Alprostan concentrate d / pr solution for infusion 0.1 mg / 0.2 ml ampoules 10 pcs. (alprostadil)

Release form

Concentrate for solution for infusion

Packing

10 ampoules.

Pharmacological action

The active substance of the drug Alprostan - alprostadil (a synthetic analogue of natural prostaglandin E1) is a vasodilator, angioprotective agent. It acts comprehensively, improving microcirculation and peripheral

blood circulation, causes vasodilation at the level of arterioles, precapillary sphincters, muscle arteries. Intracavernous administration relaxes the smooth muscles of cavernous bodies, which helps to increase blood flow and improve microcirculation in them.

Improves the rheological properties of blood, helping to increase the elasticity of red blood cells, has an effect on hemocoagulation, decreasing the adhesion and aggregation of platelets. It has a fibrinolytic effect. It has an anti-atherogenic effect, slowing down the activation of neutrophils, excessive proliferation of vascular wall cells.

Reduces total peripheral vascular resistance, blood pressure, reflexively increases the heart rate, which leads to an increase in cardiac output. Stimulates smooth muscles of the intestines, bladder and uterus, inhibits the secretion of gastric juice.

Indications

chronic obliterating diseases of the peripheral arteries of the III-IV stage (according to Fontaine's classification), accompanied by pain in the extremities at rest or trophic disorders (obliterating endarteritis with severe intermittent claudication when surgery is not indicated, atherosclerosis of limb arteries, Raynaud's syndrome with trophic disorders, diabetic angiopathy, Berger’s disease, vasculitis with systemic scleroderma, peripheral circulatory disorders in circulation super-extreme vibrations)

the need for temporary preservation of the functioning ductus arteriosus before re constructive cardiac surgery for congenital ductus-dependent heart defects in newborns.

Contraindications

acute and subacute myocardial infarction

severe or unstable form of angina pectoris

severe bronchial obstructive syndrome with signs of respiratory failure, edema or infiltrative changes in the lungs

severe liver dysfunction

condition characterized by the risk of bleeding (peptic ulcer of the stomach and duodenum in the exacerbation phase, severe damage to cerebral vessels, proliferative retinopathy with a tendency to bleeding, extensive trauma)

alprostadil

age is up to 18 years (except for the neonatal period) and older than 75 years.

Pregnancy and lactation

Alprostan is contraindicated in pregnancy. If necessary, use during lactation should decide on the termination of breastfeeding.

Composition of

1 ampoule contains:

Active ingredient:

aprotinin 100,000 KIE

Excipients:

sodium chloride - 85 mg

benzyl alcohol - 100 mg

water for injection - up to 10 ml srl41 pfp41pfrd substance: alprostadil 100 mcg

Excipient: ethanol - up to 0.2 ml.

Dosage and administration of

Adults in the treatment of chronic obliterating diseases of the arteries Alprostan are given iv in a dose of 50-200 mcg once a day or in more severe conditions 50-100 mcg 2 times a day. As a solvent, 200-500 ml of physiological saline, 5% or 10% glucose solution are used. The duration of the infusion is at least 2 hours. The solution should be prepared immediately before administration. The duration of the course of therapy averages 14 days, with a positive effect, treatment can be continued for another 7-14 days. The maximum duration of therapy is 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 congenital ductus-dependent defects in newborns, Alprostan is administered by continuous infusion through the large veins or through the umbilical artery directly at the mouth of the ductus arteriosus. The initial dose is 0.01-0.05 mcg / kg / min. If necessary, the dose can be increased to 0.1 μg / kg / min. When the therapeutic effect is achieved, the dose is reduced to the minimum maintenance (0.01-0.02 μg / kg / min).

Side effects

From the side of the central nervous system: headache, dizziness, increased fatigue, a feeling of malaise.

From the digestive system: discomfort, nausea, vomiting, diarrhea, increased activity of hepatic transaminases, hyperbilirubinemia.

From the cardiovascular system: tachycardia, arterial hypotension, angina attacks, heart rhythm disturbances, AV block, pulmonary edema, cardiovascular failure.

From the hemopoietic system: leukopenia, leukocytosis.

Allergic reactions: hives.

Other: increased sweating, body hyperthermia, increased titer of C-reactive protein with a long course of treatment (from 4 or more weeks) - hematuria tubular bones hyperostosis.

Local reactions: swelling of the extremity, into the vein of which an infusion is carried out.

In newborns:

From the side of the central nervous system: increased irritability, cramps, drowsiness.

From the digestive system: peritoneal symptoms, hyperbilirubinemia, diarrhea.

From the cardiovascular system: arterial hypotension, bradycardia, tachycardia, shock, acute heart failure, heart rhythm disturbances, AV block.

From the respiratory system: respiratory depression (up to apnea), decreased respiratory function (bradypnea, tachypnea).

From the hematopoietic system: DIC, bleeding, thrombocytopenia, anemia.

From the urinary system: decreased renal function, anuria, hematuria.

Allergic reactions: skin rash, tachyphylaxis.

Other: hyper- or hypothermia of the skin, hyperemia of the skin, hypo- or hyperglycemia, hypertonicity of the neck muscles, hypercapnia. With prolonged therapy (for several weeks), the appearance of hyperostosis in the bones of the lower extremities is possible.

With the development of side effects, it is recommended to reduce the dose of the drug.

Drug Interaction

When Alprostan is used with anticoagulants and antiplatelet agents, the risk of bleeding is increased. When used concurrently, Alprostan enhances the effect of antihypertensive agents and vasodilators.

Overdose

Symptoms: decreased blood pressure, hyperemia of the skin, weakness.

Treatment: The drug infusion should be slowed or stopped. As a rule, there is no need for specific treatment. When signs of respiratory center depression in newborns appear, IVF should be used.

Storage conditions

The drug should be stored in a dry, dark place at a temperature of 1 ° to 5 ° C, do not freeze.

Expiration

2 years.

Deystvuyuschee substances

Alprostadil

Pharmacy terms

Prescription

Dosage form

dosage form

infusion solution



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