Prescription Drug Name:

Azithromycin Tablets 600 mg

ID:

d2feb064-34c3-4e0b-b296-7ee359e25714

Code:

34391-3

DESCRIPTION


id: e5e1307d-cbba-4253-959c-e8aa3a9fb304
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Azithromycin tablets 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:
Anhydrous azithromycin is a white amorphous powder with a molecular formula of C38H72N2O12 and a molecular weight of 749.

Azithromycin tablet is supplied for oral administration as white, film-coated, oval shaped biconvex tablets containing anhydrous azithromycin 600 mg. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, corn starch, croscarmellose sodium, magnesium trisilicate, magnesium stearate, colloidal silicon dioxide, hydroxypropyl cellulose, sodium lauryl sulfate, and an aqueous film coat consisting of hypromellose, titanium dioxide and polyethylene glycol.

INDICATIONS AND USAGE


id: a8c31579-0c1b-4c6b-a962-37128421b019
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Azithromycin tablets 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.

Mycobacterial Infections

Prophylaxis of Disseminated

M

ycobacterium avium



complex (MAC) Disease

Azithromycin tablet, taken alone or in combination with rifabutin at its approved dose, is indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in persons with advanced HIV infection. (See DOSAGE AND ADMINISTRATION, CLINICAL STUDIES)

Treatment of Disseminated Mycobacterium avium complex (MAC) Disease

Azithromycin tablet, taken in combination with ethambutol, is indicated for the treatment of disseminated MAC infections in persons with advanced HIV infection. (See DOSAGE AND ADMINISTRATION, CLINICAL STUDIES)

CONTRAINDICATIONS


id: e9ab93ef-6524-4f8a-9b6c-342206dfe5a1
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Azithromycin tablets are contraindicated in patients with known hypersensitivity to azithromycin, erythromycin,  any macrolide or ketolide antibiotic

WARNINGS


id: f74f5e45-5a46-48ab-8a98-dd8c15060d2d
displayName: WARNINGS SECTION
FDA Article Code: 34071-1

Serious allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions including Stevens Johnson Syndrome and toxic epidermal necrolysis have been reported rarely in patients on azithromycin therapy. Although rare, fatalities have been reported (see CONTRAINDICATIONS). Despite initially successful symptomatic treatment of the allergic symptoms, when symptomatic therapy was discontinued, the allergic symptoms recurred soon thereafter in some patients without further azithromycin exposure. These patients required prolonged periods of observation and symptomatic treatment. The relationship of these episodes to the long tissue half-life of azithromycin and subsequent prolonged exposure to antigen is unknown at present.

If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted. Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including azithromycin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

PRECAUTIONS


id: c0aa1425-7d2c-4c04-8901-38720d8c2134
displayName: PRECAUTIONS SECTION
FDA Article Code: 42232-9

ADVERSE REACTIONS


id: e4243c8e-70eb-4e82-ab5f-f82a7a7a7d94
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. Approximately 0.7% of the patients from the multiple-dose clinical trials discontinued azithromycin tablet therapy because of treatment-related side effects. Most of the side effects leading to discontinuation were related to the gastrointestinal tract, e.g., nausea, vomiting, diarrhea, or abdominal pain. Rarely but potentially serious side effects were angioedema and cholestatic jaundice.

DOSAGE AND ADMINISTRATION (See INDICATIONS AND USAGE.)


id: eb2a334b-3540-4b50-91d3-f130b4924c04
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

HOW SUPPLIED


id: 8c61b681-c26d-4cd4-93f9-11e57011a65d
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Azithromycin tablets 600 mg are supplied as white film-coated oval shaped biconvex tablets debossed with W962 on one side and other side plain containing anhydrous azithromycin 600 mg. These are packaged as follows:

Bottles of 08      NDC 54868-6348-0

Store at 20° to 25°C (68° to 77° F). [See USP Controlled Room Temperature].

CLINICAL STUDIES IN PATIENTS WITH ADVANCED HIV INFECTION
FOR THE PREVENTION AND TREATMENT OF DISEASE DUE TO
DISSEMINATED MYCOBACTERIUM AVIUM COMPLEX (MAC)
(See INDICATIONS AND USAGE)


id: afec3564-c5d4-47ad-9a26-67fd34ff16e2
displayName: CLINICAL STUDIES SECTION
FDA Article Code: 34092-7

ANIMAL TOXICOLOGY


id: afc70a5e-28dc-4d6e-965a-120a09d1e0a9
displayName: ANIMAL PHARMACOLOGY & OR TOXICOLOGY SECTION
FDA Article Code: 34091-9

Phospholipidosis (intracellular phospholipid binding) 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 administered doses which, based on pharmacokinetics, are as low as 2 times greater than the recommended adult human dose and in rats at doses comparable to the recommended adult human dose. This effect has been reversible after cessation of azithromycin treatment. The significance of these findings for humans is unknown.

REFERENCES:

National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically-Third Edition. Approved Standard NCCLS Document M7-A3, Vol. 13, No. 25, NCCLS, Villanova, PA, December 1993.
National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests-Fifth Edition. Approved Standard NCCLS Document M2-A5, Vol. 13, No. 24, NCCLS, Villanova, PA, December 1993.
Dunne MW, Foulds G, Retsema JA. Rationale for the use of azithromycin as Mycobacterium avium chemoprophylaxis. American J Medicine 1997; 102(5C):37-49.
Meier A, Kirshner P, Springer B, et al. Identification of mutations in 23S rRNA gene of clarithromycin-resistant Mycobacterium intracellulare. Antimicrob Agents Chemother. 1994;38:381-384.
Methodology per Inderlied CB, et al. Determination of In Vitro Susceptibility of Mycobacterium avium Complex Isolates to Antimicrobial Agents by Various Methods. Antimicrob Agents Chemother 1987; 31:1697-1702. Manufactured by:

Wockhardt Limited
Mumbai, India.

Distributed by:

Wockhardt USA  LLC.
20 Waterview Blvd.
Parsippany, NJ 07054
USA.

Rev.131010