BERAPROST SODIUM

Indications & Dose:

• BY MOUTH

In primary pulmonary hypertension

60 mcg daily in three divided doses; this may be increased gradually if necessary to 180 mcg daily in three or four divided doses.

For peripheral vascular disease a dose

120 mcg daily in three divided doses is used

Contraindications:

Patients with hemorrhage (e.g., hemophilia, capillary fragility, upper gastrointestinal hemorrhage, urinary tract hemorrhage, hemoptysis, vitreous hemorrhage). Pregnant woman or woman might to be pregnant

Side Effects:

Headache, flushing, nausea, diarrhoea, and increased liver enzyme, bilirubin, and triglyceride concentrations

Cautions:

Precautions:

Interaction:

Warnings:

Beraprost Sodium) tablets should be administered with caution in the following patients. Patients on medication with anticoagulants or antiplatelet agents (e.g., aspirin and ticlopidine). [It has a risk of enhancing the activity of anticoagulants and antiplatelet agents and of promoting bleeding tendency.] Patients in menstruation. [It has a risk of promoting bleeding tendency.] Patients with bleeding tendency or diathesis thereof. [It has a risk of promoting bleeding tendency.] Hepatic function disorders: Since hepatic function disorders accompanied by jaundice and markedly increased GOT and GPT may occur, the patient should be kept under observation. Medication should be discontinued and appropriate treatments should be conducted, if such symptoms are observed.

Use in the Elderly: Since the elderly often have lowered physiological functions, this product should be administered with caution.

Use during Pregnancy or Lactation: Since safety in pregnant women has not been established, this product should not be administered to pregnant women. Since beraprost sodium has been reported to be transferred in milk in animal experiments (rats), administration of this product to nursing mothers should be avoided. If use of this product is unavoidable, the nursing mother should discontinue breast-feeding.

Pediatric use: Safety in children has not been established.

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Patient And Carer Advice: