ZITHROMAX- azithromycin dihydrate tablet, film coated ZITHROMAX- azithromycin dihydrate powder, for suspension

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Pfizer Laboratories Div Pfizer Inc

INN (Rahvusvaheline Nimetus):

AZITHROMYCIN DIHYDRATE

Koostis:

AZITHROMYCIN ANHYDROUS 600 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

ZITHROMAX is 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. Non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis Prophylaxis of Disseminated Mycobacterium avium complex (MAC) Disease ZITHROMAX, 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 ZITHROMAX, 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)]. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZITHROMAX and other antibacterial drugs, ZITHROMAX should be used only to treat infections that are prove

Toote kokkuvõte:

ZITHROMAX 600 mg tablets (engraved on front with "PFIZER" and on back with "308") are supplied as white, modified oval-shaped, film-coated tablets containing azithromycin dihydrate equivalent to 600 mg azithromycin. These are packaged in bottles of 30 tablets. ZITHROMAX tablets are supplied as follows: Bottles of 30 NDC 0069-3080-30 Tablets should be stored at or below 30°C (86°F). ZITHROMAX for oral suspension is supplied in single- dose packets containing azithromycin dihydrate equivalent to 1 gram of azithromycin as follows: Boxes of 10 single- dose packets (1 g) NDC 0069-3051-07 Boxes of 3 single- dose packets (1 g) NDC 0069-3051-75 Store single- dose packets below 30°C (86°F).

Volitamisolek:

New Drug Application

Toote omadused

ZITHROMAX- AZITHROMYCIN DIHYDRATE TABLET, FILM COATED
ZITHROMAX- AZITHROMYCIN DIHYDRATE POWDER, FOR SUSPENSION
PFIZER LABORATORIES DIV PFIZER INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZITHROMAX SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZITHROMAX.
ZITHROMAX (AZITHROMYCIN) 600 MG TABLETS, FOR ORAL USE
ZITHROMAX (AZITHROMYCIN) FOR ORAL SUSPENSION
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Warnings and Precautions, Cardiovascular Death (5.5)
11/2021
INDICATIONS AND USAGE
ZITHROMAX is a macrolide antibacterial indicated for mild to moderate
infections caused by designated,
susceptible bacteria:
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To reduce the development of drug-resistant bacteria and maintain the
effectiveness of ZITHROMAX and
other antibacterial drugs, ZITHROMAX should be used only to treat or
prevent infections that are proven or
strongly suspected to be caused by susceptible bacteria. (1.3)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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®
®
Sexually Transmitted Diseases (1.1)
Mycobacterial Infections (1.2)
Sexually Transmitted Diseases (2.1)
Mycobacterial Infections (2.2)
ZITHROMAX 600 mg tablets (3)
ZITHROMAX for oral suspension 1000 mg/5 mL (3)
Patients with known hypersensitivity to azithromycin, erythromycin,
any macrolide, or ketolide
antibiotic. (4.1)
Patients with a history of cholestatic jaundice/hepatic dysfunction
associated with prior use of
azithromycin. (4.2)
Serious (including fatal) allergic and skin reactions. Discontinue
ZITHROMAX and initiate appropriate
therapy if reaction occurs. (5.1)
Hepatotoxicity: Discontinue azithromycin immediately if signs and
symptoms of hepatitis occur. (5.2)
Infantile Hypertrophic Pyloric Stenosis (IHPS): Following the use of
azithromycin in neonates
(treatment up to 42 days of life), IHPS has been reported. Direct
parents and caregivers to contact
their physician if vomiting or irritability with