Oral Sildenafil in the Treatment of Erectile Dysfunction

Sildenafil treats erectile dysfunction by increasing blood flow to the penis during sexual stimulation. This increased blood flow can cause an erection. Sildenafil treats PAH by relaxing the blood vessels in the lungs to allow blood to flow easily.

• Sildenafil is sometimes used off-label for other medical conditions.
• Continuous use without medical supervision is not recommended.
• Follow your provider's instructions for frequency of use.

If you are taking sildenafil to treat erectile dysfunction, you should know that it does not cure erectile dysfunction or increase sexual desire. Sildenafil does not prevent pregnancy or the spread of sexually transmitted diseases such as human immunodeficiency virus (HIV). Sildenafil comes as a tablet and suspension (liquid) to take by mouth. If you are taking sildenafil to treat erectile dysfunction, follow your doctor's directions and the guidelines in this paragraph. Take sildenafil as needed before sexual activity. The best time to take sildenafil is about 1 hour before sexual activity, but you can take the medication any time from 4 hours to 30 minutes before sexual activity.

What should I know about storage and disposal of this medication?

This may not be a complete list of medicines that can interact with sildenafil. If you or someone else has used too much sildenafil, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222. For this use, sildenafil is used only when needed. Take it as your healthcare provider recommends, which is usually between 30 minutes to four hours before planned sexual activity. Do not take double or extra doses.

Does sildenafil interact with foods or drinks?

For this use, take sildenafil as your healthcare provider recommends, which is usually three times a day. If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Ask your healthcare provider if you are sildenafil 100g unsure what to do after a missed dose. This survey is being conducted by the WebMD marketing sciences department. Sildenafil usually should not be taken more than once every 24 hours. If sildenafil syrup you have certain health conditions or are taking certain medications, your doctor may tell you to take sildenafil less often. You can take sildenafil with or without food.

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However, if you take sildenafil with a high-fat meal, it will take longer for the medication to start to work.

Further information

Aspargo plans to file a new drug application with the FDA to support regulatory approval of ASP-001 for erectile dysfunction in the United States. Findings from a recent phase 1 trial show that ASP-001, an investigational sildenafil oral spray for patients with erectile dysfunction, achieved therapeutic levels at a significantly faster rate compared with traditional sildenafil citrate tablets (Viagra), announced Aspargo Labs, the developer of the formulation, in a news release.1 “The rapid and enhanced absorption profile demonstrated by ASP-001 in this phase 1 study highlight its potential to address key unmet needs in the treatment of erectile dysfunction,” said Steven Kaplan, MD, Chief Medical Officer at Aspargo Labs, director of the Men’s Wellness Program at the Mount Sinai Health System, and a professor at the Icahn School of Medicine at Mount Sinai.1 “Many patients struggle with the inconvenience and lack of spontaneity associated with planning ahead to take a tablet and the requirement to fast or time their dosing. An oral spray formulation that achieves therapeutic levels quickly could represent a significant advancement in patient-centric therapy. If approved, ASP-001 would be a welcome addition to the treatment landscape, offering patients and their partners a novel and practical option to enhance their sexual health and overall quality of life.” Overall, data from the phase 1 study showed that ASP-001 achieved initial absorption within 5 minutes of administration. At this time point, the average amount of medication in the bloodstream was 0.615 ng/mL with ASP-001, vs 0 ng/mL with sildenafil tablets.

Medical Subject Headings (MeSH) Keywords

The average level of medication in the bloodstream via mean plasma concentrations remained higher for those who received ASP-001 vs those who received sildenafil tablets for the first 30 minutes following administration. In total, the open-label, single center, 2-way crossover study included 53 healthy, fasted male volunteers. Participants were randomly assigned to receive either 4 mL of ASP-001 or to 100 mg sildenafil tablets. All those included in the trial participated in at least a 10-hour fasting period and underwent a total of 24 plasma blood samples over 24 hours. In addition to the current phase 1 study, ASP-001 is also being assessed in a companion food-effect trial to compare the amount of active drug in participants’ plasma following an administration of the medication under both fed and fasted conditions.2 In total, the study plans to enroll 38 participants. If you are taking sildenafil to treat PAH, you will probably take sildenafil three times a day with or without food. Take sildenafil at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.

Brand names

Sildenafil oral spray is currently approved in Spain, Germany, the Netherlands, Ireland, Mexico and the United Kingdom. Aspargo now plans to file a new drug application with the FDA to support regulatory approval of ASP-001 in the United States. Aspargo is also working on regulatory submissions to support approval of ASP-001 in Japan as well as several countries in the Middle East and South America. “Our innovative oral spray technology has been carefully developed sildenafil spray to provide a novel approach for administering medication, simplifying the process of drug consumption,” said Michael Demurjian, CEO of Aspargo Labs, in the news release.1 “The study data provides evidence for the safety and pharmacokinetic profile of our oral spray technology. Our research has demonstrated that ASP-001 exhibits rapid absorption, surpassing the absorption rate of Viagra tablets in the initial minutes after administration.

Allergic reaction

We look forward to collaborating with the FDA to file an NDA for ASP-001 for the treatment of ED under the 505(b)2 regulatory pathway and are enthusiastic about the opportunity to make this drug available to patients in the US.” Aspargo Labs announces data on first oral spray for erectile dysfunction, ASP-001, showing two times faster absorption compared to Viagra tablets. Aspargo announces completion of dosing of all subjects in sildenafil oral suspension bioavailability study and initiation of dosing in companion food-effect study. Sildenafil (Viagra) is used to treat erectile dysfunction (impotence; inability to get or keep an erection) in men. Sildenafil (Liqrev, Revatio) is used to improve the ability to exercise in adults (Liqrev, Revatio) and children 1 year of age and older (Revatio) with pulmonary arterial hypertension (PAH; high blood pressure in the vessels carrying blood to the lungs, causing shortness of breath, dizziness, and tiredness). Sildenafil is in a class of medications called phosphodiesterase (PDE) inhibitors. Do not take more or less of it or take it more often than prescribed by your doctor. Shake the liquid well for 10 seconds before each use to mix the medication evenly. Use the oral syringe provided with your medication to measure and take your dose. Follow the manufacturer's directions to use and clean the oral syringe. Do not mix the liquid with other medications or add anything to flavor the medication.

Medical uses

Tell your healthcare provider if you are or plan to become pregnant. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should take sildenafil while breastfeeding. If you take sildenafil after you eat a high-fat meal, such as a burger and fries, it may take longer to start working. Your healthcare provider may recommend limiting or avoiding grapefruit while taking sildenafil.

Cessation and Adverse Effects of Treatment

Grapefruit or grapefruit juice can raise sildenafil levels in your body, which can increase the risk of side effects. There are no known interactions between sildenafil and alcohol. Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. In particular, make sure that you discuss if you are using any of the following before taking sildenafil. Tell your healthcare provider about all medicines that you take or have recently taken. If you are taking sildenafil for erectile dysfunction, your doctor will probably start you on an average dose of sildenafil and increase or decrease your dose depending on your response to the medication.

• Common side effects include headache, flushing, and nasal congestion.
• Serious side effects are rare but can include vision changes and priapism.
• Report any severe reactions to your doctor immediately.

Tell your doctor if sildenafil is not working well or if you are experiencing side effects. If you are taking sildenafil for PAH, you should know that sildenafil controls PAH but does not cure it. Continue to take sildenafil even if you feel well. Do not stop taking sildenafil without talking to your doctor. Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information. tell your doctor and pharmacist if you are allergic to sildenafil, any other medications, or any of the ingredients in sildenafil tablet or suspension. Ask your pharmacist for a list of the ingredients. Some medications should not be taken with sildenafil.

Dose (mg)	Typical Usage Frequency	Time to Onset (minutes)	Duration of Effect (hours)	Notes
50	Once or twice daily	30-60	4-6	Starting dose for most patients
100	Once daily	30-60	4-6	Common for moderate ED
25	As needed	30-60	4-6	For mild ED
10	As needed	30-60	4-6	Lower dose option

Make sure you have discussed any other medications you are currently taking or plan to take before starting sildenafil with your doctor and pharmacist.

• Sildenafil should not be used with certain medications like alpha-blockers.
• Avoid alcohol consumption when taking sildenafil to reduce side effects.
• Discuss all medications with your doctor to prevent interactions.

Before starting, stopping, or changing any medications while taking sildenafil, please get the advice of your doctor or pharmacist. tell your doctor if you are taking street drugs containing nitrates ('poppers') such as amyl nitrate, amyl nitrite, or butyl nitrate while taking sildenafil. Your doctor will tell you not to take sildenafil if you are taking street drugs containing nitrates. tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take.