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REVATIO® Dosage and Administration (sildenafil)

2 DOSAGE AND ADMINISTRATION

2.1 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.

2.2 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.

2.3 Reconstitution of the Powder for Oral Suspension

Note: Reconstitute the contents of the bottle with a total volume of 90 mL (60 mL followed by 30 mL). Refer to the detailed instructions below.

  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

    Figure 1

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

    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)
    Figure 3

    Figure 3

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

    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.
    Figure 5

    Figure 5

  10. Write the expiration date of the reconstituted oral suspension on the bottle label (the expiration date of the reconstituted oral suspension is 60 days from the date of reconstitution).

Incompatibilities

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

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