Colistin Hikma 1.000.000 IU Vial

Country: Jordan

Language: English

Source: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

Active ingredient:

Colistimethate 1.000.000 iu

Available from:

شركة أدوية الحكمة - Hikma Pharmaceuticals

ATC code:

J01XB01

INN (International Name):

Colistimethate 1.000.000 iu

Dosage:

1.000.000 iu

Units in package:

1 Vial

Manufactured by:

Hikma Italia S.P.A (ايطاليا)

Patient Information leaflet

Colistin Hikma
®
Colistimethate Sodium
ACTION
Colistimethate sodium is a cyclic polypeptide antibiotic derived from
Bacillus polymyxa var. colistinus and belongs
to the polymyxin group. The polymyxin antibiotics are cationic agents
that work by damaging the cell membrane. The
resulting physiological effects are lethal to the bacterium.
Polymyxins are selective for Gram-negative bacteria that
have a hydrophobic outer membrane.
INDICATIONS
Colistin Hikma is indicated in the treatment of the following
infections where sensitivity testing suggests that they are
caused by susceptible bacteria:
• Treatment by intravenous administration of some serious infections
caused by Gram-negative bacteria, including
those of the lower respiratory tract and urinary tract, when more
commonly used systemic antibacterial agents may
be contra-indicated or may be ineffective because of bacterial
resistance (nosocomial infections).
• Treatment by inhalation of lung infection, caused by Pseudomonas
aeruginosa, in patients with cystic fibrosis (CF).
DOSAGE AND ADMINISTRATION
Posology
_Systemic Treatment:_
Colistin Hikma can be given as a 50ml intravenous infusion over a
period of 30 minutes. Patients with a totally
implantable venous access device (TIVAD) in place may tolerate a bolus
injection of up to 2 million units in 10ml given
over a minimum of 5 minutes.
The dose is determined by the severity and type of infection and the
age, weight and renal function of the patient.
Should clinical or bacteriological response be slow the dose may be
increased as indicated by the patient’s condition.
Serum level estimations are recommended especially in renal
impairment, neonates and cystic fibrosis patients. Levels
of 10–15 mg/l (approximately 125-200 units/ml) colistimethate sodium
should be adequate for most infections.
A minimum of 5 days treatment is generally recommended. For the
treatment of respiratory exacerbations in cystic
fibrosis patients, treatment should be continued for up to 12 days.
_Children and adults (including the el