Vap 20 solutiona concentrate for preparation for infusion of 20 ug/ml 1 ml ampule 5 pcs

Analog natural PGE1 (prostaglandin E1) has vasodilator (at the level of arterioles, precapillary sphincters, muscular arteries) and angioprotective antiplatelet action.

Improves microcirculation and peripheral circulation, promotes opening of collateral vessels. , Decreases total peripheral vascular resistance, blood pressure, reflex increases the heart rate, which leads to an increase in cardiac output.

It improves blood rheology, helping to increase the elasticity of the erythrocyte and reducing the adhesion / aggregation of platelets. It has fibrinolytic effect.

It stimulates the smooth muscles of the intestine, bladder and uterus; inhibits the secretion of gastric juice

Active substance:
Alprostadil

Manufacturer

BAG, Germany

Composition

Composition 1 vial contains:

active ingredient:

 * 20 ug alprostadil

auxiliaries:

ethanol &

* = PGE1 Alprostadil (prostaglandin E1).

Indications

Chronic arterial obliterative disease stages III and IV (according to Fontaine classifications).

Contraindications

Hypersensitivity to alprostadil or other components of the drug.

Side effects

When infusion,

From the nervous system and sensory organs: headache, dizziness, paresthesia, convulsions, fatigue, malaise, impaired sensitivity of the skin and mucous membranes; rare – confusion, psychosis.

Cardio-vascular system and blood (blood, hemostasis): lowering blood pressure, tachycardia, false angina, cardiac arrhythmia, AV block, redness of the skin; rarely – the development or deepening of heart failure, leukopenia or leukocytosis.

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

From the digestive tract: a sense of discomfort in the epigastric region, nausea, vomiting, diarrhea, increase in liver transaminases; rarely – hyperbilirubinemia.

From the urogenital system: rarely – renal failure, hematuria.

On the part of the musculoskeletal system: arthralgia; with prolonged continuous use (over 4 weeks) – reversible hyperostosis tubular bones.

Allergic reactions: skin rash, hives, itchy.

Other: increased sweating, hyperthermia, fever, swelling of the limbs, which is held in the vein infusion; rarely – increase in titer of C-reactive protein; reactions at the injection site – pain, swelling, erythema, sensitivity disorder, phlebitis proximal space in / Introducion (up to 40% of patients).

Very rarely (1% of cases): shock, acute heart failure, hyperbilirubinemia, bleeding, drowsiness, bradypnea, reduced respiratory function, tachypnea, anuria, renal failure, hypoglycemia, ventricular fibrillation of the heart, AV blockade II extent, supraventricular arrhythmia, the voltage neck muscles, irritability, hypothermia, hypercapnia, flushing of the skin, hematuria, peritoneal signs, tachyphylaxis, hyperkalemia, thrombocytopenia, anemia.

Neonates: apnea (frequency 10-12%), fever (14%), flushing of the skin (about 10%, especially at / and administration), bradycardia (7%), blood pressure reduction (4%), seizures ( 4%), tachycardia (3%); about 2% – diarrhea, sepsis; about 1% – heart failure, edema, DIC, hypokalemia; ≤1% – cerebral hemorrhage, excessive neck extension, hypothermia, nervous excitement, lethargy, congestive heart failure, AV blockade II extent, supraventricular tachycardia, ventricular fibrillation, bradypnea, stridor hypercapnia, respiratory depression, tachypnea, regurgitation of gastric contents, hyperbilirubinemia , anemia, bleeding, thrombocytopenia, anuria, hematuria, peritoneal signs, hypoglycemia, hyperkalemia; with long-term course of treatment (for several weeks) reported lower limb bone hyperostosis (see. also “Precautions”).

When administered intracavernosally

Local reactions: penile pain (37%), an excessively prolonged erection (4-6 hours – 4%), hematoma (3%) and ecchymosis (2%) at the injection site (associated with improper administration technique), the 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, hemorrhage at the injection site; inflammation, itching and swelling at the injection site, bleeding from the urethra, penile disorders, including Heat sensation in the penis, numbness, fungal infection, irritation, sensitivity, phimosis, rash, erythema, venous discharge, painful erection, ejaculation disorder.

Systemic effects (rare): Pain and swelling of the scrotum and testicles, frequent urination, urinary incontinence, blood pressure fluctuations (increase or decrease), tachycardia, supraventricular beats, the peripheral blood circulation, fatigue, headache, hypoesthesia, leg swelling, rash, nausea, dry mouth, increased serum creatinine, leg cramps, weakness in the buttocks, localized pain (chest, buttocks, in the pelvis, legs, genitals, abdomen), mydriasis, flu-like symptoms.

How to accept, acceptance rate and dosage

Administered intravenously. The solution should be prepared immediately before administration. 1-2 ampoules (20 .mu.g or 40 .mu.g) was dissolved in 0.9% chloride or 5% dextrose solution, sodium solution to a volume of 100-250 ml. A solution ready for use, fit within 24 hours when stored in the refrigerator (2-8 ° C) protected from light. It is impossible to use a solution prepared more than 24 hours ago.

50-250 ml of the prepared solution for infusion, alprostadil concentration – 40 g, is administered intravenously over 2 hours (333 ng / min) infusion rate of 0.4-2 ml / min. VAP20 administered 1 time per day, with severe clinical symptoms of the disease may be administered VAP20 2 times per day. Duration of treatment on average – 14 days, with a positive effect of drug treatment can continue for a further 7-14 days. The course of treatment should not exceed 4 weeks. If no positive effect within 2 weeks from the beginning of treatment continued application of the preparation should be discontinued.

If the kidney function (creatinine concentration in the serum of more than 1.5 mg / dl) starts with the intravenous administration of 20 mcg. If necessary, after 2-3 days of a single dose of 40-60 micrograms. For patients with renal insufficiency and cardiac insufficiency maximum volume of fluid injected – 50-100 ml / day. The course of treatment – 4 weeks.

Storage conditions

In the dark place at a temperature of 2-8 ° C

Active substance

Alprostadil

Interaction

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

Concomitant use of alprostadil in patients taking agents that prevent blood clotting (anticoagulants, antiplatelet agents), may increase the chance of bleeding. In combination with cefamandole, cefoperazone, tsefotetanom and thrombolytic – increases the risk of bleeding. Agonists – epinephrine, norepinephrine – reduce the vasodilator effect.

Please be aware that the drugs interactions are possible and in that case, if the above funds were used shortly before drug therapy was initiated.

Special conditions

Alprostadil can trample only prescribed by a doctor who has experience in Angiology, familiar with modern methods of continuous monitoring of the cardiovascular system and having the appropriate equipment for this.

The prepared solution is recommended to use immediately after preparation, possibly temporary storage of the resulting solution of not more than 24 hours at a temperature of from 2 to 8 ° C.

In the period of treatment is necessary to control:

• blood pressure
• heart rate
• blood biochemical parameters
• Rolling blood system (for violations of blood coagulation or simultaneous therapy drugs that affect coagulation system).

Patients with ischemic heart disease, renal (serum creatinine greater than 1.5 mg / dL) should be monitored in a hospital during alprostadil treatment and for 1 day after stopping treatment. To prevent overhydration symptoms in these patients the amount of a fluid as possible should not exceed 50-100 ml per day. It is necessary to monitor the dynamic condition of the patient (control of blood pressure and heart rate), if necessary – the control of body weight, fluid balance, measurement of central venous pressure or echocardiography (echocardiographic).

In patients with chronic lower extremity arterial occlusive diseases infusion therapy is a necessary part of complex treatment. The clinical effect is long-term in nature and can occur with a certain delay after the end of the treatment course.

Phlebitis (proximal to the injection site) is generally not a cause for discontinuation of therapy, inflammation symptoms disappear a few hours after cessation of infusion or injection site changes, specific treatment in such cases is not required. Central venous catheterization can reduce the frequency of manifestation of side effects.

Pregnancy and lactation

Alprostadil is contraindicated in pregnancy and lactation (breastfeeding).

Use in children

Neonates should be under the constant control of blood pressure, with mandatory presence of the conditions for mechanical ventilation.

There is currently no experience intracavernous administration to patients younger than 18 years.

Overdose

Symptoms: overdose of the drug may manifest a decrease in blood pressure and heart rate increasing frequency. Perhaps the development of vasovagal reactions with pale skin, sweating, nausea and vomiting, which can also be accompanied by myocardial ischemia and symptoms of heart failure, and may be pain, swelling and redness of the tissue at the site of infusion.

Treatment: it is necessary to reduce the dose or discontinue the infusion. In marked decrease in blood pressure to the patient in the supine position should be lifted up.