Sildenafil
Pulmonary Hypertension, Vasculogenic Impotence
DRUG STATUS
Approvals
US(FDA), UK(BNF)
Essential Medicine
NO
Teratogenicity
Unlisted
Pharmaceutical Class
Phosphodiesterase 5 Inhibitor
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Sildenafil
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Click HereSummary
Sildenafil is primarily used to treat erectile dysfunction, which is a condition that affects a man's ability to achieve or maintain an erection. It is also used for pulmonary arterial hypertension, a type of high blood pressure that affects the arteries in the lungs and the heart.
Sildenafil works by inhibiting an enzyme called phosphodiesterase type 5 (PDE5). This leads to increased levels of a substance called cyclic guanosine monophosphate (cGMP) in the body, which causes the smooth muscle cells to relax and enhances blood flow. In erectile dysfunction, it improves blood flow to the penis during sexual arousal, facilitating an erection. In pulmonary arterial hypertension, it relaxes the blood vessels in the lungs, lowering blood pressure and improving oxygen delivery.
For erectile dysfunction, the usual adult dose of Sildenafil is 50 mg taken as needed, approximately 1 hour before sexual activity. For pulmonary arterial hypertension, the standard dose is 20 mg taken three times daily. Sildenafil can be taken with or without food, but it's best to avoid high-fat meals as they can delay its effect.
Common side effects of Sildenafil include headache, flushing, indigestion, nasal congestion, and dizziness. Serious side effects can involve sudden vision or hearing loss, chest pain, severe low blood pressure, and allergic reactions. If you experience any severe symptoms, seek medical help immediately.
Sildenafil should not be used by individuals taking nitrates, as it can cause a dangerous drop in blood pressure. It is also contraindicated in patients with severe cardiovascular conditions, recent stroke or heart attack, or severe liver or kidney impairment. Caution is needed in people with low blood pressure, dehydration, or eye conditions.
Indications and Purpose
What is Sildenafil used for?
Sildenafil is primarily indicated for the treatment of:
- Erectile Dysfunction (ED): To help men achieve and maintain an erection during sexual activity.
- Pulmonary Arterial Hypertension (PAH): To improve exercise capacity and delay disease progression by relaxing blood vessels in the lungs.
How does Sildenafil work?
Sildenafil works by inhibiting phosphodiesterase type 5 (PDE5), an enzyme that breaks down cyclic guanosine monophosphate (cGMP). By blocking PDE5, Sildenafil increases cGMP levels, leading to relaxation of smooth muscle cells and enhanced blood flow.
- In erectile dysfunction, it improves blood flow to the penis during sexual arousal, facilitating erection.
- In pulmonary arterial hypertension, it relaxes pulmonary blood vessels, lowering blood pressure and improving oxygen delivery.
Is Sildenafil effective?
Evidence supporting Sildenafil’s effectiveness comes from clinical trials and real-world studies:
- Erectile Dysfunction (ED): Multiple placebo-controlled studies show that Sildenafil significantly improves erectile function and satisfaction in men with ED. Patients experienced improved ability to achieve and maintain erections during sexual activity.
- Pulmonary Arterial Hypertension (PAH): Studies demonstrate improved exercise capacity and reduced pulmonary pressure, validated by the 6-minute walk test and hemodynamic measurements, confirming its role in PAH treatment.
How does one know if Sildenafil is working?
The benefits of Sildenafil are evaluated through:
Patient-reported outcomes: For erectile dysfunction (ED), patient questionnaires like the International Index of Erectile Function (IIEF) assess improvements in erectile function, satisfaction, and quality of life.
Objective clinical measurements: In pulmonary arterial hypertension (PAH), the effectiveness is measured by improvements in exercise capacity (e.g., 6-minute walk test), reduced pulmonary arterial pressure, and hemodynamic parameters.
Trial data: Clinical studies compare Sildenafil's performance with placebos or other treatments to track improvements in both ED and PAH symptoms.
Directions for Use
What is the usual dose of Sildenafil?
For Erectile Dysfunction (ED):
- The recommended starting dose is 50 mg, taken 30 minutes to 1 hour before sexual activity, as needed.
- Depending on effectiveness and tolerance, the dose may be increased to 100 mg or decreased to 25 mg.
- Do not take more than 1 dose per day.
For Pulmonary Arterial Hypertension (PAH):
- The typical dose is 20 mg, taken three times a day (every 4–6 hours).
How do I take Sildenafil?
Take Sildenafil with or without food, but avoid high-fat meals as they delay its effect. Do not consume grapefruit or grapefruit juice to prevent increased side effects. Swallow the tablet with water and follow your doctor’s dosage instructions.
For how long do I take Sildenafil?
There's no set time someone should use sildenafil. How long someone takes it depends on their doctor's advice and how well it works for them.
How long does it take for Sildenafil to start working?
Sildenafil typically starts working within 30 to 60 minutes after taking it. Its effects may vary based on factors like food intake, but it generally requires sexual stimulation to work effectively.
How should I store Sildenafil?
Sildenafil should be stored at room temperature, between 68°F and 77°F (20°C to 25°C). Keep the medication in its original container, tightly closed, and away from moisture, heat, and light. It is important to store Sildenafil out of reach of children and to avoid storing it in the bathroom or areas with high humidity.
Warnings and Precautions
Who should avoid taking Sildenafil?
Sildenafil should not be used by individuals taking nitrates (e.g., nitroglycerin) as it can cause a dangerous drop in blood pressure. It is contraindicated in patients with severe cardiovascular conditions, recent stroke or heart attack, or severe liver or kidney impairment. Caution is needed in people with low blood pressure, dehydration, or eye conditions such as retinitis pigmentosa.
Can I take Sildenafil with other prescription drugs?
Sildenafil can interact with several prescription drugs, including:
- Nitrates (e.g., nitroglycerin): Can cause a dangerous drop in blood pressure.
- Alpha-blockers (e.g., tamsulosin): May also lower blood pressure and cause dizziness or fainting.
- Antifungals (e.g., ketoconazole) and antibiotics (e.g., erythromycin): Can increase Sildenafil levels in the blood, raising the risk of side effects.
- HIV protease inhibitors (e.g., ritonavir): May enhance Sildenafil's effects, leading to increased side effects.
- Rifampin: Can reduce Sildenafil's effectiveness.
Can I take Sildenafil with vitamins or supplements?
Sildenafil may interact with certain supplements, particularly those that affect blood pressure, such as nitric oxide supplements or L-arginine, which can enhance its blood pressure-lowering effects. Additionally, high doses of vitamin E or ginseng may interfere with the efficacy of Sildenafil. Always consult a healthcare provider before using supplements alongside Sildenafil to avoid adverse interactions.
Can Sildenafil be taken safely while pregnant?
Sildenafil is classified as Category C by the FDA for pregnancy, which means that animal studies have shown potential risks to the fetus, but there are no well-controlled studies in humans. It should only be used during pregnancy if the potential benefits outweigh the risks. There is limited information on the effects of Sildenafil on pregnancy, so it is generally not recommended unless prescribed by a healthcare provider for specific conditions.
Can Sildenafil be taken safely while breastfeeding?
Sildenafil is excreted in breast milk in small amounts, but its effects on a breastfeeding infant are not well-studied. While it is considered relatively safe for short-term use during lactation, it should only be used if deemed necessary by a healthcare provider. Women who are breastfeeding should consult their doctor before using Sildenafil to assess the potential risks and benefits.
Is Sildenafil safe for the elderly?
Older people often have weaker livers, kidneys, or hearts, and may take other medicines. Because of this, doctors need to be careful when deciding on the right dose of a new medicine for them. There haven't been enough older people in medical studies to know for sure if they react to the medicine differently than younger people.
Is it safe to exercise while taking Sildenafil?
Yes, it is generally safe to exercise while taking Sildenafil. However, if you experience side effects like dizziness or low blood pressure, avoid strenuous activity until you feel stable. Consult your doctor if you have any heart conditions before combining Sildenafil with exercise.
Is it safe to drink alcohol while taking Sildenafil?
The study showed that taking Viagra (sildenafil) along with a moderate amount of alcohol didn't make people's blood pressure drop any more than alcohol alone. Essentially, the combination wasn't more dangerous for blood pressure than alcohol by itself. Nobody experienced dizziness or fainting from a sudden drop in blood pressure when standing up.