Adverse reactions : תופעות לוואי

4.8    Undesirable effects
The most commonly reported adverse reaction is renal function impairment, and more rarely renal failure, usually following use of higher than recommended doses in patients with normal renal function, or failure to reduce the dosage in patients with renal impairment or when used concomitantly with other nephrotoxic antibiotics. The effect is usually reversible on discontinuation of therapy, but rarely intervention (renal replacement therapy) may be required.
High serum concentrations of colistimethate sodium, which may be associated with overdosage or failure to reduce the dosage in patients with renal impairment, have been reported to lead to neurotoxic effects such as facial paraesthesia, muscle weakness, vertigo, slurred speech, vasomotor instability, visual disturbances, confusion, psychosis and apnoea. Concomitant use with either non-depolarising muscle relaxants or antibiotics with similar neurotoxic effects can also lead to neurotoxicity. Dose reduction of colistimethate sodium may relieve symptoms.
Hypersensitivity reactions such as skin rash and angioedema have been known to occur.
In the event such reactions occur, treatment with colistimethate sodium should be withdrawn.
Adverse reactions are tabulated below by system organ class and frequency.
Frequencies are defined as very common (>1/10): common (>1/100 to <1/10): uncommon (>1/1,000 to <1/100): rare (>1/10,000 to <1/1,000) and very rare (<1/10,000), not known (cannot be estimated from the available data).


Body System               Frequency             Reported adverse reaction Immune system             Not known             Hypersensitivity reactions disorders                                       such as skin rash and angioedema
Nervous system            Very Common           Neurotoxicity such as, facial, disorders                                       mouth and peri-oral paraesthesia, headache, and muscle weakness
Not known             Dizziness
Ataxia
Skin and subcutaneous     Very Common           Pruritus tissue disorders
Renal and urinary         Very Common           Renal impairment disorders                                       demonstrated by increased blood creatinine and / or urea and / or decreased creatinine renal clearance
Rare                  Renal failure
General disorders and        Not known          Injection site reaction administration site conditions
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/