Azithromycin monohydrate 500 mg/10mL
Azithromycin monohydrate · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Gland Pharma Limited
Azithromycin Monohydrate is a prescription antibiotic injection used to treat bacterial infections. It is given intravenously and comes as a powder that must be mixed with liquid before administration.
Key Facts
- Brand Name
- Azithromycin monohydrate
- Generic Name
- Azithromycin monohydrate
- NDC Code (Product)
68083-199- Manufacturer
- Gland Pharma Limited
- Strength
- 500 mg/10mL
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA065501
- Marketing Start
- 11/09/2009
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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. 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) 1.1 Community-Acquired Pneumonia due to Chlamydophila pneumoniae , Haemophilus influenzae , Legionella pneumophila , Moraxella catarrhalis , Mycoplasma pneumoniae , Staphylococcus aureus , or Streptococcus pneumoniae in patients who require initial intravenous therapy. 1.2 Pelvic Inflammatory Disease due to Chlamydia trachomatis , Neisseria gonorrhoeae , or Mycoplasma hominis in patients who require initial intravenous therapy. If anaerobic microorg…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION [See Indications and Usage (1) and Clinical Pharmacology (12.3) ] • 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 ) 2.1 Community-Acquired Pneumonia The recommended dose of azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250 mg tablets to complete a 7- to 10-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response. 2.2 Pelvic Inflammatory Disease The recommended dose of azithromycin for injection for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous t…
Contraindications
4 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 ) 4.1 Hypersensitivity Azithromycin is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide drugs. 4.2 Hepatic Dysfunction Azithromycin is 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. ( 7.1 ) • Warfarin: Use with azithromycin may increase coagulation times; monitor prothrombin time. ( 7.2 ) 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 wit…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: Hypersensitivity [see Warnings and Precautions (5.1) ] Hepatotoxicity [see Warnings and Precautions (5.2) ] Infantile Hypertrophic Pyloric Stenosis (IHPS) [see Warnings and Precautions (5.3) ] QT Prolongation [see Warnings and Precautions (5.4) ] Cardiovascular Death [see Warnings and Precautions (5.5) ] Clostridioides difficile- Associated Diarrhea (CDAD) [see Warnings and Precautions (5.6) ] Exacerbation of Myasthenia Gravis [see Warnings and Precautions (5.7) ] Most common adverse reactions are nausea (4%), diarrhea (4%), abdominal pain (3%), or vomiting (1%). ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma at 864-879-9994 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 of intravenous azithromycin for community-acquired pneumonia, in which 2…
Frequently Asked Questions
What is Azithromycin monohydrate used for?
Azithromycin Monohydrate is a prescription antibiotic injection used to treat bacterial infections. It is given intravenously and comes as a powder that must be mixed with liquid before administration.
Is Azithromycin monohydrate a controlled substance?
Azithromycin monohydrate is not classified as a controlled substance by the DEA.
What is the generic name for Azithromycin monohydrate?
The generic name for Azithromycin monohydrate is Azithromycin monohydrate. There are 6 other brand versions of Azithromycin monohydrate.
What is the NDC code for Azithromycin monohydrate 500 mg/10mL?
The NDC (National Drug Code) for Azithromycin monohydrate 500 mg/10mL is 68083-199, listed by Gland Pharma Limited.