Description
Pharmacological action
Prostaglandin E1. It improves microcirculation and peripheral circulation, has an angioprotective effect. With systemic administration, it causes relaxation of smooth muscle fibers, has a vasodilating effect, reduces OPSS, and reduces blood pressure. In this case, a reflex increase in cardiac output and heart rate is noted. It improves the rheological properties of blood, helping to increase the elasticity of red blood cells and reducing platelet aggregation and neutrophil activity, and increases the fibrinolytic activity of blood.
It affects the metabolism, increases the utilization of glucose and oxygen, inhibits the release of free radicals and lysosomal enzymes from granulocytes and macrophages, stimulates protein synthesis, has a beneficial effect on lipid metabolism (inhibits cholesterol synthesis and lowers LDL concentration), inhibits smooth muscle proliferationcells.
Has a stimulating effect on the smooth muscles of the intestines, bladder, uterus, suppresses the secretion of gastric juice.
When administered intracavernosally, it blocks 1-adrenergic receptors in the tissues of the penis, has a relaxing effect on the smooth muscles of cavernous bodies, and helps increase blood flow and improve microcirculation. The expansion of the cavernous arteries and vessels of the trabecular smooth muscles of the corpus cavernosum leads to a rapid increase in blood flow and dilatation of lacunar spaces in the corpus cavernosum. Venous outflow through vessels located under the tunica albuginea is limited, which stimulates the development of an erection (corporal veno-occlusive mechanism). The onset of action is 5-10 minutes, the duration is 1-3 hours
Indications
The need to temporarily maintain the functioning of the ductus arteriosus until corrective surgery for congenital ductus-dependent heart defects in newborns (including mitral atresia, atresia of the pulmonary artery, atresia of the tricuspid valve, tetralogy of Fallot).
Chronic obliterating diseases of arteries of the III-IV stage (according to Fontaine’s 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 disturbances, vasculitis, scleroderma, spasms of the calf muscles, damaging effect of physical factors, especially ultra-limit vibration.
Treatment of erectile dysfunction of a neurogenic, vascular, psychogenic or mixed etiology conducting a pharmacological test in a complex of diagnostic tests for erectile dysfunction.
Contraindications
Chronic heart failure, pulmonary edema, cardiac arrhythmias, endured over the past 6 months myocardial infarction, infiltrative changes in the lungs, bronchial asthma, impaired liver function, liver disease (including history) ulcerative gastrointestinal tract history of hypersensitivity to alprostadil pregnancy, lactation.
For intracavernous administration: diseases predisposing to priapism (sickle cell anemia, myeloma, leukemia) anatomical deformities of the penis (angulation, cavernous fibrosis, Peyronie’s disease). Do not use in patients with a penile implant, as well as contraindications for sexual intercourse.
Recommendations for use
Individual, depending on the indications and the dosage form used.
Special instructions
Use caution in / a and in / in acute and subacute myocardial infarction, myocardial infarction suffered during the last 6 months, with severe or unstable form of angina pectoris, decompensated chronic heart failure, with arterial hypotension, cardiac -vascular insufficiency, with pulmonary edema, severe arrhythmias, bronchial 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 with peptic ulcer of the stomach or duodenum, severe damage to cerebral vessels, proliferative retinopathy with a tendency to bleeding, extensive trauma), hemodialysis, type 1 diabetes , especially with extensive vascular lesions (in elderly patients) due to the use of vasodilators or anticoagulants in newborns (risk of developing bradypnea, arterial hypotension, tachycardia or hyperthermia).
With caution, drive intracavernosally with thrombocytopenia, polycythemia, thrombophlebitis, venous thrombosis (including in the case of a predisposition), increased blood viscosity, balanitis, urethritis.
Should not be used in patients with a tendency to addiction and / or mental or intellectual disabilities.
In case of disorders of the blood coagulation system or with simultaneous therapy with drugs that affect the coagulation system, blood coagulation parameters should be regularly monitored during treatment with alprostadil. With systemic administration, it is necessary to control the parameters of central hemodynamics, biochemical blood parameters.
With prolonged continuous administration, apnea may develop, a negative effect on the structure of the arterial duct wall with an increased risk of rupture, and thinning of the muscle layer of the pulmonary artery. With a treatment duration of more than 4 weeks, reversible cortical proliferation of the tubular bones is possible.
In newborns, it should be used under the constant control of blood pressure, with the mandatory presence of conditions for mechanical ventilation.
There is currently no experience with intracavernous administration to patients under the age of 18 and over 75 years of age.
Alprostadil is not intended for simultaneous use with other drugs to treat erectile dysfunction.
The compliance of the used dosage form of alprostadil with specific indications for its use should be strictly observed.
Composition
Concentrate for solution for infusion 1 ml: alprostadil 20 μg
Side effects of the
From the digestive system: diarrhea, nausea, vomiting, increased activity of transaminases rarely – hyperbilirubinemia, peritoneal symptoms.
From the cardiovascular system: arterial hypotension, tachycardia, pain in the heart rarely – heart failure, cardiac arrhythmias, AV block, acute pulmonary edema.
From the side of the central nervous system and peripheral nervous system: headache, psychosis, seizures of central genesis, paresthesia rarely – inhibition.
From the respiratory system: rarely – tachypnea, respiratory distress syndrome.
From the hemopoietic system and blood coagulation system: leukocytosis, leukopenia rarely – bleeding, hypochromic anemia, thrombocytopenia.
From the urinary system: rarely – anuria, renal failure, hematuria.
From the side of metabolism: rarely – hypoglycemia, hypercapnia.
From the musculoskeletal system: joint pain, muscle tension in the neck, reversible hyperostosis of the bones.
Allergic reactions: skin rash, itching.
Other: possible hyperthermia, redness of the skin, increased sweating, swelling of the limb, which is infused.
With intracavernous administration, penile pain, prolonged erection and priapism are rare – fibrosis, swelling, fever, numbness, rashes on the penis, balanitis, hemorrhage, itching and swelling of the injection site, bleeding from the urethra, fungal infection, phimosis, painful erection and violation of ejaculation, pain in the testicles, swelling of the testicles, pain and tension of the scrotum, increased urination, urinary incontinence, pain in the buttocks, legs, abdomen, pelvic pain, lower back pain, flu-like syndrome, hypesthesia, myasthenia gravis.
active substance
Alprostadil
Terms of delivery from pharmacies
Prescription
Dosage form
solution To
