AZITHROMYCIN- azithromycin monohydrate powder, for suspension

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

azithromycin monohydrate (UNII: JTE4MNN1MD) (azithromycin - UNII:F94OW58Y8V)

Tersedia dari:

Rebel Distributors Corp.

INN (Nama Internasional):

azithromycin monohydrate

Komposisi:

azithromycin monohydrate 100 mg in 5 mL

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Azithromycin for oral suspension 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 ill

Ringkasan produk:

Azithromycin for oral suspension, USP after constitution contains a cherry flavored suspension. The dry powder before constitution is off-white to pinkish in color. The suspension after constitution is pink to red in color. Azithromycin for oral suspension, USP is supplied to provide 100 mg/5 mL or 200 mg/5 mL suspension in bottles as follows: 5 mL of constituted suspension of azithromycin for oral suspension USP, 100 mg/5 mL and 200 mg/5 mL, contains 6 mg of sodium. 100 mg/5 mL Bottle of 300 mg azithromycin contains 15 mL suspension when constituted with 9 mL of water. Each 5 mL suspension contains azithromycin monohydrate equivalent to 100 mg of azithromycin. 200 mg/5 mL Bottle of 600 mg azithromycin contains 15 mL suspension when constituted with 9 mL of water. Each 5 mL suspension contains azithromycin monohydrate equivalent to 200 mg of azithromycin. Bottle of 900 mg azithromycin contains 22.5 mL suspension when constituted with 12 mL of water. Each 5 mL suspension contains azithromycin monohydrate equivalent to 200 mg of azithromycin. Bottle of 1200 mg azithromycin contains 30 mL suspension when constituted with 15 mL of water. Each 5 mL suspension contains azithromycin monohydrate equivalent to 200 mg of azithromycin. See DOSAGE AND ADMINISTRATION for constitution instructions with each bottle type. Store dry powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Store constituted suspension at 5° to 30°C (41° to 86°F) and discard when full dosing is completed.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

AZITHROMYCIN- AZITHROMYCIN MONOHYDRATE POWDER, FOR SUSPENSION
REBEL DISTRIBUTORS CORP.
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AZITHROMYCIN FOR ORAL SUSPENSION, USP
7148
7149
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of azithromycin for
oral suspension and other antibacterial drugs, azithromycin for oral
suspension should be used only to
treat or prevent infections that are proven or strongly suspected to
be caused by bacteria.
DESCRIPTION
Azithromycin for oral suspension, USP contains 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.
Azithromycin has the following
structural formula:
C
H N O M. W. 749.00
Azithromycin, as the monohydrate, is a white to off-white crystalline
powder with a molecular formula
of C
H N O •H O and a molecular weight of 767.02. 5 mL of constituted
suspension of
azithromycin for oral suspension, 100 mg/5 mL and 200 mg/5 mL,
contains 6 mg of sodium.
Azithromycin for oral suspension, USP is supplied in bottles
containing azithromycin monohydrate
powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin
per bottle and the following
inactive ingredients: arabic gum, artificial aromatic substances,
ethyl vanillin, FD&C Red #40,
hydroxypropyl cellulose, maltodextrin, nature aromatic substances,
nature identical aromatic substances,
sucrose, tribasic sodium phosphate dodecahydrate, vanillin, and
xanthan gum. After constitution, each 5
mL of suspension contains 100 mg or 200 mg of azithromycin. The dry
powder before constituti