In many cases, medical follow-up information was limited.
It is not possible to determine whether these reported events are related directly to the use of sildenafil,
to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors.
| Region | Estimated Market Size (2023) | Growth Rate | Key Players | Typical Uses Scope |
|---|---|---|---|---|
| North America | $150 million | 5% annually | Pfizer, Cipla, Teva | ED, pulmonary hypertension |
| Europe | $100 million | 4.5% annually | Bayer, Sun Pharma | Pulmonary hypertension, off-label uses |
| Asia-Pacific | $200 million | 7% annually | Cipla, Aurobindo, Zydus | Broader use, pediatric cases |
| Rest of World | $50 million | 3.5% annually | Various local manufacturers | Growing awareness and approval |
Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking PDE-5 inhibitors, including sildenafil.
| Precaution/Contraindication | Details | Advice |
|---|---|---|
| Nitrate use | Contraindicated with sildenafil | Risk of severe hypotension |
| Cardiovascular disease risk | Use with caution | Consult cardiologist before use |
| Liver or kidney impairment | Dose adjustment needed | Monitor liver/kidney function tests |
| Allergies to sildenafil or excipients | Check ingredients before administration | Discontinue if allergic reactions occur |
The safety and efficacy of combinations of sildenafil with VIAGRA or other PDE-5 inhibitors have not been studied.
Inform patients taking sildenafil not to take VIAGRA or other PDE-5 inhibitors.
In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance.
Ask your pharmacist any questions you have about refilling your prescription. Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies. 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. Injection (Adults): 10 mg three times a day administered as an intravenous bolus injection. If priapism (painful erection greater than 6 hours in duration) is not treated immediately, penile tissue damage and permanent loss of potency could result.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Viagra Generic | 200mg | 20 Pills | 61.69€ 58.75€ | |
| Kamagra Oral Jelly | 100mg | 90 + 8 Sachets | 303.56€ 289.10€ | |
| Kamagra | 100mg | 180 + 6 Pills | 436.79€ 415.99€ | |
| Viagra Generic | 50mg | 180 + 8 Pills | 158.82€ 151.26€ | |
| Viagra Generic | 200mg | 270 + 10 Pills | 379.76€ 361.68€ | |
| Kamagra Soft Tabs | 100mg | 12 Pills | 57.55€ 54.81€ | |
| Viagra Generic | 25mg | 90 + 6 Pills | 105.03€ 100.03€ | |
| Viagra Generic | 50mg | 30 + 4 Pills | 54.26€ 51.68€ | |
| Kamagra Oral Jelly | 100mg | 110 + 9 Sachets | 334.87€ 318.92€ | |
| Kamagra | 100mg | 20 Pills | 86.09€ 81.99€ |
In a small, prematurely terminated study of patients with pulmonary hypertension (PH) secondary to sickle cell disease, vaso-occlusive
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. Hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil. Sildenafil has vasodilatory properties, resulting in mild and transient decreases in blood pressure. Before prescribing sildenafil, carefully consider whether patients with certain underlying conditions could be adversely affected by such vasodilatory effects (e.g., patients on antihypertensive therapy or with resting hypotension [blood pressure less than 90/50], fluid depletion, severe left ventricular outflow obstruction, or autonomic dysfunction).
Monitor blood pressure when co-administering blood pressure lowering drugs with sildenafil. Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD). Since there are no clinical data on administration of sildenafil to patients with veno-occlusive disease, administration of sildenafil to such patients is not recommended. Should signs of pulmonary edema occur when sildenafil is administered, consider the possibility of associated PVOD. The incidence of epistaxis was 13% in patients taking sildenafil with PAH secondary to CTD. crises requiring hospitalization were more commonly reported by patients who received sildenafil than by those randomized to placebo.
| 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 |
The effectiveness and safety of sildenafil in the treatment of PH secondary to sickle cell disease has not been established.
This effect was not seen in idiopathic over the counter drugs containing sildenafil PAH (sildenafil 3%, placebo 2%) patients. The incidence of epistaxis was also higher in sildenafil-treated patients with a concomitant oral vitamin K antagonist (9% versus 2% in those not treated with concomitant vitamin K antagonist). The safety of sildenafil is unknown in patients with bleeding disorders or active peptic ulceration. When used to treat erectile dysfunction, non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported post marketing in temporal association with the use of PDE-5 inhibitors, including sildenafil. Most patients had underlying anatomic or vascular risk factors for developing NAION, including low cup to disc ratio (“crowded disc”).
Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking sildenafil. There are no controlled clinical data on the safety or efficacy of sildenafil in patients with retinitis pigmentosa, a minority of whom have genetic disorders of retinal phosphodiesterases. Therefore, use of sildenafil in patients with retinitis pigmentosa is not recommended. Cases of sudden decrease or loss of hearing, which may be accompanied by tinnitus and dizziness, have been reported in temporal association with the use of PDE-5 inhibitors, including sildenafil. In some of the cases, medical conditions and other factors were reported that may have played a role. The following serious adverse events are discussed elsewhere in the labeling: Hypotension [see Warnings and Precautions (5.1)] Vision Loss [see Warnings and Precautions (5.4)]
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).
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)]. Hearing Loss [see Warnings and Precautions (5.5)] Priapism [see Warnings and Precautions (5.7)] Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell
The recommended dose is 10 mg administered as an intravenous bolus 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.
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 sildenafil tablets 125 the bottle with a total volume of 90 mL (60 mL followed by 30 mL). Tap the bottle to loosen the powder. Disease [see Warnings and Precautions (5.8)] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
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. 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)].