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Sildenafil 100 mg Tablet, Film Coated, 10-count — NDC 72189-069-10 (Billing 72189-0069-10)

by DIRECT RX · 10 TABLET, FILM COATED in 1 BOTTLE

This is a package of 10 tablets of Sildenafil 100 mg Tablet, Film Coated from DIRECT RX, marketed since Jun 2020 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 72189-0069-10
🏷️ FDA NDC (as labeled) 72189-069-10 billing pads the product segment with a zero
This package
Contains10-count Pack sizes2 compare ↓
Main listing for product 72189-069 · Also comes in: 30 tablets 72189-069-30
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72189-069-10
Product NDC 72189-069
11-digit billing NDC 72189006910
RxCUI 314229
UNII BW9B0ZE037
Application # ANDA202659
SPL Set ID a84a418a-155c-7be7-e053-2995a90a8158
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 2020-06-17
Route ORAL
Dosage form TABLET, FILM COATED
Substance SILDENAFIL CITRATE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

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
Quick answers
  • GSN (GCN sequence number): 039191
  • GCN: 57903
  • GPI-14 (Medi-Span): 40304070100330
  • HICL (First Databank): 018084
  • AHFS class code: 24:08.12.00
  • RxCUI (RxNorm): 314229
Why two NDCs? The FDA registers this code as 72189-069-10 — 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 → 72189-0069-10. 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.

Clinical

Label name SILDENAFIL 100 MG TABLET Ingredient Sildenafil Citrate
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Viagra, Vybrique and some sildenafil tablets and oral films treat erectile dysfunction. Revatio and other sildenafil tablets, suspension and injection tr...
  • You take it as needed, usually about 1 hour before sex, though anywhere from 30 minutes to 4 hours works. Take it no more than once a day, with or without food. Oral film goes on y...
  • How do I take it for erectile dysfunction?
  • The common ones are headache, flushing, upset stomach, a stuffy nose and dizziness. Some people notice a color tinge or blur in their vision, which is usually mild and short-lived....
📖 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.

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: 30 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
72189-0069-10 You're viewing this Main listing 10 TABLET, FILM COATED in 1 BOTTLE 2020-06-17 — Active
72189-0069-30 72189-069-30 30 TABLET, FILM COATED in 1 BOTTLE 2020-06-17 — Active

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

Pack size FAQ

What quantity is in this package?
This is a 10-count package — 10 tablet, film coated in 1 bottle.
How does this package differ from NDC 72189-0069-30?
Both are Sildenafil 100 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 10-count one, while NDC 72189-0069-30 is the 30 tablets package.
What NDC number is used to bill for this package of Sildenafil 100 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sildenafil 100 mg 00093-5343-01 Teva 100 tablets $0.132 AB Availability likely —
Sildenafil Citrate 100 mg 13668-0188-01 Torrent 100 tablets $0.132 AB Availability likely —
Sildenafil Citrate 100 mg 27241-0069-03 Ajanta 30 tablets $0.132 AB Availability likely —
Sildenafil 100 mg 31722-0711-01 Camber 100 tablets $0.132 AB Availability likely —
Sildenafil 100 mg 33342-0043-07 Macleods 30 tablets $0.132 AB Availability likely —
Sildenafil Citrate 100 mg 60290-0003-01 Umedica 30 tablets $0.132 AB Availability likely —
Sildenafil 100 mg 65862-0691-01 Aurobindo 100 tablets $0.132 AB Availability likely —
Sildenafil 100 mg 72241-0071-05 Modavar 100 tablets $0.132 AB Availability likely —
Sildenafil Citrate 100 mg 72603-0885-01 Northstar 30 tablets $0.132 AB Availability likely —
Sildenafil 100 mg 72888-0017-00 Advagen 1000 tablets $0.132 AB Availability likely —
Sildenafil Citrate 100 mg 75834-0241-00 NIVAGEN 1000 tablets $0.132 AB Availability likely —
Sildenafil 100 mg 76282-0645-01 Exelan 100 tablets $0.132 AB Availability likely —
Sildenafil Citrate 100 mg 82009-0093-01 Quallent 100 tablets $0.132 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 $83.717 AB Availability likely —
Viagra 100 mg 58151-0428-01 Viatris 100 tablets $83.717 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 mgthis 72189-0069-10 DIRECT 10 tablets — AB FDA listed —
Sildenafil 100 mg 72303-0847-01 HEC 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 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

🏛️
2020
On the market since
Jun 2020
📍
2026
Currently FDA-listed
6 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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.

Manufacturer & labeler

LabelerDIRECT RX
Application holderHETERO LABS LTD UNIT V
FDA applicationANDA202659 (ANDA)
Labeler code72189
First marketedJun 2020
Product typeHuman Prescription Drug
Portfolio204 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Patient Medication Information 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 10 words ▾

Sildenafil tablets are indicated for the treatment of erectile dysfunction.

⏱️ Dosage and Administration ~2 min read ▾

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 were 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 are 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) andClinical Pharmacology (12.3)].

💊 Dosage Forms and Strengths 75 words ▾

Sildenafil Tablets USP, 25 mg are white colored, round-shaped, biconvex, film coated tablets debossed with 'I' on one side and '35' on the other side. Sildenafil Tablets USP, 50 mg are white colored, round-shaped, biconvex, film coated tablets debossed with 'I' on one side and '36' on the other side. Sildenafil Tablets USP, 100 mg are white colored, round-shaped, biconvex, film coated tablets debossed with 'I' on one side and '58' on the other side.

⛔ Contraindications 191 words ▾

4.1Nitrates Consistent with its known effects on the nitric oxide/cGMP pathway [see Clinical Pharmacology (12.1, 12.2)] ,sildenafil tablets were 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, 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 tablets, may potentiate the hypotensive effects of GC stimulators.

⚠️ Warnings and Cautions ~3 min read ▾

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 have 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 sickle cell or related anemias.

5.3Effects on the Eye Physicians should advise patients to stop use of all phosphodiesterase type 5 (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 rare condition and a cause of decreased vision including permanent loss of vision, that has been reported rarely post-marketing in temporal association with the use of all PDE5 inhibitors. Based on published literature, the annual incidence of NAION is 2.5 to 11.8 cases per 100,000 in males aged ≥ 50.

An observational case-crossover study evaluated the risk of NAION when PDE5 inhibitor use, as a class, occurred immediately before NAION onset (within 5 half-lives), compared to PDE5 inhibitor use in a prior time period. The results suggest an approximate 2-fold increase in the risk of NAION, with a risk estimate of 2.15 (95% CI 1.06, 4.34). A similar study reported a consistent result, with a risk estimate of 2.27 (95% CI 0.99, 5.20).

Other risk factors for NAION, such as the presence of “crowded” optic disc, may have contributed to the occurrence of NAION in these studies. Neither the rare post-marke… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

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.

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 were administered to over 3700 patients (aged 19 to 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 with Sildenafil Tablets and More Frequently than Placebo in Fixed-Dose Phase II/III 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 tablets were 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 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% † 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. 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 minor events and reports too imprecise to be meaningful: Body as a Whole: face edema, photosensitivity reaction, shock, asthenia, pain, chills, accidental fall, abdominal pain, allergic reaction, chest pain, accidental injury.

Cardiovascular: angina pectoris, AV block, migraine, syncope, tachycardia, palpitation, hypoten… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

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 were 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 are 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 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 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 ~2 min read ▾

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/m2 basis (see Data).

Data Animal Data No evidence of teratogenicity, embryotoxicity or fetotoxicity was observed in rats and rabbits which received 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 tablets 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 tablets are 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 to 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 tablets, 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 to 80 mL/min) and moderate (CLcr=30 to 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 (2.5)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 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 degree of hepatic impairment [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3)].

🆘 Overdosage 65 words ▾

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 ▾

12.1Mechanism 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 Tablets on 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 to 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)]. sildenafilfigure1 Figure 1: Mean Change from Baseline in Sitting Systolic Blood Pressure, Healthy Volunteers. 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… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 94 words ▾

Sildenafil Tablets USP, 25 mg are white colored, round-shaped, biconvex, film coated tablets debossed with ' I ' on one side and '35'on the other side. Sildenafil Tablets USP, 50 mg are white colored, round-shaped, biconvex, film coated tablets debossed with ' I ' on one side and '36'on the other side. Sildenafil Tablets USP, 100 mg are white colored, round-shaped, biconvex, film coated tablets debossed with ' I ' on one side and '58' on the other side.

Recommended Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

📋 Description 124 words ▾

Sildenafil Tablet, USP an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate, USP 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 and has the following structural formula: sildenafilstructure Sildenafil citrate, USP 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 tablet, USP is formulated as white, film-coated rounde-shaped tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, USP each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin.

💬 Patient Medication Information ~3 min read ▾

Patient Information Sildenafil Tablets, USP (sil den' a fil) What is the most important information I should know about sildenafil tablets? Sildenafil tablets can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. Do not take sildenafil tablets if you take any other medicines called “nitrates.” Nitrates are used to treat chest pain (angina).

A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke. Do not take sildenafil tablets if you take medicines called guanylate cyclase stimulators which include: • Riociguat (Adempas®) a medicine that treats pulmonary arterial hypertension and chronicthromboembolic pulmonary hypertension. Tell all your healthcare providers that you take sildenafil tablets.

If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took sildenafil tablets. Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease.

Ask your doctor if your heart is healthy enough to handle the extra strain of having sex. Sildenafil tablets does not protect you or your partner from getting sexually transmitted diseases, including HIV—the virus that causes AIDS. What are sildenafil tablets?

Sildenafil tablet is a prescription medicine used to treat erectile dysfunction (ED). You will not get an erection just by taking this medicine. Sildenafil tablets helps a man with erectile dysfunction get and keep an erection only when he is sexually excited (stimulated).

Sildenafil tablets are not for use in women or children. It is not known if sildenafil tablets are safe and effective in women or children under 18 years of age. Who should not take sildenafil tablets?

Do not take sildenafil tablets if you: • take medicines called ''nitrates” (such as nitroglycerin) • use street drugs called ''poppers'' such as amyl nitrate or amyl nitrite, and butyl nitrate • take any medicines called guanylate cyclase stimulators such as riociguat (Adempas) • are allergic to sildenafil, as contained in sildenafil tablets and REVATIO, or any of the ingredients in sildenafil tablets. See the end of this leaflet for a complete list of ingredients in sildenafil tablets. What should I tell my healthcare provider before taking sildenafil tablets?

Before you take sildenafil tablets, tell your healthcare provider if you: • have or have had heart problems such as a heart attack, irregular heartbeat, angina, chest pain, narrowing of the aortic valve or heart failure • have had heart surgery within the last 6 months • have pulmonary hypertension • have had a stroke • have low blood pressure, or high blood pressure that is not controlled • have a deformed penis shape • have had an erection that lasted for more than 4 hours • have problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemia • have retinitis pigmentosa, a rare genetic (runs in families) eye disease • have ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION) • have bleeding problems • have or have had stomach ulcers • have liver problems • have kidney problems or are having kidney dialysis • have any other medical conditions Tell your healthcare provider about all the medicines you take*, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Sildenafil tablets may affect the way other medicines work, and other medicines may affect the way sildenafil tablet works causing side effects. Especially tell your healthcare provider if you take any of the following: • medicines called nitrates (see 'What is the most important information I should know about sildenafil tablets?') • medicines called guanylate cyclase stimul… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

In clinical studies, sildenafil tablets was assessed for its effect on the ability of men with erectile dysfunction (ED) to engage in sexual activity and in many cases specifically on the ability to achieve and maintain an erection sufficient for satisfactory sexual activity. Sildenafil tablets were evaluated primarily at doses of 25 mg, 50 mg and 100 mg in 21 randomized, double-blind, placebo-controlled trials of up to 6 months in duration, using a variety of study designs (fixed dose, titration, parallel, crossover).

Sildenafil tablets were administered to more than 3,000 patients aged 19 to 87 years, with ED of various etiologies (organic, psychogenic, mixed) with a mean duration of 5 years. Sildenafil tablets demonstrated statistically significant improvement compared to placebo in all 21 studies. The studies that established benefit demonstrated improvements in success rates for sexual intercourse compared with placebo.

Efficacy Endpoints in Controlled Clinical Studies The effectiveness of sildenafil tablets were evaluated in most studies using several assessment instruments. The primary measure in the principal studies was a sexual function questionnaire (the International Index of Erectile Function -IIEF) administered during a 4-week treatment-free run-in period, at baseline, at follow-up visits, and at the end of double-blind, placebo-controlled, at-home treatment. Two of the questions from the IIEF served as primary study endpoints; categorical responses were elicited to questions about (1) the ability to achieve erections sufficient for sexual intercourse and (2) the maintenance of erections after penetration.

The patient addressed both questions at the final visit for the last 4 weeks of the study. The possible categorical responses to these questions were (0) no attempted intercourse, (1) never or almost never, (2) a few times, (3) sometimes, (4) most times, and (5) almost always or always. Also collected as part of the IIEF was information about other aspects of sexual function, including information on erectile function, orgasm, desire, satisfaction with intercourse, and overall sexual satisfaction.

Sexual function data were also recorded by patients in a daily diary. In addition, patients were asked a global efficacy question and an optional partner questionnaire was administered. Efficacy Results from Controlled Clinical Studies The effect on one of the major end points, maintenance of erections after penetration, is shown in Figure 6, for the pooled results of 5 fixed-dose, dose-response studies of greater than one month duration, showing response according to baseline function.

Results with all doses have been pooled, but scores showed greater improvement at the 50 and 100 mg doses than at 25 mg. The pattern of responses was similar for the other principal question, the ability to achieve an erection sufficient for intercourse. The titration studies, in which most patients received 100 mg, showed similar results.

Figure 6 shows that regardless of the baseline levels of function, subsequent function in patients treated with sildenafil tablets were better than that seen in patients treated with placebo. At the same time, on-treatment function was better in treated patients who were less impaired at baseline. Effect of Sildenafil Tablets on Maintenance of Erection by Baseline Score sildenafilfigure6a Effect of Placebo on Maintenance of Erection by Baseline Score sildenafilfigure6b Figure 6.

Effect of Sildenafil Tablets and Placebo on Maintenance of Erection by Baseline Score. The frequency of patients reporting improvement of erections in response to a global question in four of the randomized, double-blind, parallel, placebo-controlled fixed dose studies (1797 patients) of 12 to 24 weeks duration is shown in Figure 7. These patients had erectile dysfunction at baseline that was characterized by median categorical scores of 2 (a few times) on principal IIEF questions.

Erectile dysfunction was attributed to organ… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 174 words ▾

13.1Carcinogenesis & Mutagenesis & Impairment Of Fertility Carcinogenesis Sildenafil was not carcinogenic when administered to rats for 24 months at a dose resulting in total systemic drug exposure (AUCs) for unbound sildenafil and its major metabolite of 20-and 38-times, for male and female rats, respectively, the exposures observed in human males given the Maximum Recommended Human Dose (MRHD) of 100 mg. Sildenafil was not carcinogenic when administered to mice for 18 to 21 months at dosages up to the Maximum Tolerated Dose (MTD) of 10 mg/kg/day, approximately 0.4 times the MRHD on a mg/m2 basis in a 50 kg subject.

Mutagenesis Sildenafil was negative in in vitro bacterial and Chinese hamster ovary cell assays to detect mutagenicity, and in vitro human lymphocytes and in vivo mouse micronucleus assays to detect clastogenicity. Impairment of Fertility There was no impairment of fertility in rats given sildenafil up to 60 mg/kg/day for 36 days to females and 102 days to males, a dose producing an AUC value of more than 25 times the human male AUC.

📄 Package Label / Principal Display Panel 2 words ▾

06930

72189-069-10

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