Home › NDC Lookup › Ingredients › Sildenafil Citrate › 82347-0205-04
Sildenafil 25 mg Film, 1 film — NDC 82347-0205-04 package photo

Sildenafil 25 mg Film, 1 film

by Yaral Pharma Inc. · 1 FILM in 1 POUCH (82347-0205-4)
NDC 82347-0205-04
🏷️ FDA NDC (as labeled) 82347-0205-4 billing pads the package segment with a zero
This package
Contains1 film Pack sizes3 compare ↓
Also comes in: 4 films 82347-0205-05 8 films 82347-0205-06
Rx only Brand 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) 82347-0205-4
Product NDC 82347-0205
11-digit billing NDC 82347020504
RxCUI 2735815, 2735822, 2735825, 2735829
UNII BW9B0ZE037
UPC 0382347021062
Application # NDA210858
SPL Set ID a17a970e-25a2-4807-9644-74e6d2bd2383
Established class (EPC) Phosphodiesterase 5 Inhibitor
Mechanism of action Phosphodiesterase 5 Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-02-15
Route ORAL
Dosage form FILM
Substance SILDENAFIL CITRATE
Why two NDCs? The FDA registers this code as 82347-0205-4 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 82347-0205-04. 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

LabelerYaral Pharma Inc.
Application holderIBSA INSTITUT BIOCHIMIQUE SA
FDA applicationNDA210858 (NDA)
Labeler code82347
First marketedFeb 2026
Product typeHuman Prescription Drug
Portfolio18 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

📗 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
ImprintS100
FlavorGrapefruit
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 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 PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • UNII RT9P9S09QI
    Propylene glycol monocaprylate is a synthetic compound made by combining propylene glycol with a fatty acid. It acts as an emulsifier and surfactant to help mix oil and water-based ingredients together in medicines and improve how the body absorbs the active drug.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • 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.

7 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: 4 films 8 films
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
Vybrique 25 mg 71858-0205-02 IBSA 1 film — — FDA listed —
Sildenafil 25 mgthis 82347-0205-04 Yaral 1 film — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
2025
First FDA approval
Dec 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2033
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Dec 2033. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Dec 16, 2025 RLD RS ⏳ ~7.3 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 11123287 — drug product
US 11123287 — drug product
US 11123287 — drug product
US 11123287 — drug product
Exclusivity NP
Exclusivity NP
Exclusivity NP
Exclusivity NP
2025 2027 2029 2031 2033
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (4)
PatentTypeUse codeExpires
US 11123287 ↗ Drug product — Dec 16, 2033
US 11123287 ↗ Drug product — Dec 16, 2033
US 11123287 ↗ Drug product — Dec 16, 2033
US 11123287 ↗ Drug product — Dec 16, 2033
FDA exclusivity
CodeWhat it grantsExpires
NPNew ProductDec 16, 2028
NPNew ProductDec 16, 2028
NPNew ProductDec 16, 2028
NPNew ProductDec 16, 2028
Common questions
Is there a generic version of this drug?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for this drug. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Dec 2033 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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

Medicare Part D (outpatient prescription) spending for Sildenafil Citrate (matched by generic name) — the program that covers self-administered drugs. 15 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 Sildenafil Citrate. CMS lists 3 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$8.19M
Claims incl. refills
183.9K
Beneficiaries
116.4K
Spend / beneficiary
$70.36
Spend / claim
$44.53
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
82347-0205-04 You're viewing this 1 FILM in 1 POUCH (82347-0205-4) 2026-02-15 Active
82347-0205-05 4 POUCH in 1 CARTON (82347-0205-5) / 1 FILM in 1 POUCH 2026-02-15 Active
82347-0205-06 8 POUCH in 1 CARTON (82347-0205-6) / 1 FILM in 1 POUCH 2026-02-15 Active

Pack size FAQ

What quantity is in NDC 82347-0205-04?
NDC 82347-0205-04 contains 1 film — 1 film in 1 pouch.
What is the difference between NDC 82347-0205-04 and NDC 82347-0205-05?
Both are Sildenafil 25 mg Film — the drug itself is identical. NDC 82347-0205-04 is the 1 film package, while NDC 82347-0205-05 is the 4 films package.
What NDC number is used to bill for this package of Sildenafil 25 mg Film?
Bill NDC 82347-0205-04 — the 11-digit billing format is 82347020504. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

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

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 82347-0205-4, 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: 82347-0205-04, written without dashes as 82347020504. 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 82347-0205-04, the first segment (82347) is the labeler code FDA assigned to Yaral Pharma Inc.; the middle segment (0205) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 Yaral Pharma Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 4 films (82347-0205-05), 8 films (82347-0205-06). 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?
Yaral Pharma Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ 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 35 words ▾

1. INDICATION S AND USAGE SILDENAFIL ORAL FILM is indicated for the treatment of erectile dysfunction. SILDENAFIL ORAL FILM is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED). ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2. DOSAGE AND ADMINISTRATION Dosage For most patients, the recommended dosage is 50 mg orally, taken as needed, approximately 1 hour before sexual activity. However, SILDENAFIL ORAL FILM 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 ) Dosage Modifications for Drug Interactions: Refer to the full prescribing information for recommended dosage.

( 2.2 ) Recommended Dosage in Specific Populations: Refer to the full prescribing information for recommended dosage. ( 2.3 ) Administration Administer with or without food. Place oral film directly onto the tongue where it will disintegrate and can then be swallowed with saliva without the need for water or other liquids.

Do not cut or chew SILDENAFIL ORAL FILM.

2.1Recommended Dosage For most patients, the recommended dosage is 50 mg orally administered on the tongue, taken as needed, approximately 1 hour before sexual activity. However, SILDENAFIL ORAL FILM 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 tolerability the dosage may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg, not to exceed once per day. For administration instructions, see Dosage and Administration ( 2.4 ) .

2.2Dosage Modifications for Drug Interactions Nitrates Concomitant use of nitrates in any form is contraindicated [ see Contraindications ( 4.1 ), Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.2 ) ]. Alpha Blockers Initiate SILDENAFIL ORAL FILM at 25 mg orally in patients on concomitant therapy with an alpha-blocker. Patients should be stable on alpha-blocker therapy prior to initiating SILDENAFIL ORAL FILM [see Warnings and Precautions ( 5.5 ), Drug Interactions ( 7.2 ), and Clinical Pharmacology ( 12.2 ) ] .

For administration instructions, see Dosage and Administration ( 2.4 ) . Ritonavir The maximum recommended dose and dosing frequency is 25 mg orally taken once within a 48-hour period in ritonavir-treated patients. Concomitant administration of ritonavir increased the blood levels of sildenafil by 11-fold [ see Warnings and Precautions ( 5.6 ), Drug Interactions ( 7.4 ), and Clinical Pharmacology ( 12.3 ) ] .

For administration instructions, see Dosage and Administration ( 2.4 ) . Other CYP3A4 Inhibitors The recommended starting dosage is 25 mg orally, in patients taking strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, or saquinavir) or erythromycin. Clinical data have shown that co-administration with saquinavir or erythromycin increased blood levels of sildenafil by about 3-fold [see Drug Interactions ( 7.4 ) and Clinical Pharmacology ( 12.3 ) ] .

For administration instructions, see Dosage and Administration ( 2.4 ) .

2.3Recommended Dosage in Specific Populations Age G reater than 6 5 years The recommended starting dosage is 25 mg orally in patients greater than 65 years of age [see Use in Specific Populations ( 8.5 ) ]. For administration instructions, see Dosage and Administration ( 2.4 ) . Renal Impairment The recommended starting dosage is 25 mg orally, in patients with severe renal impairment (creatinine clearance less than 30 mL/minute).

The recommended starting dosage is 50 mg, in patients with mild (creatinine clearance 50 to 80 mL/min) and moderate (creatinine clearance 30 to 49 mL/min) renal impairment [see Use in Specific Populations( 8.6 ) and Clinical Pharmacology ( 12.3 ) ]. For administration instructions, see Dosage and Administration ( 2.4 ) . Hepatic Impairment The recommended starting dosage is 25 mg orally in patients with any degree of hepatic impairment.

In volunteers with mild and moderate degrees of hepatic impairment (Child-Pugh Class A and B), sildenafil clearance was reduced, resulting in higher plasma exposure of sildena…

💊 Dosage Forms and Strengths 86 words ▾

3. DOSAGE FORMS AND STRENGTHS Oral Film: 25 mg sildenafil, opaque light blue, thin, flexible oral film imprinted with identification code S 25 50 mg sildenafil, opaque light blue, thin, flexible oral film imprinted with identification code S 50 75 mg sildenafil, opaque light blue, thin, flexible oral film imprinted with identification code S 75 100 mg sildenafil, opaque light blue, thin, flexible oral film imprinted with identification code S 100 Oral film: 25 mg, 50 mg, 75 mg, 100 mg of sildenafil ( 3 )

⛔ Contraindications ~1 min read ▾

4. CONTRAINDICATIONS Administration of SILDENAFIL ORAL FILM to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. SILDENAFIL ORAL FILM was shown to potentiate the hypotensive effect of nitrates. ( 4.1 , 7.1 , 12.2 ) Known hypersensitivity to sildenafil or any component of oral film. ( 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 ORAL FILM potentiates 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 ORAL FILM 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 ( 2.2 ), Drug Interactions ( 7.1 ), and Clinical Pharmacology ( 12.2 ) ].

4.2Hypersensitivity Reactions SILDENAFIL ORAL FILM is contraindicated in patients with a known hypersensitivity to sildenafil or any SILDENAFIL ORAL FILM component. Hypersensitivity reactions, including rash and urticaria, have been reported [see Adverse Reactions ( 6.1 )].

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

⚠️ Warnings and Cautions ~3 min read ▾

5. WARNINGS AND PRECAUTIONS Patients should not use SILDENAFIL ORAL FILM if sexual activity is inadvisable due to cardiovascular status. ( 5.1 ) Patients should seek emergency treatment if an erection lasts >4 hours.

Use SILDENAFIL ORAL FILM with caution in patients predisposed to priapism. ( 5.2 ) Patients should stop SILDENAFIL ORAL FILM 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 ORAL FILM 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 ORAL FILM and seek prompt medical attention in the event of sudden decrease or loss of hearing. ( 5.4 ) Caution is advised when SILDENAFIL ORAL FILM is co-administered with alpha-blockers or antihypertensives.

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 ORAL FILM dosage is recommended. ( 2.2 , 5.6 )

5.1Cardiovascular Risk General There is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Therefore, treatments for erectile dysfunction, including SILDENAFIL ORAL FILM should not be used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status. The following groups of patients were not included in clinical safety and efficacy trials for sildenafil, and therefore, until further information is available, SILDENAFIL ORAL FILM is not recommended for use in the following groups: 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.

Blood Pressure Decreases Patients with left ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis) and those with severely impaired autonomic control of blood pressure can be sensitive to the actions of vasodilators, including SILDENAFIL ORAL FILM. As with other PDE5 inhibitors, SILDENAFIL ORAL FILM has systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers. In healthy subjects aged 18 to 45 years, SILDENAFIL ORAL FILM 100 mg resulted in mean maximal decreases relative to placebo of 6 mmHg systolic and 3 mmHg diastolic.

In healthy subjects aged 65 years and older, SILDENAFIL ORAL FILM 100 mg resulted in mean maximal decreases relative to placebo of 14 mmHg systolic and 8 mmHg diastolic [see Clinical Pharmacology ( 12.2 )]. Prior to prescribing SILDENAFIL ORAL FILM, carefully consider whether patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects, especially in combination with sexual activity.

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. In the event of an erection that persists longer than 4 hours, instruct the patient to seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result.

Use SILDENAFIL ORAL FILM 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).

5.3 Effects on the Eye Advise patients to stop use of all pho…

🤒 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 )] The most common adverse reactions reported in clinical trials (≥ 2%) of sildenafil 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 YARAL Pharma Inc at 1-866-218-9009 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 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 (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 events in flexible-dose studies 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 but generally were reported more frequently. Table 1: Adverse Reactions Reported by ≥2% of Patients Treated with Sildenafil and More Frequent than Placebo in Fixed-Dose Clinical Studies 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% †Abnormal Vision: Mild to moderate in severity and transient, predominantly color tinge to vision, but also increased sensitivity to light, or blurred vision.

When sildenafil 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 at least once weekly, and the following adverse reactions were reported: Table 2 : Adverse Reactions Reported by ≥2% of Patients Treated with Sildenafil and More Frequent than Placebo in Flexible-Dose Clinical Studies Adverse Reaction Sildenafil N=734 Placebo 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% †Abnormal Vision: Mild to moderate in severity 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. When SILDENAFIL ORAL FILM was taken as recommended (on an as-needed basis) in a flexible-dose, placebo-controlled clinical trial of twelve weeks duration, patients took SILDENAFIL ORAL FILM at least once weekly, not more than once per day, and the following adverse reactions were reported: Table 3: Adverse Reactions Reported by ≥2% of Patients Treated with SILDENAFIL ORAL FILM and More…

🔄 Drug Interactions ~2 min read ▾

7. DRUG INTERACTIONS SILDENAFIL ORAL FILM can potentiate the hypotensive effects of nitrates, alpha blockers, and antihypertensives. ( 4.1 , 5.5 , 7.1 , 7.2 , 7.3 , 12.2 ) With concomitant use of alpha blockers, initiate SILDENAFIL ORAL FILM at 25 mg dose.

( 2.2 ) CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin) increase SILDENAFIL ORAL FILM exposure. ( 2.2 , 7.4 , 12.3 ) Ritonavir: Do not exceed a maximum single dose of 25 mg in a 48- hour period. ( 2.2 , 5.6 ) Erythromycin or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, saquinavir): Consider a starting dose of 25 mg.

( 2.2 , 7.4 )

7.1Nitrates Administration of sildenafil 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 was shown to potentiate the hypotensive effects of nitrates [see Dosage and Administration ( 2.2 ), Contraindications ( 4.1 ), Clinical Pharmacology ( 12.2 ) ] .

7.2Alpha-blockers Use caution when co-administering alpha-blockers with sildenafil because of potential additive blood pressure lowering effects. When sildenafil is co-administered with an alpha-blocker, patients should be stable on alpha blocker therapy prior to initiating sildenafil treatment and sildenafil should be initiated at the lowest dose [see Dosage and Administration ( 2.2 ),Warnings and Precautions ( 5.5 ), Clinical Pharmacology ( 12.2 ) ].

7.3Amlodipine When sildenafil 100 mg was 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 in a 48 hour period [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.6 ), Clinical Pharmacology ( 12.3 ) ]. Co-administration of erythromycin, a moderate CYP3A4 inhibitor, resulted in 160% and 182% increases in sildenafil Cmax and AUC, respectively.

Co-administration of saquinavir, a strong CYP3A4 inhibitor, resulted in 140% and 210% increases in sildenafil Cmax 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 should be considered in patients taking erythromycin or strong CYP3A4 inhibitors (such as saquinavir, ketoconazole, itraconazole) [see Dosage and Administration ( 2.2 ), Clinical Pharmacology ( 12.3 ) ].

7.5Alcohol In a drug-drug interaction study of 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: Recommended starting dose is 25 mg. ( 2.3 , 8.5 ) Severe renal impairment: Recommended starting dose is 25 mg. ( 2.3 , 8.6 ) Hepatic impairment: Recommended starting dose is 25 mg. ( 2.3 , 8.7 )

8.1Pregnancy Risk Summary SILDENAFIL ORAL FILM is not indicated for use in females. There are no data with the use of SILDENAFIL ORAL FILM 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/m2 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/m2 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 ORAL FILM is 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 ORAL FILM 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 adult (< 65 years of age) subjects. Of the total number of subjects in the clinical study of SILDENAFIL ORAL FILM, 31% were 65 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. A starting dose of SILDENAFIL ORAL FILM 25 mg is recommended in patients 65 years of age and older due to the higher systemic exposure in older subjects, and larger decreases in blood pressure observed in older subjects in a clinical pharmacology study [see Dosage and Administration ( 2.3 ) , Warning s and Precautions ( 5.1 ), Clinical Pharmacology ( 12.2 ] .

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 Cmax and AUC. A starting dose of 25 mg should be considered in patients with severe renal impairment [see Dosage and Administration ( 2.3 ) , 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 Cmax 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…

🤰 Pregnancy 165 words ▾

8.1Pregnancy Risk Summary SILDENAFIL ORAL FILM is not indicated for use in females. There are no data with the use of SILDENAFIL ORAL FILM 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/m2 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/m2 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 24 words ▾

8.4Pediatric Use SILDENAFIL ORAL FILM is not indicated for use in pediatric patients. Safety and effectiveness have not been established in pediatric patients.

🧓 Geriatric Use ~1 min read ▾

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 adult (< 65 years of age) subjects. Of the total number of subjects in the clinical study of SILDENAFIL ORAL FILM, 31% were 65 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. A starting dose of SILDENAFIL ORAL FILM 25 mg is recommended in patients 65 years of age and older due to the higher systemic exposure in older subjects, and larger decreases in blood pressure observed in older subjects in a clinical pharmacology study [see Dosage and Administration ( 2.3 ) , Warning s and Precautions ( 5.1 ), Clinical Pharmacology ( 12.2 ] .

🆘 Overdosage 68 words ▾

10 OVERDOSAGE In studies in healthy volunteers administered single sildenafil 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 S ildenafil 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 administration compared with placebo. Most studies assessed the efficacy of sildenafil 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 ORAL FILM on Blood Pressure: Single oral doses (50 mg, 75 mg, 100 mg) of VYBRIQYE administered to 12 healthy young volunteers produced decreases in supine blood pressure. The placebo-subtracted mean maximum decreases in systolic/diastolic blood pressure were 6.1/2.8 mmHg after a single 100 mg dose.

Subjects were under fasting conditions and lay in the supine position for the first 4 hours post-dose and were not initially titrated. The decrease in supine blood pressure was most notable approximately 1-2 hours after dosing. Figure 1 : Mean Change from Baseline in Supine Systolic Blood Pressure, Healthy Volunteers Single oral doses of 50 mg, 75 mg, 100 mg of SILDENAFIL ORAL FILM administered to 12 elderly volunteers produced decreases in supine blood pressure.

The placebo-subtracted maximum mean decreases in systolic/diastolic blood pressure were 13.7/8.5 mmHg after a single 100 mg dose. Subjects were under fasting conditions and lay in the supine position for the first 4 hours post-dose and were not initially titrated. The decrease in supine b…

🧬 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 148 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING SILDENAFIL ORAL FILM is supplied as oral films in individually sealed foil pouches in four dosage strengths. Each carton contains 4 or 8 pouches. The product is an opaque light blue, thin, flexible oral film with film imprint code, and characteristic lemon and grapefruit flavor with the following dimensions: Strengths (mg ) of sildenafil Film Imprint Code Film Dimensions ( shape ) NDC for Carton of 4 Pouches NDC for Carton of 8 Pouches 25 mg S25 30 mm x 15 mm (rectangular) 82347-0205-5 82347-0205-6 50 mg S50 30 mm x 30 mm (square) 82347-0210-5 82347-0210-6 75 mg S75 30 mm x 45 mm (rectangular) 82347-0215-5 82347-0215-6 100 mg S100 45 mm x 40 mm (rectangular) 82347-0220-5 82347-0220-6 Recommended Storage: Store at 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

📋 Description 203 words ▾

11 DESCRIPTION SILDENAFIL ORAL FILM (sildenafil) oral film is for treatment of erectile dysfunction and contains sildenafil citrate, 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-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate, has the molecular formula C 22 H 39 N 6 O 4 S ‧ C 6 H 8 O 7 , and the following structural formula: Sildenafil citrate is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7.

SILDENAFIL ORAL FILM is formulated as an opaque light blue, thin, flexible oral film with the characteristic lemon and grapefruit scent. The product is available in four different strengths 25, 50, 75, or 100 mg of sildenafil equivalent to 35, 70, 105, 140 mg sildenafil citrate respectively for oral administration. In addition to the active ingredient, sildenafil citrate, each oral film contains the following inactive ingredients: Blue Videojet ink, FD&C Blue No.2, glycerin, grapefruit flavor, lemon flavor, maltodextrin, polysorbate 20, polyvinyl acetate dispersion, propylene glycol monocaprylate, sucralose, titanium dioxide.

SILDENAFIL ORAL FILM contains no ingredient made from a gluten-containing grain (wheat, barley, or rye). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate, has the molecular formu

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information ) Administration Instructions Advise patients to place SILDENAFIL ORAL FILM directly onto the tongue where it will disintegrate and can then be swallowed with saliva without the need for water or other liquids. Advise patients not to cut or chew SILDENAFIL ORAL FILM [see Dosage and Administration ( 2.4 ) ] . Nitrates Physicians should discuss with patients the contraindication of SILDENAFIL ORAL FILM 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 ORAL FILM 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 ORAL FILM to augment the blood pressure lowering effect of alpha-blockers and antihypertensive medications. Concomitant administration of SILDENAFIL ORAL FILM and an alpha blocker may lead to symptomatic hypotension in some patients.

Therefore, when SILDENAFIL ORAL FILM is co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating SILDENAFIL ORAL FILM treatment and SILDENAFIL ORAL FILM should be initiated at the lowest dose [see Warnings and Precautions ( 5.5 )]. Cardiovascular Risk 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 ORAL FILM 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, including sildenafil. 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 ORAL FILM, for this uncommon condition [see Warnings and Precautions ( 5.3 ) , Adverse Reactions ( 6.2 )]. Sudden Hearing Loss Physicians should advise patients to stop taking PDE5 inhibitors, including SILDENAFIL ORAL FILM 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 ORAL FILM. 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 ) , 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.

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 )…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 82347-0060-04 · YARAL 82347-0210-04 · Yaral →
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.