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Administration of VIAGRA with nitric oxide donors such as
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This analysis was performed retrospectively, and was not powered to detect any pre-specified difference in adverse reactions. The following adverse reactions have been identified during post approval use of VIAGRA. Because these reactions 25 mg viagra are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 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. Serious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, subarachnoid and intracerebral hemorrhages, and pulmonary hemorrhage have been reported post-marketing in temporal association with the use of VIAGRA.
7.4 Ritonavir and other CYP3A4 inhibitors
Most, but not all, of these patients had preexisting cardiovascular risk factors. Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of VIAGRA without sexual activity. Others were reported to have occurred hours to days after the use of VIAGRA and sexual activity. It is not possible to determine whether these events are related directly to VIAGRA, to sexual activity, to the patient's underlying cardiovascular disease, to a combination of these factors, or to other factors [see Warnings and Precautions (5.1) and Patient Counseling Information (17)]. Hemic and Lymphatic: vaso-occlusive crisis: In a small, prematurely terminated study of REVATIO (sildenafil) in patients with pulmonary arterial hypertension (PAH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported in patients who received sildenafil than in those randomized to placebo. organic nitrates or organic nitrites in any form is contraindicated.
| 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 |
Consistent with its known effects on the nitric oxide/cGMP pathway, VIAGRA was shown to potentiate
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Viagra Professional | 100mg | 10 Pills | 44.09€ 41.99€ | |
| Viagra Super Active | 100mg | 180 + 20 Pills | 280.97€ 267.59€ | |
| Viagra Generic | 200mg | 60 + 4 Pills | 125.19€ 119.23€ | |
| Viagra Oral Jelly | 100mg | 30 + 5 Sachets | 115.76€ 110.25€ | |
| Viagra Generic | 50mg | 270 + 8 Pills | 198.48€ 189.03€ | |
| Viagra Super Active | 100mg | 120 + 16 Pills | 198.37€ 188.92€ | |
| Viagra Generic | 50mg | 30 + 4 Pills | 54.26€ 51.68€ | |
| Viagra Professional | 100mg | 360 + 6 Pills | 527.09€ 501.99€ | |
| Viagra Original | 100mg | 12 Pills | 72.54€ 69.09€ | |
| Viagra Super Active | 100mg | 360 + 30 Pills | 470.93€ 448.50€ | |
| Viagra Super Active | 100mg | 90 + 10 Pills | 165.61€ 157.72€ |
the hypotensive effects of nitrates [see Dosage
- Box with foil blister inserts
- Design incorporating pharmaceutical codes
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- Information leaflet inside box
- Manufacturing and expiry dates printed
- Security features on packaging
- Packaging with visual dosage cues
- Tactile features for visually impaired
- Simple, clean packaging aesthetic
- Environmental impact considerations
and Administration (2.3), Contraindications (4.1), Clinical Pharmacology (12.2)].
5. Warnings and Precautions
In humans, VIAGRA has no effect on bleeding time when taken alone or with aspirin. However, in vitro studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside (a nitric oxide donor). In addition, the combination of heparin and VIAGRA had an additive effect on bleeding time in the anesthetized rabbit, but this interaction has not been studied in humans. The safety of VIAGRA is unknown in patients with bleeding disorders and patients with active peptic ulceration. The use of VIAGRA offers no protection against sexually transmitted diseases.
7.2 Alpha-blockers
Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), may be considered. The following are discussed in more detail in other sections of the labeling: Cardiovascular [see Warnings and Precautions (5.1)] Prolonged Erection and Priapism [see Warnings and Precautions (5.2)] Effects on the Eye [see Warnings and Precautions (5.3)] Hearing Loss [see Warnings and Precautions (5.4)] Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives [see Warnings and Precautions (5.5)] Adverse Reactions with the Concomitant Use of Ritonavir [see Warnings and Precautions (5.6)] Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies [see Warnings and Precautions (5.7)] Effects on Bleeding [see Warnings and Precautions (5.8)] Counseling Patients About Sexually Transmitted Diseases [see Warnings and Precautions (5.9)] The most common adverse reactions reported in clinical trials (≥ 2%) are headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, and rash. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. VIAGRA was administered to over 3700 patients (aged 19–87 years) during pre-marketing clinical trials worldwide. Over 550 patients were treated for longer than one year. Use caution when co-administering alpha-blockers with VIAGRA because of potential additive blood pressure-lowering effects.
| 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" |
When VIAGRA is co-administered with an alpha-blocker, patients should
- 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
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- Child-resistant blister design
- Packaging ensuring product integrity
be stable on alpha-blocker therapy prior to initiating VIAGRA treatment
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In placebo-controlled clinical studies, the discontinuation rate due to adverse reactions for VIAGRA (2.5%) was not significantly different from placebo (2.3%). In fixed-dose studies, the incidence of some adverse reactions increased with dose. The type of adverse reactions in flexible-dose studies, which reflect the recommended dosage regimen, was similar to that for fixed-dose studies. At doses above the recommended dose range, adverse reactions were similar to those detailed in Table 1 below but generally were reported more frequently. When VIAGRA was taken as recommended (on an as-needed basis) in flexible-dose, placebo-controlled clinical trials of two to twenty-six weeks duration, patients took VIAGRA at least once weekly, and the following adverse reactions were reported: The following events occurred in <2% of patients in controlled clinical trials; a causal relationship to VIAGRA is uncertain.
5.7 Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies
Reported events include those with a plausible relation to drug use; omitted are minor events and reports too imprecise to be meaningful: Body as a Whole: face edema, photosensitivity reaction, shock, asthenia, pain, chills, accidental fall, abdominal pain, allergic reaction, chest pain, accidental injury. Metabolic and Nutritional: thirst, edema, gout, unstable diabetes, hyperglycemia, peripheral edema, hyperuricemia, hypoglycemic reaction, hypernatremia. Respiratory: asthma, dyspnea, laryngitis, pharyngitis, sinusitis, bronchitis, sputum increased, cough increased. Skin and Appendages: urticaria, herpes simplex, pruritus, sweating, skin ulcer, contact dermatitis, exfoliative dermatitis. Analysis of the safety database from controlled clinical trials showed no apparent difference in adverse reactions in patients taking VIAGRA with and without anti-hypertensive medication. and VIAGRA should be initiated at the lowest dose [see
- Blister pack with engraved logo
- Printed barcode for inventory tracking
- Packaging with warning symbols
- Child-proof cap for bottles
- Inner insert with usage instructions
- Lightweight blister for portability
- Recyclable cardboard box
- Protective foam inserts
- Discreet matte finish packaging
- Personalized branding labels
Dosage and Administration (2.3),Warnings and Precautions (5.5), Clinical Pharmacology (12.2)].
- Blister packs with 4 or 8 tablets
- Cardboard boxes containing blisters
- Aluminum foil wraps over tablets
- Labeling indicating dosage info
- Tamper-evident seal on packaging
- Pharmacy-specific packaging
- Child-resistant containers
- Clear blister cavities for visibility
- Discreet plain packaging options
- Eco-friendly biodegradable wrappers
When VIAGRA 100 mg was co-administered with amlodipine (5 mg
10. Overdosage
It is not possible to determine whether these reported events are related directly to the use of VIAGRA, to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors [see Warnings and Precautions (5.4) and Patient Counseling Information (17)]. Ocular: diplopia, temporary vision loss/decreased vision, ocular redness or bloodshot appearance, ocular burning, ocular swelling/pressure, increased intraocular pressure, retinal edema, retinal vascular disease or bleeding, and vitreous traction/detachment. Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely post-marketing in temporal association with the use of phosphodiesterase type 5 (PDE5) inhibitors, including VIAGRA. Most, but not all, of these patients had underlying anatomic or vascular risk factors for developing NAION, including but not necessarily limited to: low cup to disc ratio ("crowded disc"), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking [see Warnings and Precautions (5.3) and Patient Counseling Information (17)]. Urogenital: prolonged erection, priapism [see Warnings and Precautions (5.2) and Patient Counseling Information (17)], and hematuria. or 10 mg) to hypertensive patients, the mean additional reduction
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The clinical relevance of this finding to men treated with VIAGRA for ED is not known. Nervous: seizure, seizure recurrence, anxiety, and transient global amnesia. Hearing: Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including VIAGRA. In some of the cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events. In many cases, medical follow-up information was limited. on supine blood pressure was 8 mmHg systolic and 7 mmHg diastolic [see Warnings and Precautions (5.5), Clinical Pharmacology (12.2)].
8. Use In Specific Populations
In a separate drug interaction study, when amlodipine, 5 mg or 10 mg, and VIAGRA, 100 mg were orally administered concomitantly to hypertensive patients mean additional blood pressure reduction of 8 mmHg systolic and 7 mmHg diastolic were noted [see Drug Interactions (7.3) and Clinical Pharmacology (12.2)]. If VIAGRA is prescribed to patients taking ritonavir, caution should be used. Data from subjects exposed to high systemic levels of sildenafil are limited. Decreased blood pressure, syncope, and prolonged erection were reported in some healthy volunteers exposed to high doses of sildenafil (200–800 mg). To decrease the chance of adverse reactions in patients taking ritonavir, a decrease in sildenafil dosage is recommended [see Dosage and Administration (2.4), Drug Interactions (7.4), and Clinical Pharmacology (12.3)].
2.3 Dosage Adjustments in Specific Situations
The safety and efficacy of combinations of VIAGRA with other PDE5 Inhibitors, including REVATIO or other pulmonary arterial hypertension (PAH) treatments containing sildenafil, or other treatments for erectile dysfunction have not been studied. Such combinations may further lower blood pressure. Therefore, the use of such combinations is not recommended. There have been postmarketing reports of bleeding events in patients who have taken VIAGRA. A causal relationship between VIAGRA and these events has not been established.
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