Alprostadil Injection

1. Pharmacological action This product is an intravenous alprostadil preparation with lipid microspheres as drug carriers. Due to the encapsulation of lipid microspheres, alprostadil is not easy to be inactivated, and has the targeted characteristics of being easily distributed to damaged blood vessels, thereby exerting the effects of dilating blood vessels and inhibiting platelet aggregation. In addition, this product also has the effect of stabilizing liver cell membranes and improving liver function. 2. Toxicological action Intravenous administration to mice, rats and dogs to the maximum volume that can be tolerated is 50ml/kg [equivalent to alprostadil (prostaglandin E1) 250micro;g/kg], no animal death was observed, and no severe acute toxicity was observed. This product is non-allergenic, teratogenic and vascular irritant. [Pharmacokinetics] The content of alprostadil in the tissues of rats labeled with [3H] was the highest 5 minutes after intravenous administration, and then slowly decreased to disappear. Alprostadil is mainly distributed in kidney, liver, and lung tissues, and the lowest content is in the central nervous system, eyeballs and testicles. This product is mainly bound to plasma proteins and metabolized rapidly in the blood. Its metabolites (13, 14-dihydro-15-keto-PGE1) are mainly excreted through the kidneys. About 90% is excreted in urine within 24 hours after administration, and the rest is excreted in feces.

The main ingredient of this product is prostaglandin E1, its chemical name: (1R, 2R, 3R)-3-hydroxy-2-[(E)-(3S)-3-hydroxy-1-octenyl]-5-oxocyclopentaneheptanoic acid Molecular formula: C20H34O5 Molecular weight: 354.49 Excipients: soybean oil (for injection), lecithin (for injection), glycerol (for injection), oleic acid, sodium hydroxide, water for injection.

This product is a white milky liquid.

1. Treat limb ulcers caused by chronic arterial occlusive disease (thromboangiitis obliterans, arteriosclerosis obliterans, etc.) and limb rest pain caused by microvascular circulatory disorders, and improve cardiovascular and cerebrovascular microcirculatory disorders. 2. Antithrombotic therapy after organ transplantation to inhibit thrombosis in transplanted blood vessels. 3. Arterial duct-dependent congenital heart disease to relieve hypoxemia and maintain ductal blood flow to wait for surgical treatment. 4. For the adjuvant treatment of chronic hepatitis.

For adults, once a day, slowly inject 1-2 ml (alprostadil 5-10 μg) + 10 ml normal saline (or 5% glucose) intravenously, or directly inject slowly into a small pot.

1. Shock: Shock may occur occasionally. Observe carefully. If any abnormality is found, stop the drug immediately and take appropriate measures. 2. Injection site: Sometimes vascular pain, vasculitis, redness, and occasionally hardening and itching may occur. 3. Circulatory system: Sometimes symptoms such as worsening heart failure, pulmonary edema, chest tightness, and decreased blood pressure may occur. Stop the drug immediately if they occur. In addition, facial flushing and palpitations may occur occasionally. 4. Digestive system: Sometimes diarrhea, abdominal distension, and discomfort may occur. Occasionally, abdominal pain, loss of appetite, vomiting, constipation, and elevated transaminase may occur. 5. Mental and nervous system: Sometimes dizziness, headache, fever, fatigue, and occasionally numbness may occur. 6. Blood system: Occasionally, eosinophilia and leukopenia may occur. 7. Others: Occasionally, decreased vision, swelling in the mouth, hair loss, pain in the limbs, edema, and urticaria may occur.

The following patients are contraindicated: 1. Patients with severe heart failure (heart failure). 2. Women who are pregnant or may become pregnant. 3. Patients with a history of allergic reaction to this preparation.

Precautions for children: For children with congenital heart disease, the recommended infusion rate is 5ng/kg/min. Precautions for pregnancy and lactation: Precautions for pregnant or potentially pregnant women. Precautions for the elderly: No special instructions, please follow the doctor's advice.

Avoid mixing with plasma expanders (dextran, gelatin preparations, etc.).

Keep in dark place, store at 0-5℃, avoid freezing.

2 ml: 10 u g

12 months.

Hainan Bikai Pharmaceutical Co., Ltd.

• Founded in:

  1993-03-22

• Address:

  No. 10, Yaogu 1st Road, Haikou National High-tech Industrial Development Zone, Hainan Province

• Tax NO.:

  91460100284031692C

• Registered Funds:

  20 million yuan

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