Sildenafil Oral Film: Package Insert / Prescribing Info

Sildenafil > sildenafil film tablet


Monitor blood pressure when co-administering blood pressure lowering drugs with sildenafil.5.2 Worsening Pulmonary Vascular Occlusive

  • Sildenafil film tablets are oral medications used to treat erectile dysfunction.
  • These tablets are smooth, coated, and designed for quick swallowing.
  • They contain sildenafil citrate as the active ingredient.

DiseasePulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD).

Why is this medication prescribed?

[see Clinical Studies (14)] .Pediatric use information is approved for Viatris Specialty LLC's, REVATIO ®(sildenafil) tablets. The recommended dosage of sildenafil pfizer sildenafil 50 tablets is 20 mg three times a day. 4 CONTRAINDICATIONS Sildenafil 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 (PDE-5) 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. Since there are no clinical data on administration of sildenafil to patients with veno-occlusive disease, administration of sildenafil to such patients is not recommended.

  • Sildenafil film tablets typically start working within 30-60 minutes.
  • The recommended dose varies, often 50mg before sexual activity.
  • Do not take more than one tablet per 24 hours.

Should signs of pulmonary edema occur when sildenafil is administered, consider the possibility of associated PVOD.5.3 EpistaxisThe incidence of epistaxis was 13% in patients taking sildenafil with PAH secondary to CTD. This effect was not seen in idiopathic PAH (sildenafil 3%, placebo 2%) patients.

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The incidence of epistaxis was also higher in sildenafil-treated patients with a concomitant oral vitamin K antagonist (9% versus 2%

Drug Class Interaction Effect
Nitrates Dangerous drop in blood pressure
Alpha-Blockers Enhanced hypotensive effect
CYP3A4 inhibitors (e.g., ketoconazole, erythromycin) Increased sildenafil levels
Other PDE5 inhibitors Risk of overdose and side effects

in those not treated with concomitant vitamin K antagonist).The safety of sildenafil is unknown in patients with bleeding disorders or active

  • Store sildenafil film tablets in a cool, dry place away from children.
  • Expiry date is stamped on the package; do not use expired medication.
  • Proper storage helps maintain drug efficacy and safety.

peptic ulceration.5.4 Visual LossWhen used to treat erectile dysfunction, non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision

3. Dosage Forms and Strengths

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)] . Phosphodiesterase-5 (PDE-5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat. Known hypersensitivity to sildenafil or any component of the tablet. 5 WARNINGS AND PRECAUTIONS 5.1 HypotensionSildenafil has vasodilatory properties, resulting in mild and transient decreases in blood pressure. Before prescribing sildenafil, carefully consider whether patients with certain underlying conditions could be adversely affected by such vasodilatory effects (e.g., patients on antihypertensive therapy or with resting hypotension [blood pressure less than 90/50], fluid depletion, severe left ventricular outflow obstruction, or autonomic dysfunction). including permanent loss of vision, has been reported post marketing in temporal association with the use of PDE-5 inhibitors, including sildenafil.

  • Possible interactions include medications for HIV, antibiotics, and blood pressure.
  • Overdose symptoms include severe headaches and chest pain.
  • Seek immediate medical attention if adverse reactions occur.

Most patients had underlying anatomic or vascular risk factors for developing NAION, including low cup to disc ratio (“crowded disc”).Advise patients to seek immediate medical attention in the event of a sudden loss of vision

Before Using

Adults: 20 mg three times a day. 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 sildenafil 100mg blue pill 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 may cause serious vaso-occlusive crises.

What’s the difference between sildenafil and Viagra?

Use with strong CYP3A inhibitors: Not recommended. Concomitant PDE-5 inhibitors: Avoid use with Viagra ®or other PDE-5 inhibitors. Pediatric use information is approved for Viatris Specialty LLC's, REVATIO ®(sildenafil) tablets. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Mechanism of Action

Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE2 DOSAGE AND ADMINISTRATION2.1 Recommended Dosage in Adults3 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 use information is approved for Viatris Specialty LLC's, REVATIO ®(sildenafil) tablets. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information . 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)] . 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage in AdultsOral DosageThe recommended dosage of sildenafil tablets is 20 mg three times a day. in one or both eyes while taking sildenafil.There are no controlled clinical data on the safety or

Drug Label Information

The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, sildenafil tablet manforce 50 mg or appropriate for all patients or all specific uses. If you are a consumer or patient please visit this version. HIGHLIGHTS OF PRESCRIBING INFORMATION Sildenafil TabletsThese 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.

Sildenafil Tablets for ED

Approval: 1998INDICATIONS AND USAGEAdultsSildenafil 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)DOSAGE AND ADMINISTRATIONAdults: 20 mg three times a day. ( 2.1)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.

4.2. Manufacturing of ODFs

( 5.4, 5.5)Pulmonary hypertension (PH) secondary to sickle cell disease: sildenafil may cause serious vaso-occlusive crises. ( 5.8)ADVERSE REACTIONSDRUG INTERACTIONSUse with strong CYP3A inhibitors: Not recommended. ( 7, 12.3)Concomitant PDE-5 inhibitors: Avoid use with Viagra ®or other PDE-5 inhibitors. ( 5.6)Pediatric use information is approved for Viatris Specialty LLC's, REVATIO ®(sildenafil) tablets. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 3/2024 Sildenafil 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. efficacy of sildenafil in patients with retinitis pigmentosa, a minority of whom have genetic disorders of retinal phosphodiesterases.

Further information

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.

Drug Interactions

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.

How is sildenafil supplied (dosage forms)?

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. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication.

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