AZITHROMYCIN tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

AZITHROMYCIN MONOHYDRATE (UNII: JTE4MNN1MD) (AZITHROMYCIN - UNII:F94OW58Y8V)

Dostopno od:

MedVantx, Inc.

INN (mednarodno ime):

AZITHROMYCIN MONOHYDRATE

Sestava:

AZITHROMYCIN 250 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Azithromycin tablets USP are 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

Povzetek izdelek:

Azithromycin tablets USP, 250 mg are supplied as mottled pink, unscored, film-coated, modified-oval-shaped tablets, debossed with “93” on one side and “7146” on the other, containing azithromycin monohydrate equivalent to 250 mg of azithromycin. They are available in bottles of 30, boxes of 1 card x 6 tablets, and in unit-dose boxes of 100 (10 x 10). Azithromycin tablets USP, 500 mg are supplied as mottled pink, unscored, film-coated, modified-oval-shaped tablets, debossed with “93” on one side and “7169” on the other, containing azithromycin monohydrate equivalent to 500 mg of azithromycin. They are available in bottles of 30, boxes of 1 card x 3 tablets, and in unit-dose boxes of 100 (10 x 10). Store at 20º to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

AZITHROMYCIN- AZITHROMYCIN TABLET, FILM COATED
MEDVANTX, INC.
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AZITHROMYCIN TABLETS USP, 250 MG AND 500 MG
7146
7169
RX ONLY
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 or prevent
infections that are proven or strongly suspected to be caused by
bacteria.
DESCRIPTION
Azithromycin tablets USP 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.
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.
Azithromycin tablets USP, 250 mg and 500 mg are supplied for oral
administration as mottled pink,
unscored, film-coated, modified-oval-shaped tablets containing
azithromycin monohydrate equivalent to
250 mg or 500 mg azithromycin and the following inactive ingredients:
butylated hydroxytoluene,
calcium phosphate dibasic anhydrous, carmine, colloidal silicon
dioxide, FD&C red # 40 lake, FD&C
yellow # 6 lake, hypromellose (2910, 15cP), lactose monohydrate,
magnesium stearate, pregelatinized
starch, sodium lauryl sulfate, talc, titanium dioxide and triacetin.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
Following oral administration of a single 500 mg dose (two 250 mg
tablets) to 36 fasted healthy male
volunteers, the mean (SD) pharmacokinetic parameters were AUC
= 4.3 (