50 Pill: white, four-sided, 11mm

5.4 Visual Loss
If you don’t have ED, why is taking Viagra risky?
In case of emergency/overdose
Side effects of Sildenafil (Revatio)
5.2 Prolonged Erection and Priapism
Images for T 30

The following adverse reactions have been identified during post approval use of sildenafil tablets. These events have been chosen for inclusion either due to their seriousness, reporting frequency, lack of clear alternative causation, or a combination of these factors. 7 DRUG INTERACTIONS 7.1 NitratesAdministration of sildenafil tablets with nitric oxide donors such as organic nitrates or organic nitrites in any form is contraindicated. Consistent with its known effects on the nitric oxide/cGMP pathway, sildenafil tablets were shown to potentiate the hypotensive effects of nitrates [see Dosage and Administration (2.3), Contraindications (4.1),Clinical Pharmacology (12.2)].7.2 Alpha-blockersUse caution when co-administering alpha-blockers with sildenafil tablets because of potential additive blood pressure-lowering effects. When sildenafil tablets are 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)].7.3 AmlodipineWhen 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)].7.4 Ritonavir and other CYP3A4 inhibitorsCo-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. Co-administration of saquinavir, a strong CYP3A4 inhibitor, resulted in 140% and 210% increases in sildenafil C maxand AUC, respectively.

5.4 Visual Loss

Stronger CYP3A4 inhibitors such as ketoconazole or itraconazole could be expected to have greater effects than seen with saquinavir. 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)].7.5 AlcoholIn 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) ].

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Administration of sildenafil tablets with nitric oxide donors such as organic nitrates or organic nitrites in any form is contraindicated. Consistent with its known effects on the nitric oxide/cGMP pathway, sildenafil tablets were shown to potentiate the hypotensive effects of nitrates [see Dosage and Administration (2.3), Contraindications (4.1),Clinical Pharmacology (12.2)]. Use caution when co-administering alpha-blockers with sildenafil tablets because of potential additive blood pressure-lowering effects. When sildenafil tablets are 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)].

If you don’t have ED, why is taking Viagra risky?

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/m 2basis in a 50 kg subject.8.2 LactationRisk SummarySildenafil tablets is 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.8.4 Pediatric UseSildenafil tablets are 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 to 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 tablets, 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 to 80 mL/min) and moderate (CLcr=30 to 49 mL/min) renal impairment.

Recreational use

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 are not indicated for use in pediatric patients. 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)]. 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 Pregnancy: Teratogenic EffectsRisk SummarySildenafil tablets is not indicated for use in females.There are no data with the use of sildenafil tablets in pregnant women to inform sildenafil 100mg hexal any drug-associated risks for adverse developmental outcomes.

Sildenafil tablets are classified as phosphodiesterase inhibitors.
White sildenafil tablets are available by prescription only.
They should not be used with nitrates due to risk of dangerous drops in blood pressure.
Certain medications may interact with sildenafil, including antibiotics and antifungals.
The tablets are designed to last approximately 4-6 hours.
Overuse can lead to adverse effects like dizziness or vision changes.
Sildenafil helps men with erectile dysfunction achieve and maintain erections.
The medicine is not an aphrodisiac and requires sexual stimulation.
The tablets should be stored in a cool, dry place away from children.
Beware of counterfeit sildenafil tablets sold online.
Always verify the legitimacy of the medication before use.

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 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 case of emergency/overdose

Jet lag research

Method	Description	Onset of Action	Duration	Notes
Oral Tablet	Swallowed with water	30-60 minutes	4-6 hours	Main administration route
Sublingual	Placed under tongue for faster absorption	15-30 minutes	4-6 hours	Not standard, requires specific formulation
Chewable Tablets	Chewed before swallowing	20-40 minutes	4-6 hours	Sometimes available for quick effect

There is no information on the effects on the breastfed child, or the effects on milk production.8.4 Pediatric UseSildenafil tablets are not indicated for use in pediatric patients.

Side effects of Sildenafil (Revatio)

Consistent with its known effects on the nitric oxide/cGMP pathway, sildenafil tablets were shown to potentiate the hypotensive effects of nitrates [see Dosage and Administration (2.3), Contraindications (4.1),Clinical Pharmacology (12.2)]. Use caution when co-administering alpha-blockers with sildenafil tablets because of potential additive blood pressure-lowering effects. When sildenafil tablets are 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).

Prior authorization

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)]. 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 Pregnancy: Teratogenic EffectsRisk SummarySildenafil tablets is not indicated for use in females.There are no data with the use of sildenafil tablets in pregnant women to inform sildenafil 100mg hexal 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 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. 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 to 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 tablets, 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 to 80 mL/min) and moderate (CLcr=30 to 49 mL/min) renal impairment.

Sildenafil tablets are specifically formulated to mitigate potential side effects.
The tablet's white color is typical for certain dosages or brands.
Patients with cardiovascular issues should consult a doctor before use.
Sildenafil is sometimes used to treat certain cases of erectile dysfunction caused by depression medication.
The effects of sildenafil can be enhanced by reducing alcohol intake.
Contraceptive methods do not impact sildenafil's effectiveness.
Sildenafil does not cause spontaneous erections without sexual stimulation.
It is important to remain seated or relaxed after taking sildenafil.
The pill’s manufacturing process includes strict quality control protocols.
Beware of unregulated markets selling unverified sildenafil tablets.
Follow dosing instructions carefully to prevent overdose or underdose.

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.

Some sildenafil tablets are coated to improve taste and ease swallowing.
Sildenafil should not be used if allergic to citrate compounds.
Cost savings on generic sildenafil make it accessible to more users.
The medication requires no special diet, but avoid fatty foods close to ingestion.
Sildenafil may cause a modest drop in blood pressure temporarily.
Do not share prescribed sildenafil with others; it is tailored to individual health.
Inform your doctor of all medications and health conditions before use.
Sildenafil may have different effects based on age and health status.
The medication has been available in various formulations for convenience.
The effectiveness may vary, and some users might need dose adjustments.
Always keep sildenafil tablets out of reach of children and pets.

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.

Sildenafil tablets are sometimes prescribed for conditions other than ED.
The active ingredient aids in relaxing blood vessels in the body.
White sildenafil tablets are often associated with certain pharmaceutical brands.
Some countries have strict regulations on sildenafil distribution and sale.
Sildenafil is typically not recommended for men with severe eyesight diseases.
Adherence to prescribed guidelines optimizes treatment outcomes.
The tablets are manufactured with quality control practices to ensure safety.
Patients should avoid sudden changes in medication or dosage.
Reactions to sildenafil can be immediate or delayed; monitor closely.
Lifestyle factors like smoking can influence sildenafil’s effectiveness.
Educate yourself on proper storage to maintain medication integrity.

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 are not indicated for use in pediatric patients. Safety and effectiveness have not been established in pediatric patients.

5.2 Prolonged Erection and Priapism

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 to 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)]. No dose adjustment is required for mild (CLcr=50 to 80 mL/min) and moderate (CLcr=30 to 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)].

How is sildenafil supplied (dosage forms)?

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. 11 DESCRIPTION Sildenafil Tablet, USP an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).Sildenafil citrate, USP 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, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7.Sildenafil tablet, USP is formulated as white, film-coated round-shaped tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. 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 to 45 years) [see Clinical Pharmacology(12.3)].

Images for T 30

How it works for PAH

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. Co-administration of saquinavir, a strong CYP3A4 inhibitor, resulted in 140% and 210% increases in sildenafil C maxand AUC, respectively. Stronger CYP3A4 inhibitors such as ketoconazole or itraconazole could be expected to have greater effects than seen with saquinavir. 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)].7.5 AlcoholIn 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) ]. Administration of sildenafil tablets with nitric oxide donors such as organic nitrates or organic nitrites in any form is contraindicated. 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)]. No dose adjustment is required for mild (CLcr=50 to 80 mL/min) and moderate (CLcr=30 to 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)]. 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.

Country/Region	Legal Status	Regulatory Agency	Prescription Needed	Notes
United States	Prescription-only	FDA	Yes	Class II controlled substance
European Union	Prescription-required	EMA	Yes	Regulated as prescription drug
India	Available both OTC and RX	CDSCO	Prescription recommended	Varies by state
Australia	Prescription-only	TGA	Yes	Controlled medicine

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. 11 DESCRIPTION Sildenafil Tablet, USP an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).Sildenafil citrate, USP 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, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7.Sildenafil tablet, USP is formulated as white, film-coated round-shaped tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration.