Potential Side Effects of Sildenafil 60mg

If you have an erection, with or without pain, that lasts more than 4 hours, contact your healthcare provider or get emergency medical help right away.

Side Effect	Severity	Frequency	Notes
Headache	Mild to moderate	Common	Usually subsides within hours
Flushing	Mild	Frequent	Redness of face or neck
Nasal Congestion	Mild	Common	Stuffiness in nasal passages

A painful erection that lasts more than 6 hours must be treated right away or you can have lasting damage to your penis, including the inability to have erections.

• Consult your healthcare provider before starting sildenafil.
• Monitor blood pressure regularly if prescribed anticoagulants.
• Be cautious with activities requiring alertness post-dose.
• Treatment should be part of a broader health plan.

The most common side effects of sildenafil 200 mg REVATIO in adults include: getting red or hot in the face (flushing) The most common side effect of REVATIO in children is an erection that lasts for more than 4 hours (priapism).

Comparing Drug Interactions

The study was a randomized, double-blind, parallel-group study in 385 adults with PAH. Patients were randomly assigned 1:1:1 to one of three treatment groups (5, 20, and 80 mg TID). Most patients were PAH treatment naïve (83%). For most patients the etiology of PAH was idiopathic (72%). The most common WHO Functional Class was Class III (58% of patients).

Patient resources

Treatment groups were well balanced with respect to baseline demographics of strata history of PAH treatment and etiology of PAH, as well as the WHO Functional Class categories. The primary objective of the study was to compare sildenafil 80 mg TID versus 5 mg TID for mortality, with success defined by ruling out twice the mortality at 80 mg. The key secondary efficacy endpoint was time to first event of clinical worsening, defined as a composite endpoint of all-cause mortality, hospitalization for worsening PAH or disease progression. An additional secondary endpoint was 6MWD at Months 6 and 12. At the time of a planned interim analysis (50% deaths) it was identified that the primary efficacy objective of this protocol was met and therefore the study was stopped. These are not all the possible side effects of REVATIO.

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Store REVATIO tablets at room temperature between 68°F to 77°F (20°C to 25°C).

Which Makes You Harder?

are allergic to sildenafil or any of the ingredients in REVATIO. See the end of this leaflet for a complete list of ingredients in REVATIO. Before taking REVATIO, tell your healthcare provider about all of your medical conditions, including if you or your child: have bleeding problems or a stomach (peptic) ulcer. It is not known if REVATIO is safe in people with bleeding problems or who have a stomach ulcer. have an eye problem called retinitis pigmentosa have ever had sudden loss of vision in one or both eyes, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION) have ever had hearing problems such as ringing in the ears, dizziness, or loss of hearing have a deformed penis shape or Peyronie’s disease have any blood cell problems such as sickle cell anemia are pregnant or plan to become pregnant.

Is Viagra dosage based on age or weight?

It is not known if REVATIO will harm your unborn baby. It is not known if it can harm your baby. Talk with your healthcare provider about the best way to feed your baby during treatment with REVATIO. Tell your healthcare provider about all of the medicines you or your child take, including prescription and overthe- counter medicines, vitamins, and herbal supplements. REVATIO and certain other medicines may affect each other and can cause side effects. Store mixed (reconstituted) REVATIO oral suspension below 86°F (30°C) or in a refrigerator between 36°F to 46°F (2°C to 8°C).

Does Either Medication Reverse ED?

Especially tell your healthcare provider if you or your child take: See “What is the most important information I should know about REVATIO?” REVATIO contains sildenafil, which is the same medicine found in another medicine called VIAGRA®. VIAGRA is used for the treatment of erectile dysfunction. Do not take VIAGRA or other PDE-5 inhibitors during treatment with REVATIO. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure. Know the medicines you or your child take.

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

Keep a list of your or your child’s medicines and show it to your healthcare provider and pharmacist when you get a new medicine. Take or give REVATIO exactly as your healthcare provider tells you. Your healthcare provider may change your or your child’s dose of REVATIO as needed. Do not change your dose or stop taking REVATIO without talking to your healthcare provider. REVATIO may be prescribed to you as REVATIO sildenafil film tablet tablets or REVATIO oral suspension. Do not freeze mixed REVATIO oral suspension. Throw away (discard) any remaining REVATIO oral suspension 60 days after mixed by the pharmacist.

Condition	Risk	Recommendation
Nitrate medication use	Severe hypotension	Should not be combined
Heart disease	Increased cardiac risk	Consult a cardiologist before use
Severe liver impairment	Altered drug metabolism	Dose adjustment or avoid use

See the “Discard after” date written on the bottle label.

Precautions for Revatio

Take your prescribed dose of REVATIO tablets or oral suspension 3 times a day. See the detailed Instructions for Use that comes with REVATIO oral suspension for information on how to take or give REVATIO oral suspension. REVATIO oral suspension will be mixed for you by your pharmacist. Do not mix REVATIO oral suspension with other medicine or flavoring. If you or your child take too much REVATIO, call your healthcare provider or go to the nearest hospital emergency room right away.

The Bottom Line

What are the possible side effects of REVATIO? REVATIO may cause serious side effects, including: See “What is the most important information I should know about REVATIO?” REVATIO may cause low blood pressure that last for a short time. If you take medicines to treat high blood pressure, your healthcare provider should monitor your blood pressure during treatment with REVATIO. Decreased eyesight or permanent loss of vision in one or both eyes can be a sign of non-arteritic anterior ischemic optic neuropathy (NAION). Most people who develop NAION have certain risk factors. Keep REVATIO and all medicines out of the reach of children.

Drug Interactions

Your blood pressure could drop quickly to an unsafe level. Nitroglycerin in any form including tablets, patches, sprays, and ointments Street drugs called “poppers” (amyl nitrate, butyl nitrate or nitrite) Riociguat, a medicine that treats pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. Ask your healthcare provider or pharmacist if you are not sure if you or your child are taking a nitrate or a guanylate cyclase stimulator medicine. See “What are the possible side effects of REVATIO?” for more information about side effects. REVATIO is a prescription medicine used to treat pulmonary arterial hypertension (PAH).

Platelet-aggregation Inhibitors

PAH is a type of high blood pressure sildenafil 130mg in the arteries of your lungs. adults to improve your ability to exercise and help slow down the worsening of your physical condition. children 1 to 17 years old to improve their ability to exercise, and in children too young to do certain exercise and lung testing. It is not known if REVATIO is safe and effective in children younger than 1 year of age. Do not take REVATIO if you or your child: take riociguat, a guanylate cyclase stimulator medicine. General information about the safe and effective use of REVATIO.

• Avoid use if you have recent heart attack or stroke.
• Discuss your full medical history with your doctor.
• Be aware of the potential for allergic reactions.
• Discontinue use and consult a doctor if adverse effects occur.

Do not use REVATIO for a condition for which it was not prescribed.

What other information should I know?

You can ask your healthcare provider if you have questions about risk factors for NAION. If you notice a sudden decrease or loss of vision in one or both eyes during treatment with REVATIO, contact your healthcare provider right away. Sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness. If you notice a sudden decrease or loss of hearing during treatment with REVATIO, contact your healthcare provider right away. In men, an erection that lasts for more than 4 hours (priapism). Do not give REVATIO to other people, even if they have the same symptoms that you have. You can ask your healthcare provider or pharmacist for information about REVATIO that is written for health professionals.

• Sildenafil 60mg may interact with blood pressure medications.
• Use with caution if you have a history of priapism.
• Blood tests may be required before starting treatment.
• Regular medical check-ups are recommended.

REVATIO tablets: anhydrous dibasic calcium phosphate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin REVATIO oral suspension: citric acid anhydrous, colloidal silicon dioxide anhydrous, grape flavor, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose, titanium dioxide, and xanthan gum REVATIO® (re-VAH-tee-oh) (sildenafil) oral suspension Read this Instructions for Use before you start taking REVATIO oral suspension or giving REVATIO oral suspension to your child and each time you get a refill.

Further information

Based on the primary efficacy endpoint (mortality), the non-inferiority of sildenafil 80 mg TID arm versus 5 mg TID arm was met using a 2-sided significance level of 0.003 for the interim analysis. Primary comparison of the 80 mg TID group to the 5 mg TID group yielded the HR (99.7% CI) = 0.51 (0.22, 1.21); i.e., non-inferiority was established. Table 6: Hazard Ratios for Overall Survival, Assessed in the Proportional Hazards Model – Intent To Treat Population Kaplan-Meier estimates of survival at 3 years were 66%, 79%, and 85% in the 5-, 20-, and 80- mg TID dose groups, respectively. Sildenafil 80 mg was also superior to 5 mg for time to first event of clinical worsening with HR (99.7% CI) = 0.44 (0.22, 0.89). Table 7: Hazard Ratios for Time to First Event of Clinical Worsening – Intent To Treat Population At baseline, the median of 6MWD for the intent-to-treat (ITT) population was 332 to 352 m.

Missed Dose

At Month 6, the median change from baseline was highest for sildenafil 80 mg TID with 28 m compared to 18 m and 19 m for sildenafil 5 mg TID and sildenafil 20 mg TID groups, respectively. The same was seen at Month 12, the median change from baseline for sildenafil 80 mg TID group was 33 m compared to 17 m for sildenafil 5 mg TID and 31 m in sildenafil 20 mg TID groups. Overall, the safety data for sildenafil 20 mg TID and for the higher sildenafil 80 mg TID dose were consistent with the established safety profile of sildenafil in previous adult PAH studies [see ADVERSE REACTIONS]. REVATIO® (re-VAH-tee-oh) (sildenafil) oral suspension What is the most important information I should know about REVATIO? Never take REVATIO with any nitrate or guanylate cyclase stimulator medicines. This information does not take the place of talking to your healthcare provider about your or your child’s medical condition or treatment.

• Keep track of any side effects to report promptly.
• Avoid taking it with fatty foods for quicker absorption.
• Use as part of a comprehensive approach to ED.
• Medication adherence is key to effectiveness.

Ask your healthcare provider or pharmacist to show you how to measure and take or give your child’s prescribed dose of REVATIO oral suspension.