AZITHROMYCIN- azithromycin tablet, film coated

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Lake Erie Medical DBA Quality Care Products LLC

INN (Nama Internasional):

AZITHROMYCIN ANHYDROUS

Komposisi:

AZITHROMYCIN ANHYDROUS 500 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Azithromycin is indicated for the treatment of patients with mild to moderate infections (pneumonia: see WARNINGS ) caused by susceptible strains of the designated microorganisms in the specific conditions listed below. As recommended dosages, durations of therapy and applicable patient populations vary among these infections, please see DOSAGE AND ADMINISTRATION for specific dosing recommendations . Acute bacterial exacerbations of chronic obstructive pulmonary disease 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 Chlamydia pneumoniae , Haemophilus influenzae , Mycoplasma pneumoniae or Streptococcus pneumoniae in patients appropriate for oral therapy. NOTE: 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 s

Ringkasan produk:

Azithromycin 250 mg tablets are supplied as pink modified capsular shaped, engraved, film-coated tablets containing azithromycin dihydrate equivalent to 250 mg of azithromycin. Azithromycin 250 mg tablets are engraved with "G" on one side and "3060" on the other. These are packaged in bottles and blister cards of 6 tablets as follows: Azithromycin 500 mg tablets are supplied as pink modified capsular shaped, engraved, film-coated tablets containing azithromycin dihydrate equivalent to 500 mg of azithromycin. Azithromycin 500 mg tablets are engraved with "G" on one side and "3070" on the other. These are packaged in bottles and blister cards of 3 tablets as follows: Azithromycin tablets should be stored between 15° to 30°C (59° to 86°F). Azithromycin for oral suspension after constitution contains a flavored suspension. Azithromycin for oral suspension is supplied to provide 100 mg/5 mL or 200 mg/5 mL suspension in bottles as follows: See DOSAGE AND ADMINISTRATION for constitution instructions with each bottle type. Store dry powder below 30°C (86°F). Store constituted suspension between 5° to 30°C (41° to 86°F) and discard when full dosing is completed.

Status otorisasi:

New Drug Application Authorized Generic

Karakteristik produk

AZITHROMYCIN- AZITHROMYCIN TABLET, FILM COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
AZITHROMYCIN
AZITHROMYCIN TABLETS
AND
AZITHROMYCIN FOR ORAL SUSPENSION
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 bacteria.
DESCRIPTION
Azithromycin tablets and azithromycin for oral suspension contain the
active ingredient azithromycin, an
azalide, a subclass of macrolide antibiotics, for oral administration.
Azithromycin 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 is
derived from erythromycin; however, it differs chemically from
erythromycin in that a methyl-
substituted nitrogen atom is incorporated into the lactone ring. Its
molecular formula is C
H N O ,
and its molecular weight is 749.00. Azithromycin has the following
structural formula:
Azithromycin, as the dihydrate, is a white crystalline powder with a
molecular formula of
C
H N O •2H O and a molecular weight of 785.0.
Azithromycin is supplied for oral administration as film-coated,
modified capsular shaped tablets
containing azithromycin dihydrate equivalent to either 250 mg or 500
mg azithromycin and the following
inactive ingredients: dibasic calcium phosphate anhydrous,
pregelatinized starch, sodium
croscarmellose, magnesium stearate, sodium lauryl sulfate,
hypromellose, lactose, titanium dioxide,
triacetin and D&C Red #30 aluminum lake.
38
72
2
12
38
72
2
12
2
Azithromycin for oral suspension is supplied in bottles containing
azithromycin dihydrate powder
equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per
bottle and the following inactive
ingredients: sucrose; so