Chemical formula: C₂₀H₂₂N₈O₆S₂ Molecular mass: 690.66 g/mol
There are no adequate and well-controlled studies with ceftobiprole medocaril in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
As no data in exposed human pregnancies are available, ceftobiprole medocaril should not be used during pregnancy unless strictly necessary.
Animal studies have shown the excretion of ceftobiprole/metabolites in milk at low concentrations. It is unknown whether ceftobiprole is excreted in human milk and the risk of diarrhoea and fungal infection of the mucous membranes in the breast-fed infant cannot be excluded. The possibility of sensitisation should be taken into account. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from ceftobiprole medocaril therapy, taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
The effects of ceftobiprole medocaril on fertility in humans have not been studied. Animal studies with ceftobiprole medocaril do not indicate harmful effects with respect to fertility.
No studies on the effects on the ability to drive and use machines have been performed. However, since dizziness is a common undesirable effect, driving and using machines is not recommended while on treatment with ceftobiprole medocaril.
In therapeutic clinical studies, 1,668 subjects received ceftobiprole medocaril. Within these trials there were a total of 1,239 subjects (696 subjects in community-acquired pneumonia and nosocomial pneumonia, and 543 subjects in complicated skin and soft tissue infections, cSSTIs) who received 500 mg three times daily, 389 subjects (cSSTIs) who received 500 mg twice daily and 40 subjects (cSSTIs) who received 750 mg twice daily.
The most common adverse reactions occurring in ≥3% of patients treated with ceftobiprole medocaril were nausea, vomiting, diarrhoea, infusion site reactions, hypersensitivity (including urticaria, pruritic rash and drug hypersensitivity) and dysgeusia.
Less frequently reported, but more serious, adverse reactions include thrombocytopenia, agranulocytosis, anaphylaxis, Clostridium difficile, colitis, convulsion, agitation (including anxiety, panic attacks and nightmares), and renal failure.
The following adverse reactions were reported during therapy and during follow-up with frequencies corresponding to 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); very rare (<1/10,000); not known (cannot be estimated from the available data):
Adverse reactions from clinical studies and post-marketing reports:
Common: Fungal infection (including vulvovaginal, oral and cutaneous fungal infections)
Uncommon: Clostridium difficile colitis
Uncommon: Eosinophilia**, leukopenia, anaemia, thrombocytosis, thrombocytopenia
Not known: Agranulocytosis*
Common: Hypersensitivity (including urticaria, pruritic rash and drug hypersensitivity)
Uncommon: Anaphylaxis
Common: Hyponatraemia
Uncommon: Hypokalaemia
Uncommon: Insomnia, agitation (including anxiety, panic attacks and nightmares)
Common: Dysgeusia, headache, dizziness, somnolence**
Not known: Convulsions*
Uncommon: Dyspnoea, pharyngolaryngeal pain**, asthma
Common: Nausea, vomiting, diarrhoea, abdominal pain, dyspepsia
Common: Hepatic enzymes increased (including AST, ALT, LDH and alkaline phosphatase)
Common: Rash (including macular, papular, maculo-papular and generalised rash), pruritus
Uncommon: Muscle spasms**
Uncommon: Renal failure
Common: Infusion site reactions
Uncommon: Peripheral oedema
Uncommon: Blood triglycerides increased, blood creatinine increased, blood glucose increased
Not known: Coombs Direct Test Positive
* Based on post-marketing reports. Since these reactions were spontaneous reports post-marketing, it is not possible to reliably estimate their frequency which is therefore categorised as not known.
** Seen in cSSTI studies only
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