Oral sildenafil in the treatment of erectile dysfunction. Sildenafil Study Group

Store in a cool, dry place (room temperature or as labeled) Shake well before each use if suspension-based Use within 30–60 days of opening or per pharmacy guidance Faster absorption and onset than traditional tablets for some users Easier administration for those with pill aversion or dysphagia Supports personalized ED therapy or off-label vascular care Custom-compounded for purity and consistent concentration Sildenafil Drops – 100 mg in 30 mL Oral Liquid provide a convenient, precisely dosed alternative to traditional ED medications.

Whether used to manage erectile dysfunction, support vascular function, or enhance sexual wellness, this formulation offers flexibility, discretion, and clinical-grade reliability.

Custom-compounded for safety and absorption, it’s an ideal option for patients seeking personalized performance enhancement under medical guidance. Method of Preparation: Calculate the quantity of each ingredient for the amount to be prepared. Mix 50 mL of Ora-Plus with 50 mL of Ora-Sweet for use as the vehicle in this preparation. Obtain the required number of sildenafil citrate tablets or the required quantity of powder and place in a mortar. Pulverize the tablets, if used, to a fine powder. Add a small quantity of the Ora-Plus:Ora-Sweet mixture and mix to a smooth paste. Geometrically, add the remainder of the Ora-Plus:Ora-Sweet mixture to final volume and mix well. Use: Sildenafil citrate oral liquid has been used to treat pediatric pulmonary arterial hypertension in children in whom the risk-benefit profile of sildenafil is deemed acceptable. Packaging: Package in tight, light-resistant containers.1 Labeling: Keep out of reach of children.

Proper Use

Both the suspension and the solution were slightly pink and fruit-flavored. The suspension demonstrated stability for 91 days at both 4°C and 25°C; however, the solution was stable only for 30 days, possibly related to a nonredispersible sediment at the bottom of the container.3 A study by Nahata and colleagues that involved sildenafil citrate tablets (Revatio 20 mg) with a mixture of 1:1 Ora-Sweet and Ora-Plus at 2.5 mg/mL and pH 4.5-4.7 demonstrated stability of 91 days at both 4°C and 25°C. Also studied was a mixture of 1:7 (1% methyl cellulose:simple syrup) at pH 5.1 to 4.9 that also demonstrated stability of 91 days at both 4°C and 25°C.4 Sildenafil citrate (C22H30N6O4S.C6H8O7, MW 666.70) occurs as a white to off-white, crystalline powder that is soluble 3.5 mg/mL in water. It is formulated as tablets equivalent to 25 mg, 50 mg, and 100 mg of sildenafil for oral administration. The tablets also contain microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, lactose, triacetin, and FD&C Blue #2 Aluminum Lake.6,7 Ora-Plus is an oral suspending vehicle that accepts dilution of up to 50% or more with water, flavoring agents, or syrups while still retaining its suspending properties.

Advanced glycation end products in human penis

It has a pH of approximately 4.2 and an osmolality of about 230 mOsm/kg. It is a thixotropic vehicle with a viscosity of approximately 1,000 cps at 25°C. Ora-Plus contains purified water, microcrystalline cellulose, sodium carboxymethyl cellulose, xanthan gum, carrageenan, sodium phosphate, and citric acid as buffering agents; simethicone as an antifoaming agent; and potassium sorbate and methylparaben as preservatives.8 Ora-Sweet syrup vehicle is a flavoring vehicle for oral extemporaneous preparations. It is flavored with a citrus-berry flavor blend and contains glycerin and sorbitol to prevent cap lock, a problem associated with many syrups. It is buffered to a pH of approximately 4.2 and it has an osmolality of about 3,240 mOsm/kg.

Oral Administration

Rockville, MD: U.S. Pharmacopeial Convention, Inc; January 2018.2. Extemporaneous sildenafil citrate oral suspensions for the treatment of pulmonary hypertension in children. Design and physicochemical stability studies of paediatric oral formulations of sildenafil. Extended stability of morphine and sildenafil for oral use in infants and young children. Stability: A beyond-use date of up to 91 days may be used for this preparation.1-4 Quality Control: Quality-control assessment can include weight/volume, pH, specific gravity, active drug assay, color, rheologic properties/pourability, physical observation, and physical stability (discoloration, foreign materials, gas formation, mold growth).5 Discussion: A number of stability studies have been conducted on oral liquid formulations of sildenafil for pediatric use. From these, it appears that sildenafil is relatively stable in vehicles, with an acidic pH around 4 to 5. Sildenafil for oral suspension at 10 mg/mL (Revatio) is commercially available with a beyond-use date of 60 days after reconstitution. One study involved compounded sildenafil citrate in a citrate-buffered solution (0.1 M, pH 4) and either a syrup excipient (resulting in a suspension) or a sugar-free syrup excipient (resulting in a solution); both had pH values of approximately 4.2. Both the suspension and the solution were slightly pink and fruit-flavored. The suspension demonstrated stability for 91 days at both 4°C and 25°C; however, the solution was stable only for 30 days, possibly related to a nonredispersible sediment at the bottom of the container.3 A study by Nahata and colleagues that involved sildenafil citrate tablets (Revatio 20 mg) with a mixture of 1:1 Ora-Sweet and Ora-Plus at 2.5 mg/mL and pH 4.5-4.7 demonstrated stability of 91 days at both 4°C and 25°C. Also studied was a mixture of 1:7 (1% methyl cellulose:simple syrup) at pH 5.1 to 4.9 that also demonstrated stability of 91 days at both 4°C and 25°C.4 Sildenafil citrate (C22H30N6O4S.C6H8O7, MW 666.70) occurs as a white to off-white, crystalline powder that is soluble 3.5 mg/mL in water. It is formulated as tablets equivalent to 25 mg, 50 mg, and 100 mg of sildenafil for oral administration. The tablets also contain microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, lactose, triacetin, and FD&C Blue #2 Aluminum Lake.6,7 Ora-Plus is an oral suspending vehicle that accepts dilution of up to 50% or more with water, flavoring agents, or syrups while still retaining its suspending properties. It has a pH of approximately 4.2 and an osmolality of about 230 mOsm/kg. It is a thixotropic vehicle with a viscosity of approximately 1,000 cps at 25°C. Ora-Plus contains purified water, microcrystalline cellulose, sodium carboxymethyl cellulose, xanthan gum, carrageenan, sodium phosphate, and citric acid as buffering agents; simethicone as an antifoaming agent; and potassium sorbate and methylparaben as preservatives.8 Ora-Sweet syrup vehicle is a flavoring vehicle for oral extemporaneous preparations. It is flavored with a citrus-berry flavor blend and contains glycerin and sorbitol to prevent cap lock, a problem associated with many syrups. It is buffered to a pH of approximately 4.2 and it has an osmolality of about 3,240 mOsm/kg. Rockville, MD: U.S. Pharmacopeial Convention, Inc; January 2018.2. Extemporaneous sildenafil citrate oral suspensions for the treatment of pulmonary hypertension in children. Design and physicochemical stability studies of paediatric oral formulations of sildenafil. Extended stability of morphine and sildenafil for oral use in infants and young children.

Allen LV Jr. Standard operating procedure for performing physical quality assessment of oral and topical liquids. Bethesda, MD: American Society of Health-System Pharmacists; 2016:1918-1932.7. To comment on this article, contact rdavidson@uspharmacist.com. N Engl J Med 1998;339:59 Oral Sildenafil in the Treatment of Erectile Dysfunction Original Article, sildenafil spray N Engl J Med 1998:338;1397 - 1404 . On page 1397, the first sentence of the abstract should have read, “Sildenafil is a potent inhibitor of cyclic guanosine monophosphate hydrolysis in the corpus cavernosum,” not “a potent inhibitor of cyclic guanosine monophosphate in the corpus cavernosum,” as printed. Also, on page 1399, the second sentence under the heading “Results” should have read, “The men in the dose-escalation study had had erectile dysfunction for longer periods,” not “The men in the dose–response study,” as printed. Any commercial reuse of NEJM Group content requires permission. A novel standard‐free detection of adulteration method for sildenafil derivatives in dietary supplements, Biomedical Chromatography, 38, 8, (2024). Duplex ultrasonography and its role in the assessment of male sexual dysfunction, Male Sexual Dysfunction, (91-101), (2016).

• The medication may cause a sudden decrease in blood pressure in some users.
• Use sildenafil cautiously if you are also taking blood pressure medications.
• Do not share your medication with others to prevent misuse.

Vasodilatory and hypoglycaemic effects of two pyrano-isoflavone extractives from Eriosema kraussianum N. E. Br.

Usual Adult Dose for Erectile Dysfunction

Allen LV Jr. Standard operating procedure for performing physical quality assessment of oral and topical liquids. Bethesda, MD: American Society of Health-System Pharmacists; 2016:1918-1932.7. To comment on this article, contact rdavidson@uspharmacist.com. N Engl J Med 1998;339:59 Oral Sildenafil in the Treatment of Erectile Dysfunction Original Article, sildenafil spray N Engl J Med 1998:338;1397 - 1404 .

How does sildenafil work (mechanism of action)?

On page 1397, the first sentence of the abstract should have read, “Sildenafil is a potent inhibitor of cyclic guanosine monophosphate hydrolysis in the corpus cavernosum,” not “a potent inhibitor of cyclic guanosine monophosphate in the corpus cavernosum,” as printed. Also, on page 1399, the second sentence under the heading “Results” should have read, “The men in the dose-escalation study had had erectile dysfunction for longer periods,” not “The men in the dose–response study,” as printed. Any commercial reuse of NEJM Group content requires permission. A novel standard‐free detection of adulteration method for sildenafil derivatives in dietary supplements, Biomedical Chromatography, 38, 8, (2024). Duplex ultrasonography and its role in the assessment of male sexual dysfunction, Male Sexual Dysfunction, (91-101), (2016).

Journal of Urology

Vasodilatory and hypoglycaemic effects of two pyrano-isoflavone extractives from Eriosema kraussianum N. E. Br. Switching patients with erectile dysfunction from sildenafil citrate to tadalafil: Results of a European multicenter, open-label study of patient preference, Clinical Therapeutics, 25, 11, (2724-2737), (2003). Changing Practice Patterns in Erectile Dysfunction: A Diagnostic Algorithm for the New Millennium, Advances in Renal Replacement Therapy, 6, 4, (314-326), (1999). Switching patients with erectile dysfunction from sildenafil citrate to tadalafil: Results of a European multicenter, open-label study of patient preference, Clinical Therapeutics, 25, 11, (2724-2737), (2003).

• Sildenafil may cause dizziness; avoid driving until effects are known.
• Seek immediate medical help if an erection lasts more than 4 hours.
• Do not mix sildenafil with other ED medications unless directed.

Changing Practice Patterns in Erectile Dysfunction: A Diagnostic Algorithm for the New Millennium, Advances in Renal Replacement Therapy, 6, 4, (314-326), (1999). Applies to the following strengths: 10 mg/mL; 10 mg/12.5 mL; 20 mg; 25 mg; 50 mg; 100 mg; 75 mg TABLETS (Viagra) Initial dose: 50 mg orally once a day, as needed, about 1 hour prior to sexual activity Maintenance dose: May increase to 100 mg or decrease to 25 mg once a day, based on efficacy and tolerability.

What special dietary instructions should I follow?

Store in a cool, dry place (room temperature or as labeled) Shake well before each use if suspension-based Use within 30–60 days of opening or per pharmacy guidance Faster absorption and onset than traditional tablets for some users Easier administration for those with pill aversion or dysphagia Supports personalized ED therapy or off-label vascular care Custom-compounded for purity and consistent concentration Sildenafil Drops – 100 mg in 30 mL Oral Liquid provide a convenient, precisely dosed alternative to traditional ED medications. Whether used to manage erectile dysfunction, support vascular function, or enhance sexual wellness, this formulation offers flexibility, discretion, and clinical-grade reliability. Custom-compounded for safety and absorption, it’s an ideal option for patients seeking personalized performance enhancement under medical guidance. Method of Preparation: Calculate the quantity of each ingredient for the amount to be prepared. Mix 50 mL of Ora-Plus with 50 mL of Ora-Sweet for use as the vehicle in this preparation.

Medical Subject Headings Check Words

Obtain the required number of sildenafil citrate tablets or the required quantity of powder and place in a mortar. Pulverize the tablets, if used, to a fine powder. Add a small quantity of the Ora-Plus:Ora-Sweet mixture and mix to a smooth paste. Geometrically, add the remainder of the Ora-Plus:Ora-Sweet mixture to final volume and mix well. Use: Sildenafil citrate oral liquid has been used to treat pediatric pulmonary arterial hypertension in children in whom the risk-benefit profile of sildenafil is deemed acceptable.

Pulmonary Arterial Hypertension

Packaging: Package in tight, light-resistant containers.1 Labeling: Keep out of reach of children. Stability: A beyond-use date of up to 91 days may be used for this preparation.1-4 Quality Control: Quality-control assessment can include weight/volume, pH, specific gravity, active drug assay, color, rheologic properties/pourability, physical observation, and physical stability (discoloration, foreign materials, gas formation, mold growth).5 Discussion: A number of stability studies have been conducted on oral liquid formulations of sildenafil for pediatric use. From these, it appears that sildenafil is relatively stable in vehicles, with an acidic pH around 4 to 5. Sildenafil for oral suspension at 10 mg/mL (Revatio) is commercially available with a beyond-use date of 60 days after reconstitution. One study involved compounded sildenafil citrate in a citrate-buffered solution (0.1 M, pH 4) and either a syrup excipient (resulting in a suspension) or a sugar-free syrup excipient (resulting in a solution); both had pH values of approximately 4.2. Maximum dose: 100 mg orally once a day Comments: This drug may be taken anywhere from 30 minutes to 4 hours before sexual activity.

Study selection

TABLETS (Revatio)/ORAL SUSPENSION (Revatio, Liqrev): Initial dose: 20 mg orally 3 times a day Maintenance dose: May titrate up to 80 mg orally 3 times a day, if required, based on symptoms and tolerability. Maximum dose: 80 mg orally 3 times a day IV: 10 mg IV bolus 3 times a day Comments: No adjustment for body weight is required for IV dosing. The 10 mg IV bolus dose is predicted to provide an equivalent pharmacological effect to that of 20 mg orally. Doses up to a maximum of 80 mg orally 3 times a day are supported by delayed clinical worsening with long-term use in clinical studies despite a lack of observed dose-response improvement in exercise ability in short-term clinical studies. In adults 65 years or older, use caution with dose selection due to a higher incidence of compromised renal, cardiac, and/or hepatic function, and of concomitant disease or drug therapy.

Use: For the treatment of PAH (WHO Group I) to improve exercise ability and delay clinical worsening TABLETS (Viagra) Initial dose: 25 mg orally once a day, as needed, about 1 hour prior to sexual activity Maintenance dose: May titrate up to 100 mg orally once a day, based on effectiveness and toleration.

Renal Dose Adjustments

Applies to the following strengths: 10 mg/mL; 10 mg/12.5 mL; 20 mg; 25 mg; 50 mg; 100 mg; 75 mg TABLETS (Viagra) Initial dose: 50 mg orally once a day, as needed, about 1 hour prior to sexual activity Maintenance dose: May increase to 100 mg or decrease to 25 mg once a day, based on efficacy and tolerability. Maximum dose: 100 mg orally once a day Comments: This drug may be taken anywhere from 30 minutes to 4 hours before sexual activity. TABLETS (Revatio)/ORAL SUSPENSION (Revatio, Liqrev): Initial dose: 20 mg orally 3 times a day Maintenance dose: May titrate up to 80 mg orally 3 times a day, if required, based on symptoms and tolerability. Maximum dose: 80 mg orally 3 times a day IV: 10 mg IV bolus 3 times a day Comments: No adjustment for body weight is required for IV dosing. The 10 mg IV bolus dose is predicted to provide an equivalent pharmacological effect to that of 20 mg orally.

Cardiovascular problems

Doses up to a maximum of 80 mg orally 3 times a day are supported by delayed clinical worsening with long-term use in clinical studies despite a lack of observed dose-response improvement in exercise ability in short-term clinical studies. In adults 65 years or older, use caution with dose selection due to a higher incidence of compromised renal, cardiac, and/or hepatic function, and of concomitant disease or drug therapy. Use: For the treatment of PAH (WHO Group I) to improve exercise ability and delay clinical worsening TABLETS (Viagra) Initial dose: 25 mg orally once a day, as needed, about 1 hour prior to sexual activity Maintenance dose: May titrate up to 100 mg orally once a day, based on effectiveness and toleration. Maximum dose: 100 mg orally once a day Comments: This drug may be administered anywhere from 30 minutes to 4 hours before sexual activity. A reduced starting dose is recommended in older adults due to higher systemic exposure as compared to younger adults.

Revatio for Oral Suspension

TABLETS (Revatio)/ORAL SUSPENSION (Revatio) 1 to less than 18 years: Weight 20 kg or less: 10 mg orally 3 times a day Weight greater than 20 kg to 45 kg: 20 mg orally 3 times a day Weight greater than 45 kg: 20 mg orally 3 times a day; dose may be titrated up to a maximum of 40 mg orally 3 times a day, if required, based on symptoms and tolerability Use: For the treatment of pulmonary arterial hypertension (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standard exercise testing, pulmonary hemodynamics thought to underlie improvements in exercise ERECTILE DYSFUNCTION: Mild to Moderate Renal Dysfunction (CrCl 30 to 80 mL/min): No adjustment recommended Severe Renal Dysfunction (CrCl less than 30 mL/min): Consider a starting dose of 25 mg orally once a day, about 1 hour prior to sexual activity Mild, Moderate, or Severe Renal Dysfunction (CrCl 80 to less than 30 mL/min): No adjustment recommended ERECTILE DYSFUNCTION: Mild, Moderate, or Severe Liver Dysfunction (Child-Pugh A, B, or C): Consider a starting dose of 25 mg orally once a day, about 1 hour prior to sexual activity. Mild or Moderate Liver Dysfunction (Child-Pugh A or B): No adjustment recommended Severe Liver Dysfunction (Child-Pugh C): Data not available in this population. Initiate treatment with 25 mg orally once a day, as needed, about 1 hour prior to sexual activity Patients should be stable on alpha blocker therapy prior initiating treatment with this drug. Maximum dose: 100 mg orally once a day Comments: This drug may be administered anywhere from 30 minutes to 4 hours before sexual activity. A reduced starting dose is recommended in older adults due to higher systemic exposure as compared to younger adults. TABLETS (Revatio)/ORAL SUSPENSION (Revatio) 1 to less than 18 years: Weight 20 kg or less: 10 mg orally 3 times a day Weight greater than 20 kg to 45 kg: 20 mg orally 3 times a day Weight greater than 45 kg: 20 mg orally 3 times a day; dose may be titrated up to a maximum of 40 mg orally 3 times a day, if required, based on symptoms and tolerability Use: For the treatment of pulmonary arterial hypertension (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standard exercise testing, pulmonary hemodynamics thought to underlie improvements in exercise ERECTILE DYSFUNCTION: Mild to Moderate Renal Dysfunction (CrCl 30 to 80 mL/min): No adjustment recommended Severe Renal Dysfunction (CrCl less than 30 mL/min): Consider a starting dose of 25 mg orally once a day, about 1 hour prior to sexual activity Mild, Moderate, or Severe Renal Dysfunction (CrCl 80 to less than 30 mL/min): No adjustment recommended ERECTILE DYSFUNCTION: Mild, Moderate, or Severe Liver Dysfunction (Child-Pugh A, B, or C): Consider a starting dose of 25 mg orally once a day, about 1 hour prior to sexual activity. Mild or Moderate Liver Dysfunction (Child-Pugh A or B): No adjustment recommended Severe Liver Dysfunction (Child-Pugh C): Data not available in this population. Initiate treatment with 25 mg orally once a day, as needed, about 1 hour prior to sexual activity Patients should be stable on alpha blocker therapy prior initiating treatment with this drug.