new release of HABEKASIN® injection 200 mg for treatment of MRSA infection
Meiji Seika Kaisha (Headquarters: Chuo-ku, Tokyo; president: Tadaharu Sato) received approval for manufacturing and marketing on February 29 this year, and has received methicillin-resistant Staphylococcus aureus (MRSA) We will inform you that we will release the Havelikashin ® injection 200 mg (generic name: arbekasin sulfate injection) for infectious disease treatment on June 30.
"Havekacin® injection" is an aminoglycoside antimicrobial drug developed by the Company and was approved in 1990 as the first medicament for MRSA infection in Japan and has been used as a drug highly useful for MRSA infection up to this day . This release of "HABEKASIN® injection 200 mg" is based on the administration method that divides 200 mg daily dose for adults, which is the dosage at the time of initial approval, into two doses, from the administration method approved on February 29 this year It corresponds to partial change of dosage and dose for once-a-day administration.
Partial change of dosage/dose is to bring the benefit of this drug which shows the short-term bactericidal action depending on the concentration of the drug to higher therapeutic effect.
Regarding the therapeutic effects of antibiotics and the side effects/resistance tolerance, it has been pointed out in recent years that they are related to the pharmacokinetics of drugs. From the viewpoint of proper use of pharmaceuticals, PK/PD (pharmacokinetics and drugs Dynamics) Appropriate administration design of antibiotics based on theory is emphasized. Aminoglycoside antibiotics have been found to correlate with the maximum blood concentration and efficacy, and at the same time it has been found that there is a correlation between the lowest blood level and the occurrence of side effects, and also in this drug, the clinical drug As a result of extensive studies on the establishment of an appropriate administration method suitable for drug properties by carrying out blood monitoring, it was effective to raise the maximum blood concentration to 9 to 20 μg/ml as a guideline by administration once a day On the other hand, clinical results were suggested suggesting that suppression of the lowest blood level to 2 μg/ml or less, which is regarded as a safe area for avoiding side effects, is the optimal treatment method.
Based on this fact, we applied for approval for partial change of dosage/dose, but in addition to applying from our company for partial change of dosage/dose, in addition to applying for improvement of treatment effect and suppression of resistant bacteria, It is the circumstance that the request form was submitted to the Ministry of Health, Labor and Welfare from the corporation Japan Chemotherapy Society, and it was also the content that was desired in the clinical setting.
We will add the 200 mg formulation released this time to existing "HABEKACIN® injection" and will further contribute to the treatment of domestic MRSA infection.
Product outline of "HABEKACIN® injection 200 mg"
Sales name: "HABEKACIN® injection 200 mg"
Common name: arbekasin sulfate injection
Ingredients · Content: (HABEKACIN® injection 200 mg)
Contains 200 mg (potency) of arbekasin sulfate in 1 ml ampule 4 ml.
Adaptive fungal species: Methicillin-resistant Staphylococcus aureus (MRSA) sensitive to arbekacin
Indications Sepsis, |
