Mikacin I.M/I.V Injection
Amikacin
100mg/2ml
Julphar (Gulf Pharmaceutical Industries)
| Pack size | 2ml Ampoule x 5 |
|---|---|
| Dispensing mode | POM |
| Source | UAE |
| Agent | JULPHAR |
| Retail Price | 103.00 AED |
Available as:
Indications
Mikacin I.M/I.V Injection is used for:
Tuberculosis, Complicated and recurrent urinary tract infections, Severe Gram-negative infections, Non-tubercular mycobacterial infections, Bacterial septicemia, Infections of the respiratory tract, Bones and joints, Central nervous system and skin and soft tissue, Intra-abdominal infections, Burns, Postoperative infections, Meningitis, Peritonitis, Neonatal sepsis
Adult Dose
Parenteral
Uncomplicated urinary tract infections
Adult: 250 mg bid, given via IM, IV inj over 2-3 minutes or as IV infusion.
Severe Gram-negative infections resistant to gentamicin and tobramycin
Adult: 15 mg/kg daily in equally divided doses injected every 8 or 12 hr for 7-10 days. Max: Up to 500 mg every 8 hr in life-threatening infections.
Max cumulative dose: 15 g. Doses may be given via IM, slow IV inj over 2-3 minutes or IV infusion.
Hospital Acquired Pneumonia
20 mg/kg/day IV; may administer with antipseudomonal beta-lactam or carbapenem
Child Dose
Parenteral
Child: IV, IM 15–22.5 mg/kg/day q8h
Neonates
Aged <7 days
<29 weeks gestational age: 18 mg/kg IV/IM q48hr
30-33 weeks gestational age: 18 mg/kg IV/IM q36hr
>34 weeks gestational age: 15 mg/kg IV/IM q24hr
Aged >7 days
30-33 weeks gestational age: 15 mg/kg IV/IM q24hr
>34 weeks gestational age: 15 mg/kg IV/IM q12-18hr
Aged 8-28 days old & <29 weeks gestational age
15 mg/kg IV/IM q36hr
Neonates Aged >28 days old & <29 weeks gestational age
15 mg/kg IV/IM q24hr
Also use this dose for the following: significant asphyxia, indomethacin for PDA, poor cardiac output, or renal impairment
Renal Dose
Renal impairment: Doses should be adjusted either by administering normal doses at prolonged intervals or by administering reduced doses at fixed intervals based on the patient's CrCl or serum creatinine values.
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.
or
CrCl >90 mL/min and aged <60 yr: q8hr
CrCl 60-90 mL/min OR aged ?60 yr: q12hr
CrCl 25-60 mL/min: q24hr
CrCl 10-25 mL/min: q48hr
CrCl <10 mL/min: q72hr
Administer after dialysis in ESRD
Administration
IV/IM Administration
IM: Administer undiluted to upper outer quadrant of buttocks
IV: Infuse over 30-60 min in adults and children; infuse over 1-2 hr in infants
Reconstitution: IV infusion: For adults, add 500 mg of amikacin to 100-200 mL of compatible IV fluid (e.g. NaCl 0.9%, dextrose 5%). For pediatric patients, the vol of diluent depends on the prescribed dosage.
Contra Indications
Pregnancy, perforated ear drum, myasthenia gravis, hypersensitivity.
Precautions
Renal impairment; vertigo, tinnitus. Discontinue if signs of ototoxicity, neurotoxicity or hypersensitivity occurs; lactation. Safety has not been established for treatment period >14 days. Monitor renal function before and during treatment.
Lactation: excretion in milk unknown/not recommended
Pregnancy-Lactation
Pregnancy Category: D
Lactation: excretion in milk unknown/not recommended
Interactions
Amphotericin B may lead to increased nephrotoxicity and reduced clearance of amikacin when used together.
Potentially Fatal: Increased ototoxic or nephrotoxic effects with other nephrotoxic or ototoxic drugs. Enhanced neuromuscular blockade with neuromuscular blocking drugs. Increased risk of ototoxicity with potent diuretics.
Adverse Effects
Side effects of Amikacin :
1-10%
Neurotoxicity, Nephrotoxicity (if trough >10 mg/L), Ototoxicity
<1%
Hypotension, Headache, Drug fever, Rash, Nausea, Vomiting, Eosinophilia, Paresthesia, Tremor, Arthralgia, Weakness, Allergic reaction
Potentially Fatal: Ototoxicity, nephrotoxicity, neuromuscular blockade.
Mechanism of Action
Amikacin binds to 30S ribosomal subunits of susceptible bacteria, thus inhibiting its protein synthesis.
Note
Mikacin I.M/I.V 100mg/2ml Injection manufactured by Julphar (Gulf Pharmaceutical Industries). Its generic name is Amikacin. Mikacin I.M/I.V is availble in United Arab Emirates.
Farmaco UAE drug index information on Mikacin I.M/I.V Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.