Label: SILDENAFIL- sildenafil tablet, film coated

Clinical data have shown that co-administration with saquinavir or erythromycin

Side Effects

NDC Code(s): 31722-709-05, 31722-709-30, 31722-710-01, 31722-710-05, view more31722-710-30, 31722-711-01, 31722-711-05, 31722-711-30 If you are a consumer or patient please visit this version. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to buy pills sildenafil use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS.SILDENAFIL tablets, for oral useInitial U.S. Approval: 1998INDICATIONS AND USAGESildenafil tablet is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) (1)DOSAGE AND ADMINISTRATION• For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, sildenafil tablets may be taken anywhere from 30 minutes to 4 hours before sexual activity (2.1)• Based on effectiveness and toleration, may increase to a maximum of 100 mg or decrease to 25 mg (2.1)• Maximum recommended dosing frequency is once per day (2.1)DOSAGE FORMS AND STRENGTHSTablets: 25 mg, 50 mg, 100 mg (3)CONTRAINDICATIONS• Administration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form.

Who should not take sildenafil?

Sildenafil tablets were 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 PRECAUTIONS• Patients should not use sildenafil tablets if sexual activity is inadvisable due to cardiovascular status (5.1)• Patients should seek emergency treatment if an erection lasts >4 hours. Use sildenafil tablets with caution in patients predisposed to priapism (5.2)• Patients should stop sildenafil tablets and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION). Sildenafil tablets should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a ”crowded” optic disc may also be at an increased risk of NAION. (5.3)• Patients should stop sildenafil tablets and seek prompt medical attention in the event of sudden decrease or loss of hearing (5.4)• Caution is advised when sildenafil tablets are co-administered with alpha-blockers or anti-hypertensives. increased plasma levels of sildenafil by about 3 fold [see Drug

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Interactions (7.4)and Clinical Pharmacology (12.3)].2.5 Dosage Adjustments in Special PopulationsConsider a

4.3 Concomitant Guanylate Cyclase (GC) Stimulators

You can take it up to 4 hours before you want to have sex. Taking sildenafil alone will not cause an erection. You need to be sexually excited for it to work. The most common side effects are headaches, feeling sick, indigestion and dizziness. Many people have no side effects or only mild ones.

Common side effects

It can be dangerous to take sildenafil if you also take medicines called nitrates (often given for chest pain). The combination can cause a dangerous fall in your blood pressure. If you're not sure if you're taking a nitrate, ask your doctor or pharmacist. Do not drink grapefruit juice if you're taking sildenafil (Revatio) for pulmonary hypertension. It affects the way the medicine works. starting dose of 25 mg in patients > 65 years, patients

8.2 Lactation

Concomitant use may lead to hypotension (5.5)• Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures. In patients taking strong CYP inhibitors, such as ritonavir, sildenafil exposure is increased. Decrease in sildenafil tablets dosage is recommended (2.4, 5.6)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 Hetero Labs Limited at 866-495-1995 or FDA at 1-800-FDA-1088 or INTERACTIONS• Sildenafil tablets 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 tablets at 25 mg dose (2.3)• CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase sildenafil tablets 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: 12/2025 Sildenafil tablet is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) (1) • For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, sildenafil tablets may be taken anywhere from 30 minutes to 4 hours before sexual activity (2.1) Tablets: 25 mg, 50 mg, 100 mg (3) • Administration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. Sildenafil tablets were shown to potentiate the hypotensive effect of nitrates ( 4.1, 7.1, 12.2) • Patients should not use sildenafil tablets if sexual activity is inadvisable due to cardiovascular status (5.1) Most common adverse reactions (≥ 2%) include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness and rash (6.1) • Sildenafil tablets can potentiate the hypotensive effects of nitrates, alpha blockers, and anti-hypertensives ( 4.1, 5.5, 7.1, 7.2, 7.3, 12.2) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Drug Interactions

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 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 Pregnancy: Teratogenic Effects8.2 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 STUDIES16 HOW SUPPLIED/STORAGE AND HANDLING17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed. Sections or subsections omitted from the full prescribing information are not listed. 2 DOSAGE AND ADMINISTRATION 2.1 Dosage InformationFor 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.2.3 Dosage Adjustments in Specific SituationsSildenafil 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)].2.4 Dosage Adjustments Due to Drug InteractionsRitonavirThe 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 InhibitorsConsider a starting dose of 25 mg in patients treated with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, or saquinavir) or erythromycin. with hepatic impairment (e.g., cirrhosis), and patients with severe renal

• Side effects may include dizziness, nasal congestion, or upset stomach.
• Alcohol can reduce the effectiveness of sildenafil.
• If an erection lasts more than 4 hours, seek medical help.
• The pink pill is sometimes used recreationally, which is risky.
• Do not take the pill if you have severe heart issues.
• Always check for medical hash compatibility before use.

impairment (creatinine clearance <30 mL/minute)

• Sildenafil works by inhibiting PDE5 enzyme activity.
• The pink pill typically lasts 4 to 6 hours.
• It’s essential to follow prescribed dosage instructions.
• Off-label uses include pulmonary hypertension treatment.
• The pill should be stored in a cool, dry place.
• Generic versions of sildenafil are usually cheaper.

because administration of sildenafil tablets in

Substance or Food	Effect on Sildenafil Absorption/Action	Recommendations
Alcohol	Can impair erections, increase side effects	Limit or avoid alcohol intake
Fatty Foods	Can delay onset of action	Take on an empty stomach for faster effect
Grapefruit Juice	Increases drug concentration	Avoid to prevent overdose risk
High-fat Meals	Reduce absorption rate	Take at least 1 hour before meals or on an empty stomach

these patients resulted in higher plasma levels of sildenafil [see Use

Condition or Medication	Risk Factors	Recommendations
Heart disease	Increased cardiovascular risk	Consult doctor before use
Nitrates medications	Severe hypotension	Do not combine with sildenafil
Liver or kidney impairment	Altered drug metabolism	Dose adjustments needed
Recent stroke or bleeding	Increased bleeding risk	Avoid or seek medical advice
Hypotension	Or fluctuating blood pressure	Use with caution

in Specific Populations ( 8.5, 8.6, 8.7)and Clinical Pharmacology ( 12.3)].

Dosage and Administration:

To learn more about Boston Clinical Trials and the studies we conduct, including Female Sexual Dysfunction, please click here. Sildenafil is a medicine used to treat erection problems (erectile dysfunction). Sildenafil is also sometimes used to treat pulmonary hypertension (high blood pressure in the blood vessels that supply the lungs). If you have erection problems sildenafil works by temporarily increasing blood flow to your penis when you get sexually excited. In pulmonary hypertension it works by relaxing blood vessels in the chest.

Drug information

If you buy sildenafil for erectile dysfunction, it can also be known by the brand names Viagra, Aronix, Liberize and Nipatra. Sildenafil for pulmonary hypertension can also be known by the brand names Revatio and Grandipam. This medicine is available on prescription and you can also buy it from most pharmacies. It comes as standard tablets, chewable tablets, and as a liquid that you swallow. It usually takes 30 to 60 minutes for sildenafil to work for erectile dysfunction.