17 PATIENT COUNSELING INFORMATION

Based on the experience in adults, dose may be titrated to a maximum of 40 mg three times a

Guideline	Description	Rationale
Take on an empty stomach	Preferably 1 hour before sexual activity	Slower absorption on high-fat meals
Avoid heavy alcohol consumption	Can impair effectiveness or cause side effects	Alcohol can cause vasodilation and hypotension
Do not exceed recommended dose	To prevent adverse effects	Overdose can cause serious health issues

day for pediatric patients >45 kg, if required, based on symptoms and tolerability [ see Clinical Studies ( 14) ].

Interacting Drug / Substance	Effect	Clinical Advice
Nitrates	Severe hypotension	Do not combine
Alpha-blockers	Possible hypotension	Use with caution
CYP3A4 inhibitors (e.g., ketoconazole)	Increased sildenafil levels	Adjust dosage accordingly

The recommended dosage of sildenafil tablets are 20 mg three times a day.

8.1 Pregnancy

Vyleesi targets melanocortin receptors, which are linked to sexual function. The drug modulates the brain pathways involved in sexual response. After 3 days of taking the medication, there is a steady level of the drug in the body. However, some people do not metabolize CYP2C19, an enzyme protein, effectively, and this can cause levels of the drug to build up, resulting in side effects. Vyleesi lasts around 2.7 hours, and the average time it takes to clear the body is 6.5 hours.

Sildenafil vs. tadalafil

The drug may slow how fast the body can process other medication. Vyleesi and Addyi treat FSIAD in premenopausal people. No research has tested the drug in people during or after menopause. The medications may be beneficial for premenopausal people who: Factors that are lined with a reduced sex drive in females include: certain health conditions, such as diabetes and heart disease The FDA-approved drugs for FSIAD can have the following side effects. The side effects of Addyi can include: those who have consumed alcohol in the last 2 hours The drug can cause severe low blood pressure and fainting in people who take it with alcohol or who have liver conditions. Dose may be titrated to a maximum of 80 mg three times a day,

Aspect	Sildenafil	Tadalafil
Onset of Action	30-60 minutes	30-60 minutes
Duration of Effect	Up to 4-6 hours	Up to 36 hours
Food Interaction	Affects absorption (better on empty stomach)	Less affected by food

if required, based on symptoms and tolerability [ see Clinical Studies ( 14) ].

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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

• Sildenafil tablets are mainly used in adult men with erectile dysfunction.
• Regular use of sildenafil tablets requires medical supervision for safety.
• Do not use sildenafil tablets if you are allergic to any of the ingredients.

of sildenafil in Study A1481324 supports dosing up to a maximum of 80 mg three times a day [ see Clinical Studies ( 14) ].

6.2 Post-marketing Experience

The FDA states that Vyleesi medication can treat FSIAD in premenopausal females. A person injects it into their thigh or stomach at least 45 minutes before having sex. The effects can last for up to 24 hours. People should not use the drug more than eight times per month. The table below compares Vyleesi and Addyi: Viagra is not FDA approved for use in females.

Does sildenafil interact with other medicines (drug interactions)?

To understand why, it can help to understand what Viagra was designed to do in the male body. Usually, after sexual stimulation in a male, there is a release of nitric oxide, which increases levels of a regulatory agent in cells called cyclic guanosine monophosphate (cGMP). This increase in cGMP causes smooth muscle relaxation, and it leads to increased blood flow to the penis, resulting in an erection. In males, an erection goes down when an enzyme called phosphodiesterase type 5 (PDE-5) breaks down. Anyone who would like to try Viagra should ask a medical professional, who may prescribe the drug off-label. The recommended dosage in patients ≤20 kg is 10 mg three times a day.

• Sildenafil tablets are used to treat erectile dysfunction by improving blood flow to the penis.
• Common dosages of sildenafil tablets include 25mg, 50mg, and 100mg.
• Always follow a healthcare provider’s instructions when taking sildenafil tablets.

For pediatric patients 20 kg to 45 kg, the recommended dosage is 20 mg three times a day.

Detection in biological fluids

( 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. 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 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. 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) ]. For pediatric patients 45 kg and greater, the recommended dosage is 20 mg three times a day.

2.2 Recommended Dosage in Pediatric Patients

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. 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 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. A maximum dose in pediatric patients has not been identified. 4 CONTRAINDICATIONS Sildenafil citrate is contraindicated in patients with:Concomitant use

Before Using

irritation or a rash at the injection site darkening of the skin, resulting in dark spots called hyperpigmentation on the gums, face and breasts Vyleesi may reduce the efficiency of oral medications due to slower emptying of the gastric system. It can also make drugs containing naltrexone to treat alcohol and opioid addiction less effective, so anyone taking a drug that contains naltrexone should avoid Vyleesi. Like other drugs, Vyleesi and Addyi can cause allergic reactions. Seek immediate medical help if symptoms of an allergic reaction or anaphylaxis occur. A person should speak with a doctor before taking any supplements to boost libido.

Alcohol interaction warning

The doctor can advise on the suitabilty of the products, and they may recommend medications such as Addyi and Vyleesi. Vyleesi (bremelanotide) and Addyi (flibanserin) can help treat female sexual interest/arousal disorder (FSIAD) in premenopausal people. The FDA has not approved Viagra for use in females. The FDA also advises against taking over-the-counter supplements that are marketed to boost libido. Medication may not treat pfizer sildenafil 100 all causes of low sexual desire. of organic nitrates in any form, either regularly or intermittently,

• Sildenafil tablets typically start working within 30 to 60 minutes after ingestion.
• The effects of sildenafil tablets can last up to 4-6 hours.
• Taking sildenafil with high-fat meals may delay its effectiveness.

because of the greater risk of hypotension [see Warnings and

Proper Use

A person can contact a doctor for advice on suitable medications and other ways to help improve their libido. NDC Code(s): 76420-613-30, 76420-613-60, 76420-613-90 If you are a consumer or patient please visit this version. See full prescribing information for SILDENAFIL TABLETS.SILDENAFIL tablets, for oral useInitial U.S. 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.

Dosage for erectile dysfunction (ED)

( 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. ( 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. Precautions ( 5.1)] .Concomitant use of riociguat, a guanylate cyclase stimulator.

• Sildenafil tablets can be found in various brand names like Viagra and generic versions.
• The shelf life of sildenafil tablets is typically 2-3 years if stored properly.
• Take sildenafil tablets approximately one hour before sexual activity for best results.