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SILDENAFIL 100 mg Tablet, Film Coated, 30-count — NDC 72888-0017-30 package photo

SILDENAFIL 100 mg Tablet, Film Coated, 30-count

by Advagen Pharma Ltd · 30 TABLET, FILM COATED in 1 BOTTLE (72888-017-30)
NDC 72888-0017-30
🏷️ FDA NDC (as labeled) 72888-017-30 billing pads the product segment with a zero
This package
Contains30-count Pack sizes3 compare ↓
Also comes in: 100 tablets 72888-0017-01 1000 tablets 72888-0017-00
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

🆔 Identity & classification

FDA NDC (as labeled) 72888-017-30
Product NDC 72888-017
11-digit billing NDC 72888001730
RxCUI 312950, 314228, 314229
UNII BW9B0ZE037
UPC 0372888015309, 0372888017013, 0372888016306, 0372888016009 +4 more
Application # ANDA204882
SPL Set ID e671d887-2317-4c1c-9b68-e24cda3d3aef
Established class (EPC) Phosphodiesterase 5 Inhibitor
Mechanism of action Phosphodiesterase 5 Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-06-17
Route ORAL
Dosage form TABLET, FILM COATED
Substance SILDENAFIL CITRATE
GPI-14 40304070100330
GPI class Sildenafil Citrate
GCN Seq No 039191
GCN 57903
HICL code 018084
Ingredient (HICL) Sildenafil Citrate
HIC1 code F
Therapeutic class — broad (HIC1) Male Genital System
HIC2 code F2
Therapeutic class — intermediate (HIC2) Systemic Fertility Agents
HIC3 code F2A
Therapeutic class — specific (HIC3) Drugs To Treat Erectile Dysfunction (Ed)
AHFS code 24:08.12.00
AHFS class Phosphodiesterase Type 5 Inhibitors
FDB label name SILDENAFIL 100 MG TABLET
FDB brand name Sildenafil Citrate
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 72888-017-30 — 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 → 72888-0017-30. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Phosphodiesterase 5 Inhibitor class.

Pharmacologic class Phosphodiesterase 5 Inhibitor
Drug family (ATC) Drugs used in erectile dysfunction
How it works Phosphodiesterase 5 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

LabelerAdvagen Pharma Ltd
Application holderRUBICON RESEARCH LTD
FDA applicationANDA204882 (ANDA)
Labeler code72888
First marketedJun 2021
Product typeHuman Prescription Drug
Portfolio100 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 SILDENAFIL 100 MG TABLET Ingredient Sildenafil Citrate
📗 Our plain-language guide HelloPharmacist
  • For erectile dysfunction, you take sildenafil only when you need it — about 30 minutes to 1 hour before sexual activity works best, though anywhere from 30 minutes to 4 hours ahead...
  • Can I take Viagra or generic sildenafil just before sex, or do I need to take it every day?
  • Both sildenafil and nitrates lower blood pressure, and together their effect on blood pressure can be dangerously large — we're talking about a drop severe enough to cause fainting...
  • Why can't I take sildenafil with nitroglycerin or other nitrate medicines?
📖 Read our full Sildenafil 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 blue
ShapeOval
ImprintR;100
Size17 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 OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 68401960MK
    Crospovidone is a synthetic polymer made from polyvinylpyrrolidone. It acts as a disintegrant, helping tablets break apart quickly in the stomach so the medicine dissolves and absorbs into the body.
  • UNII L06K8R7DQK
    A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
  • 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 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 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 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.
  • UNII XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 100 tablets 1000 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
Sildenafil 100 mg 00093-5343-01 Teva 100 tablets $0.128 AB Availability likely —
Sildenafil Citrate 100 mg 13668-0188-01 Torrent 100 tablets $0.128 AB Availability likely —
Sildenafil Citrate 100 mg 27241-0069-03 Ajanta 30 tablets $0.128 AB Availability likely —
Sildenafil 100 mg 31722-0711-01 Camber 100 tablets $0.128 AB Availability likely —
Sildenafil 100 mg 33342-0043-07 Macleods 30 tablets $0.128 AB Availability likely —
Sildenafil Citrate 100 mg 60290-0003-01 Umedica 30 tablets $0.128 AB Availability likely —
Sildenafil 100 mg 65862-0691-01 Aurobindo 100 tablets $0.128 AB Availability likely —
Sildenafil 100 mg 72241-0071-05 Modavar 100 tablets $0.128 AB Availability likely —
Sildenafil Citrate 100 mg 75834-0241-00 NIVAGEN 1000 tablets $0.128 AB Availability likely —
Sildenafil 100 mg 76282-0645-01 Exelan 100 tablets $0.128 AB Availability likely —
Sildenafil Citrate 100 mg 82009-0093-01 Quallent 100 tablets $0.128 AB Availability likely —
Sildenafil Citrate 100 mg 59762-0036-01 Mylan 30 tablets $0.200 AB Discontinued —
Sildenafil 100 mg 69097-0953-02 CIPLA 30 tablets $0.259 AB FDA listed —
Viagra 100 mg 00069-4220-30 PFIZER 30 tablets $83.633 AB Availability likely —
Viagra 100 mg 58151-0428-01 Viatris 100 tablets $83.633 AB Availability likely —
Sildenafil 100 mg 31722-0967-01 Camber 100 tablets — AB FDA listed —
Sildenafil 100 mg 35561-0253-10 Bostal 30 tablets — AB FDA listed —
Sildenafil Citrate 100 mg 43063-0940-10 PD-Rx 10 tablets — AB FDA listed —
Sildenafil 100 mg 50090-5325-00 A-S 10 tablets — AB FDA listed —
Sildenafil 100 mg 50090-7964-00 A-S 10 tablets — AB FDA listed —
Sildenafil 100 mg 51655-0468-54 Northwind 15 tablets — AB FDA listed —
Sildenafil Citrate 100 mg 51655-0794-54 Northwind 15 tablets — AB FDA listed —
Sildenafil 100 mg 52817-0342-10 TruPharma 100 tablets — AB FDA listed —
Sildenafil 100 mg 55801-0340-01 Appco 30 tablets — AB FDA listed —
Sildenafil 100 mg 60219-1753-01 Amneal 100 tablets — AB FDA listed —
Sildenafil 100 mg 68071-2985-03 NuCare 30 tablets — AB FDA listed —
Sildenafil Citrate 100 mg 68071-3410-03 NuCare 30 tablets — AB FDA listed —
Sildenafil Citrate 100 mg 68071-3549-05 NuCare 15 tablets — AB FDA listed —
Sildenafil 100 mg 68071-3832-03 NuCare 30 tablets — AB FDA listed —
Sildenafil Citrate 100 mg 68071-3862-01 NuCare 10 tablets — AB FDA listed —
Sildenafil 100 mg 68071-3908-01 NuCare 10 tablets — AB FDA listed —
Sildenafil 100 mg 68071-4599-01 NuCare 10 tablets — AB FDA listed —
Sildenafil 100 mg 68071-4617-03 NuCare 30 tablets — AB FDA listed —
Sildenafil Citrate 100 mg 68788-4111-01 Preferred 10 tablets — AB FDA listed —
Sildenafil 100 mg 68788-7879-01 Preferred 10 tablets — AB FDA listed —
Sildenafil Citrate 100 mg 68788-8301-01 Preferred 10 tablets — AB FDA listed —
Sildenafil Citrate 100 mg 68788-8804-01 Preferred 10 tablets — AB FDA listed —
Sildenafil Citrate 100 mg 70954-0409-10 ANI 30 tablets — AB FDA listed —
Sildenafil 100 mg 71205-0088-10 Proficient 10 tablets — AB FDA listed —
Sildenafil 100 mg 71205-0220-10 Proficient 10 tablets — AB FDA listed —
Sildenafil Citrate 100 mg 71205-0231-10 Proficient 10 tablets — AB FDA listed —
Sildenafil 100 mg 71205-0473-10 Proficient 10 tablets — AB FDA listed —
Sildenafil 100 mg 71205-0498-02 Proficient 2 tablets — AB FDA listed —
Sildenafil Citrate 100 mg 71205-0657-10 Proficient 10 tablets — AB FDA listed —
Sildenafil 100 mg 71209-0108-01 Cadila 30 tablets — AB FDA listed —
Sildenafil 100 mg 71335-0969-00 Bryant 15 tablets — AB FDA listed —
Sildenafil 100 mg 71335-1088-00 Bryant 15 tablets — AB Discontinued —
Sildenafil Citrate 100 mg 71335-1437-00 Bryant 15 tablets — AB FDA listed —
Sildenafil 100 mg 71335-1777-00 Bryant 15 tablets — AB FDA listed —
Sildenafil Citrate 100 mg 71335-3049-00 Bryant 15 tablets — AB FDA listed —
Sildenafil 100 mg 71610-0675-02 Aphena 2 tablets — AB FDA listed —
Sildenafil 100 mg 72189-0069-10 DIRECT 10 tablets — AB FDA listed —
Sildenafil 100 mg 72303-0847-01 HEC 30 tablets — AB FDA listed —
Sildenafil Citrate 100 mg 72603-0885-01 Northstar 30 tablets — AB FDA listed —
Sildenafil 100 mg 72789-0098-10 PD-Rx 10 tablets — AB FDA listed —
Sildenafil Citrate 100 mg 72789-0406-15 PD-Rx 15 tablets — AB FDA listed —
Sildenafil 100 mg 72865-0103-01 XLCARE 100 tablets — AB FDA listed —
Sildenafil 100 mgthis 72888-0017-30 Advagen 30 tablets — AB FDA listed —
Sildenafil Citrate 100 mg 76420-0565-01 Asclemed 100 tablets — AB FDA listed —
Sildenafil Citrate 100 mg 80425-0410-01 Advanced 6 tablets — AB FDA listed —
Sildenafil Citrate 100 mg 80425-0503-01 Advanced 30 tablets — AB FDA listed —
Sildenafil 100 mg 82647-0212-14 Reyoung 1000 tablets — AB FDA listed —
Sildenafil Citrate 100 mg 82804-0025-30 Proficient 30 tablets — AB FDA listed —
Sildenafil 100 mg 59746-0436-01 Jubilant 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

🏛️
2021
On the market since
Jun 2021
📍
2026
Currently FDA-listed
5 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.

🔬 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 Sildenafil — the ingredient across all brands.

Top reported reactions

Dyspnoea13,327
Headache10,220
Death9,128
Diarrhoea7,049
Nausea6,489
Fatigue6,390
Dizziness5,857

Age at onset

Neonate254
Infant513
Child711
Adolescent306
Adult12,866
Elderly9,384

Reporter sex

126,564 reports
Male · 55%
Female · 45%
Unknown · 0%

Serious outcomes

Hospitalization43,872
Death18,356
Disabling2,111
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 5,733 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
72888-0017-00 1000 TABLET, FILM COATED in 1 BOTTLE (72888-017-00) $0.1276 / ea $127.62 2021-11-08 Active
72888-0017-01 100 TABLET, FILM COATED in 1 BOTTLE (72888-017-01) — — 2021-06-17 Active
72888-0017-30 You're viewing this 30 TABLET, FILM COATED in 1 BOTTLE (72888-017-30) — — 2021-06-17 Active

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

Pack size FAQ

What quantity is in NDC 72888-0017-30?
NDC 72888-0017-30 is a 30-count package — 30 tablet, film coated in 1 bottle.
What is the difference between NDC 72888-0017-30 and NDC 72888-0017-01?
Both are SILDENAFIL 100 mg Tablet, Film Coated — the drug itself is identical. NDC 72888-0017-30 is the 30-count package, while NDC 72888-0017-01 is the 100 tablets package.
What NDC number is used to bill for this package of SILDENAFIL 100 mg Tablet, Film Coated?
Bill NDC 72888-0017-30 — the 11-digit billing format is 72888001730. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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

🧭 About this NDC listing & data coverage

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

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 72888-017-30, 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: 72888-0017-30, written without dashes as 72888001730. 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 72888-0017-30, the first segment (72888) is the labeler code FDA assigned to Advagen Pharma Ltd; the middle segment (0017) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) 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 Advagen Pharma Ltd. 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 100 tablets (72888-0017-01), 1000 tablets (72888-0017-00). 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?
Advagen Pharma Ltd 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 31 words ▾

1 INDICATIONS AND USAGE Sildenafil tablets are indicated for the treatment of erectile dysfunction. Sildenafil tablets are phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) ( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, sildenafil tablets may be taken anywhere from 30 minutes to 4 hours before sexual activity ( 2.1 ) Based on effectiveness and toleration, may increase to a maximum of 100 mg or decrease to 25 mg ( 2.1 ) Maximum recommended dosing frequency is once per day ( 2.1 )

2.1Dosage Information For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, sildenafil tablets may be taken anywhere from 30 minutes to 4 hours before sexual activity. The maximum recommended dosing frequency is once per day. Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg.

2.2Use with Food Sildenafil tablets may be taken with or without food.

2.3Dosage Adjustments in Specific Situations Sildenafil tablets was shown to potentiate the hypotensive effects of nitrates and its administration in patients who use nitric oxide donors such as organic nitrates or organic nitrites in any form is therefore contraindicated [ see Contraindications (4.1) , Drug Interactions (7.1) , and Clinical Pharmacology (12.2) ] . When sildenafil tablets is co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating sildenafil tablets treatment and sildenafil tablets should be initiated at 25 mg [ see Warnings and Precautions (5.5) , Drug Interactions (7.2) , and Clinical Pharmacology (12.2) ].

2.4Dosage Adjustments Due to Drug Interactions Ritonavir The recommended dose for ritonavir-treated patients is 25 mg prior to sexual activity and the recommended maximum dose is 25 mg within a 48 hour period because concomitant administration increased the blood levels of sildenafil by 11-fold [ see Warnings and Precautions (5.6) , Drug Interactions (7.4) , and Clinical Pharmacology (12.3) ]. CYP3A4 Inhibitors Consider a starting dose of 25 mg in patients treated with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, or saquinavir) or erythromycin.

Clinical data have shown that co- administration with saquinavir or erythromycin increased plasma levels of sildenafil by about 3 fold [ see Drug Interactions (7.4) and Clinical Pharmacology (12.3) ].

2.5Dosage Adjustments in Special Populations Consider a starting dose of 25 mg in patients > 65 years, patients with hepatic impairment (e.g., cirrhosis), and patients with severe renal impairment (creatinine clearance <30 mL/minute) because administration of sildenafil tablets in these patients resulted in higher plasma levels of sildenafil [ see Use in Specific Populations ( 8.5 , 8.6 , 8.7 ) and Clinical Pharmacology ( 12.3 ) ].

💊 Dosage Forms and Strengths 64 words ▾

3 DOSAGE FORMS AND STRENGTHS Sildenafil tablets, USP are supplied as blue colored, oval, biconvex film coated tablets containing sildenafil citrate equivalent to 25 mg, 50 mg, or 100 mg of sildenafil. Tablets are debossed with R on one side and 25, 50 or 100 on the other to indicate the respective dosage strengths. Tablets: 25 mg, 50 mg, 100 mg ( 3 )

⛔ Contraindications ~1 min read ▾

4 CONTRAINDICATIONS Administration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. Sildenafil tablets was shown to potentiate the hypotensive effect of nitrates ( 4.1 , 7.1 , 12.2 ) Known hypersensitivity to sildenafil or any component of tablet ( 4.2 ) Administration with guanylate cyclase (GC) stimulators, such as riociguat ( 4.3 )

4.1Nitrates Consistent with its known effects on the nitric oxide/cGMP pathway [ see Clinical Pharmacology (12.1 , 12.2 ) ], sildenafil tablets was shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are using nitric oxide donors such as organic nitrates or organic nitrites in any form either regularly and/or intermittently is therefore contraindicated. After patients have taken sildenafil tablets, it is unknown when nitrates, if necessary, can be safely administered. Although plasma levels of sildenafil at 24 hours post dose are much lower than at peak concentration, it is unknown whether nitrates can be safely co-administered at this time point [ see Dosage and Administration (2.3) , Drug Interactions (7.1) , and Clinical Pharmacology (12.2) ].

4.2Hypersensitivity Reactions Sildenafil tablets are contraindicated in patients with a known hypersensitivity to sildenafil, as contained in sildenafil tablets and REVATIO (sildenafil citrate), or any component of the tablet. Hypersensitivity reactions have been reported, including rash and urticaria [ see Adverse Reactions (6.1) ].

4.3Concomitant Guanylate Cyclase (GC) Stimulators Do not use sildenafil tablets in patients who are using a GC stimulator, such as riociguat. PDE5 inhibitors, including sildenafil, may potentiate the hypotensive effects of GC stimulators.

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Patients should not use sildenafil tablets if sexual activity is inadvisable due to cardiovascular status ( 5.1 ) Patients should seek emergency treatment if an erection lasts >4 hours. Use sildenafil tablets with caution in patients predisposed to priapism ( 5.2 ) Patients should stop sildenafil tablets and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION). Sildenafil tablets should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION.

Patients with a "crowded" optic disc may also be at an increased risk of NAION. ( 5.3 ) Patients should stop sildenafil tablets and seek prompt medical attention in the event of sudden decrease or loss of hearing ( 5.4 ) Caution is advised when sildenafil tablets is co-administered with alpha-blockers or anti- hypertensives. Concomitant use may lead to hypotension ( 5.5 ) Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures.

In patients taking strong CYP inhibitors, such as ritonavir, sildenafil exposure is increased. Decrease in sildenafil tablets dosage is recommended ( 2.4 , 5.6 )

5.1Cardiovascular There is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Therefore, treatments for erectile dysfunction, including sildenafil tablets, should not be generally used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status. The evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following a complete medical assessment.

Sildenafil tablets has systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers (mean maximum decrease of 8.4/5.5 mmHg), [ see Clinical Pharmacology (12.2) ]. While this normally would be expected to be of little consequence in most patients, prior to prescribing sildenafil tablets, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects, especially in combination with sexual activity.

Use with caution in patients with the following underlying conditions which can be particularly sensitive to the actions of vasodilators including sildenafil tablets – those with left ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis) and those with severely impaired autonomic control of blood pressure. There are no controlled clinical data on the safety or efficacy of sildenafil tablets in the following groups; if prescribed, this should be done with caution. Patients who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months; Patients with resting hypotension (BP <90/50 mmHg) or hypertension (BP >170/110 mmHg); Patients with cardiac failure or coronary artery disease causing unstable angina.

5.2Prolonged Erection and Priapism Prolonged erection greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of sildenafil tablets. In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result.

Sildenafil tablets should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia). However, there are no controlled clinical data on the safety or efficacy of sildenafil tablets in patients with s…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: Cardiovascular [see Warnings and Precautions (5.1) ] Prolonged Erection and Priapism [see Warnings and Precautions (5.2) ] Effects on the Eye [see Warnings and Precautions (5.3) ] Hearing Loss [see Warnings and Precautions (5.4) ] Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives [see Warnings and Precautions (5.5) ] Adverse Reactions with the Concomitant Use of Ritonavir [see Warnings and Precautions (5.6) ] Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies [see Warnings and Precautions (5.7) ] Effects on Bleeding [see Warnings and Precautions (5.8) ] Counseling Patients About Sexually Transmitted Diseases [see Warnings and Precautions(5.9) ] The most common adverse reactions reported in clinical trials (≥ 2%) are headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, and rash.

Most common adverse reactions (≥ 2%) include headache, flushing, dyspepsia, abnormal vision,nasal congestion, back pain, myalgia, nausea, dizziness and rash ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Advagen Pharma Ltd, at 866-488-0312 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. Sildenafil tablets was administered to over 3700 patients (aged 19–87 years) during pre-marketing clinical trials worldwide. Over 550 patients were treated for longer than one year.

In placebo-controlled clinical studies, the discontinuation rate due to adverse reactions for sildenafil tablets (2.5%) was not significantly different from placebo (2.3%). In fixed-dose studies, the incidence of some adverse reactions increased with dose. The type of adverse reactions in flexible-dose studies, which reflect the recommended dosage regimen, was similar to that for fixed-dose studies.

At doses above the recommended dose range, adverse reactions were similar to those detailed in Table 1 below but generally were reported more frequently. Table 1: Adverse Reactions Reported by ≥2% of Patients Treated with sildenafil tablets and More Frequent than Placebo in Fixed-Dose Phase II/III Studies †Abnormal Vision: Mild to moderate in severity and transient, predominantly color tinge to vision, but also increased sensitivity to light, or blurred vision. Adverse Reaction 25 mg (n=312) 50 mg (n=511) 100 mg (n=506) Placebo (n=607) Headache 16% 21% 28% 7% Flushing 10% 19% 18% 2% Dyspepsia 3% 9% 17% 2% Abnormal vision† 1% 2% 11% 1% Nasal congestion 4% 4% 9% 2% Back pain 3% 4% 4% 2% Myalgia 2% 2% 4% 1% Nausea 2% 3% 3% 1% Dizziness 3% 4% 3% 2% Rash 1% 2% 3% 1% When sildenafil tablets was taken as recommended (on an as-needed basis) in flexible-dose, placebo- controlled clinical trials of two to twenty-six weeks duration, patients took sildenafil tablets at least once weekly, and the following adverse reactions were reported: Table 2.

Adverse Reactions Reported by ≥2% of Patients Treated with sildenafil tablets and More Frequent than Placebo in Flexible-Dose Phase II/III Studies † Abnormal Vision: Mild and transient, predominantly color tinge to vision, but also increased sensitivity to light or blurred vision. In these studies, only one patient discontinued due to abnormal vision. Adverse Reaction sildenafil tablets PLACEBO N=734 N=725 Headache 16% 4% Flushing 10% 1% Dyspepsia 7% 2% Nasal Congestion 4% 2% Abnormal Vision † 3% 0% Back pain 2% 2% Dizziness 2% 1% Rash 2% 1% The following events occurred in <2% of patients in controlled clinical trials; a causal relationship to sildenafil tablets is uncertain.

Reported events include those with a plausible relation to drug use; omitted are min…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Sildenafil can potentiate the hypotensive effects of nitrates, alpha blockers, and anti- hypertensives ( 4.1 , 5.5 , 7.1 , 7.2 , 7.3 , 12.2 ) With concomitant use of alpha blockers, initiate sildenafil at 25 mg dose ( 2.3 ) CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase sildenafil exposure ( 2.4 , 7.4 , 12.3 ) Ritonavir: Do not exceed a maximum single dose of 25 mg in a 48 hour period ( 2.4 , 5.6 ) Erythromycin or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, saquinavir): Consider a starting dose of 25 mg ( 2.4 , 7.4 )

7.1Nitrates Administration of sildenafil tablets with nitric oxide donors such as organic nitrates or organic nitrites in any form is contraindicated. Consistent with its known effects on the nitric oxide/cGMP pathway, sildenafil tablets was shown to potentiate the hypotensive effects of nitrates [ see Dosage and Administration (2.3) , Contraindications (4.1) , Clinical Pharmacology (12.2) ].

7.2Alpha-blockers Use caution when co-administering alpha-blockers with sildenafil tablets because of potential additive blood pressure-lowering effects. When sildenafil tablets is co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating sildenafil tablets treatment and sildenafil tablets should be initiated at the lowest dose [ see Dosage and Administration (2.3) , Warnings and Precautions (5.5) , Clinical Pharmacology (12.2) ].

7.3Amlodipine When sildenafil tablets 100 mg were co-administered with amlodipine (5 mg or 10 mg) to hypertensive patients, the mean additional reduction on supine blood pressure was 8 mmHg systolic and 7 mmHg diastolic [ see Warnings and Precautions (5.5) , Clinical Pharmacology (12.2) ].

7.4Ritonavir and other CYP3A4 inhibitors Co-administration of ritonavir, a strong CYP3A4 inhibitor, greatly increased the systemic exposure of sildenafil (11-fold increase in AUC). It is therefore recommended not to exceed a maximum single dose of 25 mg of sildenafil tablets in a 48 hour period [ see Dosage and Administration (2.4) , Warnings and Precautions (5.6) , Clinical Pharmacology (12.3) ]. Co-administration of erythromycin, a moderate CYP3A4 inhibitor, resulted in a 160% and 182% increases in sildenafil C max and AUC, respectively.

Co-administration of saquinavir, a strong CYP3A4 inhibitor, resulted in 140% and 210% increases in sildenafil C max and AUC, respectively. Stronger CYP3A4 inhibitors such as ketoconazole or itraconazole could be expected to have greater effects than seen with saquinavir. A starting dose of 25 mg of sildenafil tablets should be considered in patients taking erythromycin or strong CYP3A4 inhibitors (such as saquinavir, ketoconazole, itracanozole) [ see Dosage and Administration (2.4) , Clinical Pharmacology (12.3) ].

7.5Alcohol In a drug-drug interaction study sildenafil 50 mg given with alcohol 0.5 g/kg in which mean maximum blood alcohol levels of 0.08% was achieved, sildenafil did not potentiate the hypotensive effect of alcohol in healthy volunteers [ see Clinical Pharmacology (12.2) ].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Geriatric use: Consider a starting dose of 25 mg ( 2.5 , 8.5 ) Severe renal impairment: Consider a starting dose of 25 mg ( 2.5 , 8.6 ) Hepatic impairment: Consider a starting dose of 25 mg ( 2.5 , 8.7 )

8.1Pregnancy Risk Summary Sildenafil tablets is not indicated for use in females. There are no data with the use of sildenafil tablets in pregnant women to inform any drug-associated risks for adverse developmental outcomes. Animal reproduction studies conducted with sildenafil did not show adverse developmental outcomes when administered during organogenesis in rats and rabbits at oral doses up to 16 and 32 times, respectively, the maximum recommended human dose (MRHD) of 100 mg/day on a mg/m 2 basis ( see Data ).

Data Animal Data No evidence of teratogenicity, embryotoxicity or fetotoxicity was observed in rats and rabbits which received oral doses up to 200 mg/kg/day during organogenesis. These doses represent, respectively, about 16 and 32 times the MRHD on a mg/m 2 basis in a 50 kg subject. In the rat pre- and postnatal development study, the no observed adverse effect dose was 30 mg/kg/day given for 36 days, about 2 times the MRHD on a mg/m2 basis in a 50 kg subject.

8.2Lactation Risk Summary Sildenafil tablets are not indicated for use in females. Limited data indicate that sildenafil and its active metabolite are present in human milk. There is no information on the effects on the breastfed child, or the effects on milk production.

8.4Pediatric Use Sildenafil tablets is not indicated for use in pediatric patients. Safety and effectiveness have not been established in pediatric patients.

8.5Geriatric Use Healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil resulting in approximately 84% and 107% higher plasma AUC values of sildenafil and its active N- desmethyl metabolite, respectively, compared to those seen in healthy young volunteers (18–45 years) [ see Clinical Pharmacology (12.3) ]. Due to age-differences in plasma protein binding, the corresponding increase in the AUC of free (unbound) sildenafil and its active N-desmethyl metabolite were 45% and 57%, respectively [ see Clinical Pharmacology (12.3) ].

Of the total number of subjects in clinical studies of sildenafil, 18% were 65 years and older, while 2% were 75 years and older. No overall differences in safety or efficacy were observed between older (≥ 65 years of age) and younger (< 65 years of age) subjects. However, since higher plasma levels may increase the incidence of adverse reactions, a starting dose of 25 mg should be considered in older subjects due to the higher systemic exposure[ see Dosage and Administration (2.5)

8.6Renal Impairment No dose adjustment is required for mild (CLcr=50–80 mL/min) and moderate (CLcr=30–49 mL/min) renal impairment. In volunteers with severe renal impairment (Clcr<30 mL/min), sildenafil clearance was reduced, resulting in higher plasma exposure of sildenafil (~2 fold), approximately doubling of C max and AUC. A starting dose of 25 mg should be considered in patients with severe renal impairment [ see Dosage and Administration (2.5) and Clinical Pharmacology (12.3) ].

8.7Hepatic Impairment In volunteers with hepatic impairment (Child-Pugh Class A and B), sildenafil clearance was reduced, resulting in higher plasma exposure of sildenafil (47% for C max and 85% for AUC). The pharmacokinetics of sildenafil in patients with severely impaired hepatic function (Child- Pugh Class C) have not been studied. A starting dose of 25 mg should be considered in patients with any degree of hepatic impairment [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3) ].

🤰 Pregnancy 165 words ▾

8.1Pregnancy Risk Summary Sildenafil tablets is not indicated for use in females. There are no data with the use of sildenafil tablets in pregnant women to inform any drug-associated risks for adverse developmental outcomes. Animal reproduction studies conducted with sildenafil did not show adverse developmental outcomes when administered during organogenesis in rats and rabbits at oral doses up to 16 and 32 times, respectively, the maximum recommended human dose (MRHD) of 100 mg/day on a mg/m 2 basis ( see Data ).

Data Animal Data No evidence of teratogenicity, embryotoxicity or fetotoxicity was observed in rats and rabbits which received oral doses up to 200 mg/kg/day during organogenesis. These doses represent, respectively, about 16 and 32 times the MRHD on a mg/m 2 basis in a 50 kg subject. In the rat pre- and postnatal development study, the no observed adverse effect dose was 30 mg/kg/day given for 36 days, about 2 times the MRHD on a mg/m2 basis in a 50 kg subject.

🧒 Pediatric Use 23 words ▾

8.4Pediatric Use Sildenafil tablets is not indicated for use in pediatric patients. Safety and effectiveness have not been established in pediatric patients.

🧓 Geriatric Use 167 words ▾

8.5Geriatric Use Healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil resulting in approximately 84% and 107% higher plasma AUC values of sildenafil and its active N- desmethyl metabolite, respectively, compared to those seen in healthy young volunteers (18–45 years) [ see Clinical Pharmacology (12.3) ]. Due to age-differences in plasma protein binding, the corresponding increase in the AUC of free (unbound) sildenafil and its active N-desmethyl metabolite were 45% and 57%, respectively [ see Clinical Pharmacology (12.3) ].

Of the total number of subjects in clinical studies of sildenafil, 18% were 65 years and older, while 2% were 75 years and older. No overall differences in safety or efficacy were observed between older (≥ 65 years of age) and younger (< 65 years of age) subjects. However, since higher plasma levels may increase the incidence of adverse reactions, a starting dose of 25 mg should be considered in older subjects due to the higher systemic exposure[ see Dosage and Administration (2.5)

🆘 Overdosage 67 words ▾

10 OVERDOSAGE In studies with healthy volunteers of single doses up to 800 mg, adverse reactions were similar to those seen at lower doses but incidence rates and severities were increased. In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and it is not eliminated in the urine.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The physiologic mechanism of erection of the penis involves release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. NO then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood. Sildenafil enhances the effect of NO by inhibiting phosphodiesterase type 5 (PDE5), which is responsible for degradation of cGMP in the corpus cavernosum.

Sildenafil has no direct relaxant effect on isolated human corpus cavernosum. When sexual stimulation causes local release of NO, inhibition of PDE5 by sildenafil causes increased levels of cGMP in the corpus cavernosum, resulting in smooth muscle relaxation and inflow of blood to the corpus cavernosum. Sildenafil at recommended doses has no effect in the absence of sexual stimulation.

Binding Characteristics Studies in vitro have shown that sildenafil is selective for PDE5. Its effect is more potent on PDE5 than on other known phosphodiesterases (10-fold for PDE6, >80-fold for PDE1, >700- fold for PDE2, PDE3, PDE4, PDE7, PDE8, PDE9, PDE10, and PDE11). Sildenafil is approximately 4,000-fold more selective for PDE5 compared to PDE3.

PDE3 is involved in control of cardiac contractility. Sildenafil is only about 10-fold as potent for PDE5 compared to PDE6, an enzyme found in the retina which is involved in the phototransduction pathway of the retina. This lower selectivity is thought to be the basis for abnormalities related to color vision [ see Clinical Pharmacology (12.2) ].

In addition to human corpus cavernosum smooth muscle, PDE5 is also found in other tissues including platelets, vascular and visceral smooth muscle, and skeletal muscle, brain, heart, liver, kidney, lung, pancreas, prostate, bladder, testis, and seminal vesicle. The inhibition of PDE5 in some of these tissues by sildenafil may be the basis for the enhanced platelet antiaggregatory activity of NO observed in vitro , an inhibition of platelet thrombus formation in vivo and peripheral arterial-venous dilatation in vivo .

12.2Pharmacodynamics Effects of sildenafil tablets on Erectile Response: In eight double-blind, placebo-controlled crossover studies of patients with either organic or psychogenic erectile dysfunction, sexual stimulation resulted in improved erections, as assessed by an objective measurement of hardness and duration of erections (RigiScan ® ), after sildenafil tablets administration compared with placebo. Most studies assessed the efficacy of sildenafil tablets approximately 60 minutes post dose. The erectile response, as assessed by RigiScan ® , generally increased with increasing sildenafil dose and plasma concentration.

The time course of effect was examined in one study, showing an effect for up to 4 hours but the response was diminished compared to 2 hours. Effects of sildenafil tabletson Blood Pressure: Single oral doses of sildenafil (100 mg) administered to healthy volunteers produced decreases in sitting blood pressure (mean maximum decrease in systolic/diastolic blood pressure of 8.3/5.3 mmHg). The decrease in sitting blood pressure was most notable approximately 1–2 hours after dosing, and was not different than placebo at 8 hours.

Similar effects on blood pressure were noted with 25 mg, 50 mg and 100 mg of sildenafil tablets, therefore the effects are not related to dose or plasma levels within this dosage range. Larger effects were recorded among patients receiving concomitant nitrates [ see Contraindications (4.1) ]. Effects of sildenafil tablets on Blood Pressure When Nitroglycerin is subsequently administered: Based on the pharmacokinetic profile of a single 100 mg oral dose given to healthy normal volunteers, the plasma levels of sildenafil at 24 hours post dose are approximately 2 ng/mL (compared to peak plasma levels of approximately 440 ng/mL).

In the following patients: ag…

🧬 Mechanism of Action ~1 min read ▾

12.1Mechanism of Action The physiologic mechanism of erection of the penis involves release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. NO then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood. Sildenafil enhances the effect of NO by inhibiting phosphodiesterase type 5 (PDE5), which is responsible for degradation of cGMP in the corpus cavernosum.

Sildenafil has no direct relaxant effect on isolated human corpus cavernosum. When sexual stimulation causes local release of NO, inhibition of PDE5 by sildenafil causes increased levels of cGMP in the corpus cavernosum, resulting in smooth muscle relaxation and inflow of blood to the corpus cavernosum. Sildenafil at recommended doses has no effect in the absence of sexual stimulation.

Binding Characteristics Studies in vitro have shown that sildenafil is selective for PDE5. Its effect is more potent on PDE5 than on other known phosphodiesterases (10-fold for PDE6, >80-fold for PDE1, >700- fold for PDE2, PDE3, PDE4, PDE7, PDE8, PDE9, PDE10, and PDE11). Sildenafil is approximately 4,000-fold more selective for PDE5 compared to PDE3.

PDE3 is involved in control of cardiac contractility. Sildenafil is only about 10-fold as potent for PDE5 compared to PDE6, an enzyme found in the retina which is involved in the phototransduction pathway of the retina. This lower selectivity is thought to be the basis for abnormalities related to color vision [ see Clinical Pharmacology (12.2) ].

In addition to human corpus cavernosum smooth muscle, PDE5 is also found in other tissues including platelets, vascular and visceral smooth muscle, and skeletal muscle, brain, heart, liver, kidney, lung, pancreas, prostate, bladder, testis, and seminal vesicle. The inhibition of PDE5 in some of these tissues by sildenafil may be the basis for the enhanced platelet antiaggregatory activity of NO observed in vitro , an inhibition of platelet thrombus formation in vivo and peripheral arterial-venous dilatation in vivo .

📦 How Supplied / Storage and Handling 103 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil tablets, USP are supplied as blue, film-coated, oval biconvex tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil and debossed on the obverse and reverse sides as follows: 25 mg 50 mg 100 mg Obverse R R R Reverse 25 50 100 Bottle of 30 NDC 72888-015-30 NDC 72888-016-30 NDC 72888-017-30 Bottle of 100 Not Applicable NDC 72888-016-01 NDC 72888-017-01 Bottle of 500 NDC 72888-015-05 Not Applicable Not Applicable Bottle of 1000 Not Applicable NDC 72888-016-00 NDC 72888-017-00 Recommended Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

📋 Description 133 words ▾

11 DESCRIPTION Sildenafil tablets USP, an oral therapy for erectile dysfunction, consist of citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H - pyrazolo[4,3- d ]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula: Sildenafil citrate is a white to off-white powder, slightly soluble in water and methanol with a molecular weight of 666.7.

Sildenafil tablets, USP are formulated as blue, film-coated oval biconvex tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: crospovidone, hydrophobic colloidal silica, hypromellose, lactose monohydrate, magnesium stearate VG, microcrystalline cellulose, titanium dioxide, triacetin and FD&C Blue# 2/ Indigo Carmine Aluminium. Sildenafil citrate Structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information) Nitrates Physicians should discuss with patients the contraindication of sildenafil tablets with regular and/or intermittent use of nitric oxide donors, such as organic nitrates or organic nitrites in any form [ see Contraindications (4.1) ]. Guanylate Cyclase (GC) Stimulators Physicians should discuss with patients the contraindication of sildenafil tablets with use of guanylate cyclase stimulators such as riociguat [ see Contraindications (4.3) ].

Concomitant Use with Drugs Which Lower Blood Pressure Physicians should advise patients of the potential for sildenafil tablets to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications. Concomitant administration of sildenafil tablets and an alpha-blocker may lead to symptomatic hypotension in some patients. Therefore, when sildenafil tablets is co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating sildenafil tablets treatment and sildenafil should be initiated at the lowest dose [ see Warnings and Precautions (5.5) ].

Cardiovascular Considerations Physicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors. Patients who experience symptoms (e.g., angina pectoris, dizziness, nausea) upon initiation of sexual activity should be advised to refrain from further activity and should discuss the episode with their physician [ see Warnings and Precautions (5.1) ]. Sudden Loss of Vision Physicians should advise patients to stop use of all PDE5 inhibitors, including sildenafil tablets, and seek medical attention in the event of a sudden loss of vision in one or both eyes.

Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including possible permanent loss of vision, that has been reported rarely post-marketing in temporal association with the use of all PDE5 inhibitors. Physicians should discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye. Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a "crowded" optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitor, including sildenafil tablets, for this uncommon condition [ see Warnings and Precautions (5.3) and Adverse Reactions (6.2) ].

Sudden Hearing Loss Physicians should advise patients to stop taking PDE5 inhibitors, including sildenafil tablets, and seek prompt medical attention in the event of sudden decrease or loss of hearing. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including sildenafil tablets. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [ see Warnings and Precautions (5.4) and Adverse Reactions (6.2) ].

Priapism Physicians should warn patients that prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of sildenafil tablets. In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result [ see Warnings and Precautions (5.2) ].

Avoid Use with other PDE5 Inhibitors Physicians should inform patients not to take sildenafil tablets with other PDE5 inhibitors including REVATIO or other pulmonary arterial hypertension (PAH) treatments containing sildenafil. Sildenafil is also marketed as REVATIO for the treatment of PAH. The safety and efficacy of sildenafil tablets with other PDE…

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