Amikacin Teva

Patient Information Leaflet

Amikacina Teva 0.5 g/2 ml solution for injection, 1 g/4 ml solution for injection

amikacin sulfate
Equivalent medicinal product
Please read all of this leaflet carefully before you start using this medicine, as 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 others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Amikacina Teva is and what it is used for

This medicinal product contains amikacin, an antibiotic that belongs to the aminoglycoside group and which
acts by killing the bacteria responsible for infections in the body.
Amikacina Teva is indicated for short-term treatment of serious infections caused by bacteria known as
Gram-negative organisms, including strains of Pseudomonas and Staphylococci that are unresponsive to other
antibiotics. Specifically, Amikacina Teva is indicated for the following infections:

• Blood infections such as bacteraemia (presence of bacteria in the blood) and septicaemia (systemic illness due to bacteria in the blood), including neonatal sepsis (widespread infection in the newborn);
• Genitourinary tract infections (complicated and recurrent);
• Respiratory tract infections;
• Bone and joint infections;
• Central nervous system infections (including meningitis, infection of the membranes covering the brain and spinal cord);
• Skin infections (cutaneous and subcutaneous tissue), including infections that may occur following a burn;
• Intra-abdominal infections (including peritonitis, infection of the membrane lining the abdominal organs and cavity);
• Postoperative infections (infections that may occur after surgery).

Amikacin is not indicated for the treatment of uncomplicated urinary tract infections in their early stages,
when a less toxic antibiotic can be used.
Contact your doctor if you do not feel better or if you feel worse.

2. What you need to know before using Amikacin Teva

Do not use Amikacin Teva
if you are allergic to amikacin or to any of the other ingredients of this medicine (listed in
section 6).
It is important to bear in mind that if you are allergic to another antibiotic belonging to the
aminoglycoside family, you may also be allergic to amikacin (cross-sensitivity).

Warnings and precautions
Talk to your doctor or pharmacist before using Amikacin Teva.
Seek medical advice especially if:

• you have kidney problems;
• you have hearing or balance disorders;
• you have parkinsonism (a disease characterized by tremor, stiffness, and slowness of movement);
• you have myasthenia gravis (a disease characterized by muscle weakness and fatigue);
• you are elderly;
• you are dehydrated;
• anaesthetics or muscle-paralyzing medicines are to be used;
• you or your family members have a genetic disorder causing mitochondrial mutation or hearing loss induced by antibiotics, we recommend informing 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 Amikacin Teva.

Carefully follow your doctor's instructions regarding treatment duration and required monitoring tests, such as
audiometry (a test measuring hearing ability), blood and urine tests, to assess kidney function. Your doctor will determine the number of treatment days based on your clinical condition.
You must stop treatment and contact your doctor immediately if you experience:

• persistent ringing in the ears (tinnitus), hearing loss, dizziness, or vertigo;
• numbness and tingling of the skin, involuntary muscle contractions (muscle spasms), or sudden, uncontrolled jerking muscle movements (seizures);
• abnormal kidney function tests and reduced urine output;
• progressive loss of muscle strength and endurance;
• development of new or different symptoms from those you previously had.

While taking this medicine, it is recommended to drink plenty of fluids to maintain adequate hydration.

Children
Amikacin Teva will be used with caution and under direct medical supervision in newborns and premature infants.
Since potential amikacin-related damage to hearing and balance in children is not fully known, this antibiotic will be used in pediatric patients only when necessary and with careful monitoring.

Other medicines and Amikacin Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Pay particular attention and inform your doctor if you are taking or are due to take any of the following
medicines:

• anaesthetics (medicines that reduce pain sensitivity and cause sedation) and neuromuscular blockers (paralyzing agents such as tubocurarine, succinylcholine, decamethonium, atracurium, rocuronium, vecuronium) or citrate (used as an anticoagulant in blood transfusion bags);
• medicines that may be toxic to the ear or kidneys, such as bacitracin, kanamycin, gentamicin, tobramycin, neomycin, streptomycin, cephaloridine, paromomycin, viomycin, polymyxin B, colistin, vancomycin, other aminoglycosides, or cephalosporins and penicillins (antibiotics used to treat bacterial infections), cisplatin (and other platinum-containing medicines used to treat cancer), amphotericin B (an antifungal used to treat fungal infections), cyclosporine and tacrolimus (medicines used to prevent organ transplant rejection and to treat immune system disorders);
• diuretics used to treat high blood pressure, such as ethacrynic acid, furosemide, sodium merallurate, sodium mercaptomerin, and mannitol;
• bisphosphonates, used to treat certain bone diseases;
• vitamin B1;
• indomethacin, used to treat inflammatory and painful conditions.

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

Pregnancy
Your doctor will prescribe Amikacin Teva only if clearly needed.
Limited data are available on the use of aminoglycosides during pregnancy.
Aminoglycosides cross the placenta and may cause harm to the unborn child.

Breastfeeding
It is not known whether amikacin is excreted in breast milk. The use of Amikacin Teva during breastfeeding should be considered only if the expected benefit to the mother outweighs the potential risk to the infant.

Fertility
Animal studies have not shown effects on fertility.

Driving and using machines
After administration of Amikacin Teva, disturbances in balance, vision, and hearing may occur. It is therefore recommended to avoid driving, operating machinery, or engaging in activities requiring special alertness (see “Possible side effects”).

Amikacin Teva contains

• sodium metabisulfite: may rarely cause severe hypersensitivity reactions and bronchospasm;
• sodium: Amikacin Teva 0.5 g/2 ml injectable solution: this medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially “sodium-free”. Amikacin Teva 1 g/4 ml injectable solution: this medicine contains approximately 29 mg of sodium (the main component of table salt) per vial. This corresponds to 1.45% of the maximum daily recommended dietary intake for an adult.

3. How to use Amikacin Teva

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

Amikacin Teva must be administered by intramuscular or intravenous route. Your doctor will determine the route of administration based on the severity of the infection being treated.

Adults and adolescents over 12 years of age
The recommended dose, by intramuscular or intravenous route, is 15 mg/kg per day, given as a single daily dose or in two equal doses of 7.5 mg/kg every 12 hours.
The maximum daily dose must not exceed 1.5 g of amikacin.

In cases of endocarditis (inflammation of the membrane lining the heart and heart valves caused by infection) or febrile neutropenia (reduction in the number of a type of white blood cells accompanied by fever), Amikacin Teva should be administered twice daily, as indicated above.

Uncomplicated urinary tract infections (excluding those caused by Pseudomonas): 7.5 mg/kg/day as a single daily dose.

High-risk infections and/or those caused by Pseudomonas: the initial dose in adults may be increased to 500 mg every 8 hours, but the maximum daily dose of 1.5 g/day must never be exceeded, nor should treatment last longer than 10 days.

Children between 4 weeks of age and 12 years
The recommended dose, by intramuscular injection or slow intravenous infusion, is 15–20 mg/kg per day, given as a single daily dose or in two equal doses of 7.5 mg/kg every 12 hours.

Newborns
The recommended initial dose is 10 mg/kg, followed by doses of 7.5 mg/kg every 12 hours.

Premature infants
The recommended dose is 7.5 mg/kg every 12 hours.

Renal impairment
Your doctor will evaluate whether to reduce the daily dose or increase the interval between doses.

Duration of treatment
The duration of treatment is 3–7 days for intravenous administration and 7–10 days for intramuscular administration. If there is no clinical improvement within 3–5 days, your doctor will reassess the situation.
At the recommended doses, less severe infections caused by susceptible organisms respond to therapy within 24–48 hours.

If you use more Amikacin Teva than you should
In case of accidental ingestion/overdose of this medicine, contact your doctor immediately or go to the nearest hospital.
Taking a high dose of amikacin may lead to kidney damage, hearing impairment, and damage to the brain or nervous system, possibly resulting in neuromuscular blockade (paralysis) and respiratory arrest.

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

If you stop using Amikacin Teva
If you have any questions about using this medicine, consult your doctor or pharmacist.
Ask your doctor for advice if you intend to stop treatment.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
All antibiotics belonging to the aminoglycoside class are potentially harmful to the ear, kidneys, and neuromuscular system.
Stop treatment and contact your doctor immediately if you experience:

• skin rash, skin irritation (urticaria), itching, bronchial constriction (bronchospasm), allergic reactions (hypersensitivity), even severe ones (anaphylactic reactions, anaphylactic shock, and anaphylactoid reactions) which may present as difficulty swallowing, swelling of the face, hands and feet, eyes, lips, tongue and/or face;
• persistent perception of noise in the ear (tinnitus), balance disorders;
• blindness, retinal infarction (cessation of blood flow to the eye);
• loss of motor function (paralysis);
• impaired kidney function (acute renal failure, toxic nephropathy, presence of cells in urine, nephrotoxicity).

Other possible adverse effects include:
Uncommon (may affect up to 1 in 100 people)

• nausea;
• vomiting;
• superinfections (infections occurring in addition to existing ones) or colonization with resistant bacteria or yeasts (development of bacterial resistance or occurrence of fungal infections);
• skin irritation (skin rash).

Rare (may affect up to 1 in 1,000 people)

• reduction in haemoglobin in the blood, the substance that carries oxygen in the blood (anaemia);
• increased number of a type of white blood cells in the blood (eosinophilia);
• decreased levels of magnesium in the blood (hypomagnesaemia);
• tremor;
• altered sensation (paraesthesia);
• headache (cephalalgia);
• hearing loss (hypacusis);
• balance disorders;
• blindness;
• cessation of blood flow to the eye (retinal infarction);
• persistent perception of noise in the ear (tinnitus);
• low blood pressure (hypotension);
• itching;
• urticaria;
• joint pain (arthralgia);
• muscle contraction;
• decreased urine production (oliguria);
• increased levels of creatinine in the blood (hypercreatininaemia);
• high concentration of albumin in urine (albuminuria);
• increased levels of nitrogen in the blood (azotaemia);
• presence of red or white blood cells in urine;
• fever (pyrexia).

Not known (frequency cannot be estimated from the available data)

• allergic reactions (hypersensitivity, anaphylactic reactions, anaphylactic shock, and anaphylactoid reactions);
• paralysis;
• deafness;
• temporary interruption of breathing (apnoea);
• bronchial constriction (bronchospasm);
• impaired kidney function (acute renal failure, toxic nephropathy, presence of cells in urine).

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

5. How to store Amikacina Teva

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Diluted solutions containing 2.5 mg/ml of active substance may be used within 24 hours if stored in a refrigerator or otherwise at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
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 Amikacina Teva contains
Amikacina Teva 0.5 g/2 ml solution for injection

• The active substance is amikacin sulfate. Each vial contains 667.5 mg of amikacin sulfate (equivalent to 500 mg of amikacin).
  Amikacina Teva 1 g/4 ml solution for injection
• The active substance is amikacin sulfate. Each vial contains 1,335 g of amikacin sulfate (equivalent to 1 g of amikacin).

The other components are sodium citrate, sodium metabisulfite, sulfuric acid, water for injectable preparations.

Description of the appearance of Amikacina Teva and contents of the pack
Amikacina Teva 0.5 g/2 ml solution for injection is supplied in a carton containing 5 vials of injectable solution at 500 mg.
Amikacina Teva 1 g/4 ml solution for injection is supplied in a carton containing 1 vial of injectable solution at 1 g.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 – 20123 Milano
Manufacturer
Laboratorio Farmaceutico C.T. S.r.l. - Via Dante Alighieri, 71 - Sanremo (IM)

The following information is intended exclusively for physicians or healthcare professionals:
Official guidelines on the appropriate use of antibacterial agents should be taken into account.
The duration of treatment is 3–7 days for intravenous administration and 7–10 days for intramuscular administration. If the clinical condition has not improved within 3–5 days, consider switching to an alternative therapy based on microbiological test results.
In patients with renal dysfunction, it is recommended to reduce the daily dose and/or increase the intervals between doses to prevent drug accumulation.
A recommended method for determining doses 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.
Since renal function may change significantly during therapy, serum creatinine levels should be monitored frequently and, if necessary, dosing intervals should be adjusted accordingly.
Normal dosage 7.5 mg/kg at extended intervals:

Reduced dosage at fixed intervals: initial dose: 7.5 mg/kg; maintenance dose (every 12 hours):
Patient's creatinine clearance (ml/min) x 7.5
Normal creatinine clearance (ml/min)
Intramuscular administration is preferred, but if necessary, intravenous administration (by intravenous infusion) may be used with the same dosing regimen.
If intravenous administration is considered useful or necessary, the calculated amount of drug should be diluted so that the administration lasts at least one hour or longer.
In pediatric patients, the volume of diluent used depends on the amount of amikacin tolerated by the patient. The solution should be infused over a period of 30–60 minutes. In children, the infusion should last 1–2 hours.
For intravenous use, dilute in physiological saline or isotonic glucose solution.
Amikacin Teva must not be mixed with other antibacterial agents in the same syringes or infusion bottles.
In case of overdose or toxic reactions, hemodialysis or peritoneal dialysis should be used to accelerate the elimination of amikacin from the blood.
Amikacin levels are also reduced during continuous arterio-venous hemofiltration. In neonates, exchange transfusion may also be considered.