Pfizer spokesman Steve Danehy said in an email interview, “With any new DTC campaign we continue to evolve our approach. Pfizer DTC communications about Viagra have always sought to increase men’s awareness of ED as a treatable medical condition, inform them about the benefits and risks of therapy, and motivate them to talk to their doctors. We continue our commitment with the introduction of Viagra Single Packs--individually wrapped for convenience.” The campaign includes print ads in magazines targeting men 35 and older. BBDO created the print and TV ads, while Rapp did the digital work. When Pfizer debuted the single packs in July, a spokesman told FiercePharma that a study it ran found 50% of the 503 men queried were interested in trying the single packs.
8. Viagra Is Not A Sex Stimulant
Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg. VIAGRA was shown to potentiate the hypotensive effects of nitrates and its administration in patients who use nitric oxide donors such as organic nitrates or organic nitrites in any form is therefore contraindicated [see Contraindications (4.1), Drug Interactions (7.1), and Clinical Pharmacology (12.2)]. When VIAGRA is co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating VIAGRA treatment and VIAGRA should be initiated at 25 mg [see Warnings and Precautions (5.5), Drug Interactions (7.2), and Clinical Pharmacology (12.2)]. The recommended dose for ritonavir-treated patients is 25 mg prior to sexual activity and the recommended maximum dose is 25 mg within a 48 hour period because concomitant administration increased the blood levels of sildenafil by 11-fold [see Warnings and Precautions (5.6), Drug Interactions (7.4), and Clinical Pharmacology (12.3)]. Consider a starting dose of 25 mg in patients treated with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, or saquinavir) or erythromycin.
8.7 Hepatic Impairment
Clinical data have shown that co-administration with saquinavir or erythromycin increased plasma levels of sildenafil by about 3 fold [see Drug Interactions (7.4) and Clinical Pharmacology (12.3)]. Consider a starting dose of 25 mg in patients > 65 years, patients with hepatic impairment (e.g., cirrhosis), and patients with severe renal impairment (creatinine clearance <30 mL/minute) because administration of VIAGRA in these patients resulted in higher plasma levels of sildenafil [see Use in Specific Populations (8.5, 8.6, 8.7) and Clinical Pharmacology (12.3)]. VIAGRA is supplied as blue, film-coated, rounded-diamond-shaped tablets containing sildenafil citrate equivalent to 25 mg, 50 mg, or 100 mg of sildenafil. Tablets are debossed with PFIZER on one side and VGR25, VGR50 or VGR100 on the other to indicate the dosage strengths. Consistent with its known effects on the nitric oxide/cGMP pathway [see Clinical Pharmacology (12.1, 12.2)], 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.
Recent Major Changes
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 co-administered at this time point [see Dosage and Administration (2.3), Drug Interactions (7.1), and Clinical Pharmacology (12.2)]. 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 (6.1)]. There is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Men still get the same Viagra prescription from their doctors, and then at the pharmacy, specifically request the single pack doses. Availability depends on the pharmacy’s ability or willingness to stock the packs. Along with the new single pack ads, Pfizer is also running three other TV spots for Viagra currently. One that bowed last July, which mentions single packs now available at the end, has tallied $15 million in spending since its debut, according to real-time TV tracker iSpot.tv's data. Another ad began at the end of 2015, while the third began in March; both mention the availability of single packs in the last few seconds. The new packaging and ads may be Viagra’s move for a competitive edge against other ED drugs such as Eli Lilly’s Cialis and Bayer's Levitra, and as Viagra prepares for generic competition likely to hit in 2017. Viagra had been the fourth-largest prescription drug advertised in 2014, but dropped to No.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Viagra Original | 100mg | 92 + 4 Pills | 362.88€ 345.60€ | |
| Viagra Original | 100mg | 76 + 4 Pills | 306.59€ 291.99€ | |
| Viagra Generic | 25mg | 180 + 6 Pills | 154.93€ 147.55€ | |
| Viagra Generic | 150mg | 60 + 4 Pills | 111.25€ 105.95€ | |
| Viagra Generic | 50mg | 20 Pills | 40.52€ 38.59€ | |
| Viagra Generic | 150mg | 270 + 10 Pills | 326.61€ 311.06€ | |
| Viagra Generic | 150mg | 20 Pills | 55.02€ 52.40€ | |
| Viagra Generic | 25mg | 10 Pills | 25.19€ 23.99€ | |
| Viagra Generic | 200mg | 180 + 10 Pills | 277.56€ 264.34€ | |
| Viagra Oral Jelly | 100mg | 110 + 9 Sachets | 284.63€ 271.08€ | |
| Viagra Professional | 100mg | 20 Pills | 71.14€ 67.75€ | |
| Viagra Soft Tabs | 100mg | 180 + 10 Pills | 314.95€ 299.95€ | |
| Viagra Generic | 100mg | 90 + 6 Pills | 129.02€ 122.88€ | |
| Viagra Generic | 100mg | 360 + 10 Pills | 330.21€ 314.49€ | |
| Viagra Generic | 50mg | 90 + 6 Pills | 107.37€ 102.26€ | |
| Viagra Generic | 200mg | 10 Pills | 40.96€ 39.01€ | |
| Viagra Generic | 100mg | 10 Pills | 28.91€ 27.53€ |
10 in 2015, from $211 million down to just $125 million, according to Nielsen data.
Patient Information
Therefore, treatments for erectile dysfunction, including VIAGRA, should not be generally used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status. The evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following a complete medical assessment. VIAGRA has systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers (mean maximum decrease of 8.4/5.5 mmHg), [see Clinical Pharmacology (12.2)]. While this normally would be expected to be of little consequence in most patients, prior to prescribing VIAGRA, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects, especially in combination with sexual activity. Use with caution in patients with the following underlying conditions which can be particularly sensitive to the actions of vasodilators including VIAGRA – those with left ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis) and those with severely impaired autonomic control of blood pressure.
12.1 Viagra Mechanism of Action
There are no controlled clinical data on the safety or efficacy of VIAGRA in the following groups; if prescribed, this should be done with caution.
5.3 Effects on the Eye
1 ad spender both years at $249 million in 2014 and $220 million in 2015.
- Innovative blister design for easy opening
- Printed expiration date on pack
- Batch and serial number labels
- Instructions for use printed inside box
- Packaging with country of manufacture
- Anti-counterfeit holograms
- Customizable branding on boxes
- UV protection coating on blister
- Medical regulatory approval marks
- Secure shrink wrap over packs
Viagra sales brought in $1.3 billion in 2015 worldwide, up from $1.18 billion in both 2014 and 2013, according to Pfizer’s 2015 annual report. - see the TV ad on iSpot.tv Related Articles:Pfizer's Viagra first ED drug available in single-dose packetsUp up and away: 2015 pharma ad spending ties decade-old recordPfizer DTC message: Hey guys, women say it's cool to take Viagra 25 mg blue Viagra pills in bubble packaging.
See also:
The box containing the pills can also be seen. Package insert / product label Generic name: sildenafil citrate Dosage form: tablet, film coated Drug class: Impotence medications VIAGRA® (sildenafil citrate) tablets, for oral use VIAGRA is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) (1) For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, VIAGRA may be taken anywhere from 30 minutes to 4 hours before sexual activity (2.1) Based on effectiveness and toleration, may increase to a maximum of 100 mg or decrease to 25 mg (2.1) Maximum recommended dosing frequency is once per day (2.1) Tablets: 25 mg, 50 mg, 100 mg (3) Administration of VIAGRA to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. VIAGRA was shown to potentiate the hypotensive effect of nitrates (4.1, 7.1, 12.2) Known hypersensitivity to sildenafil or any component of tablet (4.2) Administration with guanylate cyclase (GC) stimulators, such as riociguat (4.3) Patients should not use VIAGRA if sexual activity is inadvisable due to cardiovascular status (5.1) Patients should seek emergency treatment if an erection lasts >4 hours. Use VIAGRA with caution in patients predisposed to priapism (5.2) Patients should stop VIAGRA and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION). VIAGRA should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a "crowded" optic disc may also be buy female viagra at an increased risk of NAION. Patients should stop VIAGRA and seek prompt medical attention in the event of sudden decrease or loss of hearing (5.4) Caution is advised when VIAGRA is co-administered with alpha-blockers or anti-hypertensives. Concomitant use may lead to hypotension (5.5) Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures. In patients taking strong CYP inhibitors, such as ritonavir, sildenafil exposure is increased.
12. Viagra - Clinical Pharmacology
- see the TV ad on iSpot.tv Related Articles:Pfizer's Viagra first ED drug available in single-dose packetsUp up and away: 2015 pharma ad spending ties decade-old recordPfizer DTC message: Hey guys, women say it's cool to take Viagra 25 mg blue Viagra pills in bubble packaging. The box containing the pills can also be seen. Package insert / product label Generic name: sildenafil citrate Dosage form: tablet, film coated Drug class: Impotence medications VIAGRA® (sildenafil citrate) tablets, for oral use VIAGRA is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) (1) For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, VIAGRA may be taken anywhere from 30 minutes to 4 hours before sexual activity (2.1) Based on effectiveness and toleration, may increase to a maximum of 100 mg or decrease to 25 mg (2.1) Maximum recommended dosing frequency is once per day (2.1) Tablets: 25 mg, 50 mg, 100 mg (3) Administration of VIAGRA to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. VIAGRA was shown to potentiate the hypotensive effect of nitrates (4.1, 7.1, 12.2) Known hypersensitivity to sildenafil or any component of tablet (4.2) Administration with guanylate cyclase (GC) stimulators, such as riociguat (4.3) Patients should not use VIAGRA if sexual activity is inadvisable due to cardiovascular status (5.1) Patients should seek emergency treatment if an erection lasts >4 hours.
7.1 Nitrates
Use VIAGRA with caution in patients predisposed to priapism (5.2) Patients should stop VIAGRA and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION). VIAGRA should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a "crowded" optic disc may also be buy female viagra at an increased risk of NAION. Patients should stop VIAGRA and seek prompt medical attention in the event of sudden decrease or loss of hearing (5.4) Caution is advised when VIAGRA is co-administered with alpha-blockers or anti-hypertensives. Concomitant use may lead to hypotension (5.5) Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures.
4.2 Hypersensitivity Reactions
In patients taking strong CYP inhibitors, such as ritonavir, sildenafil exposure is increased. Decrease in VIAGRA dosage is recommended (2.4, 5.6) Most common adverse reactions (≥ 2%) include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness and rash (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at 1-800-438-1985 or FDA at 1-800-FDA-1088 or VIAGRA can potentiate the hypotensive effects of nitrates, alpha blockers, and anti-hypertensives (4.1, 5.5, 7.1, 7.2, 7.3, 12.2) With concomitant use of alpha blockers, initiate VIAGRA at 25 mg dose (2.3) CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase VIAGRA exposure (2.4, 7.4, 12.3) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, VIAGRA may be taken anywhere from 30 minutes to 4 hours before sexual activity. The maximum recommended dosing frequency is once per day. Decrease in VIAGRA dosage is recommended (2.4, 5.6) Most common adverse reactions (≥ 2%) include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness and rash (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at 1-800-438-1985 or FDA at 1-800-FDA-1088 or VIAGRA can potentiate the hypotensive effects of nitrates, alpha blockers, and anti-hypertensives (4.1, 5.5, 7.1, 7.2, 7.3, 12.2) With concomitant use of alpha blockers, initiate VIAGRA at 25 mg dose (2.3) CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase VIAGRA exposure (2.4, 7.4, 12.3) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity.
- Printed foil backing on blister
- Vacuum-sealed packaging for freshness
- Digital print of batch number
- Recyclable print materials
- Secure blister with snap fit
- Minimalist design for branding
- Labelling indicating storage temperature
- User-friendly opening system
- Child-resistant blister design
- Packaging ensuring product integrity
However, VIAGRA may be taken anywhere from 30 minutes to 4 hours before sexual activity. The maximum recommended dosing frequency is once per day. Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg. VIAGRA was shown to potentiate the hypotensive effects of nitrates and its administration in patients who use nitric oxide donors such as organic nitrates or organic nitrites in any form is therefore contraindicated [see Contraindications (4.1), Drug Interactions (7.1), and Clinical Pharmacology (12.2)]. When VIAGRA is co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating VIAGRA treatment and VIAGRA should be initiated at 25 mg [see Warnings and Precautions (5.5), Drug Interactions (7.2), and Clinical Pharmacology (12.2)]. The recommended dose for ritonavir-treated patients is 25 mg prior to sexual activity and the recommended maximum dose is 25 mg within a 48 hour period because concomitant administration increased the blood levels of sildenafil by 11-fold [see Warnings and Precautions (5.6), Drug Interactions (7.4), and Clinical Pharmacology (12.3)]. Consider a starting dose of 25 mg in patients treated with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, or saquinavir) or erythromycin. Clinical data have shown that co-administration with saquinavir or erythromycin increased plasma levels of sildenafil by about 3 fold [see Drug Interactions (7.4) and Clinical Pharmacology (12.3)].
| Brand Name | Packaging Features | Market Position |
|---|---|---|
| Viagra (Pfizer) | Blue box, branded blister pack | Market leader |
| Kamagra | Similar blister packs, often generic branding | Cheaper alternative |
| SildenafilCG | Plain packaging, generic appearance | Cost-effective option |
| Revatio | Similar packaging but different color schemes | Used for pulmonary hypertension |
Consider a starting dose of 25 mg in patients > 65 years, patients with hepatic impairment (e.g., cirrhosis), and patients with severe renal impairment (creatinine clearance <30 mL/minute) because administration of VIAGRA in these patients resulted in higher plasma levels of sildenafil [see Use in Specific Populations (8.5, 8.6, 8.7) and Clinical Pharmacology (12.3)]. VIAGRA is supplied as blue, film-coated, rounded-diamond-shaped tablets containing sildenafil citrate equivalent to 25 mg, 50 mg, or 100 mg of sildenafil. Tablets are debossed with PFIZER on one side and VGR25, VGR50 or VGR100 on the other to indicate the dosage strengths. Consistent with its known effects on the nitric oxide/cGMP pathway [see Clinical Pharmacology (12.1, 12.2)], 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.
9. Viagra For Women?
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 co-administered at this time point [see Dosage and Administration (2.3), Drug Interactions (7.1), and Clinical Pharmacology (12.2)].
| Country/Region | Packaging Type | Regulatory Info |
|---|---|---|
| USA | Bottle + blister pack | FDA requirements |
| European Union | Blister packs, cartons | EMA standards |
| Asia | Small blister packs, foil wraps | Regulations vary by country |
| Australia | Child-resistant bottles | TGA compliance |
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 (6.1)]. There is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease.
Popular Categories
Pfizer spokesman Steve Danehy said in an email interview, “With any new DTC campaign we continue to evolve our approach. Pfizer DTC communications about Viagra have always sought to increase men’s awareness of ED as a treatable medical condition, inform them about the benefits and risks of therapy, and motivate them to talk to their doctors. We continue our commitment with the introduction of Viagra Single Packs--individually wrapped for convenience.” The campaign includes print ads in magazines targeting men 35 and older. BBDO created the print and TV ads, while Rapp did the digital work. When Pfizer debuted the single packs in July, a spokesman told FiercePharma that a study it ran found 50% of the 503 men queried were interested in trying the single packs.
Adverse Reactions/Side Effects
Men still get the same Viagra prescription from their doctors, and then at the pharmacy, specifically request the single pack doses. Availability depends on the pharmacy’s ability or willingness to stock the packs. Along with the new single pack ads, Pfizer is also running three other TV spots for Viagra currently. One that bowed last July, which mentions single packs now available at the end, has tallied $15 million in spending since its debut, according to real-time TV tracker iSpot.tv's data. Another ad began at the end of 2015, while the third began in March; both mention the availability of single packs in the last few seconds.
Drug Interactions
The new packaging and ads may be Viagra’s move for a competitive edge against other ED drugs such as Eli Lilly’s Cialis and Bayer's Levitra, and as Viagra prepares for generic competition likely to hit in 2017. Viagra had been the fourth-largest prescription drug advertised in 2014, but dropped to No. 10 in 2015, from $211 million down to just $125 million, according to Nielsen data. 1 ad spender both years at $249 million in 2014 and $220 million in 2015. Viagra sales brought in $1.3 billion in 2015 worldwide, up from $1.18 billion in both 2014 and 2013, according to Pfizer’s 2015 annual report. Therefore, treatments for erectile dysfunction, including VIAGRA, should not be generally used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status. The evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following a complete medical assessment.
| Label Type | Purpose | Example Content |
|---|---|---|
| Prescription Only | Legal requirement to indicate prescription status | "Rx Only" |
| Safety Warnings | Allergies, risk factors | "Keep out of reach of children" |
| Lot Number & Expiry | Traceability and safety | "Batch: 12345, Exp: 12/2025" |
| Usage Instructions | Proper administration | "Take one tablet 30 minutes before activity" |
VIAGRA has systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers (mean maximum decrease of 8.4/5.5 mmHg), [see Clinical Pharmacology (12.2)]. While this normally would be expected to be of little consequence in most patients, prior to prescribing VIAGRA, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects, especially in combination with sexual activity. Use with caution in patients with the following underlying conditions which can be particularly sensitive to the actions of vasodilators including VIAGRA – those with left ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis) and those with severely impaired autonomic control of blood pressure. There are no controlled clinical data on the safety or efficacy of VIAGRA in the following groups; if prescribed, this should be done with caution.