GMP Amikacin Sulphate 500mg 500mg/ 2ml Injection Vial Aminoglycoside Antibiotics
China GMP Amikacin Sulphate 500mg 500mg/ 2ml Injection Vial Aminoglycoside Antibiotics, Find details about China Amikacin, Antibiotic from GMP Amikacin Sulphate 500mg 500mg/ 2ml Injection Vial Aminoglycoside Antibiotics
Basic Info.
Model NO.
500mg/2ml
Pharmaceutical Technology
Chemical Synthesis
Pharmacological and Toxicology
Aminoglycoside Antibiotic
Character
Colorless or Yellowish Clear Liquid
Usage
Intramuscular Injection or Intravenous Drip
Molecular Formula
C22h43n5o13
Molecular Weight
585.6025
Einecs
253-538-5
Psa
331.94000
Trademark
Without
Transport Package
Carton
Specification
500mg/2ml
Origin
China
HS Code
3004909099
Model NO.
500mg/2ml
Pharmaceutical Technology
Chemical Synthesis
Pharmacological and Toxicology
Aminoglycoside Antibiotic
Character
Colorless or Yellowish Clear Liquid
Usage
Intramuscular Injection or Intravenous Drip
Molecular Formula
C22h43n5o13
Molecular Weight
585.6025
Einecs
253-538-5
Psa
331.94000
Trademark
Without
Transport Package
Carton
Specification
500mg/2ml
Origin
China
HS Code
3004909099
Product Desciption
Amikacin Injection 500mg/2mL
Description
Amikacin is a semisynthetic aminoglycoside antibiotic derived from kanamycin. Amikacin occurs as a white, crystalline
powder and is sparingly soluble in water. The injection consists of the sulfate salt.
Amikacin Injection is a sterile clear, colourless solution, free from specks, lint, or other visible evidence of
contamination. Each 2 mL vial contains amikacin sulfate equivalent to amikacin activity 500 mg (500,000 I.U.).
Pharmacokinetics
Absorption
Following IM administration of a single dose of amikacin of 7.5 mg/kg in adults with normal renal function, peak
plasma amikacin concentrations of 17-25 micrograms/mL are attained within 45 minutes to 2 hours.
Following IV infusion of the same dose given over 1 hour peak plasma concentrations of the drug average 38
micrograms/mL immediately following the infusion, 5.5 micrograms/mL at 4 hours, and 1.3 micrograms/mL at 8 hours.
Distribution
Following administration of usual dosages of amikacin, amikacin has been found in bone, heart, gallbladder, and lung
tissue. Amikacin is also distributed into bile, sputum, bronchial secretions, and interstitial, pleural, and synovial fluids.
Elimination
The plasma elimination half-life of amikacin is usually 2-3 hours in adults with normal renal function and is reported to
range from 30-86 hours in adults with severe renal impairment.
In adults with normal renal function, 94-98% of a single IM or IV dose of amikacin is excreted unchanged by
glomerular filtration within 24 hours. The drug may be completely recovered within approximately 10-20 days in
patients with normal renal function. Terminal elimination half-lives of greater than 100 hours have been reported in
adults with normal renal function following repeated IM or IV administration of the drug.
In patients with impaired renal function, the clearance of amikacin is decreased; the more severe the impairment, the
slower the clearance. Therefore, the interval between doses should be adjusted according to the degree of renal
impairment. Endogenous creatinine clearance rate and serum creatinine which have high correlation with serum halflife
of amikacin, may be used as a guide for this purpose (see Dossge and Administration - Impaired Renal
Function).
Indications
Amikacin Injection is indicated in the short-term treatment of serious infections caused by susceptible strains of Gramnegative
bacteria, (see Microbiology).
Staphylococcus aureus, including methicillin-resistant strains is the principal Gram-positive organism sensitive to
amikacin.
The use of amikacin in the treatment of staphylococcal infections should be restricted to second-line therapy, and
should be confined to patients suffering from severe infections caused by susceptible strains of stapylococcus who
have failed to respond or are allergic to other available antibiotics.
Amikacin Injection is indicated in the treatment of neonatal sepsis when sensitivity testing indicates that other
aminoglycosides cannot be used.
In certain severe infections such as neonatal sepsis, concomitant therapy with a penicillin type drug may be indicated
because of the possibility of infections due to Gram-positive organisms such as streptococci or pneumococci. If
concomitant treatment with a penicillin type drug is indicated, then the drugs should be administered separately and at
different sites because in-vitro mixing of the two drugs causes inactivation of amikacin.
Clinical studies have shown amikacin to be effective in treating bacteraemia, septicaemia including neonatal sepsis
and serious infections of the respiratory tract, bones and joints, central nervous system, skin and skin structures
(including those resulting from burns), intra-abdominal organs, post-operative infections and complicated and recurrent
urinary tract infections, when caused by susceptible organisms.
Contraindications
Amikacin Injection is contraindicated in patients with a known history of hypersensitivity to amikacin, any constituents
of the injection (see Description ) or in patients who may have subclinical renal or eighth nerve damage induced by
prior administration of nephrotoxic and/or ototoxic agents, as the toxicity may possibly be additive.
Pregnancy (see Use in Pregnancy) ; Lactation (see, Use in Lactation).
Use in Pregnancy
Category D. Gentamicin and other aminoglycosides cross the placenta. There is evidence of selective uptake of
gentamicin by the foetal kidney resulting in dam ge (probably reversible) to immature nephrons, Eighth cranial nerve
damage has also been reported following in-utero exposure to some of the aminoglycosides. Because of the chemical
similarity, all aminoglycosides must be considered potentially nephrotoxic and ototoxic to the foetus. It should also be
noted that therapeutic blood levels in the mother do not equate with safety for the foetus.
Use in Lactation
It is not known whether amikacin is excreted in breast milk. Since the possible harmful effect on the infant is not
known, it is recommended that if nursing mothers must be given amikacin, the infants should not be breast fed during
therapy.
Interactions with Other Drugs
If possible, do not give amikacin in conjunction with athacrynic acid, frusemide or other potent diuretics which may
themselves cause ototoxicity or enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and
tissue.
Potent diuretics:
Other neurotoxic and/or nephrotoxic agents:
If possible, avoid concurrent or sequential use of other neurotoxic and/or nephrotoxic antibiotics, including other
aminoglycosides, polymyxin B, colistin, cisplatin, vancomycin, amphotericin B, clindamycin and cephalosporins.
Anaesthetics/neuromuscular blocking agents or medications with neuromuscular blocking activity:
Concurrent use of amikacin with agents with neuromuscular blocking activity e.g. succinylcholine, tubocurarine,
decamethonium, halogenated hydrocarbon inhalation anaesthetics, opioid analgesics and massive transfusions with
citrated anticoagulated blood, should be carefully monitored; neuromuscular blockade may be enhanced, resulting in
skeletal muscle weakness and respiratory depression or paralysisi (apnea); caution is recommended when these
medications and amikacin are used concurrently during surgery or in the postoperative period, especially if there is a
possibility of incomplete reversal of neuromuscular blockade postoperatively; treatment with anticholinesterase agents
or calcium salts may help to reverse the blockade.
Penicillins:
Aminoglycosides are inactivated by solutions containing penicillins. This inactivation is brought about by the opening of
the beta-lactam ring and combination of the penicillin with an amino group of the aminoglycoside to form a biologically
inactive amide. For this reason, amikacin and penicillins should not be combined in intravenous injections/infusions.
The inactivation of some aminoglycosides by penicillins has been reported in vivo, especially in patients with renal
failure who maintain a higher level of the penicillin for a longer period of time compared to patients with normal renal
function. Therefore, when amikacin and penicillins are used together in patients with renal failure, the time of
administration of each drug should be staggered so that several hours separate each infusion.
Compatibilities
Amikacin sulfate is stable for 24 hours at room temperature in the presence of light at 5 mg/mL and 0.25 mg/mL in
0.9% Sodium Chloride Intravenous Infusion B.P. and 5% Glucose Intravenous Infusion B.P. solutions.
Adverse Reactions
Amikacin induced hepatotoxicity is not a common side effect, however it may occur. Increased serum transaminases
(ALT, AST) increased serum bilirubin, hepatomegaly, and hepatic necrosis have been reported.
The percentages below refer to incidence in clinical trials.
Dosage and Administration
Uncomplicated infections due to sensitive organisms should respond to treatment within 24 to 48 hours at the
recommended dosage. If no improvement occurs within three to five days, the use of amikacin sulfate should be reeveluated
and consideration be given to alternative therapy. Failure of the infection to respond may be due to
resistance of the organism or to the presence of septic foci requiring surgical drainage.
Whenever possible, and especially in patients with impaired renal function, peak and trough amikacin serum
concentrations should be determined and dosage adjusted where necessary to maintain desired serum
concentrations. In general, desired peak cone ntrations are between 15 to 30 micrograms/e mL, and trough
concentrations should not exceed 5 to 10 micrograms/mL. An increased risk of toxicity may be associated with
prolonged peak amikacin serum concentrations greater than 30 to 35 micrograms/mL.
Intramuscular or Intravenous Administration
The intramuscular route is preferred for most infections, but in life-threatening infections or when an intramuscular
injection is not feasible, an intravenous infusion (0.25% over 30 to 60 minutes) may be used.
The compatible diluents for intravenous use if required are as follows: 5% Glucose Intravenous Infusion B.P. in Water
for Injections B.P. and Sodium Chloride Intravenous Infusion B.P. (0.9%). Use solutions for I.V. administration within 12
hours after preparation.
Dosaga
Dosage of amikacin sulfate is expressed in terms of amikacin and calculated on a body weight basis. Dosage is
identical for both routes of administration.
The usual recommended dose of amikacin is 15mg/kg daily given in two or three equally divided doses.
Dosage given for patients with normal renal function. Initiate treatment with a loading dose of 10 mg/kg followed by 7.5
mg/kg every 12 hours. The maximum total daily dose should not exceed 15 mg/kg. Solution infusions via the I.V. route
should be given over a 1 to 2 hour period.
Insufficient clinical use has not enabled firm dosage guidelines to be established for the use of amikacin in premature
infants.
Adults and Children:
Neonates and Premature Infants:
Overdosage
Management
In the event of overdosage or toxic reactions peritoneal dialysis or haemodialysis should be conside ed. These
procedures are of particular importance in patients with impaired renal function. In the newborn infant, exchange
transfusion may also be considered.
Clinical features
Likely signs and symptoms include tinnitus, vertigo, reversible or irreversible deafness, skin rash, drug fever,
headache, paraesthesia, reduced renal function or renal failure.
Description
Amikacin is a semisynthetic aminoglycoside antibiotic derived from kanamycin. Amikacin occurs as a white, crystalline
powder and is sparingly soluble in water. The injection consists of the sulfate salt.
Amikacin Injection is a sterile clear, colourless solution, free from specks, lint, or other visible evidence of
contamination. Each 2 mL vial contains amikacin sulfate equivalent to amikacin activity 500 mg (500,000 I.U.).
Pharmacokinetics
Absorption
Following IM administration of a single dose of amikacin of 7.5 mg/kg in adults with normal renal function, peak
plasma amikacin concentrations of 17-25 micrograms/mL are attained within 45 minutes to 2 hours.
Following IV infusion of the same dose given over 1 hour peak plasma concentrations of the drug average 38
micrograms/mL immediately following the infusion, 5.5 micrograms/mL at 4 hours, and 1.3 micrograms/mL at 8 hours.
Distribution
Following administration of usual dosages of amikacin, amikacin has been found in bone, heart, gallbladder, and lung
tissue. Amikacin is also distributed into bile, sputum, bronchial secretions, and interstitial, pleural, and synovial fluids.
Elimination
The plasma elimination half-life of amikacin is usually 2-3 hours in adults with normal renal function and is reported to
range from 30-86 hours in adults with severe renal impairment.
In adults with normal renal function, 94-98% of a single IM or IV dose of amikacin is excreted unchanged by
glomerular filtration within 24 hours. The drug may be completely recovered within approximately 10-20 days in
patients with normal renal function. Terminal elimination half-lives of greater than 100 hours have been reported in
adults with normal renal function following repeated IM or IV administration of the drug.
In patients with impaired renal function, the clearance of amikacin is decreased; the more severe the impairment, the
slower the clearance. Therefore, the interval between doses should be adjusted according to the degree of renal
impairment. Endogenous creatinine clearance rate and serum creatinine which have high correlation with serum halflife
of amikacin, may be used as a guide for this purpose (see Dossge and Administration - Impaired Renal
Function).
Indications
Amikacin Injection is indicated in the short-term treatment of serious infections caused by susceptible strains of Gramnegative
bacteria, (see Microbiology).
Staphylococcus aureus, including methicillin-resistant strains is the principal Gram-positive organism sensitive to
amikacin.
The use of amikacin in the treatment of staphylococcal infections should be restricted to second-line therapy, and
should be confined to patients suffering from severe infections caused by susceptible strains of stapylococcus who
have failed to respond or are allergic to other available antibiotics.
Amikacin Injection is indicated in the treatment of neonatal sepsis when sensitivity testing indicates that other
aminoglycosides cannot be used.
In certain severe infections such as neonatal sepsis, concomitant therapy with a penicillin type drug may be indicated
because of the possibility of infections due to Gram-positive organisms such as streptococci or pneumococci. If
concomitant treatment with a penicillin type drug is indicated, then the drugs should be administered separately and at
different sites because in-vitro mixing of the two drugs causes inactivation of amikacin.
Clinical studies have shown amikacin to be effective in treating bacteraemia, septicaemia including neonatal sepsis
and serious infections of the respiratory tract, bones and joints, central nervous system, skin and skin structures
(including those resulting from burns), intra-abdominal organs, post-operative infections and complicated and recurrent
urinary tract infections, when caused by susceptible organisms.
Contraindications
Amikacin Injection is contraindicated in patients with a known history of hypersensitivity to amikacin, any constituents
of the injection (see Description ) or in patients who may have subclinical renal or eighth nerve damage induced by
prior administration of nephrotoxic and/or ototoxic agents, as the toxicity may possibly be additive.
Pregnancy (see Use in Pregnancy) ; Lactation (see, Use in Lactation).
Use in Pregnancy
Category D. Gentamicin and other aminoglycosides cross the placenta. There is evidence of selective uptake of
gentamicin by the foetal kidney resulting in dam ge (probably reversible) to immature nephrons, Eighth cranial nerve
damage has also been reported following in-utero exposure to some of the aminoglycosides. Because of the chemical
similarity, all aminoglycosides must be considered potentially nephrotoxic and ototoxic to the foetus. It should also be
noted that therapeutic blood levels in the mother do not equate with safety for the foetus.
Use in Lactation
It is not known whether amikacin is excreted in breast milk. Since the possible harmful effect on the infant is not
known, it is recommended that if nursing mothers must be given amikacin, the infants should not be breast fed during
therapy.
Interactions with Other Drugs
If possible, do not give amikacin in conjunction with athacrynic acid, frusemide or other potent diuretics which may
themselves cause ototoxicity or enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and
tissue.
Potent diuretics:
Other neurotoxic and/or nephrotoxic agents:
If possible, avoid concurrent or sequential use of other neurotoxic and/or nephrotoxic antibiotics, including other
aminoglycosides, polymyxin B, colistin, cisplatin, vancomycin, amphotericin B, clindamycin and cephalosporins.
Anaesthetics/neuromuscular blocking agents or medications with neuromuscular blocking activity:
Concurrent use of amikacin with agents with neuromuscular blocking activity e.g. succinylcholine, tubocurarine,
decamethonium, halogenated hydrocarbon inhalation anaesthetics, opioid analgesics and massive transfusions with
citrated anticoagulated blood, should be carefully monitored; neuromuscular blockade may be enhanced, resulting in
skeletal muscle weakness and respiratory depression or paralysisi (apnea); caution is recommended when these
medications and amikacin are used concurrently during surgery or in the postoperative period, especially if there is a
possibility of incomplete reversal of neuromuscular blockade postoperatively; treatment with anticholinesterase agents
or calcium salts may help to reverse the blockade.
Penicillins:
Aminoglycosides are inactivated by solutions containing penicillins. This inactivation is brought about by the opening of
the beta-lactam ring and combination of the penicillin with an amino group of the aminoglycoside to form a biologically
inactive amide. For this reason, amikacin and penicillins should not be combined in intravenous injections/infusions.
The inactivation of some aminoglycosides by penicillins has been reported in vivo, especially in patients with renal
failure who maintain a higher level of the penicillin for a longer period of time compared to patients with normal renal
function. Therefore, when amikacin and penicillins are used together in patients with renal failure, the time of
administration of each drug should be staggered so that several hours separate each infusion.
Compatibilities
Amikacin sulfate is stable for 24 hours at room temperature in the presence of light at 5 mg/mL and 0.25 mg/mL in
0.9% Sodium Chloride Intravenous Infusion B.P. and 5% Glucose Intravenous Infusion B.P. solutions.
Adverse Reactions
Amikacin induced hepatotoxicity is not a common side effect, however it may occur. Increased serum transaminases
(ALT, AST) increased serum bilirubin, hepatomegaly, and hepatic necrosis have been reported.
The percentages below refer to incidence in clinical trials.
Dosage and Administration
Uncomplicated infections due to sensitive organisms should respond to treatment within 24 to 48 hours at the
recommended dosage. If no improvement occurs within three to five days, the use of amikacin sulfate should be reeveluated
and consideration be given to alternative therapy. Failure of the infection to respond may be due to
resistance of the organism or to the presence of septic foci requiring surgical drainage.
Whenever possible, and especially in patients with impaired renal function, peak and trough amikacin serum
concentrations should be determined and dosage adjusted where necessary to maintain desired serum
concentrations. In general, desired peak cone ntrations are between 15 to 30 micrograms/e mL, and trough
concentrations should not exceed 5 to 10 micrograms/mL. An increased risk of toxicity may be associated with
prolonged peak amikacin serum concentrations greater than 30 to 35 micrograms/mL.
Intramuscular or Intravenous Administration
The intramuscular route is preferred for most infections, but in life-threatening infections or when an intramuscular
injection is not feasible, an intravenous infusion (0.25% over 30 to 60 minutes) may be used.
The compatible diluents for intravenous use if required are as follows: 5% Glucose Intravenous Infusion B.P. in Water
for Injections B.P. and Sodium Chloride Intravenous Infusion B.P. (0.9%). Use solutions for I.V. administration within 12
hours after preparation.
Dosaga
Dosage of amikacin sulfate is expressed in terms of amikacin and calculated on a body weight basis. Dosage is
identical for both routes of administration.
The usual recommended dose of amikacin is 15mg/kg daily given in two or three equally divided doses.
Dosage given for patients with normal renal function. Initiate treatment with a loading dose of 10 mg/kg followed by 7.5
mg/kg every 12 hours. The maximum total daily dose should not exceed 15 mg/kg. Solution infusions via the I.V. route
should be given over a 1 to 2 hour period.
Insufficient clinical use has not enabled firm dosage guidelines to be established for the use of amikacin in premature
infants.
Adults and Children:
Neonates and Premature Infants:
Overdosage
Management
In the event of overdosage or toxic reactions peritoneal dialysis or haemodialysis should be conside ed. These
procedures are of particular importance in patients with impaired renal function. In the newborn infant, exchange
transfusion may also be considered.
Clinical features
Likely signs and symptoms include tinnitus, vertigo, reversible or irreversible deafness, skin rash, drug fever,
headache, paraesthesia, reduced renal function or renal failure.
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