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Mirabegron 25 mg Tablet, Extended Release, 30-count — NDC 70771-1752-03 package photo

Mirabegron 25 mg Tablet, Extended Release, 30-count

by Zydus Lifesciences Limited · 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1752-3)
NDC 70771-1752-03
🏷️ FDA NDC (as labeled) 70771-1752-3 billing pads the package segment with a zero
This package
Contains30-count Pack sizes3 compare ↓
Also priced by: Part D plans $6.70/unit — full pricing hub ↓
Also comes in: 90 tablets 70771-1752-09 100 tablets 70771-1752-01
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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Mirabegron (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 · Aug 5, 2026 — CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity. (Zydus Pharmaceuticals (USA) Inc) · FDA recall D-0745-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 70771-1752-3
Product NDC 70771-1752
11-digit billing NDC 70771175203
RxCUI 1300791, 1300801
UNII MVR3JL3B2V
Application # ANDA209488
SPL Set ID 461b2b94-205a-4860-9cb4-d30267ada9df
Established class (EPC) beta3-Adrenergic Agonist
Mechanism of action Adrenergic beta3-Agonists; Cytochrome P450 2D6 Inhibitors; Cytochrome P450 3A Inhibitors; P-Glycoprotein Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-01-23
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance MIRABEGRON
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 70771-1752-3 — a 5-4-1 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 package segment → 70771-1752-03. 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 beta3-Adrenergic Agonist class.

Pharmacologic class beta3-Adrenergic Agonist
Drug family (ATC) Drugs for urinary frequency and incontinence
How it works Cytochrome P450 2D6 Inhibitors, Adrenergic beta3-Agonists, P-Glycoprotein Inhibitors, Cytochrome P450 3A 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

LabelerZydus Lifesciences Limited
Application holderZYDUS PHARMACEUTICALS USA INC
FDA applicationANDA209488 (ANDA)
Labeler code70771
First marketedJan 2024
Product typeHuman Prescription Drug
Portfolio716 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

📖 What it is MedlinePlus · NLM

Mirabegron is used alone or in combination with solifenacin (Vesicare) to treat overactive bladder (a condition in which the bladder muscles contract uncontrollably and cause frequent urination, urgent need to urinate, and inability to control urination) in adults. It is also used to treat neurogenic detrusor overactivity (a bladder control condition caused by brain, spinal cord or nerve problem) in children 3 years of age and older. Mirabegron is in a class of medications called beta-3 adrenergic agonists. It works by relaxing the bladder muscles to prevent urgent, frequent, or uncontrolled u...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Mirabegron helps your bladder muscle relax so it can hold more urine before you feel a sudden urge to go. If you're dealing with overactive bladder — the urgency, the leaks, the co...
  • What is mirabegron actually supposed to do for me?
  • For adults taking the tablet, it doesn't matter — you can take it with or without food. But if a child is taking either the tablet or the oral suspension (granules), it should alwa...
  • Does it matter if I take it with food or on an empty stomach?
📖 Read our full Mirabegron 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 Pink / Yellow
ShapeOval
Imprint1160
Size12 mm
ScoringNot scored
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 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 0WZ8WG20P6
    Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
  • 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 30IQX730WE
    Polyethylene glycol 6000 is a synthetic polymer made from ethylene glycol units. It acts as a binder, filler, and solubilizer in medicines to help hold ingredients together, add bulk, and improve how well active drugs dissolve and absorb.
  • UNII Q662QK8M3B
    Polyethylene glycol 8000 is a synthetic polymer made from ethylene oxide. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the medicine.
  • UNII 11628IH70O
    Polyethylene oxide is a synthetic polymer derived from ethylene. In medicines, it acts as a binder to hold ingredients together, a thickener to adjust texture, and a disintegrant to help the tablet or capsule break apart for absorption.
  • UNII 5K3991GVWI
    A synthetic polymer derived from ethylene that acts as a thickener, binder, and film-former in medications. It helps control how quickly the drug dissolves and improves the texture and consistency of tablets, capsules, and liquid formulations.

9 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 DailyMed — ingredient 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 $6.70 $200.92 / 30 tablets
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
Mirabegron 25 mg 68180-0151-06 Lupin 30 tablets $9.399 AB Availability likely —
Mirabegron 25 mg 69238-2860-01 Amneal 30 tablets $9.399 AB Availability likely —
Myrbetriq 25 mg 00469-2601-07 Astellas 7 tablets — AB FDA listed —
Mirabegron 25 mg 67184-0571-01 Qilu 30 tablets — AB FDA listed —
Mirabegron 25 mg 70518-4631-00 REMEDYREPACK 1 tablet — AB FDA listed —
Mirabegron 25 mg 70710-1159-01 Zydus 100 tablets — AB FDA listed —
Mirabegron 25 mgthis 70771-1752-03 Zydus 30 tablets — AB FDA listed —
Mirabegron 25 mg 71335-2807-01 Bryant 30 tablets — AB FDA listed —
Mirabegron 25 mg 71335-2809-01 Bryant 90 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

🏛️
2024
On the market since
Jan 2024
📍
2026
Currently FDA-listed
2 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.

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

Medicare Part D (outpatient prescription) spending for Myrbetriq (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Myrbetriq. CMS lists 2 products for this generic; we show the highest-spend one. 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
$395.78M
Claims incl. refills
606.8K
Beneficiaries
351.6K
Spend / beneficiary
$1,125.55
Spend / claim
$652.25
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 MIRABEGRON — the ingredient across all brands.

Top reported reactions

Fatigue2,325
Headache2,259
Dizziness2,242
Fall2,033
Diarrhoea1,999
Pain1,864
Nausea1,803

Age at onset

Neonate32
Infant1
Child14
Adolescent13
Adult2,131
Elderly3,249

Reporter sex

38,466 reports
Male · 33%
Female · 66%
Unknown · 1%

Serious outcomes

Hospitalization7,785
Death3,197
Disabling1,944
Life-threatening1,861
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3,312 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 Marketing startStatus
70771-1752-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1752-1) 2024-01-23 Active
70771-1752-03 You're viewing this 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1752-3) 2024-01-23 Active
70771-1752-09 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1752-9) 2024-01-23 Active

You're viewing the smallest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 70771-1752-03?
NDC 70771-1752-03 is a 30-count package — 30 tablet, extended release in 1 bottle.
What is the difference between NDC 70771-1752-03 and NDC 70771-1752-09?
Both are Mirabegron 25 mg Tablet, Extended Release — the drug itself is identical. NDC 70771-1752-03 is the 30-count package, while NDC 70771-1752-09 is the 90 tablets package.
What NDC number is used to bill for this package of Mirabegron 25 mg Tablet, Extended Release?
Bill NDC 70771-1752-03 — the 11-digit billing format is 70771175203. 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 ✓ 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 70771-1752-3, 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: 70771-1752-03, written without dashes as 70771175203. 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 70771-1752-03, the first segment (70771) is the labeler code FDA assigned to Zydus Lifesciences Limited; the middle segment (1752) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 Zydus Lifesciences Limited. 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 2 other package presentations of this same product, including 90 tablets (70771-1752-09), 100 tablets (70771-1752-01). 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?
Zydus Lifesciences Limited 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.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 115 words ▾

1 INDICATIONS AND USAGE Mirabegron extended-release tablets are a beta-3 adrenergic agonist indicated for the treatment of: Overactive bladder (OAB) in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency. ( 1.1 ) Neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older and weighing 35 kg or more. (1.2)

1.1Adult Overactive Bladder (OAB) Mirabegron Monotherapy Mirabegron extended-release tablets are indicated for the treatment of OAB in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency.

1.2Pediatric Neurogenic Detrusor Overactivity (NDO) Mirabegron extended-release tablets are indicated for the treatment of NDO in pediatric patients aged 3 years and older and weighing 35 kg or more.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Mirabegron extended-release tablets and Mirabegron Granules are two different products and they are not substitutable on a milligram-per-milligram basis. Select the recommended product (Mirabegron extended-release tablets and Mirabegron Granules) based on the indication and patient's weight. OAB in Adults The recommended starting dose of mirabegron extended-release tablets is 25 mg orally once daily.

( 2.2 ) After 4 to 8 weeks, the mirabegron extended-release tablets dose may be increased to 50 mg orally once daily. ( 2.2 ) NDO in Pediatric Patients 3 Years and Older Pediatric Patients weighing 35 kg or more: Use mirabegron extended-release tablets: The recommended starting dosage of mirabegron extended-release tablets is 25 mg orally once daily. After 4 to 8 weeks, the mirabegron extended-release tablets dose may be increased to 50 mg orally once daily.

(2.3) Adult or Pediatric Patients Patients with Renal or Hepatic Impairment : Refer to the full prescribing information for recommended dosage. ( 2.4 , , 2.5) Administration Mirabegron extended-release tablets: Adult patients: Swallow mirabegron extended-release tablets whole with water. Do not chew, divide, or crush.

Take with or without food. ( 2.7 ) Pediatric patients: Swallow mirabegron extended-release tablets whole with water. Do not chew, divide, or crush.

Take with food. (2.7)

2.1Important Dosage Information Mirabegron extended-release tablets and Mirabegron Granules are two different products and they are not substitutable on a milligram-per-milligram basis. Select the recommended product (Mirabegron extended-release tablets and Mirabegron Granules) based on the indication and patient's weight [see Indications and Usage ( 1 ) and Dosage and Administration (2.2, 2.3, 2.4, 2.5) ].

2.2Recommended Dosage for Adult Patients with OAB Mirabegron Monotherapy The recommended starting dosage of mirabegron extended-release tablets is 25 mg orally once daily. If needed, increase to the maximum dosage of mirabegron extended-release tablets 50 mg orally once daily after 4 to 8 weeks. For administration instructions, see Dosage and Administration (2.7) .

2.3Recommended Dosage for Pediatric Patients Aged 3 Years and Older with NDO For pediatric patients 3 years of age and older, select the appropriate product (Mirabegron extended-release tablets and Mirabegron Granules) based on the patient's weight. Pediatric Patients weighing 35 kg or more: Use mirabegron extended-release tablets The recommended starting dosage of mirabegron extended-release tablets is 25 mg orally once daily. If needed, increase to a maximum dosage of mirabegron extended-release tablets 50 mg orally once daily after 4 to 8 weeks.

For administration instructions, see Dosage and Administration (2.7).

2.4Recommended Dosage in Adult Patients with Renal or Hepatic Impairment Dosage in Adults with Renal Impairment The recommended dosage of mirabegron extended-release tablets (administered orally once daily) in adult patients with renal impairment is described in Table 1 [see Use in Specific Populations (8.6) ]. For administration instructions, see Dosage and Administration (2.7) . Table 1: Mirabegron Extended-Release Tablets Recommended Dosage in Adult Patients with Renal Impairment (Administered Orally Once Daily) Estimated GFR 1 Starting Dose Maximum Dose eGFR 30 to 89 mL/min/1.73 m 2 25 mg 50 mg eGFR 15 to 29 mL/min/1.73 m 2 25 mg 25 mg eGFR < 15 mL/min/1.73 m 2 or requiring dialysis Not Recommended 1.

Estimated GFR using the modification of diet in renal disease (MDRD) formula Dosage in Adults with Hepatic Impairment The recommended dosage of mirabegron extended-release tablets (administered orally once daily) in adult patients with hepatic impairment is described in Table 2 [see Use in Specific Populations (8.7) ]. For administration instructions, see Dosage and Administration (2.7) . Table 2: Mirabegron Recommended Dosage in Adult Patients with Hepatic Impairment (Administered Orall…

💊 Dosage Forms and Strengths 67 words ▾

3 DOSAGE FORMS AND STRENGTHS Extended-release tablets: 25 mg and 50 mg ( 3 ) Mirabegron extended-release tablets are supplied in two different strengths as described below: 25 mg peach colored, oval shaped, biconvex, film-coated tablets debossed with "1159" on one side and plain on other side 50 mg yellow colored, oval shaped, biconvex, film-coated tablets debossed with "1160" on one side and plain on other side.

⛔ Contraindications 40 words ▾

4 CONTRAINDICATIONS Mirabegron extended-release tablets are contraindicated in patients with known hypersensitivity reactions to mirabegron or any inactive ingredients of the tablet [see Adverse Reactions ( 6.1 , 6.2 )]. Hypersensitivity to mirabegron or any inactive ingredients. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Increases in Blood Pressure: Can increase blood pressure in adult or pediatric patients. Periodically monitor blood pressure, especially in hypertensive patients. Mirabegron extended-release tablets are not recommended in patients with severe uncontrolled hypertension.

( 5.1 ) Urinary Retention in Patients with Bladder Outlet Obstruction and in Patients Taking Muscarinic Antagonist Drugs for Overactive Bladder: Administer with caution in these patients because of risk of urinary retention. ( 5.2 ) Angioedema: Angioedema of the face, lips, tongue and/or larynx has been reported with mirabegron. ( 5.3 , 6.2 )

5.1Increases in Blood Pressure Increases in Blood Pressure in Adults Mirabegron can increase blood pressure. Periodic blood pressure determinations are recommended, especially in hypertensive patients. Mirabegron is not recommended for use in patients with severe uncontrolled hypertension (defined as systolic blood pressure greater than or equal to 180 mm Hg and/or diastolic blood pressure greater than or equal to 110 mm Hg) [see Clinical Pharmacology (12.2) ] .

In two, randomized, placebo-controlled, healthy adult volunteer studies, mirabegron was associated with dose-related increases in supine blood pressure. In these studies, at the maximum recommended dose of 50 mg, the mean maximum increase in systolic/diastolic blood pressure was approximately 3.5/1.5 mm Hg greater than placebo. In contrast, in adult OAB patients in clinical trials, mirabegron, taken as monotherapy, the mean increase in systolic and diastolic blood pressure at the maximum recommended mirabegron dose of 50 mg was approximately 0.5 to 1 mm Hg greater than placebo.

Worsening of pre-existing hypertension was reported infrequently in patients taking mirabegron. Increases in Blood Pressure in Pediatric Patients 3 Years and Older Mirabegron can increase blood pressure in pediatric patients. Blood pressure increases may be larger in children (3 to less than 12 years of age) than in adolescents (12 to less than 18 years of age).

Periodic blood pressure determinations are recommended. Mirabegron is not recommended for use in pediatric patients with severe uncontrolled hypertension, defined as a systolic and/or diastolic blood pressure above the 99 th percentile plus 5 mm Hg for age, sex, and stature using appropriate reference values [see Adverse Reactions (6.1)] .

5.2Urinary Retention in Patients with Bladder Outlet Obstruction and in Patients Taking Muscarinic Antagonist Medications for OAB In patients taking mirabegron, urinary retention has been reported to occur in patients with bladder outlet obstruction (BOO) and in patients taking muscarinic antagonist medications for the treatment of OAB. A controlled clinical safety study in patients with BOO did not demonstrate increased urinary retention in patients treated with mirabegron; however, mirabegron should still be administered with caution to patients with clinically significant BOO.

For example, monitor these patients for signs and symptoms of urinary retention. Mirabegron should also be administered with caution to patients taking muscarinic antagonist medications for the treatment of OAB [see Clinical Pharmacology (12.2) ] .

5.3Angioedema Angioedema of the face, lips, tongue, and/or larynx has been reported with mirabegron. In some cases, angioedema occurred after the first dose, however, cases have been reported to occur hours after the first dose or after multiple doses. Angioedema, associated with upper airway swelling, may be life-threatening.

If involvement of the tongue, hypopharynx, or larynx occurs, promptly discontinue mirabegron and provide appropriate therapy and/or measures necessary to ensure a patent airway [see Adverse Reactions (6.2) ].

5.4Patients Taking Drugs Metabolized by CYP2D6 Since mirabegron is a moderate CYP2D6 inhibitor, the systemic exposure to CYP2D6 substrates is increased when coadministered with mirabegron. Therefore, appropriate monitorin…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling. Hypertension [see Warnings and Precautions ( 5.1 )] Urinary Retention [see Warnings and Precautions ( 5.2 )] Angioedema [see Warnings and Precautions ( 5.3 )] Most commonly reported adverse reactions with mirabegron monotherapy in adult patients with OAB (> 2% and > placebo) were hypertension, nasopharyngitis, urinary tract infection, and headache. ( 6.1 ) Most commonly reported adverse reactions with mirabegron in pediatric patients with NDO (≥ 3%) were UTI, nasopharyngitis, constipation, and headache.

(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Mirabegron Monotherapy for Adult OAB In three, 12-week, double-blind, placebo-controlled, safety and efficacy studies in patients with OAB (Studies 1, 2, and 3), mirabegron was evaluated for safety in 2,736 patients [see Clinical Studies (14.1) ].

Study 1 also included an active control. For the combined Studies 1, 2, and 3,432 patients received mirabegron 25 mg, 1,375 received mirabegron 50 mg, and 929 received mirabegron 100 mg once daily. In these studies, the majority of the patients were Caucasian (94%), and female (72%) with a mean age of 59 years (range 18 to 95 years).

Mirabegron was also evaluated for safety in 1,632 patients who received mirabegron 50 mg once daily (n=812 patients) or mirabegron 100 mg (n=820 patients) in a 1-year, randomized, fixed- dose, double-blind, active-controlled, safety study in patients with OAB (Study 4). Of these patients, 731 received mirabegron in a previous 12-week study. In Study 4, 1385 patients received mirabegron continuously for at least 6 months, 1,311 patients received mirabegron for at least 9 months, and 564 patients received mirabegron for at least 1 year.

The most frequent adverse events (0.2%) leading to discontinuation in Studies 1, 2 and 3 for the 25 mg or 50 mg dose were nausea, headache, hypertension, diarrhea, constipation, dizziness, and tachycardia. Atrial fibrillation (0.2%) and prostate cancer (0.1%) were reported as serious adverse events by more than 1 patient and at a rate greater than placebo. Table 3 the lists adverse reactions, derived from all adverse events that were reported in Studies 1, 2 and 3 at an incidence greater than placebo and in 1% or more of patients treated with mirabegron 25 mg or 50 mg once daily for up to 12 weeks.

The most commonly reported adverse reactions (greater than 2% of mirabegron patients and greater than placebo) were hypertension, nasopharyngitis, urinary tract infection, and headache. Table 3: Percentages of Patients with Adverse Reactions, Derived from All Adverse Events, Exceeding Placebo Rate and Reported in ≥ 1% of OAB Patients Treated with mirabegron 25 mg or 50 mg Once Daily in Studies 1, 2, and 3 Adverse Reaction Placebo (%) Mirabegron 25 mg (%) Mirabegron 50 mg (%) Number of Patients 1380 432 1375 Hypertension * 7.6 11.3

7.5Nasopharyngitis 2.5 3.5

3.9Urinary Tract Infection 1.8 4.2

2.9Headache 3.0 2.1

3.2Constipation 1.4 1.6

1.6Upper Respiratory Tract Infection 1.7 2.1

1.5Arthralgia 1.1 1.6

1.3Diarrhea 1.3 1.2

1.5Tachycardia 0.6 1.6

1.2Abdominal Pain 0.7 1.4

0.6Fatigue 1.0 1.4 1.2 * Includes reports of blood pressure above the normal range, and BP increased from baseline, occurring predominantly in subjects with baseline hypertension Other adverse reactions reported by less than 1% of patients treated with mirabegron in Studies 1, 2, or 3 included: Cardiac disorders: palpitations, blood pressure increased [see Clinical Pharmacology (12.2) ] Eye dis…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Drug interaction studies were conducted in adult patients to investigate the effect of coadministered drugs on the pharmacokinetics of mirabegron and the effect of mirabegron on the pharmacokinetics of coadministered drugs (e.g., ketoconazole, rifampin, solifenacin succinate, tamsulosin, and oral contraceptives) [see Clinical Pharmacology (12.3) ] . No dose adjustment is recommended when these drugs are coadministered with mirabegron. The following are drug interactions for which monitoring is recommended: Drugs Metabolized by CYP2D6: Mirabegron is a CYP2D6 inhibitor and, when used concomitantly with drugs metabolized by CYP2D6, especially narrow therapeutic index drugs, appropriate monitoring and possible dose adjustment of those drugs may be necessary.

( 5.4 , 7.1 , 12.3 ) Digoxin: When initiating a combination of mirabegron and digoxin, use the lowest dose of digoxin; monitor serum digoxin concentrations to titrate digoxin dose to desired clinical effect. ( 7.2 , 12.3 )

7.1Drugs Metabolized by CYP2D6 Since mirabegron is a moderate CYP2D6 inhibitor, the systemic exposure of drugs metabolized by CYP2D6 enzyme is increased when coadministered with mirabegron. Therefore, appropriate monitoring and dose adjustment may be necessary when mirabegron is coadministered with these drugs, especially with narrow therapeutic index CYP2D6 substrates [see Warnings and Precautions (5.4) and Clinical Pharmacology (12.3) ] .

7.2Digoxin When given in combination, 100 mg mirabegron increased mean digoxin C max from 1.01 ng/mL to 1.3 ng/mL (29%) and AUC from 16.7 ng.h/mL to 19.3 ng.h/mL (27%). For patients who are initiating a combination of mirabegron and digoxin, the lowest dose for digoxin should initially be considered. Serum digoxin concentrations should be monitored and used for titration of the digoxin dose to obtain the desired clinical effect [see Clinical Pharmacology (12.3) ] .

7.3Warfarin The mean C max of S- and R- warfarin was increased by approximately 4% and AUC by approximately 9% when administered as a single dose of 25 mg after multiple doses of 100 mg mirabegron. Following a single dose administration of 25 mg warfarin, mirabegron had no effect on the warfarin pharmacodynamic endpoints such as International Normalized Ratio (INR) and prothrombin time. However, the effect of mirabegron on multiple doses of warfarin and on warfarin pharmacodynamic end points such as INR and prothrombin time has not been fully investigated [see Clinical Pharmacology (12.3) ] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1PREGNANCY Risk Summary There are no studies with the use of mirabegron in pregnant women or adolescents to inform a drug-associated risk of major birth defects, miscarriages, or adverse maternal or fetal outcomes. Mirabegron administration to pregnant animals during organogenesis resulted in reversible skeletal variations (in rats) at 22-fold (via AUC) the maximum recommended human dose (MRHD) of 50 mg/day and decreased fetal body weights (in rabbits) at 14-fold the MRHD. At maternally-toxic exposures in rats (96-fold), decreased fetal weight and increased fetal mortality were observed and, in rabbits (36-fold), cardiac findings (fetal cardiomegaly and fetal dilated aortae) were observed [see Data].

The estimated background risks of major birth defects and miscarriage for the indicated populations are unknown. In the U.S. general population, the estimated background risks of major birth defects or miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. Data Animal Data No embryo-fetal lethality or morphological fetal developmental abnormalities were produced in pregnant rats following daily oral administration of mirabegron during the period of organogenesis (Days 7 to 17 of gestation) at 0, 10, 30, 100, or 300 mg/kg, doses which were associated with systemic exposures (AUC) 0, 1, 6, 22, and 96-fold the MRHD.

Skeletal variations (wavy ribs, delayed ossification) were observed in fetuses at doses 22-fold the systemic exposure at the MRHD and were reversible during development. Exposures 96-fold the MRHD were maternally-toxic (mortality, decreased body weight gain) and associated with fetal growth reduction. Pregnant rabbits were treated with daily oral doses of mirabegron at 0, 3, 10, or 30 mg/kg/day during the period of organogenesis (Days 6 to 20 of gestation), which resulted in plasma exposures that were 0, 1, 14, or 36-fold the MRHD based on AUC.

At 10 mg/kg/day (14-fold the MRHD) and higher, fetal body weights were reduced. At 30 mg/kg/day, maternal toxicity (increased heart rate, mortality, reduced body weight gain, reduced food consumption) occurred, and fetal deaths, fetal cardiomegaly and fetal dilated aortae were observed at systemic exposure levels (AUC) 36-fold the MRHD. In a pre-and postnatal developmental study, rats were treated with daily oral doses of mirabegron at 0, 10, 30, or 100 mg/kg/day (0, 1, 6, or 22-fold the MRHD) from day 7 of gestation until day 20 after birth.

Decreased maternal body weight was observed along with decreased pup survival in the first few days after birth (92.7% survival) compared to the control group (98.8% survival), at 100 mg/kg/day (22-fold the MRHD). Pup body weight gain was reduced until postnatal day 7 but not further affected throughout the remainder of the lactation period. In utero and lactational exposure did not affect developmental milestones, behavior or fertility of offspring.

No effects were observed at 30 mg/kg/day.

8.3NURSING MOTHERS Risk Summary There are no data on the presence of mirabegron in human milk, the effects on the breastfed child, or the effects on milk production. Mirabegron-related material was present in rat milk and in the stomach of nursing pups following administrations of a single 10 mg/kg oral dose of 14 C-labeled mirabegron to lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for mirabegron and any potential adverse effects on the breastfed child from mirabegron or from the underlying maternal condition.

8.4PEDIATRIC USE The safety and effectiveness have been established only for the following pediatric indications: Mirabegron: Treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 3years of age and older and weighing 35 kg or more. The safety and effectiveness of mirabegron in pedi…

🤰 Pregnancy ~2 min read ▾

8.1PREGNANCY Risk Summary There are no studies with the use of mirabegron in pregnant women or adolescents to inform a drug-associated risk of major birth defects, miscarriages, or adverse maternal or fetal outcomes. Mirabegron administration to pregnant animals during organogenesis resulted in reversible skeletal variations (in rats) at 22-fold (via AUC) the maximum recommended human dose (MRHD) of 50 mg/day and decreased fetal body weights (in rabbits) at 14-fold the MRHD. At maternally-toxic exposures in rats (96-fold), decreased fetal weight and increased fetal mortality were observed and, in rabbits (36-fold), cardiac findings (fetal cardiomegaly and fetal dilated aortae) were observed [see Data].

The estimated background risks of major birth defects and miscarriage for the indicated populations are unknown. In the U.S. general population, the estimated background risks of major birth defects or miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. Data Animal Data No embryo-fetal lethality or morphological fetal developmental abnormalities were produced in pregnant rats following daily oral administration of mirabegron during the period of organogenesis (Days 7 to 17 of gestation) at 0, 10, 30, 100, or 300 mg/kg, doses which were associated with systemic exposures (AUC) 0, 1, 6, 22, and 96-fold the MRHD.

Skeletal variations (wavy ribs, delayed ossification) were observed in fetuses at doses 22-fold the systemic exposure at the MRHD and were reversible during development. Exposures 96-fold the MRHD were maternally-toxic (mortality, decreased body weight gain) and associated with fetal growth reduction. Pregnant rabbits were treated with daily oral doses of mirabegron at 0, 3, 10, or 30 mg/kg/day during the period of organogenesis (Days 6 to 20 of gestation), which resulted in plasma exposures that were 0, 1, 14, or 36-fold the MRHD based on AUC.

At 10 mg/kg/day (14-fold the MRHD) and higher, fetal body weights were reduced. At 30 mg/kg/day, maternal toxicity (increased heart rate, mortality, reduced body weight gain, reduced food consumption) occurred, and fetal deaths, fetal cardiomegaly and fetal dilated aortae were observed at systemic exposure levels (AUC) 36-fold the MRHD. In a pre-and postnatal developmental study, rats were treated with daily oral doses of mirabegron at 0, 10, 30, or 100 mg/kg/day (0, 1, 6, or 22-fold the MRHD) from day 7 of gestation until day 20 after birth.

Decreased maternal body weight was observed along with decreased pup survival in the first few days after birth (92.7% survival) compared to the control group (98.8% survival), at 100 mg/kg/day (22-fold the MRHD). Pup body weight gain was reduced until postnatal day 7 but not further affected throughout the remainder of the lactation period. In utero and lactational exposure did not affect developmental milestones, behavior or fertility of offspring.

No effects were observed at 30 mg/kg/day.

🧒 Pediatric Use 215 words ▾

8.4PEDIATRIC USE The safety and effectiveness have been established only for the following pediatric indications: Mirabegron: Treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 3years of age and older and weighing 35 kg or more. The safety and effectiveness of mirabegron in pediatric patients aged 3 years and older have been established for the treatment of neurogenic detrusor overactivity (NDO) and the information on this use is discussed throughout the labeling. Use of mirabegron for this indication is supported by evidence from a 52-week, open-label, baseline-controlled, multicenter, dose titration trial in pediatric patients 3 years of age and older with NDO (Study 9) [see Adverse Reactions (6.1), Clinical Studies (14.3)] .

Results showed an improvement from baseline in maximum cystometric (bladder) capacity (MCC) with mirabegron use [see Clinical Studies (14.3)] . The most commonly reported adverse reactions in Study 9 (≥3%) were UTI, nasopharyngitis, constipation, and headache. Increased mean systolic and diastolic blood pressures with use of mirabegron occurred in patients less than 12 years of age with larger increases in patients younger than 8 years of age [see Adverse Reactions (6.1)] .

Take mirabegron with food to reduce potential exposure-related risks, such as increased heart rate, as predicted by modeling of vital signs data in Study 9 [see Clinical Pharmacology (12.3)] .

🧓 Geriatric Use 66 words ▾

8.5GERIATRIC USE Of 5,648 patients who received mirabegron monotherapy in the phase 2 and 3 studies for OAB, 2,029 (35.9%) were 65 years of age or older, and 557 (9.9%) were 75 years of age or older. No overall differences in safety or effectiveness were observed between patients younger than 65 years of age and those 65 years of age or older in these studies.

🆘 Overdosage 90 words ▾

10 OVERDOSAGE Mirabegron has been administered to healthy volunteers at single doses up to 400 mg. At this dose, adverse events reported included palpitations (1 of 6 subjects) and increased pulse rate exceeding 100 beats per minute (bpm) (3 of 6 subjects). Multiple doses of mirabegron up to 300 mg daily for 10 days showed increases in pulse rate and systolic blood pressure when administered to healthy volunteers.

Treatment for overdosage should be symptomatic and supportive. In the event of overdosage, pulse rate, blood pressure and ECG monitoring is recommended.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1MECHANISM OF ACTION Mirabegron is an agonist of the human beta-3 adrenergic receptor (AR) as demonstrated by in vitro laboratory experiments using the cloned human beta-3 AR. Mirabegron relaxes the detrusor smooth muscle during the storage phase of the urinary bladder fill-void cycle by activation of beta-3 AR which increases bladder capacity. Although mirabegron showed very low intrinsic activity for cloned human beta-1 AR and beta-2 AR, results in humans indicate that beta-1 AR stimulation occurred at a mirabegron dose of 200 mg.

12.2Pharmacodynamics Urodynamics The effects of mirabegron on maximum urinary flow rate and detrusor pressure at maximum flow rate were assessed in a urodynamic study consisting of 200 male patients with lower urinary tract symptoms (LUTS) and BOO. Administration of mirabegron once daily for 12 weeks did not adversely affect the mean maximum flow rate or mean detrusor pressure at maximum flow rate in this study. Nonetheless, mirabegron should be administered with caution to patients with clinically significant BOO [see Warnings and Precautions (5.2)].

Cardiac Electrophysiology The effect of multiple doses of mirabegron 50 mg, 100 mg and 200 mg (four times the maximum recommended dose) once daily on QTc interval was evaluated in a randomized, placebo- and active-controlled (moxifloxacin 400 mg), four-treatment arm, parallel crossover study in 352 healthy subjects. In a study with demonstrated ability to detect small effects, the upper bound of the one-sided 95% confidence interval for the largest placebo-adjusted, baseline-corrected QTc based on individual correction method (QTcI) was below 10 msec.

For the 50 mg mirabegron dose group (the maximum approved dosage), the mean difference from placebo on QTcI interval at 4 to 5 hours post-dose was 3.7 msec (upper bound of the 95% CI 5.1 msec). For the mirabegron 100 mg and 200 mg doses groups (dosages greater than the maximum approved dose and resulting in substantial multiples of the anticipated maximum blood levels at 50 mg), the mean differences from placebo in QTcI interval at 4 to 5 hours post-dose were 6.1 msec (upper bound of the 95% CI 7.6 msec) and 8.1 msec (upper bound of the 95% CI 9.8 msec), respectively.

At the mirabegron 200 mg dose, in females, the mean effect was 10.4 msec (upper bound of the 95% CI 13.4 msec). In this thorough QT study, mirabegron increased heart rate on ECG in a dose-dependent manner. Maximum mean increases from baseline in heart rate for the 50 mg, 100 mg, and 200 mg dose groups compared to placebo were 6.7 bpm, 11 bpm, and 17 bpm, respectively.

In the clinical efficacy and safety studies, the change from baseline in mean pulse rate for mirabegron 50 mg was approximately 1 bpm. In this thorough QT study, mirabegron also increased blood pressure in a dose-dependent manner (see Effects on Blood Pressure) . Effects on Blood Pressure In a study of 352 healthy subjects assessing the effect of multiple daily doses of 50 mg, 100 mg, and 200 mg (four times the maximum recommended dose) of mirabegron for 10 days on the QTc interval, the maximum mean increase in supine systolic blood pressure (SBP)/diastolic blood pressure (DBP) at the maximum recommended dose of 50 mg was approximately 4.0/1.6 mm Hg greater than placebo [see Warnings and Precautions (5.1) ].

The 24-hour average increases in SBP compared to placebo were 3.0, 5.5, and 9.7 mm Hg at mirabegron doses of 50 mg, 100 mg, and 200 mg, respectively. Increases in DBP were also dose-dependent, but were smaller than SBP. In another study in 96 healthy subjects to assess the impact of age on pharmacokinetics of multiple daily doses of 50 mg, 100 mg, 200 mg, and 300 mg (six times the maximum recommended dose) of mirabegron for 10 days, SBP also increased in a dose-dependent manner.

The mean maximum increases in SBP were approximately 2.5, 4.5, 5.5 and 6.5 mm Hg for mirabegron exposures associated with doses of 50 mg, 100 mg, 200 mg and 300 mg, re…

🧬 Mechanism of Action 84 words ▾

12.1MECHANISM OF ACTION Mirabegron is an agonist of the human beta-3 adrenergic receptor (AR) as demonstrated by in vitro laboratory experiments using the cloned human beta-3 AR. Mirabegron relaxes the detrusor smooth muscle during the storage phase of the urinary bladder fill-void cycle by activation of beta-3 AR which increases bladder capacity. Although mirabegron showed very low intrinsic activity for cloned human beta-1 AR and beta-2 AR, results in humans indicate that beta-1 AR stimulation occurred at a mirabegron dose of 200 mg.

📦 How Supplied / Storage and Handling 138 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1Mirabegron extended-release tablets Mirabegron extended-release tablets, 25mg are peach colored, oval shaped, biconvex, film-coated tablets debossed with "1159" on one side and plain on other side and are supplied as follows: NDC 70771-1752-3 in bottles of 30 tablets with child-resistant closure NDC 70771-1752-9 in bottles of 90 tablets with child-resistant closure NDC 70771-1752-1 in bottles of 100 tablets with child-resistant closure Mirabegron extended-release tablets, 50mg are yellow colored, oval shaped, biconvex, film-coated tablets debossed with "1160" on one side and plain on other side and are supplied as follows: NDC 70771-1753-3 in bottles of 30 tablets with child-resistant closure NDC 70771-1753-9 in bottles of 90 tablets with child-resistant closure NDC 70771-1753-1 in bottles of 100 tablets with child-resistant closure Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

📋 Description 105 words ▾

11 DESCRIPTION Mirabegron extended-release tablets for oral use is a beta-3 adrenergic agonist. The chemical name is 2-(2-Amonothiazol-4-yl)-N-(4-(2-(2R)-hydroxy-2-phenylethylamino)ethyl)phenyl)acetamide having an empirical formula of C 21 H 24 N 4 O 2 S and a molecular weight of 396.51. The structural formula of mirabegron is: Mirabegron is a white powder.

It is practically insoluble in water. It is soluble in methanol and dimethyl sulfoxide. Each mirabegron extended-release tablet for oral use contains either 25 mg or 50 mg of mirabegron and the following inactive ingredients: polyethylene oxide, polyethylene glycol, magnesium stearate, hypromellose, ferrosoferric oxide, yellow iron oxide, and red iron oxide (25 mg tablet only). structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient and/or caregiver to read the FDA-approved patient labeling (Patient Information). Increases in Blood Pressure Inform patients and/or their caregivers that mirabegron extended-release tablets may increase blood pressure. Advise patients, especially patients with hypertension, to periodically monitor their blood pressure and report increased measurement to their health care provider [see Warnings and Precautions (5.1) ].

Urinary Retention Inform patients and/or their caregivers that mirabegron may cause urinary retention in adult patients with bladder outlet obstruction and in patients taking muscarinic antagonist medications for the treatment of OAB. Advise patients to contact their physician if they experience these effects while taking mirabegron [see Warnings and Precautions (5.2) ]. Angioedema Inform patients and/or their caregivers that mirabegron may cause angioedema.

Advise patients and/or their caregivers to promptly discontinue mirabegron and seek medical attention if angioedema associated with the upper airway swelling occurs as this may be life-threatening [see Warnings and Precautions (5.3) ]. Drug Interactions Advise patients to report their use of any other prescription or nonprescription medications or dietary supplements because co-administration with mirabegron may require a dose adjustment and/or increased monitoring of these drugs [see Drug Interactions (7) ]. Administration Instructions Mirabegron extended-release tablets Advise adult patients to swallow mirabegron whole with water and not to chew, divide, or crush.

Advise adult patients to take mirabegron with or without food. Advise pediatric patients and/or their caregivers to swallow mirabegron extended-release tablets whole with water and not to chew, divide, or crush. Advise pediatric patients to take mirabegron extended-release tablets with food.

Missed Dose Instruct patients and/or their caregivers to take any missed doses as soon as they remember, unless more than 12 hours have passed since the missed dose. If more than 12 hours have passed, the missed dose can be skipped and the next dose should be taken at the usual time. Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India Revised: 10/2024

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70771-1747-01 · Zydus 70771-1753-01 · Zydus →
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.