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Most, but not all, of these people had heart problems before taking this medicine.

Frequently asked questions

Sildenafil tablets (25 mg, 50 mg, 100 mg; Viagra, generic) and sildenafil oral film (25 mg, 50 mg, 75 mg, 100 mg; Vybrique) are used for ED. Sildenafil tablets (20 mg; Revatio, generic), sildenafil oral suspension (Revatio, generic), and sildenafil injection (Revatio, generic) are used for PAH. Sildenafil is a phosphodiesterase type 5 (PDE5) inhibitor, which breaks down cyclic GMP and enhances nitric oxide (NO) -mediated smooth muscle relaxation. In erectile dysfunction (ED), this increases blood flow to penile tissue, facilitating an erection. In pulmonary arterial hypertension (PAH), it dilates pulmonary vessels by the same mechanism, reducing pulmonary blood pressure and improving exercise capacity.

Is it Safe to Take Sildenafil While Breastfeeding?

Sildenafil first gained FDA approval on March 27, 1998. Do not take sildenafil if you are also using a nitrate drug for chest pain or heart problems, including nitroglycerin, isosorbide dinitrate, isosorbide mononitrate, and some recreational drugs such as "poppers". Taking sildenafil with a nitrate medicine can cause a sudden and serious decrease in blood pressure. Some medicines can cause unwanted or dangerous effects when chew sildenafil used with sildenafil. Tell your doctor about all your current medicines, especially riociguat (Adempas). It is not known if sildenafil caused these problems. Tell all your healthcare providers that you take sildenafil.

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If you need emergency medical care for a heart problem, it will

Adverse Effects

Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 80 mg 3 times a day.Children 1 year of age and older weighing 45 kilograms (kg) or more—20 mg 3 times a day. However the dose is usually not more than 40 mg 3 times a day.Children 1 year of age and older weighing 20 to 45 kg—20 mg 3 times a day.Children 1 year of age and older weighing 20 kg or less—10 mg 3 times a day.Children younger than 1 year of age—Use and dose must be determined by your doctor. For oral dosage forms (suspension or tablets):Adults—20 milligrams (mg) 3 times a day. Adults—20 milligrams (mg) 3 times a day.

Other Medical Problems

However, the dose is usually not more than 80 mg 3 times a day. Children 1 year of age and older weighing 45 kilograms (kg) or more—20 mg 3 times a day. However the dose is usually not more than 40 mg 3 times a day. Children 1 year of age and older weighing 20 to 45 kg—20 mg 3 times a day. Children 1 year of age and older weighing 20 kg or less—10 mg 3 times a day. be important for your healthcare provider to know when you last took sildenafil.

5.2 Worsening Pulmonary Vascular Occlusive Disease

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur: burning feeling in the chest or stomach burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings decrease in amount of urine or the frequency of urination dizziness or lightheadedness, especially when getting up suddenly from a lying or sitting position dryness, redness, scaling, or peeling of the skin increase in the size of the pupil redness, burning, or swelling of the eyes redness, itching, or tearing of the eyes seeing shades of colors differently than before swelling of the face, hands, feet, or lower legs unusual feeling of burning or stinging of the skin Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Missed Dose

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: pain or tenderness around the eyes and cheekbones diarrhea or stomach cramps (severe or continuing) numbness or tingling of the hands, legs, or feet redness, soreness, swelling, or bleeding of the gums sensation of motion, usually whirling, either of one's self or of one's surroundings sexual problems in men (continuing), including failure to experience a sexual orgasm sores in the mouth and on the lips Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. Pronunciation: sil-DEN-a-fil Generic name: sildenafil Brand names: Revatio, Viagra, Vybrique Dosage form: tablets (20 mg; 25 mg, 50 mg, 100 mg), injection (10 mg/12.5 mL), oral suspension (10 mg/mL), oral film (25 mg, 50 mg, 75 mg, 100 mg) Drug classes: Agents for pulmonary hypertension, Impotence medications Sildenafil is used to treat erectile dysfunction (ED) in adult men or pulmonary arterial hypertension (PAH) in adults and children, depending on the brand or formulation. Stop sexual activity and get medical help right away if you

• Sildenafil 12.5 mg is a lower dose used for mild erectile dysfunction.
• It helps relax blood vessels to increase blood flow.
• Often prescribed when starting treatment or for lighter symptoms.

get symptoms such as chest pain, dizziness, or nausea during sex.

Point	Rationale	Action Items
Assess cardiovascular health	To prevent adverse events	Conduct thorough patient evaluation
Dose titration	To optimize efficacy and minimize side effects	Start at 12.5 mg, adjust as needed
Patient counseling	To ensure proper use and adherence	Provide detailed instructions
Monitoring	To track effectiveness and side effects	Follow-up appointments required

Sexual activity can put an extra strain on your heart, especially if

Condition	Reason	Alternative Action
Use of Nitrates	Risk of severe hypotension	Consult doctor for alternatives
Severe Cardiovascular Disease	Increased risk during physical exertion	Adjust dosage or avoid use
Retinitis Pigmentosa	Possible risk of vision loss	Medical consultation
Hypersensitivity	Allergic reaction risk	Do not use

your heart is already weak from a heart attack or heart disease.

8.1 Pregnancy

Children younger than 1 year of age—Use and dose must be determined by your doctor. For oral dosage forms (suspension or tablets): If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep out of the reach of children.

Dosage Forms & Strengths

Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use. Store mixed oral liquid in the refrigerator. Throw away any unused mixed Revatio® oral liquid after 60 days. It is important that you tell all of your doctors that you take sildenafil. Sildenafil does not protect you or your partner from

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The most common side effects of sildenafil tablets for ED are: Abnormal vision, such as changes in color vision (such as having a blue color tinge) andblurred vision The most common side effects of sildenafil oral film for ED are: Abnormal vision, such as changes in color and blurred vision The most common side effects of sildenafil tablets/ oral suspension, and injection for PAH are: Sildenafil can cause the following serious side effects. If you have an erection that lasts more than 4 hours, get medical help right away. If it is not treated right away, priapism can permanently damage your penis. Sildenafil can decrease blood flow to the optic nerve of the eye, causing sudden vision loss. This has occurred in a small number of people taking sildenafil, most of whom also had heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoked or were over 50 years old.

Other Interactions

Sudden vision loss in one or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). Stop taking sildenafil and call your healthcare provider right away if you havesudden vision loss in one or both eyes. Some people may also have ringing in their ears (tinnitus) or dizziness. If you have these symptoms, stop taking sildenafil and contact a doctor right away. In addition, heart attack, stroke, irregular heartbeats, and death have happened rarely in people taking sildenafil. getting sexually transmitted diseases,

• This dose is often used as a starting point before increasing if needed.
• Combining with high-fat meals may slow absorption.
• Avoid grapefruit juice, as it can affect sildenafil metabolism.

including Human Immunodeficiency Virus (HIV).

5.7 Priapism

If you experience a prolonged or painful erection for 4 hours or more, contact your doctor immediately. This condition may require prompt medical treatment to prevent serious and permanent damage to your penis. If you experience a sudden loss of vision in one or both eyes, contact your doctor immediately. Check with your doctor right away if you have a sudden decrease in hearing or loss of hearing, which may be accompanied by dizziness and ringing in the ears. If you already use medicine for high blood pressure (hypertension), sildenafil could make your blood pressure go too low.

Chronic Obstructive Pulmonary Disease (COPD) (Off-Label Use)

Call your doctor right away if you have blurred vision, confusion, dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly, sweating, or unusual tiredness or weakness. This medicine does not protect you against sexually transmitted diseases (including HIV or AIDS). Use protective measures and ask your doctor if you have any questions about this. Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. Sildenafil may cause low blood pressure, which

Country	Legal Status	Can be OTC?	Prescription Required?
United States	Prescription only	No	Yes
European Union	Prescription required	No	Yes
India	Available OTC in some locations	Yes	No
Australia	Prescription required	No	Yes

may cause you to feel faint or dizzy.

Administration Instructions for Sildenafil

If you need emergency medical care for a heart problem, it is important that your doctor knows when you last took sildenafil. Do not use this medicine if you are also using a nitrate medicine, often used to treat angina or high blood pressure. Some illegal ("street") drugs called "poppers" (such as amyl nitrate, butyl nitrate, or nitrite). Do not use this medicine if you also use riociguat (Adempas®). If you will be taking this medicine for pulmonary arterial hypertension, your doctor will want to check sildenafil 20 mg tablets your progress at regular visits.

Oral Powder For Reconstitution

This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. If you take sildenafil for pulmonary arterial hypertension, do not take Viagra®, Vibrique™ or other PDE5 inhibitors, including tadalafil (Cialis®) or vardenafil (Levitra®). If you take too much sildenafil or take it together with these medicines, the chance for side effects will be higher. It is important to tell your doctor about any heart problems you have now or may have had in the past. This medicine can cause serious side effects in patients with heart problems.