Vap 20 ampoules for preparing a solution for infusion 1 ml N10
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Description
Vap 20 - a concentrate for preparation of solution for infusions for intravenous administration. Transparent colorless liquid with a characteristic smell of ethanol. The synthetic analogue of prostaglandin E1 has a vasodilator, antiplatelet and angioprotective action.
Active ingredients
Alprostadil
Composition
Alprostadil, ethanol.
Pharmacological effect
An analogue of the natural prostaglandin E1, has a vasodilator (at the level of arterioles, precapillary sphincters, muscle arteries), antiplatelet and angioprotective action. It improves microcirculation and peripheral blood circulation, promotes the opening of collateral vessels. Reduces total peripheral vascular resistance, blood pressure, reflexively increases the heart rate, which leads to an increase in the minute volume of blood. Improves the rheological properties of blood, helping to increase the elasticity of red blood cells and reducing adhesion / aggregation of platelets. It has a fibrinolytic effect. Stimulates the smooth muscles of the intestine, bladder and uterus, inhibits the secretion of gastric juice.
Pharmacokinetics
Alprostadil is a synthetic analogue of natural prostaglandin E1 with a short T1 / 2 half-life (about 10 s). When administered intravenously metabolized in the lungs (with a single passage up to 60-90%). As a result of enzymatic oxidation, biologically active ketometabolites are formed. the metabolites have a lower biological effect compared with alprostadil, and the prostaglandin E0 metabolite has an effect comparable to prostaglandin E1. Prostaglandin E0 acts longer, its T1 / 2 is about 1 min (alpha phase) and 30 min (beta phase). In all likelihood, the pharmacodynamic effect is mainly caused by this biologically active stable metabolite. The major metabolites are excreted by the kidneys - up to 88% and the intestines - 12%.
Indications
Chronic obliterating diseases of arteries of the Ш and IV stages (according to Fontaine’s classification).
Contraindications
Hypersensitivity to alprostadil or other components of the drug. Chronic heart failure, expressed cardiac arrhythmias, exacerbation of coronary heart disease, myocardial infarction or stroke in the last 6 months.Pulmonary edema, infiltrative lung disease, chronic obstructive pulmonary disease. Liver dysfunction (increased activity of aspartate aminotransferase, alanine aminotransferase or gamma-glutamyltransferase) and a history of severe liver disease, as well as diseases accompanied by an increased risk of bleeding (gastric ulcer, 12 gut, extensive trauma). Concomitant therapy with vasodilators and anticoagulants. Pregnancy and lactation. General contraindications for infusion therapy, such as heart failure in the stage of decompensation, pulmonary or brain edema, renal dysfunction (oliguria), and overhydration. Children's age up to 18 years.
Precautionary measures
Care must be taken in case of arterial hypotension, cardiovascular insufficiency, in patients on hemodialysis (drug treatment should be carried out in the postdialysis period), in patients with diabetes, especially in diabetic angiopathy.
Use during pregnancy and lactation
Contraindicated.
Dosage and administration
Enter intravenously. The solution should be prepared immediately before administration. 1-2 ampoules (20 mcg or 40 mcg) are dissolved in 0.9% sodium chloride solution or 5% dextrose solution to a volume of 100-250 ml. The solution, ready for use, is valid for 24 hours if it is stored in a refrigerator (2-8 ° C) in a dark place. Do not use the solution prepared more than 24 hours ago. 50-250 ml of the prepared solution for infusions, the concentration of alprostadil is 40 μg, administered intravenously over 2 hours (333 ng / min), the infusion rate 0.4-2 ml / min. VAP20 is administered 1 time per day; for severe clinical symptoms of the disease, it is possible to administer VAP20 2 times per day. The average duration of treatment is 14 days, with a positive effect, treatment with the drug can be continued for 7-14 days. The course of treatment should not exceed 4 weeks. In the absence of a positive effect within 2 weeks from the start of treatment, further use of the drug should be discontinued. In case of impaired renal function (serum creatinine concentration more than 1.5 mg / dL), intravenous administration begins with 20 μg. If necessary, after 2-3 days a single dose is increased to 40-60 mcg.For patients with renal failure and heart failure, the maximum volume of fluid injected is 50-100 ml / day. The course of treatment is 4 weeks.
Side effects
From the side of the central nervous system: headache, convulsive syndrome, dizziness, excessive fatigue, feeling of indisposition, impaired sensitivity of the skin and mucous membranes. Since the cardiovascular system: reduction of blood pressure, chest pain, cardiac arrhythmias, atrioventricular block. On the part of the digestive system: a feeling of discomfort in the epigastric region, dyspeptic symptoms - diarrhea, nausea, vomiting. On the part of the musculoskeletal system: reversible hyperostosis of long tubular bones (with prolonged continuous administration of 4 weeks). Local reactions: pain, swelling, erythema, impaired sensitivity, phlebitis (proximal to the site of intravenous administration). Laboratory indicators: leukocytosis, leukopenia, an increase in C-reactive protein titer, an increase in transaminase activity. Other: increased sweating, hyperthermia, edema of the limb, into which the vein is infused. Rarely: pain in the joints, confusion, convulsions of central origin, fever, chills, bradypnea, arthralgia, psychosis, renal failure, anuria. Several cases of pulmonary edema and acute left ventricular failure have been reported. Allergic reactions: skin rash, itching. The side effects associated with the use of the drug or with the catheterization procedure itself disappear after dose reduction or cessation of the infusion.
Overdose
An overdose of the drug may be manifested by a decrease in blood pressure (BP) and an increase in heart rate (HR). Vazovagal reactions may develop with pale skin, increased sweating, nausea and vomiting, which may also be accompanied by myocardial ischemia and heart failure symptoms, as well as pain, swelling and redness of the tissue at the infusion site. With symptoms of overdose, reduce the dose of the drug or stop the infusion. With a pronounced decrease in blood pressure, the patient in the prone position must raise his legs.
Interaction with other drugs
Alprostadil can enhance the effect of antihypertensive drugs, vasodilators and antianginal drugs. The simultaneous use of alprostadil in patients receiving anti-clotting agents (anticoagulants, antiplatelet agents) may increase the likelihood of bleeding. In combination with cefamandol, cefoperazone, cefotetan, and thrombolytic agents, the risk of bleeding increases. Adrenomimetics - epinephrine, norepinephrine - reduce the vasodilating effect. It must be borne in mind that drug interactions are possible even if the above remedies were used shortly before drug therapy was started.
special instructions
Alprostadil can be prescribed only 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. The prepared solution is recommended to be used directly after preparation; temporary storage of the obtained solution is possible for no more than 24 hours at a temperature of 2 to 8 ° C. During the period of treatment, it is necessary to control blood pressure and heart rate, biochemical parameters of blood, blood coagulation system (in case of blood coagulation disorders or simultaneous therapy with drugs affecting the blood coagulation system). Patients with ischemic heart disease, renal insufficiency (serum creatinine more than 1.5 mg / dL) should be monitored. in the hospital during treatment with alprostadil and within 1 day after stopping treatment. In order to avoid the onset of symptoms of overhydration in such patients, the volume of injected fluid should, if possible, not exceed 50-100 ml per day. Dynamic monitoring of the patient's condition is necessary (control of blood pressure and heart rate), if necessary - control of body weight, fluid balance, measurement of central venous pressure or echocardiography (EchoCG). In patients with chronic obliterating diseases of the arteries of the lower extremities, infusion therapy is an essential part of complex treatment. The clinical effect is long-term in nature and can manifest itself with a certain delay after the end of the course of treatment.Phlebitis (proximal to the injection site) is usually not a reason to stop therapy, signs of inflammation disappear within a few hours after stopping the infusion or changing the injection site, specific treatment in such cases is not required. Catheterization of the central vein reduces the incidence of this side effect.
Storage conditions
At a temperature of 2 to 8 ºС (in the refrigerator), in a dark place.