Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
ARTESUNATE (UNII: 60W3249T9M) (.ALPHA.-DIHYDROARTEMISININ - UNII:X0UIV26ABX)
Amivas, Inc
PRESCRIPTION DRUG
Artesunate for Injection is indicated for the initial treatment of severe malaria in adult and pediatric patients. Treatment of severe malaria with Artesunate for Injection should always be followed by a complete treatment course of an appropriate oral antimalarial regimen [see Dosage and Administration (2.1)] . Limitations of Use Artesunate for Injection does not treat the hypnozoite liver stage forms of Plasmodium and will therefore not prevent relapses of malaria due to Plasmodium vivax or Plasmodium ovale . Concomitant therapy with an antimalarial agent such as an 8-aminoquinoline drug is necessary for the treatment of severe malaria due to P. vivax or P. ovale [see Dosage and Administration (2.1)] . Known serious hypersensitivity to artesunate, such as anaphylaxis [See Warnings and Precautions (5.2) and Adverse Reactions (6.2)] . There are serious risks to the mother and fetus associated with untreated severe malaria during pregnancy; delaying treatment of severe malaria in pregnancy may result in ser
Artesunate for Injection is supplied as follows: Artesunate for Injection single-dose vial: NDC 73607-002-01 Sterile Diluent for Constitution single-dose vial: NDC 73607-003-02 Packages of 4 total vials (2 vials of Artesunate for Injection, 110 mg and 2 vials sterile diluent for Artesunate for Injection): NDC 73607-011-11 Store vials of Artesunate for Injection and sterile diluent in the carton at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Do not freeze. Avoid exposure to heat. Keep protected from light. Do not use beyond the expiration date.
New Drug Application
ARTESUNATE- ARTESUNATE AMIVAS, INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ARTESUNATE FOR INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ARTESUNATE FOR INJECTION. ARTESUNATE FOR INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2020 INDICATIONS AND USAGE Artesunate for Injection is an antimalarial indicated for the initial treatment of severe malaria in adult and pediatric patients. Treatment of severe malaria with Artesunate for Injection should always be followed by a complete treatment course of an appropriate oral antimalarial regimen. (1) Limitations of Use Artesunate for Injection does not treat the hypnozoite liver stage forms of _Plasmodium_ and will therefore not prevent relapses of malaria due to _Plasmodium vivax_ or _Plasmodium ovale_. Concomitant therapy with an antimalarial agent such as an 8-aminoquinoline drug is necessary for the treatment of severe malaria due _to P. vivax_ or _P. ovale_. (1) DOSAGE AND ADMINISTRATION • • • • DOSAGE FORMS AND STRENGTHS For Injection: 110 mg of artesunate as a powder in a single-dose vial for constitution with the supplied sterile diluent. (3) CONTRAINDICATIONS Serious hypersensitivity to artesunate, such as anaphylaxis. (4) WARNINGS AND PRECAUTIONS • • ADVERSE REACTIONS The most common adverse reactions (incidence of 2% or greater) reported with Artesunate for Injection in clinical trials of severe malaria include acute renal failure requiring dialysis, hemoglobinuria, and jaundice. (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT AMIVAS, INC AT [1-855-526-4827 (1-855- 5AMIVAS)] OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS Nevirapine or ritonavir antiretrovirals If used concomitantly, monitor for possible reduced antimalarial efficacy. (7, 12.3) Strong UGT inducers (e.g., rifampin, carbamazepine, phenytoin) The recommended dosage of Artesunate for Injection is 2.4 mg/kg administered intravenously at 0 hours, 12 hours, and Прочетете целия документ