Clarithromycin 500 mg Powder for Concentrate for Solution for Infusion

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Clarithromycin 500mg

Available from:

Max Health Limited

INN (International Name):

Clarithromycin 500 mg

Dosage:

500 mg

Pharmaceutical form:

Powder for infusion concentrate

Composition:

Active: Clarithromycin 500mg Excipient: Lactobionic acid

Prescription type:

Prescription

Manufactured by:

Ind-Swift Laboratories Limited

Therapeutic indications:

Clarithromycin intravenous infusion is indicated whenever parenteral therapy is required for treatment of sensitive microorganisms in the following conditions: · upper respiratory tract infections · lower respiratory tract infections · skin and soft tissue infections

Product summary:

Package - Contents - Shelf Life: Vial, glass, Type I clear glass - 1 dose units - 48 months from date of manufacture stored at or below 30°C 24 hours reconstituted (not refrigerated) stored at or below 25°C protect from light. Reconstituted with sterile water for injection. 48 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Reconstituted with sterile water for injection. 6 hours diluted stored at or below 25°C protect from light. In final infusion solution 48 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. In final infusion solution

Authorization date:

2013-12-11

Summary of Product characteristics

Page 1 of 22
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Clarithromycin 500 mg Powder for Concentrate for Solution for Infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 500 mg of clarithromycin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Infusion, powder for concentrate.
4.
CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
Clarithromycin I.V. is indicated whenever parenteral therapy is
required for treatment of sensitive
microorganisms in the following conditions:
•
Upper respiratory tract infections.
•
Lower respiratory tract infections (see section 4.4 and 5.1 regarding
Sensitivity testing).
•
Skin and soft tissue infections (see section 4.4 and 5.1 regarding
Sensitivity testing).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
_4.2 _
_DOSE AND METHOD OF ADMINISTRATION _
DOSE
The recommended dosage of clarithromycin I.V. in adults 18 years of
age or older is 1 gram daily,
divided into 2 equal doses, each infused, after further dilution with
an appropriate I.V. diluent, over
a 60-minute time period. At the present time, there are no data
supporting intravenous use of
clarithromycin in children.
Clarithromycin should not be given as a bolus or an intramuscular
injection.
Intravenous therapy may be limited for up to 2 to 5 days in the very
ill patient and should be changed
to oral therapy whenever possible as determined by the physician.
_DOSAGE IN PATIENTS WITH MYCOBACTERIAL INFECTIONS _
Although there currently is no data regarding use of clarithromycin
I.V. in immunocompromised
patients, data are available regarding the use of oral clarithromycin
in HIV-infected patients. In
disseminated or localized infections (_M. avium, M. intracellulare, M.
chelonae, M. fortuitum, M. _
_kansasii_), the recommended treatment, in adults, is 1000 mg/day in
two divided doses.
Page 2 of 22
_SPECIAL POPULATIONS _
RENAL IMPAIRMENT
In patients with renal impairment who have creatinine clearance less
than 30 mL/min, the dosag