Generic drug of the therapeutic class: Infectiology - Parasitology
active ingredients: Amikacin
Powder for solution for injection
Box of 20 bottles of 250 mg powder
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.
- As monotherapy, 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
. septicemic and endocardial
. meningeal (with local treatment),
. cutaneous (staphylococcal malignant skin of the face),
- Official recommendations regarding the proper use of antibacterials should be taken into account.
Dosage AMIKACINE MYLAN 250 mg Powder for solution for injection Box of 20 vials of powder of 250 mg
ABOUT NORMAL RENAL FUNCTIONS :
- Adults and children:
15 mg / kg and per day can be divided into:
. 15 mg / kg, once a day,
. 7.5 mg / kg, twice daily,
. 5 mg / kg, three times a day.
15 mg / kg / day, under control of serum concentrations of the antibiotic.
In case of uncomplicated urinary tract infection, the dosage can be reduced by half.
PATH IV (SLOW INTRAVENOUS INFUSION):
- AMIKACIN MUST NOT BE ADMINISTERED DIRECTLY.
- Amikacin should be diluted in a solution of sodium chloride or isotonic glucose at a rate of 500 mg per 200 ml of solution.
- The infusion must be administered for a period of one hour.
- Adults and children:
The daily dose is the same as when administered intramuscularly. It is also divided into 2 or 3 shots.
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 one per day.
- The daily dose can be administered as a daily injection (IM or short 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 the case of a very 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.
Amikacin can be administered subcutaneously at the same dosage as for the intramuscular route.
Amikacin can be administered intraspinal at a dosage of 0.5 mg / kg, one injection every 48 hours, repeated 3 to 4 times after sterilization of the liquid.
IN THE INSUFFICIENT RENAL :
- Dosage adjustment, regular monitoring of renal, cochlear and vestibular function are essential, and serum control dosing should be performed as far as possible.
Serum creatinine or endogenous creatinine clearance values are the best tests to assess the status of renal function and to adjust the dosage.
- 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 a 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 '> = at 40 hours, change pattern and half 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 serum concentrations.
Administration mode :
- Dissolve the contents of a 250 mg vial in 2 ml of water for injections.
- The reconstituted solution may have a slight yellow color which does not correspond to a loss of activity of the product.
- Intravenous infusion :
The following infusions can be used at a rate of 500 mg per 200 ml of solution:
. isotonic sodium chloride solution at 0.9%.
. isotonic glucose solution at 5%.
. glucose solution at 10%.
- This medicine should never be used in the following cases:
. allergy to antibiotics of the aminoglycoside family,
- Simultaneous administration of another aminoglycoside is contraindicated.
- AMIKACIN MUST NOT BE ADMINISTERED DIRECTLY .
NOT RECOMMENDED :
- This drug is generally not recommended in combination with parenteral polymyxin or botulinum toxin (see section on interactions).
- 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.
Adverse effects Amikacin Mylan
- 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 treatment, a pre-existing renal insufficiency, or by associations with ototoxic products.
- Minor allergic reactions (rash, urticaria) have been described. These phenomena stopped when the treatment was stopped.