50mg Sildenafil Citrate Tablet

Use in pulmonary veno-occlusive disease (PVOD) may cause pulmonary edema and is not recommended.

• Sildenafil 50 mg tablets should be stored in a cool, dry place away from children.
• Do not crush or break the tablets; swallow whole with water.
• Avoid alcohol while taking sildenafil as it can increase side effects.

Hearing or visual impairment: Seek medical attention if sudden decrease or loss of vision or hearing occurs.

Mechanism of action

( 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. ( 5.2)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. 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.

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

8.1 Pregnancy

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

What are the serious side effects of sildenafil?

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. Are there any safety measures I should take before using this drug?

Sildenafil vs. tadalafil

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

• Sildenafil works by relaxing blood vessels in the penis.
• It requires sexual stimulation to be effective.
• Consult a doctor before starting to ensure safety.

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) ].

• 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.

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.

More about sildenafil

( 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. Vasodilation effects may be more common in patients with hypotension or on antihypertensive therapy. 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.

• The onset of action for sildenafil is usually within 30 to 60 minutes.
• The effect can last for up to 4-6 hours.
• The duration may vary depending on individual health and dosage.

A maximum dose in pediatric patients has not been identified.

How should I take sildenafil?

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. The downside, however, is that side effects tend to last longer too.

Why does Sildenafil Citrate cause a fall in blood pressure (hypotension)?

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. Disclaimer: Healthline has made every effort to make certain sildenafil citrate 150 mg red pill that all information is factually correct, comprehensive, and up to date.

More common

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. 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. 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) ].

Detection in biological fluids

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. A prescription for this medication is refillable.

Can I take Sildenafil Citrate in my twenties?

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. Don’t worry about airport X-ray machines.

Can I get Sildenafil Citrate without a prescription?

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