Azithromycin Dihydrate (Zithromax)

Trade Name

Zithromax

Active Ingredient

Power

500 mg/5mL

Type / form

Tablets

Status

Manufacturer

Pfizer Laboratories Div Pfizer Inc

Storage and handling for Zithromax

AZITHROMYCIN DIHYDRATE Macrolide Antimicrobial [EPC],Macrolides [CS]

Disclaimer

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Azithromycin Dihydrate (Zithromax) which is also known as Zithromax and Manufactured by Pfizer Laboratories Div Pfizer Inc. It is available in strength of 500 mg/5mL per ml. Read more

Azithromycin Dihydrate (Zithromax) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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  • No data
  • ZITHROMAX (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.
  • ZITHROMAX is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria:
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZITHROMAX and other antibacterial drugs, ZITHROMAX should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. ()
  • Community-acquired pneumonia in adults ()
  • Pelvic inflammatory disease ()
  • [see and ]
  • Community-acquired pneumonia: 500 mg as a single daily dose by the intravenous route for at least two days. ()
  • Pelvic inflammatory disease in adults: 500 mg as a single daily dose by the intravenous route for one or two days. ()
  • ZITHROMAX for injection is supplied in lyophilized form in a 10 mL vial equivalent to 500 mg of azithromycin for intravenous administration.
  • ZITHROMAX (azithromycin) for injection is supplied in lyophilized form in a 10 mL vial equivalent to 500 mg of azithromycin for intravenous administration. ()
  • No data
  • Patients with known hypersensitivity to azithromycin, erythromycin, any macrolide, or ketolide antibacterial drug. ()
  • Patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin. ()
  • No data
  • Serious (including fatal) allergic reactions and skin reactions. Discontinue ZITHROMAX and initiate appropriate therapy if reaction occurs. ()
  • Hepatotoxicity: Severe and sometimes fatal, hepatoxicity has been reported. Discontinue Zithromax immediately if signs and symptoms of hepatitis occur. ()
  • Infantile Hypertrophic Pyloric Stenosis (IHPS): Following the use of azithromycin in neonates (treatment up to 42 days of life), IHPS has been reported. Direct parents and caregivers to contact their physician if vomiting or irritability with feeding occurs. ()
  • Prolongation of QT interval and cases of torsades de pointes have been reported. This risk which can be fatal should be considered in patients with certain cardiovascular disorders including known QT prolongation or history torsades de pointes, those with proarrhythmic conditions, and with other drugs that prolong the QT interval. ()
  • Clostridium difficile
  • ZITHROMAX may exacerbate muscle weakness in persons with myasthenia gravis. ()
  • Most common adverse reactions are nausea (4%), diarrhea (4%), abdominal pain (3%), or vomiting (1%). ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
  • No data
  • Nelfinavir: Close monitoring for known adverse reactions of azithromycin, such as liver enzyme abnormalities and hearing impairment, is warranted. ()
  • Warfarin: Use with azithromycin may increase coagulation times; monitor prothrombin time. ()
  • No data
  • Pediatric use: Safety and effectiveness in the treatment of patients under 16 years of age have not been established. ()
  • Geriatric use: Elderly patients may be more susceptible to development of torsades de pointes arrhythmias. ()
  • Adverse reactions experienced in higher than recommended doses were similar to those seen at normal doses particularly nausea, diarrhea, and vomiting. In the event of overdosage, general symptomatic and supportive measures are indicated as required.
  • ZITHROMAX for injection contains the active ingredient azithromycin, an azalide, a subclass of macrolide antibacterial drug, for intravenous injection. Azithromycin has the chemical name -13- [(2,6-dideoxy-3--methyl-3- -methyl-u03b1--hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-hepta-methyl- 11- [[3,4,6-trideoxy-3-(dimethylamino)-u03b2---hexopyranosyl]oxy]-1-oxa- 6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is CHNO, and its molecular weight is 749.00. Azithromycin has the following structural formula:
  • Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of CHNOu2219 2HO and a molecular weight of 785.0.
  • ZITHROMAX for injection consists of azithromycin dihydrate and the following inactive ingredients: citric acid and sodium hydroxide. ZITHROMAX for injection is supplied in lyophilized form in a 10 mL vial equivalent to 500 mg of azithromycin for intravenous administration. Reconstitution, according to label directions, results in approximately 5 mL of ZITHROMAX for intravenous injection with each mL containing azithromycin dihydrate equivalent to 100 mg of azithromycin.
  • No data
  • No data
  • In a controlled trial of community-acquired pneumonia performed in the U.S., azithromycin (500 mg as a single daily dose by the intravenous route for 2 to 5 days, followed by 500 mg/day by the oral route to complete 7 to 10 days therapy) was compared to cefuroxime (2250 mg/day in three divided doses by the intravenous route for 2 to 5 days followed by 1000 mg/day in two divided doses by the oral route to complete 7 to 10 days therapy), with or without erythromycin. For the 291 patients who were evaluable for clinical efficacy, the clinical outcome rates, i.e., cure, improved, and success (cure + improved) among the 277 patients seen at 10 to 14 days post-therapy were as follows:
  • In a separate, uncontrolled clinical and microbiological trial performed in the U.S., 94 patients with community-acquired pneumonia who received azithromycin in the same regimen were evaluable for clinical efficacy. The clinical outcome rates, i.e., cure, improved, and success (cure + improved) among the 84 patients seen at 10 to 14 days post-therapy were as follows:
  • Microbiological determinations in both trials were made at the pre-treatment visit and, where applicable, were reassessed at later visits. Serological testing was done on baseline and final visit specimens. The following combined presumptive bacteriological eradication rates were obtained from the evaluable groups:
  • Combined Bacteriological Eradication Rates for Azithromycin:
  • The presumed bacteriological outcomes at 10 to 14 days post-therapy for patients treated with azithromycin with evidence (serology and/or culture) of atypical pathogens for both trials were as follows:
  • ZITHROMAX for injection is supplied in lyophilized form under a vacuum in a 10 mL vial equivalent to 500 mg of azithromycin for intravenous administration. Each vial also contains sodium hydroxide and 413.6 mg citric acid.
  • These are packaged as follows:
  • Before reconstitution, store vials at or below 30u00b0C (86u00b0F) .
  • Patients should be informed of the following serious and potentially serious adverse reactions that have been associated with ZITHROMAXn
  • Diarrhea:
  • Licensed from Pliva Vial-Mate is a registered trademark of Baxter International Inc., Reg. U.S. Pat and TM Off.
  • This product's label may have been updated. For current full prescribing information, please visit www.pfizer.comn
  • LAB-0024-19.0
  • NDC 0069-3150-84n n
  • Zithromax
  • 500 mg
  • For infusion only
  • STERILE
  • No Latex No Preservative
  • Pfizer Injectables
  • 10 Vials
  • NDC 0069-3150-83Contains 10 of NDC 0069-3150-84n
  • Rx only
  • Zithromaxn
  • 500 mg/vial
  • Sterile
  • Forinfusion onlyEquivalent to 500 mg/vial of azithromycinTo yield 100 mg/mL* of solution when reconstituted as directed
  • No LatexNo Preservative
  • Pfizer Injectables

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