43 Oral Sildenafil in the Treatment of Erectile Dysfunction
Tablets/IV solution: Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F). Oral suspension (liquid): Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
Database entry date
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.
Sildenafil Oral Film for ED
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. Oral suspension (powder): Store below 30C (86F) in the original package in order to protect from moisture.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Viagra Generic | 200mg | 180 + 10 Pills | 277.56€ 264.34€ | |
| Viagra Generic | 100mg | 180 + 8 Pills | 199.37€ 189.88€ | |
| Kamagra Soft Tabs | 100mg | 32 Pills | 120.11€ 114.39€ | |
| Kamagra Polo | 100mg | 272 + 12 Pills | 622.94€ 593.28€ | |
| Viagra Generic | 50mg | 30 + 4 Pills | 54.26€ 51.68€ | |
| Viagra Generic | 25mg | 270 + 8 Pills | 184.26€ 175.49€ | |
| Viagra Generic | 200mg | 20 Pills | 61.69€ 58.75€ | |
| Viagra Generic | 25mg | 180 + 6 Pills | 154.93€ 147.55€ | |
| Kamagra | 100mg | 120 + 6 Pills | 330.74€ 314.99€ | |
| Kamagra Oral Jelly | 100mg | 110 + 9 Sachets | 334.87€ 318.92€ | |
| Viagra Generic | 100mg | 10 Pills | 28.91€ 27.53€ |
After reconstitution, store below 30C (86F) or in refrigerator at 2C to 8C (36F to 46F); do not freeze.
Frequently asked questions
Administration with CYP450 3A4 Inhibitors (e.g., ketoconazole, itraconazole, saquinavir) or Erythromycin: Consider a starting dose of 25 orally once a day, as needed, about 1 hour prior to sexual activity. Recommended dose: 25 mg orally, as needed, about 1 hour prior to sexual activity Maximum dose: 25 mg orally within a 48 hour period Known hypersensitivity to either the active component or to any of the ingredients; hypersensitivity reactions have been reported, including rash and urticaria In patients who are using a guanylate cyclase (GC) stimulators, such as riociguat; phosphodiesterase type 5 inhibitors (PDE5), including this drug, may potentiate the hypotensive effects of GC stimulators. In patients who are using nitric oxide donors such as organic nitrates or organic nitrites in any form either regularly and/or intermittently; this drug has been shown to potentiate the hypotensive effects of nitrates based on its mechanism of action After patients have taken this drug for ED, it is unknown when nitrates, if necessary, can be safely administered. Although plasma levels of this drug at 24 hours post-dose are much lower than at peak concentration, it is unknown whether nitrates can be safely co-administered at this time point. Concomitant use of organic nitrates in any form, either regularly or intermittently, because of sildenafil 100 mg cost the greater risk of hypotension Concomitant use of riociguat, a guanylate cyclase stimulator; PDE5 inhibitors, including this drug, may potentiate the hypotensive effects of riociguat. Oral suspension (powder): Reconstitute with water (total 90
- Some men may experience minor flushing after taking sildenafil.
- If an adverse reaction occurs, stop medication and contact your doctor.
- Be aware of possible symptoms like sudden vision loss.
mL) in separate additions; shake vigorously after each addition.
Results of the review
An oral syringe is recommended for dose measurement (and delivery). Use within 60 days after reconstitution; discard any remainder after expiration. The liquid suspension is premixed and may contain flavoring. Shake well before oral administration and use a calibrated measuring device for accurate dosing. IV: Administer as an IV bolus injection; the supplied product is ready for use. Do not mix with other medications or flavoring; insert adaptor into bottle neck.
| Condition | Caution / Notes | Risk Factors |
|---|---|---|
| Cardiovascular disease | Use with caution | Heart failure, recent MI |
| Concomitant nitrate use | Absolute contraindication | Risk of severe hypotension |
| Severe hepatic impairment | May require dose adjustment | Reduced clearance |
| Retinitis Pigmentosa | Cautious use | Potential for vision disturbances |
Consult the manufacturer product information for detailed instructions.
Mechanism of action
Known hypersensitivity to either the active component or to any of the ingredients of the tablet, injection, or oral suspension; hypersensitivity reactions have been reported, including anaphylactic reaction, anaphylactic shock, and anaphylactoid reaction Safety and efficacy have not been established in patients with ED younger than 18 years. Safety and efficacy have not been established in patients with PAH younger than 1 year. Due to high plasma protein binding and poor elimination in urine, removal via hemodialysis is unlikely. Tablets: Administer orally with or without food. Reconstitute product before oral administration, and shake well before use. Cardiovascular: Cardiac status/risk factors (prior to initiation);
- Always consult a healthcare provider before starting sildenafil.
- Do not exceed the prescribed dose to avoid side effects.
- Sildenafil can interact with nitrates, causing dangerous blood pressure drops.
blood pressure (periodically during treatment in patients
Sildenafil Citrate 20 mg/mL, Oral Paste, 60mL Syringe
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). Vasodilatory and hypoglycaemic effects of two pyrano-isoflavone extractives from Eriosema kraussianum N. E. Br.
Clinical Uses
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). 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. with PAH on concomitant anti-hypertensive agents) Drug Interactions: For concomitant use of medications that may
Chemical synthesis
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.
Viagra Tablets
To blue sildenafil 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, 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. be contraindicated or for dose adjustment (at baseline and during treatment) Ocular: NAION risk factors
- Sildenafil's effects typically last for 4-6 hours.
- It does not increase sexual desire but enhances response.
- Onset of action can be affected by age and health status.
(prior to initiation) Read the US FDA-approved
Erratum in
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.
Sildenafil Tablets or Oral Suspension for PAH
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. patient labeling (Patient Information and/or Instructions for Use).
- 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.
