AZITHROMYCIN- azithromycin monohydrate powder, for suspension

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

MedVantx, Inc.

INN (Rahvusvaheline Nimetus):

AZITHROMYCIN MONOHYDRATE

Koostis:

AZITHROMYCIN ANHYDROUS 200 mg in 5 mL

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Azithromycin for Oral Suspension USP 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 Chlamydophila pneumoniae , Haemophilus influenzae , Mycoplasma pneumoniae, or Streptococcus pneumoniae in patients appropriate for oral therapy. NOTE: Azithromycin, USP should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate

Toote kokkuvõte:

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: 300 mg (15 mL bottle) 600 mg (15 mL bottle) 900 mg (22.5 mL bottle) 1200 mg (30 mL bottle) 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, USP contains 15 mL suspension when constituted with 9 mL of water. Each 5 mL suspension contains azithromycin monohydrate equivalent to 100 mg of azithromycin, USP. 200 mg/5 mL Bottle of 600 mg azithromycin, USP contains 15 mL suspension when constituted with 9 mL of water. Each 5 mL suspension contains azithromycin monohydrate equivalent to 200 mg of azithromycin, USP. Bottle of 900 mg azithromycin, USP 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, USP. Bottle of 1200 mg azithromycin, USP contains 30 mL suspension when constituted with 15 mL of water. Each 5 mL suspension contains azithromycin monohydrate equivalent to 200 mg of azithromycin, USP. 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. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

AZITHROMYCIN- AZITHROMYCIN MONOHYDRATE POWDER, FOR SUSPENSION
MEDVANTX, INC.
----------
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, USP, an azalide, a
subclass of macrolide antibiotics, 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:
C
H N O M.W. 748.98
Azithromycin, USP, 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. 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.
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,
USP 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, USP. The dry
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