Amika IM/IV Injection

Amika IM/IV 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

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

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 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

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.

Pregnancy, perforated ear drum, myasthenia gravis, hypersensitivity.

Neurotoxicity, manifested as both bilateral auditory and vestibular ototoxicity, can occur in patients with preexisting renal damage and in patients with normal renal function treated at higher doses and/or for periods longer than those recommended. High-frequency deafness usually occurs first and can be detected only by audiometric testing Vertigo may occur and may be evidence of vestibular injury Aminoglycosides are potentially nephrotoxic Risk is greater in patients with impaired renal function and in those who receive high doses or prolonged therapy. Rarely, nephrotoxicity may not become apparent until the first few days after cessation of therapy Use with caution in premature infants and neonates because of renal immaturity and the resulting prolongation of serum half-life of the drug Neuromuscular blockade and respiratory paralysis have been reported following parenteral injection, topical instillation (as in orthopedic and abdominal irrigation or in local treatment of empyema), and oral use of aminoglycosides, especially when given soon after anesthesia or muscle relaxants If blockage occurs, calcium salts may reverse these phenomena, but mechanical respiratory assistance may be necessary Avoid concurrent or sequential use of neurotoxic and/or nephrotoxic drugs including other aminoglycosides (eg, amikacin, streptomycin, neomycin, kanamycin, gentamicin, paromomycin Cumulative listing of drugs to avoid from all aminoglycoside package inserts include amphotericin B, bacitracin, cephaloridine, cisplatin, colistin, polymyxin B, vancomycin, and viomycin Avoid potent diuretics (eg, ethacrynic acid, furosemide) because they increase risk of ototoxicity When administered intravenously, diuretics may enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue Caution in patients with renal impairment Not intended for long-term therapy; caution in patients with renal failure (not on dialysis), hypocalcemia, myasthenia gravis, and conditions that depress neuromuscular transmission Serious and potentially life-threatening hypersensitivity reactions, including anaphylaxis, reported; before therapy instituted, evaluate for previous hypersensitivity reactions to aminoglycosides; if anaphylaxis or a hypersensitivity reaction occurs, discontinue therapy and institute appropriate supportive measures Hypersensitivity pneumonitis reported; if hypersensitivity pneumonitis occurs, discontinue therapy and manage patients as medically appropriate Higher frequency of hemoptysis and bronchospasm, reported with treatment; if these occur, manage patients as medically appropriate Aminoglycosides can cause nephrotoxicity; close monitoring of patients with known or suspected renal dysfunction may be needed when prescribing drug Higher frequency of ototoxicity reported with treatment; closely monitor patients with known or suspected auditory or vestibular dysfunction; if patients develop tinnitus this may be an early symptom of ototoxicity Aminoglycosides may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function; if neuromuscular blockade occurs, it may be reversed by the administration of calcium salts, but mechanical assistance may be necessary Higher frequency of exacerbations of underlying pulmonary disease reported with treatment; treat patients as medically appropriate if this occurs Aminoglycosides can cause total, irreversible, bilateral congenital deafness in pediatric patients exposed in utero Monitoring Parameters With intravenous use Multiple daily dose regimen: one-hour (‘peak’) serum concentration should not exceed 30 mg/litre; pre-dose (‘trough’) concentration should be less than 10 mg/litre. Once daily dose regimen: pre-dose (‘trough’) concentration should be less than 5 mg/litre. Peak 15-40 mg/L, trough 5-10 mg/L Renal function should be assessed before starting an aminoglycoside and during treatment. Auditory and vestibular function should also be monitored during treatment.

Pregnancy Category: D Lactation: excretion in milk unknown/not recommended

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. Contraindicated (3) amphotericin B deoxycholate cidofovir neomycin PO Serious - Use Alternative (22) atracurium bacitracin BCG vaccine live bumetanide cholera vaccine cisatracurium contrast media (iodinated) cyclosporine ethacrynic acid furosemide ioversol microbiota oral pancuronium quinidine rapacuronium rocuronium succinylcholine tacrolimus teicoplanin torsemide typhoid vaccine live vecuronium

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.

Amikacin binds to 30S ribosomal subunits of susceptible bacteria, thus inhibiting its protein synthesis.

Amika 500mg/2ml IM/IV Injection manufactured by Doctor Tims Pharmaceuticals Ltd.. Its generic name is Amikacin. Amika is availble in Bangladesh. Farmaco BD drug index information on Amika IM/IV Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.