Revatio

What is Revatio?

• Revatio (sildenafil citrate) is a phosphodiesterase-5 (PDE-5) inhibitor used to treat pulmonary arterial hypertension

(PAH).

What are the uses of this medicine?

• Revatio (sildenafil citrate) is a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH).
• With PAH, the blood pressure in your lungs is too high.
• Your heart has to work hard to pump blood into your lungs.
• REVATIO improves the ability to exercise and can slow down worsening changes in your physical condition.

Limitations of use:

• REVATIO is not for use in children
• Adding REVATIO to another medication used to treat PAH, bosentan (Tracleer), does not result in improvement in your ability to exercise.
• REVATIO contains the same medicine as VIAGRA (sildenafil), which is used to treat erectile dysfunction (impotence).
• Do not take REVATIO with VIAGRA or other PDE-5 inhibitors.

How does this medicine work?

• Sildenafil is an inhibitor of cGMP specific phosphodiesterase type-5 (PDE-5) in the smooth muscle of the pulmonary vasculature, where PDE-5 is responsible for degradation of cGMP.
• Sildenafil, therefore, increases cGMP within pulmonary vascular smooth muscle cells resulting in relaxation.
• In patients with PAH, this can lead to vasodilation of the pulmonary vascular bed and, to a lesser degree, vasodilatation in the systemic circulation.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• take nitrate medicines
• take guanylate cyclase stimulator medicines
• are allergic to sildenafil or any other ingredient in REVATIO

What drug interactions can this medicine cause?

• REVATIO and certain other medicines can cause side effects if you take them together. The doses of some of your medicines may need to be adjusted while you take REVATIO.

Especially tell your doctor if you take

• Nitrate medicines
• Riociguat (Adempas)
• Ritonavir (Norvir) or other medicines used to treat HIV infection
• Ketoconazole (Nizoral)
• Itraconazole (Sporanox)
• High blood pressure medicine

Is this medicine FDA approved?

• It was approved for medical use in the United States and in the European Union in 1998.

How should this medicine be used?

Recommended dosage: REVATIO Tablets and Oral Suspension:

• The recommended dose of REVATIO is 5 mg or 20 mg three times a day.
• Administer REVATIO doses 4–6 hours apart.
• Treatment with doses higher than 20 mg three times a day is not recommended.

REVATIO Injection:

• 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.

Administration:

• Take REVATIO exactly as your doctor tells you.
• REVATIO may be prescribed to you as
• REVATIO tablets or REVATIO oral suspension
• Take REVATIO tablet or oral suspension 3 times a day about 4 to 6 hours apart
• Take REVATIO tablets or oral suspension at the same times every day.
• REVATIO oral suspension will be mixed for you by your pharmacist. Do not mix REVATIO oral suspension with other medicine or flavoring. Shake well for at least 10 seconds before each dose.
• If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose, and take your next dose at the regular time.
• Do not take more than one dose of REVATIO at a time.
• Do not change your dose or stop taking REVATIO on your own. Talk to your doctor first.
• If you take too much REVATIO, call your doctor or go to the nearest hospital emergency room.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 20 mg
• Injection: 10 mg /12.5 mL in a single use vial
• For Oral Suspension: 10 mg/mL (when reconstituted)

This medicine is available in fallowing brand namesː

• REVATIO

What side effects can this medication cause?

The most common side effects of this medicine include:

• Nosebleed, headache, upset stomach, getting red or hot in the face (flushing), trouble sleeping, as well as fever, erection increased, respiratory infection, nausea, vomiting, bronchitis, pharyngitis, runny nose, and pneumonia in children.

Possible side effects of REVATIO include:

• low blood pressure
• more shortness of breath than usual
• decreased eyesight or loss of sight in one or both eyes (NAION)
• sudden decrease or loss of hearing
• heart attack, stroke, irregular heartbeats, and death
• erections that last several hours

What special precautions should I follow?

• Increased mortality with increasing doses in pediatric patients. Not recommended for use in pediatric patients.
• REVATIO has vasodilatory properties, resulting in mild and transient decreases in blood pressure. Vasodilation effects may be more common in patients with hypotension or on antihypertensive therapy. 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.
• 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. Seek medical attention if sudden decrease or loss of vision or hearing occurs.
• pulmonary hypertension (PH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported by patients who received REVATIO.
• Priapism may occur.In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism (painful erection greater than 6 hours in duration) is not treated immediately, penile tissue damage and permanent loss of potency could result.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Adverse events were similar to those seen at lower doses but rates and severities were increased.

Management of overdosage:

• In cases of overdose, standard supportive measures should be adopted as required.
• Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and it is not eliminated in the urine.

Can this medicine be used in pregnancy?

• It is not known if REVATIO could harm your unborn baby.
• There are risks to the mother and fetus from untreated pulmonary arterial hypertension.

Can this medicine be used in children?

• REVATIO is not for use in children.

What are the active and inactive ingredients in this medicine?

REVATIO tablets

• Active ingredients: sildenafil citrate
• Inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, lactose monohydrate, and triacetin

REVATIO for oral suspension

• Active ingredients: sildenafil citrate
• Inactive ingredients: sorbitol, citric acid anhydrous, sucralose, sodium citrate dihydrate, xanthan gum, titanium dioxide , sodium benzoate, colloidal silicon dioxide anhydrous, and grape flavor

Who manufactures and distributes this medicine?

• Packager: Pfizer Laboratories Div Pfizer Inc

What should I know about storage and disposal of this medication?

• Store REVATIO reconstituted oral suspension below 30°C (86°F) or in a refrigerator between 2°C to 8°C (36°F to 46°F).
• Do not freeze REVATIO oral suspension
• Throw away (discard) REVATIO oral suspension after 60 days.
• Keep REVATIO and all medicines away from children.

• Dailymed label info on Revatio
• FDA Revatio

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