Vap 20 20 µg-ml 1 ml 5 pcs concentrate for the preparation of solution for infusion

Contraindications

• exacerbation of coronary heart disease, severe heart rhythm disturbances, chronic heart failure, stroke or myocardial infarction in the last 6 months;
• pulmonary edema, chronic obstructive and infiltrative pulmonary diseases;
• diseases accompanied by an increased risk of bleeding (for example, peptic ulcer of the stomach or duodenum, extensive trauma);
• history of liver dysfunction and severe disease;
• general contraindications for infusion therapy, such as overhydration, cerebral or pulmonary edema, renal impairment (oliguria), decompensated heart failure;
• children under 18 years of age;
• period of pregnancy and lactation;
• simultaneous use of anticoagulants or vasodilators;
• hypersensitivity to any component of the drug.

Carefully:

• arterial hypotension;
• cardiovascular failure in patients on hemodialysis;
• diabetes;
• diabetic angiopathy.

Concentrate for the preparation of solution for infusion VAP 20 (Vap 20)

Instructions for medical use of the drug

Description of pharmacological action

Prostaglandin E1 preparation. Improves microcirculation and peripheral circulation, has an angioprotective effect. When administered systemically, it causes relaxation of smooth muscle fibers, has a vasodilating effect, reduces peripheral vascular resistance, and lowers blood pressure. In this case, there is a reflex increase in cardiac output and heart rate. Improves the rheological properties of blood, helping to increase the elasticity of red blood cells and reducing platelet aggregation and neutrophil activity, increases the fibrinolytic activity of the blood. It affects metabolism, increases the utilization of glucose and oxygen, suppresses the release of free radicals and lysosomal enzymes from granulocytes and macrophages, stimulates protein synthesis, has a beneficial effect on lipid metabolism (suppressing cholesterol synthesis and reducing LDL concentration), and inhibits the proliferation of smooth muscle cells. Has a stimulating effect on the smooth muscles of the intestines, bladder, and uterus; suppresses the secretion of gastric juice. When administered intracavernosally, it blocks α1-adrenergic receptors in the tissues of the penis, has a relaxing effect on the smooth muscles of the cavernous bodies, increases blood flow and improves microcirculation. Dilation of the cavernous arteries and vessels of the trabecular smooth muscle of the cavernous bodies leads to a rapid increase in blood flow and dilatation of the lacunar spaces in the cavernous bodies. Venous outflow through the vessels located under the tunica albuginea is limited, which stimulates the development of an erection (“corporal veno-occlusive mechanism”). Onset of action is 5-10 minutes, duration is 1-3 hours.

Indications for use

The need to temporarily maintain the functioning of the ductus arteriosus until corrective surgery is performed for congenital ductus-dependent heart defects in newborns (including mitral atresia, pulmonary atresia, tricuspid valve atresia, tetralogy of Fallot). Chronic obliterating diseases of the arteries, stage III-IV (according to Fontaine classification). Obliterating endarteritis with severe “intermittent” claudication (with impossible surgical revascularization of the lower limb), obliterating atherosclerosis, diabetic angiopathy, thromboangiitis obliterans (Buerger’s disease), Raynaud’s syndrome with trophic disorders, vasculitis, scleroderma, cramps of the calf muscles, the damaging influence of physical factors, especially super-limit vibration. Treatment of erectile dysfunction of neurogenic, vascular, psychogenic or mixed etiology; conducting a pharmacological test as part of a set of diagnostic tests for erectile dysfunction.

Release form

Concentrate for the preparation of solution for infusion 20 mcg/ml; dark glass ampoule 1 ml with holder for ampoules, cardboard pack 10; Concentrate for the preparation of solution for infusion 20 mcg/ml; dark glass ampoule 1 ml with holder for ampoules, cardboard pack 5;

Pharmacodynamics

Alprostadil has a wide spectrum of pharmacological action. Among its most significant effects are vasodilation, suppression of platelet aggregation, and a stimulating effect on the smooth muscles of the intestines, uterus and other smooth muscle organs. Improves microcirculation, increases peripheral blood flow, and has a vasoprotective effect. When administered systemically, it causes relaxation of the smooth muscle fibers of the vascular wall, has a vasodilating effect, reduces peripheral vascular resistance, and lowers 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.

Pharmacokinetics

When administered intravenously, alprostadil is rapidly metabolized. With a single passage through the lungs, up to 60-90% is metabolized. Enzymatic oxidation produces 3 biologically active metabolites: 15-keto-PGE1, 15-keto-13,14-dihydro-PGE1 and 13,14-dihydro-PGE1. Keto metabolites have a lower biological effect compared to alprostadil; the 13,14-dihydro-PGE1 metabolite has a comparable effect to PGE1. The pharmacodynamic effect is due mainly to this biologically active metabolite. T1/2 of 13,14-dihydro-PGE1 is about 1 min. The main metabolites are excreted primarily in the urine and, to a lesser extent, in the feces. When administered intracavernosally, the concentration of alprostadil and its main metabolite - 15-oxo-13,14-dihydro-PgE1 - is determined only in the cavernous bodies. After intracavernosal administration of 20 μg of alprostadil, the content of the main metabolite in the peripheral bloodstream increased and reached a maximum 30 minutes after injection, and then returned to the initial level 60 minutes after injection, while the levels of alprostadil in the peripheral bloodstream were slightly higher than baseline. Alprostadil, when entering the systemic circulation during intracavernous administration, is very quickly metabolized. Excreted in the form of metabolites.

Use during pregnancy

Alprostadil is contraindicated during pregnancy and lactation (breastfeeding).

Contraindications for use

Chronic heart failure, pulmonary edema, cardiac arrhythmias, myocardial infarction within the last 6 months; infiltrative changes in the lungs, bronchial asthma; liver dysfunction, liver disease (including history); history of ulcerative lesions of the gastrointestinal tract; hypersensitivity to alprostadil; pregnancy, lactation. For intracavernous administration: diseases predisposing to the occurrence of priapism (sickle cell anemia, myeloma, leukemia); anatomical deformations of the penis (angulation, cavernous fibrosis, Peyronie's disease). Do not use in patients with a penile implant, or with contraindications for sexual intercourse.

Side effects

From the digestive system: diarrhea, nausea, vomiting, increased transaminase activity; rarely - hyperbilirubinemia, peritoneal symptoms. From the cardiovascular system: arterial hypotension, tachycardia, pain in the heart; rarely - heart failure, heart rhythm disturbances, AV block, acute pulmonary edema. From the central nervous system and peripheral nervous system: headache, psychosis, convulsions of central origin, paresthesia; rarely - lethargy. From the respiratory system: rarely - tachypnea, respiratory distress syndrome. From the hematopoietic system and blood coagulation system: leukocytosis, leukopenia; rarely - bleeding, hypochromic anemia, thrombocytopenia. From the urinary system: rarely - anuria, renal failure, hematuria. Metabolic disorders: rarely - hypoglycemia, hypercapnia. From the musculoskeletal system: joint pain, neck muscle tension, reversible hyperostosis of tubular bones. Allergic reactions: skin rash, itching. Other: possible hyperthermia, redness of the skin, increased sweating, swelling of the limb into which the infusion is being administered. With intracavernous injection, pain in the penis, prolonged erection and priapism are possible; rarely - fibrosis, edema, feeling of heat, numbness, rashes on the penis, balanitis, hemorrhages, itching and swelling of the injection site, bleeding from the urethra, fungal infection, phimosis, painful erection and impaired ejaculation, pain in the testicular area, testicular swelling, pain and scrotal tension, increased urination, urinary incontinence, pain in the buttocks, legs, abdomen, pain in the pelvis, lower back, flu-like syndrome, hypoesthesia, myasthenia.

Directions for use and doses

Individual, depending on the indications and dosage form used.

Overdose

Symptoms: decreased blood pressure, skin hyperemia, weakness; in newborns (in addition) - apnea, bradycardia. Treatment: slowing down or stopping the infusion, symptomatic therapy; If signs of depression of the respiratory center appear in newborns, mechanical ventilation is indicated.

Interactions with other drugs

With simultaneous use, alprostadil enhances the effect of antihypertensive drugs and vasodilators, anticoagulants, and antiplatelet agents.

Precautions for use

Alprostadil for infusion can only be used by doctors with experience in angiology, familiar with modern methods of continuous monitoring of the state of the cardiovascular system and who have the appropriate equipment for this. During the treatment period, monitoring of blood pressure, heart rate, biochemical parameters and blood coagulation is necessary (in case of disorders of the blood coagulation system or during simultaneous therapy with drugs that affect the coagulation system). Patients with coronary artery disease, as well as patients with peripheral edema and renal dysfunction (serum creatinine >1.5 mg/dL) should be monitored in the hospital during treatment with alprostadil and for 24 hours after its cessation. To avoid the appearance of symptoms of overhydration in patients with renal failure, the volume of fluid administered should, if possible, not exceed 50–100 ml/day. Dynamic monitoring of the patient's condition is mandatory: monitoring blood pressure and heart rate, and, if necessary, monitoring body weight, fluid balance, measuring central venous pressure or conducting an echocardiographic study. Phlebitis (proximal to the injection site), as a rule, is not a reason to discontinue therapy; signs of inflammation disappear a few hours after stopping the infusion or changing the injection site; No specific treatment is required in such cases. Central vein catheterization can reduce the incidence of this side effect of the drug. Due to the risk of apnea in newborns, alprostadil should be used in institutions with qualified personnel and equipment necessary to provide intensive care for children, under constant monitoring of blood pressure, with conditions for immediate mechanical ventilation. Apnea (see Side Effects) is most common in neonates weighing less than 2 kg at birth and usually occurs within the first hour of infusion. Administration of alprostadil to newborns can lead to obstruction of the pylorus. This effect appears to depend on the duration of therapy and the cumulative dose of the drug. Neonates receiving alprostadil at recommended doses for more than 120 hours should be monitored closely. When treating erectile dysfunction, treatmentable causes of erectile dysfunction should be diagnosed before starting alprostadil therapy. Dose selection must be carried out individually for each patient, under the supervision of a doctor, with monitoring of the state of the cardiovascular system and the duration of erections. To reduce the likelihood of developing a prolonged erection or priapism when selecting a dose, it is necessary to increase it slowly until the minimum effective dose is reached (the appearance of an erection lasting no more than 1 hour and sufficient for sexual intercourse). During dose selection, the patient should be under medical supervision until the erection disappears. If the first dose is ineffective, a second, higher dose can be administered no earlier than 1 hour later. If there is a response, the interval between doses should be at least 1 day. Self-injections can be prescribed to patients only after detailed instructions to the patient and mastering the technique of self-injections. Treatment begins with a dose selected by the doctor. The patient is recommended to visit the attending physician every 3 months to assess the effectiveness and safety of treatment and, if necessary, to adjust the dose. The patient should be warned that during treatment he must inform the doctor about all cases of erection lasting more than 4 hours. Untimely correction of priapism can lead to irreversible damage to the tissue of the penis and long-term loss of potency.

Special instructions for use

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.

Storage conditions

List B.: In a dark place, at a temperature of 2–8 °C. Prepared solution - no more than 24 hours.

Best before date

36 months

ATX classification:

C Cardiovascular system

C01 Drugs for the treatment of heart diseases

C01E Other drugs for the treatment of heart disease

C01EA Prostaglandins

C01EA01 Alprostadil

Directions for use and dosage

VAP 20 is intended for intravenous administration.

The solution is prepared immediately before administration: 1–2 ampoules of the concentrate are dissolved in a 0.9% sodium chloride solution or 5% dextrose solution to a volume of 100–250 ml.

50–250 ml of the prepared infusion solution is administered over 2 hours at a rate of 0.4–2 ml/minute. The frequency of infusions is 1 time per day, in severe cases of the disease – 2 times per day.

The average course of treatment is 14 days; if a positive effect from initial therapy is achieved, the use of the drug can be continued for another 7–14 days. The maximum duration of treatment is 4 weeks.

If after 2 weeks there is no improvement in the condition, further use of VAP 20 is not advisable.

If renal function is impaired (serum creatinine concentration exceeds 1.5 mg/dL), the initial dose is 20 mcg; after 2-3 days, if necessary, it is increased to 40–60 mcg. In case of renal and heart failure, the volume of administered fluid should not exceed 50–100 ml per day. Duration of therapy is 4 weeks.

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Side effects

• from the cardiovascular system: heart rhythm disturbances, chest pain, decreased blood pressure, atrioventricular block;
• from the musculoskeletal system: with long-term continuous administration of 4 weeks - reversible hyperostosis of long tubular bones;
• from the central nervous system: excessive fatigue, impaired sensitivity of the skin and mucous membranes, headache, feeling of malaise, dizziness, convulsions;
• from the digestive system: dyspepsia (diarrhea, nausea, vomiting), discomfort in the epigastric region;
• laboratory parameters: increased transaminase activity, increased titer of C-reactive protein, leukopenia, leukocytosis;
• rarely: confusion, psychosis, fever, chills, joint pain, arthralgia, anuria, renal failure, bradypnea, central convulsions, pulmonary edema, acute left ventricular failure;
• allergic reactions: skin rashes, itching;
• other: hyperthermia, increased sweating, swelling of the limb into which the infusion is administered;
• local reactions: loss of sensitivity, erythema, swelling, pain, phlebitis (proximal to the intravenous injection site).

Side effects disappear after reducing the dose of the drug or stopping the infusion.

If the dosage is exceeded, the following reactions are possible: decreased blood pressure, increased heart rate, vasovagal reactions, accompanied by symptoms such as increased sweating, pale skin, nausea, vomiting, possibly myocardial ischemia and symptoms of heart failure. Redness, swelling, and pain at the infusion site may also occur. In these cases, it is necessary to reduce the dose of the drug or stop administration. If there is a significant decrease in blood pressure, the patient should take a lying position and raise his legs.

Side effects

With infusion administration
From the nervous system and sensory organs: headache, dizziness, paresthesia, convulsive syndrome, increased fatigue, feeling of malaise, impaired sensitivity of the skin and mucous membranes; rarely - confusion, psychosis.

From the cardiovascular system and blood (hematopoiesis, hemostasis): decreased blood pressure, tachycardia, cardialgia, heart rhythm disturbances, AV block, redness of the skin; rarely - development or worsening of heart failure, leukopenia or leukocytosis.

From the respiratory system: shortness of breath; rarely - respiratory distress syndrome, acute pulmonary edema.

From the gastrointestinal tract: discomfort in the epigastric region, nausea, vomiting, diarrhea, increased activity of liver transaminases; rarely - hyperbilirubinemia.

From the genitourinary system: rarely - renal failure, hematuria.

From the musculoskeletal system: arthralgia; with long-term continuous use (more than 4 weeks) - reversible hyperostosis of tubular bones.

Allergic reactions: skin rashes, urticaria, itching.

Other: increased sweating, hyperthermia, chills, swelling of the limb into which the infusion is being administered; rarely - an increase in the titer of C-reactive protein; reactions at the injection site - pain, swelling, erythema, sensitivity disorder, phlebitis proximal to the injection site (up to 40% of patients).

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.

In newborns: apnea (frequency 10–12%), elevated temperature (14%), hyperemia of the skin (about 10%, especially with intravenous administration), bradycardia (7%), decreased blood pressure (4%), convulsions ( 4%), tachycardia (3%); about 2% - diarrhea, sepsis; about 1% - cardiac arrest, edema, disseminated intravascular coagulation syndrome, hypokalemia; ≤1% - cerebral hemorrhage, excessive neck extension, hypothermia, nervous agitation, lethargy, congestive heart failure, 2nd degree AV block, supraventricular tachycardia, ventricular fibrillation, bradypnea, stridor, hypercapnia, respiratory depression, tachypnea, gastric regurgitation, hyperbilirubinemia , anemia, bleeding, thrombocytopenia, anuria, hematuria, peritoneal symptoms, hypoglycemia, hyperkalemia; with long-term treatment (several weeks), hyperostosis in the bones of the lower extremities has been reported (see also “Precautions”).

With intracavernosal injection

Local reactions: pain in the penis (37%), excessively prolonged erection (up to 4-6 hours - 4%), hematoma (3%) and ecchymosis (2%) at the injection site (associated with improper injection technique), formation of fibrous nodules and Peyronie's disease (3–8%), swelling of the penis (1%), rash on the penis (1%); less than 1% - priapism (0.4%), balanitis, hemorrhages at the injection site; inflammation, itching and swelling at the injection site, bleeding from the urethra, penile disorders, incl. feeling of heat in the penis, numbness, fungal infection, irritation, hypersensitivity, phimosis, rash, erythema, venous discharge, painful erection, ejaculation disorder.

Systemic effects (rare): pain and swelling of the scrotum and testicles, increased frequency of urination, urinary incontinence, fluctuations in blood pressure (increase or decrease), tachycardia, supraventricular extrasystole, impaired peripheral circulation, fatigue, headache, hypoesthesia, swelling of the legs, hyperhidrosis, nausea, dry mouth, increased serum creatinine, calf muscle cramps, weakness in the buttocks, localized pain (in the chest, buttocks, pelvis, legs, genitals, abdomen), mydriasis, influenza-like syndrome.

special instructions

VAP 20 should only be used by a physician who has experience in the treatment of angiological diseases, is familiar with modern methods of continuous monitoring of the cardiovascular system and has the appropriate equipment for this.

For chronic obliterating diseases of the arteries of the lower extremities, treatment with VAP 20 is a necessary component of complex therapy. The clinical effect may appear with some delay after completion of the course and is long-term.

During the treatment period, it is necessary to monitor blood pressure (BP) and heart rate (HR), biochemical blood parameters, as well as indicators of the blood coagulation system (in case of disorders of the blood coagulation system or simultaneous use of drugs that affect the coagulation system).

Patients with renal failure and coronary heart disease should be in the hospital under the supervision of the attending physician during therapy and for 24 hours after its completion. To prevent the development of overhydration, the volume of daily fluid administered in such patients should, if possible, not exceed 50–100 ml. Dynamic monitoring of their condition is required: monitoring blood pressure and heart rate, if necessary, monitoring fluid balance and body weight, measuring central venous pressure or echocardiography.

Phlebitis (proximal to the injection site) is usually not a reason to discontinue treatment. Signs of inflammation usually disappear within a few hours after stopping the infusion or changing the injection site. Specific therapy is not required in this case. Central venous catheterization can reduce the incidence of this side effect.

A solution prepared more than 24 hours ago is unsuitable for use.

VAP 20 may affect the speed of reactions and the ability to concentrate, especially at the beginning of treatment, when the dose is increased, when the drug is discontinued, and also in case of simultaneous use of alcohol.

Vap 20

Vap 20 (INN - alprostadil) is a vasodilator for use in andrology to stimulate erectile function. It is also used for the treatment of chronic obliterating diseases. Activates the movement of blood through the capillaries and has a capillary protective effect. Reduces excess tone of the smooth muscles of the vascular wall, increases the lumen of blood vessels, reduces their resistance to blood flow, and lowers blood pressure. Improves the rheological characteristics of blood, increasing the ability of red blood cells to deform, preventing platelets from sticking together, and suppressing the activity of neutrophil granulocytes. Increases the fibrinolytic potential of the blood. Promotes better absorption of glucose and oxygen by cells, has an antioxidant effect, activates protein synthesis, improves the blood lipid profile (reduces the amount of total and “bad” cholesterol), and prevents the proliferation of smooth muscle cells. When introduced into the cavernous tissue of the penis, it inactivates alpha-1 adrenergic receptors in the penile tissue, relaxes the smooth muscles of the cavernous bodies, increases the lumen of the cavernous arteries, and ensures increased blood flow to the head of the penis. At the same time, it limits venous outflow, maintaining blood supply to the cavernous tissue sufficient to maintain a full erection. It begins to act 5-10 minutes after the injection. The stable effect lasts for 1-3 hours. When introduced into the body, it quickly undergoes metabolic transformations. Elimination from the body is carried out mainly by the kidneys and to a lesser extent by the intestines. With intracavernous administration, the peak concentration of active substances is achieved after half an hour. Possible undesirable side effects with systemic administration: frequent bowel movements with watery stools (more than three times a day), painful sensation in the epigastric region, chest, oral cavity and pharynx, preceding vomiting (as well as vomiting itself), arterial hypotension, rapid heartbeat, cardiac pain, cephalgia, sensation of goosebumps, changes in the peripheral blood picture (decrease or increase in the number of leukocytes), difficulty urinating, decreased functional activity of the kidneys, presence of traces of blood in the urine, joint pain, excessive tone of the muscles supporting the neck, skin rashes, urticaria, a feeling of painful tickling irritation of the skin, causing the need to scratch the irritated area, a decrease in glucose levels and an increase in the amount of carbon dioxide in the blood, local accumulation of excess body fluid, hyperemia of the skin, hyperhidrosis.

When inserted into the cavernous tissue, penile pain, prolonged painful erection are possible, rarely - swelling, a feeling of excess heat, skin rashes in the area of ​​insertion, inflammation of the glans penis, bleeding from the urethra, mycoses, pain in the testicles, frequent urination, pain in the buttocks , lower extremities, pelvic and lumbar pain, flu-like symptoms, muscle weakness, increased fatigue. Vap 20 is not used for decompensated myocardial dysfunction of a chronic nature, acute severe left ventricular failure with pulmonary venous hypertension and alveolar edema, arrhythmia, within six months after myocardial infarction, bronchial asthma, liver failure, ulcerative-erosive lesions of the gastrointestinal tract, during pregnancy and breastfeeding. Contraindications for intracavernous administration are additionally a physiological tendency to priapism (presence of sickle cell anemia, multiple myeloma, pathological decrease in the level of leukocytes in the blood), morphological deformations of the penis. Not used in persons under 18 and over 75 years of age due to the lack of clinical data on the effectiveness and safety of the drug in people of these age groups. It is not recommended to use Vap 20 together with other drugs to correct erectile function.

Drug interactions

Alprostadil may enhance the effect of vasodilators, antianginal and antihypertensive drugs.

With the simultaneous use of drugs that prevent blood clotting (anticoagulants or antiplatelet agents), thrombolytics, cefoperazone, cefotetan, cefamandole, the risk of bleeding increases.

Adrenergic agonists (epinephrine and norepinephrine) reduce the vasodilating effect of the drug.

It is important to consider that the described drug interactions are possible even if the listed drugs were used shortly before starting alprostadil therapy.