CLARITHROMYCIN tablet, film coated

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

RedPharm Drug, Inc.

INN (Medzinárodný Name):

CLARITHROMYCIN

Zloženie:

CLARITHROMYCIN 500 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

1.1 Acute Bacterial Exacerbation of Chronic Bronchitis Clarithromycin tablets, USP 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)] . 1.2 Acute Maxillary Sinusitis Clarithromycin tablets, USP 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)] . 1.3 Community-Acquired Pneumonia Clarithromycin tablets, USP are indicated [see Indications and Usage (1.9)] for the treatment of mild to moderate infections caused by susceptible isolates due to: Haemophilus influenzae (in adults) Mycoplasma pneumoniae, Streptococcus pneumoniae, Chlamydophila pneumoniae 1.4 Pharyngitis/Tonsillitis Clarithromycin tablets, USP are indicated for the treatment of mild to moderate

Prehľad produktov:

Clarithromycin tablets, USP are supplied as white to off-white oval film-coated tablets in the following packaging sizes: 250 mg tablets: (imprinted in blue with the “S39” on one side) Bottles of 60 ( NDC 0527-1931-06) 500 mg tablets: (debossed with the “S4” on one side) Bottles of 60 ( NDC 0527-1932-06) Store clarithromycin tablets, USP at controlled room temperature 20° to 25°C (68° to 77°F) in a well-closed container.

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

CLARITHROMYCIN- CLARITHROMYCIN TABLET, FILM COATED
REDPHARM DRUG, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
CLARITHROMYCIN
TABLETS, USP safely and effectively. See full prescribing information
for
CLARITHROMYCIN TABLETS, USP.
Clarithromycin tablets USP, for oral use
Initial U.S. Approval: 1991
RECENT MAJOR CHANGES
Warnings and Precautions, Serious Adverse Reactions with Concomitant
Use with Other
Drugs (5.4) 10/2015
INDICATIONS AND USAGE
Clarithromycin is a macrolide antimicrobial indicated for mild to
moderate infections
caused by designated, susceptible bacteria in the following:
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)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
clarithromycin and other antibacterial drugs, clarithromycin 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
Adults: clarithromycin 250 mg or 500 mg every 12 hours for 7–14 days
(2.2)
H. pylori eradication (in combination with lansoprazole/amoxicillin,
omeprazole/amoxicillin,
or omeprazole): clarithromycin 500 mg every 8 or 12 hours for 10–14
days. See full
prescribing information (FPI) for additional information. (2.3)
Pediatric Patients: clarithromycin 15 mg/kg/day divided every 12 hours
for 10 days (2.4)
Mycobacterial Infections: clarithromycin 500 mg every 12 hours;
clarithromycin 7.5
mg/kg up to 500 mg every 12 hours in pediatric patients (2.5)
Reduce dose in moderate renal impairment with concomitant atazanavir
or ritonavir-
containing regimens and in severe rena