrequent and when present have been associated with certain underlying factors such as preexisting arrhythmias, metabolic abnormalities (e.g., hypokalemia), abnormal digoxin levels and catheter insertion. Milrinone was not shown to be arrhythmogenic in an electrophysiology study. Supraventricular arrhythmias were reported in 3.8% of the patients receiving milrinone.

The incidence of both supraventricular and ventricular arrhythmias has not been related to the dose or plasma milrinone concentration. Other cardiovascular adverse reactions include hypotension, 2.9% and angina/chest pain, 1.2%. In the post-marketing experience, there have been rare cases of “torsades de pointes” reported.

CNS Effects Headaches, usually mild to moderate in severity, have been reported in 2.9% of patients receiving milrinone. Other Effects Other adverse reactions reported, but not definitely related to the administration of milrinone include hypokalemia, 0.6%; tremor, 0.4%; and thrombocytopenia, 0.4%. Isolated spontaneous reports of bronchospasm and anaphylactic shock have been received; and in the post-marketing experience, liver function test abnormalities and skin reactions such as rash have been reported.

Post-Marketing Adverse Event Reports In addition to adverse events reported from clinical trials, the following events have been reported from worldwide post-marketing experience with milrinone: Isolated spontaneous reports of bronchospasm and anaphylactic shock. Liver function test abnormalities and skin reactions such as rash. Administration site conditions: Infusion site reaction.

To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 45 words

Drug Interactions No untoward clinical manifestations have been observed in limited experience with patients in whom milrinone was used concurrently with the following drugs: digitalis glycosides; lidocaine, quinidine; hydralazine, prazosin; isosorbide dinitrate, nitroglycerin; chlorthalidone, furosemide, hydrochlorothiazide, spironolactone; captopril; heparin, warfarin, diazepam, insulin; and potassium supplements.

🤰 Pregnancy 112 words

Pregnancy Oral administration of milrinone to pregnant rats and rabbits during organogenesis produced no evidence of teratogenicity at dose levels up to 40 mg/kg/day and 12 mg/kg/day, respectively. Milrinone did not appear to be teratogenic when administered intravenously to pregnant rats at doses up to 3 mg/kg/day (about 2.5 times the maximum recommended clinical intravenous dose) or pregnant rabbits at doses up to 12 mg/kg/day, although an increased resorption rate was apparent at both 8 mg/kg/day and 12 mg/kg/day (intravenous) in the latter species.

There are no adequate and well-controlled studies in pregnant women. Milrinone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 12 words

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

🧓 Geriatric Use 80 words

Use in Elderly Patients There are no special dosage recommendations for the elderly patient. Ninety percent of all patients administered milrinone in clinical studies were within the age range of 45 to 70 years, with a mean age of 61 years. Patients in all age groups demonstrated clinically and statistically significant responses.

No age-related effects on the incidence of adverse reactions have been observed. Controlled pharmacokinetic studies have not disclosed any age-related effects on the distribution and elimination of milrinone.

🆘 Overdosage 43 words

OVERDOSAGE Doses of milrinone may produce hypotension because of its vasodilator effect. If this occurs, administration of milrinone should be reduced or temporarily discontinued until the patient's condition stabilizes. No specific antidote is known, but general measures for circulatory support should be taken.

🧬 Clinical Pharmacology ~3 min read

CLINICAL PHARMACOLOGY Milrinone is a positive inotrope and vasodilator, with little chronotropic activity different in structure and mode of action from either the digitalis glycosides or catecholamines. Milrinone, at relevant inotropic and vasorelaxant concentrations, is a selective inhibitor of peak III cAMP phosphodiesterase isozyme in cardiac and vascular muscle. This inhibitory action is consistent with cAMP mediated increases in intracellular ionized calcium and contractile force in cardiac muscle, as well as with cAMP dependent contractile protein phosphorylation and relaxation in vascular muscle.

Additional experimental evidence also indicates that milrinone is not a beta-adrenergic agonist nor does it inhibit sodium-potassium adenosine triphosphatase activity as do the digitalis glycosides. Clinical studies in patients with congestive heart failure have shown that milrinone produces dose-related and plasma drug concentration-related increases in the maximum rate of increase of left ventricular pressure. Studies in normal subjects have shown that milrinone produces increases in the slope of the left ventricular pressure-dimension relationship, indicating a direct inotropic effect of the drug.

Milrinone also produces dose-related and plasma concentration-related increases in forearm blood flow in patients with congestive heart failure, indicating a direct arterial vasodilator activity of the drug. Both the inotropic and vasodilatory effects have been observed over the therapeutic range of plasma milrinone concentrations of 100 ng/mL to 300 ng/mL. In addition to increasing myocardial contractility, milrinone improves diastolic function as evidenced by improvements in left ventricular diastolic relaxation.

The acute administration of intravenous milrinone has also been evaluated in clinical trials in excess of 1600 patients with chronic heart failure, heart failure associated with cardiac surgery, and heart failure associated with myocardial infarction. The total number of deaths, either on therapy or shortly thereafter (24 hours) was 15, less than 0.9%, few of which were thought to be drug-related. Pharmacokinetics Following intravenous injections of 12.5 mcg/kg to 125 mcg/kg to congestive heart failure patients, milrinone had a volume of distribution of 0.38 liters/kg, a mean terminal elimination half-life of 2.3 hours, and a clearance of 0.13 liters/kg/hr.

Following intravenous infusions of 0.2 mcg/kg/min to 0.7 mcg/kg/min to congestive heart failure patients, the drug had a volume of distribution of about 0.45 liters/kg, a mean terminal elimination half-life of 2.4 hours, and a clearance of 0.14 liters/kg/hr. These pharmacokinetic parameters were not dose-dependent, and the area under the plasma concentration versus time curve following injections was significantly dose-dependent. Milrinone has been shown (by equilibrium dialysis) to be approximately 70% bound to human plasma protein.

The primary route of excretion of milrinone in man is via the urine. The major urinary excretions of orally administered milrinone in man are milrinone (83%) and its 0-glucuronide metabolite (12%). Elimination in normal subjects via the urine is rapid, with approximately 60% recovered within the first two hours following dosing and approximately 90% recovered within the first eight hours following dosing.

The mean renal clearance of milrinone is approximately 0.3 liters/min, indicative of active secretion. Pharmacodynamics In patients with heart failure due to depressed myocardial function, milrinone produced a prompt dose and plasma concentration related increase in cardiac output and decreases in pulmonary capillary wedge pressure and vascular resistance, which were accompanied by mild-to-moderate increases in heart rate. Additionally, there is no increased effect on myocardial oxygen consumption.

In uncontrolled studies, hemodynamic improvement during intravenous therapy with milrinone was accompanied by clinical symptomatic improveme…

📦 How Supplied / Storage and Handling 193 words

HOW SUPPLIED Milrinone Lactate Injection, USP is supplied as 10 mL single dose vials in a box of 10, NDC 0143-9710-10, or box of 25, NDC 0143-9710-25; as 20 mL single dose vials in a box of 10, NDC 0143-9709-10; as a 50 mL single dose vial in a box of 1, NDC 0143-9708-01, or box of 10, NDC 0143-9708-10, containing a sterile, clear, colorless to pale yellow solution. Each mL contains milrinone lactate equivalent to 1 mg milrinone. Milrinone Lactate in 5% Dextrose Injection in Flexible Containers are supplied as 100 mL (200 mcg/mL) in 5% Dextrose Injection single units, NDC 0143-9719-10; as 200 mL (200 mcg/mL) in 5% Dextrose Injection single units, NDC 0143-9718-10.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid freezing. Exposure of pharmaceutical products to heat should be minimized.

Avoid excessive heat. Brief exposure of Flexible Containers up to 40ºC (104ºF) does not adversely affect the product. Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A.

Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised: 5/2025 PIN238-WES/5

📦 Storage and Handling 77 words

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid freezing. Exposure of pharmaceutical products to heat should be minimized.

Avoid excessive heat. Brief exposure of Flexible Containers up to 40ºC (104ºF) does not adversely affect the product. Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A.

Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised: 5/2025 PIN238-WES/5

📋 Description ~1 min read

DESCRIPTION Milrinone Lactate is a member of a class of bipyridine inotropic/vasodilator agents with phosphodiesterase inhibitor activity, distinct from digitalis glycosides or catecholamines. Milrinone lactate is designated chemically as 1,6-dihydro-2-methyl-6-oxo-[3,4´-bipyridine]-5-carbonitrile lactate and has the following structure: CH 3 CHOHCOOH Milrinone is an off-white to tan crystalline compound with a molecular weight of 211.2 and a molecular formula of C 12 H 9 N 3 O. It is slightly soluble in methanol, and very slightly soluble in chloroform and in water.

As the lactate salt, it is stable and colorless to pale yellow in solution. Milrinone Lactate is available as sterile aqueous solutions of the lactate salt of milrinone for injection or infusion intravenously. Sterile, single dose vials: Single dose vials of 10, 20 and 50 mL contain in each mL milrinone lactate equivalent to 1 mg milrinone and 47 mg Dextrose, Anhydrous, USP, in Water for Injection, USP.

The pH is adjusted to between 3.2 and 4.0 with lactic acid or sodium hydroxide. The total concentration of lactic acid can vary between 0.95 mg/mL and 1.29 mg/mL. These vials require preparation of dilutions prior to administration to patients intravenously.

Pre-Mix Flexible Containers : The Flexible Containers provide two ready-to-use dilutions of milrinone in volumes of 100 mL and 200 mL of 5% Dextrose Injection. Each mL contains milrinone lactate equivalent to 200 mcg (0.2 mg) milrinone. The nominal concentration of lactic acid is 0.282 mg/mL.

Each mL also contains 49.4 mg Dextrose Anhydrous, USP. The pH is adjusted to between 3.2 and 4.0 with lactic acid or sodium hydroxide. The flexible plastic container is comprised of polypropylene with a foil overwrap.

Water can permeate the plastic into the overwrap, but the amount is insufficient to significantly affect the pre-mix solution. chemical structure

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.