PRIMACOR Solution for injection Ref.[27628] Active ingredients: Milrinone

For intravenous administration.

Adults

Primacor Injection should be given as a loading dose of 50 µg/kg administered over a period of 10 minutes usually followed by a continuous infusion at a dosage titrated between 0.375 µg/kg/min and 0.75 µg/kg/min according to haemodynamic and clinical response, but should not exceed 1.13 mg/kg/day total dose.

The following provides a guide to maintenance infusion delivery rate based upon a solution containing milrinone 200 µg/ml prepared by adding 40 ml diluent per 10 ml ampoule (400 ml diluent per 100 ml Primacor Injection). 0.45% saline, 0.9% saline or 5% glucose may be used as diluents.

Solutions of different concentrations may be used according to patient fluid requirements. The duration of therapy should depend upon the patient’s response. In congestive cardiac failure, patients have been maintained on the infusion for up to 5 days, although the usual period is 48 – 72 hours. In acute states following cardiac surgery, it is unlikely that treatment need be maintained for more than 12 hours.

Renal impairment

Dosage adjustment required. Data obtained from patients with severe renal impairment but without heart failure have demonstrated that the presence of renal impairment significantly increases the terminal elimination half-life of milrinone. For patients with clinical evidence of renal impairment, the loading dose is not affected, but the following maintenance infusion rates are recommended using the infusion solution described above.

The infusion rate should be adjusted according to haemodynamic response.

Elderly

Experience so far suggests that no special dosage recommendations are necessary.

Paediatric population

In published studies selected doses for infants and children were:

Intravenous loading dose: 50–75 µg/kg administered over 30–60 minutes.

Intravenous continuous infusion: To be initiated on the basis of hemodynamic response and the possible onset of undesirable effects between 0.25–0.75 µg/kg/min for a period up to 35 hours.

In clinical studies on low cardiac output syndrome in infants and children under 6 years of age after corrective surgery for congenital heart disease 75 µg/kg loading dose over 60 minutes followed by a 0.75 µg/kg/min infusion for 35 hours significantly reduced the risk of development of low cardiac output syndrome.

Results of pharmacokinetic studies (see section 5.2) have to be taken into consideration.

Renal impairment

Due to lack of data the use of milrinone is not recommended in paediatric population with renal impairment (see section 4.4).

Patent ductus arteriosus

If the use of milrinone is desirable in preterm or term infants at risk of/with patent ductus arteriosus, the therapeutic need must be weighed against potential risks (see sections 4.4, 4.8, 5.2, and 5.3).

Overdose of intravenous Primacor may produce hypotension (because of its vasodilatory effect) and cardiac arrhythmia. If this occurs, Primacor Injection administration should be reduced or temporarily discontinued until the patient’s condition stabilises. No specific antidote is known, but general measures for circulatory support should be taken.

36 months when unopened. A diluted solution of Primacor Injection should be used within 24 hours.

Store below 25°C. Do not freeze.

Type 1 colourless, glass ampoules 10ml or 20ml packed in lots of 10.

Not all pack sizes may be marketed.

Infusion solutions diluted as recommended with 0.45% saline, 0.9% saline or 5% glucose should be freshly prepared before use. Parenteral drug products should be examined visually and should not be used if particulate matter or discolouration are present.