AZITHROMYCIN DIHYDRATE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AZITHROMYCIN DIHYDRATE (UNII: 5FD1131I7S) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M)

Available from:

DIRECT RX

INN (International Name):

AZITHROMYCIN DIHYDRATE

Composition:

AZITHROMYCIN ANHYDROUS 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Adults 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 should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate

Product summary:

Azithromycin Tablets, USP 250 mg are supplied as white, oval, biconvex film coated tablets containing azithromycin dihydrate equivalent to 250 mg of azithromycin.  Azithromycin Tablets, USP 250 mg are engraved “APO” on one side and “AZ250” on the other side. These are packaged in bottles and blister cards of 6 tablets as follows: Azithromycin Tablets, USP 500 mg are  supplied as white, oval, biconvex film coated tablets containing azithromycin dihydrate equivalent to 500 mg of azithromycin.  Azithromycin Tablets, USP 500 mg are engraved “APO” on one side and “AZ500” on the other. These are packaged in bottles and blister cards of 3 tablets as follows: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Preserve in tight container

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AZITHROMYCIN DIHYDRATE- AZITHROMYCIN DIHYDRATE TABLET, FILM COATED
DIRECT RX
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AZITHROMYCIN DIHYDRATE
DESCRIPTION SECTION
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. Its
molecular formula is C38H72N2O12,
and its molecular weight is 749. Azithromycin has the following
structural formula:
Azithromycin, as the dihydrate, is a white crystalline powder with a
molecular formula of
C38H72N2O12•2H2O and a molecular weight of 785.
Azithromycin is supplied for oral administration as film-coated, white
oval shaped biconvex tablets
containing azithromycin dihydrate equivalent to either 250 mg or 500
mg azithromycin and the following
inactive ingredients: dibasic calcium phosphate dihydrate,
hydroxypropyl cellulose, croscarmellose
sodium, magnesium stearate and Opadry II white (Opadry II white
contains the following components:
hypromellose, lactose monohydrate, titanium dioxide and triacetin).
CLINICAL PHARMACOLOGY SECTION
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 AUC0-72 =
4.3 (1.2) mcg·h/mL; Cmax =
0.5 (0.2) mcg/mL; Tmax = 2.2 (0.9) hours.
With a regimen of 500 mg (two 250 mg capsules*) on day 1, followed by
250 mg daily (one 250 mg
capsule) on days 2 through 5, the pharmacokinetic parameters of
azithromycin in plasma in healthy
young adults (18 to 40 years of age) are portrayed in the chart below.
Cmin and Cmax rem