SILDENAFIL CITRATE Neonatal

MEDICATION	DOSAGES & INTERVALS OF ADMINISTRATION	ROUTE & FINAL DILUTION	DILUTION INSTRUCTIONS	STABILITY	RATE OF INFUSION & COMMENTS
SILDENAFIL CITRATE (Neo) (Viagra) Mechanism of action: Phosphodiesterase-5 enzyme inhibitor. 2.5 mg/mL suspension (Prepared by Pharmacy) Ref: 220 - 225 Last update: 2023-08-01	PULMONARY HYPERTENSION, weaning from nitric oxide: Initial: 0.25 to 0.5 mg/kg/dose Q6 to 8H adjusted according to response. Suggested maximum dose: 1 mg/kg/dose Q6H When discontinuing drug therapy wean dose gradually. TEST DOSE DURING CARDIAC CATHETERISATION 0.25 to 0.5 mg/kg	PO	Supplied by Pharmacy	30 days	COMMENTS: The FDA recommends that sildenafil not be prescribed to patients aged 1 - 17 years old for pulmonary arterial hypertension due to one RCT demonstrating an increased risk of mortality in patients using high doses of sildenafil compared to lower doses, and no benefit with any dose in exercise ability. In certain patients, the benefits of chronic sildenafil use may outweigh the risks. Health Canada and the FDA do not offer any recommendations for use of sildenafil in neonates or patients < 1 year old. Pharmacokinetic Data: no data available for neonates and infants. Dose in neonates and older infants derived from adult dose on mg/kg weight basis (60 to 70 kg adult) using usual adult doses of 25 to 50 mg. In adults peak concentration occurs in approximately 60 minutes. Only 40% of dose reaches systemic circulation due to extensive first-pass metabolism in intestinal wall and liver. Hepatic or Renal Dysfunction: clearance is impaired in moderate to severe hepatic or renal dysfunction. Use one-half initial starting dose and monitor. Adverse Effects: dyspepsia, flushing, nasal congestion, rash. Drug Interactions: Increase plasma concentrations of Sildenafil: Erythromycin, clarithromycin, ketoconazole, fluconazole, itraconazole, cimetidine. Use one-half starting dose of sildenafil if patient receiving one of above drugs and monitor. Decrease plasma concentrations of Sildenafil: Rifampin Contraindications: do not use in patients receiving other antihypertensive agents - nitrates or nitrites (nitroglycerin, nitroprusside), alpha blockers, and calcium channel blockers. Severe systemic hypotension can occur. Standard Prescription: sildenafil__mg PO Q__H (__mg/kg/dose)

MEDICATION

DOSAGES & INTERVALS OF ADMINISTRATION

ROUTE & FINAL DILUTION

DILUTION INSTRUCTIONS

STABILITY

RATE OF INFUSION & COMMENTS

SILDENAFIL CITRATE (Neo)
(Viagra)

Mechanism of action:

Phosphodiesterase-5 enzyme inhibitor.

2.5 mg/mL suspension (Prepared by Pharmacy)

Ref: 220 - 225

Last update: 2023-08-01

PULMONARY HYPERTENSION, weaning from nitric oxide:
Initial: 0.25 to 0.5 mg/kg/dose Q6 to 8H adjusted according to response.
Suggested maximum dose: 1 mg/kg/dose Q6H

When discontinuing drug therapy wean dose gradually.

TEST DOSE DURING CARDIAC CATHETERISATION
0.25 to 0.5 mg/kg

Supplied by Pharmacy

30 days

COMMENTS:

The FDA recommends that sildenafil not be prescribed to patients aged 1 - 17 years old for pulmonary arterial hypertension due to one RCT demonstrating an increased risk of mortality in patients using high doses of sildenafil compared to lower doses, and no benefit with any dose in exercise ability. In certain patients, the benefits of chronic sildenafil use may outweigh the risks.

Health Canada and the FDA do not offer any recommendations for use of sildenafil in neonates or patients < 1 year old.

Pharmacokinetic Data: no data available for neonates and infants. Dose in neonates and older infants derived from adult dose on mg/kg weight basis (60 to 70 kg adult) using usual adult doses of 25 to 50 mg. In adults peak concentration occurs in approximately 60 minutes. Only 40% of dose reaches systemic circulation due to extensive first-pass metabolism in intestinal wall and liver.

Hepatic or Renal Dysfunction: clearance is impaired in moderate to severe hepatic or renal dysfunction. Use one-half initial starting dose and monitor.

Adverse Effects: dyspepsia, flushing, nasal congestion, rash.

Drug Interactions:
Increase plasma concentrations of Sildenafil:
Erythromycin, clarithromycin, ketoconazole, fluconazole, itraconazole, cimetidine.
Use one-half starting dose of sildenafil if patient receiving one of above drugs and monitor.

Decrease plasma concentrations of Sildenafil:
Rifampin

Contraindications: do not use in patients receiving other antihypertensive agents - nitrates or nitrites (nitroglycerin, nitroprusside), alpha blockers, and calcium channel blockers. Severe systemic hypotension can occur.

Standard Prescription:

sildenafil__mg PO Q__H (__mg/kg/dose)