Azithromycin 200 mg/5mL
Azithromycin · POWDER, FOR SUSPENSION · NuCare Pharmaceuticals,Inc.
Azithromycin is a powder, for suspension containing azithromycin at 200 mg/5mL, taken oral. Manufactured by NuCare Pharmaceuticals,Inc..
Key Facts
- Brand Name
- Azithromycin
- Generic Name
- Azithromycin
- NDC Code (Product)
68071-4779- Manufacturer
- NuCare Pharmaceuticals,Inc.
- Strength
- 200 mg/5mL
- Dosage Form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA211147
- Marketing Start
- 08/06/2018
Recall History
PD-Rx Pharmaceuticals, Inc.
cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.
American Health Packaging
CGMP Deviations: Firm did not adequately investigate customer complaints.
Kroger Specialty Pharmacy, Inc.
Lack of Processing Controls.
American Health Packaging
CGMP Deviations: Firm did not adequately investigate customer complaints.
Wockhardt Usa Inc.
CGMP Deviations: Firm did not adequately investigate customer complaints.
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Wockhardt Usa Inc.
CGMP Deviations: Firm did not adequately investigate customer complaints.
Health Innovations Pharmacy, Inc
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
PD-Rx Pharmaceuticals, Inc.
cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.
Wockhardt Usa Inc.
CGMP Deviations: Firm did not adequately investigate customer complaints.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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 cervicitis in adults () • Genital ulcer disease in men () • Acute otitis media in pediatric patients (6 months of age and older) ( 1.2 ) • Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) (, 1.2 ) • Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) (, 1.2 ) Limitation of Use: Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of mode…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • 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…
Contraindications
4 CONTRAINDICATIONS • 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. 4.2 Hepatic Dysfunction Azithromycin tablets are contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin.
Drug Interactions
7 DRUG INTERACTIONS • 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. [see Adverse Reactions (6) ] 7.2 Warfarin Spontaneous postmarketing reports suggest that concomitant administration of azithromycin may potentiate the effects of oral anticoagulants such as warfarin, although the prothrombin time was not affected in the dedicated drug interaction study with azithromycin and warfarin. Prothrombin times should be carefully monitored while patients are receiving azithromycin and oral anticoagulants concomitantly. 7.3 Potential Drug-Drug Interaction with Macrolides Interactions with digoxin,…
Adverse Reactions
6 ADVERSE REACTIONS 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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials, most of the reported side effects were mild to moderate in severity and were reversible upon discontinuation of the drug. Potentially serious adverse reactions of angioedema and cholestatic jaundice were rep…
Frequently Asked Questions
What is Azithromycin used for?
Azithromycin contains Azithromycin. It is a powder, for suspension taken oral. Consult your doctor for specific uses.
Is Azithromycin a controlled substance?
Azithromycin is not classified as a controlled substance by the DEA.
What is the generic name for Azithromycin?
The generic name for Azithromycin is Azithromycin. There are 8 other brand versions of Azithromycin.
What is the NDC code for Azithromycin 200 mg/5mL?
The NDC (National Drug Code) for Azithromycin 200 mg/5mL is 68071-4779, listed by NuCare Pharmaceuticals,Inc..