INTRODUCTION ABOUT AMIKANIT 500 INJECTION

AMIKANIT 500 INJECTION contains Amikacin which belongs to a group of medicines called Aminoglycoside Antibiotic. It is used in the management of serious infections caused by the bacteria that are sensitive to amikacin such as respiratory tract and lung infections, gastrointestinal infections, inflammation of the inner lining of the heart, infected burns, or bacterial infections of the blood.

Prior to or during the management with AMIKANIT 500 INJECTION, your doctor might ask you take some diagnostic tests to check your kidney function, hearing and levels of AMIKANIT 500 INJECTION in your blood.

AMIKANIT 500 INJECTION is not recommended for use in patients with myasthenia gravis (severe weakness of body muscles). Before receiving AMIKANIT 500 INJECTION inform your doctor if you have kidney problems, hearing difficulty or tinnitus (ringing or buzzing in the ears), an antibiotic-related hearing loss or a mitochondrial mutation disease (a condition caused by variations in the mitochondrial genome).

AMIKANIT 500 INJECTION should be used with caution in pregnant and breast-feeding women only if considered necessary. Contact your doctor before receiving it. Caution must be exercised while using AMIKANIT 500 INJECTION in premature or new-born infants.

AMIKANIT 500 INJECTION should be used with caution in elderly patients above the age of 60 years. Consult your doctor before receiving it. The most common side effects of receiving AMIKANIT 500 INJECTION are tinnitus (ringing in the ears), hearing problem, inner ear damage, decrease in excretion of urine. Consult your doctor if the symptoms do not resolve or worsen.

USES OF AMIKANIT 500 INJECTION

It is used in the management of serious infections caused by the bacteria that are sensitive to amikacin

HOW AMIKANIT 500 INJECTION WORKS

AMIKANIT 500 INJECTION acts on the bacteria and disrupt the important life functions of the bacteria. It interferes with the present bacteria and disrupts the cell membrane along with hampering its various cellular function which leads to bacterial death. It also stops the further spread of the infection this way.

DIRECTIONS FOR USE

AMIKANIT 500 INJECTION will be given to you only by a doctor or a nurse into a vein or muscle as an intramuscular or intravenous injection or as infusion (drip). Your doctor will determine the correct dose and duration for you based upon your body weight, age and severity of disease condition.

SIDE EFFECTS OF AMIKANIT 500 INJECTION

COMMON

tinnitus (ringing sensation in the ears)
hearing problem, inner ear damage
kidney function problems (nausea, vomiting, loss of appetite, changes in urination, sleep problems)
decrease in excretion of urine

UNCOMMON

infections caused by resistant yeast or bacteria
nausea
vomiting
rash

RARE

changes in level of blood cells such as reduced platelets and red blood cells, reduced or increased white blood cells (fatigue, weight loss, feeling of being unwell, paleness)
low levels of magnesium in the blood (fatigues, muscle weakness or cramps, numbness)
tremors
sensory disturbances
headache
dizziness or vertigo (spinning feeling)
balance disorders
abnormal tingling or ‘pins and needles’ feeling
blindness or other vision disturbances
retinopathy (changes in the retina of your eye)
low blood pressure
phlebitis (inflammation of vein walls)
itching, hives, joint pain
muscle twitching
fever
liver function changes (dark urine, pale stool, fever, abdominal pain, jaundice)
increase in heart rate
heart muscle inflammation

Stop receiving AMIKANIT 500 INJECTION and inform your doctor immediately if you experience any of the following side effects:

persisting ringing in your ears
decrease in the amount of urine you produce
severe allergic reaction characterised by sudden itchy rash (hives), swelling of the feet, ankles, hands, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), feeling of faintness
paralysis
deafness or loss of hearing
sudden loss of breathing
severe kidney failure

HOW TO MANAGE SIDE EFFECTS

Dizziness Or Drowsiness

Try to rest and relax. Get enough sleep. If you feel dizzy, avoid from driving or operating machinery. Avoid alcohol consumption as it aggravates dizziness. Contact your doctor if dizziness worsens.

Headache

Rest and relax. Consume plenty of electrolytes and water. If necessary, apply a balm to the head to relieve the pain. Do not consume alcohol. Consult your doctor if the headache did not improve.

Nausea And Vomiting

Stick to simple meals while receiving AMIKANIT 500 INJECTION. Avoid eating rich or spicy food. Do not take any medication by yourself. Ask for your doctor’s advice if nausea doesn’t improve or worsens. Eat light, bland foods and avoid oily, deep fried or sweet foods. Avoid carbonated drinks. Ask for your doctor’s advice if vomiting doesn’t improve or worsens.

Skin Rash Or Itching

Hot water may irritate your skin, so avoid taking hot showers. Do not scratch the affected area. Contact your doctor if rash worsens.

WARNING & PRECAUTIONS

PREGNANCY

Monitoring required

AMIKANIT 500 INJECTION should be used with caution in pregnant women only if considered necessary. Contact your doctor before receiving AMIKANIT 500 INJECTION.

BREASTFEEDING

Consult your doctor

AMIKANIT 500 INJECTION should be used with caution in breast feeding women only if considered necessary as it is not known if it is excreted into breast milk. Contact your doctor before receiving AMIKANIT 500 INJECTION.

DRIVING AND USING MACHINES

Use with Caution

Do not drive or operate machines, if you feel dizzy after receiving AMIKANIT 500 INJECTION.

KIDNEY

Use with Caution

AMIKANIT 500 INJECTION should be used with caution in patients with kidney problems. Your doctor might monitor your kidney function. Consult your doctor before receiving AMIKANIT 500 INJECTION

ALLERGY

Contraindicated

Do not receive AMIKANIT 500 INJECTION if you are allergic (hypersensitive) to amikacin or any other aminoglycoside or allergic to sulphites or to other ingredients of this medicine.

USE IN PEDIATRICS

Use with Caution

AMIKANIT 500 INJECTION should be used with caution in premature and new-born infants. Ask your child’s doctor for advice.

USE IN GERIATRICS

Use with Caution

AMIKANIT 500 INJECTION should be used with caution in elderly patients. Your doctor might adjust your dose depending on your kidney function. Consult your doctor before receiving AMIKANIT 500 INJECTION.

OTHERS

AMIKANIT 500 INJECTION is not recommended for use if you:

suffer from myasthenia gravis (severe weakness of body muscles)

Before receiving AMIKANIT 500 INJECTION, inform your doctor if you:

have tinnitus or difficulty hearing (ringing or buzzing in the ears)
or any member of your family suffers from an antibiotic-related hearing loss
or any member of your family have mitochondrial mutation disease (a condition caused by variations in the mitochondrial genome, the components of your cells that help make energy)

INTERACTIONS

A. Drug-Drug interactions:

Before receiving AMIKANIT 500 INJECTION, inform your doctor if you are taking any of the following medicines:

diuretics (water tablets) such as furosemide and ethacrynic acid (used to get rid of fluid build-up in the body)
indomethacin (used to reduce inflammation)
other antibiotics such as penicillin, cephalosporins, gentamycin, tobramycin (used to manage certain infections)
bisphosphonates such as alendronate (medicine used to manage bone mass loss)
vitamin B1 (thiamine) (medicine used to metabolize carbohydrates, proteins, and fats)
platinum compounds (metals used in chemotherapy) such as cisplatin, carboplatin, oxaliplatin
muscle relaxants such as atracurium, rocuronium, vecuronium (used to relax muscles)
anaesthetics such as methoxyflurane (used before surgery)

Overdosage:

AMIKANIT 500 INJECTION will be administered to you only by a doctor or a nurse in a hospital, and so it is unlikely to receive an overdose. However, inform your doctor immediately if you experience any unusual symptoms.

SYNOPSIS

Drug	:	Amikacin
Pharmacological Category	:	Aminoglycoside Antibiotics
Therapeutic Indication	:	Serious bacterial infections
Dosage Forms	:	Eye drops, Injection, Infusion

MORE INFORMATION

Keep AMIKANIT 500 INJECTION out of the sight and reach of children
Store AMIKANIT 500 INJECTION below 25°C

FAQs ABOUT AMIKANIT 500 INJECTION

Q: What is AMIKANIT 500 INJECTION and why is it prescribed?

A: AMIKANIT 500 INJECTION contains Amikacin which belongs to a group of medicines called Aminoglycoside Antibiotic. It is used in the management of serious infections caused by the bacteria that are sensitive to amikacin.

Q: How much time does it take to administer AMIKANIT 500 INJECTION?

A: AMIKANIT 500 INJECTION will be given to you only by a doctor or a nurse into a vein or muscle as an intramuscular or intravenous injection or as infusion (drip). If given as an infusion, it may take from 30-60 minutes and 1-2 hours for infants. Your doctor will determine the correct dose and duration of AMIKANIT 500 INJECTION for you based upon your body weight, age and severity of disease condition.

Q: Is it safe to use AMIKANIT 500 INJECTION in children?

A: AMIKANIT 500 INJECTION should be used with caution in premature and neonatal infants and kidney function should be monitored. Consult your doctor before receiving AMIKANIT 500 INJECTION.

Q: Can I receive AMIKANIT 500 INJECTION while breast feeding?

A: AMIKANIT 500 INJECTION should be used in breastfeeding women only if considered necessary as it is not known whether AMIKANIT 500 INJECTION passes through into breast milk. Contact your doctor before receiving AMIKANIT 500 INJECTION.

Q: Do I need to undergo any tests prior to, or while being managed with AMIKANIT 500 INJECTION?

A: Prior to or during the management with AMIKANIT 500 INJECTION, your doctor might ask you take some diagnostic tests to check your kidney function, hearing and levels of AMIKANIT 500 INJECTION in your blood. You doctor will also make sure that you are well hydrated.

REFERENCES

1. K.D. Tripathi. Aminoglycoside Antibiotics. Essentials of medical pharmacology. Eighth edition. 2019. Page – 799.

2. Sizar O, Rahman S, Sundareshan V. Amikacin. StatPearls. NIH National Library of Medicine. National Center for Biotechnology Information. October 2021. [Accessed on 8th October 2022] https://www.ncbi.nlm.nih.gov/books/NBK430908/

3. Taccone, F.S., Laterre, PF., Spapen, H. et al. Revisiting the loading dose of amikacin for patients with severe sepsis and septic shock. Biomed Central. BMC. April 2010. [Accessed on 8th October 2022] https://ccforum.biomedcentral.com/articles/10.1186/cc8945

4. Maria S. Ramirez, Marcelo E. Tolmasky. Amikacin: Uses, Resistance, and Prospects for Inhibition. Molecules. NIH National Library of Medicine. National Center for Biotechnology Information. December 2017. [Accessed on 8th October 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5889950/

5. Hospira UK Limited. Electronic Medicines Compendium (EMC). [Revised in February 2022] [Accessed on 8th October 2022] https://www.medicines.org.uk/emc/files/pil.3784.pdf

6. MIAS Pharma Limited. Medicines Compendium (EMC). [Revised in September 2021] [Accessed on 8th October 2022] https://www.medicines.org.uk/emc/files/pil.11189.pdf

7. Fresenius Kabi Manufacturing SA (Pty) Ltd. Amikacin. [Revised in April 2019] [Accessed on 8th October 2022] https://www.sahpra.org.za/wp-content/uploads/2020/02/Amikacin-Fresenius_PIL_Fresenius-Kabi_MCC-format-02-March-2012.pdf

8. Square Pharmaceuticals Ltd. Amikacin. [Accessed on 8th October 2022] https://www.squarepharma.com.bd/downloads/1636429189_pdoc_Akicin%20DS.pdf

9. Heritage Pharmaceuticals. Amikacin Sulfate. Dailymed. [Revised in November 2021] [Accessed on 8th October 2022] https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a43188fa-f228-4acd-8a5d-9a3462034f4b

10. Bosch Pharmaceuticals. Amkay Injection (Amikacin). [Accessed on 8th October 2022] https://bosch-pharma.com/product/amkay-25mg-injections/#description

USEFUL DIAGNOSTIC TESTS

Complete blood count
Peripheral Smear Examination
Kidney Function Test
Hearing Function Test

AUTHOR DETAILS

Written By Dr. Priyanka Goel - BDS

Last updated on 21 Mar 2023 | 05:33 PM(IST)

AMICIN 500mg Injection 2ml (se)

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