Azithromycin Tablets USP, 250 mg and 500 mg, 7146, 7169, Rx only

/Azithromycin Tablets USP, 250 mg and 500 mg, 7146, 7169, Rx only
Azithromycin Tablets USP, 250 mg and 500 mg, 7146, 7169, Rx only2018-09-06T09:12:40+00:00

Prescription Drug Name:

Azithromycin Tablets USP, 250 mg and 500 mg, 7146, 7169, Rx only

ID:

60bf8e22-284b-4dc0-9c03-694813cc89ac

Code:

34391-3

DESCRIPTION


id: 2c0a5f10-bbd2-4f0e-b488-088e38d0cac6
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Azithromycin Tablets USP contain 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-azacyclopentadecan15-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:

C38H72N2O12 M.W. 748.98 Azithromycin, USP, as the monohydrate, is a white to off-white crystalline powder with a molecular formula of C38H72N2O12•H2O and a molecular weight of 767. 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, USP 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.

INDICATIONS AND USAGE


id: a6a33910-6ff6-460c-b0f9-046a108f95fa
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

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.

CONTRAINDICATIONS


id: 320b87a8-23f9-42cb-8aad-c779add9e3be
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Azithromycin is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic. Azithromycin is contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin.

ADVERSE REACTIONS


id: aad0e87c-2b58-47b3-95f3-bfd0857385b4
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

In clinical trials, most of the reported side effects were mild to moderate in severity and were reversible upon discontinuation of the drug. Potentially serious side effects of angioedema and cholestatic jaundice were reported rarely. Approximately 0.7% of the patients (adults and pediatric patients) from the 5 day multiple-dose clinical trials discontinued azithromycin therapy because of treatment-related side effects. In adults given 500 mg/day for 3 days, the discontinuation rate due to treatment-related side effects was 0.6%. In clinical trials in pediatric patients given 30 mg/kg, either as a single dose or over 3 days, discontinuation from the trials due to treatment-related side effects was approximately 1% (see DOSAGE AND ADMINISTRATION ). Most of the side effects leading to discontinuation were related to the gastrointestinal tract, e.g., nausea, vomiting, diarrhea, or abdominal pain (see CLINICAL STUDIES, Pediatric Patients ).

DOSAGE AND ADMINISTRATION


id: fad4cd1b-3982-44bf-ac1b-779eda4aecd3
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY .)

HOW SUPPLIED


id: 60b51adc-df94-4a1f-8dc3-7292584e7673
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Azithromycin Tablets USP are available as follows: 250 mg: 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, USP. They are available in bottles of 30, boxes of 1 card x 6 tablets, and in unit-dose boxes of 100 tablets (10 x 10). 500 mg: 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, USP. They are available in bottles of 30, boxes of 1 card x 3 tablets, and in unit-dose boxes of 100 tablets (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). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

CLINICAL STUDIES


id: 454d21ed-2f8c-4067-8f5b-1867719dc25c
displayName: CLINICAL STUDIES SECTION
FDA Article Code: 34092-7

(See INDICATIONS AND USAGE and Pediatric Use .)

ANIMAL TOXICOLOGY


id: 6affc0e3-39f8-4f48-876f-fb8bc3412bb0
displayName: ANIMAL PHARMACOLOGY & OR TOXICOLOGY SECTION
FDA Article Code: 34091-9

Phospholipidosis (intracellular phospholipid accumulation) has been observed in some tissues of mice, rats, and dogs given multiple doses of azithromycin. It has been demonstrated in numerous organ systems (e.g., eye, dorsal root ganglia, liver, gallbladder, kidney, spleen, and pancreas) in dogs treated with azithromycin at doses which, expressed on the basis of mg/m2, are approximately equal to the recommended adult human dose, and in rats treated at doses approximately one-sixth of the recommended adult human dose. This effect has been shown to be reversible after cessation of azithromycin treatment. Phospholipidosis has been observed to a similar extent in the tissues of neonatal rats and dogs given daily doses of azithromycin ranging from 10 days to 30 days. Based on the pharmacokinetic data, phospholipidosis has been seen in the rat (30 mg/kg dose) at observed Cmax value of 1.3 mcg/mL (six times greater than the observed Cmax of 0.216 mcg/mL at the pediatric dose of 10 mg/kg). Similarly, it has been shown in the dog (10 mg/kg dose) at observed Cmax value of 1.5 mcg/mL (seven times greater than the observed same Cmax and drug dose in the studied pediatric population). On a mg/m2 basis, 30 mg/kg dose in the neonatal rat (135 mg/m2) and 10 mg/kg dose in the neonatal dog (79 mg/m2) are approximately 0.5 and 0.3 times, respectively, the recommended dose in the pediatric patients with an average body weight of 25 kg. Phospholipidosis, similar to that seen in the adult animals, is reversible after cessation of azithromycin treatment. The significance of these findings for animals and for humans is unknown.

REFERENCES


id: c94f83c8-89a0-49c1-8493-9e3f21593602
displayName: REFERENCES SECTION
FDA Article Code: 34093-5

Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard Ninth Edition. CLSI document M07-A9. CLSI 950 West Valley Rd, Suite 250, Wayne, PA 19087, 2012.
CLSI, Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Second Informational Supplement. CLSI document M100-S22. CLSI, Wayne, PA 19087, 2012.
CLSI. Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard – Eleventh Edition. CLSI document M02-A11. CLSI, Wayne, PA 19087, 2012.
Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 91010, Israel Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. M 11/2012

PRINCIPAL DISPLAY PANEL


id: f66e9c20-c0ce-4769-a59c-015c323ddc42
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4