Usual Adult Dose for Erectile Dysfunction

Use as needed for ED:

• Initial dose: 10 mg orally once a day, as needed, prior to sexual activity
• Maintenance dose: 5 to 20 mg orally once a day, as needed, prior to sexual activity based on individual efficacy and tolerability

Comment: Consider that this drug has shown to improve erectile dysfunction up to 36 hours following dosing, when used as needed.

Once a day use for ED:

• Initial dose: 2.5 mg orally once a day at approximately the same time, without regard to timing of sexual activity
• Maintenance dose: 2.5 to 5 mg orally once a day based on individual efficacy and tolerability.

Once daily use for ED and Benign Prostatic Hyperplasia (BPH):

• 5 mg orally once a day at approximately the same time, without regard to timing of sexual activity

Use: Treatment of erectile dysfunction (ED)

Usual Adult Dose for Pulmonary Hypertension

Adcirca (R):

• 40 mg orally once a day

Comment: Dividing the 40 mg dose over the course of the day is not recommended.

Usual Adult Dose for Benign Prostatic Hyperplasia

Once daily use for BPH:

• 5 mg orally once a day at approximately the same time

Concomitant administration with finasteride:

• 5 mg orally once a day at approximately the same time, for up to 26 weeks

Comments: The incremental benefit of this drug decreases from 4 weeks until 26 weeks. The incremental benefit of this drug beyond 26 weeks is unknown.

Once daily use for ED and BPH:

• 5 mg orally once a day at approximately the same time, without regard to timing of sexual activity

Use: Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH)

Renal Dose Adjustments

Use as needed for ED:

• CrCl 30 to 50 mL/min: 5 mg orally once a day. The maximum dose is 10 mg not more than once in every 48 hours.
• CrCl less than 30 mL/min or on hemodialysis: The maximum dose is 5 mg orally once every 72 hours.

Once a day use for ED:

• CrCl 30 mL/min or greater: Data not available
• CrCl less than 30 mL/min or on hemodialysis: Not recommended.

Once a day use for BPH:

• CrCl 30 to 50 mL/min: 2.5 orally once a day. An increase to 5 mg may be considered based on individual response.
• CrCl less than 30 mL/min or on hemodialysis: Not recommended.

Pulmonary Arterial Hypertension:
Adcirca (R):

• CrCl 31 to 80 mL/min: 20 mg orally once a day. Increase to 40 mg orally once a day based on individual tolerability.
• CrCl less than 30 mL/min and on hemodialysis: Use should be avoided.

Liver Dose Adjustments

Use as needed for ED:

• Mild to moderate hepatic dysfunction (Child-Pugh Class A and B): 10 mg orally once a day
• Severe hepatic dysfunction (Child-Pugh Class C): Not recommended.

Once a day use for ED:

• Mild to moderate hepatic dysfunction (Child-Pugh Class A and B): Use with caution.
• Severe hepatic dysfunction (Child-Pugh Class C): Not recommended

Pulmonary Arterial Hypertension:
Adcirca (R):

• Mild to moderate hepatic dysfunction (Child-Pugh Class A and B): 20 mg orally once a day
• Severe hepatic dysfunction (Child-Pugh Class C): Use should be avoided.

Dose Adjustments

Concomitant administration with alpha blockers:

• Erectile Dysfunction: 2.5 mg orally once a day
• Comment: Patients should be stable on alpha blocker therapy prior to initiating treatment with this drug.

Concomitant administration with CYP450 3A4 inhibitors (ketoconazole, ritonavir):

• Use as needed for ED: No more than 10 mg orally every 72 hours
• Once a day dose for ED: No more than 2.5 mg orally once a day

Pulmonary Arterial Hypertension:
Adcirca (R):

• No dose adjustment is required in patients 65 years or older without renal impairment or hepatic impairment.

Coadministration of Adcirca (R) in patients on ritonavir:

• 20 mg orally once a day.
• Increase to 40 mg once a day based upon individual tolerability.

Coadministration of ritonavir in patients on Adcirca (R):

• Avoid use of Adcirca (R) during the initiation of ritonavir.
• Stop Adcirca 24 hours prior to starting ritonavir.
• Resume Adcirca (R) at 20 mg orally once a day, after at least 1 week following the initiation of ritonavir.
• Increase to 40 mg orally once a day based upon individual tolerability.

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• This drug may be taken with or without food.
• The tablets should not be split.
• In patients with anginal chest pain requiring nitroglycerin within 48 hours following intake of this drug, nitrates should be only be administered under close medical supervision with appropriate hemodynamic monitoring.

General:

• This drug is indicated for treatment of erectile dysfunction, for signs and symptoms of benign prostate hyperplasia in male adult patients, and is also marketed as Adcirca (R) for the treatments of pulmonary arterial hypertension (PAH).

Monitoring:

• Cardiovascular: Blood pressure

Patient advice:

• Patients who experience cardiovascular symptoms upon initiation of sexual activity should refrain from further sexual activity and seek immediate medical attention.
• Patients taking this drug for erectile dysfunction should not take Adcirca (R) or other PDE5 inhibitors.
• Patients should seek emergency treatment if an erection, whether painful or not, lasts more than 4 hours.
• Patients should seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking this drug.
• Patients should seek immediately medical attention in the event of sudden decrease or loss of hearing while taking this drug.

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