Silfin Oral Spray

Overall, the safety data for sildenafil 80 mg TID dose in Study A1481324 was consistent with the established safety profile of sildenafil in previous adult PAH studies.

Benefits and Advantages Over Traditional ED Tablets

Adverse reactions were generally transient and mild to moderate in nature. The overall frequency of discontinuation in sildenafil-treated patients was 3% (20 mg and 40 mg three times a day) and 8% (80 mg three times a day). The overall frequency of discontinuation for placebo was 3%. Most Common Adverse Reactions in Patients Treated with Sildenafil 20 mg, 40 mg, 80 mg and Placebo Three Times Per Day in SUPER-1 (More Frequent in Sildenafil-Treated Patients than Placebo-Treated Patients) In a placebo-controlled fixed dose titration study (PACES-1) of sildenafil (starting with recommended dose of 20 mg and increased to 40 mg and then 80 mg all three times a day) as an adjunct to intravenous epoprostenol in patients with PAH, no new safety issues were identified except for edema, which occurred in 25% of subjects in the combined sildenafil + epoprostenol group compared with 13% of subjects in the epoprostenol group [see Clinical Studies (14)]. In a study to assess the effects of multiple doses of sildenafil on mortality in adults with PAH (StudyA1481324), the lower dose 5 mg TID group showed a higher observed number of deaths (all related to underlying disease/disease under study), serious adverse events, and severe adverse events than the 20 mg and 80 mg TID groups [see Clinical Studies (14)]. Sildenafil was studied in a total of 234 PAH pediatric patients 1 to 17 years of age in a 16-week, double-blind placebo-controlled study (STARTS-1); 220 patients continued in a long-term extension study (STARTS-2).

Product	Dosage	Quantity + Bonus	Price
Viagra Generic	150mg	360 + 10 Pills	423.48€ 403.31€	Buy
Kamagra Oral Jelly	100mg	90 + 8 Sachets	303.56€ 289.10€	Buy
Kamagra Soft Tabs	100mg	120 + 6 Pills	311.78€ 296.93€	Buy
Viagra Generic	100mg	60 + 4 Pills	96.36€ 91.77€	Buy
Kamagra Polo	100mg	120 + 6 Pills	327.15€ 311.57€	Buy
Viagra Generic	50mg	10 Pills	26.87€ 25.59€	Buy
Viagra Generic	200mg	90 + 6 Pills	170.79€ 162.66€	Buy
Kamagra Soft Tabs	100mg	60 + 4 Pills	180.59€ 171.99€	Buy
Viagra Generic	25mg	270 + 8 Pills	184.26€ 175.49€	Buy
Kamagra Polo	100mg	180 + 8 Pills	446.52€ 425.26€	Buy
Kamagra Oral Jelly	100mg	110 + 9 Sachets	334.87€ 318.92€	Buy
Viagra Generic	100mg	270 + 10 Pills	270.47€ 257.59€	Buy
Kamagra	100mg	180 + 6 Pills	436.79€ 415.99€	Buy
Kamagra	100mg	60 + 4 Pills	201.34€ 191.75€	Buy
Viagra Generic	200mg	270 + 10 Pills	379.76€ 361.68€	Buy
Kamagra	100mg	120 + 6 Pills	330.74€ 314.99€	Buy
Viagra Generic	200mg	60 + 4 Pills	125.19€ 119.23€	Buy

Erection increased was observed in 9% of patients treated with sildenafil in STARTS-1.

Shipping & Returns

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 sildenafil oral jelly 100 mg 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. In many cases, medical follow-up information was limited.

1. Delay sprays (lidocaine/benzocaine)

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. Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking PDE-5 inhibitors, including sildenafil. 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. No other new adverse reactions were identified in pediatric patients [see Use in Specific Populations (8.4)].

Are You Buying the Wrong Spray?

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.

What are the most common side effects of sildenafil?

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. Adverse events with sildenafil injection were similar to those seen with oral tablets.

16. How is Sildenafil Oral Suspension supplied

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. This effect was not seen in idiopathic PAH (sildenafil 3%, placebo 2%) patients.

6.2 Postmarketing Experience

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. The following adverse reactions have been identified during post approval use of sildenafil (marketed for both PAH and erectile dysfunction).

• Sildenafil spray offers a non-invasive alternative to injections.
• It promotes blood flow to the penile area.
• The onset of action is usually faster than tablets.
• It is an option for men who dislike swallowing pills.
• The spray may reduce gastrointestinal discomfort.
• Consistent use without medical advice is discouraged.
• Dose titration might be necessary for effectiveness.
• It may be used in combination with other ED treatments.
• Possible side effects include nasal congestion or dizziness.
• Proper storage extends the shelf life of the spray.
• Contact a healthcare provider if adverse effects occur.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hezkue® (sildenafil) 12.5mg/actuation, oromucosal spray, suspension

If priapism (painful erection greater than 6 hours in duration) is not treated immediately, penile tissue damage and permanent loss of potency could result. In a small, prematurely terminated study of patients with pulmonary hypertension (PH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported by patients who received sildenafil than by those randomized to placebo. The effectiveness and safety of sildenafil in the treatment of PH secondary to sickle cell disease has not been established. 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)] 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 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. In a 12-week, placebo-controlled clinical study and an open-label extension study (SUPER-1) in 277 sildenafil-treated adults with PAH (WHO Group I) [see Clinical Studies (14)] the adverse reactions that were reported by at least 10% of sildenafil-treated patients in any dosing group, and were more frequent in sildenafil-treated patients than in placebo-treated patients are shown in Table 1. In postmarketing experience with sildenafil at doses indicated for erectile dysfunction, serious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, pulmonary hemorrhage, and subarachnoid and intracerebral hemorrhages have been reported in temporal association with the use of the drug.

Aspect	Description	Usage Mode	Potential Benefits
Definition	A topical spray containing sildenafil for erectile dysfunction	Oral spray application	Rapid absorption and discreet use
Main Ingredients	Sildenafil citrate, ethanol, flavoring agents	Composition details	Minimizes systemic side effects
Market Availability	Limited to certain countries, clinical trials ongoing	Distribution channels	Varies by regulation

Most, but not all, of these patients had preexisting cardiovascular risk factors. Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of sildenafil without sexual activity.

• Sildenafil spray can enhance male sexual performance.
• It is often used when oral pills are not suitable.
• The spray allows for targeted delivery to the bloodstream.
• Rapid onset makes it suitable for spontaneous encounters.
• Use the spray exactly as directed by the healthcare professional.
• There is a risk of priapism with overuse.
• The spray may cause minor irritation at the application site.
• It is advisable to have medical supervision during use.
• The spray’s effectiveness depends on individual health.
• It is recommended to avoid alcohol for better results.
• Regular follow-up visits ensure safe use over time.

Others were reported to have occurred hours to days after use concurrent with sexual activity.

Step	Instruction	Tips
Preparation	Shake the bottle before use	Ensure proper mixing
Positioning	Hold spray 2-3 inches from the tongue/mucosa	Avoid spitting immediately
Administration	Press spray button for 1-2 seconds	Do not swallow immediately
Post-application	Wait 10 minutes before sexual activity	For optimal absorption

It is not possible to determine whether these events are related directly to sildenafil, to sexual activity, to the patient’s underlying cardiovascular disease, or to a combination of these or other factors.

Special considerations when taking this medicine

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.

Hezkue FAQs

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.