Revatio
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Uses
REVATIO is indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. 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)].
History
There is currently no drug history available for this drug.
Other Information
REVATIO, phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA® for erectile dysfunction.
Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo [4,3-d] pyrimidin-5-yl)-4-ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula:
Sildenafil citrate is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7.
REVATIO (sildenafil) Tablets: REVATIO is formulated as white, film-coated round tablets for oral administration. Each tablet contains sildenafil citrate equivalent to 20 mg of sildenafil. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, lactose monohydrate, and triacetin.
REVATIO (sildenafil) Injection: REVATIO is supplied as a clear, colorless, sterile, ready to use solution in a single-use vial containing 10 mg/12.5 mL of sildenafil. Each mL of solution contains 1.124 mg sildenafil citrate (equivalent to 0.8 mg sildenafil), 50.5 mg dextrose and water for injection.
REVATIO (sildenafil) for Oral Suspension: REVATIO is supplied as white to off-white powders containing 1.57 g of sildenafil citrate (equivalent to1.12 g sildenafil) in an amber glass bottle intended for constitution. . Following constitution with 90 mL water, the volume of the oral suspension is 112 mL and the oral suspension contains 10 mg/mL sildenafil. The inactive ingredients include sorbitol, citric acid anhydrous, sucralose, sodium citrate dihydrate, xanthan gum, titanium dioxide, sodium benzoate, colloidal silicon dioxide anhydrous and grape flavor. In addition to the bottle, a press-in bottle adapter and an oral dosing syringe (with 0.5 mL and 2 mL dose markings) are provided.
Sources
Revatio Manufacturers
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Pfizer Laboratories Div Pfizer Inc
![Revatio (Sildenafil Citrate) Tablet, Film Coated Revatio (Sildenafil Citrate) Injection, Solution Revatio (Sildenafil Citrate) Powder, For Suspension [Pfizer Laboratories Div Pfizer Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Revatio | Pfizer Laboratories Div Pfizer Inc
2.1 REVATIO Tablets and Oral SuspensionThe recommended dose of REVATIO is 5 mg or 20 mg three times a day. Administer REVATIO doses 4–6 hours apart.
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.
2.2 REVATIO InjectionREVATIO 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.
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.
2.3 Reconstitution of the Powder for Oral Suspension Tap the bottle to release the powder. Remove the cap. Accurately measure out 60 mL of water and pour the water into the bottle. (Figure 1)
Figure 1
Replace the cap and shake the bottle vigorously for a minimum of 30 seconds. (Figure 2)
Figure 2
Remove the cap. 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. (Figure 3)
Figure 3
Replace the cap and shake the bottle vigorously for a minimum of 30 seconds. (Figure 4)
Figure 4
Remove the cap. 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 constituted oral suspension on the bottle label (the expiration date of the constituted oral suspension is 60 days from the date of constitution).Incompatibilities
Do not mix with any other medication or additional flavoring agent.
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Cardinal Health
Revatio | Cardinal Health
2.1 Pulmonary Arterial Hypertension (PAH)REVATIO Tablets
The recommended dose of REVATIO is 20 mg three times a day (TID). REVATIO tablets should be taken approximately 4–6 hours apart, with or without food.
In the clinical trial no greater efficacy was achieved with the use of higher doses. Treatment with doses higher than 20 mg TID is not recommended. Dosages lower than 20 mg TID were not tested. Whether dosages lower than 20 mg TID are effective is not known.
REVATIO Injection
REVATIO injection is for the continued treatment of patients with pulmonary arterial hypertension (PAH) who are currently prescribed oral REVATIO and who are temporarily unable to take oral medication.
The recommended dose is 10 mg (corresponding to 12.5 mL) administered as an intravenous bolus injection three times a day. The dose of REVATIO injection does not need to be adjusted for body weight.
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.
![Revatio (Sildenafil Citrate) Tablet, Film Coated [Cardinal Health]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f757f066-8288-4d6c-8c5e-2471007c7966&name=77af9ffd-f15f-4cf5-acad-446765d1f7f4-07.jpg)
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