RECENT MAJOR CHANGES

Due to the Coronavirus (COVID-19) outbreak worldwide, the global demand for some Personal Protective Equipment (PPE) is exceeding current supply availability.

What Are Warnings and Precautions for Sildenafil?

Rarely, a sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness, may occur. Stop taking sildenafil and get medical help right away if these effects occur. Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur. Get medical help right away if you have any very serious side effects, including: increased shortness of breath or trouble breathing A very serious allergic reaction to this drug is rare.

What should I know about sildenafil before taking it?

However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: itching/swelling (especially of the face/tongue/throat) This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. You may report side effects to FDA at 1-800-FDA-1088 or at In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. Before taking sildenafil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

Before taking sildenafil,

This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (such as heart attack or life-threatening irregular heartbeat in the past 6 months, chest pain/angina, heart failure) penis conditions (such as angulation, fibrosis/scarring, Peyronie's disease) conditions that may increase the risk of priapism (such as sickle cell anemia, leukemia, multiple myeloma) eye problems (such as retinitis pigmentosa, sudden decreased vision, NAION) other lung conditions (such as pulmonary veno-occlusive disease) This drug may make you dizzy or cause vision problems. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. 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. 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. 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.

• Sildenafil 20 mg tablets are manufactured by several pharmaceutical companies.
• Generic versions are usually less expensive than brand-name options.
• The drug works by inhibiting phosphodiesterase type 5 enzyme.
• Patients should report any unusual symptoms promptly.
• It is important to have a proper diagnosis before starting treatment.

Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with NYHA Functional Class II-III symptoms.

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Etiologies were idiopathic (71%) or associated with connective tissue disease (25%).

• Sildenafil 20 mg tablets are sometimes used off-label for pulmonary hypertension.
• The medication can cause priapism, a painful, prolonged erection.
• Wait at least 24 hours before taking another dose.
• Avoid grapefruit juice, which can increase drug levels.
• Report any allergic reactions such as rash or difficulty breathing.

(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.

• 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.

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.

5.4 Visual Loss

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. 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. (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. (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.

Comparing Which Works Faster

Talk to your doctor if you are using marijuana (cannabis). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, sildenafil should be used only when clearly needed. Since high blood pressure in the lungs is a serious condition that can harm both a pregnant woman and her unborn baby, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, discuss with your doctor right away the benefits and risks of using this medication during pregnancy.

This medication requires a prescription.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug are: Sildenafil can cause a serious drop in your blood pressure when used with nitrates.

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A serious drop in blood pressure can lead to dizziness, fainting, and rarely heart attack or stroke. Do not use sildenafil with any of the following: certain drugs used to treat chest pain/angina (nitrates such as nitroglycerin, isosorbide) recreational drugs called "poppers" containing amyl or butyl nitrite If you are also taking an alpha blocker medication (such as doxazosin, tamsulosin) to treat an enlarged prostate/BPH or high blood pressure, your blood pressure may get too low which can lead to dizziness or fainting. 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). 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.

• 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.

Vasodilation effects may be more common in patients with hypotension or on antihypertensive therapy. Use in pulmonary veno-occlusive disease may cause pulmonary edema and is not recommended.

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

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.

Detection in biological fluids

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. 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. 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.

What should I know about storage and disposal of this medication?

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. 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.

Sildenafil may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

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. 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.

Usual Pediatric Dose for:

Do not double pfizer sildenafil 50 the dose to catch up. Store at room temperature away from light and moisture. 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.