Viagra – Meaning in Hindi

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Sildenafil 100 mg film-coated tablets

Aurobindo Pharma – Milpharm Ltd. contact details

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Last updated on emc: 25 Oct 2022

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1. Name of the medicinal product
2. Qualitative and quantitative composition
3. Pharmaceutical form
4. Clinical particulars
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Fertility, pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. Pharmacological properties
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. Pharmaceutical particulars
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. Marketing authorisation holder
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
10. Date of revision of the text

This information is intended for use by health professionals

Each film-coated tablet contains 100 mg Sildenafil (as sildenafil citrate).

Each 100 mg film-coated tablet contains 7.3 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

White to off-white, round (11.2 mm diameter), biconvex film-coated tablets debossed with “SL” on one side and 100 on the other side.

Sildenafil is indicated in adult men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.

In order for Sildenafil to be effective, sexual stimulation is required.

The recommended dose is 50mg taken as needed approximately one hour before sexual activity. Based on efficacy and tolerability, the dose may be increased to 100mg or decreased to 25mg. The maximum recommended dose is 100 mg. The maximum recommended dosing frequency is once per day. If Sildenafil is taken with food, the onset of activity may be delayed compared to the fasted state (see Section 5.2).

Dosage adjustments are not required in elderly patients (≥ 65 years old).

Renal impairment The dosing recommendations described in “Use in adults” apply to patients with mild to moderate renal impairment (creatinine clearance = 30-80 ml/min).

Hepatic impairment Since sildenafil clearance is reduced in patients with hepatic impairment (e.g. cirrhosis) a 25mg dose should be considered. Based on efficacy and tolerability, the dose may be increased step-wise to 50mg and 100mg as necessary.

Sildenafil is not indicated for individuals below 18 years of age.

Use in patients taking other medicinal products With the exception of ritonavir for which co-administration with sildenafil is not advised (see Section 4.4) a starting dose of 25mg should be considered in patients receiving concomitant treatment with CYP3A4 inhibitors (see Section 4.5).

In order to minimise the potential of developing postural hypotension in patients receiving alpha-blocker treatment, patients should be stabilised on alpha-blocker therapy prior to initiating sildenafil treatment. In addition, initiation of sildenafil at a dose of 25 mg should be considered (see Sections 4.4 and 4.5).

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1..

Consistent with its known effects on the nitric oxide/cyclic guanosine monophosphate (cGMP) pathway (see Section 5.1), sildenafil was shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitric oxide donors (such as amyl nitrite) or nitrates in any form is therefore contraindicated.

The co-administration of PDE5 inhibitors, including sildenafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (see section 4.5).

Agents for the treatment of erectile dysfunction, including sildenafil, should not be used in men for whom sexual activity is inadvisable (e.g. patients with severe cardiovascular disorders such as unstable angina or severe cardiac failure).

Sildenafil is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).

A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treatment is considered.

Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Sildenafil has vasodilator properties, resulting in mild and transient decreases in blood pressure (see Section 5.1). Prior to prescribing sildenafil, physicians should carefully consider whether their patients with certain underlying conditions could be adversely affected by such vasodilatory effects, especially in combination with sexual activity. Patients with increased susceptibility to vasodilators include those with left ventricular outflow obstruction (e.g., aortic stenosis, hypertrophic obstructive cardiomyopathy), or those with the rare syndrome of multiple system atrophy manifesting as severely impaired autonomic control of blood pressure.

Sildenafil potentiates the hypotensive effect of nitrates (see Section 4.3).

Serious cardiovascular events, including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular haemorrhage, transient ischaemic attack, hypertension and hypotension have been reported post-marketing in temporal association with the use of Sildenafil. Most, but not all, of these patients had pre-existing cardiovascular risk factors. Many events were reported to occur during or shortly after sexual intercourse and a few were reported to occur shortly after the use of Sildenafil without sexual activity. It is not possible to determine whether these events are related directly to these factors or to other factors.

Agents for the treatment of erectile dysfunction, including sildenafil, should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie’s disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia).

Prolonged erections and priapism have been reported with sildenafil in post-marketing experience. In the event of an erection that persists for longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result.

Concomitant use with other PDE5 inhibitors or other treatments for erectile dysfunction The safety and efficacy of combinations of sildenafil with other PDE5 inhibitors, or other pulmonary arterial hypertension (PAH) treatments containing sildenafil (REVATIO), or other treatments for erectile dysfunction have not been studied. Therefore the use of such combinations is not recommended.

Cases of visual defects have been reported spontaneously in connection with the intake of sildenafil and other PDE5 inhibitors (see section 4.8). Cases of non-arteritic anterior ischaemic optic neuropathy, a rare condition, have been reported spontaneously and in an observational study in connection with the intake of sildenafil and other PDE5 inhibitors (see section 4.8). Patients should be advised that in the event of any sudden visual defect, they should stop taking sildenafil and consult a physician immediately (see section 4.3).

Co-administration of sildenafil with ritonavir is not advised (see Section 4.5).

Caution is advised when sildenafil is administered to patients taking an alpha-blocker, as the coadministration may lead to symptomatic hypotension in a few susceptible individuals (see Section 4.5). This is most likely to occur within 4 hours post sildenafil dosing. In order to minimise the potential for developing postural hypotension, patients should be hemodynamically stable on alpha-blocker therapy prior to initiating sildenafil treatment. Initiation of sildenafil at a dose of 25 mg should be considered (see Section 4.2). In addition, physicians should advise patients what to do in the event of postural hypotensive symptoms.

Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro. There is no safety information on the administration of sildenafil to patients with bleeding disorders or active peptic ulceration. Therefore sildenafil should be administered to these patients only after careful benefit-risk assessment.

The film coating of the Sildenafil tablet contains lactose. Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Sildenafil is not indicated for use by women.

This medicine contains less than 1 mmol sodium (23 mg) per each tablet, that is to say essentially ‘sodium-free’.

Effects of other medicinal products on sildenafil

Sildenafil metabolism is principally mediated by the cytochrome P450 (CYP) isoforms 3A4 (major route) and 2C9 (minor route). Therefore, inhibitors of these isoenzymes may reduce sildenafil clearance and inducers of these isoenzymes may increase sildenafil clearance.

Population pharmacokinetic analysis of clinical trial data indicated a reduction in sildenafil clearance when co-administered with CYP3A4 inhibitors (such as ketoconazole, erythromycin, cimetidine). Although no increased incidence of adverse events was observed in these patients, when sildenafil is administered concomitantly with CYP3A4 inhibitors, a starting dose of 25mg should be considered.

Co-administration of the HIV protease inhibitor ritonavir, which is a highly potent P450 inhibitor, at steady state (500mg twice daily) with sildenafil (100mg single dose) resulted in a 300% (4-fold) increase in sildenafil Cmax and a 1,000% (11-fold) increase in sildenafil plasma AUC. At 24 hours, the plasma levels of sildenafil were still approximately 200ng/ml, compared to approximately 5ng/ml when sildenafil was administered alone. This is consistent with ritonavir’s marked effects on a broad range of P450 substrates. Sildenafil had no effect on ritonavir pharmacokinetics. Based on these pharmacokinetic results co-administration of sildenafil with ritonavir is not advised (see Section 4.4) and in any event the maximum dose of sildenafil should under no circumstances exceed 25mg within 48 hours.

Co-administration of the HIV protease inhibitor saquinavir, a CYP3A4 inhibitor, at steady state (1200mg three times a day) with sildenafil (100mg single dose) resulted in a 140% increase in sildenafil Cmax and a 210% increase in sildenafil AUC. Sildenafil had no effect on saquinavir pharmacokinetics (see Section 4.2). Stronger CYP3A4 inhibitors such as ketoconazole and itraconazole would be expected to have greater effects.

When a single 100mg dose of sildenafil was administered with erythromycin, a moderateCYP3A4 inhibitor, at steady state (500mg twice daily for 5 days), there was a 182% increase in sildenafil systemic exposure (AUC). In normal healthy male volunteers, there was no evidence of an effect of azithromycin (500mg daily for 3 days) on the AUC, Cmax, Tmax, elimination rate constant, or subsequent half-life of sildenafil or its principal circulating metabolite. Cimetidine (800mg), a cytochrome P450 inhibitor and non-specific CYP3A4 inhibitor, caused a 56% increase in plasma sildenafil concentrations when co-administered with sildenafil (50mg) to healthy volunteers.

Grapefruit juice is a weak inhibitor of CYP3A4 gut wall metabolism and may give rise to modest increases in plasma levels of sildenafil.

Single doses of antacid (magnesium hydroxide/aluminium hydroxide) did not affect the bioavailability of sildenafil.

Although specific interaction studies were not conducted for all medicinal products, population pharmacokinetic analysis showed no effect of concomitant medication on sildenafil pharmacokinetics when grouped as CYP2C9 inhibitors (such as tolbutamide, warfarin, phenytoin), CYP2D6 inhibitors (such as selective serotonin reuptake inhibitors, tricyclic antidepressants), thiazide and related diuretics, loop and potassium sparing diuretics, angiotensin converting enzyme inhibitors, calcium channel blockers, beta-adrenoreceptor antagonists or inducers of CYP450 metabolism (such as rifampicin, barbiturates). In a study of healthy male volunteers, co-administration of the endothelin antagonist, bosentan, (an inducer of CYP3A4 [moderate], CYP2C9 and possibly of CYP2C19) at steady state (125 mg twice a day) with sildenafil at steady state (80 mg three times a day) resulted in 62.6% and 55.4% decrease in sildenafil AUC and Cmax, respectively. Therefore, concomitant administration of strong CYP3A4 inducers, such as rifampin, is expected to cause greater decreases in plasma concentrations of sildenafil.

Nicorandil is a hybrid of potassium channel activator and nitrate. Due to the nitrate component it has the potential to result in aserious interaction with sildenafil.

Effects of sildenafil on other medicinal products

Sildenafil is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC50 >150 μM). Given sildenafil peak plasma concentrations of approximately 1 μM after recommended doses, it is unlikely that Sildenafil will alter the clearance of substrates of these isoenzymes.

There are no data on the interaction of sildenafil and non-specific phosphodiesterase inhibitors such as theophylline or dipyridamole.

Consistent with its known effects on the nitric oxide/cGMP pathway (see Section 5.1), sildenafil was shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitric oxide donors or nitrates in any form is therefore contraindicated (see Section 4.3).

Riociguat: Preclinical studies showed additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat. In clinical studies, riociguat has been shown to augment the hypotensive effects of PDE5 inhibitors. There was no evidence of favourable clinical effect of the combination in the population studied. Concomitant use of riociguat with PDE5 inhibitors, including sildenafil, is contraindicated (see section 4.3).

Concomitant administration of sildenafil to patients taking alpha-blocker therapy may lead to symptomatic hypotension in a few susceptible individuals. This is most likely to occur within 4 hours post sildenafil dosing (see Sections 4.2 and 4.4). In three specific drug-drug interaction studies, the alpha-blocker doxazosin (4 mg and 8 mg) and sildenafil (25 mg, 50 mg, or 100 mg) were administered simultaneously to patients with benign prostatic hyperplasia (BPH) stabilized on doxazosin therapy. In these study populations, mean additional reductions of supine blood pressure of 7/7 mmHg, 9/5 mmHg, and 8/4 mmHg, and mean additional reductions of standing blood pressure of 6/6 mmHg, 11/4 mmHg, and 4/5 mmHg, respectively, were observed. When sildenafil and doxazosin were administered simultaneously to patients stabilized on doxazosin therapy, there were infrequent reports of patients who experienced symptomatic postural hypotension. These reports included dizziness and light-headedness, but not syncope.

No significant interactions were shown when sildenafil (50mg) was co-administered with tolbutamide (250mg) or warfarin (40mg), both of which are metabolised by CYP2C9.

Sildenafil (50mg) did not potentiate the increase in bleeding time caused by acetyl salicylic acid (150mg).

Sildenafil (50mg) did not potentiate the hypotensive effects of alcohol in healthy volunteers with mean maximum blood alcohol levels of 80 mg/dl.

Pooling of the following classes of antihypertensive medication; diuretics, beta-blockers, ACE inhibitors, angiotensin II antagonists, antihypertensive medicinal products (vasodilator and centrally-acting), adrenergic neurone blockers, calcium channel blockers and alpha-adrenoceptor blockers, showed no difference in the side effect profile in patients taking sildenafil compared to placebo treatment. In a specific interaction study, where sildenafil (100mg) was co-administered with amlodipine in hypertensive patients, there was an additional reduction on supine systolic blood pressure of 8 mmHg. The corresponding additional reduction in supine diastolic blood pressure was 7 mmHg. These additional blood pressure reductions were of a similar magnitude to those seen when sildenafil was administered alone to healthy volunteers (see Section 5.1).

Sildenafil (100mg) did not affect the steady state pharmacokinetics of the HIV protease inhibitors, saquinavir and ritonavir, both of which are CYP3A4 substrates.

In healthy male volunteers, sildenafil at steady state (80 mg t.i.d.) resulted in a 49.8% increase in bosentan AUC and a 42% increase in bosentan Cmax (125 mg b.i.d.).

Addition of a single dose of sildenafil to sacubitril/valsartan at steady state in patients with hypertension was associated with a significantly greater blood pressure reduction compared to administration of sacubitril/valsartan alone. Therefore, caution should be exercised when sildenafil is initiated in patients treated with sacubitril/valsartan.

Sildenafil is not indicated for use by women.

There are no adequate and well-controlled studies in pregnant or breastfeeding women.

No relevant adverse effects were found in reproduction studies in rats and rabbits following oral administration of sildenafil.

There was no effect on sperm motility or morphology after single 100 mg oral doses of sildenafil in healthy volunteers (see section 5.1).

Sildenafil may have a minor influence on the ability to drive and use machines.

As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be aware of how they react to Sildenafil, before driving or operating machinery.

The safety profile of Sildenafil is based on 9570 patients in 74 double-blind placebo-controlled clinical studies. The most commonly reported adverse reactions in clinical studies among sildenafil treated patients were headache, flushing, dyspepsia, nasal congestion, dizziness, nausea, hot flush, visual disturbance, cyanopsia and vision blurred.

Adverse reactions from post-marketing surveillance has been gathered covering an estimated period>10 years. Because not all adverse reactions are reported to the Marketing Authorisation Holder and included in the safety database, the frequencies of these reactions cannot be reliably determined.

In the table below all medically important adverse reactions, which occurred in clinical trials at an incidence greater than placebo are listed by system organ class and frequency Very common (≥1/10), Common (≥1/100 to

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Table 1: Medically important adverse reactions reported at an incidence greater than placebo in controlled clinical studies and medically important adverse reactions reported through post-marketing surveillance

Non-arteritic anterior ischaemic optic neuropathy (NAION), *

Respiratory, thoracic and mediastinal disorders

Skin and subcutaneous tissue disorders

Musculoskeletal and connective tissue disorders

Reproductive system and breast disorders

General disorders and administration site conditions

*Reported during post-marketing surveillance only

**Visual colour distortions: Chloropsia, Chromatopsia, Cyanopsia, Erythropsia and Xanthopsia

***Lacrimation disorders: Dry eye, Lacrimal disorder and Lacrimation increased

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme

In single dose volunteer studies of doses up to 800mg, adverse reactions were similar to those seen at lower doses, but the incidence rates and severities were increased. Doses of 200mg did not result in increased efficacy but the incidence of adverse reactions (headache, flushing, dizziness, dyspepsia, nasal congestion, altered vision) was 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 not eliminated in the urine.

Pharmacotherapeutic group: Urologicals; Drugs used in erectile dysfunction. ATC Code: G04B E03.

Sildenafil is an oral therapy for erectile dysfunction. In the natural setting, i.e. with sexual stimulation, it restores impaired erectile function by increasing blood flow to the penis.

The physiological mechanism responsible for erection of the penis involves the release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. Nitric oxide 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 is a potent and selective inhibitor of cGMP specific phosphodiesterase type 5 (PDE5) in the corpus cavernosum, where PDE5 is responsible for degradation of cGMP. Sildenafil has a peripheral site of action on erections. Sildenafil has no direct relaxant effect on isolated human corpus cavernosum but potently enhances the relaxant effect of NO on this tissue. When the NO/cGMP pathway is activated, as occurs with sexual stimulation, inhibition of PDE5 by sildenafil results in increased corpus cavernosum levels of cGMP. Therefore sexual stimulation is required in order for sildenafil to produce its intended beneficial pharmacological effects.

Studies in vitro have shown that sildenafil is selective for PDE5, which is involved in the erection process. Its effect is more potent on PDE5 than on other known phosphodiesterases. There is a 10-fold selectivity over PDE6 which is involved in the phototransduction pathway in the retina. At maximum recommended doses, there is an 80-fold selectivity over PDE1, and over 700-fold over PDE 2, 3, 4, 7, 8, 9, 10 and 11. In particular, sildenafil has greater than 4,000-fold selectivity for PDE5 over PDE3, the cAMP-specific phosphodiesterase isoform involved in the control of cardiac contractility.

Two clinical studies were specifically designed to assess the time window after dosing during which sildenafil could produce an erection in response to sexual stimulation. In a penile plethysmography (RigiScan) study of fasted patients, the median time to onset for those who obtained erections of 60% rigidity (sufficient for sexual intercourse) was 25 minutes (range 12-37 minutes) on sildenafil. In a separate RigiScan study, sildenafil was still able to produce an erection in response to sexual stimulation 4-5 hours post-dose.

Sildenafil causes mild and transient decreases in blood pressure which, in the majority of cases, do not translate into clinical effects. The mean maximum decreases in supine systolic blood pressure following 100mg oral dosing of sildenafil was 8.4 mmHg. The corresponding change in supine diastolic blood pressure was 5.5 mmHg. These decreases in blood pressure are consistent with the vasodilatory effects of sildenafil, probably due to increased cGMP levels in vascular smooth muscle. Single oral doses of sildenafil up to 100mg in healthy volunteers produced no clinically relevant effects on ECG.

In a study of the hemodynamic effects of a single oral 100mg dose of sildenafil in 14 patients with severe coronary artery disease (CAD) (>70% stenosis of at least one coronary artery), the mean resting systolic and diastolic blood pressures decreased by 7% and 6% respectively compared to baseline. Mean pulmonary systolic blood pressure decreased by 9%. Sildenafil showed no effect on cardiac output, and did not impair blood flow through the stenosed coronary arteries.

A double-blind, placebo-controlled exercise stress trial evaluated 144 patients with erectile dysfunction and chronic stable angina who regularly received anti-anginal medicinal products (except nitrates). The results demonstrated no clinically relevant differences between sildenafil and placebo in time to limiting angina.

Mild and transient differences in colour discrimination (blue/green) were detected in some subjects using the Farnsworth-Munsell 100 hue test at 1 hour following a 100mg dose, with no effects evident after 2 hours post-dose. The postulated mechanism for this change in colour discrimination is related to inhibition of PDE6, which is involved in the phototransduction cascade of the retina. Sildenafil has no effect on visual acuity or contrast sensitivity. In a small size placebo-controlled study of patients with documented early age-related macular degeneration (n=9), sildenafil (single dose, 100mg) demonstrated no significant changes in visual tests conducted (visual acuity, Amsler grid, colour discrimination simulated traffic light, Humphrey perimeter and photostress).

There was no effect on sperm motility or morphology after single 100mg oral doses of sildenafil in healthy volunteers (see section 4.6)..

Further information on clinical trials

In clinical trials sildenafil was administered to more than 8000 patients aged 19-87. The following patient groups were represented: elderly (19.9%), patients with hypertension (30.9%), diabetes mellitus (20.3%), ischaemic heart disease (5.8%), hyperlipidaemia (19.8%), spinal cord injury (0.6%), depression (5.2%), transurethral resection of the prostate (3.7%), radical prostatectomy (3.3%). The following groups were not well represented or excluded from clinical trials: patients with pelvic surgery, patients post-radiotherapy, patients with severe renal or hepatic impairment and patients with certain cardiovascular conditions (see Section 4.3).

In fixed dose studies, the proportions of patients reporting that treatment improved their erections were 62% (25mg), 74% (50mg) and 82% (100mg) compared to 25% on placebo. In controlled clinical trials, the discontinuation rate due to sildenafil was low and similar to placebo.

Across all trials, the proportion of patients reporting improvement on sildenafil were as follows: psychogenic erectile dysfunction (84%), mixed erectile dysfunction (77%), organic erectile dysfunction (68%), elderly (67%), diabetes mellitus (59%), ischaemic heart disease (69%), hypertension (68%), TURP (61%), radical prostatectomy (43%), spinal cord injury (83%), depression (75%). The safety and efficacy of sildenafil was maintained in long term studies.

The European Medicines Agency has waived the obligation to submit the results of studies with Sildenafil in all subsets of the paediatric population for the treatment of erectile dysfunction. See 4.2 for information on paediatric use.

Sildenafil is rapidly absorbed. Maximum observed plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state. The mean absolute oral bioavailability is 41% (range 25-63%). After oral dosing of sildenafil AUC and Cmax increase in proportion with dose over the recommended dose range (25-100mg).

When sildenafil is taken with food, the rate of absorption is reduced with a mean delay in Tmax of 60 minutes and a mean reduction in Cmax of 29%.

The mean steady state volume of distribution (Vd) for sildenafil is 105 l, indicating distribution into the tissues. After a single oral dose of 100 mg, the mean maximum total plasma concentration of sildenafil is approximately 440 ng/ml (CV 40%). Since sildenafil (and its major circulating N-desmethyl metabolite) is 96% bound to plasma proteins, this results in the mean maximum free plasma concentration for sildenafil of 18 ng/ml (38 nM). Protein binding is independent of total drug concentrations.

In healthy volunteers receiving sildenafil (100mg single dose), less than 0.0002% (average 188ng) of the administered dose was present in ejaculate 90 minutes after dosing.

Sildenafil is cleared predominantly by the CYP3A4 (major route) and CYP2C9 (minor route) hepatic microsomal isoenzymes. The major circulating metabolite results from N-demethylation of sildenafil. This metabolite has a phosphodiesterase selectivity profile similar to sildenafil and an in vitro potency for PDE5 approximately 50% that of the parent drug. Plasma concentrations of this metabolite are approximately 40% of those seen for sildenafil. The N-desmethyl metabolite is further metabolised, with a terminal half life of approximately 4 h.

The total body clearance of sildenafil is 41 l/h with a resultant terminal phase half life of 3-5 h. After either oral or intravenous administration, sildenafil is excreted as metabolites predominantly in the faeces (approximately 80% of administered oral dose) and to a lesser extent in the urine (approximately 13% of administered oral dose).

Pharmacokinetics in special patient groups

Healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil, resulting in approximately 90% higher plasma concentrations of sildenafil and the active N-desmethyl metabolite compared to those seen in healthy younger volunteers (18-45 years). Due to age-differences in plasma protein binding, the corresponding increase in free sildenafil plasma concentration was approximately 40%.

In volunteers with mild to moderate renal impairment (creatinine clearance = 30-80 ml/min), the pharmacokinetics of sildenafil were not altered after receiving a 50mg single oral dose. The mean AUC and Cmax of the N-desmethyl metabolite increased up to 126% and up to 73% respectively, compared to age-matched volunteers with no renal impairment. However, due to high inter-subject variability, these differences were not statistically significant. In volunteers with severe renal impairment (creatinine clearance < 30 ml/min), sildenafil clearance was reduced, resulting in mean increases in AUC and Cmax of 100% and 88% respectively compared to age-matched volunteers with no renal impairment. In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased by 200% and 79% respectively.

In volunteers with mild to moderate hepatic cirrhosis (Child-Pugh A and B) sildenafil clearance was reduced, resulting in increases in AUC (84%) and Cmax (47%) compared to age-matched volunteers with no hepatic impairment. The pharmacokinetics of sildenafil in patients with severely impaired hepatic function have not been studied.

Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development..

Viagra – Meaning in Hindi

Sildenafil, sold under the brand name Viagra, among others, is a medication used to treat erectile dysfunction and pulmonary arterial hypertension. It is unclear if it is effective for treating sexual dysfunction in women. It is taken by mouth or by injection into a vein. Onset is typically within twenty minutes and lasts for about two hours. Also see ” Sildenafil ” on Wikipedia

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About Viagra in Hindi

See Viagra meaning in Hindi, Viagra definition, translation and meaning of Viagra in Hindi. Find Viagra similar words, Viagra synonyms. Learn and practice the pronunciation of Viagra. Find the answer of what is the meaning of Viagra in Hindi. देेखें Viagra का हिन्दी मतलब, Viagra का मीनिंग, Viagra का हिन्दी अर्थ, Viagra का हिन्दी अनुवाद।

Tags for the entry “Viagra”

What is Viagra meaning in Hindi, Viagra translation in Hindi, Viagra definition, pronunciations and examples of Viagra in Hindi. Viagra का हिन्दी मीनिंग, Viagra का हिन्दी अर्थ, Viagra का हिन्दी अनुवाद

Does It Matter If I Take Viagra with Water or Milk?

Whether you’re taking Viagra for the first time or you’ve been on it for a while, here are some tips to make sure it works well when you need it, including how to take it with water and milk.

How long does Viagra take to work?

According to the Food and Drug Administration (FDA), Viagra is absorbed quickly and starts to work within an hour. But, depending on the dose of Viagra and other individual factors, it can take as little as 30 minutes to as long as 4 hours to work.

Yes, as a matter of fact, it does. Certain foods or drinks can speed up, slow down, or change the way a medication, such as Viagra, works.

Viagra is one of the most popular erectile dysfunction (ED) medications available today. ED is a common condition with many causes , so it’s important to talk with your doctor first to determine if Viagra is the right medication for your symptoms.

Yes. Water is a great way to take Viagra.

One of the most common side effects of Viagra is stomach upset or dyspepsia. For many men, this side effect is bothersome and can make sexual activity uncomfortable. Water may help avoid that.

What happens when you take Viagra with water?

PDE5 inhibitors like Viagra work by relaxing smooth muscle tissue in the penis to allow blood to flow in. This can lead to an erection if you’re aroused. But Viagra isn’t selective and has effects on smooth muscle tissue in other parts of the body like the lower esophageal sphincter (LES), a ring that closes off the esophagus from the stomach.

When the LES muscle relaxes, it can cause small amounts of stomach acid to leak into your esophagus, causing indigestion or acid reflux.

Taking Viagra with a full glass of water can help move the medication into your stomach faster.

Water can also make sure the pill doesn’t get stuck in your throat or esophagus and cause pain, coughing, choking, or burning.

How to take Viagra with water

Stick with room temperature water when taking medication. Hot water can potentially dissolve the coating of a medication.
Take Viagra with at least half to a full glass of water to help it do its job.

If dyspepsia or nausea bothers you too much, talk to your doctor. They may be able to lower the dose of Viagra or suggest over-the-counter (OTC) products like antacids to help.

Don’t take OTC products without talking to your doctor or pharmacist. There may be interactions with other medications you’re already taking.

Yes. There are no clinical studies that show Viagra taken with milk causes any side effects or interactions.

But whole milk has 8 grams of fat, and studies show high fat meals can cause upset stomach and slow the absorption of Viagra.

Also, if you’re allergic to milk or have lactose intolerance, this might increase your risk of stomach upset or acid reflux if you take it with Viagra.

Taking Viagra with milk probably won’t be harmful. Just know that your body might tolerate the combination differently than if taken with water, such as experiencing delayed time to an erection.

A 2018 study of healthy volunteers taking a 50-milligram dose of sildenafil (Viagra) with a nutritional drink showed that taking both together led to slowed absorption and delayed emptying of the stomach. This may increase gastrointestinal side effects like upset stomach, nausea, and a feeling of fullness.

To prevent some interactions, it’s best to avoid taking Viagra with fruit juice.

Fruit juices can interact with medications and increase or decrease their effects.

Viagra may interact with certain fruit juices like grapefruit , pomelo , and potentially even pomegranate juice if taken together.

The effect of taking Viagra with juice depends on the amount of juice you drink, the dose of the medication, and individual metabolic factors, or how your body reacts individually.

Taking Viagra with a heavy or high fat meal can slow the time it takes Viagra to start working by about an hour. Fatty foods might also increase the risk of stomach upset.

A full stomach may also make sexual activity uncomfortable.

You can take Viagra an hour before sexual activity either on an empty stomach or with a light meal to avoid delayed absorption of the medication.

caution

Don’t take more than one dose per day or increase your dose if you think it didn’t work. Taking too much can cause serious side effects like priapism, an erection lasting more than 4 hours.

Other major issues that can come with doubling a dose include low blood pressure, headache, and vision changes.

The effectiveness of Viagra and any side effects you experience depend on many factors, including the dose, your age, genetic factors, any existing health conditions, and other medications you may be taking.

The best way to take Viagra is either 1 hour before sex on an empty stomach or 2 hours after a meal to avoid a delay in effectiveness.

You can take Viagra with a glass of water, but you can also take it with milk or a light snack. Keep in mind that taking Viagra with whole milk or food may impact its effectiveness.

Always talk to your doctor or pharmacist about the best way to take Viagra, including if there are foods or drinks you should avoid.

If you experience serious side effects from Viagra, call your doctor. For a medical emergency, call 911 right away.

Last medically reviewed on September 30, 2020

How we reviewed this article:

Healthline has strict sourcing guidelines and relies on peer-reviewed studies, academic research institutions, and medical associations. We avoid using tertiary references. You can learn more about how we ensure our content is accurate and current by reading our editorial policy.

Al-Ghazawi MA, et al. (2010). The effects of pummelo juice on pharmacokinetics of sildenafil in healthy adult male Jordanian volunteers. DOI:
10.1007/s00228-009-0738-0
Carbone F, et al. (2018). The effect of sildenafil on gastric motility and satiation in healthy controls. DOI:
10.1177/2050640618766933
Fuchs J. (2009). The amount of liquid patients use to take tablets or capsules.
ncbi.nlm.nih.gov/pmc/articles/PMC4139049/
Hakky TS, et al. (2015). Current use of phosphodiesterase inhibitors in urology. DOI:
10.5152/tud.2015.46354
Huang SA, et al. (2013). Phosphodiesterase-5 (PDE5) inhibitors in the management of erectile dysfunction.
ncbi.nlm.nih.gov/pmc/articles/PMC3776492/
Jetter A, et al. (2002). Effects of grapefruit juice on the pharmacokinetics of sildenafil. DOI:
10.1067/mcp.2002.121236
Senthilkumaran S, et al. (2012). Priapism, pomegranate juice, and sildenafil: Is there a connection? DOI:
10.4103/0974-7796.95560
Viagra (sildenafil citrate). (2010).
accessdata.fda.gov/drugsatfda_docs/label/2011/020895s036lbl.pdf
Zucchi A, et al. (2019). The first-generation phosphodiesterase 5 inhibitors and their pharmacokinetic issue. DOI:
10.1111/andr.12683

Our experts continually monitor the health and wellness space, and we update our articles when new information becomes available.

Sildenafil

Sildenafil (Viagra) is used to treat erectile dysfunction (impotence; inability to get or keep an erection) in men. Sildenafil (Revatio) is used to improve the ability to exercise in adults with pulmonary arterial hypertension (PAH; high blood pressure in the vessels carrying blood to the lungs, causing shortness of breath, dizziness, and tiredness). Children should not usually take sildenafil, but in some cases, a doctor may decide that sildenafil (Revatio) is the best medication to treat a child’s condition. Sildenafil is in a class of medications called phosphodiesterase (PDE) inhibitors. Sildenafil treats erectile dysfunction by increasing blood flow to the penis during sexual stimulation. This increased blood flow can cause an erection. Sildenafil treats PAH by relaxing the blood vessels in the lungs to allow blood to flow easily.

If you are taking sildenafil to treat erectile dysfunction, you should know that it does not cure erectile dysfunction or increase sexual desire. Sildenafil does not prevent pregnancy or the spread of sexually transmitted diseases such as human immunodeficiency virus (HIV).

How should this medicine be used?

Sildenafil comes as a tablet and suspension (liquid; Revatio only) to take by mouth.

If you are taking sildenafil to treat erectile dysfunction, follow your doctor’s directions and the guidelines in this paragraph. Take sildenafil as needed before sexual activity. The best time to take sildenafil is about 1 hour before sexual activity, but you can take the medication any time from 4 hours to 30 minutes before sexual activity. Sildenafil usually should not be taken more than once every 24 hours. If you have certain health conditions or are taking certain medications, your doctor may tell you to take sildenafil less often. You can take sildenafil with or without food. However, if you take sildenafil with a high-fat meal, it will take longer for the medication to start to work.

If you are taking sildenafil to treat PAH, follow your doctor’s directions and the guidelines in this paragraph. You will probably take sildenafil three times a day with or without food. Take sildenafil at around the same times every day, and space your doses about 4 to 6 hours apart.

Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take sildenafil exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Shake the liquid well for 10 seconds before each use to mix the medication evenly. Use the oral syringe provided with your medication to measure and take your dose. Follow the manufacturer’s directions to use and clean the oral syringe. Do not mix the liquid with other medications or add anything to flavor the medication.

If you are taking sildenafil for erectile dysfunction, your doctor will probably start you on an average dose of sildenafil and increase or decrease your dose depending on your response to the medication. Tell your doctor if sildenafil is not working well or if you are experiencing side effects.

If you are taking sildenafil for PAH, you should know that sildenafil controls PAH but does not cure it. Continue to take sildenafil even if you feel well. Do not stop taking sildenafil without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

Other uses for this medicine

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before taking sildenafil,

tell your doctor and pharmacist if you are allergic to sildenafil, any other medications, or any of the ingredients in sildenafil products. Ask your pharmacist for a list of the ingredients.
do not take sildenafil if you are taking or have recently taken riociguat (Adempas) or nitrates (medications for chest pain) such as isosorbide dinitrate (Isordil), isosorbide mononitrate (Monoket), and nitroglycerin (Minitran, Nitro-Dur, Nitromist, Nitrostat, others). Nitrates come as tablets, sublingual (under the tongue) tablets, sprays, patches, pastes, and ointments. Ask your doctor if you are not sure whether any of your medications contain nitrates.
do not take street drugs containing nitrates such as amyl nitrate and butyl nitrate (‘poppers’) while taking sildenafil.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), tamsulosin (Flomax, in Jalyn), and terazosin; amlodipine (Norvasc, in Amturnide, in Tekamlo); certain antifungals such as itraconazole (Onmel, Sporanox) and ketoconazole (Nizoral); anticoagulants (‘blood thinners’) such as warfarin (Coumadin, Jantoven); certain barbiturates such as butalbital (in Butapap, in Fioricet, in Fiorinal, others) and secobarbital (Seconal); beta blockers such as atenolol (Tenormin, in Tenoretic), labetalol (Trandate), metoprolol (Lopressor, Toprol XL, in Dutoprol), nadolol (Corgard, in Corzide), and propranolol (Hemangeol, Inderal LA, InnoPran); bosentan (Tracleer); cimetidine ; efavirenz (Sustiva, in Atripla); erythromycin (E.E.S., E-Mycin, Erythrocin); HIV protease inhibitors including amprenavir (Agenerase; no longer available in the U.S.), atazanavir (Reyataz, in Evotaz), darunavir (Prezista, in Prezcobix), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), saquinavir (Invirase), and tipranavir (Aptivus); nevirapine (Viramune); other medications or devices to treat erectile dysfunction; medications for high blood pressure; certain medications for seizures including carbamazepine (Carbatrol, Epitol, Tegretol, others), phenobarbital, and phenytoin (Dilantin, Phenytek); rifabutin (Mycobutin); and rifampin (Rifadin, Rimactane, in Rifamate, in Rifater). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with sildenafil, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
tell your doctor what herbal products you are taking or plan to take, especially St. John’s wort.
tell your doctor if you smoke, if you have ever had an erection that lasted for several hours, and if you have recently lost a large amount of body fluids (dehydration). This can happen if you are sick with fever, diarrhea, or vomiting; sweat a lot; or do not drink enough liquids. Also tell your doctor if you have or have ever had pulmonary veno-occlusive disease (PVOD; blockage of veins in the lungs); a stomach ulcer; heart, kidney, or liver disease; a heart attack; an irregular heartbeat; a stroke; chest pain; high or low blood pressure; high cholesterol; a bleeding disorder; blood circulation problems;blood cell problems such as sickle cell anemia (a disease of the red blood cells), multiple myeloma (cancer of the plasma cells), or leukemia (cancer of the white blood cells); conditions affecting the shape of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie’s disease); or diabetes. Also tell your doctor if you or any of your family members have or have ever had an eye disease such as retinitis pigmentosa (an inherited eye condition that causes loss of vision) or if you have ever had sudden severe vision loss, especially if you were told that the vision loss was caused by a blockage of blood flow to the nerves that help you see.
if you are a woman and you are taking sildenafil to treat PAH, tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking sildenafil, call your doctor.
if you are having surgery, including dental surgery, tell your doctor or dentist that you are taking sildenafil.
if you are taking sildenafil to treat erectile dysfunction, tell your doctor if you have ever been advised by a healthcare professional to avoid sexual activity for medical reasons or if you have ever experienced chest pain during sexual activity. Sexual activity may be a strain on your heart, especially if you have heart disease. If you experience chest pain, dizziness, or nausea during sexual activity, call your doctor immediately and avoid sexual activity until your doctor tells you otherwise.
tell all your healthcare providers that you are taking sildenafil. If you ever need emergency medical treatment for a heart problem, the healthcare providers who treat you will need to know when you last took sildenafil.

What special dietary instructions should I follow?

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine.

What should I do if I forget a dose?

If you are taking sildenafil for erectile dysfunction, you are unlikely to miss a dose since this medication is taken as needed, not on a regular dosing schedule.

If you are taking sildenafil for PAH, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Sildenafil may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

headache
heartburn
diarrhea
flushing (feeling of warmth)
nosebleeds
difficulty falling asleep or staying asleep
numbness, burning, or tingling in the arms, hands, feet, or legs
muscle aches
changes in color vision (seeing a blue tinge on objects or having difficulty telling the difference between blue and green)
sensitivity to light

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

sudden severe loss of vision (see below for more information)
blurred vision
sudden decrease or loss of hearing
ringing in ears
dizziness or lightheadedness
fainting
chest pain
worsening shortness of breath
erection that is painful or lasts longer than 4 hours
itching or burning during urination
rash

Some patients experienced a sudden loss of some or all of their vision after they took sildenafil or other medications that are similar to sildenafil. The vision loss was permanent in some cases. It is not known if the vision loss was caused by the medication. If you experience a sudden loss of vision while you are taking sildenafil, call your doctor immediately. Do not take any more doses of sildenafil or similar medications such as tadalafil (Cialis) or vardenafil (Levitra) until you talk to your doctor.

There have been reports of heart attack, stroke, irregular heartbeat, bleeding in the brain or lungs, high blood pressure, and sudden death in men who took sildenafil for erectile dysfunction. Most, but not all, of these people had heart problems before taking sildenafil. It is not known whether these events were caused by sildenafil, sexual activity, heart disease, or a combination of these and other causes.Talk to your doctor about the risks of taking sildenafil.

Some patients experienced a sudden decrease or loss of hearing after they took sildenafil or other medications that are similar to sildenafil. The hearing loss usually involved only one ear and did not always improve when the medication was stopped. It is not known if the hearing loss was caused by the medication. If you experience a sudden loss of hearing, sometimes with ringing in the ears or dizziness, while you are taking sildenafil, call your doctor immediately. If you are taking sildenafil (Viagra) for erectile dysfunction, do not take any more doses of sildenafil (Viagra) or similar medications such as tadalafil (Cialis) or vardenafil (Levitra) until you talk to your doctor. If you are taking sildenafil (Revatio) for PAH, do not stop taking your medication until you talk to your doctor.

Sildenafil may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store the tablets at room temperature and away from excess heat and moisture (not in the bathroom). Store the suspension at room temperature or in a refrigerator, but do not freeze it. Dispose of any unused suspension after 60 days.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of emergency/overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

What other information should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand names

American Society of Health-System Pharmacists, Inc. Disclaimer

AHFS ® Patient Medication Information™. © Copyright, 2022. The American Society of Health-System Pharmacists ® , 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

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