5.9 Counseling Patients about Sexually Transmitted Diseases

Warnings for other groups

When sildenafil tablets 100 mg were co-administered with amlodipine (5 mg or 10 mg) to hypertensive patients, the mean additional reduction on supine blood pressure was 8 mmHg systolic and 7 mmHg diastolic [ see Warnings and Precautions (5.5), Clinical Pharmacology (12.2)]. Co-administration of ritonavir, a strong CYP3A4 inhibitor, greatly increased the systemic exposure of sildenafil (11-fold increase in AUC). It is therefore recommended not to exceed a maximum single dose of 25 mg of sildenafil tablets in a 48 hour period [ see Dosage and Administration (2.4), Warnings and Precautions (5.6), Clinical Pharmacology (12.3)]. Co-administration of erythromycin, a moderate CYP3A4 inhibitor, resulted in a 160% and 182% increases in sildenafil C maxand AUC, respectively.

Product	Dosage	Quantity + Bonus	Price
Viagra Professional	100mg	60 + 2 Pills	146.74€ 139.75€
Priligy Generic Dapoxetine	60mg	60 + 8 Pills	183.06€ 174.34€
Priligy Generic Dapoxetine	60mg	90 + 10 Pills	265.64€ 252.99€
Priligy Generic Dapoxetine	60mg	10 Pills	47.63€ 45.36€
Cialis Generic	60mg	180 + 10 Pills	313.11€ 298.20€
Priligy Generic Dapoxetine	60mg	20 + 4 Pills	77.31€ 73.63€
Cialis Black	80mg	60 + 4 Pills	150.98€ 143.79€
Levitra Generic	60mg	120 + 8 Pills	372.33€ 354.60€
Priligy Generic Dapoxetine	60mg	180 + 10 Pills	494.76€ 471.20€
Priligy Generic Dapoxetine	60mg	30 + 6 Pills	106.65€ 101.57€
Viagra Generic	150mg	20 Pills	55.02€ 52.40€
Priligy Generic Dapoxetine	60mg	120 + 10 Pills	341.26€ 325.01€

A starting dose of 25 mg of sildenafil tablets should be considered in patients taking erythromycin or strong CYP3A4 inhibitors (such as saquinavir, ketoconazole, itracanozole) [ see Dosage and Administration (2.4), Clinical Pharmacology (12.3)].

5.8 Effects on Bleeding

In cases of overdose, standard supportive measures should be adopted as required. 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.

CAS registry number (Chemical Abstracts Service)

In a drug-drug interaction study sildenafil 50 mg given with alcohol 0.5 g/kg in which mean maximum blood alcohol levels of 0.08% was achieved, sildenafil did not potentiate the hypotensive effect of alcohol in healthy volunteers [ see Clinical Pharmacology (12.2)].

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.

8 USE IN SPECIFIC POPULATIONS 8.1 PregnancySildenafil tablets is not indicated for use in females.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).DataAnimal DataNo evidence of teratogenicity, embryotoxicity or fetotoxicity was observed in rats and rabbits which received oral doses up to 200 mg/kg/day during organogenesis. These doses represent, respectively, about 16 and 32 times the MRHD on a mg/m 2basis in a 50 kg subject. 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.8.2 LactationSildenafil tablets are not indicated for use in females.Limited data indicate that sildenafil and its active metabolite are present in human milk. There is no information on the effects tadalafil with dapoxetine tablets on the breastfed child, or the effects on milk production.8.4 Pediatric UseSildenafil tablets is not indicated for use in pediatric patients. Safety and effectiveness have not been established in pediatric patients.8.5 Geriatric UseHealthy 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)].

Sildenafil Citrate and Dapoxetine Tablets Benefits

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)]. 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 dapoxetine 5mg 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.

Warnings for people with certain health conditions

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)]. 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 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. 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)8.6 Renal ImpairmentNo dose adjustment is required for mild (CLcr=50–80 mL/min) and moderate (CLcr=30–49 mL/min) renal impairment. 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.

Focus Area	Description	Expected Outcomes
New Delivery Systems	Development of fast-dissolving or transdermal patches	Improved compliance and onset time
Combination Therapies	Combining sildenafil with other agents for enhanced effects	Broader treatment spectrum
Reduced Side Effects	Formulations aiming to minimize adverse reactions	Better patient tolerability
Personalized Medicine	Genetic-based dosing and predictions	More precise and safe therapy

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)].

8.2 Lactation

These doses represent, respectively, about 16 and 32 times the MRHD on a mg/m 2basis in a 50 kg subject. 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.8.2 LactationSildenafil tablets are not indicated for use in females.Limited data indicate that sildenafil and its active metabolite are present in human milk. There is no information on the effects tadalafil with dapoxetine tablets on the breastfed child, or the effects on milk production.8.4 Pediatric UseSildenafil tablets is not indicated for use in pediatric patients. Safety and effectiveness have not been established in pediatric patients.8.5 Geriatric UseHealthy 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)]. 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.

How sildenafil is used

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)8.6 Renal ImpairmentNo dose adjustment is required for mild (CLcr=50–80 mL/min) and moderate (CLcr=30–49 mL/min) renal impairment. 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. 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.

12.1 Mechanism of Action

Product Sertraline Tablets BP 50 mg

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. Limited data indicate that sildenafil and its active metabolite are present in human milk. There is no 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)]. 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 dapoxetine 5mg 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)].

Why is Priligy priced so high?

Use caution when co-administering alpha-blockers with sildenafil tablets because of potential additive blood pressure-lowering effects. When sildenafil tablets is co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating sildenafil tablets treatment and sildenafil tablets should be initiated at the lowest dose [ see Dosage and Administration (2.3), Warnings and Precautions (5.5), Clinical Pharmacology (12.2)]. When sildenafil tablets 100 mg were co-administered with amlodipine (5 mg or 10 mg) to hypertensive patients, the mean additional reduction on supine blood pressure was 8 mmHg systolic and 7 mmHg diastolic [ see Warnings and Precautions (5.5), Clinical Pharmacology (12.2)]. Co-administration of ritonavir, a strong CYP3A4 inhibitor, greatly increased the systemic exposure of sildenafil (11-fold increase in AUC). It is therefore recommended not to exceed a maximum single dose of 25 mg of sildenafil tablets in a 48 hour period [ see Dosage and Administration (2.4), Warnings and Precautions (5.6), Clinical Pharmacology (12.3)].

Premature ejaculation

Co-administration of erythromycin, a moderate CYP3A4 inhibitor, resulted in a 160% and 182% increases in sildenafil C maxand AUC, respectively. A starting dose of 25 mg of sildenafil tablets should be considered in patients taking erythromycin or strong CYP3A4 inhibitors (such as saquinavir, ketoconazole, itracanozole) [ see Dosage and Administration (2.4), Clinical Pharmacology (12.3)]. In a drug-drug interaction study sildenafil 50 mg given with alcohol 0.5 g/kg in which mean maximum blood alcohol levels of 0.08% was achieved, sildenafil did not potentiate the hypotensive effect of alcohol in healthy volunteers [ see Clinical Pharmacology (12.2)]. 8 USE IN SPECIFIC POPULATIONS 8.1 PregnancySildenafil tablets is not indicated for use in females.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).DataAnimal DataNo 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 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 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.

How to Do Sildenafil Citrate and Dapoxetine Tablets Work

Sildenafil tablets is not indicated for use in females. 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.

Allergy warning

Sildenafil tablets are not indicated for use in females. Limited data indicate that sildenafil and its active metabolite are present in human milk. There is no 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. 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 helps improve erectile response in men with ED.
Dapoxetine may enhance control over ejaculation for men with PE.
Combining sildenafil and dapoxetine can improve sexual satisfaction.
Use sildenafil with caution in patients with heart conditions.
Dapoxetine has a short half-life, suitable for on-demand use.
Patients should avoid high-fat meals immediately before taking sildenafil.
Dapoxetine should be taken with a full glass of water.
Both drugs are contraindicated in patients with certain heart problems.

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.