7. DRUG INTERACTIONS

However, Sildenafil tablets may be taken anywhere from 30 minutes to 4 hours before sexual activity ( 2.1) Based on effectiveness and toleration, may increase to a maximum of 100 mg or decrease to 25 mg ( 2.1) Maximum recommended dosing frequency is once per day ( 2.1) Administration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form.

• Side effects from high doses may include dizziness, flushing, or stomach upset.
• The onset of action is typically within 30 to 60 minutes after intake.
• Patients should avoid heavy meals before taking sildenafil for quicker results.
• Overdose symptoms include chest pain, loss of vision, and fainting.
• Sildenafil is not a cure for erectile dysfunction but enhances blood flow temporarily.
• Medical review is crucial for safety when considering high-dose sildenafil.

Sildenafil citrate was shown to potentiate the hypotensive effect of nitrates ( 4.1, 7.1, 12.2) Known hypersensitivity to sildenafil or any component of tablet ( 4.2) Administration with guanylate cyclase (GC) stimulators, such as riociguat ( 4.3) Patients should not use sildenafil citrate if sexual activity is inadvisable due to cardiovascular status ( 5.1) Patients should seek emergency treatment if an erection lasts >4 hours. Use sildenafil citrate with caution in patients predisposed to priapism ( 5.2) Patients should stop sildenafil tablets and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION).

Patients should stop sildenafil tablets and seek prompt medical attention in the event of sudden decrease or loss of hearing ( 5.4) Caution is advised when Sildenafil citrate is co-administered with alpha- blockers or anti-hypertensives.

Sildenafil Citrate 120mg Availability

However, tadalafil has a few distinctions from sildenafil. Tadalafil is the generic name for the erectile dysfunction drug Cialis. There are two versions of the drug: a version that can be taken as needed Cialis 5-mg daily dosing is the only PDE5 inhibitor dose approved for treating an enlarged prostate; improving ED symptoms is an added benefit of the daily dose. Because of the “as needed” version of tadalafil, some users may find this option more convenient. The downside, however, is that side effects tend to last longer too.

Interactions that increase your risk for side effects

The main difference between generic sildenafil and Viagra is marketing. The main ingredient in Viagra is sildenafil, meaning that the drugs are essentially the same. However, Viagra is marketed and prescribed strictly for erectile dysfunction, while generic sildenafil can be prescribed for PAH as well. Viagra is also sildenafil film tablet known as “the little blue pill” because of its blue color, while generic sildenafil tends to be a white color. Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up to date.

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses. If you are a consumer or patient please visit this version. Concomitant use may lead to hypotension ( 5.5) Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures.

Decrease in Sildenafil citrate dosage is recommended ( 2.4, 5.6) Most common adverse reactions (≥ 2%) include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness and rash ( 6.1).

Before You Use It: Important Precautions

When filling your prescription, be sure to call ahead to make sure your pharmacy carries it. Many insurance companies require prior authorization for this drug. This means your doctor may need to get approval from your insurance company before your insurance company will pay for the prescription. Sildenafil under the brand name Viagra is prescribed to treat erectile dysfunction by increasing blood flow to the penis during arousal. Sildenafil under the brand name Revatio is often prescribed to help adults with PAH get more exercise by treating their condition.

Pulmonary Arterial Hypertension

What if I forget to take it? If you are taking Revatio and you forget to take your scheduled dose, take it as soon as possible. However, you should never double your dosage. If you completely miss a dose and it’s time for the next dose, skip the one you missed. Are there any safety measures I should take before using this drug?

How sildenafil is used

Like most medications, there are precautions you should take before using this drug. Make sure you talk with your doctor about: any other drugs, medications, herbs, or supplements you take or plan to take any medical conditions or surgeries you have or plan to have if you are pregnant or plan to become pregnant There are other drugs available to treat your condition. Some may be better suited for you than others. Talk with your doctor about other drug options that may work for you. Sildenafil and tadalafil are alike because they both can treat ED and PAH. To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc.

at 1-800-912-9561 or FDA at 1-800-FDA-1088 or Sildenafil citrate can potentiate the hypotensive effects of nitrates, alpha blockers, and anti-hypertensives ( 4.1, 5.5, 7.1, 7.2, 7.3, 12.2) With concomitant use of alpha blockers, initiate sildenafil citrate at 25 mg dose ( 2.3) CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase Sildenafil citrate exposure ( 2.4, 7.4, 12.3) Ritonavir: Do not exceed a maximum single dose of 25 mg in a 48 hour period ( 2.4, 5.6) Erythromycin or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, saquinavir): Consider a starting dose of 25 mg ( 2.4, 7.4) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

8.5 Geriatric Use

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS.SILDENAFIL tablets, for oral useInitial U.S. Approval:1998RECENT MAJOR CHANGESWarnings and Precautions, Effects on the Eye ( 5.3) 08/2017INDICATIONS AND USAGESildenafil citrate is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED). (1)DOSAGE AND ADMINISTRATIONFor most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, Sildenafil tablets may be taken anywhere from 30 minutes to 4 hours before sexual activity ( 2.1)Based on effectiveness and toleration, may increase to a maximum of 100 mg or decrease to 25 mg ( 2.1)Maximum recommended dosing frequency is once per day ( 2.1)DOSAGE FORMS AND STRENGTHSTablets: 50 mg ( 3)CONTRAINDICATIONSAdministration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form.

CAUTION & WARNING:

Sildenafil citrate was shown to potentiate the hypotensive effect of nitrates ( 4.1, 7.1, 12.2)Known hypersensitivity to sildenafil or any component of tablet ( 4.2)Administration with guanylate cyclase (GC) stimulators, such as riociguat ( 4.3)WARNINGS AND PRECAUTIONSPatients should not use sildenafil citrate if sexual activity is inadvisable due to cardiovascular status ( 5.1)Patients should seek emergency treatment if an erection lasts >4 hours. Use sildenafil citrate with caution in patients predisposed to priapism ( 5.2)Patients should stop sildenafil tablets and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION). Sildenafil tablets should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a” crowded” optic disc may also be at an increased risk of NAION. ( 5.3)Patients should stop sildenafil tablets and seek prompt medical attention in the event of sudden decrease or loss of hearing ( 5.4)Caution is advised when Sildenafil citrate is co-administered with alpha- blockers or anti-hypertensives. Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE2 DOSAGE AND ADMINISTRATION2.1 Dosage Information2.2 Use with Food2.3 Dosage Adjustments in Specific Situations2.4 Dosage Adjustments Due to Drug Interactions2.5 Dosage Adjustments in Special Populations3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS4.1 Nitrates4.2 Hypersensitivity Reactions4.3 Concomitant Guanylate Cyclase (GC) Stimulators5 WARNINGS AND PRECAUTIONS5.1 Cardiovascular5.2 Prolonged Erection and Priapism5.3 Effects on the Eye5.4 Hearing Loss5.5 Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives5.6 Adverse Reactions with the Concomitant Use of Ritonavir5.7 Combination with other

Frequently asked questions

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 citrate dosage is recommended ( 2.4, 5.6)ADVERSE REACTIONSMost 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 Torrent Pharma Inc. at 1-800-912-9561 or FDA at 1-800-FDA-1088 or INTERACTIONSSildenafil citrate can potentiate the hypotensive effects of nitrates, alpha blockers, and anti-hypertensives ( 4.1, 5.5, 7.1, 7.2, 7.3, 12.2)With concomitant use of alpha blockers, initiate sildenafil citrate at 25 mg dose ( 2.3)CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase Sildenafil citrate exposure ( 2.4, 7.4, 12.3)Ritonavir: Do not exceed a maximum single dose of 25 mg in a 48 hour period ( 2.4, 5.6)Erythromycin or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, saquinavir): Consider a starting dose of 25 mg ( 2.4, 7.4)USE IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 12/2024 Warnings and Precautions, Effects on the Eye ( 5.3) 08/2017 Sildenafil citrate is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED). For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. PDE5 Inhibitors or Other Erectile Dysfunction Therapies5.8 Effects on Bleeding5.9 Counseling Patients About Sexually Transmitted Diseases6 ADVERSE REACTIONS6.1 Clinical Trials Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS7.1 Nitrates7.2 Alpha-blockers7.3 Amlodipine7.4 Ritonavir and other CYP3A4 inhibitors7.5 Alcohol8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.4 Pediatric Use8.5 Geriatric Use8.6 Renal Impairment8.7 Hepatic Impairment10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility14 CLINICAL STUDIES17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed.

• Sildenafil 120 mg can cause flushing and nasal congestion as common side effects.
• It is important to follow medical advice to minimize health risks.
• The drug's effectiveness can be influenced by other health conditions like diabetes.
• Consuming grapefruit or grapefruit juice may affect sildenafil’s metabolism.
• Patients should seek emergency care if experiencing an erection lasting longer than 4 hours.
• Sildenafil’s effects typically last about 4-6 hours, depending on individual factors.