Clarithromycin 500mg powder for concentrate for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Clarithromycin

Available from:

Mercury Pharma Group Ltd

ATC code:

J01FA09

INN (International Name):

Clarithromycin

Dosage:

500mg

Pharmaceutical form:

Powder for solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010500; GTIN: 5099602996106

Summary of Product characteristics

OBJECT 1
CLARITHROMYCIN 500 MG, POWDER FOR CONCENTRATE
FOR SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 19-Apr-2018 | Concordia
International - formerly AMCo
1. Name of the medicinal product
Clarithromycin 500 mg, Powder for Concentrate for Solution for
Infusion
2. Qualitative and quantitative composition
Each vial contains 500 mg clarithromycin (as lactobionate).
Each millilitre of final reconstituted/diluted solution for infusion
contains 2 mg clarithromycin (as
lactobionate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for Concentrate for Solution for Infusion.
White crystalline powder
4. Clinical particulars
4.1 Therapeutic indications
Clarithromycin 500 mg, powder for concentrate for solution for
infusion is indicated when parenteral
therapy is required for treatment of infections, caused by
clarithromycin-susceptible organisms in the
following conditions:
- Community acquired pneumonia
- Acute exacerbation of chronic bronchitis
- Acute bacterial sinusitis (adequately diagnosed)
- Bacterial pharyngitis and tonsillitis
- Skin and soft tissue infections
Clarithromycin 500 mg, powder for concentrate for solution for
infusion is indicated in adults and
children 12 years and older.
“Consideration should be given to official guidance on the
appropriate use of antibacterial agents.
4.2 Posology and method of administration
Posology
Adults and adolescents: The recommended dose is 1.0 gram daily of
Clarithromycin powder for
concentrate for solution for infusion (appropriately diluted as
described below), administered as two
separate 500mg doses at 12 hourly intervals.
Children aged 12 or less: Use of Clarithromycin powder for concentrate
for solution for infusion is not
recommended for children younger than 12 years. Use clarithromycin
Paediatric Suspension.
Children older than 12 years: As for adults.
Elderly: Same as for adults.
Renal Impairment:
Patients with severe renal impairment, with creatinine clearance less
than 30ml/min, the dosage of
clarithromycin