Start content

Sildenafil Tablets

Sildenafil > sildenafil tablets 125


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. Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking sildenafil.

11. Sildenafil Oral Suspension Description

Advise patients taking sildenafil tablets not to take VIAGRA or other PDE-5 inhibitors. • Advise patients to seek immediate medical attention for a sudden loss of vision in one or both eyes while taking sildenafil tablets. • Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking sildenafil tablets. Trademarks are the property of their respective owners. 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.

Dosage for pulmonary arterial hypertension (PAH)

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. 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.

Product Dosage Quantity + Bonus Price
Kamagra Soft Tabs100mg84 + 4 Pills233.05€ 221.95€
Kamagra100mg60 + 4 Pills201.34€ 191.75€
Kamagra Polo100mg180 + 8 Pills446.52€ 425.26€
Viagra Generic100mg270 + 10 Pills270.47€ 257.59€
Viagra Generic200mg360 + 10 Pills481.98€ 459.03€
Viagra Generic200mg180 + 10 Pills277.56€ 264.34€
Viagra Generic100mg20 Pills45.58€ 43.41€
Viagra Generic25mg10 Pills25.19€ 23.99€
Viagra Generic200mg20 Pills61.69€ 58.75€
Viagra Generic200mg10 Pills40.96€ 39.01€
Viagra Generic25mg120 + 6 Pills125.56€ 119.58€
Kamagra Soft Tabs100mg272 + 12 Pills593.42€ 565.16€
Kamagra Soft Tabs100mg20 Pills79.79€ 75.99€
Viagra Generic100mg120 + 6 Pills149.50€ 142.38€

Cases of sudden decrease or loss sildenafil 100 mg cost 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.

5. Warnings and Precautions

Note: Reconstitute the contents of the bottle with a total volume of 90 mL (60 mL followed by 30 mL). Tap sildenafil spray the bottle to loosen the powder. 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.

5.5 Hearing Loss

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. 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.

Interaction Effect Management Tips
Nitrates Severe hypotension, danger to life Avoid combination
Alpha-blockers Risk of hypotension Use with caution, monitor blood pressure
CYP3A4 inhibitors Increased sildenafil levels, risk of side effects Dose adjustments may be needed
Other PDE-5 inhibitors Increased risk of adverse effects Use separate medications

The safety and efficacy of combinations of sildenafil with VIAGRA or other PDE-5 inhibitors have not been studied.

5.5 Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives

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)]. Known hypersensitivity to sildenafil or any component of the tablet, injection, or oral suspension. 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).

5.6 Combination with Other PDE-5 Inhibitors

Monitor sildenafil oral jelly 100mg lovegra blood pressure when co-administering blood pressure lowering drugs with sildenafil. 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. The safety of sildenafil is unknown in patients with bleeding disorders or active peptic ulceration. Inform patients taking sildenafil 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, 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. 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. 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).

Parameter Details Value
Absorption Rapid, peak plasma levels in 30-120 min Yes
Half-life Time to reduce plasma concentration by half 3-5 hours
Metabolism Liver via CYP3A4 enzyme Primarily
Excretion Mainly via feces, some via urine Yes

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). Adverse events with sildenafil injection were similar to those seen with oral tablets. Concomitant use of sildenafil with nitrates in any form is contraindicated [see Contraindications (4)].

Concomitant use of sildenafil with strong CYP3A inhibitors is not recommended [see Clinical Pharmacology (12.3)].

Concomitant use of sildenafil with moderate-to-strong CYP3A inducers (such as bosentan) decreases the sildenafil exposure.

LinkOut - more resources

For oral suspension: 10 mg/mL (when reconstituted) (3) Vasodilation effects may be more common in patients with hypotension or on antihypertensive therapy. Pulmonary hypertension (PH) secondary to sickle cell disease: Sildenafil may cause serious vaso-occlusive crises. 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.

What’s the dosage of Cialis vs. Viagra?

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. 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)]. Dose up-titration of sildenafil may be needed when initiating treatment with moderate-to-strong CYP3A inducers.

Reduce the dose of sildenafil to 20 mg three times a day when discontinuing treatment with moderate-to-strong CYP3A inducers [see Clinical Pharmacology (12.3) and Clinical Studies (14)]. Animal reproduction studies conducted with sildenafil showed no evidence of embryo-fetal toxicity or teratogenicity at doses up to 32- and 65-times the recommended human dose (RHD) of 20 mg three times a day in rats and rabbits, respectively (see Data).

PAGE TOP