Sildenafil Oral Solution Uses and Benefits

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 REVATIO.

Condition	Risk Factors	Alternative Recommendations
Use with nitrates	Severe hypotension	Avoid concomitant use
Severe hepatic impairment	Altered drug metabolism	Dose adjustment or alternative therapy
Cardiovascular instability	Risk of adverse events	Medical evaluation required
Retinitis pigmentosa	Potential retinal toxicity	Consult ophthalmologist

It is not possible to determine whether these reported events are related directly to the use of REVATIO, 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 REVATIO.

Aspect	Oral Solution	Tablets
Onset of action	Faster due to quicker absorption	Slightly slower
Ease of dose adjustment	Easy to modify dose in small increments	Fixed doses
Swallowing difficulties	Easier for children and elderly	Requires swallowing whole
Taste masking	Usually palatable with flavors	No taste masking needed
Storage and stability	Sensitive to temperature and light	Generally more stable

The safety and efficacy of combinations of REVATIO with VIAGRA or other PDE-5 inhibitors have not been studied. Inform patients taking REVATIO not to take VIAGRA or other PDE-5 inhibitors.

Revatio dosage forms

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 REVATIO. Physicians should also discuss the increased risk of NAION with patients who have sildenafil pills 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 REVATIO in patients with retinitis pigmentosa, a minority whom have genetic disorders of retinal phosphodiesterases. Prescribe REVATIO with caution in these patients. 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 REVATIO than by those randomized to placebo.

• The medication works by relaxing blood vessels in the penis.
• It increases blood flow, resulting in an erection during sexual activity.
• It requires sexual stimulation to be effective.

The effectiveness and safety of REVATIO in the treatment of PAH secondary to sickle cell anemia has not been established.

Product	Dosage	Quantity + Bonus	Price
Viagra Generic	50mg	360 + 10 Pills	225.33€ 214.60€	Buy
Viagra Generic	150mg	60 + 4 Pills	111.25€ 105.95€	Buy
Kamagra Polo	100mg	12 Pills	60.21€ 57.34€	Buy
Kamagra Polo	100mg	180 + 8 Pills	446.52€ 425.26€	Buy
Viagra Generic	25mg	270 + 8 Pills	184.26€ 175.49€	Buy
Kamagra Polo	100mg	272 + 12 Pills	622.94€ 593.28€	Buy
Kamagra Soft Tabs	100mg	272 + 12 Pills	593.42€ 565.16€	Buy
Kamagra Oral Jelly	100mg	21 Sachets	95.92€ 91.35€	Buy
Kamagra Soft Tabs	100mg	32 Pills	120.11€ 114.39€	Buy
Viagra Generic	50mg	120 + 6 Pills	129.64€ 123.47€	Buy
Viagra Generic	100mg	120 + 6 Pills	149.50€ 142.38€	Buy
Kamagra Oral Jelly	100mg	30 + 5 Sachets	136.20€ 129.71€	Buy

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.

• It is not recommended for use in children or women.
• Overdose symptoms include dizziness, vision changes, and prolonged erections.
• Seek urgent medical help in case of overdose.

Safety data of REVATIO in adults were obtained from the 12-week, placebo-controlled clinical study (Study 1) and an open-label extension study in 277 REVATIO-treated patients with PAH, WHO Group I [see Clinical Studies (14)].

11. Sildenafil Oral Suspension Description

This effect was not seen in idiopathic PAH (REVATIO 3%, placebo 2%) patients. The incidence of epistaxis was also higher in REVATIO-treated patients with a concomitant oral vitamin K antagonist (9% versus 2% in those not treated with concomitant vitamin K antagonist). The safety of REVATIO 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 postmarketing in temporal association with the use of phosphodiesterase type 5 (PDE-5) inhibitors, including sildenafil. Most, but not all, of these patients had underlying anatomic or vascular risk factors for developing NAION, including but not necessarily limited to: low cup to disc ratio ("crowded disc"), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking.

Drugs you should not use with 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. The results suggest an approximate 2-fold increase in the risk of NAION, with a risk estimate of 2.15 (95% CI 1.06, 4.34). A similar study reported a consistent result, with a risk estimate of 2.27 (95% CI 0.99, 5.20). Other risk factors for NAION, such as the presence of "crowded" optic disc, may have contributed to the occurrence of NAION in these studies. The overall frequency of discontinuation in REVATIO-treated patients on 20 mg three times a day was 3% and was the same for the placebo group.

• Patients should avoid heavy meals before taking sildenafil solution.
• Use caution if combining with other blood pressure medications.
• Regular medical check-ups are advised during treatment.

In Study 1, the adverse reactions that were reported by at least 3% of REVATIO-treated patients (20 mg three times a day) and were more frequent in REVATIO-treated patients than in placebo-treated patients are shown in Table 1.

Parameter	Value	Description	Notes
Absorption time	30-60 minutes	Time to reach peak plasma levels	Faster onset compared to tablets
Peak plasma concentration	150-200 ng/mL	Max systemic concentration	Varies per dose and individual
Half-life	4-5 hours	Time to reduce concentration by half	Helps determine dosing intervals
Bioavailability	40-50%	Fraction reaching systemic circulation	Slightly variable across patients

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.

This article is cited by

Replace the cap on the bottle.Figure 5 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). White, film-coated, round tablets engraved with "RVT20" containing sildenafil citrate equivalent to sildenafil products over the counter 20 mg of sildenafil. White to off-white powders containing 1.57 g of sildenafil citrate (equivalent to 1.12 g of sildenafil) in a bottle intended for reconstitution. A 2 mL oral syringe (with 0.5 mL and 2 mL dose markings) and a press-in bottle adaptor are also provided. Concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension [see Warnings and Precautions (5.2)].

Are you currently using Sildenafil (Viagra, Revatio)?

PDE-5 inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat. In a long-term trial in pediatric patients with PAH, an increase in mortality with increasing REVATIO dose was observed. Deaths were first observed after about 1 year and causes of death were typical of patients with PAH. Use of REVATIO, particularly chronic use, is not recommended in children [see Use in Specific Populations (8.4)]. REVATIO has vasodilatory properties, resulting in mild and transient decreases in blood pressure.

Competing interests

Before prescribing REVATIO, 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 [BP 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 REVATIO. Since there are no clinical data on administration of REVATIO to patients with veno-occlusive disease, administration of REVATIO to such patients is not recommended. Should signs of pulmonary edema occur when REVATIO is administered, consider the possibility of associated PVOD. The incidence of epistaxis was 13% in patients taking REVATIO with PAH secondary to CTD. The incidence of retinal hemorrhage with REVATIO 20 mg three times a day was 1.4% versus 0% placebo and for all REVATIO 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 REVATIO 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 REVATIO (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 REVATIO + epoprostenol group than in the epoprostenol group (greater than 6% difference) are shown in Table 2 [see Clinical Studies (14)].

8. Use In Specific Populations

Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity [see Clinical Studies (14)]. The recommended dose of REVATIO is 5 mg or 20 mg three times a day. Administer REVATIO doses 4–6 hours apart. In the clinical trial no greater efficacy was achieved with the use of higher doses. Treatment with doses higher than 20 mg three times a day is not recommended.

8.6 Patients with Hepatic Impairment

REVATIO injection is for the continued treatment of patients with PAH who are currently prescribed oral REVATIO and who are temporarily unable to take oral medication. The recommended dose is 2.5 mg or 10 mg administered as an intravenous bolus injection three times a day. The dose of REVATIO injection does not need to be adjusted for body weight. A 10 mg dose of REVATIO injection is predicted to provide pharmacological effect of sildenafil and its N-desmethyl metabolite equivalent to that of a 20 mg oral dose. Tap the bottle to release the powder.

12.1 Sildenafil Oral Suspension Mechanism of Action

Accurately measure out 60 mL of water and pour the water into the bottle. Accurately measure out another 30 mL of water and add this to the bottle. You should always add a total of 90 mL of water irrespective of the dose prescribed. Press the bottle adaptor into the neck of the bottle (as shown on Figure 5, below). The adaptor is provided so that you can fill the oral syringe with medicine from the bottle. REVATIO injection was studied in a 66-patient, placebo-controlled study in patients with PAH at doses targeting plasma concentrations between 10 and 500 ng/mL (up to 8 times the exposure of the recommended dose). Adverse events with REVATIO injection were similar to those seen with oral tablets. 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.

Owner

Fabienne Heyne
[email protected]

Design & Implementation

Jonas Bünter
www.jonas.work

Photography

Angelika Annen
www.angelikaannen.ch