AZITHROMYCIN powder, for suspension

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Preferred Pharmaceuticals, Inc.

INN (International Name):

AZITHROMYCIN DIHYDRATE

Sammensætning:

AZITHROMYCIN ANHYDROUS 1 g

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Azithromycin 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 Azithromycin, 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, 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 azithromycin and other antibacterial drugs, azithromycin should be used only to treat infection

Produkt oversigt:

Azithromycin for oral suspension is supplied in single- dose packets containing azithromycin dihydrate equivalent to 1 gram of azithromycin as follows: 1 single- dose packet (1 g) NDC 68788-0713-1 Store single- dose packets between 5° and 30°C (41° and 86°F).

Autorisation status:

New Drug Application

Produktets egenskaber

AZITHROMYCIN- AZITHROMYCIN POWDER, FOR SUSPENSION
PREFERRED PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AZITHROMYCIN SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AZITHROMYCIN.
AZITHROMYCIN 600 MG TABLETS AND ORAL SUSPENSION
INITIAL U.S. APPROVAL: 1991
INDICATIONS AND USAGE
AZITHROMYCIN is a macrolide antibacterial indicated for mild to
moderate infections caused by
designated, susceptible bacteria:
•
•
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of azithromycin and
other antibacterial drugs, azithromycin 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
•
•
DOSAGE FORMS AND STRENGTHS
•
•
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
ADVERSE REACTIONS
The most common adverse reactions are diarrhea (5%), nausea (3%),
abdominal pain (3%), or vomiting,
(no percent given) (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GREENSTONE LLC AT
1-800-438-1985 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
Sexually Transmitted Diseases (1.1)
Mycobacterial Infections (1.2)
Sexually Transmitted Diseases (2.1)
Mycobacterial Infections (2.2)
Azithromycin 600 mg tablets (3)
Azithromycin 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
Azithromycin 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),