Amisys Injection

Amisys Sulfate is a semi-synthetic aminoglycoside antibiotic. Amisys is active in vitro against Pseudomonas species, Escherichia coli, Proteus species, Providencia species, Klebsiella-Enterobacter species, Acinetobacter species, and Citrobacter freundii. When strains of the above organisms are found to be resistant to other aminoglycosides, including Gentamicin, TobrAmykin and KanAmykin, many are susceptible to Amisys. Amisys sulfate is active in vitro against penicillinase and nonpenicillinase-producing Staphylococcus species including methicillin-resistant strains.

Uses

Amisys is used for the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria. It is effective in bacterial septicemia (including neonatal sepsis); in serious infections of the respiratory tract, bones and joints, central nervous system (including meningitis) and skin and soft tissue; intra abdominal infections (including peritonitis); and in bums and post operative infections (including post-vascular surgery). Amisys is also effective in serious complicated and recurrent urinary tract infections due to susceptible Gram-negative organisms. It may be considered as initial therapy in suspected Gram-negative infections and therapy may be instituted before obtaining the results of susceptibility. Amisys is also effective in infections caused by Gentamycln and/or TobrAmykin resistant strains of Gram-negative organisms. Amisys has also been shown to be effective in Staphylococcal infection and may be considered as initial therapy under certain condition in the treatment of known suspected Staphylococcal disease such as, severe infections where the causative organism may either a Gram-negative bacterium or Staphylococcus infection due to susceptible strains of Staphylococcal I Gram-negative infections. In certain severe infections such as neonatal sepsis, concomitant therapy with a penicillin type drug may be used because of the possibility of infections due to Gram positive organism such as streptococci or pneumococci.

Amisys is also used to associated treatment for these conditions: Bacterial Peritonitis, Bacterial Sepsis, Bone and Joint Infections, Burns, Central Nervous System Infections, Endophthalmitis, Infection caused by staphylococci, Infective pulmonary exacerbation of cystic fibrosis, Intra-Abdominal Infections, Lung Infection, Meningitis, Bacterial, Mycobacterium avium complex infection, Neonatal Sepsis, Nosocomial Pneumonia, Postoperative Infections, Respiratory Tract Infection Bacterial, Skin and Subcutaneous Tissue Bacterial Infections, Tuberculosis (TB), Grade 1, grade 2, grade 3, grade 4 Urinary Tract Infection, Severe Bacterial Infections

Trade Name Amisys
Generic Amikacin
Other Names Amikacin, Amikacina, Amikacine, Amikacinum
Weight 100mg/2ml, 500mg/2ml
Type Injection
Formula C22H43N5O13
Weight Average: 585.6025
Monoisotopic: 585.285736487
Protein binding

The protein binding of amikacin in serum is ≤ 10%.

Therapeutic Class Aminoglycosides
Manufacturer Kumudini Pharma Ltd
Available Country Bangladesh
Last Updated: June 23, 2021 at 11:16 am

Dosage

Amisys dosage

Adults and children: 15mg/kg/day in two equally- divided doses (equivalent to 500 mg bid in adults). Use of the 100 mg/2 ml strength is recommended for children for the accurate measurement of the appropriate dose.

Neonates and premature children: An initial loading dose of 10 mg/kg followed by 15 mg/kg/day in two equally divided doses.

Elderly: Doses should be adjusted under impaired renal function in elderly.

Life-threatening infections and/or those caused by pseudomonas: The adult dose may be increased to 500 mg every eight hours but should neither exceed 1.5 gm/day nor be administered for a period longer than 10 days. A maximum total adult dose of 15 gm should not be exceeded.

Urinary tract infections (Other than pseudomonal infections): 7.5 mg/kg/day in two equally divided doses (equivalent to 250 mg bid in adults).

Impaired renal function: In patient with impaired renal function the daily dose should be reduced and/or the intervals between doses increased to avoid accumulation of the drug. Simple doses schedule for renal impairment is given below:

Renal function Dosage schedule

Mild impairment 500 mg every 18 hours

Moderate impairment 500 mg every 24 hours

Severe impairment 250 mg every 24 hours.

 

Administration:

Intramuscular or intravenous administration: For most infections the intramuscular route is preferred, but in life threatening infections, or in patients in whom intramuscular injection route is not feasible the intravenous route may be used.

Intraperitoneal use: Amisys may be used as an irrigant after recovery from anesthesia in concentration of 0.25%.

Other routes of administration: Amisys in concentration of 0.25% may be used satisfactorily as an irrigating solution in abscess cavities, the pleural space, the peritoneum and the cerebral ventricles.

Intramuscular or intravenous administration: For most infections the intramuscular route is preferred, but in life threatening infections, or in patients in whom intramuscular injection route is not feasible the intravenous route may be used.

Intraperitoneal use: Amisys may be used as an irrigant after recovery from anesthesia in concentration of 0.25%. 

Other routes of administration: Amisys in concentration of 0.25% may be used satisfactorily as an irrigating solution in abscess cavities, the pleural space, the peritoneum and the cerebral ventricles.

Side Effects

When the recommended precautions and dosages are followed the incidence of toxic reactous, such as tinnitus vertigo, and partial reversible or irreversible deafness, skin rash, drug fever, headache, paraesthesia, nausea and vomiting is low. Urinary signs of renal irritation, azotaemia and oliguria have been reported.

Precaution

Since Amisys is present in high concentrations in the renal excretory system, patients should be well hydrated to minimize chemical irritation of the renal tubules. If azotemia increases, treatment should be stopped. Monitoring of renal function during treatment with aminoglycosides is particularly important.

Interaction

Concurrent administration of Amisys with myorelaxants leads to potentiation of their effects and there is a possibility of cessation of the breathing. The combination with other Aminoglycoside antibiotics should be avoided because of the augmentation of their ototoxic and nephrotoxic effects. Concurrent administration of Amisys with fast acting diuretics increases the risk of ototoxicity in patients with renal failure. Combination with Cephalosporins or Polymixins increases the risk of nephrotoxicity.

Food Interaction

No interactions found.

Volume of Distribution

  • 24 L (28% of body weight healthy adult subjects).

Following administration of usual dosages of amikacin, amikacin has been found in bone, heart, gallbladder, and lung tissue. Amisys is also distributed into bile, sputum, bronchial secretions, and interstitial, pleural, and synovial fluids.

Half Life

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.

Clearance

The mean serum clearance rate is about 100 mL/min and the renal clearance rate is 94 mL/min in subjects with normal renal function.

Pregnancy & Breastfeeding use

The safety of Amisys in pregnancy has not yet been established.

Contraindication

Amisys injection is contraindicated in patients with a known history of hypersensitivity to Amisys.

Special Warning

Impaired renal function: In patient with impaired renal function the daily dose should be reduced and/or the intervals between doses increased to avoid accumulation of the drug. Simple doses schedule for renal impairment is given below:

  • Mild impairment: 500 mg every 18 hours
  • Moderate impairment: 500 mg every 24 hours
  • Severe impairment: 250 mg every 24 hours.

Pediatric Use: Safety and effectiveness of Amisys for injection in children or adolescents under 16 years have not been established

Acute Overdose

In the event of overdose or toxic reaction, peritoneal dialysis or hemodialysis will aid in the removal of Amisys from the blood.

Interaction with other Medicine

No information regarding drug interaction of Amisys is available.

Storage Condition

Store in a cool dry place protected from light. Keep out of reach of children.

Amisys contains Amikacin see full prescribing information from innovator Monograph