Medicinal Products

AMIKACIN B. BRAUN 2.5 mg / mL

Generic drug of the therapeutic class: Infectiology - Parasitology
active ingredients: Amikacin
laboratory: B-Braun Melsungen

Injection solution for IV infusion
Box of 10 bottles of 100 ml
All forms

Indication

Treatment of severe infections caused by bacteria that are sensitive to amikacin (see section 5.1 Pharmacodynamic properties ), when less toxic antibiotics are not effective. Under these conditions, AMIKACINE B. BRAUN 2.5 mg / ml solution for infusion may be used in case of:

· Low nosocomial respiratory infections, including severe pneumonia.

· Intra-abdominal infections, including peritonitis,

· Urinary infections complicated and recurrent.

· Skin and soft tissue infections, including burn infections.

Initial empirical treatment of sepsis and documented bacteremia.

Bacterial endocarditis.

Postoperative intra-abdominal infections.

AMIKACIN B. BRAUN 2.5 mg / ml solution for infusion may also be used in the treatment of patients with bacteremia associated or suspected of being associated with any of the above infections.

AMIKACIN B. BRAUN 2.5 mg / ml solution for infusion is generally used in combination with other appropriate antibiotics to cover the bacterial spectrum encountered in the infection.

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

Dosage AMIKACINE B. BRAUN 2.5 mg / mL Solution for IV infusion Pack of 10 bottles of 100 ml

AMIKACIN B. BRAUN 2.5 mg / ml solution for infusion should be administered exclusively by intravenous infusion. The recommended infusion time is 30 minutes but can be up to 60 minutes.

Patients with normal renal function

Adults and adolescents over 12 years (body weight over 33 kg):

The recommended intravenous dose for adults and adolescents with normal renal function (creatinine clearance ≥ 50 ml / min) is 15 mg / kg bw / day. It can be administered in a single dose or divided into 2 equal doses, namely 7.5 mg / kg of body weight every 12 hours.

The total daily dose can not exceed 1.5 g. In case of endocarditis and in febrile neutropenic patients, the dose should be administered twice a day as the data supporting the daily dose administration at one time is not sufficient.

Infants, babies and children (body weight over 12.5 kg):

The intravenous dose (slow intravenous infusion) recommended in children with normal renal function is 15 to 20 mg / kg / day. It may be administered in a dose of 15 to 20 mg / kg once daily or in doses of 7.5 mg / kg every 12 hours. In case of endocarditis and in febrile neutropenic patients, the dose should be administered twice daily as the data supporting the once-daily dosing is not sufficient.

Neonates:

An initial loading dose of 10 mg / kg followed by 7.5 mg / kg every 12 hours (see sections Warnings and Precautions and Pharmacokinetic Properties ).

premature:

In premature infants, the recommended dose is 7.5 mg / kg every 12 hours (see Warnings and Precautions and Pharmacokinetic Properties sections).

Perfusion volumes in patients with normal renal function:

Dose (mg) per kg of body weight

Body weight

AMIKACIN B. BRAUN 2.5 mg / ml (100 ml = 250 mg)

2.5 kg

5 kg

10 kg

12.5 kg

20 kg

30 kg

40 kg

50 kg

60 kg

70 kg

80 kg

90 kg

100 kg

amikacin
(Mg)

7.5

7.50

15, 00

30, 00

37.50

60, 00

90, 00

120.00

150.00

180.00

210.00

240.00

270.00

300.00

ml

15

15, 00

30, 00

60, 00

75.00

120.00

180.00

240.00

300.00

360.00

420.00

480.00

540.00

600.00

20

20.00

40, 00

80, 00

100.00

160.00

240.00

320.00

400.00

480.00

560.00

640.00

720.00

800.00

Body weight

The use of an infusion pump guarantees a precise dosage of AMIKACINE B. BRAUN 2.5 mg / ml solution for infusion.

This solution is a ready-to-use formulation that should not be diluted prior to administration and is intended for single use only.

To avoid an overdose, especially in children, the most appropriate dosage should be chosen.

Specific recommendations for intravenous administration

In pediatric patients, the amount of diluents used will depend on the amount of amikacin supported by the patient. Generally, the solution should be administered by infusion for 30 to 60 minutes. In infants, the infusion should last from 1 to 2 hours.

Maximum daily dose:

In case of life-threatening infection, the dose may be increased up to 1.5 g per day but should not be administered for more than 10 days and only under constant surveillance. In adults, a total dose of 15 g should not be exceeded: any other treatment with aminoglycosides previously administered should be included in this calculation.

Due to the need for dose adjustments, administration of amikacin in a single daily dose is not recommended in patients with impaired immunity, renal impairment, cystic fibrosis, ascites or extensive burns ( more than 20% of the skin), in elderly patients and in case of pregnancy.

Duration of treatment

The total duration of treatment should be limited to 7 to 10 days, depending on the severity of the infection. In case of severe and complicated infection, when treatment with amikacin exceeds 10 days, the relevance of treatment with amikacin should be reevaluated because the continuation of treatment will require the monitoring of serum amikacine and kidney, hearing and vestibular.

Patients with infections caused by susceptible organisms should respond to treatment within 24 to 48 hours if the recommended dosage is followed. In the absence of a clinical response in three to five days, another treatment should be considered.

Monitoring the concentration of the drug

Blood samples will be taken at the end of a dosing interval (minimum concentration) and immediately after the end of the infusion (maximum concentration). The serum concentration of amikacin should be monitored on the second or third day following the start of treatment, then twice a week (see Warnings and Precautions ). The concentration should not exceed 30 to 35 micrograms / ml 30 minutes and 90 minutes after infusion. The minimum concentration should never be less than 10 micrograms / ml. Monitoring of plasma concentration is strongly recommended in patients with renal impairment.

Dosage in patients with renal insufficiency

Note: Administration of the once-daily dose of amikacin is not recommended in patients with impaired renal function (creatinine clearance <50 ml / min).

In patients with renal impairment with a glomerular filtration rate of less than 70 ml / min, dose reduction or longer dosing intervals are recommended because amikacin accumulation may occur. In patients with renal impairment, the loading dose is 7.5 mg amikacin / kg body weight. The dosing interval for each patient is calculated by multiplying by 9 the serum creatinine level. For example, if the creatinine concentration is 2 mg / 100 ml, the recommended individual dose (7.5 mg / kg body weight) should be given every 2 x 9 = 18 hours.

In patients with chronic renal insufficiency with known creatinine clearance, the maintenance dose administered every 12 hours is calculated using the following formula:

(creatinine clearance of the patient in ml / minute ÷ normal creatinine clearance in ml / minute) x amikacin 7.5 mg / kg body weight.

The values ​​presented in the table below can serve as benchmarks.

Clearance of creatinine

Daily dose of amikacin

Amikacin dose per 12 hours for a 70 kg patient

[Ml / min]

[mg / kg body weight / day]

[Mg]

70

-

80

7.6

-

8

266

-

280

60

-

69

6.4

-

7.6

224

-

266

50

-

59

5.4

-

6.4

186

-

224

40

-

49

4.2

-

5.4

147

-

186

30

-

39

3.2

-

4.2

112

-

147

20

-

29

2.1

-

3.1

77

-

112

15

-

19

1.6

-

2.0

56

-

77

Patients on hemodialysis or peritoneal dialysis will receive half of the usual dose at the end of the dialysis procedure.

Elderly patients may require lower maintenance doses than younger adults to achieve a therapeutic plasma concentration.

Amikacin is excreted renally. Renal function should be evaluated as soon as possible and the dosage should be adjusted if necessary.

Obese patients

Amikacin diffuses poorly in adipose tissue. The appropriate dose can be calculated based on the patient's estimated ideal body weight and adding 40% of the excess to determine the dose in mg / kg. The dose should be adjusted according to the results of the monitoring of the plasma concentration. The maximum dose of 1.5 g per day should not be exceeded. The duration of treatment should be limited to 7 to 10 days.

Patients with ascites

Higher doses should be administered to achieve adequate serum concentration, given the relatively larger distribution in the fluid compartment.

Against indications

Hypersensitivity to amikacin, other aminoglycosides or to any of the excipients.

Myasthenia gravis.

Adverse effects Amikacin B. Braun

Under certain conditions, amikacin has ototoxic and / or nephrotoxic effects. In rare cases, renal failure is observed in patients treated with amikacin. It usually disappears when the treatment is stopped.

Important note regarding the treatment:

Renal failure and hearing loss due to neurological effects can largely be avoided through precautionary measures. Check kidney status and hearing and balance before, during and after treatment. Maintain proper hydration and urine production. Monitor the concentration of the drug in serum in patients at particular risk and adjust the dose accordingly (see section 4.2 ).

Adverse reactions that are considered to be at least treatment-related are listed below by organ system class and frequency. The following terminology has been used to classify the occurrence of adverse effects:

Very common

(≥ 1/10)

Frequent

(≥ 1/100 to <1/10)

Rare

(≥ 1/1000 to <1/100)

Rare

(≥ 1/10 000 to <1/1000)

Very rare

(<1 / 10, 000),

Not known (can not be estimated from the available data)

Infections and infestations:

Rare:

Superinfection or colonization (by yeast-like fungi or resistant germs)

Hematological and lymphatic system disorders:

Rare:

Anemia, leukopenia, granulocytopenia, thrombocytopenia, eosinophilia

Immune system disorders:

Rare:

Hypersensitivity reactions 3

Very rare:

Anaphylactic shock (isolated cases)

Not known:

Cross-reactivity between aminoglycosides

Metabolism and nutrition disorders:

Rare:

hypomagnesemia

Nervous system disorders:

Rare:

Dizziness 1, vertigo 1

Rare:

Headache, migraine, paresthesia, tremors

Eye disorders:

Rare:

Nystagmus 1

Affections of the ear and labyrinth:

Rare:

Tinnitus 1, pressure in the ears 1, hearing loss 1

Very rare:

Deafness 1 (isolated cases)

Vascular disorders:

Rare:

hypotension

Respiratory, thoracic and mediastinal disorders:

Rare:

Depression of respiratory function 4

Very rare:

Respiratory paralysis 4 (isolated cases)

Gastrointestinal disorders:

Rare:

Nausea 1

Rare:

vomiting

Skin and subcutaneous tissue disorders:

Rare:

Rash, exanthem, pruritus, urticaria (hypersensitivity reactions) 3

Musculoskeletal and connective tissue disorders:

Rare:

arthralgia

Very rare:

Neuromuscular blocking

Renal and urinary disorders:

Rare:

Renal tubular involvement 2, renal failure 2

Very rare:

Toxic nephropathy, acute renal failure

General disorders and administration site defects:

Rare:

Medicated fever 3

investigations:

Rare:

Increased aspartate aminotransferase, increased alanine aminotransferase, increased (mild and transient) alkaline phosphatase

Additional information on some adverse effects

(1)

These effects have been noted particularly if the recommended dosage is exceeded, for treatments lasting more than 10 days or when the dose has not been reduced appropriately in patients with renal impairment. The first symptoms of vestibular disorders are dizziness, nausea and vomiting. Clinical examination often reveals nystagmus. Vestibular disorders are almost always reversible. The first symptoms of cochlear dysfunction often include a decrease in the perception of high frequencies (≥4, 000 Hertz), which precedes the loss of hearing and which only audiometry can detect.

(2)

Renal tubular involvement with renal failure is also an uncommon side effect. The mechanism of renal involvement involves accumulation in lysosomes, inhibition of phospholipases and tubular cell necrosis after repeated administration of amikacin. Once-a-day dosing may reduce the risk of nephrotoxicity. Renal impairment is reversible to varying degrees but exacerbates the risk of an accumulation process that may cause or enhance ototoxic effects. Elevation of creatinine concentration in the serum, presence of albumin, red and white blood cells or cylinders in the urine, uremia and oliguria are possible.

(3)

Rare side effects are hypersensitivity reactions such as rash, itching, hives and drug fever.

(4)

In rare cases, if the intravenous infusion of the drug is too fast, the respiratory function may experience severe depression. In isolated cases, this may result in respiratory paralysis. The risk also exists when amikacin is administered in combination with anesthetic and muscle relaxants (see section 4.5 ).

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