Stribild Access
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin tablets, USP and other antibacterial drugs, azithromycin tablets, USP should be used only to treat 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.
Azithromycin tablets, USP are a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below.
Prophylaxis of Disseminated Mycobacterium avium complex (MAC) Disease
Azithromycin tablet, USP taken alone or in combination with rifabutin at its approved dose, is indicated for the prevention of disseminated MAC disease in persons with advanced HIV infection [see Dosage and Administration (2)].
Treatment of Disseminated MAC Disease
Azithromycin tablet, USP taken in combination with ethambutol, is indicated for the treatment of disseminated MAC infections in persons with advanced HIV infection [see Use in Specific Populations (8.4) and Clinical Studies (14.1)].
History
There is currently no drug history available for this drug.
Other Information
Azithromycin tablets, USP contain the active ingredient azithromycin, a macrolide antibacterial drug, 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 38H72N2O12, and its molecular weight is 749. Azithromycin has the following structural formula:
Anhydrous azithromycin USP 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.
Sources
Stribild Access Manufacturers
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Gilead Sciences, Inc.
![Stribild Access (Elvitegravir, Cobicistat, Emtricitabine, And Tenofovir Disoproxil Fumarate) Tablet, Film Coated [Gilead Sciences, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Stribild Access | Wockhardt Usa Llc.
[see Indications and Usage (1)]
Azithromycin tablets, USP may be taken with or without food. However, increased tolerability has been observed when tablets are taken with food.
Azithromycin for oral suspension (single dose 1g packet) is not for pediatric use. For pediatric suspension see the prescribing information for azithromycin for oral suspension 100 mg/5 mL and 200 mg/5 mL bottles.
2.2 Mycobacterial Infections Prevention of Disseminated MAC InfectionsThe recommended dose of azithromycin for the prevention of disseminated Mycobacterium avium complex (MAC) disease is: 1200 mg taken once weekly. This dose of azithromycin tablets, USP 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.
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