Nekacin

Italy
Brand name Nekacin
Form solution for injection
Active substance / Dosage
AMIKACIN SULFATE
Prescription type Restricted prescription – hospital or equivalent facility use only
ATC code
J01GB06
Registration number 033190
Manufacturer NEW RESEARCH S.R.L.
Nekacin solution for injection

Table of Contents

Package leaflet: Information for the patient

NEKACIN

“500 mg injection solution”
“1000 mg injection solution”
amikacin
Generic medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be dangerous.
  • If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

  1. What NEKACIN is and what it is used for
  2. What you need to know before using NEKACIN
  3. How to use NEKACIN
  4. Possible side effects
  5. How to store NEKACIN
  6. Contents of the pack and other information

1. What NEKACIN is and what it is used for

NEKACIN contains the active substance amikacin.
Amikacin belongs to a group of medicines called antibiotics, which are used to treat serious infections caused by bacteria that can be killed (sensitive) by the active substance amikacin.
NEKACIN has proven effective:

  • in the treatment of bacteraemia (presence of bacteria in the blood), septicemia (a systemic illness due to persistent presence of bacteria in the blood), and blood infections in newborns (neonatal sepsis);
  • in the treatment of respiratory tract infections, bone and joint infections, central nervous system (CNS) infections (including meningitis), endo-abdominal infections (including peritonitis), burn infections, and postoperative infections (after surgery);
  • in the treatment of complicated and recurrent genitourinary tract infections.

Official guidelines on the appropriate use of antibiotics should be taken into account.

2. What you should know before taking NEKACIN

Do not take NEKACIN

  • If you are allergic (hypersensitive) to amikacin, to other similar substances (aminoglycosides), or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking NEKACIN:

  • If you have kidney or hearing problems. Injectable amikacin may cause further damage to the kidneys and hearing; therefore, your doctor will check the function of your hearing and kidneys before deciding whether to start treatment.
  • If you are allergic to other antibiotics of the same class (aminoglycosides).
  • If you are being treated with other antibiotics of the same class (aminoglycosides). Amikacin is potentially toxic to the hearing and kidneys.
  • If you are pregnant or breastfeeding (see "Pregnancy and breastfeeding").
  • If you or your family members have a genetic disorder causing mitochondrial mutation or hearing loss induced by antibiotics, please inform your doctor or pharmacist before taking an aminoglycoside, as certain mitochondrial mutations associated with this product may increase the risk of hearing loss. Your doctor may recommend genetic testing before administering NEKACIN.

While using NEKACIN, always keep in mind that:

  • Amikacin, like all antibiotics of the same class (aminoglycosides), is potentially toxic to the ear, kidneys, and nervous system. Therefore, your doctor will continuously monitor the function of these organs and advise you to avoid concomitant administration with other medicines that have similar toxicity (see "Other medicines and NEKACIN").
  • The risk of kidney toxicity is reduced if NEKACIN is administered at the recommended doses to well-hydrated patients with normal kidney function.
  • If symptoms of kidney problems occur, your doctor will keep you under close monitoring and may advise you to:
    • undergo regular monitoring of kidney function;
    • increase fluid intake to avoid dehydration, in case of symptoms of kidney irritation;
    • reduce the administered dose, in case of evident kidney dysfunction;
    • discontinue treatment, if high levels of nitrogen in the blood (hyperazotemia) occur or if there is a progressive decrease in urine output (oliguria).
  • In patients with kidney problems (renal insufficiency), if NEKACIN is administered for more than five days, your doctor will perform a hearing test (audiogram) both before starting and during treatment.
  • If you experience ringing in the ears, hearing loss, or reduced high-frequency hearing on subsequent audiograms, stop taking the medicine and inform your doctor.
  • When amikacin is indicated in combination with other antibiotics, NEKACIN must not be mixed with such agents either in syringes or infusion vials.
  • The safety of amikacin use during pregnancy has not yet been established; therefore, in pregnant women and very young infants, the product should be administered only if clearly needed and under direct medical supervision (see "Pregnancy and breastfeeding").
  • It is not known whether amikacin is excreted in breast milk. As a general rule, breastfeeding should not be allowed in women receiving medicines that may pass into breast milk (see "Pregnancy and breastfeeding").
  • NEKACIN contains sodium metabisulfite, a substance that may cause allergic reactions, including life-threatening anaphylactic reactions or less severe ones, and severe asthma attacks, particularly in sensitive individuals and especially in asthmatics.
  • Cases of irreversible deafness, kidney impairment, and death due to neuromuscular blockade have been reported following the use of aminoglycoside medicines such as NEKACIN for irrigation during surgical procedures.
  • As with other antibiotics, the use of amikacin may lead to the proliferation of bacteria resistant to antibiotics. In such cases, treatment should be discontinued and you should consult your doctor, who will advise on appropriate therapy.
  • Following intravitreal injection (injection into the eye) of amikacin, possible onset of retinal infarction has been reported, sometimes resulting in permanent vision loss.

You should pay attention to the following:
The harmful effect of amikacin on the ear and auditory nerve:

  • may be enhanced in patients with impaired kidney function, and/or in otherwise healthy patients treated with amikacin or similar drugs for more than 5–7 days;
  • may manifest through various symptoms such as dizziness, numbness, skin tingling, muscle twitching, and convulsions.

The harmful effect of amikacin on the neuromuscular system:

  • may be enhanced in patients with neuromuscular disorders such as myasthenia gravis or parkinsonism;
  • may manifest as impaired transmission of nerve impulses and muscle contraction (neuromuscular blockade) and respiratory paralysis (respiratory arrest).

The harmful effect of amikacin on the kidneys:

  • may be enhanced in patients with impaired kidney function, in patients receiving high doses of amikacin or prolonged treatment, in elderly patients, and in dehydrated patients. Your doctor will perform tests to assess your kidney function before starting treatment and during therapy.

Children
Amikacin should be used with caution in premature infants and newborns due to their incomplete kidney development and the consequent prolonged drug concentrations in the blood.
Following intravitreal administration (injection into the eye) of amikacin, retinal ischemia has been observed, sometimes leading to permanent vision loss.

Other medicines and NEKACIN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
In particular, avoid administration of NEKACIN and contact your doctor if you are taking:

  • medicines that cause damage to the nervous system, hearing, and kidneys, such as bacitracin, cisplatin, amphotericin B, cyclosporine, tacrolimus, cephaloridine, paromomycin, viomycin, polymyxin B, colistin, vancomycin, or other aminoglycoside antibiotics such as kanamycin, gentamicin, tobramycin, neomycin, streptomycin. Avoid concomitant or sequential administration of these medicines, as their toxic effects may add to those of amikacin;
  • aminoglycoside antibiotics and cephalosporins: concomitant parenteral use increases the risk of kidney damage;
  • potent diuretic medicines (diuretics) such as ethacrynic acid, furosemide, and mannitol, since some diuretics themselves may cause hearing damage and, when administered intravenously, may increase amikacin toxicity.

Inform your doctor if you are taking:

  • bisphosphonates (used to treat bone diseases). Concomitant use with NEKACIN increases the risk of low blood calcium levels;
  • platinum-containing compounds (used in anticancer therapy). The risk of kidney toxicity and possible hearing toxicity increases with simultaneous administration;
  • anesthetics and muscle relaxants such as succinylcholine, decamethonium, atracurium, rocuronium, vecuronium, or in patients undergoing massive blood transfusions treated with citrate to prevent clotting. With these medicines, the use of NEKACIN increases the risk of respiratory paralysis;
  • penicillins (antibiotics) and aminoglycosides. The use of amikacin with penicillin-class antibiotics and aminoglycosides, when administered simultaneously via separate routes, may reduce the effectiveness of NEKACIN;
  • indomethacin (anti-inflammatory). Concurrent use may increase amikacin blood levels in newborns;
  • thiamine (vitamin B1). Amikacin administered simultaneously causes loss of thiamine efficacy due to the presence of sodium metabisulfite, a component of NEKACIN.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
You should take NEKACIN only under direct medical supervision if you are pregnant, and your doctor will assess whether the potential benefits outweigh the possible risks to you and your baby.
Aminoglycosides cross the placental barrier, and cases of total, bilateral, and irreversible congenital deafness have been reported in children whose mothers received streptomycin during pregnancy.

Breastfeeding
It is not known whether NEKACIN is excreted in breast milk. In such cases, a decision must be made whether to discontinue breastfeeding or to discontinue therapy.

Fertility
Reproduction toxicity studies in mice and rats revealed no effects on fertility or fetal toxicity.

Driving and using machines
No studies have been conducted on the effects on the ability to drive and use machines. However, this ability may be impaired if any of the adverse effects listed in section 4 occur.

NEKACIN contains

  • sodium metabisulfite: may rarely cause severe hypersensitivity reactions and bronchospasm;
  • sodium: NEKACIN 500 mg injectable solution contains less than 1 mmol (23 mg) of sodium per vial, i.e., it is essentially "sodium-free". NEKACIN 1000 mg injectable solution contains approximately 29 mg of sodium (the main component of table salt) per vial. This corresponds to 1.45% of the maximum daily intake recommended in an adult's diet.

3. How to take NEKACIN

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

For intramuscular or intravenous administration in adults and adolescents with normal renal
function, the recommended dose is:
Adults and children over 12 years of age:
15 mg/kg/day, administered as a single daily dose or divided into two equal doses, i.e.
7.5 mg/kg every 12 hours.
The total daily dose must not exceed 1.5 g.
In patients with endocarditis or febrile neutropenia, the dosing schedule should consist of two
daily administrations, as there are insufficient data to support once-daily administration.

Children between 4 weeks and 12 years of age:
The recommended intramuscular or intravenous dose (slow intravenous infusion) is 15–20 mg/kg/day,
administered either as a single daily dose of 15–20 mg/kg or divided into two doses of 7.5 mg/kg every 12 hours.
In patients with endocarditis or febrile neutropenia, the dosing schedule should consist of two
daily administrations, as there are insufficient data to support once-daily administration.

Newborns: initial loading dose: 10 mg/kg; continue with 7.5 mg/kg every 12 hours.
Premature infants: the recommended dose is 7.5 mg/kg every 12 hours.

At the recommended dosage, less severe infections caused by amikacin-sensitive organisms
respond within 24–48 hours.

Duration of treatment: 3–7 days for intravenous administration and 7–10 days for intramuscular administration.

Impaired renal function:
The daily dose should be reduced and/or the intervals between doses extended to prevent drug accumulation.
A recommended method for determining the dose in patients with suspected or confirmed impaired renal function
is to multiply the serum creatinine concentration by 9: the result represents the interval, expressed in hours, between doses.
For example, if the serum creatinine level is 2 mg, the recommended dose should be administered every 18 hours.

NEKACIN must be administered alone. NEKACIN may be indicated as concomitant therapy
with other antibacterial agents in mixed infections or superinfections; in such cases, NEKACIN must not be mixed
with other antibacterial agents in the same syringes or infusion bottles.

For intravenous infusion, the recommended dose is:
Adults:
The volume of solution (200 ml for the 1000 mg vial) should be administered over a period of 60 minutes or longer.

Children:
The volume of solution to be used will depend strictly on the amount of antibiotic the child must receive;
the infusion solution should be administered over 30–60 minutes; in younger children, the infusion should last 1–2 hours.

Amikacin must not be mixed with other infusion substances, but must be administered alone,
according to the established dosing schedule.

If you take more NEKACIN than you should
Administration of high doses of amikacin may damage the kidneys, the optic nerves, or cause muscular blockade (paralysis).
In such cases, treatment with amikacin must be discontinued immediately and you should contact your doctor or go to the nearest hospital.
Calcium salts may be used to counteract the paralyzing effect. If necessary, urinary excretion (diuresis) may be increased to remove amikacin from the body.
Additional measures may include dialysis or, in newborns, blood exchange; however, specialist consultation must be obtained before implementing such measures.

If you forget to take NEKACIN
Do not take a double dose to make up for the missed dose.

If you stop taking NEKACIN
Do not discontinue treatment without first consulting your doctor. The duration of treatment is 7–10 days.
It is important that you complete the full course of treatment even if you start to feel better after a few days.
If you stop taking this medicine too early, the infection may not be completely cured and symptoms may recur or worsen.
You may also develop resistance to the antibiotic.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The main side effects that may occur during treatment with amikacin are:
toxicity affecting the auditory nerve, kidney toxicity, and muscle blockade.
These toxicities occur more frequently in patients with impaired renal function, in patients receiving other drugs toxic to the ear and kidneys, and in patients treated for prolonged periods and/or with doses higher than those recommended (see “Warnings and precautions”).
If you experience any of the following serious side effects, stop administration of NEKACIN immediately and contact your doctor right away or go to the nearest hospital.

  • Severe allergic reaction with sudden onset (anaphylactic shock);
  • Deafness;
  • Respiratory paralysis;
  • Severe kidney problems and presence of cells in the urine.

The frequency of these reactions is not known, i.e. cannot be estimated based on available data.

Other side effects that may occur with NEKACIN

Uncommon side effects: may affect up to 1 in 100 patients:
Emergence of new superimposed infections, or colonization by antibiotic-resistant bacteria and/or yeasts;

  • Nausea, vomiting;
  • Skin rash.

Rare side effects: may affect up to 1 in 1,000 patients:

  • Pathological reduction in blood hemoglobin levels (anemia), increased number of eosinophils (a type of white blood cell);
  • Decreased magnesium levels in the blood;
  • Tremor, headache, balance disorders;
  • Blindness, retinal infarction (eye infarction);
  • Tinnitus (ringing in the ears), hearing impairment;
  • Decreased blood pressure;
  • Itching, urticaria (hives);
  • Reduced urinary output (oliguria), increased serum creatinine concentration, presence of albumin (a blood protein) in the urine, increased blood nitrogen levels (azotemia), red blood cells in the urine, white blood cells in the urine;
  • Fever;
  • Anemia, eosinophilia;
  • Arthralgia (joint pain), muscle contractions.

Side effects with unknown frequency (frequency cannot be estimated from available data)

  • Allergic reactions;
  • Breathing difficulty (apnea), narrowing of the bronchial lumen (bronchospasm);
  • Paralysis;
  • Deafness, sensorineural deafness;
  • Acute renal failure, toxic nephropathy, cells in the urine.

────────────────────────────────────────────────────
See “Warnings and precautions”
Amikacin is not formulated for intraocular (intravitreal) use.
Blindness and retinal infarction have been reported following intravitreal administration (injection into the eye) of amikacin.
────────────────────────────────────────────────────

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NEKACIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after "Exp.".
The expiry date refers to the last day of that month. The expiry date applies to the product in its original packaging, stored correctly and unopened.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What NEKACIN contains
The active substance is amikacin.
Each vial of NEKACIN 500 mg injectable solution contains 667.5 mg of amikacin sulfate equivalent to 500 mg of amikacin.
Each vial of NEKACIN 1000 mg injectable solution contains 1335 mg of amikacin sulfate equivalent to 1000 mg of amikacin.
The other components are: Sodium citrate, Sodium metabisulfite, Sulfuric acid, Water for injectable preparations.

Description of the appearance of NEKACIN and package contents
NEKACIN is an injectable solution suitable for both intramuscular and intravenous administration.
The solution is contained in glass vials.
NEKACIN 500 mg injectable solution is available in a carton containing 5 glass vials of 2 ml each.
NEKACIN 1000 mg injectable solution is available in a carton containing 1 glass vial of 4 ml.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
New Research S.r.l.
Via Tiburtina, 1143 – 00156 Rome, Italy

Manufacturers
Lab. It. Biochim. Farm.co LISAPHARMA SpA
Via Licinio, 11 - 22036 Erba (CO), Italy
Biomedica Foscama Industria Chimico-Farmaceutica SpA
Via Morolense, 87 Ferentino (FR), Italy

June 2023