Medicinal Products

AMIKACINE MYLAN Enf Nour 50 mg / 1 mL

Generic drug of the therapeutic class: Infectiology - Parasitology
active ingredients: Amikacin
laboratory: Mylan

Injectable solution
Box of 20 ampoules of 1 mL
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.

· In monotherapy, they are limited to Gram-negative bacilli infections 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, in particular in their manifestations:

o renal, urological and genital

o septicemic and endocardial,

o meningeal (with local treatment),

o respiratory,

o cutaneous (staphylococcal malignant skin of the face),

o articular.

This dosage is suitable for pediatric use.

Official recommendations concerning the appropriate use of antibacterials should be taken into account.

Dosage AMIKACINE MYLAN Enf Nour 50 mg / 1 mL Solution for injection Box of 20 ampoules of 1 mL

· In the subject with normal renal function
Intramuscular route

o Children:
15 mg / kg / day which can be divided into:

§ 7.5 mg / kg twice daily

§ 5 mg / kg three times a day

o Infants:
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.

Route IV (slow intravenous infusion)

o Amikacin should not be administered intravenously directly.

o Amikacin should be diluted in a solution of isotonic sodium chloride 0.9% or isotonic glucose, 5%.

o The infusion should be administered for a period of 30 minutes to 1 hour.
The daily dose is the same as when administered intramuscularly.
It is also divided into 2 or 3 infusions.

Subcutaneous route
Amikacin can be administered subcutaneously at the same dosage as for the intramuscular route.
Intra-rachidian way
Amikacin can be administered intratracheally at the dosage of 0.5 mg / kg, one injection every 48 hours, repeated 3 to 4 times after sterilization of the cerebrospinal fluid.

· In patients with renal insufficiency
Dosage adjustment, regular monitoring of renal, cochlear, and vestibular function are required, and serum control assays 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.
The dosage should be adapted to the degree of renal impairment by spacing and / or reducing doses.
One of the methods proposed is to calculate the interval between the injections 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.
In practice, 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 T½, the value of T½ being given by the relation :
T½ (hour) = 0.3 x Cr mg / l for example, for creatinine (Cr) at 40 mg / l, we will have:
T½ (hour) = 0.3 x 40 = 12 hours
T '= 3 T½ = 3 x 12 = 36 hours
If T 'is greater than 40 hours, change the pattern and make ½ dose every T½.

· 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.

Against indications

· This medication should never be used in the following cases:

o Allergy to antibiotics of the aminoglycoside family

o myasthenia

· Simultaneous administration of another aminoglycoside is contraindicated.

· This medicine is generally not recommended in combination with parenteral Polymyxine or botulinum toxin (see section 4.5 ).

Adverse effects Amikacin Mylan Enf Nour

· Nephrotoxicity: This medicine 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 cochleobuccal 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.

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