Medicinal Products

ALPROSTADIL PANPHARMA 0.5 mg / 1 mL

Prostine VR Generic Drug
Therapeutic class: Cardiology and angiology
Active ingredients: Alprostadil
laboratory: Panmedica

Injectable solution
Box of 1 ampoule of 1 mL
All forms

Indication

Temporary maintenance of arterial duct patency until curative or palliative intervention in children with ductal-dependent congenital heart disease, including:

Right obstacles:

· Stenosis or pulmonary atresia,

· Tricuspid atresia,

· Tetralogy of Fallot,

· Transposition of the big ships.

Left obstacles:

· Coarctation of the aorta,

· Interruption of the aortic arch,

· Transposition of large vessels with intact interventricular septum.

Dosage ALPROSTADIL PANPHARMA 0.5 mg / 1 mL Solution for injection 1 ampoule of 1 ml

Important: Never administer the product directly by intravenous injection and always dilute beforehand.

The recommended route of administration for Alprostadil Panpharma is IV infusion in a large vein. Another possibility is that of a catheter whose tip is placed next to the entrance of the arterial canal, via the umbilical artery.

· The starting dose is 0.1 μg alprostadil per kilogram body weight per minute (0.1 μg per kg per min). When a response is obtained (PaO2 increase in right obstacles, systemic blood pressure and blood pH in left-hand obstructions), reduce the infusion rate to administer the minimal dosage required to maintain a response. therapeutic. Thus the infusion rate can be reduced from 0.1 to 0.05, then 0.025 and 0.01 μg per kg per min. If the response at a dosage of 0.01 μg / kg / min is insufficient, the flow may be increased to 0.4 μg / kg / min, although, in general, higher infusion rates do not produce no more marked effects.

· The infusion will be continued until the surgical procedure can be performed, which is usually only a matter of hours.

· Alprostadil is recommended in children under 10 days of age. Exceptions may be considered if the use of such a treatment seems justified in the eyes of the user physician.

• There is no evidence to date that the development of inoperable lesions, such as left ventricular hypoplasia, may be aggravated by the use of alprostadil.

Dilute 1 ml Alprostadil Panpharma solution for injection (500 μg alprostadil) in a sterile isotonic solution of sodium chloride or glucose (see Storage conditions).

The dilution and infusion rate to bring 0.1 μg / kg / min are according to the table below:

Volume (ml) to dilute 500 μg

alprostadil

Approximate concentration obtained (μg / ml)

Infusion rate (ml / kg / min)

250

2

0.05

100

5

0.02

50

10

0.01

25

20

0.005

Example : to bring 0.1 μg / kg / min to a child weighing 2.5 kg, using a solution of 1 ml of Alprostadil Panpharma diluted in 100 ml of isotonic serum:

Infusion rate:

0.02 ml / kg / min × 2.5 kg = 0.05 ml / min or 3.0 ml / h of solution containing 5 μg / ml of alprostadil.

Reduce the dosage from 0.1 μg / kg / min to 0.05 μg / kg / min by reducing pump flow when the desired effect on the arterial duct is achieved.

Do not use the preparation obtained after 24 hours.

Dosing table providing 0.1 μg / kg / min of Alprostadil Panpharma

newborn weight

(in kg)

Alprostadil Panpharma by

minute (μg / min)

Alprostadil Panpharma

per hour (μg / h)

Alprostadil Panpharma

soil 5 μg / ml perf flow rate (ml / h)

0.5

0.05

3

0.6

1

0.10

6

1.2

1.5

0.15

9

1.8

2

0.20

12

2.4

2.5

0.25

15

3

3

0.30

18

3.6

3.5

0.35

21

4.2

4

0.40

24

4.8

4.5

0.45

27

5.4

5

0.50

30

6

5.5

0.55

33

6.6

Table of dosage providing 0.05 μg / kg / min of Alprostadil Panpharma:

newborn's weight

(in kg)

Alprostadil Panpharma by

minute (μg / min)

Alprostadil Panpharma

per hour (μg / h)

Alprostadil Panpharma

soil 5 μg / ml perf flow rate (ml / h)

0.5

0, 025

1.5

0.3

1

0, 050

3

0.6

1.5

0, 075

4.5

0.9

2

0, 100

6

1.2

2.5

0, 125

7.5

1.5

3

0, 150

9

1.8

3.5

0, 175

10.5

2.1

4

0, 200

12

2.4

4.5

0, 225

13.5

2.7

5

0, 250

15

3

5.5

0, 275

16.5

3.3

The effectiveness of alprostadil will be appreciated as follows:

For the straight obstacles:

· An increase in PaO 2,

· Observation of the opening of the arterial duct during surgery or, possibly, angiocardiography.

For the left obstacles:

A decrease in the pressure gradient between the pulmonary artery and the aorta,

· An increase in femoral pulse,

· A decrease in acidosis,

· An increase in diuresis,

· An improvement in congestive heart failure,

· Confirmation of dilation of the arterial duct by angiocardiography and / or surgery.

Side effects Alprostadil Panpharma

Out of a total of 436 observations, the most common adverse events or concomitant events with alprostadil infusion were:

· Cardiovascular system: flush (10%), bradycardia (6.7%), hypotension (3.9%), tachycardia (2.8%), cardiac arrest (1.1%) and edema (1.1%) ;

Central nervous system: fever (13.8%) and stroke (4.1%);

· Respiratory system: apnea (11.5%) most commonly observed in cyanotic infants, particularly those with a birth weight of less than 2 kg, and usually appearing during the first hour of infusion. Thus, alprostadil should only be used in the presence of respiratory resuscitation;

· Digestive system: diarrhea (1.6%);

· Hematology: disseminated intravascular coagulation (1.1%);

· Metabolism: hypokalemia (1.1%).

If flush, fever (and therefore tachycardia), apnea are likely related to alprostadil (disappearance by changing the position of the catheter), other complications may be considered as consequences of heart disease

Popular Posts

Category Medicinal Products, Next Article