HomeNDC LookupIngredientsFelodipine › 23155-0048-01
FELODIPINE 2.5 mg Tablet, Extended Release, 100-count — NDC 23155-0048-01 package photo

FELODIPINE 2.5 mg Tablet, Extended Release, 100-count

by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. · 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-048-01)
NDC 23155-0048-01
🏷️ FDA NDC (as labeled) 23155-048-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.1205 NADAC Per package$12.05 / 100 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.3744/unit · Part D plans $0.3632/unit — full pricing hub ↓
Also comes in: 100 tablets 23155-0048-05
Rx only Generic On market Non-controlled
🗂️ Data synced Aug 27, 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) 23155-048-01
Product NDC 23155-048
11-digit billing NDC 23155004801
NCPDP billing unit EA — each (per item)
RxCUI 402695, 402696, 402698
UNII OL961R6O2C
UPC 0323155049015, 0323155050011
Application # ANDA201964
SPL Set ID 0bef7cf2-012b-4804-ac93-0a8b333035db
Established class (EPC) Dihydropyridine Calcium Channel Blocker
Mechanism of action Calcium Channel Antagonists
Chemical class Dihydropyridines
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-11-08
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance FELODIPINE
GCN Seq No 021743
GCN 02620
HICL code 006205
Ingredient (HICL) Felodipine
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A9
Therapeutic class — intermediate (HIC2) Calcium Antagonists
HIC3 code A9A
Therapeutic class — specific (HIC3) Calcium Channel Blocking Agents
AHFS code 24:28.08.00
AHFS class Dihydropyridines
FDB label name FELODIPINE ER 2.5 MG TABLET
FDB brand name Felodipine Er
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 23155-048-01 — 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 → 23155-0048-01. 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 Dihydropyridine Calcium Channel Blocker class.

Pharmacologic class Dihydropyridine Calcium Channel Blocker
Drug family (ATC) Beta blocking agents and calcium channel blockers, ACE inhibitors and calcium channel blockers, Dihydropyridine derivatives
How it works Calcium Channel 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

LabelerHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application holderHERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC
FDA applicationANDA201964 (ANDA)
Labeler code23155
First marketedNov 2013
Product typeHuman Prescription Drug
Portfolio253 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 FELODIPINE ER 2.5 MG TABLET Ingredient Felodipine
📗 Our plain-language guide HelloPharmacist
  • Felodipine is prescribed to lower high blood pressure (hypertension). Keeping your blood pressure under control with this medicine helps reduce your risk of serious events like str...
  • Mostly yes, but two things matter. First, avoid grapefruit juice entirely — it can more than double the amount of felodipine in your blood, which raises your risk of side effects....
  • Can I eat or drink normally when I take this tablet?
  • Swallow it whole, every time. Felodipine is an extended-release tablet, which means it's designed to release the medicine slowly over the day. Crushing or chewing it would release...
📖 Read our full Felodipine guide →
2
Nutrient depletion considerations

Felodipine may be associated with lower levels of 2 nutrients — 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 Yellow / White
ShapeRound
ImprintI33
Size11 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 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • 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 RFW2ET671P
    Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
  • UNII Z78RG6M2N2
    Hypromellose 2208 is a plant-derived thickening agent used as a binder and film-coating material in tablets and capsules. It helps hold ingredients together and creates a protective coating that controls how quickly the medicine dissolves.
  • UNII R75537T0T4
    Hypromellose 2910 is a plant-derived thickening agent made from cellulose. It serves as a binder that holds tablet ingredients together, a film-coating for pills, and a viscosity controller in liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 6M3P64V0NC
    A fine powder made from magnesium, aluminum, and silicon compounds. It absorbs moisture and helps keep medicine ingredients from clumping or separating, so the product stays stable and flows smoothly during manufacturing.
  • 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 7YC686GQ8F
    A synthetic oily substance made from castor oil. It works as a solubilizer and emulsifier to help mix oily and water-based ingredients together in the medicine.
  • UNII 7CV7WJK4UI
    Sodium stearyl fumarate is a synthetic compound made from stearyl alcohol and fumaric acid. It acts as a lubricant and glidant in tablets and capsules, helping ingredients flow smoothly during manufacturing and preventing sticking.
  • 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.

11 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 eaPer package
Retail pharmacies payNADAC · weekly $0.121 $12.05 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.3744 $37.44 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.3632 $36.32 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.272 $0.112
▼ Down 51% over the last 24 months.
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
Felodipine 2.5 mg 00603-3581-21 Endo 100 tablets $0.120 AB Availability likely
Felodipine 2.5 mg 13668-0132-01 Torrent 100 tablets $0.120 AB Availability likely
Felodipine 2.5 mgthis 23155-0048-01 Heritage 100 tablets $0.120 AB Availability likely
Felodipine 2.5 mg 57237-0108-01 Rising 100 tablets $0.120 AB Availability likely
Felodipine 2.5 mg 62135-0646-90 Chartwell 90 tablets $0.120 AB Availability likely
Felodipine 2.5 mg 68462-0233-01 Glenmark 100 tablets $0.120 AB Availability likely
Felodipine 2.5 mg 69367-0264-01 Westminster 100 tablets $0.120 AB Availability likely
Felodipine 2.5 mg 61442-0431-01 Carlsbad 100 tablets AB FDA listed
Felodipine 2.5 mg 63629-2017-01 Bryant 500 tablets AB FDA listed
Felodipine 2.5 mg 63629-2193-01 Bryant 100 tablets AB Discontinued
Felodipine 2.5 mg 63629-2194-01 Bryant 500 tablets AB Discontinued
Felodipine 2.5 mg 65862-0673-01 Aurobindo 100 tablets AB FDA listed
Felodipine 2.5 mg 69117-0028-01 Yiling 100 tablets AB FDA listed
Felodipine 2.5 mg 71205-0920-00 Proficient 100 tablets AB FDA listed
Felodipine 2.5 mg 72162-1158-01 Bryant 100 tablets AB FDA listed
Felodipine 2.5 mg 72162-1742-05 Bryant 500 tablets AB FDA listed
Felodipine 2.5 mg 72162-2568-01 Bryant 100 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

🏛️
2013
On the market since
Nov 2013
📍
2026
Currently FDA-listed
13 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

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

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

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 23155-0048-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
202
Units reimbursed last 4 qtrs
10.6K
Gross reimbursed last 4 qtrs
$4K
Avg / prescription
$19.71
Avg / unit
$0.3744
Latest quarter Q4 2025
53Rx
Medicaid pays / ea
$0.3744
gross reimbursed
vs
NADAC / ea
$0.1205
acquisition cost
=
Spread
+$0.2539
+211% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
100% FFS
Fee-for-service · 202 Rx Managed care · 0 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 5,363 units · 27.4 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 5,272 units · 13.5 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
13.527.4
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 27.4 /100k
2 California 13.5 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
Drug total (last 4 qtrs): 203 Rx · 10,590 units · $3,970 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Felodipine ER (matched by generic name) — the program that covers self-administered drugs. 10 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Felodipine ER. 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
$1.98M
Claims incl. refills
75.6K
Beneficiaries
60.6K
Spend / beneficiary
$32.70
Spend / claim
$26.20
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 Felodipine — the ingredient across all brands.

Top reported reactions

Fatigue1,108
Dyspnoea1,002
Dizziness1,000
Diarrhoea887
Nausea887
Headache883
Pain852

Age at onset

Neonate1
Adolescent1
Adult511
Elderly939

Reporter sex

11,328 reports
Male · 51%
Female · 49%
Unknown · 0%

Serious outcomes

Hospitalization5,005
Life-threatening920
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 837 291
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
23155-0048-01 You're viewing this 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-048-01) $0.1205 / ea $12.05 2013-11-08 Active
23155-0048-05 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-048-05) 2013-11-08 Active

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

Pack size FAQ

What quantity is in NDC 23155-0048-01?
NDC 23155-0048-01 is a 100-count package — 100 tablet, extended release in 1 bottle.
What is the difference between NDC 23155-0048-01 and NDC 23155-0048-05?
Both are FELODIPINE 2.5 mg Tablet, Extended Release — the drug itself is identical. NDC 23155-0048-01 is the 100-count package, while NDC 23155-0048-05 is the 100 tablets package.
What NDC number is used to bill for this package of FELODIPINE 2.5 mg Tablet, Extended Release?
Bill NDC 23155-0048-01 — the 11-digit billing format is 23155004801. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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

📄 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 ~2 min read

INDICATIONS AND USAGE Felodipine extended-release tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including felodipine.

Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (eg, on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Felodipine extended-release tablets, USP may be administered with other antihypertensive agents.

⏱️ Dosage and Administration ~1 min read

DOSAGE AND ADMINISTRATION The recommended starting dose is 5 mg once a day. Depending on the patient's response, the dosage can be decreased to 2.5 mg or increased to 10 mg once a day. These adjustments should occur generally at intervals of not less than 2 weeks.

The recommended dosage range is 2.5-10 mg once daily. In clinical trials, doses above 10 mg daily showed an increased blood pressure response but a large increase in the rate of peripheral edema and other vasodilatory adverse events (see ADVERSE REACTIONS ). Modification of the recommended dosage is usually not required in patients with renal impairment.

Felodipine extended-release tablets should regularly be taken either without food or with a light meal (see CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism ). Felodipine extended-release tablets should be swallowed whole and not crushed or chewed. Geriatric Use - Patients over 65 years of age are likely to develop higher plasma concentrations of felodipine (see CLINICAL PHARMACOLOGY ).

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range (2.5 mg daily). Elderly patients should have their blood pressure closely monitored during any dosage adjustment. Patients with Impaired Liver Function - Patients with impaired liver function may have elevated plasma concentrations of felodipine and may respond to lower doses of felodipine extended-release tablets; therefore, patients should have their blood pressure monitored closely during dosage adjustment of felodipine extended-release tablets (see CLINICAL PHARMACOLOGY ).

Contraindications 14 words

CONTRAINDICATIONS Felodipine extended-release tablets are contraindicated in patients who are hypersensitive to this product.

🤒 Adverse Reactions ~3 min read

ADVERSE REACTIONS In controlled studies in the United States and overseas, approximately 3000 patients were treated with felodipine as either the extended-release or the immediate-release formulation. The most common clinical adverse events reported with felodipine extended-release administered as monotherapy at the recommended dosage range of 2.5 mg to 10 mg once a day were peripheral edema and headache. Peripheral edema was generally mild, but it was age and dose related and resulted in discontinuation of therapy in about 3% of the enrolled patients.

Discontinuation of therapy due to any clinical adverse event occurred in about 6% of the patients receiving felodipine extended-release tablets, principally for peripheral edema, headache, or flushing. Adverse events that occurred with an incidence of 1.5% or greater at any of the recommended doses of 2.5 mg to 10 mg once a day (felodipine extended-release tablets, N = 861; Placebo, N = 334), without regard to causality, are compared to placebo and are listed by dose in the table below. These events are reported from controlled clinical trials with patients who were randomized to a fixed dose of felodipine extended-release tablets or titrated from an initial dose of 2.5 mg or 5 mg once a day.

A dose of 20 mg once a day has been evaluated in some clinical studies. Although the antihypertensive effect of felodipine extended-release tablets is increased at 20 mg once a day, there is a disproportionate increase in adverse events, especially those associated with vasodilatory effects (see DOSAGE AND ADMINISTRATION ). Percent of Patients with Adverse Events in Controlled Trials* of Felodipine Extended-Release Tablets (N = 861) as Monotherapy without Regard to Causality (Incidence of discontinuations shown in parentheses) Body System Adverse Events Placebo N=334 2.5 mg N=255 5 mg N=581 10 mg N= 408 Body as a whole Peripheral Edema 3.3 (0.0) 2.0 (0.0) 8.8 (2.2) 17.4 (2.5) Asthenia 3.3 (0.0) 3.9 (0.0) 3.3 (0.0) 2.2 (0.0) Warm Sensation 0.0 (0.0) 0.0 (0.0) 0.9 (0.2) 1.5 (0.0) Cardiovascular Palpitation 2.4 (0.0) 0.4 (0.0) 1.4 (0.3) 2.5 (0.5) Digestive Nausea 1.5 (0.9) 1.2 (0.0) 1.7 (0.3) 1.0 (0.7) Dyspepsia 1.2 (0.0) 3.9 (0.0) 0.7 (0.0) 0.5 (0.0) Constipation 0.9 (0.0) 1.2 (0.0) 0.3 (0.0) 1.5 (0.2) Nervous Headache 10.2 (0.9) 10.6 (0.4) 11.0 (1.7) 14.7 (2.0) Dizziness 2.7 (0.3) 2.7 (0.0) 3.6 (0.5) 3.7 (0.5) Paresthesia 1.5 (0.3) 1.6 (0.0) 1.2 (0.0) 1.2 (0.2) Respiratory Upper Respiratory Infection 1.8 (0.0) 3.9 (0.0) 1.9 (0.0) 0.7 (0.0) Cough 0.3 (0.0) 0.8 (0.0) 1.2 (0.0) 1.7 (0.0) Rhinorrhea 0.0 (0.0) 1.6 (0.0) 0.2 (0.0) 0.2 (0.0) Sneezing 0.0 (0.0) 1.6 (0.0) 0.0 (0.0) 0.0 (0.0) Skin Rash 0.9 (0.0) 2.0 (0.0) 0.2 (0.0) 0.2 (0.0) Flushing 0.9 (0.3) 3.9 (0.0) 5.3 (0.7) 6.9 (1.2) *Patients in titration studies may have been exposed to more than one dose level of felodipine extended-release tablets.

Adverse events that occurred in 0.5 up to 1.5% of patients who received felodipine extended-release tablets in all controlled clinical trials at the recommended dosage range of 2.5 mg to 10 mg once a day, and serious adverse events that occurred at a lower rate, or events reported during marketing experience (those lower rate events are in italics) are listed below. These events are listed in order of decreasing severity within each category, and the relationship of these events to administration of felodipine extended-release tablets are uncertain: Body as a Whole : Chest pain, facial edema, flu-like illness Cardiovascular : Myocardial infarction, hypotension, syncope, angina pectoris , arrhythmia , tachycardia, premature beats Digestive: Abdominal pain, diarrhea, vomiting, dry mouth, flatulence, acid regurgitation Endocrine: Gynecomastia Hematologic: Anemia Metabolic : ALT (SGPT) increased Musculoskeletal: Arthralgia, back pain, leg pain, foot pain, muscle cramps, myalgia, arm pain, knee pain, hip pain Nervous/Psychiatric : Insomnia, depression, anxiety disorders, irritability, nervousness, somn…

🆘 Overdosage 213 words

OVERDOSAGE Oral doses of 240 mg/kg and 264 mg/kg in male and female mice, respectively, and 2390 mg/kg and 2250 mg/kg in male and female rats, respectively, caused significant lethality. In a suicide attempt, one patient took 150 mg felodipine together with 15 tablets each of atenolol and spironolactone and 20 tablets of nitrazepam. The patient's blood pressure and heart rate were normal on admission to hospital; he subsequently recovered without significant sequelae.

Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly bradycardia. If severe hypotension occurs, symptomatic treatment should be instituted. The patient should be placed supine with the legs elevated.

The administration of intravenous fluids may be useful to treat hypotension due to overdosage with calcium antagonists. In case of accompanying bradycardia, atropine (0.5 mg -1 mg) should be administered intravenously. Sympathomimetic drugs may also be given if the physician feels they are warranted.

It has not been established whether felodipine can be removed from the circulation by hemodialysis. To obtain up-to-date information about the treatment of overdose, consult your Regional Poison-Control Center. Telephone numbers of certified poison-control centers are listed in the Physicians' Desk Reference (PDR) .

In managing overdose, consider the possibilities of multiple-drug overdoses, drug-drug interactions, and unusual drug kinetics in your patient.

🧬 Clinical Pharmacology ~3 min read

CLINICAL PHARMACOLOGY Mechanism of Action Felodipine is a member of the dihydropyridine class of calcium channel antagonists (calcium channel blockers). It reversibly competes with nitrendipine and/or other calcium channel blockers for dihydropyridine binding sites, blocks voltage-dependent Ca++ currents in vascular smooth muscle and cultured rabbit atrial cells, and blocks potassium-induced contracture of the rat portal vein. In vitro studies show that the effects of felodipine on contractile processes are selective, with greater effects on vascular smooth muscle than cardiac muscle.

Negative inotropic effects can be detected in vitro , but such effects have not been seen in intact animals. The effect of felodipine on blood pressure is principally a consequence of a dose-related decrease of peripheral vascular resistance in man, with a modest reflex increase in heart rate (see Cardiovascular Effects ). With the exception of a mild diuretic effect seen in several animal species and man, the effects of felodipine are accounted for by its effects on peripheral vascular resistance.

Pharmacokinetics and Metabolism Following oral administration, felodipine is almost completely absorbed and undergoes extensive first-pass metabolism. The systemic bioavailability of felodipine is approximately 20%. Mean peak concentrations following the administration of felodipine extended-release tablets are reached in 2.5 to 5 hours.

Both peak plasma concentration and the area under the plasma concentration time curve (AUC) increase linearly with doses up to 20 mg. Felodipine is greater than 99% bound to plasma proteins. Following intravenous administration, the plasma concentration of felodipine declined triexponentially with mean disposition half-lives of 4.8 minutes, 1.5 hours, and 9.1 hours.

The mean contributions of the three individual phases to the overall AUC were 15, 40 and 45%, respectively, in the order of increasing t 1/2 . Following oral administration of the immediate-release formulation, the plasma level of felodipine also declined polyexponentially with a mean terminal t 1/2 of 11 to 16 hours. The mean peak and trough steady-state plasma concentrations achieved after 10 mg of the immediate-release formulation given once a day to normal volunteers, were 20 and 0.5 nmol/L, respectively.

The trough plasma concentration of felodipine in most individuals was substantially below the concentration needed to effect a half-maximal decline in blood pressure (EC 50 ) [4 - 6 nmol/L for felodipine], thus precluding once-a-day dosing with the immediate-release formulation. Following administration of a 10-mg dose of felodipine, the extended-release formulation, to young, healthy volunteers, mean peak and trough steady-state plasma concentrations of felodipine were 7 and 2 nmol/L, respectively. Corresponding values in hypertensive patients (mean age 64) after a 20-mg dose of felodipine extended-release tablets were 23 and 7 nmol/L.

Since the EC 50 for felodipine is 4 to 6 nmol/L, a 5-mg to 10-mg dose of felodipine extended-release tablets in some patients, and a 20-mg dose in others, would be expected to provide an antihypertensive effect that persists for 24 hours (see Cardiovascular Effects below and DOSAGE AND ADMINISTRATION ). The systemic plasma clearance of felodipine in young healthy subjects is about

0.8L/min, and the apparent volume of distribution is about 10 L/kg. Following an oral or intravenous dose of 14 C-labeled felodipine in man, about 70% of the dose of radioactivity was recovered in urine and 10% in the feces. A negligible amount of intact felodipine is recovered in the urine and feces (< 0.5%).

Six metabolites, which account for 23% of the oral dose, have been identified; none has significant vasodilating activity. Following administration of felodipine extended-release tablets to hypertensive patients, mean peak plasma concentrations at steady state are about 20% higher than after a single dose. Blood pressure response is cor…

📦 How Supplied / Storage and Handling 182 words

HOW SUPPLIED Felodipine Extended-Release Tablets, USP are available containing 2.5 mg, 5 mg or 10 mg of felodipine, USP. The 2.5 mg tablet is a yellow colored, circular shaped, biconvex, film coated tablet de-bossed with 'I31' on one side and plain on other side. They are available as follows: NDC 23155-048-01 bottles of 100 tablets The 5 mg tablet is a light yellow colored, circular shaped, biconvex, film coated tablet de-bossed with 'I32' on one side and plain on other side.

They are available as follows: NDC 23155-049-01 bottles of 100 tablets The 10 mg tablet is a white colored, circular shaped, biconvex, film coated tablet de-bossed with 'I33' on one side and plain on other side. They are available as follows: NDC 23155-050-01 bottles of 100 tablets Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Manufactured by: USV Private Limited Daman - 396210, India Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG(3784) Revised: 12/2022 logo

📋 Description 170 words

DESCRIPTION Felodipine is a calcium antagonist (calcium channel blocker). Felodipine is a dihydropyridine derivative that is chemically described as ± ethyl methyl 4-(2, 3-dichlorophenyl)-1, 4-dihydro-2, 6-dimethyl-3, 5-pyridinedicarboxylate. Its empirical formula is C 18 H 19 Cl 2 NO 4 and its structural formula is: Felodipine, USP is a light yellow to yellow, crystalline powder with molecular weight of 384.26.

It is insoluble in water and is freely soluble in acetone and in methanol; very slightly soluble in heptane. Felodipine is a racemic mixture. Felodipine extended-release tablets, USP provide extended release of felodipine.

They are available as tablets containing 2.5 mg, 5 mg or 10 mg of felodipine, USP for oral administration. Inactive ingredients are: polyoxyl 40 hydrogenated castor oil, magnesium aluminum silicate, hypromellose 2208, lactose monohydrate, hydroxypropyl cellulose, sodium stearyl fumarate, hypromellose 2910 5cP, titanium dioxide and PEG 400. The 2.5 mg tablet strength also contains Iron oxide yellow, D&C yellow #10 aluminum lake and the 5 mg tablet strength also contains Iron oxide yellow.

USP dissolution test pending. Image

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.