Drug Catalog - Product Detail
AZITHROMYCIN TB 600MG 30
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00378-1535-93 | MYLAN | 30EA | 600MG | NA |
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Description
DESCRIPTION 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 C 38 H 72 N 2 O 12 , and its molecular weight is 749.0. Azithromycin has the following structural formula: Azithromycin, USP (monohydrate) is a white to off-white crystalline powder with a molecular formula of C 38 H 72 N 2 O 12 •H 2 O and a molecular weight of 767.0. Azithromycin tablets contain azithromycin monohydrate equivalent to 600 mg azithromycin, USP. The tablets are supplied as blue, oval-shaped, film-coated tablets. They also contain the following inactive ingredients: cetyl alcohol, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, FD&C Blue No. 2 aluminum lake, hypromellose, magnesium stearate, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide and triacetin. Axithromycin Structural Formula
How Supplied
HOW SUPPLIED Azithromycin Tablets are available containing azithromycin monohydrate equivalent to 600 mg azithromycin. The 600 mg tablets are blue film-coated, oval, unscored tablets debossed with M 535 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-1535-93 bottles of 30 tablets NDC 0378-1535-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Indications & Usage
INDICATIONS AND USAGE 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. Appropriate culture and susceptibility tests should be performed before treatment to determine the causative organism and its susceptibility to azithromycin. Therapy with azithromycin tablets may be initiated before results of these tests are known; once the results become available, antimicrobial therapy should be adjusted accordingly. 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 susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Mycobacterial Infections Prophylaxis of Disseminated Mycobacterium Avium Complex (MAC) Disease Azithromycin tablets, 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 and CLINICAL STUDIES .) Treatment of Disseminated Mycobacterium Avium Complex (MAC) Disease Azithromycin tablets, taken in combination with ethambutol, is indicated for the treatment of disseminated MAC infections in persons with advanced HIV infection. (See DOSAGE AND ADMINISTRATION and CLINICAL STUDIES .)
Dosage and Administration
DOSAGE AND ADMINISTRATION (See INDICATIONS AND USAGE .) Pediatric Use For pediatric suspension, please refer to the INDICATION AND USAGE and DOSAGE AND ADMINISTRATION sections of the prescribing information for Azithromycin for Oral Suspension 100 mg/5mL and 200 mg/5mL. Azithromycin tablets may be taken without regard to food. However, increased tolerability has been observed when tablets are taken with food. Prevention of Disseminated MAC Infections The recommended dose of azithromycin for the prevention of disseminated Mycobacterium avium complex (MAC) disease is: 1200 mg taken once weekly. This dose of azithromycin may be combined with the approved dosage regimen of rifabutin. Treatment of Disseminated MAC Infections Azithromycin should be taken at a daily dose of 600 mg, in combination with ethambutol at the recommended daily dose of 15 mg/kg. Other antimycobacterial drugs that have shown in vitro activity against MAC may be added to the regimen of azithromycin plus ethambutol at the discretion of the physician or health care provider.