In the following patients: age >65 years, hepatic impairment (e.g., cirrhosis), severe renal
- Sildenafil is used to treat erectile dysfunction in men.
- Dapoxetine is primarily prescribed for premature ejaculation.
- Sildenafil increases blood flow to the penis during arousal.
- Dapoxetine works by delaying serotonin reuptake, extending ejaculation time.
- Both medications require a prescription from a healthcare provider.
- Sildenafil usually takes about 30-60 minutes to work.
- Dapoxetine is typically taken 1-3 hours before sexual activity.
- Combining sildenafil and dapoxetine should only be done under medical guidance.
impairment (e.g., creatinine clearance <30 mL/min), and concomitant use of erythromycin or strong
Drug Label Information
NO then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood.Sildenafil enhances the effect of NO by inhibiting phosphodiesterase type 5 (PDE5), which is responsible for degradation of cGMP in the corpus cavernosum. When sexual stimulation causes local release of NO, inhibition of PDE5 by sildenafil causes increased levels of cGMP in the corpus cavernosum, resulting in smooth muscle relaxation and inflow of blood to the corpus cavernosum. Sildenafil at recommended doses has no effect in the absence of sexual stimulation.Binding CharacteristicsStudies in vitrohave shown that sildenafil is selective for PDE5. Its effect is more potent on PDE5 than on other known phosphodiesterases (10-fold for PDE6, >80-fold dapoxetin sildenafil for PDE1, >700- fold for PDE2, PDE3, PDE4, PDE7, PDE8, PDE9, PDE10, and PDE11). Sildenafil is approximately 4,000-fold more selective for PDE5 compared to PDE3.
Mechanism of action
PDE3 is involved in control of cardiac contractility. Sildenafil is only about 10-fold as potent for PDE5 compared to PDE6, an enzyme found in the retina which is involved in the phototransduction pathway of the retina. This lower selectivity is thought to be the basis for abnormalities related to color vision [ see Clinical Pharmacology (12.2)].In addition to human corpus cavernosum smooth muscle, PDE5 is also found in other tissues including platelets, vascular and visceral smooth muscle, and skeletal muscle, brain, heart, liver, kidney, lung, pancreas, prostate, bladder, testis, and seminal vesicle. The inhibition of PDE5 in some of these tissues by sildenafil may be the basis for the enhanced platelet antiaggregatory activity of NO observed in vitro, an inhibition of platelet thrombus formation in vivoand peripheral arterial-venous dilatation in vivo.12.2 PharmacodynamicsEffects ofsildenafil tablets on Erectile Response:In eight double-blind, placebo-controlled crossover studies of patients with either organic or psychogenic erectile dysfunction, sexual stimulation resulted in improved erections, as assessed by an objective measurement of hardness and duration of erections (RigiScan ®), after sildenafil tablets administration compared with placebo. Most studies assessed the efficacy of sildenafil tablets approximately 60 minutes post dose. CYP3A4 inhibitors, plasma levels of sildenafil at 24 hours post dose have been
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Kamagra Gold | 50 mg | 12 Pills | 47.30€ 45.05€ | |
| Kamagra Soft Tabs | 100mg | 12 Pills | 57.55€ 54.81€ | |
| Cialis Black | 80mg | 90 + 6 Pills | 207.88€ 197.98€ | |
| Kamagra Oral Jelly | 100 mg | 63 + 7 Sachets | 224.18€ 213.50€ | |
| Priligy Generic Dapoxetine | 60mg | 120 + 10 Pills | 341.26€ 325.01€ | |
| Viagra Generic | 200mg | 90 + 6 Pills | 170.79€ 162.66€ | |
| Priligy Generic Dapoxetine | 60mg | 30 + 6 Pills | 106.65€ 101.57€ | |
| Priligy Generic Dapoxetine | 60mg | 10 Pills | 47.63€ 45.36€ | |
| Priligy Generic Dapoxetine | 60mg | 180 + 10 Pills | 494.76€ 471.20€ | |
| Priligy Generic Dapoxetine | 60mg | 20 + 4 Pills | 77.31€ 73.63€ | |
| Viagra Generic | 25mg | 180 + 6 Pills | 154.93€ 147.55€ | |
| Viagra Generic | 150mg | 360 + 10 Pills | 423.48€ 403.31€ | |
| Priligy Generic Dapoxetine | 60mg | 90 + 10 Pills | 265.64€ 252.99€ | |
| Priligy Generic Dapoxetine | 60mg | 60 + 8 Pills | 183.06€ 174.34€ |
found to be 3 to 8 times higher than those seen in healthy volunteers.
Adverse effects
The erectile response, as assessed by RigiScan ®, generally increased with increasing sildenafil dose and plasma concentration. The time course of effect was examined in one study, showing an effect for up to 4 hours but the response was diminished compared to 2 hours.Effects ofsildenafil tabletson Blood Pressure:Single oral doses of sildenafil (100 mg) administered to healthy volunteers produced decreases in sitting blood pressure (mean maximum decrease in systolic/diastolic blood pressure of 8.3/5.3 mmHg). The decrease in sitting blood pressure was most notable approximately 1–2 hours after dosing, and was not different than placebo at 8 hours. Similar effects on blood pressure were noted with 25 mg, 50 mg and 100 mg of sildenafil tablets, therefore the effects are not related to dose or plasma levels within this dosage range. Larger effects were recorded among patients receiving concomitant nitrates [ see Contraindications (4.1)].Effects ofsildenafil tablets on Blood Pressure When Nitroglycerin is subsequently administered:Based on the pharmacokinetic profile of a single 100 mg oral dose given to healthy normal volunteers, the plasma levels of sildenafil at 24 hours post dose are approximately 2 ng/mL (compared to peak plasma levels of approximately 440 ng/mL). Although plasma levels of sildenafil at 24 hours post dose are much lower than at peak concentration, it is unknown whether nitrates can be safely
| Condition | Explanation | Alternative Approach |
|---|---|---|
| Nitrate medications | Dangerous interaction leading to hypotension | Consult healthcare provider |
| Severe liver or kidney disease | Altered drug metabolism and excretion | Dose adjustment or avoidance |
| Hypersensitivity to ingredients | Allergic reactions possible | Discontinue use immediately |
| Heart conditions | Increased cardiovascular risks | Medical evaluation required |
co-administered at this time point [ see Contraindications (4.1)].Effects ofSildenafil tablets on
7.4 Ritonavir and other CYP3A4 inhibitors
In volunteers with severe renal impairment (Clcr<30 mL/min), sildenafil clearance was reduced, resulting in higher plasma exposure of sildenafil (~2 fold), approximately doubling of C maxand AUC. A starting dose of 25 mg should be considered in patients with severe renal impairment [ see Dosage and Administration (2.5)and Clinical Pharmacology (12.3)].8.7 Hepatic ImpairmentIn volunteers with hepatic impairment (Child-Pugh Class A and B), sildenafil clearance was reduced, resulting in higher plasma exposure of sildenafil (47% for C maxand 85% for AUC). The pharmacokinetics of sildenafil in patients with severely impaired hepatic function (Child- Pugh Class C) have not been studied. A starting dose of 25 mg should be considered in patients with any degree of hepatic impairment [see Dosage and Administration (2.5)and Clinical Pharmacology (12.3)]. Sildenafil tablets is not indicated for use in females.
Why it’s used
There are no data with the use of sildenafil tablets in pregnant women to inform any drug-associated risks for adverse developmental outcomes. Animal reproduction studies conducted with sildenafil did not show adverse developmental outcomes when administered during organogenesis in rats and rabbits at oral doses up to 16 and 32 times, respectively, the maximum recommended human dose (MRHD) of 100 mg/day on a mg/m 2basis ( see Data). No evidence of teratogenicity, embryotoxicity or fetotoxicity was observed in rats and rabbits which received oral doses up to 200 mg/kg/day during organogenesis. In the rat pre- and postnatal development study, the no observed adverse effect dose was 30 mg/kg/day given for 36 days, about 2 times the MRHD on a mg/m2 basis in a 50 kg subject. Sildenafil tablets are not indicated for use in females.
Sildenafil vs. tadalafil
Limited data indicate that sildenafil and its active metabolite are present in human milk. There is no tadalafil with dapoxetine online information on the effects on the breastfed child, or the effects on milk production. Sildenafil tablets is not indicated for use in pediatric patients. Safety and effectiveness have not been established in pediatric patients. Healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil resulting in approximately 84% and 107% higher plasma AUC values of sildenafil and its active N- desmethyl metabolite, respectively, compared to those seen in healthy young volunteers (18–45 years) [ see Clinical Pharmacology (12.3)]. Blood Pressure When Co-administered with Alpha-Blockers:Three double-blind, placebo-controlled, randomized, two-way crossover studies were
- Sildenafil is not recommended for use by women.
- Dapoxetine is approved specifically for men with PE.
- Both drugs help improve sexual confidence and performance.
- Proper hydration can help mitigate side effects.
- Patients with retinal disorders should consult a healthcare professional.
- Use of these medications does not protect against sexually transmitted infections.
- Combining medications without medical guidance can be dangerous.
- Inform your doctor if you experience any adverse reactions.
conducted to assess the interaction of sildenafil tablets with doxazosin, an alpha-adrenergic blocking agent.Study 1: sildenafil tablets with DoxazosinIn the first study, a single oral
Publication types
Due to age-differences in plasma protein binding, the corresponding increase in the AUC of free (unbound) sildenafil and its active N-desmethyl metabolite were 45% and 57%, respectively [ see Clinical Pharmacology (12.3)]. Of the total number of subjects in clinical studies of sildenafil, 18% were 65 years and older, while 2% were 75 years and older. No overall differences in safety or efficacy were observed between older (≥ 65 years of age) and younger (< 65 years of age) subjects. However, since higher plasma levels may increase the incidence of adverse reactions, a starting dose of 25 mg should be considered in older subjects due to the higher systemic exposure[ see Dosage and Administration (2.5) No dose adjustment is required for mild (CLcr=50–80 mL/min) and moderate (CLcr=30–49 mL/min) renal impairment. A starting dose of 25 mg should be considered in patients with severe renal impairment [ see Dosage and Administration (2.5)and Clinical Pharmacology (12.3)].
Sildenafil and dapoxetine
In volunteers with hepatic impairment (Child-Pugh Class A and B), sildenafil clearance was reduced, resulting in higher plasma exposure of sildenafil (47% for C maxand 85% for AUC). 10 OVERDOSAGE In studies with healthy volunteers of single doses up to 800 mg, adverse dapoxetine tadalafil tablets reactions were similar to those seen at lower doses but incidence rates and severities were increased.In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and it is not eliminated in the urine. In studies with healthy volunteers of single doses up to 800 mg, adverse reactions were similar to those seen at lower doses but incidence rates and severities were increased. In cases of overdose, standard supportive measures should be adopted as required.
Full Text Sources
11 DESCRIPTION Sildenafil tablets USP, an oral therapy for erectile dysfunction, consist of citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H- pyrazolo[4,3- d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:Sildenafil citrate is a white to off-white powder, slightly soluble in water and methanol with a molecular weight of 666.7.Sildenafil tablets, USP are formulated as blue, film-coated oval biconvex tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. Sildenafil tablets USP, an oral therapy for erectile dysfunction, consist of citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H- pyrazolo[4,3- d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula: Sildenafil citrate is a white to off-white powder, slightly soluble in water and methanol with a molecular weight of 666.7. Sildenafil tablets, USP are formulated as blue, film-coated oval biconvex tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of ActionThe physiologic mechanism of erection of the penis involves release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. dose of sildenafil tablets100 mg or matching placebo was administered in a
- Sildenafil can cause a drop in blood pressure in some users.
- Dapoxetine's adverse effects are usually mild and transient.
- Patients on medication for heart disease should consult a doctor first.
- Sexual activity itself can pose risks for some health conditions.
- Combining sildenafil with other ED medications is not recommended.
- Dapoxetine may interact with other serotonergic drugs.
- Use caution when operating machinery after taking these drugs.
- Always inform your doctor about other medications being used.
2-period crossover design to 4 generally healthy males with benign prostatic hyperplasia (BPH).
- Sildenafil's effects last approximately 4-6 hours.
- Dapoxetine's onset is rapid, within 1-3 hours of intake.
- Side effects of sildenafil may include nasal congestion and visual changes.
- Dapoxetine may cause dry mouth and sweating as side effects.
- Combining these drugs might increase the risk of side effects.
- Usage should be based on a healthcare provider’s assessment.
- Patients with kidney or liver issues need dosage adjustments.
- Proper storage of medications is essential to maintain efficacy.