CLARITHROMYCIN tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Nopērc to tagad

Lejuplādēt Produkta apraksts (SPC)
16-10-2020

Aktīvā sastāvdaļa:

CLARITHROMYCIN (UNII: H1250JIK0A) (CLARITHROMYCIN - UNII:H1250JIK0A)

Pieejams no:

Bryant Ranch Prepack

SNN (starptautisko nepatentēto nosaukumu):

CLARITHROMYCIN

Kompozīcija:

CLARITHROMYCIN 500 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Clarithromycin tablets are indicated in adults for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae , Haemophilus parainfluenzae , Moraxella catarrhalis , or Streptococcus pneumoniae [see Indications and Usage (1.9)] . Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae , Moraxella catarrhalis , or Streptococcus pneumoniae [see Indications and Usage (1.9)] . Clarithromycin tablets are indicated [see Indications and Usage (1.9)] for the treatment of mild to moderate infections caused by susceptible isolates due to: Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Streptococcus pyogenes as an alternative in individuals who cannot use first line therapy. Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Staphylococ

Produktu pārskats:

Product: 63629-6763 NDC: 63629-6763-1 28 TABLET in a BOTTLE NDC: 63629-6763-2 20 TABLET in a BOTTLE NDC: 63629-6763-3 60 TABLET in a BOTTLE

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

                                CLARITHROMYCIN- CLARITHROMYCIN TABLET
BRYANT RANCH PREPACK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLARITHROMYCIN TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CLARITHROMYCIN
TABLETS.
CLARITHROMYCIN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Contraindications, Lomitapide, Lovastatin, and Simvastatin (4.5)
09/2019
Warnings and Precautions, QT Prolongation (5.2)
11/2018
Warnings and Precautions, Serious Adverse Reactions Due to Concomitant
Use with Other Drugs
(5.4)
09/2019
Warnings and Precautions, Embryo-fetal Toxicity (5.7)
12/2018
INDICATIONS AND USAGE
Clarithromycin is a macrolide antimicrobial indicated for mild to
moderate infections caused by designated, susceptible
bacteria in the following:
•
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Limitations of Use
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of clarithromycin tablets and other
antibacterial drugs, clarithromycin tablets should be used only to
treat or prevent infections that are proven or strongly
suspected to be caused by bacteria. (1.9)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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Acute Bacterial Exacerbation of Chronic Bronchitis in Adults (1.1)
Acute Maxillary Sinusitis (1.2)
Community-Acquired Pneumonia (1.3)
Pharyngitis/Tonsillitis (1.4)
Uncomplicated Skin and Skin Structure Infections (1.5)
Acute Otitis Media in Pediatric Patients (1.6)
Treatment and Prophylaxis of Disseminated Mycobacterial Infections
(1.7)
_Helicobacter pylori_ Infection and Duodenal Ulcer Disease in Adults
(1.8)
Adults: clarithromycin tablets 250 mg or 500 mg every 12 hours for 7
to 14 days (2.2)
_H. pylori_ eradication (in combination with lansoprazole/amoxicillin,
omeprazole/amoxicillin, or omeprazole):
clarithromycin tablets 500 mg every 8 or 12 hours for 10 to 14 days.
See full prescribing information (FPI) for
additional information. (2.3)
Pediatric 
                                
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