Pharmacy No. 84. Delivery of medicines to your home and office.

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Vazaprostan®

Use IV and IV with caution in acute and subacute myocardial infarction, in myocardial infarction suffered within the last 6 months, in severe or unstable angina, decompensated chronic heart failure, in arterial hypotension, cardiovascular failure, in pulmonary edema, severe arrhythmias, broncho-obstructive syndrome (severe with signs of respiratory failure), with infiltrative changes in the lungs, liver failure (including a history), with an increased risk of bleeding (including gastric ulcer or duodenum, severe damage to cerebral vessels, proliferative retinopathy with a tendency to bleeding, extensive trauma), hemodialysis, type 1 diabetes, especially with extensive vascular damage (in elderly patients); against the background of the use of vasodilators or anticoagulants; in newborns (risk of developing bradypnea, arterial hypotension, tachycardia or hyperthermia).

Use intracavernosally with caution in case of thrombocytopenia, polycythemia, thrombophlebitis, venous thrombosis (including in case of predisposition), increased blood viscosity, balanitis, urethritis.

Should not be used in patients with a tendency to drug addiction and/or mental or intellectual disorders.

In case of disorders of the blood coagulation system or during simultaneous treatment with drugs that affect the coagulation system, blood coagulation parameters should be regularly monitored during treatment with alprostadil. With systemic administration, monitoring of central hemodynamic parameters and biochemical blood parameters is necessary.

With long-term continuous administration, apnea may develop, a negative effect on the structure of the wall of the ductus arteriosus with an increased risk of rupture, and thinning of the muscular layer of the pulmonary artery. With a treatment duration of more than 4 weeks, reversible cortical proliferation of tubular bones is possible.

In newborns, it should be used under constant blood pressure monitoring, with mandatory conditions for mechanical ventilation.

There is currently no experience with intracavernosal administration to patients under 18 years of age and over 75 years of age.

Alprostadil is not intended for simultaneous use with other drugs for the treatment of erectile dysfunction.

The compliance of the dosage form of alprostadil used with the specific indications for its use should be strictly observed.

Instructions for use VASAPROSTAN

The solution must be prepared immediately before the infusion. The lyophilisate dissolves immediately after adding saline. At first, the solution may turn out milky-cloudy. This effect is created by air bubbles and is not significant. After a short time the solution becomes transparent.

It is not allowed to use a solution prepared more than 12 hours ago.

Intra-arterial administration

To obtain a solution for intravenous administration, the contents of one ampoule of lyophilisate (corresponding to 20 mcg of alprostadil) should be dissolved in 50 ml of physiological solution. In the absence of other prescriptions, half an ampoule of Vazaprostan (corresponding to 10 mcg of alprostadil) should be administered intravenously over 60-120 minutes using an infusion device. If necessary, especially in the presence of necrosis, under strict tolerance control, the dose can be increased to 1 ampoule (20 mcg alprostadil). This dose is usually used as a single daily infusion.

If intravenous administration of the drug is carried out through an installed catheter, depending on tolerability and severity of the disease, a dose of 0.1-0.6 ng/kg body weight/min is recommended with administration of the drug over 12 hours using an infusion device (corresponding to 1/4- 11/2 ampoules of Vazaprostan).

Intravenous administration

To obtain a solution for intravenous administration, the contents of two ampoules of lyophilisate (corresponding to 40 mcg of alprostadil) should be dissolved in 50-250 ml of physiological solution and the resulting solution should be administered intravenously over 2 hours. This dose is applied 2 times a day.

Or the contents of 3 ampoules (corresponding to 60 mcg of alprostadil) are dissolved in 50-250 ml of physiological solution and administered intravenously for 3 hours 1 time per day.

The average duration of treatment is 14 days; if the effect is positive, treatment with the drug can be continued for another 7-14 days. If there is no positive effect within 2 weeks from the start of treatment, further use of the drug should be discontinued.

In patients with renal failure (serum creatinine more than 1.5 mg/dL)

IV administration of Vazaprostan should be started with 20 mcg for 2 hours. If necessary, after 2-3 days the single dose can be increased to 40-60 mcg.

For patients with renal and heart failure

the maximum volume of administered fluid is 50-100 ml/day. The duration of treatment is 4 weeks.

VAZAPROSTAN

Side effects

Possible side effects are listed below by body system and frequency of occurrence: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (> 1/10000, <1/1000), very rare (<1/10000), unknown (cannot be estimated from available data).
When using the drug Vazaprostan®, the following undesirable effects are observed:

Disorders of the hematopoietic and lymphatic system:

Rarely:

thrombocytopenia, leukopenia, leukocytosis;

Very rarely:

bleeding, anemia.

Nervous system disorders:

Often:

headache;

Rarely:

confusion, central convulsions;

Very rarely:

drowsiness, dizziness;

Unknown:

cerebrovascular accident.

Cardiac disorders:

Infrequently:

decreased systolic blood pressure, tachycardia, angina pectoris;

Rarely:

arrhythmia, biventricular heart failure, pulmonary edema;

Very rarely:

acute heart failure, ventricular fibrillation, second degree atrioventricular block, supraventricular arrhythmia;

Unknown:

myocardial infarction.

Vascular disorders:

Very rarely:

shock.

Disorders of the respiratory system, chest and mediastinal organs:

Rarely:

pulmonary edema;

Very rarely:

bradypnea, decreased respiratory function, tachypnea, hypercapnia;

Unknown:

dyspnea.

Vazaprostan lyophilisate for the preparation of solution for inf 60 µg N 10

Active substance: alprostadil (alprostadil)

Lyophilisate for preparing a solution for infusion in the form of a white hygroscopic mass.

1 amp.
alprostadil (clathrate complex with alfadex)	60 mcg

Excipients: alphadex (α-cyclodextrin), anhydrous lactose.

Glass ampoules (10) - cardboard packs.

pharmachologic effect

Prostaglandin E1 (PG E1) preparation. Improves microcirculation and peripheral circulation, has a vasoprotective effect.

When administered systemically, it causes relaxation of smooth muscle fibers, has a vasodilating effect, and reduces peripheral vascular resistance without changing blood pressure. In this case, there is a reflex increase in cardiac output and heart rate.

Helps increase the elasticity of red blood cells, reduces platelet aggregation and neutrophil activity, increases the fibrinolytic activity of the blood.

Has a stimulating effect on the smooth muscles of the intestines, bladder, and uterus; suppresses the secretion of gastric juice.

Indications of the drug Vazaprostan®

chronic obliterating diseases of the arteries of stages III and IV (according to Fontaine classification).

Dosage regimen

The solution must be prepared immediately before the infusion. The lyophilisate dissolves immediately after adding saline. At first, the solution may appear milky-cloudy. This effect is created by air bubbles and is not significant. After a short time the solution becomes transparent.

It is not allowed to use a solution prepared more than 12 hours ago.

Intra-arterial administration

Lyophilisate for the preparation of solution for infusion: 1 amp./20 mcg alprostadil

To obtain a solution for intravenous administration, the contents of 1 ampoule of lyophilisate (corresponding to 20 mcg of alprostadil) should be dissolved in 50 ml of physiological solution. In the absence of other prescriptions, half an ampoule of Vazaprostan (corresponding to 10 mcg of alprostadil) should be administered intravenously over 60-120 minutes using an infusion device. If necessary, especially in the presence of necrosis, under strict tolerance control, the dose can be increased to 1 ampoule (20 mcg alprostadil). This dose is usually used as a single daily infusion.

Intravenous administration

Lyophilisate for the preparation of solution for infusion: 1 amp./20 mcg alprostadil

To obtain a solution for intravenous administration, the contents of 2 ampoules of lyophilisate (corresponding to 40 mcg of alprostadil) should be dissolved in 50-250 ml of physiological solution and the resulting solution should be administered intravenously over 2 hours. This dose is applied 2 times a day.

Or the contents of 3 ampoules (corresponding to 60 mcg of alprostadil) are dissolved in 50-250 ml of physiological solution and administered intravenously for 3 hours 1 time per day.

Before use, consultation with a specialist is required. The method of administration and dosage regimen of a particular drug depend on its release form and other factors. The optimal dosage regimen is determined by the doctor. Storage mode, interactions and side effects are indicated in the instructions.

Side effect

From the central nervous system and peripheral nervous system: headache, dizziness, convulsive syndrome, increased fatigue, feeling of malaise, impaired sensitivity of the skin and mucous membranes.
From the cardiovascular system: decreased blood pressure, chest pain, heart rhythm disturbances, AV block.
From the digestive system: discomfort in the epigastrium, nausea, vomiting, diarrhea.
From the musculoskeletal system: hyperostosis of long tubular bones (with therapy for more than 4 weeks).
Allergic reactions: skin rash, itching.
Local reactions: erythema, swelling, pain, sensory disturbance, phlebitis (proximal to the IV injection site).
Other: increased sweating, hyperthermia, swelling of the limb into which the infusion is administered.
Laboratory indicators: leukocytosis, leukopenia, increased titer of C-reactive protein, increased transaminase levels.
Rarely: arthralgia, confusion, central convulsions, fever, chills, bradypnea, psychosis, renal failure, anuria. Several cases of pulmonary edema and acute left ventricular failure have been reported.
Extremely rare (up to 1% of cases): shock, acute heart failure, hyperbilirubinemia, bleeding, drowsiness, bradypnea, decreased respiratory function, tachypnea, anuria, renal dysfunction, hypoglycemia, ventricular fibrillation, 2nd degree AV block, supraventricular arrhythmia, tension neck muscles, increased irritability, hypothermia, hypercapnia, skin hyperemia, hematuria, peritoneal symptoms, tachyphylaxis, hyperkalemia, thrombocytopenia, anemia.
Side effects associated with the use of the drug or the catheterization procedure itself are reversible after reducing the dose or stopping the infusion.

Contraindications for use

chronic heart failure in the stage of decompensation;
severe heart rhythm disturbances;
exacerbation of ischemic heart disease;
myocardial infarction in the last 6 months;
pulmonary edema;
infiltrative lung diseases;
chronic obstructive pulmonary diseases;
liver dysfunction (increased levels of AST, ALT, GGT);
history of liver disease;
diseases accompanied by an increased risk of bleeding (peptic ulcer of the stomach and duodenum, severe damage to the blood vessels of the brain, proliferative retinopathy with a tendency to bleeding, extensive trauma);
concomitant therapy with vasodilators and anticoagulant drugs;
pregnancy;
lactation period (breastfeeding);
age under 18 years (efficacy and safety have not been established);
hypersensitivity to alprostadil and other components of the drug.

Vazaprostan should be prescribed with caution in case of arterial hypotension, cardiovascular failure (monitoring the volume load of the carrier solution is required), patients on hemodialysis (treatment should be carried out in the post-dialysis period), patients with type 1 diabetes mellitus, especially with extensive vascular lesions.

Use during pregnancy and breastfeeding

The use of Vazaprostan during pregnancy is contraindicated.
If it is necessary to use the drug during lactation, breastfeeding should be stopped.

Use in children

Contraindication: age under 18 years (efficacy and safety have not been established).

special instructions

Vazaprostan can only be used by doctors who have experience in angiology, are familiar with modern methods of continuous monitoring of the cardiovascular system and have the appropriate equipment for this.

When carrying out therapy with Vazaprostan, blood pressure, heart rate, biochemical blood parameters, blood clotting indicators should be monitored (in case of disorders of the blood coagulation system or during simultaneous therapy with drugs that affect the coagulation system).