11 DESCRIPTION

Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE2 DOSAGE AND ADMINISTRATION2.1 Recommended Dosage in Adults2.2 Recommended Dosage in Pediatric Patients3 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

5.5 Hearing Loss

Don’t worry about airport X-ray machines. You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled container with you. Don’t put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold.

Incidence not known

If you’re taking this drug for PAH, your doctor may monitor your blood pressure and pulse regularly. 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. 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.

• The medication can cause dizziness; avoid driving until effects are known.
• Be aware of possible vision disturbances such as blurred vision or sensitivity.
• Seek medical advice if vision changes persist or worsen.

Sections or subsections omitted from the full prescribing information are not listed.

• Certain health conditions, like retinitis pigmentosa, may contraindicate use of sildenafil.
• Always disclose your full medical history to your healthcare provider.
• Monitor for any unusual symptoms after taking the medication.

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 Patients (1 to 17 Years old)Sildenafil tablets are indicated

in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standardized exercise testing, pulmonary hemodynamics thought to underly improvements in exercise [ see Clinical Studies ( 14) ].

5.1 Hypotension

Sildenafil and tadalafil are alike because they both can treat ED and PAH. 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.

How is sildenafil supplied (dosage forms)?

The downside, however, is that side buy sildenafil citrate online canada effects tend to last longer too. 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 known as “the little blue pill” because of its blue color, while generic sildenafil tends to be a white color. Sildenafil 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 Patients (1 to 17 Years old) Sildenafil tablets are indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standardized exercise testing, pulmonary hemodynamics thought to underly improvements in exercise [ see Clinical Studies ( 14) ]. 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage in AdultsOral DosageThe recommended dosage of sildenafil tablets are 20 mg three times a day.

Route of administration

Sildenafil under the brand name Revatio is often prescribed to help adults with PAH get more exercise by treating their condition. 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.

Pulmonary hypertension

Are there any safety measures I should take before using this drug? 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. Dose may be titrated to a maximum of 80 mg three times a day, if required, based on symptoms and tolerability [ see Clinical Studies ( 14) ].Although dose-response improvement in exercise ability was not observed in short-term studies in adults with PAH, the delay in clinical worsening with long-term use of sildenafil in Study A1481324 supports dosing up to a maximum of 80

• Do not take sildenafil with heavy or fatty meals, as they can delay absorption.
• Regular physical activity can improve erectile function alongside medication.
• Maintain a healthy weight and lifestyle for better results.

mg three times a day [ see Clinical Studies ( 14) ].2.2 Recommended Dosage in Pediatric PatientsOral DosageThe recommended dosage in patients ≤20 kg is 10 mg three times a day.For pediatric patients 20 kg to 45 kg, the recommended dosage is 20 mg three times a day.For pediatric patients 45 kg and greater, the recommended dosage is 20 mg three times a day.

What happens if I miss a dose?

( 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 may cause serious vaso-occlusive crises. ( 5.8)ADVERSE REACTIONSDRUG INTERACTIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 9/2023 • Adults: 20 mg three times a day Dose may be increased based on symptoms and tolerability. o ≤20 kg: 10 mg three times a day o 20 kg to 45 kg: 20 mg three times a day o >45 kg: 20 mg three times a day. Dose may be increased based on symptoms and tolerability.

Can I take Sildenafil Citrate in my twenties?

Vasodilation effects may be more common in patients with hypotension or on antihypertensive therapy. Use in pulmonary veno-occlusive disease (PVOD) 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 (PH) secondary to sickle cell disease: Sildenafil citrate may cause serious vaso-occlusive crises. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. A maximum dose in pediatric patients has not been identified.

8.7 Patients with Renal Impairment

Take it at the same time every day. For ED: You can take this drug at any time of day. For PAH: Take this drug three times per day about 4–6 hours apart. Store sildenafil tablets at room temperature between 59°F and 86°F (15°C and 30°C). Don’t store this medication in moist or damp areas, such as bathrooms.

Before taking sildenafil,

A prescription for this medication is refillable. You should not need a new prescription for this medication to be refilled. Your doctor will write the number of refills authorized on your prescription. When flying, never put it into a checked bag. Keep it in your carry-on bag. Based on the experience in adults, dose may be titrated to a maximum of 40 mg three times a day for pediatric patients >45 kg, if required, based on symptoms and tolerability [ see Clinical Studies ( 14) ].

Before Using

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up to date. You should always consult your doctor or other healthcare professional before taking any medication. NDC Code(s): 76420-613-30, 76420-613-60, 76420-613-90 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 use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS.SILDENAFIL tablets, for oral useInitial U.S.

More common

Approval: 1998INDICATIONS AND USAGEAdultsSildenafil citrate is 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)Pediatric Patients (1 to17 years old)Sildenafil tablet is indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standard exercise testing, pulmonary hemodynamics thought to underly improvements in exercise ( 1, 14)DOSAGE AND ADMINISTRATION• Adults: 20 mg three times a day Dose may be increased based on symptoms and tolerability. ( 2.1)• Pediatric patients (2.2)o ≤20 kg: 10 mg three times a dayo 20 kg to 45 kg: 20 mg three times a dayo >45 kg: 20 mg three times a day. Dose may be increased based on symptoms and tolerability.DOSAGE FORMS AND STRENGTHSTablets :20 mg ( 3)CONTRAINDICATIONSWARNINGS AND PRECAUTIONSVasodilation effects may be more common in patients with hypotension or on antihypertensive therapy. ( 5.1)Use in pulmonary veno-occlusive disease (PVOD) may cause pulmonary edema and is not recommended.