Abelcet – Indications, Posology, Against indications, Undesirable effects Source RESIP-BCB

Abelcet – Indications, Posology, Against indications, Undesirable effects  Source RESIP-BCB
ABELCET 5 mg/ml Suspension to be diluted for perfusion Box of 10 Bottles of 20 ml
Therapeutic class:   Infectiology – Parasitology
Active ingredients:   Amphotéricine B
Statute:   Drug subjected to medical regulation
Laboratory:   Cephalon

Indications

Treatment of aspergilloses and the systemic candidoses:
- at the subjects having developed an impaired renal function under amphotéricine B defined by:
. the rise in the creatininemy above 220 micromol/L or,
. the lowering of the clearance of creatinin below 25 ml/min;
- in the event of preexistent and persistent deterioration of the renal function defined by:
. creatininemy higher than 220 micromol/L or,
. the clearance of creatinin lower than 25 ml/min.

Posology

- Abelcet is a sterile suspension apyrogene to be only diluted for intravenous perfusion.
- The amount recommended is of 5,0 mg/kg/jour during 14 to 21 days. Abelcet must be managed by intravenous perfusion with a flow of 2,5 mg/kg/heure.
- Taking into account the allergic risks, a amount-test initial of 1,0 Mg must be managed into IV slow (15 min) to highlight a sensitivity.
- In the event of aggravation of the renal function under Abelcet, the continuation of the treatment must be discussed according to the benefit ratio/estimated risk. In the absence of validated diagram of posological adaptation, it is proposed to lower the amounts of Abelcet to 2,5 mg/kg in a transitory way, or to space the perfusions temporarily.
- In the actual position of knowledge, no diagram however makes it possible to guarantee at the same time the effectiveness and the harmlessness of the treatment.
- One can use a filter on the line of perfusion for perfuser Abelcet. The diameter of the pores will not have to be lower than 5,0 microns.

Against indications

CONTRA-INDICATE:
Abelcet is contra-indicated among patients presenting a known over-sensitiveness to the one of the components.
DISADVISE:
This drug is generally disadvised with the sultopride (see heading interactions).

Undesirable effects

- The side effects which were reported with the conventional amphotéricine B can occur with Abelcet.
- A premedication (by ex: with paracetamol) can be managed to prevent occurred of the side effects related to the perfusion. The principal undesirable effects met include shivers, fever, nausea and vomiting.
- Generals:
Fever (sometimes accompanied by shivers usually appearing 15 to 20 minutes after the beginning of the treatment), faintness, weight loss, flush.
- Gastro-intestinal:
Anorexia, nauseas, vomiting, diarrhea, dyspepsia, pains gastric.
- Hematologic:
Weakens normochrome normocytaire, agranulocytose, defects of coagulation, thrombocytopenia, leucopenia, éosinophilie.
- Buildings:
Pain at the point of injection with or without phlebitis or thrombophlébite.
- Locomotors:
Generalized pains, including muscular and articular pains.
- Neurological:
Cephalgias, convulsions, hearing impairment, buzzes of ears, giddinesses transitory, peripheral eye troubles or diplopia, neuropathies, other neurological symptoms. Exceptional cases of leuco-encephalopathies were generally reported at subjects having undergone a total body irradiation.
- Renal:
Deteriorations of the renal function: azotemy, increase in serum creatinin, hypokaliemy, hypomagnesemy, hyposthénurie, distal tubular acidosis and néphrocalcinose histological even permanent impaired renal function if administration of important total amounts.
- Allergic:
Anaphylactic reactions.
- Cardiovascular:
Cardiac arrest, arrhythmias (ventricular fibrillations), cardiac failure, hypertension, hypotension, shock.
- Dermatological:
Rash, in particular maculopapuleux, prurit.
- Pulmonary:
Dyspnea, bronchospasme, pulmonary edema noncardiogenic.