AZITHROMYCIN- azithromycin monohydrate injection, powder, lyophilized, for solution

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

AZITHROMYCIN MONOHYDRATE (UNII: JTE4MNN1MD) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M)

Доступна с:

Athenex Pharmaceutical Division, LLC.

ИНН (Международная Имя):

azithromycin monohydrate

состав:

azithromycin anhydrous 500 mg in 5 mL

Администрация маршрут:

INTRAVENOUS

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Azithromycin for injection is a macrolide antibacterial drug indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions listed below. due to Chlamydophila pneumoniae, Haemophilus influenzae, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus, or Streptococcus pneumoniae in patients who require initial intravenous therapy. due to Chlamydia trachomatis , Neisseria gonorrhoeae , or Mycoplasma hominis in patients who require initial intravenous therapy. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with azithromycin for injection. Azithromycin for injection should be followed by azithromycin by the oral route as required [see Dosage and Administration ( 2)] . To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Azithromycin is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide drugs. Azithromycin is contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin. Risk Summary Available data from published literature and postmarketing experience over several decades with azithromycin use in pregnant women have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). Developmental toxicity studies with azithromycin in rats, mice, and rabbits showed no drug-induced fetal malformations at doses up to 4, 2, and 2 times, respectively, an adult human daily dose of 500 mg based on body surface area. Decreased viability and delayed development were observed in the offspring of pregnant rats administered azithromycin from day 6 of pregnancy through weaning at a dose equivalent to 4 times an adult human daily dose of 500 mg based on body surface area (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Available data from published observational studies, case series, and case reports over several decades do not suggest an increased risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes with azithromycin use in pregnant women. Limitations of these data include the lack of randomization and inability to control for confounders such as underlying maternal disease and maternal use of concomitant medications. Animal Data Reproductive and developmental toxicology studies have not been conducted using IV administration of azithromycin to animals. Azithromycin administered during the period of organogenesis did not cause fetal malformations in rats and mice at oral doses up to 200 mg/kg/day (moderately maternally toxic). Based on body surface area, this dose is approximately 4 (rats) and 2 (mice) times an adult human daily dose of 500 mg. In rabbits administered azithromycin at oral doses of 10, 20, and 40 mg/kg/day during organogenesis, reduced maternal body weight and food consumption were observed in all groups; no evidence of fetotoxicity or teratogenicity was observed at these doses, the highest of which is estimated to be 2 times an adult human daily dose of 500 mg based on body surface area. In a pre- and post-natal development study, azithromycin was administered orally to pregnant rats from day 6 of pregnancy until weaning at doses of 50 or 200 mg/kg/day. Maternal toxicity (reduced food consumption and body weight gain; increased stress at parturition) was observed at the higher dose. Effects in the offspring were noted at 200 mg/kg/day during the post-natal development period (decreased viability, delayed developmental landmarks). These effects were not observed in a pre- and post-natal rat study when up to 200 mg/kg/day of azithromycin was given orally beginning on day 15 of pregnancy until weaning. Risk Summary Azithromycin is present in human milk (see Data) . Non-serious adverse reactions have been reported in breastfed infants after maternal administration of azithromycin (see Clinical Considerations) . There are no available data on the effects of azithromycin on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for azithromycin and any potential adverse effects on the breastfed infant from azithromycin or from the underlying maternal condition. Clinical Considerations Advise women to monitor the breastfed infant for diarrhea, vomiting, or rash. Data Azithromycin breastmilk concentrations were measured in 20 women after receiving a single 2 g oral dose of azithromycin during labor. Breastmilk samples collected on days 3 and 6 postpartum as well as 2 and 4 weeks postpartum revealed the presence of azithromycin in breastmilk up to 4 weeks after dosing. In another study, a single dose of azithromycin 500 mg was administered intravenously to 8 women prior to incision for cesarean section. Breastmilk (colostrum) samples obtained between 12 and 48 hours after dosing revealed that azithromycin persisted in breastmilk up to 48 hours. Safety and effectiveness of azithromycin for injection in children or adolescents under 16 years have not been established. In controlled clinical studies, azithromycin has been administered to pediatric patients (age 6 months to 16 years) by the oral route. For information regarding the use of azithromycin for oral suspension in the treatment of pediatric patients, [see Indications and Usage ( 1), and Dosage and Administration ( 2)] of the prescribing information for azithromycin for oral suspension 100 mg/5 mL and 200 mg/5 mL bottles. Pharmacokinetic studies with intravenous azithromycin have not been performed in older volunteers. Pharmacokinetics of azithromycin following oral administration in older volunteers (65 to 85 years old) were similar to those in younger volunteers (18 to 40 years old) for the 5-day therapeutic regimen. In multiple-dose clinical trials of intravenous azithromycin in the treatment of community-acquired pneumonia, 45% of patients (188/414) were at least 65 years of age and 22% of patients (91/414) were at least 75 years of age. No overall differences in safety were observed between these subjects and younger subjects in terms of adverse reactions, laboratory abnormalities, and discontinuations. Similar decreases in clinical response were noted in azithromycin- and comparator-treated patients with increasing age. Azithromycin for injection contains 114 mg (4.96 mEq) of sodium per vial. At the usual recommended doses, patients would receive 114 mg (4.96 mEq) of sodium. The geriatric population may respond with a blunted natriuresis to salt loading. The total sodium content from dietary and non-dietary sources may be clinically important with regard to such diseases as congestive heart failure. Elderly patients may be more susceptible to development of torsades de pointes arrhythmias than younger patients [see Warnings and Precautions ( 5.4)] .

Обзор продуктов:

Azithromycin for Injection, USP is supplied as follows: Azithromycin for Injection, USP is supplied in lyophilized form under a vacuum in a 10 mL single-dose vial equivalent to 500 mg of azithromycin for intravenous administration. Each vial also contains sodium hydroxide and 384.5 mg citric acid. Storage Conditions Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. *Normosol ® -M in 5% dextrose and Normosol ® -R in 5% dextrose are the trademarks of Hospira.

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

AZITHROMYCIN- AZITHROMYCIN MONOHYDRATE INJECTION, POWDER, LYOPHILIZED,
FOR
SOLUTION
ATHENEX PHARMACEUTICAL DIVISION, LLC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AZITHROMYCIN FOR
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
AZITHROMYCIN FOR
INJECTION.
AZITHROMYCIN FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Warnings and Precautions, Cardiovascular Death ( 5.5)
11/2021
INDICATIONS AND USAGE
Azithromycin for injection is a macrolide antibacterial drug indicated
for mild to moderate infections
caused by designated, susceptible bacteria:
Community-acquired pneumonia in adults ( 1.1)
Pelvic inflammatory disease ( 1.2)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of azithromycin and
other antibacterial drugs, azithromycin should be used only to treat
or prevent infections that are proven
or strongly suspected to be caused by susceptible bacteria. ( 1.3)
DOSAGE AND ADMINISTRATION
Community-acquired pneumonia: 500 mg as a single daily dose by the
intravenous route for at least
two days. ( 2.1)
Pelvic inflammatory disease in adults: 500 mg as a single daily dose
by the intravenous route for one or
two days. ( 2.2)
DOSAGE FORMS AND STRENGTHS
Azithromycin for Injection, USP is supplied in lyophilized form in a
10 mL single-dose vial equivalent to 500
mg of azithromycin for intravenous administration. ( 3)
CONTRAINDICATIONS
Patients with known hypersensitivity to azithromycin, erythromycin,
any macrolide, or ketolide
antibacterial drug. ( 4.1)
Patients with a history of cholestatic jaundice/hepatic dysfunction
associated with prior use of
azithromycin. ( 4.2)
WARNINGS AND PRECAUTIONS
Serious (including fatal) allergic and skin reactions. Discontinue
azithromycin and initiate appropriate
therapy if reaction occurs. ( 5.1)
Hepatotoxicity: Severe and sometimes fatal, hepatoxicity has been
reported. Discontinue azithromycin
immediately if signs and sym