Medicinal Products

AMIKACIN DAKOTA PHARM 50 mg

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

Lyophilisate for parenteral use
Box of 1 vial of 50 mg
All forms

Indication

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
. septicemic and endocardial
. meningeal (with local treatment),
. respiratory,
. cutaneous (staphylococcal malignant skin of the face),
. joint.
- This dosage is suitable for pediatric use.
- Official recommendations regarding the proper use of antibacterials should be taken into account.

Dosage AMIKACINE DAKOTA PHARM 50 mg Lyophilisate for parenteral use Box of 1 vial of 50 mg

Dosage:
ABOUT NORMAL RENAL FUNCTIONS :
INTRAMUSCULAR PATH:
- Children:
15 mg / kg / day which can be divided into:
. 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.
In case of uncomplicated urinary tract infection, the dosage can be reduced by half.
PATH IV (SLOW INTRAVENOUS INFUSION):
- Amikacin should not be administered directly via the intravenous route .
- Amikacin should be diluted in saline or isotonic glucose solution.
- 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 WAY:
Amikacin can be administered subcutaneously at the same dosage as for the intramuscular route.
INTRARACHIDIAN ROUTE:
Amikacin can be administered intratracheally at a dosage of 0.5 mg / kg, once every 48 hours, repeated 3-4 times after sterilization of the cerebrospinal fluid.
IN THE INSUFFICIENT RENAL :
- 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 to assess the status of renal function and to adjust the dosage.
- The dosage should be adapted to the degree of renal impairment by spacing and / or reducing doses.
- One of the methods proposed and 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.
- 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 creatinine (Cr) at 40 mg / L, we will have:
T1 / 2 (hour) = 0.3 x 40 = 12 hours,
T '= 3 T 1/2 = 3 x 12 = 36 hours.
If T 'is greater than 40 hours, change the pattern and make 1/2 every T1 / 2 dose.
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 50 mg vial in 1 ml of water for injections.

Against indications

CONTRAINDICATED:
- Allergy to antibiotics of the aminoglycoside family.
- Myasthenia.
- Simultaneous administration of another aminoglycoside is contraindicated.
Amikacin should not be administered intravenously directly .
NOT RECOMMENDED :
This drug is generally not recommended in combination with parenteral Polymyxine or botulinum toxin (see section INTERACTIONS).

Adverse Reactions Amikacin Dakota Pharm

- 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.

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