Zithromax Powder for Oral Suspension

Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2) ] Azithromycin is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: • Acute bacterial exacerbations of chronic bronchitis in adults () • Acute bacterial sinusitis in adults () • Uncomplicated skin and skin structure infections in adults () • Urethritis and ce …

• Adult Patients Infection Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity) Pharyngitis/tonsillitis (second-line therapy) Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
• Acute bacterial exacerbations of chronic bronchitis (mild to moderate) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5 or 500 mg once daily for 3 days
• Acute bacterial sinusitis 500 mg once daily for 3 days
• Genital ulcer disease (chancroid) Non-gonococcal urethritis and cervicitis One single 1 gram dose
• Gonococcal urethritis and cervicitis One single 2 gram dose. • Pediatric Patients Infection Recommended Dose/Duration of Therapy Acute otitis media (6 months of age and older) 30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5
• Acute bacterial sinusitis (6 months of age and older) 10 mg/kg once daily for 3 days
• Community-acquired pneumonia (6 months of age and older) 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5
• Pharyngitis/tonsillitis (2 years of age and older) 12 mg/kg once daily for 5 days. …

Azithromycin Tablets USP, 250 mg are white to off-white, modified capsule shaped, film-coated biconvex tablets, debossed with “66” on one side and “D” on other side. These are packaged in bottles and blister packs. Azithromycin Tablets USP, 500 mg are white to off-white, oval shaped, film-coated biconvex tablets, debossed with “67” on one side and “D” on other side. …

• [see , Indications and Usage , and ] Safety and effectiveness in the treatment of
• Pediatric patients with acute otitis media, acute bacterial sinusitis and community-acquired pneumonia under 6 months of age have not been established
• Use of azithromycin
• For the treatment of acute bacterial sinusitis and community-acquired pneumonia
• Pediatric patients (6 months of age or greater) is supported by adequate and well-controlled trials
• Adults. …

In multiple-dose clinical trials of oral azithromycin, 9% of patients were at least 65 years of age (458/4949) and 3% of patients (144/4949) were at least 75 years of age. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in response between the elderly and younger patients, but greater sensitivity of some older individ …

• Advise the patient to read the FDA-approved patient labeling (Patient Information)
• General Patient Counseling Azithromycin tablets can be taken with or without food
• Patients should also be cautioned not to take aluminum- and magnesium-containing antacids and azithromycin simultaneously
• The patient should be directed to discontinue azithromycin immediately and contact a physician if any signs of an allergic reaction occur
• Direct parents or caregivers to contact their physician if vomiting and irritability with feeding occurs in the infant
• Patients should be counseled that antibacterial drugs including azithromycin should only be used to treat bacterial infections. …

• Patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide drug. () • Patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin. () 4.1 Hypersensitivity Azithromycin tablets are contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide drug. …

• 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. () 7.1 Nelfinavir Co-administration of nelfinavir at steady-state with a single oral dose of azithromycin resulted in increased azithromycin serum concentrations. Although a dose adjustment of azithromycin is not recommended when administered in combination with nelfinavir, close monitoring for known adverse reactions of azithromycin, such as liver enzyme abnormalities and hearing impairment, is warranted. …

• Serious (including fatal) allergic and skin reactions: Discontinue azithromycin if reaction occurs. () • Hepatotoxicity: Severe, and sometimes fatal, hepatotoxicity has been reported. Discontinue azithromycin 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. …

The following clinically significant adverse reactions are described elsewhere in labeling: • Hypersensitivity [see ] • Hepatotoxicity [see ] • Infantile Hypertrophic Pyloric Stenosis (IHPS) [see ] • QT Prolongation [see Warnings and Precautions (5.4) ] • Cardiovascular Death [see ] • Clostridioides difficile- Associated Diarrhea (CDAD) [see ] • Exacerbation of Myasthenia Gravis [see ] Most common adverse reactions are diarrhea (5 to 14%), nausea (3 to 18%), abdominal pain (3 to 7%), or vomiting (2 to 7%). ( ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

8.1 Pregnancy 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) . …

Adverse reactions experienced at 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.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.