AZITHROMYCIN MONOHYDRATE tablet, film coated

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

DIRECT RX

INN (국제 이름):

AZITHROMYCIN MONOHYDRATE

구성:

AZITHROMYCIN ANHYDROUS 250 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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)]. 1.1 Adult Patients Acute bacterial exacerbations of chronic bronchitis due to Haemophilus

제품 요약:

Azithromycin tablets USP, 250 mg are supplied as white, oval, biconvex, unscored, film-coated tablets, debossed with “787” on one side and “PLIVA” on the other, containing azithromycin monohydrate equivalent to 250 mg of azithromycin, USP, available in boxes of 1 card x 6 tablets and in a bundle of 3 boxes x 6 tablets (18). Azithromycin tablets USP, 500 mg are supplied as blue, capsule shaped, biconvex, unscored, film-coated tablets, debossed with “788” on one side and “PLIVA” on the other, containing azithromycin monohydrate equivalent to 500 mg of azithromycin, USP, available in boxes of 1 card x 3 tablets and in a bundle of 3 boxes x 3 tablets (9). Store at 20º to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

AZITHROMYCIN MONOHYDRATE- AZITHROMYCIN MONOHYDRATE TABLET, FILM COATED
DIRECT RX
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AZITHROMYCIN MONOHYDRATE
INDICATIONS & USAGE SECTION
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)].
1.1 Adult Patients
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