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Since there are no clinical data on administration of sildenafil citrate to patients
8.4 Pediatric Use
Pulmonary hypertension (PH) secondary to sickle cell disease: Sildenafil citrate may cause serious vaso-occlusive crises. • Use with strong CYP3A inhibitors: Not recommended. 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.
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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. 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 are 20 mg three times a day. [see Clinical Studies (14)]Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) tablets. with veno-occlusive disease, administration of sildenafil citrate to such patients is not recommended.
- The medication may cause flushing and upset stomach in some users.
- Use with caution in elderly patients due to increased sensitivity.
- Monitor blood pressure regularly if prescribed for cardiovascular issues.
Should signs of pulmonary edema occur when sildenafil citrate is administered, consider the possibility of associated
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PVOD.5.3 EpistaxisThe incidence of epistaxis was 13% in patients taking sildenafil citrate with PAH secondary to CTD.
4.2 Hypersensitivity Reactions
A rapid micro quantification method of paracetamol in suppositories using differential scanning calorimetry. Tita B, Jurca T, Tita D. Thermal stability of pentoxifylline: active substance and tablets. Kumar N, Goindi S, Saini B, Bansal G. Thermal characterization and compatibility studies of itraconazole and excipients for development of solid lipid nanoparticles.
Sildenafil Tablets or Oral Suspension for PAH
Cordella C, Antinelli JF, Aurieres C, Faucon JP, Bass DC, Sbirrazzuoli N. Use of differential scanning calorimetry (DSC) as a new technique for detection of adulteration in honeys.1. Study of adulteration effect on honey thermal behavior. Detection of adulteration in Iranian olive oils using instrumental (GC, NMR, DSC) methods. Mansor TST, Man YBC, Shuhaimi M. This effect was not seen in idiopathic PAH (sildenafil 3%, placebo 2%) patients.
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Thermal analysis of the antiretroviral zidovudine (AZT) and evaluation of the compatibility with excipients used in solid dosage forms. The authors would like to thank the Malaysian National Pharmaceutical Control Bureau for their assistance, and the University of Malaya for the financial support for this project. Open Access This article is distributed under the terms of the Creative Commons Attribution License which permits any use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited. Fast detection of sildenafil in adulterated commercial products using differential scanning calorimetry. If you are a healthcare professional or from the pharmaceutical industry please visit this version.
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See full prescribing information for SILDENAFIL TABLETS.SILDENAFIL tablets, for oral useInitial U.S. Approval: 1998RECENT MAJOR CHANGESIndications and Usage (1) 1/2023Dosage and Administration (Error! Hyperlink reference not valid., 2.2) 1/2023INDICATIONS 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)DOSAGE AND ADMINISTRATION• Adults: 20 mg three times a day. Hyperlink reference not valid.) (2)DOSAGE FORMS AND STRENGTHS•Tablets: 20 mg (3)CONTRAINDICATIONSWARNINGS AND PRECAUTIONS•Vasodilation effects may be more common in patients with hypotension or on antihypertensive therapy. The incidence of epistaxis was also higher in sildenafil-treated patients
5.4 Hearing Loss
Employment of differential scanning calorimetry in detecting lard adulteration in virgin coconut oil. Detection of butter adulteration with water using differential scanning calorimetry. In: Analytical profiles of drug substances and excipients, vol 27. Moffat AC, Osselton MD, Widdop B. Clarke’s analysis of sildenafil tables drugs and poisons in pharmaceuticals, body fluids and postmortem material.
What should I know about sildenafil before taking it?
The Merck index: an encyclopedia of chemicals drugs and biologicals. Chapter 3: different thermal analysis and different scanning calorimetry. Thermal methods of analysis principles, applications and problems. Verma RK, Garg S. Compatibility studies isosorbide mononitrate and selected excipients used in the development of extended release formulations. with a concomitant oral vitamin K antagonist (9% versus 2%
8.1 Pregnancy
Therefore, it can be concluded that DSC can be used as a potential tool for fast detection of sildenafil in commercial products. Jung J, Hermanns-Clausen M, Weinmann W. Anorectic sibutramine detected in a chinese herbal drug for weight loss. Li L, Low MY, Lie X, Bloodworth BC, Koh HL. Isolation and structural elucidation of a new sildenafil analogue from a functional coffee.
Regulatory & Marketing
Cohen AP, Benner C, McCormick D. Use of a pharmaceutically adulterated dietary supplement, Pai You Guo, among Brazilian-born women in the United States. 2D and 3D 1H NMR, a useful tool for analysis of complex mixture: application to herbal drugs or dietary supplements for erectile dysfunction. Malaysian laws on poisons and sale of drugs: Sales of Drug Act 1952. Petaling Jaya: International Law Book Services; 2013. in those not treated with concomitant vitamin K antagonist).The safety
5.2 Worsening Pulmonary Vascular Occlusive Disease
(5.1)•Use in pulmonary veno-occlusive disease (PVOD) sildenafil products over the counter 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 INTERACTIONS• Use with strong CYP3A inhibitors: Not recommended. (7, 12.3)• Concomitant PDE-5 inhibitors: Avoid use with Viagra® or other PDE-5 inhibitors.
Does sildenafil interact with other medicines (drug interactions)?
(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: 9/2025 • 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 is not recommended. Hearing or visual impairment: Seek medical attention if sudden decrease or loss of vision or hearing occurs. of sildenafil citrate is unknown in patients with bleeding disorders or
- This medication can interact with certain antibiotics and antifungals.
- Never change dosage or frequency without medical advice.
- Continuous use should be monitored by a healthcare professional for safety.
active peptic ulceration.5.4 Visual LossWhen used to treat erectile dysfunction,
What happens if I overdose?
The recommended dosage of sildenafil tablets are 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, sildenafil 100mg blue pill including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil. 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)] .
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Phosphodiesterase-5 (PDE5) 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 citrate has vasodilatory properties, resulting in mild and transient decreases in blood pressure. Before prescribing sildenafil tablets, 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). Monitor blood pressure when co-administering blood pressure lowering drugs with sildenafil citrate.5.2 Worsening Pulmonary Vascular Occlusive DiseasePulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD). non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported postmarketing
- Sildenafil LP 100 mg may interact with nitrate medications.
- Do not use sildenafil tablets LP 100 mg if allergic to sildenafil.
- Report any severe side effects such as prolonged erection immediately.
in temporal association with the use of PDE-5 inhibitors, including sildenafil.
| Parameter | Value | Description | Observation |
|---|---|---|---|
| Absorption Time | 30-60 minutes | Time to reach peak plasma concentration | Typically within 1 hour |
| Bioavailability | ~40% | Fraction of dose reaching systemic circulation | Slightly reduced by food intake |
| Half-life | 4-5 hours | Time for blood concentration to reduce by half | Influences dosing frequency |
| Peak Plasma | 90-180 ng/mL | Maximum concentration after dose | Varies with individual factors |
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