Alostin Injection (Alprostadil) (Pre-filled)

Adult administration

1. For chronic arterial occlusive disease, progressive systemic sclerosis, systemic lupus erythematosus, Raynaud's disease, and diabetic skin ulcers: Typically, adults receive 1-2 milliliters (5-10 micrograms of alprostadil) once daily, either as is or mixed with an infusion for slow intravenous or continuous infusion based on symptoms. 2. For ductus arteriosus-dependent congenital heart disease: Initially administer 5 ng/kg/min of alprostadil mixed in an infusion, maintaining this dose initially.

This medication may induce apnea when administered to newborns with ductus arteriosus-dependent congenital heart disease; therefore, it should be used only in medical institutions with respiratory management facilities. It should not be used in patients with severe heart failure or active bleeding, and it should be avoided in pregnant women or those who might become pregnant. Patients allergic to this medication or its ingredients, or who have sensitivities to soybean oil, soy, or peanuts, should also avoid its use. Patients with heart failure, glaucoma, peptic ulcers, interstitial pneumonia, renal failure, or a tendency to bleed should use this medication with caution. There may be an increased risk of bleeding for patients on anticoagulants, platelet inhibitors, or thrombolytics. This medication may cause side effects such as vascular pain, redness at the injection site, vomiting, abdominal pain, fever, etc. For newborns, adverse reactions like apnea, diarrhea, and hyponatremia have been reported. Serious side effects may include shock, anaphylaxis, loss of consciousness, worsening heart failure, pulmonary edema, progression of interstitial pneumonia, intracranial hemorrhage, gastrointestinal bleeding, and blood cell reduction; immediate cessation and appropriate measures are required if abnormal symptoms arise. During administration, monitoring for the occurrence of side effects is crucial, particularly for newborns or severely ill patients who require extra caution. This medication should not be mixed with other medications, especially plasma expanders or contrast agents. Safety has not been established for use in pregnant or breastfeeding women, and its safety has not been confirmed in children except for those with ductus arteriosus-dependent congenital heart disease. Elderly patients may have diminished physiological functions; dosage adjustments should be made with caution. Additionally, because this medication contains lipid emulsions, patients with lipid metabolism disorders should check their serum lipid levels and adjust their dosage accordingly. When used alongside anticoagulants or platelet inhibitors, the risk of bleeding may increase, hence consultation with healthcare professionals is advised. The medication must be administered according to medical personnel's instructions regarding proper dosage and infusion rate, and any abnormal symptoms should be promptly reported.

Serious side effects

• Urticaria
• severe swelling (edema)
• chest tightness
• difficulty breathing
• cold sweat
• pallor
• apnea
• shock
• anaphylactic syndrome
• laryngeal edema

Mild side effects

• Vascular pain
• redness at the injection site
• vomiting
• abdominal pain
• fever
• diarrhea
• hyponatremia
• elevated and lowered blood pressure
• vasculitis
• facial flushing

This medication should be stored in a sealed container to prevent air ingress and must not be allowed to freeze. It should be maintained at a temperature of 5 degrees Celsius or below and stored in a dark place away from direct light.

Appearance

A pre-filled injection in a colorless, transparent glass vial sealed with rubber stoppers at both ends, containing a white, uniform emulsion.

Package unit

1mL/vial × 10 vials 2mL/vial × 10 vials