AZITHROMYCIN MONOHYDRATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AZITHROMYCIN MONOHYDRATE (UNII: JTE4MNN1MD) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M)

Available from:

REMEDYREPACK INC.

INN (International Name):

AZITHROMYCIN MONOHYDRATE

Composition:

AZITHROMYCIN ANHYDROUS 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Azithromycin tablets 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 appropria

Product summary:

Azithromycin tablets USP are supplied in the following strengths and package configurations: Azithromycin tablets USP, 250 mg are supplied as pink, oval shaped film-coated tablets, engraved with "LU" on one side and "L11" on the other side containing azithromycin monohydrate USP equivalent to 250 mg of azithromycin USP. NDC: 70518-0803-00 PACKAGING: 6 in 1 BLISTER PACK Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AZITHROMYCIN MONOHYDRATE- AZITHROMYCIN MONOHYDRATE TABLET
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AZITHROMYCIN TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
AZITHROMYCIN TABLETS.
AZITHROMYCIN TABLETS, 250 MG AND 500 MG, FOR ORAL USE
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Warnings and Precautions, Cardiovascular Death ( 5.5) 11/2021
INDICATIONS AND USAGE
Azithromycin tablets are a macrolide antibacterial drug indicated for
mild to moderate infections caused
by designated, susceptible bacteria:
Acute bacterial exacerbations of chronic bronchitis in adults ( 1.1)
Acute bacterial sinusitis in adults ( 1.1)
Uncomplicated skin and skin structure infections in adults ( 1.1)
Urethritis and cervicitis in adults ( 1.1)
Genital ulcer disease in men ( 1.1)
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) ( 1.1,
1.2)
Pharyngitis/tonsillitis in adults and pediatric patients (2 years of
age and older) ( 1.1, 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 moderate to severe illness or risk factors. ( 1.3)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of azithromycin
tablets and other antibacterial drugs, azithromycin tablets should be
used only to treat infections that are
proven or strongly suspected to be caused by susceptible bacteria. (
1.4)
DOSAGE AND ADMINISTRATION
ADULT PATIENTS ( 2.1)
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, follow