The shelf life of sildenafil syrup depends on formulation and storage.
Expiry dates should always be checked before use.
Improper storage can lead to degradation of active ingredients.
The liquid form allows for precise dose adjustments.
Careful titration is essential to avoid overdose risks.

The effectiveness and safety of Sildenafil for Oral Suspension in the treatment of PAH secondary to sickle cell anemia has not been established. In a long-term trial in pediatric patients with PAH, an increase in mortality with increasing Sildenafil for Oral Suspension dose was observed. Use of Sildenafil for Oral Suspension, particularly chronic use, is not recommended in children [see Use in Specific Populations (8.4)]. Monitor blood pressure when co-administering blood pressure lowering drugs with Sildenafil for Oral Suspension. Should signs of pulmonary edema occur when Sildenafil for Oral Suspension is administered, consider the possibility of associated PVOD.

Highlights of Prescribing Information

It is not possible to determine whether these reported events are related directly to the use of Sildenafil for Oral Suspension, 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 for Oral Suspension.5.7 Combination with other PDE-5 inhibitorsSildenafil is also marketed as VIAGRA®. The safety and efficacy of combinations of Sildenafil for Oral Suspension with VIAGRA or other PDE-5 inhibitors have not been studied. Inform patients taking Sildenafil for Oral Suspension not to take VIAGRA or other PDE-5 inhibitors.5.8 PriapismUse Sildenafil for Oral Suspension with caution in patients with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie's disease) or in patients who have conditions, which may predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia). If priapism (painful erection greater than 6 hours in duration) is not treated immediately, penile tissue damage and permanent loss of potency could result.5.9 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell AnemiaIn 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 for Oral Suspension than by those randomized to placebo. The effectiveness and safety of Sildenafil for Oral Suspension in the treatment of PAH secondary to sickle cell anemia has not been established.

Altitude sickness

In a long-term trial in pediatric patients with PAH, an increase in mortality with increasing Sildenafil for Oral Suspension dose was observed. Use of Sildenafil for Oral Suspension, particularly chronic use, is not recommended in children [see Use in Specific Populations (8.4)]. Monitor blood pressure when co-administering blood pressure lowering drugs with Sildenafil for Oral Suspension. Should signs of pulmonary edema occur when Sildenafil for Oral Suspension is administered, consider the possibility of associated PVOD. The incidence of epistaxis was also higher in Sildenafil for Oral Suspension-treated patients with a concomitant oral vitamin K antagonist (9% versus 2% in those not treated with concomitant vitamin K antagonist). The incidence of epistaxis was also higher in Sildenafil for Oral Suspension-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 for Oral Suspension 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 sildenafil citrate tablet been reported postmarketing in temporal association with the use of phosphodiesterase type 5 (PDE-5) inhibitors, including sildenafil.

Product	Dosage	Quantity + Bonus	Price
Kamagra Polo	100mg	120 + 6 Pills	327.15€ 311.57€
Kamagra Polo	100mg	60 + 4 Pills	189.39€ 180.37€
Kamagra Oral Jelly	100mg	63 + 7 Sachets	224.18€ 213.50€
Kamagra Soft Tabs	100mg	84 + 4 Pills	233.05€ 221.95€
Viagra Generic	150mg	120 + 8 Pills	177.58€ 169.12€
Viagra Generic	100mg	270 + 10 Pills	270.47€ 257.59€
Kamagra Polo	100mg	12 Pills	60.21€ 57.34€
Kamagra Polo	100mg	84 + 4 Pills	244.49€ 232.85€
Viagra Generic	100mg	90 + 6 Pills	129.02€ 122.88€
Kamagra Polo	100mg	180 + 8 Pills	446.52€ 425.26€
Viagra Generic	50mg	180 + 8 Pills	158.82€ 151.26€
Kamagra	100mg	84 + 6 Pills	264.44€ 251.85€
Kamagra	100mg	180 + 6 Pills	436.79€ 415.99€
Kamagra	100mg	32 Pills	121.24€ 115.47€
Kamagra Polo	100mg	32 Pills	125.88€ 119.89€
Kamagra Oral Jelly	100mg	10 Sachets	54.55€ 51.95€
Viagra Generic	150mg	360 + 10 Pills	423.48€ 403.31€

Based on published literature, the annual incidence of NAION is 2.5–11.8 cases per 100,000 males aged ≥50 per year in the general population. An observational case-crossover study evaluated the risk of NAION when PDE-5 inhibitor use, as a class, occurred immediately before NAION onset (within 5 half-lives), compared to PDE-5 inhibitor use in a prior time period.

Side Effects

Adverse Reactions/Side Effects

Other risk factors for NAION, such as the presence of “crowded” optic disc, may have contributed to the occurrence of NAION in these studies.

What are some things I need to know or do while I take Sildenafil Oral Suspension?

The safety of Sildenafil for Oral Suspension 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 sildenafil citrate tablet been reported postmarketing in temporal association with the use of phosphodiesterase type 5 (PDE-5) inhibitors, including sildenafil. Based on published literature, the annual incidence of NAION is 2.5–11.8 cases per 100,000 males aged ≥50 per year in the general population. An observational case-crossover study evaluated the risk of NAION when PDE-5 inhibitor use, as a class, occurred immediately before NAION onset (within 5 half-lives), compared to PDE-5 inhibitor use in a prior time period. Other risk factors for NAION, such as the presence of “crowded” optic disc, may have contributed to the occurrence of NAION in these studies.

Sildenafil vs. tadalafil

Neither the rare postmarketing reports, nor the association of PDE-5 inhibitor use and NAION in the observational studies, substantiate a causal relationship between PDE-5 inhibitor use and NAION [see Adverse Reactions (6.2]. Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking PDE-5 inhibitors, including Sildenafil for Oral Suspension. Physicians should also discuss the increased risk of NAION with patients who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators, such as PDE-5 inhibitors. There are no controlled clinical data on the safety or efficacy of Sildenafil for Oral Suspension in patients with retinitis pigmentosa, a minority whom have genetic disorders of retinal phosphodiesterases. Prescribe Sildenafil for Oral Suspension with caution in these patients. Neither the rare postmarketing reports, nor the association of PDE-5 inhibitor use and NAION in the observational studies, substantiate a causal relationship between PDE-5 inhibitor use and NAION [see Adverse Reactions (6.2]. Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking PDE-5 inhibitors, including Sildenafil for Oral Suspension. Physicians should also discuss the increased risk of NAION with patients who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators, such as PDE-5 inhibitors.

Sildenafil syrup can cause side effects like headaches, flushing, or dizziness.
Combining sildenafil syrup with nitrates can be dangerous.
The syrup's consistency may vary; formulation stability is key.
Misuse or overdose can lead to serious cardiovascular issues.
Always consult a doctor before using sildenafil syrup.

There are no controlled clinical data on the safety or efficacy of Sildenafil for Oral Suspension in patients with retinitis pigmentosa, a minority whom have genetic disorders of retinal phosphodiesterases.

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.

Prescribe Sildenafil for Oral Suspension with caution in these patients. It is not possible to determine whether these reported events are related directly to the use of Sildenafil for Oral Suspension, 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 for Oral Suspension.

3 DOSAGE FORMS AND STRENGTHS

Indications and Usage for Sildenafil Oral Suspension

Inform patients taking Sildenafil for Oral Suspension not to take VIAGRA or other PDE-5 inhibitors. In a small, prematurely terminated study of patients with pulmonary hypertension (PH) secondary to sickle cell disease, 200mg sildenafil citrate vaso-occlusive crises requiring hospitalization were more commonly reported by patients who received Sildenafil for Oral Suspension than by those randomized to placebo.

8.4 Pediatric Use

The following serious adverse events are discussed elsewhere in the labeling: Mortality with pediatric use [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)] Hypotension [see Warnings and Precautions (5.2)] Vision loss [see Warnings and Precautions (5.5)] Hearing loss [see Warnings and Precautions (5.6)] Priapism [see Warnings and Precautions (5.8)] Vaso-occlusive crisis [see Warnings and Precautions (5.9)] 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. Safety data of Sildenafil for Oral Suspension in adults were obtained from the 12-week, placebo-controlled clinical study (Study 1) and an open-label extension study in 277 Sildenafil for Oral Suspension-treated patients with PAH, WHO Group I[see Clinical Studies (14)]. The overall frequency of discontinuation in Sildenafil for Oral Suspension-treated patients on 20 mg three times a day was 3% and was the same for the placebo group. In Study 1, the adverse reactions that were reported by at least 3% of Sildenafil for Oral Suspension-treated patients (20 mg three times a day) and were more frequent in Sildenafil for Oral Suspension-treated patients than in placebo-treated patients are shown in Table 1. At doses higher than the recommended 20 mg three times a day, there was a greater incidence of some adverse reactions including flushing, diarrhea, myalgia and visual disturbances.

Sildenafil Uses

Visual disturbances were identified as mild and transient, and were predominately color-tinge to vision, but also increased sensitivity to light or blurred vision. 6 ADVERSE REACTIONS The following serious adverse events are discussed elsewhere in the labeling:Mortality with pediatric use [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)]Hypotension [see Warnings and Precautions (5.2)]Vision loss [see Warnings and Precautions (5.5)]Hearing loss [see Warnings and Precautions (5.6)]Priapism [see Warnings and Precautions (5.8)]Vaso-occlusive crisis [see Warnings and Precautions (5.9)]6.1 Clinical Trials ExperienceBecause 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.Safety data of Sildenafil for Oral Suspension in adults were obtained from the 12-week, placebo-controlled clinical study (Study 1) and an open-label extension study in 277 Sildenafil for Oral Suspension-treated patients with PAH, WHO Group I[see Clinical Studies (14)].The overall frequency of discontinuation in Sildenafil for Oral Suspension-treated patients on 20 mg three times a day was 3% and was the same for the placebo group.In Study 1, the adverse reactions that were reported by at least 3% of Sildenafil for Oral Suspension-treated patients (20 mg three times a day) and were more frequent in Sildenafil for Oral Suspension-treated patients than in placebo-treated patients are shown in Table 1. Adverse reactions were generally transient and mild to moderate in nature.At doses higher than the recommended 20 mg three times a day, there was a greater incidence of some adverse reactions including flushing, diarrhea, myalgia and visual disturbances. Visual disturbances were identified as mild and transient, and were predominately color-tinge to vision, but also increased sensitivity to light or blurred vision.The incidence of retinal hemorrhage with Sildenafil for Oral Suspension 20 mg three times a day was 1.4% versus 0% placebo and for all Sildenafil for Oral Suspension doses studied was 1.9% versus 0% placebo. The incidence of eye hemorrhage at both 20 mg three times a day and at all doses studied was 1.4% for Sildenafil for Oral Suspension versus 1.4% for placebo. The patients experiencing these reactions had risk factors for hemorrhage including concurrent anticoagulant therapy.In a placebo-controlled fixed dose titration study (Study 2) of Sildenafil for Oral Suspension (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, the adverse reactions that were more frequent in the Sildenafil + epoprostenol group than in the epoprostenol group (greater than 6% difference) are shown in Table 2 [see Clinical Studies (14)].6.2 Postmarketing ExperienceThe following adverse reactions have been identified during post approval use of sildenafil (marketed for both PAH and erectile dysfunction). 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. The following serious adverse events are discussed elsewhere in the labeling: Mortality with pediatric use [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)] Hypotension [see Warnings and Precautions (5.2)] Vision loss [see Warnings and Precautions (5.5)] Hearing loss [see Warnings and Precautions (5.6)] Priapism [see Warnings and Precautions (5.8)] Vaso-occlusive crisis [see Warnings and Precautions (5.9)] 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. Safety data of Sildenafil for Oral Suspension in adults were obtained from the 12-week, placebo-controlled clinical study (Study 1) and an open-label extension study in 277 Sildenafil for Oral Suspension-treated patients with PAH, WHO Group I[see Clinical Studies (14)]. The overall frequency of discontinuation in Sildenafil for Oral Suspension-treated patients on 20 mg three times a day was 3% and was the same for the placebo group. In Study 1, the adverse reactions that were reported by at least 3% of Sildenafil for Oral Suspension-treated patients (20 mg three times a day) and were more frequent in Sildenafil for Oral Suspension-treated patients than in placebo-treated patients are shown in Table 1.

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

At doses higher than the recommended 20 mg three times a day, there was a greater incidence of some adverse reactions including flushing, diarrhea, myalgia and visual disturbances.

Further information

It is not possible to determine whether these reported events are related directly to the use of Sildenafil for Oral Suspension, 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 for Oral Suspension. Inform patients taking Sildenafil for Oral Suspension not to take VIAGRA or other PDE-5 inhibitors. In a small, prematurely terminated study of patients with pulmonary hypertension (PH) secondary to sickle cell disease, 200mg sildenafil citrate vaso-occlusive crises requiring hospitalization were more commonly reported by patients who received Sildenafil for Oral Suspension than by those randomized to placebo. 6 ADVERSE REACTIONS The following serious adverse events are discussed elsewhere in the labeling:Mortality with pediatric use [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)]Hypotension [see Warnings and Precautions (5.2)]Vision loss [see Warnings and Precautions (5.5)]Hearing loss [see Warnings and Precautions (5.6)]Priapism [see Warnings and Precautions (5.8)]Vaso-occlusive crisis [see Warnings and Precautions (5.9)]6.1 Clinical Trials ExperienceBecause 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.Safety data of Sildenafil for Oral Suspension in adults were obtained from the 12-week, placebo-controlled clinical study (Study 1) and an open-label extension study in 277 Sildenafil for Oral Suspension-treated patients with PAH, WHO Group I[see Clinical Studies (14)].The overall frequency of discontinuation in Sildenafil for Oral Suspension-treated patients on 20 mg three times a day was 3% and was the same for the placebo group.In Study 1, the adverse reactions that were reported by at least 3% of Sildenafil for Oral Suspension-treated patients (20 mg three times a day) and were more frequent in Sildenafil for Oral Suspension-treated patients than in placebo-treated patients are shown in Table 1.

Jet lag research

Adverse reactions were generally transient and mild to moderate in nature.At doses higher than the recommended 20 mg three times a day, there was a greater incidence of some adverse reactions including flushing, diarrhea, myalgia and visual disturbances. Visual disturbances were identified as mild and transient, and were predominately color-tinge to vision, but also increased sensitivity to light or blurred vision.The incidence of retinal hemorrhage with Sildenafil for Oral Suspension 20 mg three times a day was 1.4% versus 0% placebo and for all Sildenafil for Oral Suspension doses studied was 1.9% versus 0% placebo. The incidence of eye hemorrhage at both 20 mg three times a day and at all doses studied was 1.4% for Sildenafil for Oral Suspension versus 1.4% for placebo. The patients experiencing these reactions had risk factors for hemorrhage including concurrent anticoagulant therapy.In a placebo-controlled fixed dose titration study (Study 2) of Sildenafil for Oral Suspension (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, the adverse reactions that were more frequent in the Sildenafil + epoprostenol group than in the epoprostenol group (greater than 6% difference) are shown in Table 2 [see Clinical Studies (14)].6.2 Postmarketing ExperienceThe following adverse reactions have been identified during post approval use of sildenafil (marketed for both PAH and erectile dysfunction). 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. Visual disturbances were identified as mild and transient, and were predominately color-tinge to vision, but also increased sensitivity to light or blurred vision.