"The U.S. Food and Drug Administration today approved Opsumit (macitentan), a new drug to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive and debilitating disease that can lead to death or the need for lung transpla"...
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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
Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity [see Clinical Studies].
DOSAGE AND ADMINISTRATION
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.
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.
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 60 days from the date of constitution).
Do not mix with any other medication or additional flavoring agent.
Dosage Forms And Strengths
White, film-coated, round tablets engraved with “RVT20” containing sildenafil citrate equivalent to 20 mg of sildenafil.
Single use vial containing 10 mg/12.5 mL of sildenafil.
REVATIO for Oral Suspension
White to off-white powders containing 1.57 g of sildenafil citrate (equivalent to 1.12 g of sildenafil) in a bottle intended for constitution. Following constitution 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.
Storage And Handling
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 20°C - 25°C (68°F - 77°F) ; excursions permitted to 15°C - 30°C (59°F -86°F) [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 single-use glass vial.
|Vial individually packaged in a carton||10 mg /12.5 mL||0069-0338-01|
Recommended Storage for REVATIO Injection: Store at controlled room temperature 20°C - 25°C (68°F -77°F); excursions permitted to 15°C - 30°C (59°F - 86°F) [see USP Controlled Room Temperature].
REVATIO powder for oral suspension is supplied in amber glass bottles. Each bottle contains white to off-white powders containing 1.57 g of sildenafil citrate (equivalent to1.12 g sildenafil). Following constitution, the volume of the oral suspension is 112 mL (10 mg sildenafil/mL). A 2 mL oral dosing syringe (with 0.5 mL and 2 mL dose markings) 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 30°C (86°F) in the original package in order to protect from moisture.
Constituted Oral Suspension
Store below 30°C (86°F) or in refrigerator at 2°C to 8°C (36° F - 46°F). Do not freeze. The shelf-life of the constituted oral suspension is 60 days. Any remaining oral suspension should be discarded 60 days after constitution.
Distributed by: Pfizer Labs, Division of Pfizer Inc., NY, NY 10017. Issued Jan/2014
Last reviewed on RxList: 2/13/2014
This monograph has been modified to include the generic and brand name in many instances.
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