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Use of REVATIO, particularly chronic use, is not recommended in children [see Use in Specific Populations (8.4)].

Instruction	Explanation	Additional Notes
Take on an empty stomach	Absorption may be faster	Avoid heavy or fatty meals
Do not mix with alcohol	Can increase side effects	Use responsibly
Avoid driving immediately after	May cause dizziness or visual disturbances	Wait until effects subside
Follow prescribed dosage	To prevent adverse effects	Consult doctor if unsure

REVATIO has vasodilatory properties, resulting in mild and transient decreases in blood pressure. Before prescribing REVATIO, carefully consider whether patients with certain underlying conditions could be adversely affected by such sildenafil citrate tables vasodilatory effects (e.g., patients on antihypertensive therapy or with resting hypotension [BP less than 90/50], fluid depletion, severe left ventricular outflow obstruction, or autonomic dysfunction).

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Monitor blood pressure when co-administering blood pressure lowering drugs with REVATIO. Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD). Since there are no clinical data on administration of REVATIO to patients with veno-occlusive disease, administration of REVATIO to such patients is not recommended.

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• It is FDA-approved for the treatment of pulmonary arterial hypertension as well.
• The medication can be affected by some foods, especially high-fat meals.
• Sildenafil may interact with certain medications, such as alpha-blockers.
• Dosage adjustment might be necessary based on individual health conditions.
• It typically takes effect within 30 minutes to 1 hour after intake.
• Avoid alcohol consumption when taking sildenafil to minimize side effects.
• Store the medication at room temperature away from moisture and heat.

Should signs of pulmonary edema occur when REVATIO is administered, consider the possibility of associated PVOD.

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• The medication is available by prescription from healthcare providers.
• Patients with heart conditions should consult a doctor before use.
• Overdose symptoms may include severe dizziness or prolonged erections.
• Sildenafil is not suitable for women or children.
• Use caution in patients with liver or kidney impairment.
• Following prescribed directions ensures safety and effectiveness.

The incidence of epistaxis was 13% in patients taking REVATIO with PAH secondary to CTD. This effect was not seen in idiopathic PAH (REVATIO 3%, placebo 2%) patients. The incidence of epistaxis was also higher in REVATIO-treated patients with a concomitant oral vitamin K antagonist (9% versus 2% in those not treated with concomitant vitamin K antagonist). The safety of REVATIO is unknown in patients with bleeding disorders or active peptic ulceration.

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For some medications, taking more than the recommended amount may lead to side effects or overdose. Call your doctor right away if you believe you’ve taken too sildenafil oral jelly 100 mg much Viagra. Another option is to call America’s Poison Control Centers at 800-222-1222 or use its online tool. If you have severe symptoms, immediately call 911 or your local emergency number, or go to the nearest emergency room. REVATIO- sildenafil citrate tablet, film coated REVATIO- sildenafil citrate injection, solution REVATIO- sildenafil citrate powder, for suspension Pfizer Laboratories Div Pfizer Inc REVATIO is indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening.

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The delay in clinical worsening was demonstrated when REVATIO was added to background epoprostenol therapy [see Clinical Studies (14)]. Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II–III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%). Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity [see Clinical Studies (14)]. The recommended dose of REVATIO is 5 mg or 20 mg three times a day. Administer REVATIO doses 4–6 hours apart.

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In the clinical trial no greater efficacy was achieved with the use of higher doses. Treatment with doses higher than 20 mg three times a day is not recommended. REVATIO injection is for the continued treatment of patients with PAH who are currently prescribed oral REVATIO and who are temporarily unable to take oral medication. The recommended dose is 2.5 mg or 10 mg administered as an intravenous bolus injection three times a day. The dose of REVATIO injection does not need to be adjusted for body weight. When used to treat erectile dysfunction, non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported postmarketing in temporal association with the use of phosphodiesterase type 5 (PDE-5) inhibitors, including sildenafil. Most, but not all, of these patients had underlying anatomic or vascular risk factors for developing NAION, including but not necessarily limited to: low cup to disc ratio ("crowded disc"), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking. Based on published literature, the annual incidence of NAION is 2.5–11.8 cases per 100,000 males aged ≥ 50 per year in the general population.

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An observational case-crossover study evaluated the risk of NAION when PDE-5 inhibitor use, as a class, occurred immediately before NAION onset (within 5 half-lives), compared to PDE-5 inhibitor use in a prior time period. Neither the rare postmarketing reports, nor the association of PDE-5 inhibitor use and NAION in the observational studies, substantiate a causal relationship between PDE-5 inhibitor use and NAION [see Adverse Reactions (6.2].

Route of administration

A 10 mg dose of REVATIO injection is predicted to provide pharmacological effect of sildenafil and its N-desmethyl metabolite equivalent to that of a 20 mg oral dose. Note: Reconstitute the contents of the bottle with a total volume of 90 mL (60 mL followed by 30 mL). Tap the bottle to release the powder. Accurately measure out 60 mL of water and pour the water into the bottle. Replace the cap and shake the bottle vigorously for a minimum of 30 seconds.

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Accurately measure out another 30 mL of water and add this to the bottle. You should always add a total of 90 mL of water irrespective of the dose prescribed. Press the bottle adaptor into the neck of the bottle (as shown on Figure 5, below). The adaptor is provided so that you can fill the oral syringe with medicine from the bottle. Replace the cap on the bottle.Figure 5 Write the expiration date of the reconstituted oral suspension on the bottle label (the expiration date of the reconstituted oral suspension is 60 days from the date of reconstitution).

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White, film-coated, round tablets engraved with "RVT20" containing sildenafil citrate sildenafil citrate 100mg tablets equivalent to 20 mg of sildenafil. White to off-white powders containing 1.57 g of sildenafil citrate (equivalent to 1.12 g of sildenafil) in a bottle intended for reconstitution. Following reconstitution with 90 mL of water, the volume of the oral suspension is 112 mL and the oral suspension contains 10 mg/mL sildenafil. A 2 mL oral syringe (with 0.5 mL and 2 mL dose markings) and a press-in bottle adaptor are also provided. Concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension [see Warnings and Precautions (5.2)]. Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking PDE-5 inhibitors, including REVATIO. Physicians should also discuss the increased risk of NAION with patients who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators, such as PDE-5 inhibitors.

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Typical dosages

Viagra tablets may be taken with or without food. Keep in mind that meals high in fat may cause Viagra to take longer than usual to start working. Do not take more than one dose of Viagra per day. Doing this can increase your risk for serious side effects. It’s important that you do not use more Viagra than your doctor prescribes. There are no controlled clinical data on the safety or efficacy of REVATIO in patients with retinitis pigmentosa, a minority whom have genetic disorders of retinal phosphodiesterases. Prescribe REVATIO with caution in these patients.

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Cases of sudden decrease or loss of hearing, which may be accompanied by tinnitus and dizziness, have been reported in temporal association with the use of PDE-5 inhibitors, including REVATIO.

Side Effect	Frequency	Severity
Headache	Common	Mild to moderate
Flushing	Common	Mild
Nasal Congestion	Occasional	Mild
Dyspepsia (Indigestion)	Occasional	Mild
Dizziness	Less common	Mild to moderate

In some of the cases, medical conditions and other factors were reported that may have played a role. It is not possible to determine whether these reported events are related directly to the use of REVATIO, to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors. Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking PDE-5 inhibitors, including REVATIO. The safety and efficacy of combinations of REVATIO with VIAGRA or other PDE-5 inhibitors have not been studied. Inform patients taking REVATIO not to take VIAGRA or other PDE-5 inhibitors.

Overdose/Missed Dose

PDE-5 inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat. Known hypersensitivity to sildenafil or any component of the tablet, injection, or oral suspension. Hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil. In a long-term trial in pediatric patients with PAH, an increase in mortality with increasing REVATIO dose was observed. Deaths were first observed after about 1 year and causes of death were typical of patients with PAH. If priapism (painful erection greater than 6 hours in duration) is not treated immediately, penile tissue damage and permanent loss of potency could result.