Active Ingredient: Sildenafil
Sildenafil is indicated for treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
10 - 30 mg
From 3.333 To 10 mg 3 time(s) per day every day for 30 day(s)
30 mg
The recommended dose is 10mg (corresponding to 12.5ml) three times a day administered as an intravenous bolus injection.
A 10mg dose of sildenafil solution for injection is predicted to provide exposure of sildenafil and its N-desmethyl metabolite and pharmacological effects comparable to those of a 20mg oral dose.
In general, any dose adjustment should be administered only after a careful benefit-risk assessment. A downward dose adjustment to 10mg twice daily should be considered when sildenafil is co-administered to patients already receiving CYP3A4 inhibitors like erythromycin or saquinavir. A downward dose adjustment to 10mg once daily is recommended in case of co-administration with more potent CYP3A4 inhibitors like clarithromycin, telithromycin and nefazodone. For the use of sildenafil with the most potent CYP3A4 inhibitors. Dose adjustments for sildenafil may be required when co-administered with CYP3A4 inducers.
Dose adjustments are not required in elderly patients. Clinical efficacy as measured by 6-minute walk distance could be less in elderly patients.
For intravenous use as a bolus injection.
Oral
60 - 60 mg
From 20 To 20 mg 3 time(s) per day every day
60 mg
60 mg
The recommended dose is 20mg three times a day (TID). Physicians should advise patients who forget to take Revatio to take a dose as soon as possible and then continue with the normal dose. Patients should not take a double dose to compensate for the missed dose.
In general, any dose adjustment should be administered only after a careful benefit-risk assessment. A downward dose adjustment to 20mg twice daily should be considered when sildenafil is co-administered to patients already receiving CYP3A4 inhibitors like erythromycin or saquinavir. A downward dose adjustment to 20mg once daily is recommended in case of co-administration with more potent CYP3A4 inhibitors clarithromycin, telithromycin and nefazodone. For the use of sildenafil with the most potent CYP3A4 inhibitors. Dose adjustments for sildenafil may be required when co-administered with CYP3A4 inducers.
It should be taken with or without food.
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