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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Vybrique
Generic Name
Sildenafil Oral Film
Active Ingredient
SildenafilCategory
Phosphodiesterase 5 Inhibitor [EPC]
Salt Form
Citrate
Variants
4
References used for this content
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Vybrique, you must consult a qualified healthcare professional.
| 50 mg/1 | FILM | ORAL | 43328-017 |
Detailed information about Vybrique
Sildenafil is a potent phosphodiesterase type 5 (PDE5) inhibitor used primarily to treat erectile dysfunction and pulmonary arterial hypertension by promoting smooth muscle relaxation and increased blood flow.
Dosage for sildenafil depends entirely on the condition being treated and the patient's individual response and tolerability.
Sildenafil is FDA-approved for the treatment of pulmonary arterial hypertension in children (ages 1 to 17). However, the FDA has issued warnings regarding high doses in pediatric populations due to an increased risk of mortality observed in long-term trials. Pediatric dosing is strictly weight-based and must be managed by a specialist in pediatric cardiology or pulmonology. Sildenafil is NOT approved for the treatment of erectile dysfunction in the pediatric population.
In the event of an overdose, standard supportive measures should be adopted. Symptoms of overdose may include severe hypotension (low blood pressure), fainting, and prolonged erections (priapism). Sildenafil is highly protein-bound and not eliminated by renal dialysis. If an overdose is suspected, contact a poison control center or seek emergency medical attention immediately.
> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose or stop taking the medication without medical guidance, as this could lead to a recurrence of symptoms or clinical worsening.
Common side effects are generally mild to moderate and often diminish as the body adjusts to the medication. According to clinical trial data, the most frequently reported adverse reactions include:
Sildenafil is a powerful vasodilator, and its use requires careful medical screening. Patients must disclose their full medical history, especially any history of heart disease, stroke, or blood pressure issues. Sildenafil should never be used by individuals who use organic nitrates in any form (e.g., nitroglycerin, isosorbide dinitrate), as the combination can lead to a life-threatening drop in blood pressure.
No FDA black box warnings for Sildenafil. While sildenafil lacks a black box warning, the contraindication with nitrates is the most critical safety point emphasized in all clinical literature and labeling.
There is a degree of cardiac risk associated with sexual activity; therefore, physicians should consider the cardiovascular status of patients prior to initiating sildenafil. Sildenafil has systemic vasodilatory properties that result in transient decreases in blood pressure. While this is normally of little consequence, it can be dangerous in patients with left ventricular outflow obstruction (e.g., aortic stenosis) or severely impaired autonomic control of blood pressure.
Sildenafil is strictly prohibited in the following scenarios:
Sildenafil is classified under the previous FDA Pregnancy Category B. In animal studies, there was no evidence of teratogenicity (birth defects) or adverse effects on fertility. In the context of PAH (Revatio), sildenafil is sometimes used during pregnancy if the clinical need outweighs the risks, as untreated PAH carries a very high mortality rate for both the mother and the fetus. However, there are no adequate and well-controlled studies in pregnant women. It is not indicated for use in women for the treatment of ED.
Limited data indicate that sildenafil and its active metabolite pass into breast milk in very small amounts. It is unlikely to cause adverse effects in the nursing infant. However, breastfeeding mothers should consult their healthcare provider to discuss the risks and benefits before using sildenafil, particularly for the treatment of PAH.
Sildenafil is approved for use in children (1 to 17 years) only for the treatment of pulmonary arterial hypertension. The FDA has cautioned against the use of high doses in children because a long-term clinical trial showed a higher risk of death in children taking high doses compared to those on low doses. It is not approved for any other condition in the pediatric population.
Sildenafil is a selective and potent inhibitor of phosphodiesterase type 5 (PDE5). PDE5 is the predominant isozyme in the human corpus cavernosum and is also present in the smooth muscle of the pulmonary vasculature. By inhibiting PDE5, sildenafil prevents the hydrolysis of cyclic guanosine monophosphate (cGMP) into 5'-GMP. cGMP is the secondary messenger of nitric oxide; its accumulation leads to the relaxation of vascular smooth muscle and increased blood flow. In the penis, this facilitates an erection during sexual stimulation. In the lungs, it causes vasodilation of the pulmonary arterial bed.
The onset of action for erectile dysfunction is typically 30 to 60 minutes. The duration of effect can last up to 4 hours, though the peak effect usually occurs within the first 2 hours. Sildenafil does not cause an erection in the absence of sexual stimulation. In the treatment of PAH, sildenafil produces a significant reduction in pulmonary vascular resistance and an increase in cardiac output without significantly affecting systemic blood pressure at recommended doses.
| Parameter | Value |
Common questions about Vybrique
Sildenafil is primarily used to treat two distinct medical conditions: erectile dysfunction (ED) and pulmonary arterial hypertension (PAH). For ED, it helps men achieve and maintain an erection by increasing blood flow to the penis in response to sexual stimulation. For PAH, it works by relaxing the blood vessels in the lungs, which lowers blood pressure in the pulmonary arteries and improves the heart's ability to pump blood. This helps patients with PAH exercise more effectively and slows the progression of the disease. It is marketed under the brand names Viagra for ED and Revatio for PAH. Always use this medication under the direct supervision of a healthcare provider.
The most frequently reported side effects of sildenafil include headaches, facial flushing, and indigestion (dyspepsia). Some users also experience nasal congestion, dizziness, or changes in vision, such as a temporary blue tint to their sight or blurred vision. These side effects are usually mild and tend to resolve as the medication wears off. However, if you experience a painful erection lasting more than four hours, sudden vision loss, or hearing loss, you must seek emergency medical attention immediately. It is important to discuss your risk for side effects with your doctor before starting the medication.
It is generally recommended to limit or avoid alcohol consumption while taking sildenafil. Alcohol acts as a vasodilator and can enhance the blood-pressure-lowering effects of sildenafil, leading to dizziness, lightheadedness, or fainting. Additionally, alcohol is a common cause of erectile dysfunction and can make the medication less effective for its intended purpose. Consuming large amounts of alcohol can also increase the heart rate and cause palpitations when combined with sildenafil. For the best results and safety, talk to your doctor about what amount of alcohol, if any, is safe for you.
Sildenafil is generally not used in women except for the treatment of pulmonary arterial hypertension (PAH). In cases of PAH, a doctor may prescribe it during pregnancy if the benefits to the mother's health outweigh the potential risks to the fetus, as untreated PAH is extremely dangerous during pregnancy. Animal studies have not shown a risk of birth defects, but there are no comprehensive studies in humans. It is not approved for use in women for sexual dysfunction. If you are pregnant or planning to become pregnant, you must discuss the use of this medication with your specialist.
For the treatment of erectile dysfunction, sildenafil typically begins to work within 30 to 60 minutes after oral administration. However, some men may feel the effects as early as 20 minutes or as late as two hours. The onset of action can be significantly delayed if the medication is taken with a high-fat meal, as fat slows down the absorption process. For the treatment of pulmonary arterial hypertension, the medication works continuously to manage blood pressure, and it may take several weeks of consistent use to notice an improvement in exercise capacity. It is best taken on an empty stomach for the fastest results in ED.
If you are taking sildenafil for erectile dysfunction, you can stop taking it at any time without physical withdrawal symptoms, as it is used on an as-needed basis. However, if you are taking sildenafil (Revatio) for pulmonary arterial hypertension, you should never stop taking it suddenly. Abruptly discontinuing the medication can cause your pulmonary blood pressure to rise rapidly, which can lead to a severe worsening of your condition and shortness of breath. Any changes to your PAH treatment plan must be carefully managed and supervised by your cardiologist or pulmonologist. Always consult your doctor before making changes to your regimen.
If you are using sildenafil for erectile dysfunction, a missed dose is not an issue because the medication is only taken when needed. Do not take more than one dose in a 24-hour period. If you are taking it for pulmonary arterial hypertension on a regular schedule, take the missed dose as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose and continue with your regular timing. Never take two doses at once to make up for a missed one. Consistency is key for managing PAH effectively.
There is no clinical evidence to suggest that sildenafil causes weight gain. Weight changes were not reported as a significant side effect in the clinical trials for either Viagra or Revatio. If you notice sudden weight gain or swelling in your hands and feet (edema) while taking sildenafil, this could be a sign of a worsening heart condition or other underlying health issues, and you should contact your doctor. It is always important to monitor your overall health and report any significant changes to your medical team. Sildenafil's primary effects are on the vascular system, not metabolism or fat storage.
Sildenafil has several significant drug interactions, the most dangerous being with nitrates (like nitroglycerin) used for chest pain. This combination can cause a fatal drop in blood pressure. It also interacts with alpha-blockers used for prostate issues, certain HIV medications like ritonavir, and some antibiotics or antifungal drugs. Because of these risks, it is vital to provide your doctor with a complete list of all prescription drugs, over-the-counter medicines, vitamins, and herbal supplements you are currently taking. Your doctor may need to adjust your dose or choose a different treatment to ensure your safety.
Yes, sildenafil is widely available as a generic medication in various strengths. Generic versions of both the 20 mg tablets (for PAH) and the 25 mg, 50 mg, and 100 mg tablets (for ED) have been approved by the FDA and are generally more cost-effective than the brand-name versions. Generic sildenafil contains the same active ingredient and meets the same rigorous standards for quality, strength, and purity as the brand-name drugs. You should only purchase generic sildenafil from a reputable pharmacy with a valid prescription to ensure you are receiving a safe and effective product. Talk to your pharmacist about generic options.
Other drugs with the same active ingredient (Sildenafil)
> Warning: Stop taking Sildenafil and call your doctor immediately if you experience any of these serious symptoms.
Long-term use of sildenafil is generally considered safe when taken as prescribed. However, some studies have investigated the potential for "psychological dependence" in men using it for ED, where they feel unable to perform without the medication even if the underlying physical cause is addressed. In patients with PAH, long-term use requires continuous monitoring of liver function and pulmonary pressures to ensure the drug remains effective and safe. There is no evidence that sildenafil causes physical addiction or withdrawal symptoms upon discontinuation.
No FDA black box warnings for Sildenafil. However, there are significant "Contraindications" and "Warnings and Precautions" that carry similar weight in clinical practice, particularly regarding the use of nitrates.
Report any unusual symptoms or side effects to your healthcare provider. You may also report side effects to the FDA at 1-800-FDA-1088. Documenting side effects helps improve the safety profile of the medication for all patients.
Sildenafil should be used with caution in patients with anatomical deformations of the penis (such as Peyronie's disease) or in patients who have conditions which may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia).
Physicians should advise patients to stop use of all PDE5 inhibitors and seek medical attention in the event of a sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a rare condition and a cause of decreased vision including permanent loss of vision.
Sudden decrease or loss of hearing has been reported in temporal association with the intake of PDE5 inhibitors. It is not determined whether these events are related directly to the drug or to other factors.
For patients taking sildenafil for erectile dysfunction, routine lab monitoring is generally not required specifically for the drug, though the underlying causes of ED (like diabetes or high cholesterol) should be monitored. For patients with PAH (Revatio), regular monitoring of exercise capacity, pulmonary hemodynamics, and liver function tests may be necessary, especially when starting or adjusting the dose.
Sildenafil can cause dizziness and vision changes. Patients should be aware of how they react to the medication before driving or operating heavy machinery. If you experience dizziness or blurred vision, avoid these activities until the symptoms resolve.
Alcohol can increase the risk of side effects such as dizziness, headache, and increased heart rate. Furthermore, alcohol is a known depressant and can impair erectile function, potentially counteracting the benefits of sildenafil. It is recommended to limit alcohol consumption while taking this medication.
For ED, sildenafil can be stopped at any time without a tapering schedule. For PAH, patients should not stop taking sildenafil abruptly, as this can lead to a rapid increase in pulmonary blood pressure and a worsening of symptoms. Any discontinuation of PAH therapy must be managed closely by a physician.
> Important: Discuss all your medical conditions with your healthcare provider before starting Sildenafil, particularly if you have a history of heart attack, stroke, or life-threatening heart rhythm problems within the last six months.
Sildenafil is not known to significantly interfere with common laboratory tests, such as blood counts or basic metabolic panels. However, always inform your laboratory technician and doctor of all medications you are taking.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking. A complete list is vital to prevent dangerous drug-drug interactions.
These conditions require a careful risk-benefit analysis by a healthcare professional:
While there is no documented cross-sensitivity between sildenafil and unrelated drug classes, patients who have had an allergic reaction to other PDE5 inhibitors (such as tadalafil or vardenafil) should be monitored closely, as they may share similar inactive components or structural features.
> Important: Your healthcare provider will evaluate your complete medical history, including heart health and current medications, before prescribing Sildenafil to ensure it is safe for you.
Clinical studies of sildenafil did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, because elderly patients often have decreased renal and hepatic function, which can lead to higher plasma concentrations of sildenafil, the starting dose for ED is typically reduced to 25 mg. There is also a higher prevalence of concurrent medications in this age group, increasing the risk of drug interactions.
In patients with hepatic cirrhosis (Child-Pugh Class A and B), sildenafil clearance is reduced, resulting in higher area under the curve (AUC) and Cmax values. A starting dose of 25 mg for ED is recommended. Sildenafil has not been extensively studied in patients with severe hepatic impairment (Child-Pugh Class C).
> Important: Special populations require individualized medical assessment. Always inform your doctor about your age, pregnancy status, or any organ impairment to ensure the safest possible treatment plan.
| Bioavailability | ~41% |
| Protein Binding | ~96% |
| Half-life | ~4 hours |
| Tmax | 0.5 – 2.0 hours |
| Metabolism | Primarily CYP3A4, minor CYP2C9 |
| Excretion | Fecal 80%, Renal 13% |
Sildenafil is the prototypical member of the Phosphodiesterase 5 Inhibitor [EPC] class. Other medications in this class include tadalafil (Cialis), vardenafil (Levitra), and avanafil (Stendra). While they share the same primary mechanism of action, they differ in their pharmacokinetic profiles, such as half-life and the influence of food on absorption.