Label: SILDENAFIL tablet Sildenafil > sildenafil 20 mg tablets Overdose/Missed Dose Liver Dose Adjustments Adverse Effects 5.2 Worsening Pulmonary Vascular Occlusive Disease 8.7 Patients with Renal Impairment Non-medical use Use with strong CYP3A inhibitors: Not recommended. Concomitant PDE-5 inhibitors: Avoid use with Viagra ®or other PDE-5 inhibitors. Overdose/Missed Dose (5.1)Use in pulmonary veno-occlusive disease (PVOD) may cause pulmonary edema and is not recommended. (5.2)Hearing or visual impairment: Seek medical attention if sudden decrease or loss of vision or hearing occurs. (5.4, 5.5)Pulmonary hypertension (PH) secondary to sickle cell disease: Sildenafil citrate canada sildenafil may cause serious vaso-occlusive crises. (5.8)ADVERSE REACTIONSDRUG INTERACTIONSUse with strong CYP3A inhibitors: Not recommended. ( 7, 12.3)Concomitant PDE-5 inhibitors: Avoid use with Viagra ®or other PDE-5 inhibitors. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Parameter Description Absorption Rapid, within 30-60 minutes Bioavailability Approximately 40% Metabolism Mainly hepatic via CYP3A4 enzyme Excretion Mainly in feces, some in urine Half-life About 4 hours Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE2 DOSAGE AND ADMINISTRATION2.1 Recommended Dosage in Adults3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS5 WARNINGS AND PRECAUTIONS5.1 Hypotension5.2 Worsening Pulmonary Vascular Occlusive Disease5.3 Epistaxis5.4 Visual Loss5.5 Hearing Loss5.6 Combination with other PDE-5 Inhibitors5.7 Priapism5.8 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Disease6 ADVERSE REACTIONS6.1 Clinical Trials Experience6.2 Post-marketing Experience7 DRUG INTERACTIONS8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.4 Pediatric Use8.5 Geriatric Use8.6 Patients with Hepatic Impairment8.7 Patients with Renal 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 20 mg tablets are available by prescription only.Common side effects include headaches, flushing, and nasal congestion.It is important to follow the prescribed dosage for safety.Avoid alcohol and high-fat meals when taking sildenafil.Consult a doctor if you experience sudden vision loss. 1 INDICATIONS AND USAGE AdultsSildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies (14)] .Pediatric use information is approved for Viatris Specialty LLC’s, REVATIO (sildenafil) tablets. 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Safe use of sildenafil requires assessment of heart conditions.It may cause temporary visual disturbances like blurred vision.Do not drive or operate machinery until effects are known.Use with caution if you have high or low blood pressure.Discuss any other medications with your healthcare provider. 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage in AdultsOral DosageThe recommended dosage of sildenafil tablet is 20 mg three times a day [see Clinical Studies (14)] .Pediatric use information is approved for Viatris Specialty LLC’s, REVATIO (sildenafil) tablets. Parameter Details Onset of Action 30-60 minutes Peak Effect About 1 hour Duration of Effect 4-6 hours Factors Influencing Food intake, alcohol, metabolism The recommended dosage of sildenafil tablet is 20 mg three times a day [see Clinical Studies (14)] . 4 CONTRAINDICATIONS Sildenafil tablets are contraindicated in patients with:Concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension [see Warnings and Precautions (5.1)] .Concomitant use of riociguat, a guanylate cyclase stimulator. Side Effect Frequency Severity Management Tips Headache Common Mild Hydration, pain relievers Flushing Common Mild Cool environment, relaxation Nasal Congestion Less frequent Mild Use of decongestants Dizziness Less frequent Mild Sit or lie down immediately Phosphodiesterase-5 (PDE-5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat.Known hypersensitivity to sildenafil or any component of the tablet. Liver Dose Adjustments Please note that our compounds are exclusively provided for individual patient and are not for office use. Your prescriber can mail or fax in the prescription You can mail in the original prescription We can contact your prescriber for you You can transfer your prescription from another pharmacy We have convenient ways to get your prescription to us: Fax to (800) 786-1405 or (844) 922-7379Send electronically (e-prescribe) by: Searching for CareFirst Specialty Pharmacy in Mount Laurel, NJ 08054Using our NCPDP# 3151266Phone into (844) 822-7379 Fax to (800) 786-1405 or (844) 922-7379 Send electronically (e-prescribe) by: Searching for CareFirst Specialty Pharmacy in Mount Laurel, NJ 08054Using our NCPDP# 3151266 Searching for CareFirst Specialty Pharmacy in Mount Laurel, NJ 08054 For more information about our products and services: Please complete the prescriber form onlineEmail us at [email protected] We are a nationally accredited PCAB compounding pharmacy and a .Pharmacy verified website. A verified .Pharmacy website designation ensures our patients and prescribing partners that our website is verified and safe. Please contact us if your pet needs a custom strength. Troches and suppositories require refrigeration (ice packs) and will incur an extra charge of $19.95 per order. Sildenafil vs. tadalafil 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: 1998INDICATIONS AND USAGEAdultsSildenafil tablets are a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening. (1)DOSAGE AND ADMINISTRATIONAdults: 20 mg three times a day. (2.1)DOSAGE FORMS AND STRENGTHSTablets: 20 mg (3)CONTRAINDICATIONSWARNINGS AND PRECAUTIONSVasodilation effects may be more common in patients with hypotension or on antihypertensive therapy. Sildenafil tablets are contraindicated in patients with: Concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension [see Warnings and Precautions (5.1)] . Adverse Effects Take sildenafil tablets at the same times every day. If it is close to your next dose, skip the missed dose, and take your next dose at the regular time. Do not change your dose or stop taking sildenafil tablets on your own. If you take too much sildenafil tablets, call your doctor or go to the nearest hospital emergency room. What are the possible side effects of sildenafil tablets? Oral Administration Lie down if you feel faint or dizzy. More shortness of breath than usual may be due to your underlying medical condition. decreased eyesight or loss of sight in one or both eyes (NAION). If you notice a sudden decrease or loss of eyesight, talk to your doctor right away. It is not possible to determine whether these events are related directly to this class of oral medicines, including sildenafil tablets, or to other diseases or medicines, to other factors, or to a combination of factors. Phosphodiesterase-5 (PDE-5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat. 5.2 Worsening Pulmonary Vascular Occlusive Disease Medicines are sometimes prescribed for purposes that are not in the patient leaflet. This patient leaflet summarizes the most important information about sildenafil tablets. You can ask your doctor or pharmacist for information about sildenafil tablets that is written for health professionals. For more information go to or call 1-855-361-3993. What are the ingredients in sildenafil tablets? Erectile Dysfunction This product’s label may have been updated. For current full prescribing information, please visit This Patient Information has been approved by the U.S. Food and Drug Administration Sildenafil is a vasodilator, which will relax blood vessels and increase blood flow to lungs and other specific organs. To process your order we will require a prescription from you or your Prescriber. We will only compound and dispense upon receipt of a valid patient specific prescription. Before prescribing sildenafil citrate, carefully consider whether patients with certain underlying conditions could be adversely affected by such vasodilatory effects (e.g., patients on antihypertensive therapy or with resting hypotension [blood pressure less than 90/50], fluid depletion, severe left ventricular outflow obstruction, or autonomic dysfunction). Most patients had underlying anatomic or vascular risk factors for developing NAION, including low cup to disc ratio (“crowded disc”).Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking sildenafil citrate.There are no controlled clinical data on the safety or efficacy of sildenafil citrate in patients with retinitis pigmentosa, a minority of whom have genetic disorders of retinal phosphodiesterases. 8.7 Patients with Renal Impairment heart attack, stroke, irregular heartbeats, and death. Most of these happened in men who already had heart problems. If it is not treated right away, priapism can permanently damage your penis. The most common side effects with sildenafil tablets include: Nosebleed, headache, upset stomach, getting red or hot in the face (flushing), trouble sleeping, as well as fever, erection increased, respiratory infection, nausea, vomiting, bronchitis, pharyngitis, runny nose, and pneumonia in children. Tell your doctor if you have any side effect that bothers you or doesn’t go away. Pulmonary hypertension These are not all the possible side effects of sildenafil tablets. For more information, ask your doctor or pharmacist. You may report side effects to FDA at 1-800-FDA-1088. Store sildenafil tablets at sildenafil 45 mg chewable tablets controlled room temperature, between 20°C to 25°C (68°F to 77°F). Keep sildenafil tablets and all medicines away from children. If priapism (painful erection greater than 6 hours in duration) is not treated immediately, penile tissue damage and permanent loss of potency could result.5.8 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell DiseaseIn a small, prematurely terminated study of patients with pulmonary hypertension (PH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported by patients who received sildenafil citrate than by those randomized to placebo. Non-medical use (5.6)Pediatric use information is approved for Viatris Specialty LLC’s, REVATIO (sildenafil) tablets. However, due to Viatris Specialty LLC’s marketing exclusivity rights, this drug product is not labeled with that information.See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 3/2026 Sildenafil tablets are a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening. Adults: 20 mg three times a day. Use in pulmonary veno-occlusive disease (PVOD) may cause pulmonary edema and is not recommended. Pulmonary hypertension (PH) secondary to sickle cell disease: Sildenafil citrate may cause serious vaso-occlusive crises. 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