Sildenafil Citrate 50mg Tablet

Sildenafil > sildenafil citrate tablets 50 mg


Sildenafil citrate is contraindicated in patients with: Concomitant

Before taking this medicine

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 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.

Why it’s used

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. ( 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. use of organic nitrates in any form, either

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regularly or intermittently, because of the greater risk

Specifications Product specifications and dimensions

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. 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 vs. tadalafil

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. of hypotension [see Warnings and Precautions ( 5.1)] .

Side Effect Frequency Severity Notes
Headache Common Mild Usually temporary
Flushing Common Mild Sudden redness of face
Nasal Congestion Common Mild Runny nose
Dyspepsia (Indigestion) Less common Mild Heartburn, upset stomach
Dizziness Less common Mild When standing up quickly

Phosphodiesterase-5 (PDE5) inhibitors, including sildenafil, may

  • People with certain health conditions should consult their doctor before use.
  • Conditions include heart disease, low blood pressure, or kidney/liver issues.
  • Adjustments to dosage may be necessary based on health status.

potentiate the hypotensive effects of riociguat.

What other drugs will affect sildenafil?

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. However, tadalafil has a few distinctions from sildenafil. Tadalafil is the generic name for the erectile dysfunction drug Cialis.

Dosage Forms & Strengths

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. 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. Known hypersensitivity to sildenafil or any component of the tablet.

  • Sildenafil citrate tablets are part of a class called phosphodiesterase inhibitors.
  • They improve blood flow to achieve and sustain an erection.
  • The medication is not a cure for erectile dysfunction but treats symptoms.

5 WARNINGS AND PRECAUTIONS 5.1 HypotensionSildenafil citrate has vasodilatory

  • The medication's effectiveness may be reduced in men taking certain antidepressants.
  • Age can affect how the body responds to sildenafil.
  • Dose adjustments are sometimes necessary for older adults.

properties, resulting in mild and transient decreases in blood pressure.

Storage Condition Details Notes
Temperature Store at room temperature 20-25°C Protect from moisture
Light exposure Keep in original packaging Protect from light
Humidity Avoid humid environments Use dry area
Out of reach of children Keep in locked cabinets Safety precaution

Before prescribing sildenafil tablets, carefully consider whether patients with certain underlying

6.2 Postmarketing Experience

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. ( 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.

Dosage for pulmonary arterial hypertension (PAH)

o sildenafil film tablet ≤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. 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. conditions could be adversely affected by such vasodilatory effects (e.g., patients

Sildenafil Citrate Tablets 50mg Bottle 1000/Bottle Each 1453829

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) ]. The 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) ]. The recommended dosage in patients ≤20 kg is 10 mg three times a day.

Discover the Benefits of ABHA Card registration

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. 4 CONTRAINDICATIONS Sildenafil citrate is 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 ( 5.1)] .Concomitant use of riociguat, a guanylate cyclase stimulator. Phosphodiesterase-5 (PDE5) 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. on antihypertensive therapy or with resting hypotension [blood pressure less than 90/50], fluid depletion, severe left ventricular outflow obstruction, or autonomic dysfunction).

Brand Name Manufacturer Country of Origin Availability
Viagra Pfizer USA Widely available
Kamagra Ajanta Pharma India Limited markets
Sildenafil Sandoz Novartis Switzerland Prescription only
Revatio Pfizer USA For pulmonary hypertension
Bedrocan Canadian Medical Cannabis Canada Not for oral use