Its use is now one of the standard treatments for erectile dysfunction, including for males with diabetes mellitus.
- Sildenafil's patent expired, leading to generic versions in pill form.
- The syrup form may be compounded at pharmacies if needed.
- It is crucial to verify the source and quality of compounded syrup.
- Sildenafil's effects typically begin within 30-60 minutes.
- The duration of action is approximately 4-6 hours.
Tentative evidence suggests that sildenafil may help males who experience antidepressant-induced erectile dysfunction.
| Condition | Details | Remarks |
|---|---|---|
| Temperature | Store between 15°C to 30°C | Protect from excessive heat |
| Light Exposure | Keep in a dark place or in opaque container | Protect from light |
| Humidity | Avoid high humidity environments | Prevent product degradation |
| Shelf Life | Typically 2 years from manufacturing date | Check expiry date before use |
While sildenafil improves some markers of disease in people with pulmonary arterial hypertension, it does not appear to affect the risk of death or serious side effects.
Consumer Information Use and Disclaimer
[8] It can be taken orally (swallowed by mouth), intravenously (injection into a vein), or through the sublingual route (dissolved under the tongue). [8][10] Onset when taken orally is typically within twenty minutes and lasts for about two hours. Common side effects include headaches, heartburn, and flushed skin. [8] Caution is advised in those with cardiovascular disease. [8] Rare but serious side effects include vision problems, hearing loss, and prolonged erection (priapism) that can lead to damage to the penis. Sildenafil and other PDE5 inhibitors are used off-label to alleviate vasospasm and treat severe ischemia and ulcers in fingers and toes for people with secondary Raynaud's phenomenon;[9][21] these drugs have moderate efficacy for reducing the frequency and duration of vasospastic episodes.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Kamagra Soft Tabs | 100mg | 60 + 4 Pills | 180.59€ 171.99€ | |
| Viagra Generic | 100mg | 10 Pills | 28.91€ 27.53€ | |
| Kamagra Oral Jelly | 100mg | 30 + 5 Sachets | 136.20€ 129.71€ | |
| Kamagra | 100mg | 60 + 4 Pills | 201.34€ 191.75€ | |
| Kamagra Polo | 100mg | 12 Pills | 60.21€ 57.34€ | |
| Viagra Generic | 200mg | 180 + 10 Pills | 277.56€ 264.34€ | |
| Kamagra Oral Jelly | 100mg | 90 + 8 Sachets | 303.56€ 289.10€ | |
| Viagra Generic | 150mg | 30 + 2 Pills | 72.32€ 68.88€ | |
| Kamagra | 100mg | 32 Pills | 121.24€ 115.47€ | |
| Viagra Generic | 25mg | 10 Pills | 25.19€ 23.99€ | |
| Viagra Generic | 150mg | 270 + 10 Pills | 326.61€ 311.06€ | |
| Kamagra | 100mg | 12 Pills | 55.64€ 52.99€ | |
| Kamagra Oral Jelly | 100mg | 110 + 9 Sachets | 334.87€ 318.92€ | |
| Viagra Generic | 100mg | 30 + 4 Pills | 60.91€ 58.01€ | |
| Kamagra Soft Tabs | 100mg | 272 + 12 Pills | 593.42€ 565.16€ |
[9] As of 2016,[update] their role more generally in Raynaud's was not clear.
13. Nonclinical Toxicology
[8] Sildenafil should not be taken by people on nitric oxide donors such as nitroglycerin, as this may result in a serious drop in blood pressure. Sildenafil acts by blocking phosphodiesterase 5 (PDE5), an enzyme that promotes breakdown of cGMP, which regulates blood flow in the penis. [8] It requires sexual arousal to work, and does not by itself cause or increase sexual arousal. [8] It also results in dilation of the blood vessels in the lungs. Pfizer originally discovered the medication in 1989 while looking for a treatment for angina. Sildenafil has shown some potential for improving exercise performance oral sildenafil at high altitudes.
| Aspect | Sildenafil Syrup | Sildenafil Tablets |
|---|---|---|
| Ease of administration | Easy for children or those swallowing difficulties | Convenient for most adults |
| Dosage flexibility | Precise dosage adjustments possible | Fixed doses, less flexible |
| Onset of action | Usually quicker due to liquid form | Similar, around 30–60 min |
| Bioavailability | Slightly higher (due to faster absorption) | Slightly lower |
| Storage requirements | Same storage conditions | Same storage conditions |
However, its overall efficacy is not clear.
DOSAGE FORMS AND STRENGTHS
Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking sildenafil. All brand names listed are the registered trademarks of their respective owners and are not trademarks of Novitium Pharma LLC. PATIENT INFORMATION This Patient Information has been approved by the U.S. Food and Drug Administration.LB4137-03Revised: 01/2024Instructions for UseSildenafil (sil den’ a fil)for oral suspensionRead this Instructions for Use before you start taking sildenafil oral suspension and each time you get a refill. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.Important information:Ask your healthcare provider or pharmacist to show you how to measure and take your prescribed dose of sildenafil oral suspension.Your pharmacist will mix (reconstitute) sildenafil oral suspension before it is given to you.
Why it’s used
Do not take or give sildenafil oral suspension and contact your pharmacist if the medicine in the bottle is still a powder.Always use the oral dosing syringe that comes with sildenafil oral suspension. If your carton does not come with an oral dosing syringe, contact your pharmacist.Do not take or give sildenafil oral suspension if the bottle adaptor is not in the bottle. If the bottle adaptor is not in the bottle, contact your pharmacist.Sildenafil oral suspension should not be mixed with any other medicine or flavoring.Supplies you will need to take or give a dose of sildenafil oral suspension (See Figure A):1 bottle of sildenafil oral suspension with pre-inserted bottle adaptor1 oral dosing syringe (provided in the carton)Step 1. Shake the bottle of sildenafil oral suspension for 10 seconds before each use. Slowly pull back the plunger of the oral dosing syringe until the bottom of the plunger is even with the mL marking on the syringe for your prescribed dose. Sildenafil has been studied for high-altitude pulmonary edema (HAPE), but its use is currently not recommended for that indication.
- Sildenafil syrup is sometimes used in pediatric cases, off-label.
- Off-label use in children requires careful dosage adjustment.
- Lack of standardization makes typical dosing guidelines difficult.
- Pharmacokinetics in syrup form are less well-studied.
- Always seek professional medical advice before use.
In clinical trials, the most common adverse effects of sildenafil use included headache, flushing, indigestion, nasal congestion, and impaired vision, including photophobia and blurred vision.
| Country | Approval Status | Regulatory Body | Remarks |
|---|---|---|---|
| United States | Approved for pulmonary hypertension, off-label for ED | FDA | Prescription medication |
| European Union | Approved with similar indications | EMA | Prescription required |
| India | Approved for ED and pulmonary hypertension | CDSCO | Over the counter in some regions |
| Canada | Approved, prescription-only | Health Canada | Strict prescribing guidelines |
[4] Some sildenafil users have complained of seeing everything tinted blue (cyanopsia).
5.8 Priapism
(See Figure E)If your dose of sildenafil oral suspension is 1 mL (10 mg), measure 0.5 mL two times for a total of 1 mL of sildenafil oral suspension.If your dose of sildenafil oral suspension is more than 2 mL (20 mg), you will need to divide the dose. Follow the instructions given to you by your healthcare provider or pharmacist about how to prepare the divided dose.If you see air bubbles in the oral dosing syringe, slowly push the plunger all the way up so that sildenafil oral suspension flows back into the bottle and repeat Step 4.Step 5. (See Figure F) Do not press on the plunger of the oral dosing syringe at this time.Step 6. Put the tip sildenafil tablets 125 of the oral dosing syringe into your mouth and point it towards the inside of the cheek. (See Figure G)If you are giving sildenafil oral suspension, make sure they are in an upright position before giving the medicine.Step 7.
Pulmonary hypertension
Store the oral dosing syringe with the sildenafil oral suspension bottle.How should I store sildenafil oral suspension?Store mixed (reconstituted) sildenafil oral suspension below 86°F (30°C) or in a refrigerator between 36°F to 46°F (2°C to 8°C).Do not freeze mixed sildenafil oral suspension.Throw away (discard) any remaining sildenafil oral suspension 60 days after mixed by the pharmacist. See the “Discard after” date written on the bottle label.Keep sildenafil for oral suspension and all medicines out of the reach of children.Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) for Oral Suspension. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.All brand names listed are the registered trademarks of their respective owners and are not trademarks of Novitium Pharma LLC.Manufactured by:Novitium Pharma LLC,70 Lake Drive, East WindsorNew Jersey 08520This Instruction for Use has been approved by the U.S. Food and Drug Administration.LB4137-03Revised: 01/2024 This Patient Information has been approved by the U.S. Food and Drug Administration. [24] This cyanopsia can be explained because sildenafil, while selective for PDE5, does have some affinity for PDE6, which is the phosphodiesterase found in the retina. Patients thus taking the drug may experience colorvision abnormalities.
5.5 Hearing Loss
[11] It was approved for medical use in the United States and in the European Union in 1998. [5][8][11][12] In 2023, it was the 151st most commonly prescribed medication in the United States, with more than 3 million prescriptions. [13][14] It is available as a generic medication. [15][16] In the United Kingdom, it is available as a pharmacy medicine. The primary indication of sildenafil is treatment of erectile dysfunction (inability to sustain a satisfactory erection to complete sexual intercourse). Some complained of blurriness and loss of peripheral vision.
INFORMATION ABOUT SILDENAFIL
If your dose of sildenafil oral suspension is more than 2 mL (20 mg), you will need to divide the dose. If you see air bubbles in the oral dosing syringe, slowly push the plunger all the way up so that sildenafil oral suspension flows back into the bottle and repeat Step 4. If you are giving sildenafil oral suspension, make sure they are in sildenafil 5mg for sale an upright position before giving the medicine. Store the oral dosing syringe with the sildenafil oral suspension bottle. Store mixed (reconstituted) sildenafil oral suspension below 86°F (30°C) or in a refrigerator between 36°F to 46°F (2°C to 8°C).
Allergy warning
This Instruction for Use has been approved by the U.S. Food and Drug Administration. Sildenafil, sold under the brand name Viagra among others, is a medication used to treat erectile dysfunction and pulmonary arterial hypertension. [4][8] It is also sometimes used off-label for the treatment of certain symptoms in secondary Raynaud's phenomenon. [9] It is unclear if it is effective for treating sexual dysfunction in females. In July 2005, the US Food and Drug Administration (FDA) updated labeling for tadalafil (Cialis), vardenafil (Levitra), and sildenafil (Viagra) to reflect a small number of post-marketing reports of sudden vision loss, while acknowledging that "...it is not possible to determine whether these oral medicines for erectile dysfunction were the cause of the loss of eyesight or whether the problem is related to other factors such as high blood pressure or diabetes, or to a combination of these problems. "[25] A careful review of pooled data from clinical trials containing well documented information about the dose and duration of exposure to the drug for a large number of patients, yields no evidence for an increased risk of non-arteritic anterior ischemic optic neuropathy or other adverse ocular events associated with PDE5 inhibitor use.
4. Contraindications
Read this Instructions for Use before you start taking sildenafil oral suspension and each time you get a refill. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. Ask your healthcare provider or pharmacist to show you how to measure and take your prescribed dose of sildenafil oral suspension. Your pharmacist will mix (reconstitute) sildenafil oral suspension before it is given to you. Do not take or give sildenafil oral suspension and contact your pharmacist if the medicine in the bottle is still a powder.
Interactions that increase your risk for side effects
Always use the oral dosing syringe that comes with sildenafil oral suspension. Do not take or give sildenafil oral suspension if the bottle adaptor is not in the bottle. Sildenafil oral suspension should not be mixed with any other medicine or flavoring. Supplies you will need to take or give a dose of sildenafil oral suspension (See Figure A): 1 bottle of sildenafil oral suspension with pre-inserted bottle adaptor 1 oral dosing syringe (provided in the carton) Shake the bottle of sildenafil oral suspension for 10 seconds before each use. If your dose of sildenafil oral suspension is 1 mL (10 mg), measure 0.5 mL two times for a total of 1 mL of sildenafil oral suspension.