Amikacin-Ferein (Solution, Lyophilisate, Powder) Instructions for Use
ATC Code
J01GB06 (Amikacin)
Active Substance
Amikacin (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Antibiotic of the aminoglycoside group
Pharmacotherapeutic Group
Antibiotic-aminoglycoside
Pharmacological Action
A broad-spectrum semi-synthetic antibiotic of the aminoglycoside group. It has a bactericidal effect. Actively penetrating through the bacterial cell membrane, it irreversibly binds to the 30S subunit of bacterial ribosomes and thereby inhibits the synthesis of the pathogen’s protein.
It is highly active against aerobic gram-negative bacteria: Pseudomonas aeruginosa, Escherichia coli, Shigella spp., Salmonella spp., Klebsiella spp., Enterobacter spp., Serratia spp., Providencia stuartii.
It is also active against some gram-positive bacteria: Staphylococcus spp. (including strains resistant to penicillin, methicillin, some cephalosporins), some strains of Streptococcus spp.
It is not active against anaerobic bacteria.
Pharmacokinetics
After intramuscular administration, it is rapidly and completely absorbed. It is distributed in all body tissues. Plasma protein binding is low (0-10%). It crosses the placental barrier.
It is not metabolized. It is excreted in the urine unchanged. T1/2 – 2-4 hours.
Indications
Severe infectious and inflammatory diseases caused by microorganisms sensitive to amikacin: peritonitis, sepsis, neonatal sepsis, CNS infections (including meningitis), bone and joint infections (including osteomyelitis), endocarditis, pneumonia, pleural empyema, lung abscess, purulent skin and soft tissue infections, infected burns, frequently recurrent urinary tract infections, biliary tract infections.
ICD codes
| ICD-10 code | Indication |
| A40 | Streptococcal sepsis |
| A41 | Other sepsis |
| G00 | Bacterial meningitis, not elsewhere classified |
| I33 | Acute and subacute endocarditis |
| J15 | Bacterial pneumonia, not elsewhere classified |
| J85 | Abscess of lung and mediastinum |
| J86 | Pyothorax (pleural empyema) |
| K65.0 | Acute peritonitis (including abscess) |
| K81.0 | Acute cholecystitis |
| K81.1 | Chronic cholecystitis |
| K83.0 | Cholangitis |
| L01 | Impetigo |
| L02 | Cutaneous abscess, furuncle and carbuncle |
| L03 | Cellulitis |
| L08.0 | Pyoderma |
| L08.8 | Other specified local infections of skin and subcutaneous tissue |
| M00 | Pyogenic arthritis |
| M86 | Osteomyelitis |
| N10 | Acute tubulointerstitial nephritis (acute pyelonephritis) |
| N11 | Chronic tubulointerstitial nephritis (chronic pyelonephritis) |
| N30 | Cystitis |
| N34 | Urethritis and urethral syndrome |
| P36 | Bacterial sepsis of newborn |
| T79.3 | Posttraumatic wound infection, not elsewhere classified |
| ICD-11 code | Indication |
| 1B70.1 | Streptococcal cellulitis of the skin |
| 1B70.2 | Staphylococcal cellulitis of the skin |
| 1B70.Z | Bacterial cellulitis or lymphangitis caused by unspecified bacterium |
| 1B72.0 | Bullous impetigo |
| 1B72.1 | Nonbullous impetigo |
| 1B72.Z | Impetigo, unspecified |
| 1B75.0 | Furuncle |
| 1B75.1 | Carbuncle |
| 1B75.2 | Furunculosis |
| 1B75.3 | Pyogenic skin abscess |
| 1B7Y | Other specified pyogenic bacterial infections of skin or subcutaneous tissue |
| 1C44 | Non-pyogenic bacterial infections of skin |
| 1D01.0Z | Bacterial meningitis, unspecified |
| 1G40 | Sepsis without septic shock |
| BB4Z | Acute or subacute endocarditis, unspecified |
| CA40.0Z | Bacterial pneumonia, unspecified |
| CA43.Z | Abscess of lung or mediastinum, unspecified |
| CA44 | Pyothorax |
| DC12.0Z | Acute cholecystitis, unspecified |
| DC12.1 | Chronic cholecystitis |
| DC13 | Cholangitis |
| DC50.0 | Primary peritonitis |
| DC50.2 | Peritoneal abscess |
| DC50.Z | Peritonitis, unspecified |
| EA50.3 | Staphylococcal scarlet fever |
| EB21 | Pyoderma gangrenosum |
| FA1Z | Infectious arthropathies, unspecified |
| FB84.Z | Osteomyelitis or osteitis, unspecified |
| GB50 | Acute tubulo-interstitial nephritis |
| GB51 | Acute pyelonephritis |
| GB55.Z | Chronic tubulo-interstitial nephritis, unspecified |
| GB5Z | Renal tubulo-interstitial diseases, unspecified |
| GC00.Z | Cystitis, unspecified |
| GC02.Z | Urethritis and urethral syndrome, unspecified |
| KA60 | Fetal or neonatal sepsis |
| NF0A.3 | Posttraumatic wound infection, not elsewhere classified |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Solution, Lyophilisate, Powder
The dosage is set individually, taking into account the severity and localization of the infection, and the sensitivity of the pathogen. It is administered intramuscularly, intravenous administration is also possible (bolus over 2 minutes or drip).
For intramuscular or intravenous administration to adults and adolescents – 5 mg/kg every 8 hours or 7.5 mg/kg every 12 hours for 7-10 days. For children, the initial dose is 10 mg/kg, then 7.5 mg/kg every 12 hours.
Maximum doses for adults: daily dose – 1.5 g.
Adverse Reactions
From the digestive system: increased activity of hepatic transaminases, hyperbilirubinemia, nausea, vomiting.
Allergic reactions: skin rash, itching, fever; rarely – angioedema.
From the hematopoietic system: anemia, leukopenia, granulocytopenia, thrombocytopenia.
From the nervous system: headache, drowsiness, impaired neuromuscular transmission, hearing loss, up to the development of irreversible deafness, vestibular disorders.
From the urinary system: oliguria, proteinuria, microhematuria; rarely – renal failure.
Contraindications
Severe renal impairment, acoustic neuritis, pregnancy, hypersensitivity to antibiotics of the aminoglycoside group.
Use in Pregnancy and Lactation
Amikacin is contraindicated during pregnancy.
If it is necessary to use during lactation, the issue of discontinuing breastfeeding should be decided.
Use in Renal Impairment
Contraindicated in severe renal impairment.
Patients with impaired renal excretory function require dosage adjustment depending on the creatinine clearance values.
The risk of nephrotoxic effects increases with the use of amikacin in high doses or in predisposed patients.
Pediatric Use
For children, the initial dose is 10 mg/kg, then 7.5 mg/kg every 12 hours.
Geriatric Use
Use with caution in elderly patients.
Special Precautions
Use with caution in patients with myasthenia gravis and parkinsonism, as well as in elderly persons.
Patients with impaired renal excretory function require dosage adjustment depending on the creatinine clearance values.
It is not recommended to use Amikacin in patients with hypersensitivity to other aminoglycosides due to the risk of cross-allergy.
The risk of ototoxic and nephrotoxic effects increases with the use of amikacin in high doses or in predisposed patients.
Drug Interactions
The risk of nephrotoxic effects increases with the concomitant use of amikacin with amphotericin B, vancomycin, methoxyflurane, enflurane, NSAIDs, radiocontrast agents, cephalothin, cyclosporine, cisplatin, polymyxins.
The risk of ototoxic effects increases with the concomitant use of amikacin with “loop” diuretics (furosemide, ethacrynic acid), cisplatin.
With concomitant use with penicillins (in renal failure), the antimicrobial effect is reduced.
With concomitant use with ethyl ether and neuromuscular blocking agents, the risk of respiratory depression increases.
Amikacin is incompatible in solution with penicillins, cephalosporins, amphotericin B, chlorothiazide, erythromycin, heparin, nitrofurantoin, thiopental, and also, depending on the composition and concentration of the solution, with tetracyclines, B vitamins, vitamin C and potassium chloride.
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Rx Only
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Lyophilisate for preparation of solution for intravenous and intramuscular administration 500 mg: vial 1 pc.
Marketing Authorization Holder
Bryntsalov-A, JSC (Russia)
Dosage Form
 |
Amikacin-Ferein | Lyophilisate for preparation of solution for intravenous and intramuscular administration 500 mg: vial 1 pc. |
Dosage Form, Packaging, and Composition
| Lyophilisate for preparation of solution for intravenous and intramuscular administration | 1 vial |
| Amikacin (as sulfate) | 500 mg |
500 mg – vials (1) – cardboard packs.
500 mg – vials (5) – contour cell blisters (10) – cardboard boxes.
Solution for intravenous and intramuscular injection 250 mg/ml: 2 ml or 4 ml amp. 5, 10, 50, 100, 124, 220, 250, 375, 500, 1000, 1150, 1800, or 2100 pcs.
Marketing Authorization Holder
Bryntsalov-A, JSC (Russia)
Dosage Form
|
Amikacin-Ferein | Solution for intravenous and intramuscular injection 250 mg/ml: 2 ml or 4 ml amp. 5, 10, 50, 100, 124, 220, 250, 375, 500, 1000, 1150, 1800, or 2100 pcs. |
Dosage Form, Packaging, and Composition
Solution for intravenous and intramuscular injection transparent, colorless or slightly yellowish.
| 1 ml | |
| Amikacin (as sulfate) | 250 mg |
Excipients: sodium citrate dihydrate 25.1 mg, sodium disulfite 6.6 mg, water for injection up to 1 ml.
2 ml – glass ampoules (5) – contour cell blisters (1) – cardboard packs.
2 ml – glass ampoules (5) – contour cell blisters (2) – cardboard packs.
2 ml – glass ampoules (5) – contour cell blisters (10) – cardboard boxes (for hospitals).
2 ml – glass ampoules (5) – contour cell blisters (20) – cardboard boxes (for hospitals).
2 ml – glass ampoules (5) – contour cell blisters (25) – cardboard boxes (for hospitals).
2 ml – glass ampoules (5) – contour cell blisters (44) – cardboard boxes (for hospitals).
2 ml – glass ampoules (5) – contour cell blisters (50) – cardboard boxes (for hospitals).
2 ml – glass ampoules (5) – contour cell blisters (75) – cardboard boxes (for hospitals).
2 ml – glass ampoules (5) – contour cell blisters (100) – cardboard boxes (for hospitals).
2 ml – glass ampoules (5) – contour cell blisters (200) – cardboard boxes (for hospitals).
2 ml – glass ampoules (5) – contour cell blisters (230) – cardboard boxes (for hospitals).
2 ml – glass ampoules (5) – contour cell blisters (360) – cardboard boxes (for hospitals).
2 ml – glass ampoules (5) – contour cell blisters (420) – cardboard boxes (for hospitals).
4 ml – glass ampoules (5) – contour cell blisters (1) – cardboard packs.
4 ml – glass ampoules (5) – contour cell blisters (2) – cardboard packs.
4 ml – glass ampoules (5) – contour cell blisters (10) – cardboard boxes (for hospitals).
4 ml – glass ampoules (5) – contour cell blisters (20) – cardboard boxes (for hospitals).
4 ml – glass ampoules (5) – contour cell blisters (25) – cardboard boxes (for hospitals).
4 ml – glass ampoules (5) – contour cell blisters (44) – cardboard boxes (for hospitals).
4 ml – glass ampoules (5) – contour cell blisters (50) – cardboard boxes (for hospitals).
4 ml – glass ampoules (5) – contour cell blisters (75) – cardboard boxes (for hospitals).
4 ml – glass ampoules (5) – contour cell blisters (100) – cardboard boxes (for hospitals).
4 ml – glass ampoules (5) – contour cell blisters (200) – cardboard boxes (for hospitals).
4 ml – glass ampoules (5) – contour cell blisters (230) – cardboard boxes (for hospitals).
4 ml – glass ampoules (5) – contour cell blisters (360) – cardboard boxes (for hospitals).
4 ml – glass ampoules (5) – contour cell blisters (420) – cardboard boxes (for hospitals).
Powder for solution for intravenous and intramuscular administration 250 mg: vial. 1, 5 or 10 pcs.
Marketing Authorization Holder
Bryntsalov-A, JSC (Russia)
Dosage Form
|
Amikacin-Ferein | Powder for solution for intravenous and intramuscular administration 250 mg: vial. 1, 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Powder for preparation of solution for intravenous and intramuscular administration white or almost white, crystalline, hygroscopic.
| 1 vial | |
| Amikacin (as sulfate) | 250 mg |
250 mg – vials (1) – cardboard packs.
250 mg – vials (5) – contour cell blisters made of PVC film (1) – cardboard packs.
250 mg – vials (5) – contour cell blisters made of PVC film (2) – cardboard packs.
250 mg – vials (5) – contour cell blisters made of PVC film (1) and flexible packaging based on aluminum foil or combined material on a paper base – cardboard packs.
250 mg – vials (5) – contour cell blisters made of PVC film (2) and flexible packaging based on aluminum foil or combined material on a paper base – cardboard packs.
250 mg – vials (5) – contour cell blisters made of PVC film (10) – cardboard packs (for hospitals).
250 mg – vials (5) – contour cell blisters made of PVC film (10) and flexible packaging based on aluminum foil or combined material on a paper base – cardboard packs (for hospitals).
Powder for solution for intravenous and intramuscular administration 500 mg: fl. 1, 5, or 10 pcs.
Marketing Authorization Holder
Bryntsalov-A, JSC (Russia)
Dosage Form
|
Amikacin-Ferein | Powder for solution for intravenous and intramuscular administration 500 mg: fl. 1, 5, or 10 pcs. |
Dosage Form, Packaging, and Composition
Powder for preparation of solution for intravenous and intramuscular administration white or almost white, crystalline, hygroscopic.
| 1 vial | |
| Amikacin (as sulfate) | 500 mg |
500 mg – vials (1) – cardboard packs.
500 mg – vials (5) – contour cell blisters made of PVC film (1) – cardboard packs.
500 mg – vials (5) – contour cell blisters made of PVC film (2) – cardboard packs.
500 mg – vials (5) – contour cell blisters made of PVC film (1) and flexible packaging based on aluminum foil or combined material on a paper base – cardboard packs.
500 mg – vials (5) – contour cell blisters made of PVC film (2) and flexible packaging based on aluminum foil or combined material on a paper base – cardboard packs.
500 mg – vials (5) – contour cell blisters made of PVC film (10) – cardboard packs (for hospitals).
500 mg – vials (5) – contour cell blisters made of PVC film (10) and flexible packaging based on aluminum foil or combined material on a paper base – cardboard packs (for hospitals).
Powder for solution for intravenous and intramuscular administration 1000 mg: vial 1, 5, or 10 pcs.
Marketing Authorization Holder
Bryntsalov-A, JSC (Russia)
Dosage Form
|
Amikacin-Ferein | Powder for solution for intravenous and intramuscular administration 1000 mg: vial 1, 5, or 10 pcs. |
Dosage Form, Packaging, and Composition
Powder for solution for intravenous and intramuscular administration white or almost white, crystalline, hygroscopic.
| 1 vial | |
| Amikacin (as sulfate) | 1000 mg |
1000 mg – vials (1) – cardboard packs.
1000 mg – vials (5) – contour cell packs made of polyvinyl chloride film (1) – cardboard packs.
1000 mg – vials (5) – contour cell packs made of polyvinyl chloride film (2) – cardboard packs.
1000 mg – vials (5) – contour cell packs made of polyvinyl chloride film (1) and flexible packaging based on aluminum foil or combined material on a paper base – cardboard packs.
1000 mg – vials (5) – contour cell packs made of polyvinyl chloride film (2) and flexible packaging based on aluminum foil or combined material on a paper base – cardboard packs.
1000 mg – vials (5) – contour cell packs made of polyvinyl chloride film (10) – cardboard packs (for hospitals).
1000 mg – vials (5) – contour cell packs made of polyvinyl chloride film (10) and flexible packaging based on aluminum foil or combined material on a paper base – cardboard packs (for hospitals).
Powder for solution for intravenous and intramuscular administration 500 mg: vial 1, 10, or 50 pcs.
Marketing Authorization Holder
Mapichem AG (Switzerland)
Manufactured By
Jiangsu Wuzhong Pharmaceutical Group Co. Ltd Suzhou No. 6 Pharmaceutical Factory (China)
Dosage Form
|
Amikacin sulfate | Powder for solution for intravenous and intramuscular administration 500 mg: vial 1, 10, or 50 pcs. |
Dosage Form, Packaging, and Composition
| Powder for solution for intravenous and intramuscular administration | 1 vial |
| Amikacin (as sulfate) | 500 mg |
500 mg – vials (1) – cardboard packs.
500 mg – vials (10) – cardboard packs.
500 mg – vials (50) – cardboard boxes.
Powder for solution for intravenous and intramuscular administration 500 mg: fl. 1 pc.
Marketing Authorization Holder
Vial, LLC (Russia)
Manufactured By
NORTH CHINA PHARMACEUTICAL CORPORATION (China)
Dosage Form
|
Amikacin-Vial | Powder for solution for intravenous and intramuscular administration 500 mg: fl. 1 pc. |
Dosage Form, Packaging, and Composition
| Powder for solution for intravenous and intramuscular administration | 1 vial |
| Amikacin (as sulfate) | 500 mg |
500 mg – vials (1) – cardboard packs.
Powder for solution for intravenous and intramuscular administration 500 mg: vial 1 pc. (packed by Ozon)
Marketing Authorization Holder
Vial, LLC (Russia)
Manufactured By
NORTH CHINA PHARMACEUTICAL CORPORATION (China)
Labeled By
OZON, LLC (Russia)
Dosage Form
|
Amikacin-Vial | Powder for solution for intravenous and intramuscular administration 500 mg: vial 1 pc. (packed by Ozon) |
Dosage Form, Packaging, and Composition
| Powder for solution for intravenous and intramuscular administration | 1 vial |
| Amikacin (as sulfate) | 500 mg |
500 mg – vials (1) – cardboard packs.
![Amikacin-Ferein [Solution, Lyophilisate, Powder] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Amikacin-Ferein [Solution, Lyophilisate, Powder] 2")