Patient Eligibility for Sildenafil 60mg Therapy
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).
- Do not drive or operate machinery after taking sildenafil.
- Sexual activity with underlying health risks should be discussed.
- Be aware of potential dizziness or vision changes.
- Follow your healthcare provider’s dosage instructions closely.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
| Parameter | Value | Notes |
|---|---|---|
| Absorption time | 30-120 minutes | Peak plasma levels typically in 60 min |
| Half-life | Approx. 4 hours | Duration varies by individual |
| Oral bioavailability | About 40% | Depends on food and other factors |
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.
Different sildenafil strengths
Reduce the dose of REVATIO to 20 mg three times a day when discontinuing treatment with moderate-to-strong CYP3A inducers [see CLINICAL PHARMACOLOGY and Clinical Studies]. Included as part of the PRECAUTIONS section. REVATIO has vasodilatory properties, resulting in mild and transient decreases in blood pressure. 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 [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 REVATIO.
Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes
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 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. This effect was not seen in idiopathic PAH (REVATIO 3%, placebo 2%) patients.
More common
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 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 REVATIO. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
| Form | Description | Suitable for |
|---|---|---|
| Tablets | Standard oral tablets | Most common form |
| Orally disintegrating tablets | Dissolves on tongue | For easier administration |
| Liquid suspension | Less common, for special cases | Difficult swallowing patients |
Disease-Associated Maternal And/Or Embryo/Fetal Risk Pregnant women with untreated pulmonary arterial hypertension are at risk for heart failure, stroke, preterm delivery, and maternal and fetal death.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Viagra Generic | 200mg | 90 + 6 Pills | 170.79€ 162.66€ | |
| Viagra Generic | 200mg | 20 Pills | 61.69€ 58.75€ | |
| Viagra Generic | 150mg | 120 + 8 Pills | 177.58€ 169.12€ | |
| Viagra Generic | 50mg | 90 + 6 Pills | 107.37€ 102.26€ | |
| Viagra Generic | 50mg | 30 + 4 Pills | 54.26€ 51.68€ | |
| Viagra Generic | 25mg | 120 + 6 Pills | 125.56€ 119.58€ | |
| Viagra Generic | 150mg | 90 + 6 Pills | 147.18€ 140.17€ | |
| Kamagra Polo | 100mg | 272 + 12 Pills | 622.94€ 593.28€ | |
| Viagra Generic | 50mg | 10 Pills | 26.87€ 25.59€ | |
| Kamagra Soft Tabs | 100mg | 32 Pills | 120.11€ 114.39€ | |
| Viagra Generic | 100mg | 20 Pills | 45.58€ 43.41€ | |
| Kamagra Oral Jelly | 100mg | 30 + 5 Sachets | 136.20€ 129.71€ | |
| Kamagra Polo | 100mg | 60 + 4 Pills | 189.39€ 180.37€ | |
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No evidence of teratogenicity, embryotoxicity, or fetotoxicity was observed in pregnant rats or rabbits dosed with sildenafil 200 mg/kg/day during organogenesis, a level that is, on a mg/m² basis, 32- and 65-times, respectively, the recommended human dose (RHD) of 20 mg three times a day.
Warnings for Revatio
There are no controlled clinical data on the safety or efficacy of REVATIO in patients with retinitis pigmentosa, a minority of whom have genetic disorders of retinal phosphodiesterases. Therefore, use of REVATIO in patients with retinitis pigmentosa sildenafil 100mg lowest price 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 REVATIO. In some of the cases, medical conditions and other factors were reported that may have played a role. 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.
Azole Antifungals
Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking PDE-5 inhibitors, including REVATIO. 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. 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 REVATIO than by those randomized to placebo.
Other Interactions
The effectiveness and safety of REVATIO in the treatment of PH secondary to sickle cell disease has not been established. Advise the patient to read the FDA-approved patient labeling (PATIENT INFORMATION and Instructions for Use). Inform patients of contraindication of REVATIO with regular and/or intermittent use of organic nitrates. Inform patients that sildenafil is also marketed as VIAGRA for erectile dysfunction. Advise patients taking REVATIO not to take VIAGRA or other PDE-5 inhibitors. In a rat pre- and postnatal development study, the no-observed-adverse-effect dose was 30 mg/kg/day (equivalent to 5-times the RHD on a mg/m² basis).
- Take sildenafil on an empty stomach for faster effect.
- It typically takes about 30-60 minutes to work.
- Its effects can last for up to 4-6 hours.
- Proper hydration can enhance its effectiveness.
Limited published data from a case report describe the presence of sildenafil and its active metabolite in human milk.
Is Sildenafil Safe?
Advise patients to seek immediate medical attention for a sudden loss of vision in one or both eyes while taking REVATIO. Such an event may be a sign of NAION. Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking REVATIO. These events may be accompanied by tinnitus and dizziness. Sildenafil was not carcinogenic when administered to rats for up to 24 months at 60 mg/kg/day, a dose resulting in total systemic exposure (AUC) to unbound sildenafil and its major metabolite 33- and 37-times, for male and female rats, respectively, the human exposure at the RHD of 20 mg three times a day.
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:
Sildenafil was not carcinogenic when administered to male and female mice for up to 21 and 18 months, respectively, at doses up to a maximally tolerated level of 10 mg/kg/day, a dose equivalent to the RHD on a mg/m² basis. Sildenafil was negative in in vitro bacterial and Chinese hamster ovary cell assays to detect mutagenicity, and in vitro human lymphocytes and in vivo mouse micronucleus assays to detect clastogenicity. There was no impairment of fertility in male or female rats given up to 60 mg sildenafil/kg/day, a dose producing a total systemic exposure (AUC) to unbound sildenafil and its major metabolite of 19- and 38-times for males and females, respectively, the human exposure at the RHD of 20 mg three times a day. Limited published data from randomized controlled trials, case-controlled trials, and case series do not report a clear association with sildenafil and major birth defects, miscarriage, or adverse maternal or fetal outcomes when sildenafil is used during pregnancy. There are risks to the mother and fetus from untreated pulmonary arterial hypertension (see Clinical Considerations). There is insufficient information about the effects of sildenafil on the breastfed infant and no information on the effects of sildenafil on milk production.
How Much Sildenafil is Too Much?
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. REVATIO 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). Erection increased was observed in 9% of patients treated with sildenafil in STARTS-1. No other new adverse reactions were identified in pediatric patients [see Use In Specific Populations]. Adverse events with REVATIO injection were similar to those seen with oral tablets.
Organic Nitrates, Nitrites, and Nitric Oxide Donors
The following adverse reactions have been identified during post approval use of sildenafil (marketed for both PAH and erectile dysfunction). 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. 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. Others were reported to have occurred hours to days after use concurrent with sexual activity. 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.
Platelet-aggregation Inhibitors
NAION [see WARNINGS AND PRECAUTIONS, Patient Counseling Information]. Concomitant use of REVATIO with nitrates in any form is contraindicated [see CONTRAINDICATIONS]. Concomitant use of REVATIO with strong CYP3A inhibitors is not recommended [see CLINICAL PHARMACOLOGY]. Concomitant use of REVATIO with moderate-to-strong CYP3A inducers (such as bosentan) decreases the sildenafil exposure. Dose up-titration of REVATIO may be needed when initiating treatment with moderate-to-strong CYP3A inducers. Limited clinical data during lactation preclude a clear determination of the risk of REVATIO to an infant during lactation.
- Sildenafil 60mg does not protect against sexually transmitted infections.
- Use condoms as a protective measure.
- Discuss any pre-existing conditions with your doctor.
- Its safety in women has not been established.
The safety and efficacy of REVATIO have been established in pediatric patients 1 to 17 years old, for the treatment of PAH (WHO Group I) to improve exercise ability and, in patients too young to perform standard exercising testing, pulmonary hemodynamics thought to underlie improvements in exercise.
| Study | Percentage of Effective Responses | Notes |
|---|---|---|
| Clinical trial A | 70% | Improved erections in majority of users |
| Real-world study B | 65% | Varies with individual health status |
| Meta-analysis C | 75% | Combined data from multiple studies |