Brands of Amikacin in Kenya
Amilab -500,Laborate Pharmaceuticals India Limited
Amika,Swiss Parenterals (Pvt.) Ltd
Amikanex,Umedica Laboratories Pvt Ltd
Amikin®, Bristol Myers Squibb
Lanomycin®, Pharmathen
Kacin®,Advanced Chemical Industries Limited
Makcin®,Makcur Laboratories Limited
Mica® ,Brawn Laboratories Ltd.
AMIKACIN MODE OF ACTION
Amikacin is a polycationic, semisynthetic, bactericidal aminoglycoside. Amikacin enters the bacterial cell by binding to negatively charged components of the bacterial cell wall disrupting the overall architecture of the cell wall. The primary mechanism of action is the disruption and inhibition of protein synthesis in the target bacteria by binding to the 30S ribosomal subunit.
INDICATIONS
Amikacin Injection is a semi-synthetic, aminoglycoside antibiotic which is active against a broad spectrum of Gram-negative organisms, including pseudomonas and some Gram-positive organisms.
Sensitive Gram-negative organisms include; Pseudomonas aeruginosa, Escherichia coli., indole-positive and indole-negative Proteus spp., Klebsiella, Enterobacter and Serratia spp., Minea-Herralae, Citrobacter freundii, Salmonella, Shigella, Acinetobacter and Providencia spp.
Many strains of these Gram-negative organisms resistant to gentamicin and tobramycin show sensitivity to amikacin in vitro.
The principal Gram-positive organism sensitive to amikacin is Staphylococcus aureus, including some methicillin-resistant strains. Amikacin has some activity against other Gram-positive organisms including certain strains of Streptococcus pyogenes, Enterococci and Diplococcus pneumoniae.
Amikacin is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria, including Pseudomonas species. Although amikacin is not the drug of choice for infections due to staphylococci, at times it may be indicated for the treatment of known or suspected staphylococcal disease. These situations include: the initiation of therapy for severe infections when the organisms suspected are either Gram-negative or staphylococci, patients allergic to other antibiotics, and mixed staphylococcal/Gram-negative infections.
Therapy with amikacin may be instituted prior to obtaining the results of sensitivity testing. Surgical procedures should be performed where indicated.
Consideration should be given to official guidance on the appropriate use of antibacterial Agents.
DOSAGEÂ AND ADMINISTRATION
Amikacin sulphate injection may be given intramuscularly or intravenously.
Amikacin should not be physically premixed with other drugs, but should be administered separately according to the recommended dose and route.
The patient’s pre-treatment bodyweight should be obtained for calculation of correct dosage.
The status of renal function should be estimated by measurement of the serum creatinine concentration or calculation of the endogenous creatinine clearance rate. The blood urea nitrogen (BUN) is much less reliable for this purpose. Reassessment of renal function should be made periodically during therapy.
Whenever possible, amikacin concentrations in serum should be measured to assure adequate, but not excessive levels. It is desirable to measure both peak and trough serum concentrations intermittently during therapy. Peak concentrations (30-90 minutes after injection) above 35 mcg/ml and trough concentrations (just prior to the next dose) above 10 mcg/ml should be avoided. Dosage should be adjusted as indicated. In patients with normal renal function, once-daily dosing may be used; peak concentrations in these cases may exceed 35 mcg/ml.
For most infections the intramuscular route is preferred, but in life-threatening infections, or in patients in whom intramuscular injection is not feasible, the intravenous route, either slow bolus (2 to 3 minutes) or infusion (0.25% over 30 minutes) may be used.
Intramuscular and intravenous administration
At the recommended dosage level, uncomplicated infections due to sensitive organisms should respond to therapy within 24 to 48 hours.
If clinical response does not occur within three to five days, consideration should be given to alternative therapy.
If required, suitable diluents for intravenous use are: Normal saline, 5% dextrose in water. Once the product has been diluted the solution must be used as soon as possible and NOT STORED.
Adults and Children over 12 years
The recommended intramuscular or intravenous dosage for adults and adolescents with normal renal function (creatinine clearance ≥50 ml/min) is 15 mg/kg/day which may be administered as a single daily dose or divided into 2 equal doses i.e. 7.5 mg/kg q 12 h. The total daily dose should not exceed 1.5 g. In endocarditis and in febrile neutropenic patients, dosing should be twice daily, as there is not enough data to support once daily dosing.
Children 4 weeks to 12 years
The recommended intramuscular or intravenous (slow intravenous infusion) dose in children with normal renal function is 15-20 mg/kg/day which may be administered as 15-20 mg/kg, once a day; or as 7.5 mg/kg q 12 h. In endocarditis and in febrile neutropenic patients dosing should be twice daily, as there is not enough data to support once daily dosing.
Neonates
An initial loading dose of 10 mg/kg followed by 7.5 mg/kg q 12 h .
Premature Infants
The recommended dose in prematures is 7.5 mg/kg in every 12 hours .
The usual duration of treatment is 7 to 10 days. The total daily dose by all routes of administration should not exceed 15-20 mg/kg/day. In difficult and complicated infections where treatment beyond 10 days is considered, the use of amikacin sulphate injection should be re-evaluated and, if continued, renal, auditory, vestibular function should be monitored, as well as serum amikacin levels.
If definite clinical response does not occur within 3 to 5 days, therapy should be stopped and the antibiotic susceptibility pattern of the invading organism should be rechecked. Failure of the infection to respond may be due to resistance of the organism or to the presence of septic foci requiring surgical drainage.
Intravenous administration
The solution is administered to adults over a 30 to 60 minute period.
Specific recommendation for intravenous administration
In paediatric patients the amount of diluents used will depend on the amount of amikacin tolerated by the patient. The solution should normally be infused over a 30 to 60 minute period. Infants should receive a 1 to 2 hour infusion.
Elderly
Amikacin is excreted by the renal route, renal function should be assessed whenever possible and dosage adjusted as described under impaired renal function.
Life-threatening infections and/or those caused by pseudomonas
The adult dose may be increased to 500 mg every eight hours but should never exceed 1.5 g/day nor be administered for a period longer than 10 days. A maximum total adult dose of 15 g should not be exceeded.
Urinary tract infections: (other than pseudomonas infections)
7.5 mg/kg/day in two equally divided doses (equivalent to 250 mg b.i.d. in adults). As the activity of amikacin is enhanced by increasing the pH, a urinary alkalinising agent may be administered concurrently.
CONTRAINDICATIONS
Amikacin sulphate injection is contraindicated in patients with known allergy to amikacin or any component of the formulation.
A history of hypersensitivity or serious toxic reactions to aminoglycosides may contraindicate the use of any aminoglycoside because of the known cross sensitivities of patients to drugs in this class.
Aminoglycosides may impair neuromuscular transmission, and should not be given to patients with myasthenia gravis.
DRUG INTERACTIONS
The concurrent or serial use of other neurotoxic, ototoxic or nephrotoxic agents, particularly bacitracin, cisplatin, amphotericin B, ciclosporin, tacrolimus, cephaloridine, paromomycin, viomycin, polymyxin B, colistin, vancomycin, or other aminoglycosides should be avoided either systemically or topically because of the potential for additive effects. Where this is not possible, monitor carefully.
Increased nephrotoxicity has been reported following concomitant parenteral administration of aminoglycoside antibiotics and cephalosporins. Concomitant cephalosporin use may spuriously elevate creatinine serum level determinations.
The concurrent use of amikacin sulfate injection with potent diuretics (ethacrynic acid or furosemide) should be avoided since diuretics by themselves may cause ototoxicity. In addition, when administered intravenously, diuretics may enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue.
In Vitro admixture of aminoglycosides with beta-lactam antibiotics (penicillins or cephalosporins) may result in significant mutual inactivation. A reduction in serum activity may also occur when an aminoglycoside or penicillin-type drug is administered in vivo by separate routes. Inactivation of the aminoglycoside is clinically significant only in patients with severely impaired renal function. Inactivation may continue in specimens of body fluids collected for assay, resulting in inaccurate aminoglycoside readings. Such specimens should be properly handled (assayed promptly, frozen, or treated with beta-lactamase).
There is an increased risk of hypocalcaemia when aminoglycosides are administered with bisphosphonates.
There is an increased risk of nephrotoxicity and possibly of ototoxicity when aminoglycosides are administered with platinum compounds.
Concomitantly administered thiamine (vitamin B1) may be destroyed by the reactive sodium bisulfite component of the amikacin sulfate formulation.
The intraperitoneal use of amikacin is not recommended in patients under the influence of anaesthetics or muscle-relaxing drugs (including ether, halothane, d-tubocurarine, succinylcholine and decamethonium) as neuromuscular blockade and consequent respiratory depression may occur.
Indomethacin may increase the plasma concentration of amikacin in neonates.
ADVERSE EFFECTS
| System Organ Class | Frequency | Adverse Effects |
| Infections and Infestations | Uncommon | Superinfections or colonisation with resistant bacteria or yeast |
| Blood and lymphatic system disorders | Rare | Anaemia, eosinophilia |
| Immune system disorders | Not known | Anaphylactic response (anaphylactic reaction, anaphylactic shock and anaphylactoid reaction), hypersensitivity |
| Metabolism and nutrition disorders | Rare | Hypomagnesaemia |
| Nervous system disorders | Not known | Paralysis |
| Rare | Tremor, paresthesia, headache, balance disorder | |
| Eye disorders | Rare | Blindness, retinal infarction |
| Ear and labyrinth Disorders | Rare | Tinnitus, hypoacusis |
| Not known | Deafness, deafness neurosensory | |
| Vascular disorders | Rare | Hypotension |
| Respiratory, thoracic and mediastinal disorders | Not known | Apnoea, bronchopasm |
| Gastrointestinal disorders | Uncommon | Nausea, vomiting |
| Skin and subcutaneous tissue disorders | Uncommon | Rash |
| Rare | Pruritus, urticaria | |
| Musculoskeletal, connective tissue and bone disorders | Rare | Arthralgia, muscle twitching |
| Renal and urinary disorders | Not known | Renal failure acute, nephropathy toxic, cells in urine |
| Rare | Oliguria, blood creatinine increased, albuminuria, azotemia, red blood cells urine, white blood cells urine | |
| General disorders and administration site conditions | Rare | Pyrexia |
Reporting of suspected adverse reactions:
The PPB Department of Pharmacovigilance was set up with a vision to develop, implement and continuously upgrade an appropriate system for detecting, reporting, and monitoring adverse drug reactions (ADRs) and other relevant problems with medicines in Kenya. The department strives to ensure the safety and efficacy of pharmaceutical products in Kenya.
Reporting suspected adverse reactions after authorization of the medicinal product are important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals/ Patients are encouraged to report any suspected adverse reactions via Pharmacovigilance Yellow Form, pv@pharmacyboardkenya.org or clicking below button:
Amikacin in Kenya
Amikacin in Kenya
Amikacin in Kenya
Amikacin in Kenya
Amikacin in Kenya
Amikacin in Kenya
Clinical | Pharmacokinetic data
Pregnancy Category: US: D (Evidence of risk)
Routes of Administration: intramuscular, intravenous
Bioavailability: >90%
Protein Binding: 0–11%
Metabolosim: Mostly unmetabolized
Onset of Action: N/A
Elimination Half life: 2–3 hours
Excretion: Kidney
Legal Status | Dosage forms & Strengths
Prescription Category:
Prescription only Medicine (POM) , â„ž-only
Narcotic Drugs and Psychotropic Substances (Control ) Act Schedule:
This drug is not a controlled substance under Narcotic Drugs and Psychotropic Substances (Control ) Act
Dosage Forms | Strengths:
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Drug Images
References/ Citation:
- Smith, Craig R., et al. “Controlled comparison of amikacin and gentamicin.” New England Journal of Medicine 296.7 (1977): 349-353.
- de Gatta, MM Fdez, et al. “Pharmacokinetics of amikacin in intensive care unit patients.” Journal of clinical pharmacy and therapeutics 21.6 (1996): 417-421.
- SARUBBI Jr, FELIX A., and J. HEYWARD HULL. “Amikacin serum concentrations: prediction of levels and dosage guidelines.” Annals of internal medicine 89.5_Part_1 (1978): 612-618.
- Bodey, Gerald P., et al. “Pharmacology of amikacin in humans.” Antimicrobial agents and chemotherapy 5.5 (1974): 508-512.