Label: SILDENAFIL tablet

Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening.

Usual Adult Dose for Erectile Dysfunction

Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company. HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product.

Drugs you should not use with sildenafil

This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs. Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.

Other Medical Problems

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment. If you can't find what you were looking for, please contact us using one of the methods below so we can better serve you. Due to the Coronavirus (COVID-19) outbreak worldwide, the global demand for some Personal Protective oral sildenafil Equipment (PPE) is exceeding current supply availability. In addition, the manufacturing of the PPE and many other wound care/infection prevention products have been impacted by the global response to the Coronavirus. The delay in clinical worsening was demonstrated when sildenafil tablets were added to background epoprostenol therapy [see Clinical Studies (14)].

Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II-III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).

• 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.

2 DOSAGE AND ADMINISTRATION 2.1 Sildenafil TabletsOral 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.

However, due to Viatris Specialty LLC’s marketing exclusivity rights, this drug product is not labeled with that information.

8.2 Lactation

Your doctor may adjust your medications to minimize your risk of low blood pressure. Other medications can affect the removal of sildenafil from your body, which may affect how sildenafil works. Do not take this medication with any other product that contains sildenafil or other similar medications for erectile dysfunction-ED or pulmonary hypertension (such as tadalafil, vardenafil). If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away.

Looking for a Different Strength?

US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe dizziness, fainting, painful/prolonged erection. Do not share this medication with others. Lab and/or medical tests (such as eye exams, blood pressure) may be done while you are taking this medication.

How sildenafil is used

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up. Store at room temperature away from light and moisture. Pediatric use information is approved for Viatris Specialty LLC’s, REVATIO (sildenafil) tablets. 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 (5.2)] .Concomitant use of riociguat, a guanylate cyclase stimulator.

What Are Side Effects Associated with Using Sildenafil?

(5.9)ADVERSE REACTIONSMost common adverse reactions greater than or equal to 3% and more frequent than placebo were epistaxis, headache, dyspepsia, flushing, insomnia, erythema, dyspnea, and rhinitis. (6.1, 6.2)To report SUSPECTED ADVERSE REACTIONS, contact AvKARE, Inc. at 1-855-361-3993 or FDA at 1-800-FDA-1088 or INTERACTIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 10/2018 Warnings and Precautions, Visual Loss (5.5) 07/2017 Sildenafil tablets are a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise ability and delay clinical worsening. Tablet: 20 mg three times a day, 4 to 6 hours apart (2.1) Increased mortality with increasing doses in pediatric patients. Vasodilation effects may be more common in patients with hypotension or on antihypertensive therapy.

What is sildenafil used for?

Use in pulmonary veno-occlusive disease may cause pulmonary edema and is not recommended. Hearing or visual impairment: Seek medical attention if sudden decrease or loss of vision or hearing occurs. Pulmonary hypertension secondary to sickle cell disease: Sildenafil citrate may cause serious vaso-occlusive crises. Most common adverse reactions greater than or equal to 3% and more frequent than placebo were epistaxis, headache, dyspepsia, flushing, insomnia, erythema, dyspnea, and rhinitis. To report SUSPECTED ADVERSE REACTIONS, contact AvKARE, Inc.

Warnings for other groups

at 1-855-361-3993 or FDA at 1-800-FDA-1088 or See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*RECENT MAJOR CHANGES1 INDICATIONS AND USAGE2 DOSAGE AND ADMINISTRATION2.1 Sildenafil Tablets3 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 Anemia6 ADVERSE REACTIONS6.1 Clinical Trials Experience6.2 Postmarketing 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 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. 1 INDICATIONS AND USAGE Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when sildenafil tablets were added to background epoprostenol therapy [see Clinical Studies (14)].Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II-III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%). PDE-5 inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat.Known hypersensitivity to sildenafil or any component of the tablet. Hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil.

• Sildenafil 20 mg can interact with nitrates used for chest pain.
• Store tablets at room temperature, away from moisture.
• Do not crush or split the tablets; swallow whole.
• It is not recommended for use by women or children.
• Known for its rapid onset, usually within 30 minutes.

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 (5.2)] .

What other information should I know?

While you may see product availability reduction in the near-term, please be assured that we at McGuff Medical are continuing to work diligently to ensure an uninterrupted supply of products and alternative products to you. Additionally, in order to ensure healthcare providers have access to the PPEs they need, the McGuff Company is temporarily limiting PPEs to healthcare providers. As always, please feel free to reach out to our McGuff Customer Service team with any questions that you may have. If you are a consumer or patient please visit this version. HIGHLIGHTS OF PRESCRIBING INFORMATION Sildenafil Tablets, USPRx OnlyThese highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively.

What should I do if I accidentally use too much sildenafil?

See full prescribing information for SILDENAFIL TABLETS.SILDENAFIL tablets, for oral useInitial U.S. Approval: 1998RECENT MAJOR CHANGESWarnings and Precautions, Visual Loss (5.5) 07/2017INDICATIONS AND USAGESildenafil tablets are a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise ability and delay clinical worsening. Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with NYHA Functional Class II-III symptoms. Etiologies were idiopathic (71%) or associated with connective tissue disease (25%). (1)DOSAGE AND ADMINISTRATIONTablet: 20 mg three times a day, 4 to 6 hours apart (2.1)DOSAGE FORMS AND STRENGTHSTablets: 20 mg (3)CONTRAINDICATIONSWARNINGS AND PRECAUTIONSIncreased mortality with increasing doses in pediatric patients.

Patient resources

Not recommended for use in pediatric patients. (5.1)Vasodilation effects may be more common in patients with hypotension or on antihypertensive therapy. (5.2)Use in pulmonary veno-occlusive disease may cause pulmonary edema and is not recommended. (5.3)Hearing or visual impairment: Seek medical attention if sudden decrease or loss of vision or hearing occurs. (5.5, 5.6)Pulmonary hypertension secondary to sickle cell disease: Sildenafil citrate may cause serious vaso-occlusive crises.