Micafungin package insert pdf

Noxafil is an azole antifungal agent indicated for. Mycamine is a sterile, lyophilized product for intravenous iv infusion that contains micafungin sodium. Rats administered micafungin sodium for 3 months at 32 mgkgday. Breakthrough invasive candidiasis in patients on micafungin. The purpose of this site is to make the package inserts for south african medicines available to the public in electronic format. In general, micafungin is widely distributed throughout the body. Each vial contains 50 mg of amphotericin b, usp, intercalated into a liposomal membrane consisting of approximately 0. The responses to echinocandin therapy in each study were determined by the investigator at the end of therapy as cured, improved, or failed. Mycamine micafungin is an antifungal medication that fights infections caused by fungus. Jan 20, 2020 mycamine micafungin is an antifungal medication that fights infections caused by fungus. Mycamine is a sterile, lyophilized product for intravenous iv infusion that.

Since grapefruit juice is known to inhibit cyp3amediated metabolism of oral amiodarone in the intestinal mucosa, resulting in increased plasma levels of amiodarone, do not drink grapefruit juice during treatment. Composition and packaging section of the product monograph. Since grapefruit juice is known to inhibit cyp3amediated metabolism of oral amiodarone in the intestinal mucosa, resulting in increased plasma levels of amiodarone, do not drink grapefruit juice during treatment with oral amiodarone see drug interactions 7. Antimicrobial activity ambisome has shown in vitro activity comparable to amphotericin b against the following organisms. Mycamine support solutions, a component of astellas pharma support solutions sm, offers access and reimbursement support to help patients overcome challenges to accessing mycamine micafungin for injection. Diflucan tablets contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole and the following inactive ingredients. However, since cmv usually causes latent infections and since foscarnet, like. Equilibrate the refrigerated vial of noxafilposaconazoleinjectionto room temperature. Micafungins penetration into the cns is not fully defined. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Highlights of prescribing information these highlights do not include all the information needed to use cancidas safely and effectively.

Unchanged micafungin is the principal circulating compound in systemic circulation. You must also submit final promotional materials and package insert s, accompanied by a. Ambisome package insert pdf name of the medicinal product. Mar 20, 2020 noxafil is an azole antifungal agent indicated for. Micafungin is an echinocandin antifungal with a spectrum of activity that includes most candida species. Compare prices, print coupons and get savings tips for mycamine micafungin and other candidiasis and thrush drugs at cvs, walgreens, and other pharmacies. Mitomycin for injection is a sterile dry mixture of mitomycin and mannitol, which, when reconstituted with sterile water for injection, provides a solution for intravenous administration. Micafungin is an attractive antifungal drug in infants on ecmo because it is. Aspergillus fumigatus, aspergillus flavus, candida albicans, candida krusei, candida lusitaniae. Current recommended dosing for invasive candidiasis is 100 mg intravenously iv daily, with no adjustment in renal or mildtomoderate hepatic dysfunction.

Dailymed brevital sodium methohexital sodium injection. Mycamine is for use in adults and pediatric patients. Food and drug administration fda has approved its supplemental new drug application snda for mycamine micafungin for injection in support of the treatment of candidemia, acute disseminated candidiasis, candida peritonitis and abscesses without meningoencephalitis andor ocular dissemination. Based on the limited data, an echinocandin drug eg, anidulafungin, caspofungin, micafungin is recommended by the cdc as initial therapy for treatment of c auris infections. A total of 14 drugdrug interaction studies were conducted in healthy. Jan 01, 2017 micafungin injection is used to help the body overcome serious fungus infections, such as candidemia, acute disseminated candidiasis, candida peritonitis and abscess, and esophageal candidiasis. Dec 15, 2012 micafungin and levofloxacin are often used in combination as part of broadspectrum empirical antimicrobial therapy in hospitalized patients. Micafungin sodium 208538732 additional information hepatic carcinomas and adenomas were observed in a 6month intravenous toxicology study with an 18month recovery period of micafungin sodium in rats designed to assess the reversibility of hepatocellular lesions. Mycamine 50 mg powder for concentrate for solution for infusion mycamine 100 mg powder for concentrate for solution for infusion. The maximum loading dose and the daily maintenance dose should not exceed 70. Effectiveness and safety of micafungin in managing invasive fungal. It inhibits the production of beta1,3glucan, an essential component of fungal cell walls. Micafungin therapy in a critically ill, morbidly obese patient.

Micafungin, like other cyclic lipopeptides, noncompetitively inhibits the fungal specific enzyme 1,3betadglucan synthase, an enzyme essential for. Micafungin trade name mycamine is an echinocandin antifungal drug developed by astellas pharma. Linear relationship between dose and auc over dosage range of 50150 mg daily and 38 mgkg daily. Micafungin is a semisynthetic echinocandin derived from a natural product of the fungus coleophama empedri with potent antifungal activity. Micafungin has been shown to be metabolised to several compounds. Etest is a wellestablished method for antimicrobial susceptibility testing in microbiology laboratories around the world. Micafungin trade name mycamine is an echinocandin antifungal drug used to treat and prevent invasive fungal infections including candidemia, abscesses and esophageal candidiasis. Micafungin in the treatment of invasive candidiasis and. Pdf micafungin in the treatment of invasive candidiasis and. Micafungin sodium pharmacokinetics absorption plasma concentrations. Micafungin sodium is a semisynthetic lipopeptide echinocandin synthesized by a chemical modification of a fermentation product of coleophoma empetri f11899.

Mics were determined and hotspot regions within fks genes were sequenced. Mycamine 50mg and 100mg powder for concentrate for solution. Data suggest that less than 5% of a dose gets distributed into the cerebrospinal fluid csf. Mycamine is a sterile, white, powder for injection containing the. In clinical trials, one class iii patients death was judged attributable to the interruption of flolan. Micafungin s penetration into the cns is not fully defined. As the only fdacleared assay for micafungin susceptibility testing of. Each vial contains either mitomycin 5 mg and mannitol 10 mg, or mitomycin 20 mg and mannitol 40 mg, or mitomycin 40 mg and mannitol 80 mg. Mycamine micafungin dosing, indications, interactions. The mean duration of micafungin therapy was comparable for micafungin 100 mgday and 150 mgday 7. Micafungin package insert download here free healthcaremagic app to ask a doctor all the information, content and live chat provided on the site is intended to be for informational purposes only, and not a substitute for professional or medical advice.

Reconstitute mycamine vials by aseptically adding 5 ml of one of the. Micafungin, like other cyclic lipopeptides, noncompetitively inhibits the fungal specific enzyme 1,3betadglucan synthase, an enzyme essential for fungal cell wall synthesis. Ambisome amphotericin b liposome for injection description ambisome for injection is a sterile, nonpyrogenic lyophilized product for intravenous infusion. Mycamine micafungin sodium dose, indications, adverse. Micafungin is also used to prevent candida infections in patients having a stem cell transplant. Micafungin package insert doctor answers on healthcaremagic. Fda approves expanded indication of mycamine micafungin. A lower dose of micafungin sodium equivalent to 5 times the human auc in the 6month rat study resulted in a lower incidence of adenomas and carcinomas following 18 months recovery. These were all multiinstitutional studies, the details of which are described elsewhere 4, 28, 30, 35, 45, 56, 60, 61, 63.

Micafungin side effects, dosage, interactions drugs. Eliminate the time required to manage multiple protocols and increase productivity and efficiency by consolidating your antifungal susceptibility testing onto a single format with thermo scientific sensititre yeastone plates. Jul 24, 2019 methohexital sodium is a rapid, ultrashortacting barbiturate anesthetic. Mycamine is used to treat infections caused by the candida fungus. Mycamine, innmicafungin european medicines agency europa. The package inserts are indexed in three different ways. Micafungin by injection national library of medicine. The efficacy and safety will be evaluated at baseline, the during the treatment, at the end of treatment eot and two weeks after eot.

For candida species, a bimodal wildtype mic distribution for echinocandins exists, but resistance to echinocandins is rare. Download leaflet view the patient leaflet in pdf format. Mycamine micafungin for injection, for intravenous use. Micafungin injection is used to help the body overcome serious fungus infections, such as candidemia, acute disseminated candidiasis, candida peritonitis and abscess, and esophageal candidiasis. Correlation of mic with outcome for candida species tested. Visual compatibility of micafungin sodium and levofloxacin. Has not been adequately studied in patients with endocarditis, osteomyelitis, and meningoencephalitis due to candida. Do not mix micafungin with any other medicines, or give other medicines through the.

Pharmacoeconomic analysis of micafungin mycamine 100 mg and. Zosyn is a monosodium salt of piperacillin and a monosodium salt of tazobactam containing a. Nafcillin for injection, usp sagent pharmaceuticals. Mycamine 50 mg powder for concentrate for solution for infusion. Each singleuse vial contains 50 mg or 100 mg micafungin sodium, 200 mg. Each gram is buffered with 40 mg sodium citrate and contains 66. Methohexital sodium for injection is a freezedried, sterile, nonpyrogenic mixture of methohexital sodium with 6% anhydrous sodium carbonate added as a buffer. We characterized isolates from patients with invasive candidiasis ic breaking through. Micafungin treatment for ic or prophylaxis for candida infection was. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Etest consists of a predefined gradient of antibiotic concentrations on a plastic strip and is used to determine the minimum inhibitory concentration mic of antibiotics, antifungal agents and antimycobacterial agents. Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Mycamine fda prescribing information, side effects and uses.

The duration of micafungin dosing in these rat studies 3 or 6 months exceeds the usual duration of mycamine dosing in patients, which is typically less than. It is also used to prevent candida fungal infections in stem cell transplant patients. Micafungin must be given slowly through an iv infusion, and each injection can take at least 1 hour to complete. Flolan is a potent pulmonary and systemic vasodilator and can cause hypotension and other. It inhibits the production of beta1, 3glucan, an essential component of fungal cell walls development of ta in the post within 12 months from20 years mean 4. Methohexital sodium is a rapid, ultrashortacting barbiturate anesthetic. Micafungin is an echinocandin antifungal agent available for clinical use in japan, europe, and the united states. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for dilantin phenytoin. Mucomist respirator solution, acetylcysteine usp 200 mg ml solution for inhalation not for injection description mucomist respirator solution is a derivative of the amino acid, cysteine. Mycamine support solutions provides information regarding patient healthcare coverage options and financial assistance options that may be available to help patients with financial needs. Micafungin and levofloxacin are often used in combination as part of broadspectrum empirical antimicrobial therapy in hospitalized patients.

The infusion bagbottle containing the diluted infusion solution should be inserted into. Do not use if there is any evidence of precipitation or foreign matter. Pharmacokinetics and safety of micafungin in infants supported with. So mg micaungln equivalent to so mg mecafungtn sodium. Mycamine micafungin is an intravenous echinocandin initially approved on 16mar2005 for the. Mucomist respirator solution acetylcysteine usp 200 mg. Guidelines from the infectious diseases society of america recommend the use of micafungin and levofloxacin concomitantly as alternative therapy in highrisk febrile neutropenic patients to prevent fungal and bacterial infections, respectively. Do not mix micafungin with any other medicines, or.