Micafungin Sodium for Injection

Micafungin is a semisynthetic lipopeptide compound that competitively inhibits the synthesis of 1,3-b-D glucan, an essential component of fungal cell walls. Micafungin has broad-spectrum antifungal activity against Aspergillus and Candida, the main pathogens of deep fungal infections.

The main ingredient of this product is micafungin sodium. Excipients: lactose, anhydrous citric acid, sodium hydroxide

The following infections caused by Aspergillus and Candida species: fungemia, respiratory tract mycoses, gastrointestinal mycoses.

Aspergillosis: The general daily single dose for adults is 50-150 mg of micafungin sodium, intravenously infused once a day. For patients with severe or refractory aspergillosis, the dose can be increased to 300 mg/day depending on the patient's condition. Candidiasis: The general daily single dose for adults is 50 mg of micafungin sodium, intravenously infused once a day. For patients with severe or refractory candidiasis, the dose can be increased to 300 mg/day depending on the patient's condition. When this product is intravenously infused, it should be dissolved in normal saline, glucose injection or supplement solution. The infusion time should be no less than 30 minutes when the dose is less than 75 mg, and the infusion time should be no less than 1 hour when the dose is more than 75 mg. Do not use water for injection to dissolve this product (the solution is non-isotonic). Note: Since the safety of increasing the dose of this product to 300 mg per day for the treatment of severe or refractory infections has not been fully established, caution must be exercised when using this dose. Closely observe the patient's condition. (There have been no clinical trials in Japan with doses exceeding 150 mg per day, and clinical trials in other countries with doses of 300 mg per day are very limited.) For patients weighing 50 kg or less, the dose should not exceed 6 mg per kilogram of body weight per day.

In the Phase II clinical trial in Japan, 12 of the 67 patients treated (17.9/100) reported 12 adverse reactions to this product (excluding abnormal laboratory test values), including 2 cases of phlebitis (3/100), arthritis, vascular pain, chills, headache, hypertension, palpitations, diarrhea, loose stools, rash and maculopapular rash 1 case each (1.5/100). Laboratory test values abnormalities included: 3 cases of ALP increase (4.5/100) in 67 cases, 3 cases of BUN increase (4.5/100) in 67 cases, 2 cases of r-GT (3/100) in 66 cases, 2 cases of ALT (GLT) increase (3/100) in 67 cases, 2 cases of creatinine increase (3/100) in 67 cases, etc. 1. Possible adverse reactions in clinical practice Hematological abnormalities: Neutropenia (incidence 1.5/100), thrombocytopenia or hemolytic anemia may occur. Patients should be closely monitored through regular examinations, etc. If such abnormalities are observed, appropriate measures such as discontinuation of treatment must be taken. Shock, anaphylactic reactions: Shock or anaphylactic reactions may occur. Patients must be closely observed, and if abnormalities such as abnormal blood pressure, oral discomfort, dyspnea, diffuse flushing, angioedema or urticaria occur, treatment should be discontinued. If necessary, appropriate measures must be taken such as maintaining a patent airway, or using epinephrine, steroid hormones or antihistamines. Abnormal liver function or jaundice: Abnormal liver function or jaundice such as increased AST (GOT) and increased ALT (GPT) may occur. Acute renal failure: Severe renal insufficiency such as acute renal failure may occur.

It is contraindicated for those who have a history of allergy to any ingredient of this product.

Not yet clear.

Store tightly sealed.

50 mg