CLARITHROMYCIN tablet, film coated

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

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Produktens egenskaper Produktens egenskaper (SPC)
10-05-2023

Aktiva substanser:

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

Tillgänglig från:

Direct_Rx

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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

Produktsammanfattning:

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 60 500 mg tablets: (debossed with the “S4” on one side) Bottles of 60 mycin tablets, USP at controlled room temperature 20° to 25°C (68° to 77°F) in a well-closed container.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

                                CLARITHROMYCIN- CLARITHROMYCIN TABLET, FILM COATED
DIRECT_RX
----------
CLARITHROMYCIN
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
infections caused by susceptible isolates due to Streptococcus
pyogenes as an
alternative in individuals who cannot use first line therapy.
1.5 Uncomplicated Skin and Skin Structure Infections
Clarithromycin tablets, USP are indicated for the treatment of mild to
moderate
infections caused by susceptible isolates due to Staphylococcus
aureus, or
Streptococcus pyogenes.
1.6 Acute Otitis Media
Clarithromycin tablets, USP are indicated in pediatric patients for
the treatment of mild to
moderate infections caused by susceptible isolates due to Haemophilus
influenzae,
Moraxella catarrhalis, or Streptococcus pneumoniae[see Clinical
Studies (14.2)] .
1.7 Treatment and Prophylaxis of Disseminated Mycobacterial Infections
Clarithromycin tablets, USP are indicated for the treatment of mild to
moderate
infections caused by susceptible isolates due to Mycobacterium avium
or Mycobacterium
intracellulare in patients with advanced HIV infection [
                                
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