REVATIO Solution for injection Ref.[7442] Active ingredients: Sildenafil

Treatment should only be initiated and monitored by a physician experienced in the treatment of pulmonary arterial hypertension. In case of clinical deterioration in spite of Revatio treatment, alternative therapies should be considered. Revatio solution for injection should be administered to patients already prescribed oral Revatio as a replacement for oral administration under conditions where they are temporarily unable to take oral Revatio therapy.

Safety and effectiveness of doses higher than 12.5ml (10mg) TID have not been established.

Posology

Adults

The recommended dose is 10mg (corresponding to 12.5ml) three times a day administered as an intravenous bolus injection (see section 6.6).

A 10mg dose of Revatio 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.

Patients using other medicinal products

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, see section 4.3. Dose adjustments for sildenafil may be required when co-administered with CYP3A4 inducers (see section 4.5).

Special populations

Elderly (≥65 years)

Dose adjustments are not required in elderly patients. Clinical efficacy as measured by 6-minute walk distance could be less in elderly patients.

Renal impairment

Initial dose adjustments are not required in patients with renal impairment, including severe renal impairment (creatinine clearance <30ml/min). A downward dose adjustment to 10mg twice daily should be considered after a careful benefit-risk assessment only if therapy is not well-tolerated.

Hepatic impairment

Initial dose adjustments are not required in patients with hepatic impairment (Child-Pugh class A and B). A downward dose adjustment to 10mg twice daily should be considered after a careful benefit-risk assessment only if therapy is not well-tolerated.

Revatio is contraindicated in patients with severe hepatic impairment (Child-Pugh class C) (see section 4.3).

Paediatric population

Revatio solution for injection is not recommended for use in children below 18 years due to insufficient data on safety and efficacy.

Discontinuation of treatment

Limited data suggest that the abrupt discontinuation of oral Revatio is not associated with rebound worsening of pulmonary arterial hypertension. However to avoid the possible occurrence of sudden clinical deterioration during withdrawal, a gradual dose reduction should be considered. Intensified monitoring is recommended during the discontinuation period.

Method of administration

Revatio solution for injection is for intravenous use as a bolus injection.

See section 6.6 for instructions of use.

In single dose volunteer studies of oral doses up to 800mg, adverse reactions were similar to those seen at lower doses, but the incidence rates and severities were increased. At single oral doses of 200mg the incidence of adverse reactions (headache, flushing, dizziness, dyspepsia, nasal congestion, and altered vision) was increased.

In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and not eliminated in the urine.

3 years.

This medicinal product does not require any special storage conditions.

Each pack contains one 20ml clear, type I glass vial with a chlorobutyl rubber stopper and an aluminium overseal.

This medicinal product does not require dilution or reconstitution before use.

One 20ml vial contains 10 mg of sildenafil (as citrate). The recommended dose of 10mg requires a volume of 12.5ml, to be administered as an intravenous bolus injection.

Chemical and physical compatibility has been demonstrated with the following diluents:

5% glucose solution
sodium chloride 9mg/ml (0.9%) solution
Lactated Ringer’s solution
5% glucose/0.45% sodium chloride solution
5% glucose/lactated Ringer’s solution
5% glucose/20 mEq potassium chloride solution

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.