Medicinal Products


Generic drug of the therapeutic class: Infectiology - Parasitology
active ingredients: Amikacin
laboratory: Sanofi-Aventis France

Lyophilisate for parenteral use
Box of 1 vial of 500 mg
All forms


They arise from the antibacterial activity and pharmacokinetic characteristics of amikacin. They take into account both the clinical studies that the drug has given and its place in the range of antibacterial products currently available.
- They are limited to infections with Gram-negative bacilli defined as sensitive, especially in their renal and urological manifestations.
- The combination of amikacin with another antibiotic may be justified in certain infections with sensitive germs based on bacteriological data, especially in their manifestations:
. Renal, urological and genital.
. Septicemia and endocarditis.
. Meningeal (with local treatment).
. Breathing.
. Cutaneous (staphylococcal malignant skin of the face).
. Joint.
- Official recommendations regarding the proper use of antibacterials should be taken into account.

Dosage AMIKACINE WINTHROP 500 mg Lyophilisate for parenteral use Box of 1 vial of 500 mg

The contents of a 500 mg vial must be reconstituted in 4 ml of water ppi.
- Adults and children:
15 mg / kg / day which can be divided into:
. 15 mg / kg once a day,
. 7.5 mg / kg twice daily,
. 5 mg / kg three times daily.
- Infants:
15 mg / kg / day, under control of serum levels of the antibiotic.
Since the provision of aminoglycosides, it has been shown that it is possible, by the same daily dosage, to reduce the number of administrations. Conventionally, the number of injection was 3 per day, especially for the maximum doses, sometimes 2 per day. The experience gained indicates that in general the number of injection is 2 or even 1 alone per day:
- The daily dose can be administered as a daily injection (IM or slow infusion):
. in patients younger than 65,
. in patients with normal renal function,
. when the treatment does not exceed 10 days,
. in the absence of neutropenia,
. excluding Gram-positive infections,
. for Gram-negative infections excluding Pseudomonas and Serratia .
- In these circumstances, at least an identical efficacy and a sometimes better tolerance have been demonstrated with a daily injection compared to the conventional modalities (q 8 hours).
- In other cases, twice daily administration of the usual dose is most often recommended, apart from renal insufficiency, which involves maintaining the usual measures.
- Plasma assays are useful when treatment should exceed 7 to 10 days; a residual concentration of less than 5 μg / ml indicates that the chosen rate of administration is adapted to the patient's purification capacities.
- In case of extremely serious infection, the daily dose may exceptionally be increased to 1.50 g in adults and the monitoring of renal and auditory functions must be reinforced.
- In general, the total dose per treatment should not exceed 15 g.
Administration mode :
- The contents of a 500 mg vial must be reconstituted in 4 ml of water ppi.
- The reconstituted amikacin solution should then be diluted in isotonic sodium chloride solution or 5% isotonic glucose solution.
- In adults:
. The amikacin solution will be diluted to 500 mg of amikacin per 100 or 200 ml of solution.
. The infusion should be administered for a period of 1 hour.
- In the term newborn, the infant and the child:
The volume of dilution to be used must allow the administration of an infusion during a period:
. 1 or 2 hours in the infant and the newborn at term,
. 30 minutes to 1 hour in the child.
- Adults and children:
The daily dose is the same as when administered IM. It is also divided into 1, 2 or 3 infusions.
- Infants and newborns at term:
15 mg / kg / day, under control of serum levels of the antibiotic, if treatment duration exceeds 4 to 5 days.
- The contents of a 500 mg vial must be reconstituted in 4 ml of water ppi.
Amikacin can be administered subcutaneously at the same dosage as for the intramuscular route.
- The contents of a 500 mg vial must be reconstituted in 4 ml of water ppi.
- Amikacin can be administered intraspinal at a dosage of 0.5 mg / kg once every 48 hours, repeated 3 to 4 times after sterilization of the cerebrospinal fluid.
- Dosage adjustment, regular monitoring of renal, cochlear, and vestibular function are essential, and serum control dosing should be performed as much as possible.
Serum creatinine or endogenous creatinine clearance values ​​are the best tests for assessing kidney function status and adjusting dosage.
- One of the methods proposed is to calculate the interval between the injections by taking into account the rate of serum creatinine which will have to be determined regularly during treatment in order to be able to adapt the dosage accurately to the variations of the renal function.
Practically, we will begin with a loading dose of 7.5 mg / kg which will be repeated, knowing that the time interval T 'between each injection will be equal to 3 T1 / 2.
The value of T1 / 2 being given by the relation:
T1 / 2 (hour) = 0.3 x Cr (mg / L),
for example, for serum creatinine at 40 mg / L, we will have:
T1 / 2 (hour) = 0.3 x 40 = 12 hours,
T '= 3 T1 / 2 = 3 x 12 = 36 hours.
If T 'is greater than 40 hours, change the pattern and make half a dose every T1 / 2.
- In hemodialysis: after a loading dose of 5 to 7.5 mg / kg, determine the doses to be administered after each session taking into account the serum concentrations.

Against indications

This medicine MUST NEVER BE USED in case:
- allergic to antibiotics of the aminoglycoside family,
- simultaneous administration with other aminoglycosides (see interactions),
- myasthenia.
The use of this drug is not recommended:
- During pregnancy: The use of this drug is not recommended during pregnancy because of a potential risk of fetal ototoxicity and nephrotoxicity. Its use will be strictly limited to serious infectious diseases. Indeed, in clinical cases some cases of neonatal cochleovestibular involvement have been described with aminoglycosides, especially streptomycin and kanamycin, and animal studies have shown cochlear and renal involvement. In the case of exposure to this drug during pregnancy, an evaluation of the auditory (auto-emission) and renal function of the newborn is recommended.
- in combination with polymyxin B, botulinum toxin and colistin (see section on interactions).

Adverse effects Amikacine Winthrop

- Nephrotoxicity: This drug belongs to the aminoglycoside family for which cases of renal failure have been reported. Most of the time, they were related to too high dosage or prolonged treatment, previous renal damage, haemodynamic disorders, or combinations of products known to be nephrotoxic.
- Ototoxicity: this drug belongs to the aminoglycoside family for which cases of cochleovestibular involvement have been reported. They were favored by too high a dosage, a long duration of the treatment, a functional renal insufficiency of the elderly subjects or by associations with ototoxic products.
- Minor allergic reactions (rash, urticaria) have been described. These phenomena stopped when the treatment was stopped.

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