16 HOW SUPPLIED/STORAGE AND HANDLING

For people with heart problems: This drug can lower your blood pressure. If you’ve had certain heart problems in the last 6 months, ask your doctor whether this drug is safe for you. These problems include a heart attack, stroke, or life threatening heart rhythm problem. Also talk with your doctor if you have a low or high resting blood pressure, or a history of heart failure or coronary artery disease. For people with pulmonary veno-occlusive disease (PVOD): Taking this drug may worsen your heart function. For people with eye problems: This drug may cause sudden loss of vision in one or both eyes.

What other drugs will affect sildenafil?

Sildenafil oral tablet doesn’t cause drowsiness, but it can cause other side effects, including: flushing (reddening and warming of the face) an erection that lasts longer than normal If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk with your doctor or pharmacist. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following: Symptoms can include:blurry visionconfusiondizzinessfaintinglightheadednessnausea or vomitingsleepinessweakness Increased shortness of breath or trouble breathing Priapism (an erection that lasts more than 4 hours) Symptoms can include:sudden vision loss in one or both eyes sudden vision loss in one or both eyes Symptoms can include:sudden hearing losstinnitus (ringing in your ears)dizziness Heart problems, such as heart attack, stroke, or irregular heart rate.

Starting Sildenafil: Recommended First-Time Dosage

Symptoms can include:chest painshortness of breathdizzinesstrouble speakingconfusionnausea or vomitingfeeling lightheaded Priapism warning: This drug can cause priapism, which is an erection that won’t go away. If you have an erection that lasts more than 4 hours, call 911 or go to the nearest emergency room. If it’s not treated right away, this condition can cause permanent damage to your penis. Sudden vision loss warning: This drug can cause sudden vision loss in one or both eyes. This can be a sign of a serious eye problem.

5.1 Cardiovascular

If this occurs, stop taking sildenafil and call your doctor right away. Sudden hearing loss warning: This drug can cause hearing loss, tinnitus (ringing in your ears), or dizziness. If you have sudden hearing loss with or without tinnitus or dizziness, stop taking sildenafil and call your doctor right away. Use in children warning: Children generally should not take sildenafil; however, there are instances where the drug is considered the best treatment option. Talk with your child’s doctor to better understand the benefits and risks associated with this treatment option. This may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION). If you’ve already had NAION or have crowded optic disc, you may have a higher risk for NAION and vision changes with this drug. For people with problems with the shape of their penis: If you have a problem with the shape of your penis, such as Peyronie’s disease, this drug raises your risk for having an erection that lasts more than 4 hours.

Side Effect	Frequency	Severity	Notes
Headache	Common	Mild	Usually subsides after a few hours
Flushing	Common	Mild	Feeling of warmth or redness
Nasal Congestion	Less Common	Mild	Stuffiness in nose
Dizziness	Less Common	Moderate	Caution when standing up quickly
Vision Changes	Rare	Mild to Moderate	Blurred or blue-tinted vision

For people with a history of stomach ulcers or bleeding: This drug raises your risk for stomach bleeding, ulcers, or small holes in the lining of your digestive system. These events can be fatal (cause death). They can happen at any time, with or without symptoms. For people with sickle cell anemia: This drug may cause a common painful complication of sickle cell anemia called vaso-occlusive crisis. If you have sickle cell anemia, ask your doctor whether this drug is safe for you.

• Patient support resources are available for those taking sildenafil.
• Many pharmaceutical manufacturers offer patient assistance programs.
• Non-profit organizations provide information and support for ED and PAH.
• The Pulmonary Hypertension Association offers resources for PAH patients.
• Urology care foundations provide educational materials on ED treatments.
• Online forums and support groups can offer peer support and shared experiences.
• Healthcare providers are the primary source for personalized medical advice.
• Pharmacists are an excellent resource for information on dosing and side effects.
• Mental health professionals can help address psychological aspects of ED.
• Cardiac rehabilitation may be recommended for some PAH patients.
• A multidisciplinary approach often yields the best patient outcomes.

For pregnant women: Research in animals has not shown a risk to the fetus when the mother takes the drug.

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However, there aren’t enough studies done in humans using the drug for PAH to show if the drug poses a risk to the fetus. Talk with your doctor if you’re pregnant or planning sildenafil softgel capsule to become pregnant. It appears unlikely that this drug will harm a pregnancy.

• 20mg sildenafil provides a balance between effectiveness and safety.
• It is not a cure for ED but helps achieve and maintain an erection.
• Using sildenafil without medical advice can be risky.
• The medication may cause nasal congestion or stomach upset.
• Always follow the dosage instructions provided by your healthcare provider.

However, this drug should only be used during pregnancy if clearly needed. Viagra or generic sildenafil for ED should not be used in women. For women who are breastfeeding: When used for PAH, sildenafil may pass into breast milk and may cause side effects in a child who is breastfed. Talk with your doctor if you breastfeed your child.

Parameter	Description	Typical Value
Absorption Time	Time to reach peak plasma levels	30-120 minutes
Half-life	Time for plasma concentration to reduce by half	4 hours
Bioavailability	Percentage of dose that reaches circulation	40%
Metabolism	Mainly processed in the liver	Cytochrome P450 enzymes
Excretion	Mainly via feces and urine	-

You may need to decide whether to stop breastfeeding or stop taking this medication. For seniors: The kidneys, liver, or heart of older adults may not work as well as they used to.

Dosages of Sildenafil

They can also include erections that buy sildenafil citrate online canada last longer than normal. Increased side effects can include low blood pressure, dizziness, or vision problems. Certain antibiotics, such as clarithromycin or erythromycin.Increased side effects can include low blood pressure, dizziness, or vision problems. Certain antifungals, such as ketoconazole or itraconazole.Increased side effects can include low blood pressure, dizziness, or vision problems. Side effects from other drugs: Taking sildenafil with certain medications raises your risk for side effects from these drugs.

12.1 Sildenafil Tablets Mechanism of Action

Alpha-blockers, such as terazosin, tamsulosin, doxazosin, alfuzosin, or silodosin.Increased side effects can include a drop in blood pressure, or fainting. Increased side effects can include a drop in blood pressure, or fainting. Blood pressure drugs, such as amlodipine.Increased side effects can include blood pressure that’s too low. Increased side effects can include blood pressure that’s too low. Other drugs for erectile dysfunction, such as avanafil, tadalafil, or vardenafil.Increased side effects can include low blood pressure or erections that last longer than normal Increased side effects can include low blood pressure or erections that last longer than normal Disclaimer: Our goal is to provide you with the most relevant and current information.

Why it’s used

However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking. Sildenafil can cause a severe allergic reaction. If you develop these symptoms, call 911 or go to the nearest emergency room. This can cause your body to process drugs more slowly. As a result, a higher amount of a drug stays in your body for a longer time. This raises your risk for side effects.

Overdose/Missed Dose

Sildenafil oral tablet can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well. To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking.

Usual Adult Dose for:

To find out how this drug might interact with something else you’re taking, talk with your doctor or pharmacist. Examples of drugs that can cause interactions with sildenafil are listed below. Do not take these drugs with sildenafil. Doing so can cause dangerous effects in the body. Nitrates, such as isosorbide mononitrate, isosorbide dinitrate, or nitroglycerin.Taking these drugs with sildenafil can cause your blood pressure to drop suddenly to an unsafe level.

2.3 Dosage Adjustments in Specific Situations

Taking these drugs with sildenafil can cause your blood pressure to drop suddenly to an unsafe level. Guanylate cyclase stimulators, such as riociguat.Taking these drugs with sildenafil can cause your blood pressure to drop suddenly to an unsafe level. Side effects from sildenafil: Taking sildenafil with certain medications raises your risk for side effects from sildenafil. This is because the amount of sildenafil in your body is increased. HIV drugs, such as ritonavir, indinavir, saquinavir, or atazanavir.Increased side effects can include low blood pressure, dizziness, or vision problems. For children: This drug isn’t recommended in children younger than 18 years.

Storage Requirement	Temperature Range	Light Exposure	Humidity Control	Notes
Room Temperature	20–25°C (68–77°F)	Keep away from direct sunlight	Keep in a dry place	Keep out of reach of children
Avoid Humidity	≤60% RH	Store in original container	Avoid bathroom storage	Protect from moisture
Temperature Fluctuations	Avoid extreme temperatures	-	-	Prevent degradation

In one study, children with PAH who took this drug had an increased chance for death.

If you take too much

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death). The use of drinks that contain alcohol raises your risk for low blood pressure from sildenafil. If you drink alcohol, talk with your doctor. You may need to have your blood pressure monitored while you take this drug. All possible dosages and drug forms may not be included here. Your dosage, drug form, and how often you take the drug will depend on: how you react to the first dose Strengths: 25 mg, 50 mg, 100 mg Strengths: 25 mg, 50 mg, 100 mg Typical dosage: 50 mg, taken as needed about 1 hour before sexual activity. It can be taken 30 minutes to 4 hours before sexual activity. Maximum dosage: 100 mg once per day.

• Special populations require careful consideration before prescribing.
• In elderly patients (65+), clearance may be reduced; start with a lower dose.
• No dose adjustment is typically needed for patients with mild renal impairment.
• For moderate renal impairment (CrCl 30-80 mL/min), caution is advised.
• In severe renal impairment (CrCl <30 mL/min), a 25mg dose is often recommended.
• For hepatic impairment (Child-Pugh A and B), a 25mg starting dose is advised.
• Sildenafil is not recommended for patients with severe hepatic impairment.
• Safety and efficacy in pediatric patients for ED have not been established.
• Revatio is approved for pediatric PAH patients aged 1 year and older.
• The dose for pediatric PAH is based on body weight and must be carefully calculated.
• Use during pregnancy is only for PAH and requires a careful risk/benefit analysis.

This drug has not been confirmed to be safe or effective in children younger than 18 years. Senior dosage (ages 65 years and older) The kidneys, liver, or heart of older adults may not work as well as they used to. This raises your risk of side effects. Your doctor may start you on a lowered dosage of sildenafil. This can help prevent levels of this drug from building up in your body.

• Regulatory status of sildenafil varies by country but generally requires a prescription.
• In the UK, it is a Prescription Only Medicine (POM) but can be prescribed by pharmacists.
• In some countries, it may be available in limited quantities without a prescription.
• The FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for Revatio.
• The REMS is designed to inform healthcare providers about the serious risks.
• This includes the risk of use with nitrates and the potential for hearing loss.
• The medication is subject to controlled substance regulations in some regions.
• Traveling with prescription medication requires carrying it in original packaging.
• It is advisable to have a copy of the prescription or a doctor's note when traveling.
• Laws regarding the importation of prescription drugs are strict and vary.
• Always check the legal status of the medication in your destination country.

Typical dosage: 5 or 20 mg, taken three times per day about 4 to 6 hours apart Maximum dosage: 20 mg, taken three times per day about 4 to 6 hours apart This drug shouldn’t be used in children younger than 18 years of age. Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. Always speak with your doctor or pharmacist about dosages that are right for you. Sildenafil oral tablet is used for short-term treatment of ED and long-term treatment of PAH. It comes with serious risks if you don’t take it as prescribed. If you stop taking the drug suddenly or don’t take it at all: For ED: Your ED symptoms won’t improve.