VIAGRA® (sildenafil citrate)
Help may be on the way for Viagra users who like how the little blue pill works for them but wish it were quicker to take effect. Researchers have found that sildenafil, the active ingredient in Viagra, delivered in the form of a mouth or nasal spray produces results in just over a minute, a big improvement over the 30 to 60 minutes it now takes Viagra to become effective. The spray doesn’t boast the same duration of action — four or five hours — as Viagra in pill form, but it does allow greater spontaneity and reportedly remains effective for up to 90 minutes, which should allow more than enough time for sexual activity for all but the hardiest of men.
12. Sildenafil Oral Suspension - Clinical Pharmacology
The Taiwanese study, confined to laboratory and animal testing, found that sublingual delivery (a couple of squirts under the tongue) of sildenafil produced significantly higher bioavailability of the active ingredient at lower doses. It noted that earlier studies of nasal spray applications of sildenafil also produced higher bioavailability of the active ingredient, because both nasal and sublingual sprays bypassed liver metabolism of the drug, which sharply reduces bioavailability. Findings from the Taiwanese study were very similar to those reported from the pilot clinical trials of SUD-003 (DuroMist) in Australia. In those trials, researchers found that two 10-milligram sprays of the drug produced the same bioavailability of the active ingredient as a single 25-milligram tablet of the drug. Three 10-milligram sprays (30 milligrams in all) of SUD-003 produced systemic exposure that was 40 percent greater than that produced by a 25-milligram tablet.
More common
The implications for potential users of these alternative delivery methods, should they become available, are significant. Interviewed for an article posted at the website of The Sun in the United Kingdom, Doug Savage, M.D., a specialist in the treatment of male sexual dysfunction, said the spontaneity afforded by such drugs, “would definitely be welcomed by many men with erectile problems.” Although it would appear that delivery of sildenafil by mouth or nasal spray is slowly but surely moving closer to becoming a reality, it should be noted that these innovative delivery systems have been in the works for several years. NovaDel, which originally developed the SUD-003 spray system, sildenafil film tablet conducted preliminary testing as far back as 2010. If you would like to stay abreast of the latest developments on the consumer health front, check out our blog. We specialize in providing our over 1,000,000 customers with relevant product and condition information created by our professional editorial staff which includes our team of medical writers, medical practitioners, and health educators.
Hezkue dosage
Package insert / product label Generic name: sildenafil citrate Dosage form: powder, for oral suspension Drug classes: Agents for pulmonary hypertension, Impotence medications Adults Sildenafil 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. Pediatric Patients (1 to 17 years old) Sildenafil for oral suspension is indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (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 (1, 14) Adults: 20 mg orally three times a day. Dose may be increased based on symptoms and tolerability. Pediatric patients (2.2) ≤ 20 kg: 10 mg three times a day20 kg to 45 kg: 20 mg three times a day> 45 kg: 20 mg three times a day. ≤ 20 kg: 10 mg three times a day 20 kg to 45 kg: 20 mg three times a day > 45 kg: 20 mg three times a day. And if the spray is eventually approved, it will offer yet another form of treatment for men with erectile dysfunction. News about some form of Viagra mouth spray has been breaking on multiple fronts. From Taiwan come the results of an animal study that showed low doses of sildenafil mixed with food-grade propylene glycol produced the desired results in rabbits when squirted under the animals’ tongues. Positive results were seen 78 seconds after the spray was administered. SUDA Ltd., based in Osborne Park, Western Australia, announced that it is moving ahead on discussions with the U.S.
| Side Effect | Mild | Moderate | Severe | Notes |
|---|---|---|---|---|
| Headache | ✓ | Common initial side effect | ||
| Nasal Congestion | ✓ | Due to vasodilation effects | ||
| Dizziness | ✓ | Especially if taken on empty stomach | ||
| Priapism (Prolonged Erection) | ✓ | Medical emergency | ||
| Changes in Vision | ✓ | Visual disturbances, usually temporary |
Food and Drug Administration about its SUD-003 oral spray formulation of sildenafil, which was patented in Australia in early 2015. SUDA acquired rights to the oral sildenafil application, then code-named NVD-401, when it acquired virtually all the assets, including intellectual property, of New Jersey-based NovaDel Pharma Inc. in July 2013. The Australian company has already completed pilot clinical trials on SUD-003, which would be marketed under the brand name DuroMist. Those trials, conducted with a study group of 24 healthy adult male subjects, were designed “to assess the relative bioavailability and safety of one, two, and three sprays of 10-milligram/0.12-milliliter of DuroMist, compared to a 25-milligram Viagra tablet.” In the introduction to the Taiwanese study, published in the September 2016 issue of “Journal of Pharmaceutical Sciences,” the research team enumerates some of the drawbacks of sildenafil in pill form, which is the only form now on the market.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Viagra Generic | 50mg | 360 + 10 Pills | 225.33€ 214.60€ | |
| Viagra Generic | 100mg | 360 + 10 Pills | 330.21€ 314.49€ | |
| Viagra Generic | 200mg | 60 + 4 Pills | 125.19€ 119.23€ | |
| Viagra Generic | 150mg | 120 + 8 Pills | 177.58€ 169.12€ | |
| Viagra Generic | 100mg | 270 + 10 Pills | 270.47€ 257.59€ | |
| Kamagra | 100mg | 84 + 6 Pills | 264.44€ 251.85€ | |
| Kamagra Polo | 100mg | 84 + 4 Pills | 244.49€ 232.85€ | |
| Kamagra Oral Jelly | 100mg | 63 + 7 Sachets | 224.18€ 213.50€ | |
| Viagra Generic | 25mg | 60 + 4 Pills | 71.99€ 68.56€ | |
| Kamagra Oral Jelly | 100mg | 10 Sachets | 54.55€ 51.95€ | |
| Kamagra Polo | 100mg | 180 + 8 Pills | 446.52€ 425.26€ | |
| Viagra Generic | 25mg | 120 + 6 Pills | 125.56€ 119.58€ |
These include a first-pass effect of 70 percent (the amount of the active ingredient that is metabolized and never becomes bioavailable or systemically active), slow onset of action, and multiple adverse side effects. Among the side effects experienced with higher doses (greater than 50 milligrams) of sildenafil in pill form are dizziness, loss of consciousness, diarrhea, abnormal vision, nasal congestion, upset stomach, rash, increase in urinary tract infections, and cardiac risk.
All substitutes
For pediatric patients 20 kg to 45 kg, the recommended dosage is 20 mg three times a day. For pediatric patients 45 kg and greater, the recommended dosage is 20 mg three times a day. A maximum dose in pediatric patients has not been identified. Based on the experience in adults, dose may be titrated to a maximum of 40 mg three times a day for pediatric patients > 45 kg, if required, based on symptoms and tolerability [see Clinical Studies (14)]. Note: Reconstitute the contents of the bottle with a total volume of 90 mL (60 mL followed by 30 mL).
1. Delay sprays (lidocaine/benzocaine)
Tap the bottle to loosen the powder. Add 60 mL of water to the bottle. Replace the cap and shake the bottle vigorously for a minimum of 30 seconds. Add another 30 mL of water to the bottle. Remove cap and press the bottle adaptor into the neck of the bottle. The Taiwanese study, confined to laboratory and animal testing, found that sublingual delivery (a couple of squirts under the tongue) of sildenafil produced significantly higher bioavailability of the active ingredient at lower doses. It noted that earlier studies of nasal spray applications of sildenafil also produced higher bioavailability of the active ingredient, because both nasal and sublingual sprays bypassed liver metabolism of the drug, which sharply reduces bioavailability. Findings from the Taiwanese study were very similar to those reported from the pilot clinical trials of SUD-003 (DuroMist) in Australia.
- Sildenafil spray utilizes absorption through oral mucosa.
- It provides a discreet alternative for erectile issues.
- Use the spray about 10-20 minutes before intimacy.
- It generally has fewer gastrointestinal side effects.
- The spray must be kept out of reach of children.
- Users should avoid alcohol to prevent adverse reactions.
- Compatibility with other medications should be checked.
- The spray may be part of a comprehensive ED treatment plan.
- Discontinue use and consult a doctor if adverse reactions occur.
- The spray’s effectiveness can improve confidence in men.
- Training on proper application enhances safety and effectiveness.
In those trials, researchers found that two 10-milligram sprays of the drug produced the same bioavailability of the active ingredient as a single 25-milligram tablet of the drug. Three 10-milligram sprays (30 milligrams in all) of SUD-003 produced systemic exposure that was 40 percent greater than that produced by a 25-milligram tablet.
When to Seek Professional Advice
Help may be on the way for Viagra users who like how the little blue pill works for them but wish it were quicker to take effect. Researchers have found that sildenafil, the active ingredient in Viagra, delivered in the form of a mouth or nasal spray produces results in just over a minute, a big improvement over the 30 to 60 minutes it now takes Viagra to become effective. The spray doesn’t boast the same duration of action — four or five hours — as Viagra in pill form, but it does allow greater spontaneity and reportedly remains effective for up to 90 minutes, which should allow more than enough time for sexual activity for all but the hardiest of men. And if the spray is eventually approved, it will offer yet another form of treatment for men with erectile dysfunction. News about some form of Viagra mouth spray has been breaking on multiple fronts.
Sprays vs. Supplements
From Taiwan come the results of an animal study that showed low doses of sildenafil mixed with food-grade propylene glycol produced the desired results in rabbits when squirted under the animals’ tongues. Positive results were seen 78 seconds after the spray was administered. SUDA Ltd., based in Osborne Park, Western Australia, announced that it is moving ahead on discussions with the U.S. Food and Drug Administration about its SUD-003 oral spray formulation of sildenafil, which was patented in Australia in early 2015. SUDA acquired rights to the oral sildenafil application, then code-named NVD-401, when it acquired virtually all the assets, including intellectual property, of New Jersey-based NovaDel Pharma Inc.
8.4 Pediatric Use
in July 2013. The Australian company has already completed pilot clinical trials on SUD-003, which would be marketed under the brand name DuroMist. Those trials, conducted with a study group of 24 healthy adult male subjects, were designed “to assess the relative bioavailability and safety of one, two, and three sprays of 10-milligram/0.12-milliliter of DuroMist, compared to a 25-milligram Viagra tablet.” In the introduction to the Taiwanese study, published in the September 2016 issue of “Journal of Pharmaceutical Sciences,” the research team enumerates some of the drawbacks of sildenafil in pill form, which is the only form now on the market. These include a first-pass effect of 70 percent (the amount of the active ingredient that is metabolized and never becomes bioavailable or systemically active), slow onset of action, and multiple adverse side effects. Among the side effects experienced with higher doses (greater than 50 milligrams) of sildenafil in pill form are dizziness, loss of consciousness, diarrhea, abnormal vision, nasal congestion, upset stomach, rash, increase in urinary tract infections, and cardiac risk. The implications for potential users of these alternative delivery methods, should they become available, are significant. Interviewed for an article posted at the website of The Sun in the United Kingdom, Doug Savage, M.D., a specialist in the treatment of male sexual dysfunction, said the spontaneity afforded by such drugs, “would definitely be welcomed by many men with erectile problems.” Although it would appear that delivery of sildenafil by mouth or nasal spray is slowly but surely moving closer to becoming a reality, it should be noted that these innovative delivery systems have been in the works for several years.
- Sildenafil spray is a modern alternative for ED therapy.
- It reduces the waiting time before sexual activity.
- The spray is generally well-tolerated with proper use.
- It might be prescribed for specific health conditions.
- The method of administration differs from oral tablets.
- Use of the spray should be coordinated with a doctor.
- It can be used alongside other treatments under supervision.
- The spray dose can be adjusted for optimal response.
- Patients should report any unusual symptoms promptly.
- Sildenafil spray offers privacy compared to other methods.
- Read all warnings and precautions on product packaging.
NovaDel, which originally developed the SUD-003 spray system, sildenafil film tablet conducted preliminary testing as far back as 2010. If you would like to stay abreast of the latest developments on the consumer health front, check out our blog. We specialize in providing our over 1,000,000 customers with relevant product and condition information created by our professional editorial staff which includes our team of medical writers, medical practitioners, and health educators. Package insert / product label Generic name: sildenafil citrate Dosage form: powder, for oral suspension Drug classes: Agents for pulmonary hypertension, Impotence medications Adults Sildenafil 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. Pediatric Patients (1 to 17 years old) Sildenafil for oral suspension is indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (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 (1, 14) Adults: 20 mg orally three times a day.
| Condition | Risk | Recommendation |
|---|---|---|
| Use of Nitrates | Severe hypotension | Do not use |
| Cardiovascular Diseases | Increased risk of adverse effects | Consult a doctor |
| Allergy to Sildenafil or components | Allergic reaction | Avoid use |
| Severe Liver or Kidney Impairment | Altered drug metabolism | Medical clearance required |
Dose may be increased based on symptoms and tolerability. Pediatric patients (2.2) ≤ 20 kg: 10 mg three times a day20 kg to 45 kg: 20 mg three times a day> 45 kg: 20 mg three times a day.
Important Considerations Before Using Impotence Sprays
Injection (Adults): 10 mg three times a day administered sildenafil products over the counter as an intravenous bolus injection. For oral suspension: 10 mg/mL (when reconstituted) (3) 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. Pulmonary hypertension (PH) secondary to sickle cell disease: Sildenafil may cause serious vaso-occlusive crises.
Hassle-Free Exchanges
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Sildenafil for oral suspension is 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 Patients (1 to 17 Years Old) Sildenafil for oral suspension is indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standardized exercise testing, pulmonary hemodynamics thought to underlie improvements in exercise [see Clinical Studies (14)]. The recommended dosage of sildenafil for oral suspension is 20 mg three times a day. Dose may be titrated to a maximum of 80 mg three times a day, if required, based on symptoms and tolerability [see Clinical Studies (14)].
Hezkue FAQs
Although dose-response improvement in exercise ability was not observed in short-term studies in adults with PAH, the delay in clinical worsening with long-term use of sildenafil in Study A1481324 supports dosing up to a maximum of 80 mg three times a day [see Clinical Studies (14)]. The recommended dose is 10 mg administered as an intravenous bolus sildenafil otc injection three times a day. The dose of sildenafil injection does not need to be adjusted for body weight. A 10 mg dose of sildenafil injection is predicted to provide pharmacological effect of sildenafil and its N-desmethyl metabolite equivalent to that of a 20 mg oral dose. The recommended dosage in patients ≤ 20 kg is 10 mg three times a day. ≤ 20 kg: 10 mg three times a day 20 kg to 45 kg: 20 mg three times a day > 45 kg: 20 mg three times a day. Injection (Adults): 10 mg three times a day administered sildenafil products over the counter as an intravenous bolus injection. For oral suspension: 10 mg/mL (when reconstituted) (3) 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. Pulmonary hypertension (PH) secondary to sickle cell disease: Sildenafil may cause serious vaso-occlusive crises.
Delivery Options
Write the expiration date of the reconstituted oral suspension on the bottle label (the expiration date of the reconstituted oral suspension is 60 days from the date of reconstitution). Do not mix with any other medication or additional flavoring agent. White to off-white granular powder containing 1.57 g of sildenafil citrate USP (equivalent to 1.12 g sildenafil) in a bottle intended for reconstitution. Following reconstitution with 90 mL of water, the volume of the oral suspension is 112 mL and the oral suspension contains 10 mg/mL sildenafil. A 2 mL oral syringe (with 1 mL and 2 mL dose markings) and a press-in bottle adaptor are also provided. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Sildenafil for oral suspension is 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 Patients (1 to 17 Years Old) Sildenafil for oral suspension is indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standardized exercise testing, pulmonary hemodynamics thought to underlie improvements in exercise [see Clinical Studies (14)]. The recommended dosage of sildenafil for oral suspension is 20 mg three times a day. Dose may be titrated to a maximum of 80 mg three times a day, if required, based on symptoms and tolerability [see Clinical Studies (14)]. Although dose-response improvement in exercise ability was not observed in short-term studies in adults with PAH, the delay in clinical worsening with long-term use of sildenafil in Study A1481324 supports dosing up to a maximum of 80 mg three times a day [see Clinical Studies (14)]. The recommended dose is 10 mg administered as an intravenous bolus sildenafil otc injection three times a day. The dose of sildenafil injection does not need to be adjusted for body weight. A 10 mg dose of sildenafil injection is predicted to provide pharmacological effect of sildenafil and its N-desmethyl metabolite equivalent to that of a 20 mg oral dose. The recommended dosage in patients ≤ 20 kg is 10 mg three times a day. For pediatric patients 20 kg to 45 kg, the recommended dosage is 20 mg three times a day.
| Storage Condition | Temperature Range | Protection Required | Shelf Life |
|---|---|---|---|
| Room Temperature | 20-25°C | Keep away from heat and moisture | 2 years |
| Refrigeration Recommended | 2-8°C | Avoid freezing | N/A |
| Exposure to sunlight | No direct sunlight | Store in a dark place | N/A |
For pediatric patients 45 kg and greater, the recommended dosage is 20 mg three times a day. A maximum dose in pediatric patients has not been identified. Based on the experience in adults, dose may be titrated to a maximum of 40 mg three times a day for pediatric patients > 45 kg, if required, based on symptoms and tolerability [see Clinical Studies (14)]. Note: Reconstitute the contents of the bottle with a total volume of 90 mL (60 mL followed by 30 mL). Tap the bottle to loosen the powder. Add 60 mL of water to the bottle. Replace the cap and shake the bottle vigorously for a minimum of 30 seconds. Add another 30 mL of water to the bottle. Remove cap and press the bottle adaptor into the neck of the bottle. Write the expiration date of the reconstituted oral suspension on the bottle label (the expiration date of the reconstituted oral suspension is 60 days from the date of reconstitution).
Sildenafil Suspension dosage
Sildenafil for oral suspension 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)]. Phosphodiesterase-5 (PDE-5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat. Known hypersensitivity to sildenafil or any component of the tablet, injection, or oral suspension. Do not mix with any other medication or additional flavoring agent. White to off-white granular powder containing 1.57 g of sildenafil citrate USP (equivalent to 1.12 g sildenafil) in a bottle intended for reconstitution. Following reconstitution with 90 mL of water, the volume of the oral suspension is 112 mL and the oral suspension contains 10 mg/mL sildenafil. A 2 mL oral syringe (with 1 mL and 2 mL dose markings) and a press-in bottle adaptor are also provided. Sildenafil for oral suspension 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)]. Phosphodiesterase-5 (PDE-5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat. Known hypersensitivity to sildenafil or any component of the tablet, injection, or oral suspension.
