In patients taking strong CYP inhibitors, such as ritonavir, sildenafil exposure is increased.
| Parameter | Value | Description |
|---|---|---|
| Absorption Time | 30-60 minutes | Time to reach peak plasma concentration |
| Bioavailability | 40% | Percentage of dose that reaches systemic circulation |
| Half-life | 4-5 hours | Time for plasma concentration to reduce by half |
| Metabolism | Liver (primarily CYP3A4) | Enzymes responsible for breakdown |
| Excretion | Feces and urine | Routes of elimination |
Decrease in sildenafil dosage is recommended (2.4, 5.6)ADVERSE REACTIONSMost common adverse reactions ( >2%) include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness and rash (6.1)To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc.
- The medication is generally well tolerated when used correctly.
- Erectile response to sildenafil varies among individuals.
- Avoid heavy or greasy foods before taking the pill.
- Some side effects are more common in first-time users.
- Notify your doctor if your condition worsens or persists.
- Sildenafil 100 mg may also be prescribed for other health issues.
- Do not take sildenafil if you have recent history of stroke or heart attack.
- Confirm your allergies with your healthcare provider before use.
- Always store medication in a secure location away from children.
at 1-866-850-2876 or FDA at 1-800-FDA-1088 or INTERACTIONSSildenafil can potentiate the hypotensive effects of nitrates, alpha blockers, and anti-hypertensives ( 4.1, 5.5, 7.1, 7.2, 7.3, 12.2)With concomitant use of alpha blockers, initiate sildenafil at 25 mg dose ( 2.3)CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase sildenafil exposure ( 2.4, 7.4, 12.3)Erythromycin or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, saquinavir): Consider a starting dose of 25 mg
What special precautions should I follow?
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. 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.
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Check with your doctor right away if you have a sudden decrease in buy sildenafil citrate online canada 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. 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. ( 2.4, 7.4)Ritonavir: Do not exceed a maximum single dose of 25 mg in a 48 hour period ( 2.4, 5.6)USE IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 4/2025 Sildenafil is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) (1) For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity.
| Condition | Risk | Recommendations |
|---|---|---|
| Use of Nitrates | Severe hypotension risk | Do not co-administer |
| Severe Liver Impairment | Altered drug metabolism | Consult healthcare provider |
| Retinitis Pigmentosa | Potential risk of vision issues | Use with caution |
| Recent Stroke or Heart Attack | Cardiac stress | Medical evaluation required |
| Hypotension (Low Blood Pressure) | Worsening symptoms | Monitor blood pressure during use |
However, sildenafil tablets may be taken anywhere from 30 minutes to 4 hours before sexual activity (2.1) Based on effectiveness and toleration, may increase to a maximum of 100 mg or decrease to 25 mg (2.1) Maximum recommended dosing frequency is once per day (2.1) Tablets: 25 mg, 50 mg, 100 mg (3) Administration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form.
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Sildenafil tablets was shown to potentiate the hypotensive effect of nitrates ( 4.1, 7.1, 12.2) Known hypersensitivity to sildenafil or any component of tablet ( 4.2) Administration with guanylate cyclase (GC) stimulators, such as riociguat ( 4.3) Patients should not use sildenafil if sexual activity is inadvisable due to cardiovascular status (5.1) Patients should seek emergency treatment if an erection lasts >4 hours.
6.1 Clinical Trials Experience
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS.SILDENAFIL tablets, for oral useInitial U.S. Approval: 1998INDICATIONS AND USAGESildenafil is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) (1)DOSAGE AND ADMINISTRATIONFor most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, sildenafil tablets may be taken anywhere from 30 minutes to 4 hours before sexual activity (2.1)Based on effectiveness and toleration, may increase to a maximum of 100 mg or decrease to 25 mg (2.1)Maximum recommended dosing frequency is once per day (2.1)DOSAGE FORMS AND STRENGTHSTablets: 25 mg, 50 mg, 100 mg (3)CONTRAINDICATIONSAdministration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. Sildenafil tablets was shown to potentiate the hypotensive effect of nitrates ( 4.1, 7.1, 12.2)Known hypersensitivity to sildenafil or any component of tablet ( 4.2)Administration with guanylate cyclase (GC) stimulators, such as riociguat ( 4.3)WARNINGS AND PRECAUTIONSPatients should not use sildenafil if sexual activity is inadvisable due to cardiovascular status (5.1)Patients should seek emergency treatment if an erection lasts >4 hours.
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Use sildenafil with caution in patients predisposed to priapism (5.2)Patients should stop sildenafil and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION). Sildenafil should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a “crowded” optic disc may also be at an sildenafil pick up increased risk of NAION. (5.3)Patients should stop sildenafil and seek prompt medical attention in the event of sudden decrease or loss of hearing (5.4)Caution is advised when sildenafil is co-administered with alpha-blockers or anti-hypertensives. Concomitant use may lead to hypotension (5.5)Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures. Use sildenafil with caution in patients predisposed to priapism (5.2) Patients should stop sildenafil and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION). Patients should stop sildenafil and seek prompt medical attention in the event of sudden decrease or loss of hearing (5.4) Caution is advised when sildenafil is co-administered with alpha-blockers or anti-hypertensives.
Detection in biological fluids
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. 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.
What causes an erection?
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. 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. If you are a consumer or patient please visit this version. Concomitant use may lead to hypotension (5.5) Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures.
- Sildenafil 100 mg does not protect against sexually transmitted diseases.
- It is not recommended for women or children.
- The medication can sometimes cause back pain or muscle aches.
- Use sildenafil only as prescribed to minimize risks.
- Some users report facial flushing after taking the pill.
- Avoid excessive physical activity immediately after taking the drug.
- Always read the patient information leaflet before use.
- Do not share your medication with others.
- Sildenafil may cause nasal stuffiness or congestion.
Decrease in sildenafil dosage is recommended (2.4, 5.6) Most common adverse reactions ( >2%) include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness and rash (6.1) Sildenafil can potentiate the hypotensive effects of nitrates, alpha blockers, and anti-hypertensives ( 4.1, 5.5, 7.1, 7.2, 7.3, 12.2) With concomitant use of alpha blockers, initiate sildenafil at 25 mg dose (
- Sildenafil 100 mg tablets are primarily used to treat erectile dysfunction.
- The medication works by increasing blood flow to the penis.
- It is usually taken 30-60 minutes before sexual activity.
- Do not take more than one tablet per 24 hours to avoid overdose.
- Common side effects include headache, flushing, and nasal congestion.
- Sildenafil 100 mg should be used only under medical supervision.
- Avoid consuming high-fat meals close to the time of intake.
- It may interact with nitrates, leading to dangerous blood pressure drops.
- Store in a cool, dry place away from children and pets.
2.3) CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase sildenafil exposure ( 2.4, 7.4, 12.3) Erythromycin or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, saquinavir): Consider a starting dose of 25 mg ( 2.4, 7.4) Ritonavir: Do not exceed a maximum single dose of 25 mg in a 48 hour period ( 2.4, 5.6) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
2. Contradiction of Welgra 100
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. 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).
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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 your progress at regular visits. 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.