NISKACIN 500 Injection 1's

INTRODUCTION ABOUT NISKACIN 500 INJECTION

NISKACIN 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 NISKACIN 500 INJECTION, your doctor might
ask you take some diagnostic tests to check your kidney function, hearing and
levels of NISKACIN 500 INJECTION in your blood.

NISKACIN 500 INJECTION is not recommended for use in patients with myasthenia
gravis (severe weakness of body muscles). Before receiving NISKACIN 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).

NISKACIN 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 NISKACIN 500 INJECTION in
premature or new-born infants.

NISKACIN 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 NISKACIN 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 NISKACIN 500 INJECTION

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

HOW NISKACIN 500 INJECTION WORKS

NISKACIN 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

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

!### BREASTFEEDING

Consult your doctorNISKACIN 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 NISKACIN 500 INJECTION.

!### DRIVING AND USING MACHINES

Use with CautionDo not drive or operate machines, if you feel dizzy after receiving NISKACIN 500
INJECTION.

!### KIDNEY

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

!### ALLERGY

ContraindicatedDo not receive NISKACIN 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 CautionNISKACIN 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 CautionNISKACIN 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 NISKACIN 500 INJECTION.

OTHERS

NISKACIN 500 INJECTION is not recommended for use if you:

• suffer from myasthenia gravis (severe weakness of body muscles)

Before receiving NISKACIN 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 NISKACIN 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:

NISKACIN 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 NISKACIN 500 INJECTION out of the sight and reach of children
• Store NISKACIN 500 INJECTION below 25°C

FAQs ABOUT NISKACIN 500 INJECTION

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

A: NISKACIN 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 NISKACIN 500 INJECTION?

A: NISKACIN 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
NISKACIN 500 INJECTION for you based upon your body weight, age and severity of
disease condition.

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

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

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

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

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

A: Prior to or during the management with NISKACIN 500 INJECTION, your doctor
might ask you take some diagnostic tests to check your kidney function, hearing
and levels of NISKACIN 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]

3. Taccone, F.S., Laterre, PF., Spapen, H. et al. Revisiting the loading dose of
   amikacin for patients with severe sepsis and se
   April 2010. [Accessed on 8th October
   2022]

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]

5. Hospira UK Limited. Electronic Medicines Compendium (EMC). [Revised
   inFebruary 2022] [Accessed on 8th October
   2022]

6. MIAS Pharma Limited. Medicines Compendium (EMC). [Revised inSeptember 2021]
   [Accessed on 8th October
   2022]

7. Fresenius Kabi Manufacturing SA (Pty) Ltd. Amikacin. [Revised in April 2019]
   [Accessed on 8th October
   2022]

8. Square Pharmaceuticals Ltd. Amikacin. [Accessed on 8th October
   2022]

9. Heritage Pharmaceuticals. Amikacin Sulfate. Dailymed. [Revised in November
   2021] [Accessed on 8th October
   2022]

10. Bosch Pharmaceuticals. Amkay Injection (Amikacin). [Accessed on 8th October
    2022]

USEFUL DIAGNOSTIC TESTS

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