Azithromycin

Azithromycin

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin tablets USP and other antibacterial drugs, azithromycin tablets USP 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 tablets USP are 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)].

 

•Acute bacterial exacerbations of chronic bronchitis due to

Haemophilus influenzae

,

Moraxella catarrhalis,

or

Streptococcus pneumoniae

. •Acute bacterial sinusitis due to

Haemophilus influenzae

,

Moraxella catarrhalis.

or

Streptococcus pneumoniae

. •Community-acquired pneumonia due to

Chlamydophila pneumoniae

,

Haemophilus influenzae

,

Mycoplasma pneumoniae,

or

Streptococcus pneumoniae

in patients appropriate for oral therapy. •Pharyngitis/tonsillitis caused by

Streptococcus pyogenes

as an alternative to first-line therapy in individuals who cannot use first-line therapy. •Uncomplicated skin and skin structure infections due to

Staphylococcus aureus

,

Streptococcus pyogenes

, or

Streptococcus agalactiae

. •Urethritis and cervicitis due to

Chlamydia trachomatis

or

Neisseria gonorrhoeae

. •Genital ulcer disease in men due to

Haemophilus ducreyi

(chancroid). Due to the small number of women included in clinical trials, the efficacy of azithromycin in the treatment of chancroid in women has not been established.

 

[see Use in Specific Populations (8.4) and Clinical Studies (14.2)]

•Acute otitis media (> 6 months of age) caused by

Haemophilus influenzae

,

Moraxella catarrhalis,

or

Streptococcus pneumoniae

•Community-acquired pneumonia (> 6 months of age) due to

Chlamydophila pneumoniae

,

Haemophilus influenzae

,

Mycoplasma pneumonia

, or

Streptococcus pneumoniae

in patients appropriate for oral therapy. •Pharyngitis/tonsillitis (> 2 years of age) caused by

Streptococcus pyogenes

as an alternative to first-line therapy in individuals who cannot use first-line therapy.

 

Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following:

•patients with cystic fibrosis, •patients with nosocomial infections, •patients with known or suspected bacteremia, •patients requiring hospitalization, •elderly or debilitated patients, or •patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia).

 

History

There is currently no drug history available for this drug.

Other Information

Azithromycin tablets USP contain the active ingredient azithromycin, USP, a macrolide antibacterial drug, for oral administration. Azithromycin, USP has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin, USP is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring.

Azithromycin, USP has the following structural formula:

MM1

C38H72N2O12 M.W. 749

Azithromycin, USP, as the monohydrate, is a white crystalline powder with a molecular formula of C38H72N2O12•H2O and a molecular weight of 767.

Azithromycin tablets USP are supplied for oral administration as tablets containing azithromycin monohydrate equivalent to either 250 mg or 500 mg azithromycin, USP and the following inactive ingredients: corn starch, dibasic calcium phosphate anhydrous, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium citrate, sodium lauryl sulfate, and titanium dioxide.

The 500 mg tablets also contain FD&C blue #2.

 

Azithromycin Manufacturers


  • Remedyrepack Inc.
    Azithromycin Tablet, Film Coated [Remedyrepack Inc. ]
  • Preferred Pharmaceuticals, Inc.
    Azithromycin Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]
  • Remedyrepack Inc.
    Azithromycin Tablet, Film Coated [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Azithromycin Tablet, Film Coated [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Azithromycin Tablet, Film Coated [Remedyrepack Inc. ]
  • American Health Packaging
    Azithromycin Tablet, Film Coated [American Health Packaging]
  • American Health Packaging
    Azithromycin Tablet, Film Coated [American Health Packaging]
  • Remedyrepack Inc.
    Azithromycin Tablet, Film Coated [Remedyrepack Inc. ]
  • Cardinal Health
    Azithromycin (Azithromycin Monohydrate) Injection, Powder, Lyophilized, For Solution [Cardinal Health]
  • Remedyrepack Inc.
    Azithromycin Tablet, Film Coated [Remedyrepack Inc. ]
  • Proficient Rx Lp
    Azithromycin Powder, For Suspension [Proficient Rx Lp]
  • Kaiser Foundation Hospitals
    Azithromycin Tablet, Film Coated [Kaiser Foundation Hospitals]
  • Rebel Distributors Corp.
    Azithromycin (Azithromycin) Tablet, Film Coated [Rebel Distributors Corp.]
  • Dispensing Solutions Inc.
    Azithromycin Tablet, Film Coated [Dispensing Solutions Inc.]
  • Physicians Total Care, Inc.
    Azithromycin (Azithromycin Monohydrate) Powder, For Suspension [Physicians Total Care, Inc.]
  • Apotex Corp.
    Azithromycin (Azithromycin For Injection Injection, Powder, Lyophilized, For Solution) Injection [Apotex Corp.]
  • Wockhardt Usa Llc.
    Azithromycin Tablet, Film Coated [Wockhardt Usa Llc.]
  • Wockhardt Limited
    Azithromycin Tablet, Film Coated [Wockhardt Limited]
  • Wockhardt Limited
    Azithromycin Tablet, Film Coated [Wockhardt Limited]
  • Wockhardt Usa Llc.
    Azithromycin Tablet, Film Coated [Wockhardt Usa Llc.]
  • Stat Rx Usa Llc
    Azithromycin Tablet, Film Coated [Stat Rx Usa Llc]
  • Remedyrepack Inc.
    Azithromycin Tablet [Remedyrepack Inc. ]
  • American Health Packaging
    Azithromycin Tablet, Film Coated [American Health Packaging]
  • Lake Erie Medical Dba Quality Care Products Llc
    Azithromycin Tablet [Lake Erie Medical Dba Quality Care Products Llc]
  • Physicians Total Care, Inc.
    Azithromycin Tablet, Film Coated [Physicians Total Care, Inc.]
  • Cardinal Health
    Azithromycin Injection, Powder, Lyophilized, For Solution [Cardinal Health]
  • Dispensing Solutions, Inc.
    Azithromycin Tablet, Film Coated [Dispensing Solutions, Inc.]
  • Dispensing Solutions, Inc.
    Azithromycin Tablet, Film Coated [Dispensing Solutions, Inc.]
  • Dispensing Solutions, Inc.
    Azithromycin Powder, For Suspension [Dispensing Solutions, Inc.]
  • Rebel Distributors Corp.
    Azithromycin (Azithromycin Monohydrate) Powder, For Suspension [Rebel Distributors Corp.]
  • Remedyrepack Inc.
    Azithromycin Tablet [Remedyrepack Inc. ]
  • Medvantx, Inc.
    Azithromycin Tablet, Film Coated [Medvantx, Inc.]
  • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    Azithromycin Tablet, Film Coated [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]
  • Remedyrepack Inc.
    Azithromycin (Azithromycin Anhydrous) Tablet [Remedyrepack Inc. ]
  • H.j. Harkins Company, Inc.
    Azithromycin Tablet, Film Coated [H.j. Harkins Company, Inc.]
  • Avpak
    Azithromycin (Azithromycin) Tablet, Film Coated [Avpak]
  • Physicians Total Care, Inc.
    Azithromycin Tablet, Film Coated [Physicians Total Care, Inc.]
  • Physicians Total Care, Inc.
    Azithromycin Powder, For Suspension [Physicians Total Care, Inc.]
  • Unit Dose Services
    Azithromycin Tablet, Film Coated [Unit Dose Services]
  • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    Azithromycin Tablet, Film Coated [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]
  • American Health Packaging
    Azithromycin Tablet, Film Coated [American Health Packaging]
  • Unit Dose Services
    Azithromycin Tablet, Film Coated [Unit Dose Services]
  • Major Pharmaceuticals
    Azithromycin Tablet, Film Coated [Major Pharmaceuticals]
  • Pd-rx Pharmaceuticals, Inc.
    Azithromycin Tablet, Film Coated [Pd-rx Pharmaceuticals, Inc.]
  • Remedyrepack Inc.
    Azithromycin (Azithromycin Monohydrate) Tablet, Film Coated [Remedyrepack Inc. ]
  • Lake Erie Medical Dba Quality Care Products Llc
    Azithromycin Tablet, Film Coated [Lake Erie Medical Dba Quality Care Products Llc]
  • Pliva Inc.
    Azithromycin Injection, Powder, Lyophilized, For Solution [Pliva Inc.]
  • Remedyrepack Inc.
    Azithromycin Tablet, Film Coated [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Azithromycin Tablet, Film Coated [Remedyrepack Inc. ]
  • Sun Pharmaceutical Industries Limited
    Azithromycin Injection, Powder, Lyophilized, For Solution [Sun Pharmaceutical Industries Limited ]
  • Medvantx, Inc.
    Azithromycin Tablet, Film Coated [Medvantx, Inc.]
  • Remedyrepack Inc.
    Azithromycin Tablet, Film Coated [Remedyrepack Inc. ]
  • Sandoz Inc
    Azithromycin Tablet, Film Coated [Sandoz Inc]
  • Preferred Pharmaceuticals, Inc
    Azithromycin Tablet, Film Coated [Preferred Pharmaceuticals, Inc]
  • Remedyrepack Inc.
    Azithromycin Tablet, Film Coated [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Azithromycin Tablet, Film Coated [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Azithromycin Tablet, Film Coated [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Azithromycin Tablet, Film Coated [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Azithromycin Tablet, Film Coated [Remedyrepack Inc. ]
  • Hospira, Inc.
    Azithromycin (Azithromycin Monohydrate) Injection, Powder, Lyophilized, For Solution [Hospira, Inc.]
  • Hospira, Inc.
    Azithromycin (Azithromycin Monohydrate) Injection, Powder, Lyophilized, For Solution [Hospira, Inc.]
  • Sagent Pharmaceuticals
    Azithromycin (Azithromycin Monohydrate) Injection, Powder, Lyophilized, For Solution [Sagent Pharmaceuticals]
  • American Health Packaging
    Azithromycin Tablet, Film Coated [American Health Packaging]
  • Remedyrepack Inc.
    Azithromycin Tablet, Film Coated [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Azithromycin (Azithromycin Monohydrate) Tablet, Film Coated [Remedyrepack Inc. ]
  • Cardinal Health
    Azithromycin Tablet, Film Coated [Cardinal Health]
  • Remedyrepack Inc.
    Azithromycin Tablet, Film Coated [Remedyrepack Inc. ]
  • Clinical Solutions Wholesale
    Azithromycin Tablet, Film Coated [Clinical Solutions Wholesale]
  • Clinical Solutions Wholesale
    Azithromycin Powder, For Suspension [Clinical Solutions Wholesale]
  • Fresenius Kabi Usa, Llc
    Azithromycin (Azithromycin Monohydrate) Injection, Powder, Lyophilized, For Solution [Fresenius Kabi Usa, Llc]
  • Aidarex Pharmaceuticals Llc
    Azithromycin Tablet, Film Coated [Aidarex Pharmaceuticals Llc]
  • Fresenius Kabi Usa, Llc
    Azithromycin (Azithromycin Monohydrate) Injection, Powder, Lyophilized, For Solution [Fresenius Kabi Usa, Llc]
  • Mckesson Packaging Services A Business Unit Of Mckesson Corporation
    Azithromycin Tablet, Film Coated [Mckesson Packaging Services A Business Unit Of Mckesson Corporation]
  • Remedyrepack Inc.
    Azithromycin Tablet, Film Coated [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Azithromycin Tablet, Film Coated [Remedyrepack Inc. ]
  • Pd-rx Pharmaceuticals, Inc.
    Azithromycin Tablet, Film Coated [Pd-rx Pharmaceuticals, Inc.]
  • Cardinal Health
    Azithromycin Tablet, Film Coated [Cardinal Health]
  • Cardinal Health
    Azithromycin Tablet, Film Coated [Cardinal Health]
  • Medvantx, Inc.
    Azithromycin (Azithromycin Monohydrate) Powder, For Suspension [Medvantx, Inc.]
  • Greenstone Llc
    Azithromycin Tablet, Film Coated Azithromycin Powder, For Suspension [Greenstone Llc]
  • Greenstone Llc
    Azithromycin Tablet, Film Coated Azithromycin Powder, For Suspension [Greenstone Llc]
  • Baxter Healthcare Corporation
    Azithromycin Injection, Powder, Lyophilized, For Solution [Baxter Healthcare Corporation]
  • Cardinal Health
    Azithromycin (Azithromycin Monohydrate) Injection, Powder, Lyophilized, For Solution [Cardinal Health]
  • Direct Rx
    Azithromycin Powder, For Suspension [Direct Rx]
  • Pd-rx Pharmaceuticals, Inc.
    Azithromycin Tablet, Film Coated [Pd-rx Pharmaceuticals, Inc.]
  • Aphena Pharma Solutions – Tennessee, Llc
    Azithromycin Tablet, Film Coated [Aphena Pharma Solutions – Tennessee, Llc]
  • Sandoz Inc
    Azithromycin Tablet, Film Coated [Sandoz Inc]
  • Fresenius Kabi Usa, Llc
    Azithromycin (Azithromycin Monohydrate) Injection, Powder, Lyophilized, For Solution [Fresenius Kabi Usa, Llc]
  • Cardinal Health
    Azithromycin Tablet, Film Coated [Cardinal Health]
  • Preferred Pharmaceuticals, Inc.
    Azithromycin Powder, For Suspension [Preferred Pharmaceuticals, Inc.]
  • Preferred Pharmaceuticals, Inc.
    Azithromycin (Azithromycin Monohydrate) Powder, For Suspension [Preferred Pharmaceuticals, Inc.]
  • Preferred Pharmaceuticals, Inc.
    Azithromycin Powder, For Suspension [Preferred Pharmaceuticals, Inc.]
  • Preferred Pharmaceuticals, Inc.
    Azithromycin Tablet, Film Coated [Preferred Pharmaceuticals, Inc.]
  • Clinical Solutions Wholesale
    Azithromycin Tablet, Film Coated [Clinical Solutions Wholesale]