HomeNDC LookupIngredientsPropranolol Hydrochloride › 62559-0521-01
INDERAL LA propranolol hydrochloride 80 mg Capsule, Extended Release, 100-count — NDC 62559-0521-01 package photo

INDERAL LA propranolol hydrochloride 80 mg Capsule, Extended Release, 100-count

by ANI Pharmaceuticals, Inc. · 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-521-01)
NDC 62559-0521-01
🏷️ FDA NDC (as labeled) 62559-521-01 billing pads the product segment with a zero
This package
Contains100-count Pack sizes2 compare ↓
Also priced by: Part D plans $73.37/unit — full pricing hub ↓
Also comes in: 30 capsules 62559-0521-30
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 10, 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) 62559-521-01
Product NDC 62559-521
11-digit billing NDC 62559052101
NCPDP billing unit EA — each (per item)
UNII F8A3652H1V
UPC 0362559521017, 0362559523011, 0362559522014, 0362559520010
Application # NDA018553
SPL Set ID 35d28979-36b1-4630-b85e-a44e0a443734
Established class (EPC) beta-Adrenergic Blocker
Mechanism of action Adrenergic beta-Antagonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-04-28
Route ORAL
Dosage form CAPSULE, EXTENDED RELEASE
Substance PROPRANOLOL HYDROCHLORIDE
GCN Seq No 005116
GCN 03230
HICL code 002101
Ingredient (HICL) Propranolol Hcl
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J7
Therapeutic class — intermediate (HIC2) Antiadrenergics
HIC3 code J7C
Therapeutic class — specific (HIC3) Beta-Adrenergic Blocking Agents
AHFS code 12:16.08.04
AHFS class Non-Sel. Beta-Adrenergic Blocking Agents
FDB label name INDERAL LA 80 MG CAPSULE
FDB brand name Inderal La
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 62559-521-01 — a 5-3-2 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 product segment → 62559-0521-01. 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 beta-Adrenergic Blocker class.

Pharmacologic class beta-Adrenergic Blocker
Drug family (ATC) Beta blocking agents, non-selective
How it works Adrenergic beta-Antagonists
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

LabelerANI Pharmaceuticals, Inc.
Application holderANI PHARMACEUTICALS INC
FDA applicationNDA018553 (NDA)
Labeler code62559
First marketedApr 2017
Product typeHuman Prescription Drug
Portfolio299 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 INDERAL LA 80 MG CAPSULE Ingredient Propranolol Hcl
📖 What it is MedlinePlus · NLM

Propranolol is used to treat high blood pressure irregular heartbeats pheochromocytoma (tumor on a small gland near the kidneys) certain types of tremor hypertrophic subaortic stenosis (a heart muscle disease angina (chest pain) migraine headaches Propranolol is also used to improve survival after a heart attack. Propranolol is in a class of medications called beta blockers. It works by relaxing blood vessels and slowing heart rate to improve blood flow and decrease blood pressure.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Please don't stop propranolol on your own — even if you feel great. Stopping suddenly, especially if you have angina or any underlying heart disease, can cause a dangerous rebound...
  • Can I stop taking propranolol if I feel fine and my blood pressure is under control?
  • Bronchial asthma is actually a contraindication for propranolol, meaning it should not be used if you have asthma. Propranolol blocks receptors in your airways that help keep them...
  • I have asthma — is it safe for me to take propranolol?
📖 Read our full Propranolol guide →
1
Nutrient depletion considerations

Propranolol Hydrochloride may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color White / Blue
ShapeCapsule
ImprintINDERAL;LA;160
Size19 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 UF064M00AF
    Diethyl phthalate is a clear, colorless liquid made from phthalic acid. It's used in medicines as a plasticizer to make tablet coatings flexible and as a solvent to help dissolve and distribute active ingredients evenly throughout the product.
  • UNII 3DYK7UYZ62
    Ethylcellulose is a plant-fiber derivative used as a binder and film-coating agent in tablets and capsules. It helps hold ingredients together and can create a protective coating that controls how quickly the medicine dissolves.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII PN2ZH5LOQY
    A synthetic red dye approved by the FDA for use in foods, medicines, and cosmetics. It serves as a colorant to make tablets, capsules, and liquids visually distinctive for product identification.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII G4U024CQK6
    Hypromellose phthalate is a plant-derived polymer coating material. It's used to coat tablets or capsules so the medicine dissolves in the intestines rather than the stomach, protecting it from stomach acid or reducing stomach irritation.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

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

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

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $73.37 $7,336.78 / 100 capsules
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
Propranolol Hydrochloride 80 mg 00228-2779-11 Actavis 100 capsules $0.193 AB Availability likely
Propranolol Hydrochloride 80 mg 00527-4117-37 Lannett 100 capsules $0.193 AB Availability likely
propranolol hydrochloride 80 mg 51991-0818-01 Breckenridge 100 capsules $0.193 AB Availability likely
Propranolol Hydrochloride 80 mg 60687-0226-01 American 1 capsule $0.193 AB Availability likely
Propranolol Hydrochloride ER 80 mg 62559-0531-01 ANI 100 capsules $0.204 AB FDA listed
propranolol hydrochloride 80 mg 42291-0523-01 AvKARE 100 capsules AB FDA listed
propranolol hydrochloride 80 mg 50090-1501-00 A-S 30 capsules AB FDA listed
Propranolol Hydrochloride 80 mg 50090-7263-00 A-S 30 capsules AB FDA listed
propranolol hydrochloride 80 mg 60760-0589-30 St. 30 capsules AB FDA listed
Inderal La 80 mgthis 62559-0521-01 ANI 100 capsules AB FDA listed
InnoPran XL 80 mg 62559-0590-14 ANI 14 capsules BX FDA listed
Inderal XL 80 mg 62559-0600-14 ANI 14 capsules BX FDA listed
propranolol hydrochloride 80 mg 63629-2072-01 Bryant 100 capsules AB FDA listed
Propranolol Hydrochloride 80 mg 63629-9953-01 Bryant 100 capsules AB FDA listed
Propranolol Hydrochloride 80 mg 70518-3552-00 REMEDYREPACK 90 capsules AB FDA listed
propranolol hydrochloride 80 mg 71335-2315-01 Bryant 100 capsules AB FDA listed
Propranolol Hydrochloride 80 mg 82619-0133-01 Creekwood 100 capsules FDA listed
propranolol hydrochloride 80 mg 84677-0036-01 Golden 100 capsules AB FDA listed
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
2017
On the market since
Apr 2017
📍
2026
Currently FDA-listed
9 years listed
🔓
·
Generic versions listed
see equivalents
Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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 Inderal La — 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 Inderal La. 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
$1.25M
Claims incl. refills
265
Beneficiaries
156
Spend / beneficiary
$8,007.93
Spend / claim
$4,714.10
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 INDERAL LA (this brand).

Top reported reactions

Nausea1,569
Fatigue1,345
Headache1,307
Diarrhoea1,042
Dizziness998
Dyspnoea995
Pain857

Age at onset

Neonate46
Infant128
Child34
Adolescent29
Adult1,900
Elderly1,047

Reporter sex

20,170 reports
Male · 30%
Female · 69%
Unknown · 0%

Serious outcomes

Hospitalization6,146
Death2,060
Life-threatening1,031
Disabling671
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2,098 840
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
62559-0521-01 You're viewing this 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-521-01) 2017-04-28 Active
62559-0521-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-521-30) 2024-08-05 Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 62559-0521-01?
NDC 62559-0521-01 is a 100-count package — 100 capsule, extended release in 1 bottle.
What is the difference between NDC 62559-0521-01 and NDC 62559-0521-30?
Both are INDERAL LA propranolol hydrochloride 80 mg Capsule, Extended Release — the drug itself is identical. NDC 62559-0521-01 is the 100-count package, while NDC 62559-0521-30 is the 30 capsules package.
What NDC number is used to bill for this package of INDERAL LA propranolol hydrochloride 80 mg Capsule, Extended Release?
Bill NDC 62559-0521-01 — the 11-digit billing format is 62559052101. 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 62559-521-01, 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: 62559-0521-01, written without dashes as 62559052101. 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 62559-0521-01, the first segment (62559) is the labeler code FDA assigned to ANI Pharmaceuticals, Inc.; the middle segment (0521) 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 ANI Pharmaceuticals, 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 30 capsules (62559-0521-30). 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?
ANI Pharmaceuticals, 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.
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 118 words

INDICATIONS AND USAGE Hypertension Inderal LA is indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Inderal LA is not indicated in the management of hypertensive emergencies.

Angina Pectoris Due to Coronary Atherosclerosis Inderal LA is indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Migraine Inderal LA is indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use.

Hypertrophic Subaortic Stenosis Inderal LA improves NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis.

⏱️ Dosage and Administration ~2 min read

DOSAGE AND ADMINISTRATION General Inderal LA provides propranolol hydrochloride in a sustained-release capsule for administration once daily. If patients are switched from Inderal Tablets to Inderal LA Capsules, care should be taken to assure that the desired therapeutic effect is maintained. Inderal LA should not be considered a simple mg-for-mg substitute for Inderal.

Inderal LA has different kinetics and produces lower blood levels. Retitration may be necessary, especially to maintain effectiveness at the end of the 24-hour dosing interval. Hypertension The usual initial dosage is 80 mg Inderal LA once daily, whether used alone or added to a diuretic.

The dosage may be increased to 120 mg once daily or higher until adequate blood pressure control is achieved. The usual maintenance dosage is 120 to 160 mg once daily. In some instances a dosage of 640 mg may be required.

The time needed for full hypertensive response to a given dosage is variable and may range from a few days to several weeks. Angina Pectoris Starting with 80 mg Inderal LA once daily, dosage should be gradually increased at three- to seven-day intervals until optimal response is obtained. Although individual patients may respond at any dosage level, the average optimal dosage appears to be 160 mg once daily.

In angina pectoris, the value and safety of dosage exceeding 320 mg per day have not been established. If treatment is to be discontinued, reduce dosage gradually over a period of a few weeks (see " WARNINGS " ). Migraine The initial oral dose is 80 mg Inderal LA once daily.

The usual effective dose range is 160 to 240 mg once daily. The dosage may be increased gradually to achieve optimal migraine prophylaxis. If a satisfactory response is not obtained within four to six weeks after reaching the maximal dose, Inderal LA therapy should be discontinued.

It may be advisable to withdraw the drug gradually over a period of several weeks depending on the patient's age, comorbidity, and dose of Inderal LA. Hypertrophic Subaortic Stenosis The usual dosage is 80 to 160 mg Inderal LA once daily.

Contraindications 29 words

CONTRAINDICATIONS Propranolol is contraindicated in 1) cardiogenic shock; 2) sinus bradycardia and greater than first-degree block; 3) bronchial asthma; and 4) in patients with known hypersensitivity to propranolol hydrochloride.

⚠️ Warnings ~2 min read

WARNINGS Angina Pectoris There have been reports of exacerbation of angina and, in some cases, myocardial infarction, following abrupt discontinuance of propranolol therapy. Therefore, when discontinuance of propranolol is planned, the dosage should be gradually reduced over at least a few weeks, and the patient should be cautioned against interruption or cessation of therapy without the physician's advice. If propranolol therapy is interrupted and exacerbation of angina occurs, it usually is advisable to reinstitute propranolol therapy and take other measures appropriate for the management of unstable angina pectoris.

Since coronary artery disease may be unrecognized, it may be prudent to follow the above advice in patients considered at risk of having occult atherosclerotic heart disease who are given propranolol for other indications. Hypersensitivity and Skin Reactions Hypersensitivity reactions, including anaphylactic/anaphylactoid reactions, have been associated with the administration of propranolol (see ADVERSE REACTIONS ). Cutaneous reactions, including Stevens-Johnson Syndrome, toxic epidermal necrolysis, exfoliative dermatitis, erythema multiforme, and urticaria, have been reported with use of propranolol (see ADVERSE REACTIONS ).

Cardiac Failure Sympathetic stimulation may be a vital component supporting circulatory function in patients with congestive heart failure, and its inhibition by beta blockade may precipitate more severe failure. Although beta-blockers should be avoided in overt congestive heart failure, some have been shown to be highly beneficial when used with close follow-up in patients with a history of failure who are well compensated and are receiving diuretics as needed. Beta-adrenergic blocking agents do not abolish the inotropic action of digitalis on heart muscle.

In Patients without a History of Heart Failure, continued use of beta-blockers can, in some cases, lead to cardiac failure. Nonallergic Bronchospasm (e.g., Chronic Bronchitis, Emphysema) In general, patients with bronchospastic lung disease should not receive beta-blockers. Propranolol should be administered with caution in this setting since it may provoke a bronchial asthmatic attack by blocking bronchodilation produced by endogenous and exogenous catecholamine stimulation of beta-receptors.

Major Surgery Chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery, however the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures. Hypoglycemia Beta-blockers may prevent early warning signs of hypoglycemia, such as tachycardia, and increase the risk for severe or prolonged hypoglycemia at any time during treatment, especially in patients with diabetes mellitus or children and patients who are fasting (i.e., surgery, not eating regularly, or are vomiting).

If severe hypoglycemia occurs, patients should be instructed to seek emergency treatment. Hypoglycemia has been reported in patients taking propranolol after prolonged physical exertion and in patients with renal insufficiency. Thyrotoxicosis Beta-adrenergic blockade may mask certain clinical signs of hyperthyroidism.

Therefore, abrupt withdrawal of propranolol may be followed by an exacerbation of symptoms of hyperthyroidism, including thyroid storm. Propranolol may change thyroid-function tests, increasing T 4 and reverse T 3 , and decreasing T 3 . Wolff-Parkinson-White Syndrome Beta-adrenergic blockade in patients with Wolff-Parkinson-White syndrome and tachycardia has been associated with severe bradycardia requiring treatment with a pacemaker.

In one case, this result was reported after an initial dose of 5 mg propranolol.

🤒 Adverse Reactions 205 words

ADVERSE REACTIONS The following adverse events were observed and have been reported in patients using propranolol. Cardiovascular: Bradycardia; congestive heart failure; intensification of AV block; hypotension; paresthesia of hands; thrombocytopenic purpura; arterial insufficiency, usually of the Raynaud type. Central Nervous System: Light-headedness; mental depression manifested by insomnia, lassitude, weakness, fatigue; catatonia; visual disturbances; hallucinations; vivid dreams; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability, slightly clouded sensorium, and decreased performance on neuropsychometrics.

For immediate release formulations, fatigue, lethargy, and vivid dreams appear dose related. Gastrointestinal: Nausea, vomiting, epigastric distress, abdominal cramping, diarrhea, constipation, mesenteric arterial thrombosis, ischemic colitis. Allergic: Hypersensitivity reactions, including anaphylactic/anaphylactoid reactions; pharyngitis and agranulocytosis; erythematous rash; fever combined with aching and sore throat; laryngospasm; respiratory distress.

Respiratory: Bronchospasm. Hematologic: Agranulocytosis, nonthrombocytopenic purpura, and thrombocytopenic purpura. Autoimmune: Systemic lupus erythematosus (SLE).

Skin and Mucous Membranes: Stevens-Johnson Syndrome, toxic epidermal necrolysis, dry eyes, exfoliative dermatitis, erythema multiforme, urticaria, alopecia, SLE-like reactions, and psoriasisiform rashes. Oculomucocutaneous syndrome involving the skin, serous membranes, and conjunctivae reported for a beta-blocker (practolol) have not been associated with propranolol. Genitourinary: Male impotence; Peyronie's disease.

To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions ~2 min read

Drug Interactions Caution should be exercised when Inderal LA is administered with drugs that have an affect on CYP2D6, 1A2, or 2C19 metabolic pathways. Co-administration of such drugs with propranolol may lead to clinically relevant drug interactions and changes on its efficacy and/or toxicity (see Drug Interactions in PHARMACOKINETICS AND DRUG METABOLISM ). Alcohol when used concomitantly with propranolol, may increase plasma levels of propranolol.

Cardiovascular Drugs Antiarrhythmics Propafenone has negative inotropic and beta-blocking properties that can be additive to those of propranolol. Quinidine increases the concentration of propranolol and produces greater degrees of clinical beta-blockade and may cause postural hypotension. Amiodarone is an antiarrhythmic agent with negative chronotropic properties that may be additive to those seen with β-blockers such as propranolol.

The clearance of lidocaine is reduced with administration of propranolol. Lidocaine toxicity has been reported following co-administration with propranolol. Caution should be exercised when administering Inderal LA with drugs that slow A-V nodal conduction, e.g., lidocaine and calcium channel blockers.

Digitalis Glycosides Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia. Calcium Channel Blockers Caution should be exercised when patients receiving a beta-blocker are administered a calcium-channel-blocking drug with negative inotropic and/or chronotropic effects.

Both agents may depress myocardial contractility or atrioventricular conduction. There have been reports of significant bradycardia, heart failure, and cardiovascular collapse with concurrent use of verapamil and beta-blockers. Co-administration of propranolol and diltiazem in patients with cardiac disease has been associated with bradycardia, hypotension, high degree heart block, and heart failure.

ACE Inhibitors When combined with beta-blockers, ACE inhibitors can cause hypotension, particularly in the setting of acute myocardial infarction. The antihypertensive effects of clonidine may be antagonized by beta-blockers. Inderal LA should be administered cautiously to patients withdrawing from clonidine.

Alpha Blockers Prazosin has been associated with prolongation of first dose hypotension in the presence of beta-blockers. Postural hypotension has been reported in patients taking both beta-blockers and terazosin or doxazosin. Reserpine Patients receiving catecholamine-depleting drugs, such as reserpine should be closely observed for excessive reduction of resting sympathetic nervous activity, which may result in hypotension, marked bradycardia, vertigo, syncopal attacks, or orthostatic hypotension.

Inotropic Agents Patients on long-term therapy with propranolol may experience uncontrolled hypertension if administered epinephrine as a consequence of unopposed alpha-receptor stimulation. Epinephrine is therefore not indicated in the treatment of propranolol overdose (see OVERDOSAGE ). Isoproterenol and Dobutamine Propranolol is a competitive inhibitor of beta-receptor agonists, and its effects can be reversed by administration of such agents, e.g., dobutamine or isoproterenol.

Also, propranolol may reduce sensitivity to dobutamine stress echocardiography in patients undergoing evaluation for myocardial ischemia. Non-Cardiovascular Drugs Nonsteroidal Anti-Inflammatory Drugs Nonsteroidal anti-inflammatory drugs (NSAIDs) have been reported to blunt the antihypertensive effect of beta-adrenoreceptor blocking agents. Administration of indomethacin with propranolol may reduce the efficacy of propranolol in reducing blood pressure and heart rate.

Antidepressants The hypotensive effects of MAO inhibitors or tricyclic antidepressants may be exacerbated when administered with beta-blockers by interfering with the beta-blocking activity of propranolol. Anesthetic Agents Methoxyflurane and trichloroet…

🤰 Pregnancy 179 words

Pregnancy In a series of reproductive and developmental toxicology studies, propranolol was given to rats by gavage or in the diet throughout pregnancy and lactation. At doses of 150 mg/kg/day, but not at doses of 80 mg/kg/day (equivalent to the MRHD on a body surface area basis), treatment was associated with embryotoxicity (reduced litter size and increased resorption rates) as well as neonatal toxicity (deaths). Propranolol hydrochloride also was administered (in the feed) to rabbits (throughout pregnancy and lactation) at doses as high as 150 mg/kg/day (about 5 times the maximum recommended human oral daily dose).

No evidence of embryo or neonatal toxicity was noted. There are no adequate and well-controlled studies in pregnant women. Intrauterine growth retardation, small placentas, and congenital abnormalities have been reported in neonates whose mothers received propranolol during pregnancy.

Neonates whose mothers are receiving propranolol at parturition have exhibited bradycardia, hypoglycemia and/or respiratory depression. Adequate facilities for monitoring such infants at birth should be available. Inderal LA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 32 words

Pediatric Use Safety and effectiveness of propranolol in pediatric patients have not been established. Bronchospasm and congestive heart failure have been reported coincident with the administration of propranolol therapy in pediatric patients.

🧓 Geriatric Use 84 words

Geriatric Use Clinical studies of Inderal LA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of the decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage 156 words

OVERDOSAGE Propranolol is not significantly dialyzable. In the event of overdosage or exaggerated response, the following measures should be employed: General: If ingestion is or may have been recent, evacuate gastric contents, taking care to prevent pulmonary aspiration. Supportive Therapy: Hypotension and bradycardia have been reported following propranolol overdose and should be treated appropriately.

Glucagon can exert potent inotropic and chronotropic effects and may be particularly useful for the treatment of hypotension or depressed myocardial function after a propranolol overdose. Glucagon should be administered as 50 to 150 mcg/kg intravenously followed by continuous drip of 1 to 5 mg/hour for positive chronotropic effect. Isoproterenol, dopamine or phosphodiesterase inhibitors may also be useful.

Epinephrine, however, may provoke uncontrolled hypertension. Bradycardia can be treated with atropine or isoproterenol. Serious bradycardia may require temporary cardiac pacing.

The electrocardiogram, pulse, blood pressure, neurobehavioral status and intake and output balance must be monitored. Isoproterenol and aminophylline may be used for bronchospasm.

🧬 Clinical Pharmacology ~2 min read

CLINICAL PHARMACOLOGY General Propranolol is a nonselective, beta-adrenergic receptor-blocking agent possessing no other autonomic nervous system activity. It specifically competes with beta-adrenergic receptor-stimulating agents for available receptor sites. When access to beta-receptor sites is blocked by propranolol, the chronotropic, inotropic, and vasodilator responses to beta-adrenergic stimulation are decreased proportionately.

At dosages greater than required for beta blockade, propranolol also exerts a quinidine-like or anesthetic-like membrane action, which affects the cardiac action potential. The significance of the membrane action in the treatment of arrhythmias is uncertain. Inderal LA should not be considered a simple mg-for-mg substitute for conventional propranolol and the blood levels achieved do not match (are lower than) those of two to four times daily dosing with the same dose (see DOSAGE AND ADMINISTRATION ).

When changing to Inderal LA from conventional propranolol, a possible need for retitration upwards should be considered, especially to maintain effectiveness at the end of the dosing interval. In most clinical settings, however, such as hypertension or angina where there is little correlation between plasma levels and clinical effect, Inderal LA has been therapeutically equivalent to the same mg dose of conventional Inderal as assessed by 24-hour effects on blood pressure and on 24-hour exercise responses of heart rate, systolic pressure, and rate pressure product.

Mechanism of Action The mechanism of the antihypertensive effect of propranolol has not been established. Among the factors that may be involved in contributing to the antihypertensive action include: (1) decreased cardiac output, (2) inhibition of renin release by the kidneys, and (3) diminution of tonic sympathetic nerve outflow from vasomotor centers in the brain. Although total peripheral resistance may increase initially, it readjusts to or below the pretreatment level with chronic use of propranolol.

Effects of propranolol on plasma volume appear to be minor and somewhat variable. In angina pectoris, propranolol generally reduces the oxygen requirement of the heart at any given level of effort by blocking the catecholamine-induced increases in the heart rate, systolic blood pressure, and the velocity and extent of myocardial contraction. Propranolol may increase oxygen requirements by increasing left ventricular fiber length, end diastolic pressure, and systolic ejection period.

The net physiologic effect of beta-adrenergic blockade is usually advantageous and is manifested during exercise by delayed onset of pain and increased work capacity. Propranolol exerts its antiarrhythmic effects in concentrations associated with beta-adrenergic blockade, and this appears to be its principal antiarrhythmic mechanism of action. In dosages greater than required for beta blockade, propranolol also exerts a quinidine-like or anesthetic-like membrane action which affects the cardiac action potential.

The significance of the membrane action in the treatment of arrhythmias is uncertain. The mechanism of the anti-migraine effect of propranolol has not been established. Beta-adrenergic receptors have been demonstrated in the pial vessels of the brain.

📦 How Supplied / Storage and Handling ~1 min read

HOW SUPPLIED Inderal ® LA (propranolol hydrochloride) Long-Acting Capsules Each white/light-blue capsule, imprinted with three rings and reverse imprinted ‘INDERAL LA 60’, contains 60 mg of propranolol hydrochloride USP (equivalent to 52.60 mg of propranolol) and are available in: Bottles of 30 NDC 62559-520-30 Bottles of 100 NDC 62559-520-01 Each light-blue capsule, imprinted with three rings and reverse imprinted ‘INDERAL LA 80’, contains 80 mg of propranolol hydrochloride USP (equivalent to 70.14 mg of propranolol) and are available in: Bottles of 30 NDC 62559-521-30 Bottles of 100 NDC 62559-521-01 Each light-blue/dark-blue capsule, imprinted with three rings and reverse imprinted ‘INDERAL LA 120’, contains 120 mg of propranolol hydrochloride USP (equivalent to 105.21 mg of propranolol) and are available in: Bottles of 30 NDC 62559-522-30 Bottles of 100 NDC 62559-522-01 Each dark-blue capsule, imprinted with three rings and reverse imprinted ‘INDERAL LA 160’, contains 160 mg of propranolol hydrochloride USP (equivalent to 140.28 mg of propranolol) and are available in: Bottles of 30 NDC 62559-523-30 Bottles of 100 NDC 62559-523-01 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature] Protect from light, moisture, freezing, and excessive heat.

Dispense in a tight, light-resistant container as defined in the USP. For medical inquires, contact ANI Pharmaceuticals, Inc. at 1-855-204-1431. Distributed by: ANI Pharmaceuticals, Inc.

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📋 Description ~1 min read

DESCRIPTION Inderal ® LA (propranolol hydrochloride) is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its molecular and structural formulae are: C 16 H 21 NO 2 · HCl Propranolol hydrochloride USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80.

Inderal LA is formulated to provide a sustained release of propranolol hydrochloride USP. Inderal LA is available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. • Each Inderal LA 60 mg capsule contains 60 mg propranolol hydrochloride USP (equivalent to 52.60 mg of propranolol). • Each Inderal LA 80 mg capsule contains 80 mg propranolol hydrochloride USP (equivalent to 70.14 mg of propranolol). • Each Inderal LA 120 mg capsule contains 120 mg propranolol hydrochloride USP (equivalent to 105.21 mg of propranolol). • Each Inderal LA 160 mg capsule contains 160 mg propranolol hydrochloride USP (equivalent to 140.28 mg of propranolol).

The inactive ingredients contained in Inderal LA capsules are: diethyl phthalate, hypromellose phthalate, ethylcellulose, povidone, polyethylene glycol, corn starch, sucrose, hypromellose, gelatin capsules and titanium dioxide. In addition Inderal LA 60 mg capsules contain D&C Red No. 28 and FD&C Blue No.

1; Inderal LA 80 mg and 120 mg capsules contain FD&C Red No. 3 and FD&C Blue No. 1; Inderal LA 160 mg capsules contain FD&C Blue No.

1. FDA approved dissolution specifications differ from USP. inderal-la-01

💬 Information for Patients 33 words

Information for Patients Inform patients or caregivers that there is a risk of hypoglycemia when Inderal LA is given to patients who are fasting or who are vomiting. Monitor for symptoms of hypoglycemia.

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.