Amikaver 500mg

Ingredients: Amikacin sulfate: 500mg.

Uses (Indications)

Amikacin is indicated for the treatment of severe/life-threatening infections, especially of unknown etiology or suspected bacteremia due to Gram-negative bacilli. The drug is used in combination with cephalosporins, penicillins and other antibiotics, depending on the type of infection.

Treatment should be based on bacterial culture results.
Usually, it should be combined with a beta-lactam antibiotic.
In systemic infections caused by P.aeruginosa, combined with Piperacillin.
If endocarditis is due to S.faecalis or alpha Streptococcus, combine with ampicillin or benzylpenicillin respectively.
For the treatment of anaerobic bacteria, combine with Metronidazole or another anaerobic antibacterial agent.
Amikacin is reserved for special use only in cases where there is possible resistance to Gentamycin or Tobramycin.

Dosage

The usual dose for adults and older children with normal renal function is 15 mg/kg/day, divided into equal doses to be injected every 8 or 12 hours. The daily dose should not exceed 15 mg/kg or 1.5 g.
Newborns and premature infants: Initial loading dose 10 mg/kg, followed by 7.5 mg/kg every 12 hours.
There is now evidence that once-daily injection of aminoglycosides is at least as effective and may be less toxic than multiple daily injections.
In patients with renal impairment, serum amikacin concentrations should be determined, renal function monitored, and dosage adjusted.
Based on serum drug concentrations and the degree of renal impairment, in patients with renal impairment, doses of 7.5 mg/kg body weight may be used, at intervals shown in the table below, depending on serum creatinine concentrations or creatinine clearance.

Serum creatinine (micromol/l)	Creatinine clearance (ml/min/1.73 m²)	Dosage interval (hours)
<110	> 100	12
111 -150	100-55	15
151 -200	54-40	18
201 -255	39-30	24
256-335	29-22	30
>336	<22	>36

Use

Intramuscular injection or intravenous infusion. For intravenous infusion, for adults, mix 500mg Amikacin in 100-200ml of 0.9% sodium chloride solution or 5% dextrose solution, infuse over 30-60 minutes.
For children, the volume of infusion depends on the patient's needs, but there should be enough to infuse over 1–2 hours in young children, or 30–60 minutes in older children.

Overdose

In case of overdose or toxic reaction, hemodialysis or peritoneal dialysis may be used to accelerate the elimination of amikacin.
In newborns, blood transfusion may be required.

Do not use in case of (Contraindications)

Hypersensitivity to aminoglycosides, myasthenia gravis.

Undesirable effects (Side effects)

Undesirable effects depend on the dose. Common, ADR>1/100:

Whole body: Dizziness.
Urinary: Proteinuria, increased creatinine and increased blood urea.
Hearing: Decreased hearing, toxicity to the vestibular system such as nausea and loss of balance.

Uncommon, 1/1000 < ADR <1/100:

Whole body: Fever.
Blood: Eosinophilia.
Skin: Rash.
Liver: Increased transaminases.
Urinary: increased blood creatinine, albuminuria, urine with red blood cells, white blood cells and oliguria.

Rare, ADR < 1/1000:

Whole body: Headache
Blood: Anemia, leukopenia, thrombocytopenia.
Circulation: Hypertension
Nervous system: Paresthesia, tremor, myasthenia, paralysis.
Other organs: Arthralgia.
Ear: Deaf.

Inform your doctor of any unwanted side effects encountered while using the drug. Instructions for handling ADR:

Rapid-acting diuretics such as furosemide increase the risk of ototoxicity and nephrotoxicity.
If the patient has been previously treated with drugs that have the potential to be toxic to the ears or kidneys, such as other aminoglycosides, attention must be paid to the danger of drug accumulation.
Some preparations containing sodium sulfite may cause severe allergic reactions, especially in people with a history of asthma.
In renal failure, use amikacin only when absolutely necessary and adjust the dosage according to changes in blood creatinine concentration or creatinine clearance. Renal function and hearing should be monitored. Serum drug concentrations should be checked.

Interactions with other drugs

Concurrent or sequential use of amikacin with other nephrotoxic or ototoxic agents may increase the dangerous toxicity of aminoglycosides. Use of amikacin with neuromuscular blocking agents may increase the risk of neuromuscular blockade leading to respiratory paralysis. Amikacin may enhance the effects of curare muscle relaxants and anesthetics. Amikacin may also interact with certain other drugs such as broad-spectrum penicillins, furosemide, bumetanide, or indomethacin.

Notes on use (warnings and precautions)

Amikacin should be used with caution, especially in the elderly and young children, because of the high risk of ototoxicity and nephrotoxicity. Hearing and renal function should be monitored. Prolonged and/or repeated use should be avoided. Concomitant or sequential use of other drugs with ototoxic or nephrotoxic potential (systemic or topical) should be avoided.
Do not exceed recommended dose.
It is essential to quantify drug concentrations in serum when used in patients with renal impairment.
When the patient drinks plenty of water and has normal kidney function, there is little risk of kidney toxicity, provided the recommended dose is not exceeded.
Monitoring of renal function during aminoglycoside therapy in elderly patients with reduced renal function is particularly important.
Amikacin should be used with caution in patients with muscle dysfunction, such as myasthenia gravis or Parkinson's disease, because this drug causes severe muscle weakness due to its curare-like effect on the neuromuscular junction.
As with other antibiotics, use of amikacin may result in overgrowth of nonsusceptible organisms. If this occurs, appropriate therapy should be instituted.
Amikacin should not be mixed with other drugs, especially beta-lactam antibiotics.

Pregnant and lactating women

Pregnant women:

Aminoglycosides may cause fetal harm when administered to a pregnant woman.
If amikacin is used during pregnancy or if pregnancy occurs while taking the drug, the patient must be apprised of the potential hazard to the fetus, including myasthenic syndrome. Therefore, safety in pregnancy has not been established.

Breastfeeding women:

It is not known whether amikacin passes into breast milk. As a general rule, do not breast-feed while taking this medication, because many drugs are excreted in milk.