Recommended Topic Related To:

Revatio

"The U.S. Food and Drug Administration today approved Anoro Ellipta (umeclidinium and vilanterol inhalation powder) for the once-daily, long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease ("...

Revatio

Revatio

INDICATIONS

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

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)

Figure 1

Measure out 60 mL of water - Illustration

4. Replace the cap and shake the bottle vigorously for a minimum of 30 seconds. (Figure 2)

Figure 2

Replace the cap and shake the bottle vigorously - Illustration

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)

Figure 3

Measure out another 30 mL of water - Illustration

7. Replace the cap and shake the bottle vigorously for a minimum of 30 seconds. (Figure 4)

Figure 4

Replace the cap and shake the bottle vigorously - Illustration

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.

Figure 5

Press the bottle adaptor into the neck of the bottle - Illustration

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).

Incompatibilities

Do not mix with any other medication or additional flavoring agent.

HOW SUPPLIED

Dosage Forms And Strengths

REVATIO Tablets

White, film-coated, round tablets engraved with “RVT20” containing sildenafil citrate equivalent to 20 mg of sildenafil.

REVATIO Injection

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:

REVATIO Tablets
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.

REVATIO Injection
Package Configuration Strength NDC
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 to 1.12 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
Package Configuration Strength NDC
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. January 2014

Last reviewed on RxList: 3/21/2014
This monograph has been modified to include the generic and brand name in many instances.

A A A

Revatio - User Reviews

Revatio User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Revatio sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.

advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations