Medicinal Products

ANSATIPINE 150 mg

Generic drug of the therapeutic class: Infectiology - Parasitology
Active ingredients: Rifabutin
laboratory: Serb

capsule
Box of 90
All forms

Indication

1. Preventive treatment of mycobacterial infections caused by M. avium complex (MAC) in HIV-infected individuals with a CD4 count below 100 / mm3.
2. Curative treatment of mycobacterial infections caused by M. avium complex (MAC) in subjects infected with the HIV virus in the context of multidrug therapy.
3. Treatment of multidrug-resistant tuberculosis especially with rifampicin.
Official recommendations concerning the appropriate use of antibacterials should be taken into account.

Dosage ANSATIPINE 150 mg Capsule Box of 90

Single oral administration .
There is no need to consider the timing of food intake.
- Adults:
The recommended doses in adults are:
. Preventive treatment :
1) Preventive treatment of mycobacterial infections caused by M. avium complex in HIV-infected individuals : 2 capsules at 150 mg, ie 300 mg of rifabutin once daily .
This treatment must be continuous. But, in case of occurrence of mycobacteriosis, a curative treatment is necessary.
The dosage of rifabutin should be reduced to 150 mg / day when given as prophylaxis and in combination with indinavir.
The dosage of rifabutin should be reduced to 150 mg / day when given as prophylaxis and in combination with nelfinavir.
. Curative treatment :
In all cases, Ansatipine will be prescribed in the context of an antimycobacterial multidrug therapy.
2) Curative treatment of mycobacterial infections caused by M. avium complex in HIV infected subjects: 4 capsules, ie 600 mg of rifabutin per day for subjects weighing more than 50 kg and 3 capsules, ie 450 mg of rifabutin per day for subjects weighing less than 50 kg at least for 6 months after negativation of the last crops.
In case of association with clarithromycin (refer to the section on warnings and precautions for use).
3) Treatment of multidrug-resistant tuberculosis:
the optimal dosage is not definitively established. It appears to be at least 450 mg / 24 hours and probably 600 mg / 24 hours.
- Elderly people:
No dosage adjustment is necessary in the elderly.
- Children:
The use of rifabutin is not recommended due to the lack of studies in children.

Against indications

CONTRAINDICATED:
- Hypersensitivity to rifamycins.
- Renal failure.
- Concomitant use of saquinavir (see interactions).
NOT RECOMMENDED :
- Child: The use of rifabutin is not recommended given the absence of studies in children.
Pregnancy and lactation: No information is currently available on the passage of rifabutin across the placental barrier or into breast milk. Experimental work in rats has shown that there is no detectable level of rifabutin in the amniotic fluid and only traces in the fetus. As a precautionary measure, it is recommended that Ansatipine be not prescribed in pregnant women and lactating women unless the therapeutic benefit appears to outweigh the risk.
- Association not recommended for estroprogestatives and progestins (used as contraceptives), with ritonavir.

Adverse effects Ansatipine

Note :
Ansatipine may stain red-orange urine, stool, skin and secretions (including tears with a risk of permanent staining of soft contact lenses).
- Most common side effects:
. myalgia / arthralgia,
. rash,
. taste modification,
. neutropenia required discontinuation in 2% of treated patients.
- Other undesirable effects:
Reversible uveitis of moderate to severe intensity has been reported. Risk of onset is very low when rifabutin is used at 300 mg / day, as monotherapy, for the prevention of MAC infections, but increases when rifabutin is administered at higher doses in combination with clarithromycin (or other macrolides). The potential role of fluconazole (or related drugs) in increasing this risk has not yet been established. No cases have been reported in patients treated with Ansatipine (150 to 600 mg / day) in combination with other drugs used in the treatment of pulmonary tuberculosis.
- Other adverse effects observed when combined with other anti-TB drugs:
. digestive disorders (nausea, vomiting) 8 to 12%,
. hepatic disorders (increased liver enzymes, jaundice) 8 to 12%,
. thrombocytopenia, anemia (4 to 9%),
. fever (2-4%).

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