17 PATIENT COUNSELING INFORMATION

Based on the pharmacokinetic profile of a single 100 mg

Precautions for Viagra

Physicians should discuss with patients the contraindication of VIAGRA with use of guanylate cyclase stimulators such as riociguat [see CONTRAINDICATIONS]. Physicians should advise patients of the potential for VIAGRA to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications. Concomitant administration of VIAGRA and an alpha-blocker may lead to symptomatic hypotension in some patients. Therefore, when VIAGRA is co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating VIAGRA treatment and VIAGRA should be initiated at the lowest dose [see WARNINGS AND PRECAUTIONS]. Patients who experience symptoms (e.g., angina pectoris, dizziness, nausea) upon initiation of sexual activity should be advised to refrain from further activity and should discuss the episode with their physician [see WARNINGS AND PRECAUTIONS].

What Are the Available Sildenafil Dosages?

Physicians should advise patients to stop use of all PDE5 inhibitors, including VIAGRA, and seek medical attention in the event of a sudden loss of vision in one or both eyes. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors. Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a “crowded” optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitor, including VIAGRA, for this uncommon condition [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS]. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS]. Physicians should warn patients that prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of VIAGRA.

Key takeaways

If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result [see WARNINGS AND PRECAUTIONS]. Physicians should inform patients not to take VIAGRA with other PDE5 inhibitors including REVATIO or other pulmonary arterial hypertension (PAH) treatments containing sildenafil. The safety and efficacy of VIAGRA with other PDE5 inhibitors, including REVATIO, have not been studied [see WARNINGS AND PRECAUTIONS]. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), may be considered [see WARNINGS AND PRECAUTIONS]. Sildenafil was not carcinogenic when administered to rats for 24 months at a dose resulting in total systemic drug exposure (AUCs) for unbound sildenafil and its major metabolite of 29-and 42-times, for male and female rats, respectively, the exposures observed in human males given the Maximum Recommended Human Dose (MRHD) of 100 mg. oral dose given to healthy

Side Effect	Frequency	Severity	Notes
Headache	Very common	Mild	Usually resolves with time
Flushing	Common	Mild	Due to vasodilation
Nasal Congestion	Common	Mild	Congestion of nasal passages
Dizziness	Less common	Mild	Especially when standing up quickly
Dyspepsia	Less common	Mild	Indigestion or stomach upset
Visual Disturbances	Rare	Variable	Changes in color perception or blurred vision

normal volunteers, the plasma levels

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of sildenafil at 24 hours post dose are approximately 2

What to avoid

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]. No 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 Cmax and AUC. A starting dose of 25 mg should be considered in patients with severe renal impairment [see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY]. 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 max and 85% for AUC).

How does sildenafil work (mechanism of action)?

A starting dose of 25 mg should be considered in patients with any degree of hepatic impairment [see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY]. In cases of overdose, standard supportive measures should be adopted as required. Consistent with its known effects on the nitric oxide/cGMP pathway [see CLINICAL PHARMACOLOGY], VIAGRA was shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are using nitric oxide donors such as organic nitrates or organic nitrites in any form either regularly and/or intermittently is therefore contraindicated. After patients have taken VIAGRA, it is unknown when nitrates, if necessary, can be safely administered. Although plasma levels of sildenafil at 24 hours post dose are much lower than at peak concentration, it is unknown whether nitrates can be safely coadministered at this time point [see DOSAGE AND ADMINISTRATION, DRUG INTERACTIONS, and CLINICAL PHARMACOLOGY].

MEDICAL EQUIPMENT

VIAGRA is contraindicated in patients with a known hypersensitivity to sildenafil, as contained in VIAGRA and REVATIO, or any component of the tablet. Hypersensitivity reactions have been reported, including rash and urticaria [see ADVERSE REACTIONS]. Do not use VIAGRA in patients who are using a GC stimulator, such as riociguat. PDE5 inhibitors, including VIAGRA, may potentiate the hypotensive effects of GC stimulators. The physiologic mechanism of erection of the penis involves release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. ng/mL (compared to peak plasma

How much is Viagra without insurance?

NO then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood. Sildenafil at sildenafil 60mg recommended doses has no effect in the absence of sexual stimulation. Studies in vitro have shown that sildenafil is selective for PDE5. This lower selectivity is thought to be the basis for abnormalities related to color vision [see Pharmacodynamics]. In addition to human corpus cavernosum smooth muscle, PDE5 is also found in other tissues including platelets, vascular and visceral smooth muscle, and skeletal muscle, brain, heart, liver, kidney, lung, pancreas, prostate, bladder, testis, and seminal vesicle.

What does Viagra do for ED?

The inhibition of PDE5 in some of these tissues by sildenafil may be the basis for the enhanced platelet antiaggregatory activity of NO observed in vitro, an inhibition of platelet thrombus formation in vivo and peripheral arterial-venous dilatation in vivo. In eight double-blind, placebo-controlled crossover studies of patients with either organic or psychogenic erectile dysfunction, sexual stimulation resulted in improved erections, as assessed by an objective measurement of hardness and duration of erections (RigiScan®), after VIAGRA administration compared with placebo. Most studies assessed the efficacy of VIAGRA approximately 60 minutes post dose. The erectile response, as assessed by RigiScan®, generally increased with increasing sildenafil dose and plasma concentration. The time course of effect was examined in one study, showing an effect for up to 4 hours but the response was diminished compared to 2 hours.

What happens with ED?

Single oral doses of sildenafil (100 mg) administered to healthy volunteers produced decreases in sitting blood pressure (mean maximum decrease in systolic/diastolic blood pressure of 8.3/5.3 mmHg). The decrease in sitting blood pressure was most notable approximately 1-2 hours after dosing, and was not different than placebo at 8 hours. Similar effects on blood pressure were noted with 25 mg, 50 mg and 100 mg of VIAGRA, therefore the effects are not related to dose or plasma levels within this dosage range. Larger effects were recorded among patients receiving concomitant nitrates [see CONTRAINDICATIONS]. Figure 1: Mean Change from Baseline in Sitting Systolic Blood Pressure, Healthy Volunteers. levels of approximately 440 ng/mL).

• Sildenafil 100 mg does not protect against sexually transmitted diseases.
• It is not recommended for women or children.
• The medication can sometimes cause back pain or muscle aches.
• Use sildenafil only as prescribed to minimize risks.
• Some users report facial flushing after taking the pill.
• Avoid excessive physical activity immediately after taking the drug.
• Always read the patient information leaflet before use.
• Do not share your medication with others.
• Sildenafil may cause nasal stuffiness or congestion.

Although plasma levels of sildenafil at 24 hours

• Sildenafil 100 mg is often part of a broader treatment plan.
• It’s important to follow your doctor’s instructions precisely.
• Overuse can lead to priapism, a painful and prolonged erection.
• It is not a cure for erectile dysfunction but helps manage symptoms.
• Do not take sildenafil if you are on medications containing nitroglycerin.
• Regular check-ups may be necessary to monitor health effects.
• The medication has been available since the late 1990s.
• Use caution when combining sildenafil with blood pressure medications.
• Seek immediate medical help if you experience vision loss.

post dose are much lower than at peak

Condition	Details	Rationale
Temperature	Store below 25°C (77°F)	Preserves chemical stability
Humidity	Keep in a dry place	Prevents clumping and degradation
Light	Protect from direct sunlight	Prevents breakdown of active ingredient
Container	Original blister or tightly closed bottle	Maintains stability and prevents contamination

concentration, it is unknown whether nitrates can be

• Sildenafil was originally developed to treat pulmonary hypertension.
• The 100 mg dosage is often prescribed when lower doses are ineffective.
• It can cause vision changes such as blurred vision or a blue tint.
• Alcohol consumption can enhance side effects and reduce effectiveness.
• Patients with heart conditions should consult a doctor before use.
• The medication is available by prescription only in many countries.
• Use with caution in patients with kidney or liver impairment.
• Report any allergic reactions like rash or difficulty breathing immediately.
• Sildenafil may cause dizziness; avoid operating heavy machinery after intake.

safely co-administered at this time point [see CONTRAINDICATIONS].

What happens if I overdose?

Sildenafil was not carcinogenic when administered to mice for 18-21 months at dosages up to the Maximum Tolerated Dose (MTD) of 10 mg/kg/day, approximately 0.6 times the MRHD on a mg/m² basis. Sildenafil was negative in in vitro bacterial and Chinese hamster ovary cell assays to detect mutagenicity, and in vitro human lymphocytes and in vivo mouse micronucleus assays to detect clastogenicity. VIAGRA is not indicated for use in women. There are no adequate and well-controlled studies of sildenafil in pregnant women. Based on animal data, VIAGRA is not predicted to increase the risk of adverse developmental outcomes in humans.

Related treatment guides

No 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 20 and 40 times the Maximum sildenafil 45 mg chewable tablets Recommended Human Dose (MRHD) on a mg/m² basis 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. In the nonpregnant rat the AUC at this dose was about 20 times human AUC. VIAGRA is not indicated for use in pediatric patients.

Frequently asked questions

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]. 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]. Of the total number of subjects in clinical studies of Viagra, 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.