Clarithromycin

CLARITHROMYCIN- clarithromycin for suspension
A-S Medication Solutions

1 INDICATIONS AND USAGE

1.1 Acute Bacterial Exacerbation of Chronic Bronchitis

Clarithromycin is 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 is 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 is 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 clarithromycin [in adults and pediatric patients]

1.4 Pharyngitis/Tonsillitis

Clarithromycin is 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 is 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 is 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 is 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 [see Clinical Studies (14.1) ].

1.9 Limitations of Use

There is resistance to macrolides in certain bacterial infections caused by Streptococcus pneumoniae and Staphylococcus aureus. Susceptibility testing should be performed when clinically indicated.

1.10 Usage

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 susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

Clarithromycin for oral suspension may be given with or without food.

2.4 Pediatric Dosage

The recommended daily dosage is 15 mg/kg/day divided every 12 hours for 10 days (up to the adult dose). Refer to dosage regimens for mycobacterial infections in pediatric patients for additional dosage information [see Dosage and Administration (2.5) ].

2.5 Dosage Regimens for Mycobacterial Infections

For the treatment of disseminated infection due to Mycobacterium avium complex (MAC), clarithromycin is recommended as the primary agents. Clarithromycin should be used in combination with other antimycobacterial drugs (e.g. ethambutol) that have shown in vitro activity against MAC or clinical benefit in MAC treatment [see Clinical Studies (14.1) ].

Adult Patients

For treatment and prophylaxis of mycobacterial infections in adults, the recommended dose of clarithromycin is 500 mg every 12 hours.

Pediatric Patients

For treatment and prophylaxis of mycobacterial infections in pediatric patients, the recommended dose is 7.5 mg/kg every 12 hours up to 500 mg every 12 hours. [see Use in Specific Populations (8.4) and Clinical Studies (14.1) ].

Clarithromycin therapy should continue if clinical response is observed. Clarithromycin can be discontinued when the patient is considered at low risk of disseminated infection.

2.6 Dosage Adjustment in Patients with Renal Impairment

See Table 2 for dosage adjustment in patients with moderate or severe renal impairment with or without concomitant atazanavir or ritonavir-containing regimens [see Drug Interactions (7) ].

Table 2. Clarithromycin Dosage Adjustments in Patients with Renal Impairment

Recommended ClarithromycinDosage Reduction
Patients with severe renal impairment (CLcr of <30 mL/min)
Reduce the dosage of Clarithromycin by 50%
Patients with moderate renal impairment (CLcr of 30 to 60 mL/min) taking concomitant atazanavir or ritonavir-containing regimens
Reduce the dosage of Clarithromycin by 50%
Patients with severe renal impairment (CLcr of <30 mL/min) taking concomitant atazanavir or ritonavir-containing regimens
Reduce the dosage of Clarithromycin by 75%

2.7 Dosage Adjustment Due to Drug Interactions

Decrease the dose of clarithromycin by 50 % when co-administered with atazanavir [see Drug Interactions (7) ]. Dosage adjustments for other drugs when co-administered with clarithromycin may be recommended due to drug interactions [see Drug Interactions (7) ].

2.8 Reconstitution of Clarithromycin for Oral Suspension

The supplied clarithromycin granules must be reconstituted with water prior to administration of clarithromycin for oral suspension. Table 3 below indicates the volume of water to be added when reconstituting. To reconstitute:

a.
Add half the volume of water to the bottle containing the clarithromycin granules and shake vigorously.
b.
Add the remainder of water to the bottle and shake.

Shake well before each use. After mixing, store at 15° to 30°C (59° to 86°F) and use within

14 days. Do not refrigerate.

Table 3. Volume of Water to be Added When Reconstituting Clarithromycin Granules

Total Volume After Reconstitution

Clarithromycin Concentration After Reconstitution

Amount of Water to be Added

50 mL

125 mg/5 mL

29.5 mL

100 mL

125 mg/5 mL

59 mL

50 mL

250 mg/5 mL

28.5 mL

100 mL

250 mg/5 mL

57 mL

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