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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].
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
The efficacy of REVATIO in the treatment of pulmonary arterial hypertension (PAH) has not been adequately evaluated in patients taking bosentan.
DOSAGE AND ADMINISTRATION
REVATIO Tablets and Oral Suspension
The recommended dose of REVATIO is 20 mg three times a day (TID). 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 TID 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 10 mg (12.5 mL) administered as an intravenous bolus injection three times a day (TID). 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.
Reconstitution of the Powder for Oral Suspension
1. Tap the bottle to release the powder.
2. Remove the cap.
3. Accurately measure out 60 mL of water and pour the water into the bottle. (Figure 1)
4. Replace the cap and shake the bottle vigorously for a minimum of 30 seconds. (Figure 2)
5. Remove the cap.
6. 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)
7. Replace the cap and shake the bottle vigorously for a minimum of 30 seconds. (Figure 4)
8. Remove the cap.
9. 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.
10. Write the expiration date of the constituted oral suspension on the bottle label (the expiration date of the constituted oral suspension is 30 days from the date of constitution).
Do not mix with any other medication or additional flavoring agent.
Dosage Forms and Strengths
REVATIO tablets are supplied as white, film-coated, round tablets engraved with "RVT20" containing sildenafil citrate equivalent to 20 mg of sildenafil.
REVATIO injection is supplied as a single use vial containing 10 mg (12.5 mL) of sildenafil.
REVATIO for Oral Suspension
REVATIO for oral suspension is supplied in 125 mL bottles containing 32.27 g of a white to off-white powder. Following constitution with water, the volume of the oral suspension is 112 mL and each bottle contains 1.57 g of sildenafil citrate (1.12 g sildenafil). A 2 mL oral syringe and a press-in bottle adaptor are also provided.
REVATIO tablets are supplied as white, film-coated, round tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows:
|Package Configuration||Strength||NDC||Engraving on Tablet|
|Bottle of 90 Tablets||20 mg||0069-4190-68||RVT20|
Recommended Storage for REVATIO Tablets: Store at controlled room temperature 68°F - 77°F (20°C -25°C); excursions permitted to 59°F -86°F(15°C -30°C) [see USP Controlled Room Temperature].
REVATIO injection is supplied as a clear, colorless, sterile, ready to use solution containing 10 mg sildenafil (12.5 mL) presented in a glass vial.
|Vial individually packaged in a carton||10mg(12.5mL)||0069-0338-01|
Recommended Storage for REVATIO Injection: Store at controlled room temperature 68°F - 77°F (20°C - 25°C); excursions permitted to 59°F -86°F (15°C -30°C) [see USP Controlled Room Temperature].
REVATIO powder for oral suspension is supplied in 125 mL amber glass bottles. Each bottle contains 32.27 g of powder for oral suspension. Following constitution, the volume of the oral suspension is 112 mL (10 mg sildenafil/mL). A 2 mL oral dosing syringe and a press-in bottle adaptor are also provided.
|REVATIO Powder for Oral Suspension|
|Powder for oral suspension - bottle||10 mg/mL (when reconstituted)||0069-0336-21|
Recommended storage for REVATIO for oral suspension: Store below 86°F (30°C) in the original package in order to protect from moisture. The shelf-life of the powder for oral suspension is 24 months.
Constituted Oral Suspension
Store below 86°F (30°C) or in refrigerator at 36° F - 46°F (2°C to 8°C). Do not freeze. The shelf-life of the constituted oral suspension is 30 days. Any remaining oral suspension should be discarded 30 days after constitution.
Distributed by: Pfizer Labs, Division of Pfizer Inc, NY, NY 10017. Revised: August 2012
Last reviewed on RxList: 9/17/2012
This monograph has been modified to include the generic and brand name in many instances.
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