Participants were randomly assigned to receive either 4 mL of ASP-001 or to 100 mg sildenafil tablets.
Usual Pediatric Dose for Pulmonary Hypertension
In particular, make sure that you discuss any of the following. Tell your healthcare provider if you have any of the following. Heart problems, such as heart rhythm problems, chest pain, or heart failure Heart attack, stroke, or heart surgery within the past six months High blood pressure that is still too high despite taking medicines for it Peyronie's disease, or a penis with an abnormal curve or shape An erection lasting longer than four hours A blood disorder, such as sickle cell anemia An inherited eye disease called retinitis pigmentosa Vision loss, or a problem with the nerve between your eyes and brain (optic nerve) Health conditions or factors that raise the risk of optic nerve problems, such as diabetes, high cholesterol, smoking, being older than 50, or having a “crowded disc,” which is something an eye doctor may see in an eye exam Pulmonary veno-occlusive disease, a condition where blood vessels in the lungs are blocked It is not known if or how sildenafil could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. Tell your healthcare provider if you are breastfeeding or plan to breastfeed.
Jet lag research
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. 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. All those included in the trial participated in at least a 10-hour fasting
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period and underwent a total of 24 plasma blood samples over 24 hours.
See also:
Any of the ingredients in the specific product dispensed Your pharmacist can tell you all of the ingredients in the specific sildenafil products they stock. Sildenafil should not be taken while you are using certain other medicines. Before taking sildenafil, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details. Do not take sildenafil unless it has been prescribed to you by a healthcare provider.
How were decisions on the relevance of primary studies made?
Do not share sildenafil with other people, even if they have the same condition as you. Keep sildenafil out of the reach of children. If you keep sildenafil oral liquid in a refrigerator, make sure to keep it away from children who also use the refrigerator. Sexual activity can put extra strain on your heart, which may be unsafe for people with certain health problems, such as a recent heart attack. Talk to your healthcare provider to see if your heart is strong enough for sex. 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
Information & Authors
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. 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.
Cardiovascular problems
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. 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. drug in participants’ plasma following an administration of the medication under both
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|---|---|---|---|---|
| Viagra | Pfizer | 25, 50, 100 mg | $10-$20 per pill | Most well-known sildenafil brand |
| Revatio | Pfizer | 20 mg (for PAH) | Varies | Approved for pulmonary hypertension |
| Sildenafil Sandoz | Sandoz (Novartis) | 50, 100 mg | Lower cost option | Generic version |
| Kamagra | Ajanta Pharma | 50, 100 mg | Lower cost | Popular generic alternative |
fed and fasted conditions.2 In total, the study plans to enroll 38 participants.
Comment in
This may occur along with dizziness and ringing in the ears. Stop taking sildenafil and get help right away if you have sudden hearing loss or suddenly have trouble hearing as well as usual. Sildenafil may cause a mild and temporary drop in blood pressure. You may be at a higher risk if you have certain health conditions or take blood pressure medicines. If you feel faint or dizzy, lie down.
Mechanism of Action
Tell your healthcare provider right away if you have any of the following symptoms of low blood pressure. You may be at higher risk for this if you take a blood thinner medicine. Tell your healthcare provider if you get nosebleeds often while taking sildenafil. If your nosebleed is severe or will not stop after applying pressure, get help right away. People who are allergic to any of the following should not take sildenafil. Sildenafil oral spray is currently approved in Spain, Germany, the Netherlands, Ireland, Mexico and the United Kingdom.
| 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 |
Aspargo now plans to file a new drug application with the FDA to support regulatory approval of ASP-001 in the United States.
Metrics & Citations
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 unsure what to do after a missed dose. This survey is being conducted by the WebMD marketing sciences department. 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.
Does sildenafil cause different side effects in females?
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. 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. Aspargo is also working on regulatory submissions to support approval of ASP-001 in
- Sildenafil can improve exercise capacity in pulmonary hypertension patients.
- Regular monitoring may be required for long-term use.
- Be aware of potential side effects related to blood pressure changes.
Japan as well as several countries in the Middle East and South America.
- Sildenafil is available by prescription only in most countries.
- The medication comes in various dosages, typically 25mg, 50mg, and 100mg.
- Adjust dosage as directed by your healthcare provider.
“Our innovative oral spray technology has been carefully developed to provide a
How should this medicine be used?
While less common, the most serious side effects of sildenafil are described below, along with what to do if they happen. Sildenafil may cause allergic reactions, which can be serious. Stop taking sildenafil and get help right away if you have any of the following symptoms of a serious allergic reaction. Swelling of the face, lips, mouth, tongue, or throat Itching, skin rash, or pale red bumps on the skin called hives Sildenafil may cause an unwanted erection that is persistent, painful, and that may occur without sexual arousal. Permanent damage to the penis may occur if priapism is not treated quickly.
Sildenafil, a novel effective oral therapy for male erectile dysfunction
Stop taking sildenafil and get emergency help if you have any of the following symptoms of priapism. Erection lasting for more than four hours Erection that is unrelated to sexual stimulation Sildenafil can cause mild, temporary vision changes such as seeing a blue tint, abnormal colors, blurry vision, or sensitivity to light. Though rare, some people have reported permanent vision loss. Stop taking sildenafil and get help right away if you have sudden vision loss in one or both eyes. Sudden hearing loss has been reported after taking sildenafil. 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
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If you feel chest pain, dizziness, or nausea during sex, stop and contact your healthcare provider right away. Sildenafil does not protect against sexually transmitted infections, including HIV. Sildenafil belongs to a group of medicines, known as phosphodiesterase-5 (PDE-5) inhibitors, which are used to treat erectile dysfunction or pulmonary arterial hypertension. You should not take more than one PDE-5 inhibitor medicine. Medicines in this group include avanafil (Stendra), sildenafil (Viagra, Revatio, and others), tadalafil (Cialis and others), and vardenafil (Levitra, Staxyn).
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Use an accurate measuring device to measure your dose of sildenafil oral liquid. A household spoon is not an accurate measuring device and may cause you to take the wrong dose. Ask your pharmacist to recommend an appropriate measuring device. Tell your healthcare provider about all of your sildenafil citrate tablets for female health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if sildenafil is right for you. provides evidence for the safety and pharmacokinetic profile of our oral spray technology.
| Parameter | Description | Typical Value | Notes |
|---|---|---|---|
| Absorption Rate | How quickly sildenafil enters bloodstream | Rapid | Peaks in 30-120 minutes |
| Bioavailability | Percentage of dose reaching systemic circulation | ~40% | Affected by food intake |
| Half-life | Time for plasma concentration to reduce by half | 3-5 hours | Determines dosing frequency |
| Peak Plasma Concentration | Maximum concentration after dose | 1 hour | Influenced by gastric emptying and food intake |