Skip to Content

ISONIAZID 50 MG/2 ML SOLUTION FOR INJECTION

Active substance(s): ISONIAZID

View full screen / Print PDF » Download PDF ⇩
Transcript
Artwork Information
Product Title:

Isoniazid 50 mg/2 ml Solution for Injection

Date:

10-07-15

Label Number:

15-004

Font size:

Helvetica Condensed, Zapf Dingbats

Fonts Used:

7pt

Version 2

Product Size:

148 x 420mm

Colours Used:

Black

Magenta text, keylines and shading are NOT to be printed

ALLIANCE
Package leaflet: Information for the user

Isoniazid 50 mg/2 ml Solution for Injection
Isoniazid
Read all of this leaflet carefully before you start using this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have further questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet
1. What Isoniazid is and what it is used for
2. What you need to know before you use Isoniazid
3. How to use Isoniazid
4. Possible side effects
5. How to store Isoniazid
6. Contents of the pack and other information
1. What Isoniazid is and what it is used for
Isoniazid 50 mg/2 ml Solution for Injection contains Isoniazid. Isoniazid belongs to a group of medicines
called antibacterials, which work by killing the bacteria that cause tuberculosis (also known as TB).
Isoniazid is used to treat tuberculosis inside the lungs (pulmonary TB) and outside the lungs
(extra-pulmonary TB).
You will receive your doses of Isoniazid by injections given to you by a doctor or nurse.
Tuberculosis is a serious disease. It is important that you receive effective treatment for this condition
as it can be passed on to other people and, if left untreated, it can be fatal.
2. What you need to know before you use Isoniazid
Do not use Isoniazid if you
• are allergic to Isoniazid, or any of the other ingredients of this medicine (listed in Section 6).
Warnings and Precautions
Talk to your doctor or pharmacist before using this medicine if you:
• have kidney problems or have been told by your doctor that you have a slow acetylator status. Your doctor
may wish to change your dose.
• have liver problems including hepatitis.
• are alcohol dependent or drink excessively. You may be more likely to suffer from fits or mental
disturbances if you regularly drink alcohol whilst taking this medicine.
• have previously had “fits” or suffer from epilepsy. This medicine can increase the likelihood of fits.
• have a mental illness (psychosis). This medicine can increase the likelihood of experiencing mental
disturbances.
• suffer from porphyria (a rare illness which affects the metabolism).
• have suffered from pancreatitis caused by taking Isoniazid in the past.
Children and adolescents
This medicine can be used in children and adolescents of all ages.
Other medicines and Isoniazid
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor or pharmacist if you are taking:
• phenytoin, primidone, carbamazepine or ethosuximide (used to treat epilepsy)
• rifampicin and cycloserine (antibiotics used to treat infections, including tuberculosis)
• diazepam (used to treat conditions including anxiety and sleep problems)
• triazolam (usually used as a sedative to treat severe sleep problems)
• chlorzoxazone (used for treating discomfort caused by muscle spasms)
• theophylline (used in asthma, chronic obstructive pulmonary disease, bronchitis and heart failure)
• disulfiram (used in alcohol dependence)
• prednisolone (used in a wide range of inflammatory and auto-immune conditions)
• levodopa (used in the treatment of conditions, such as Parkinson's disease).
Your doctor may wish to monitor you closely if you are using Isoniazid with these medications.
Isoniazid with food and alcohol
While you are being treated with Isoniazid, you should not have cheese, red wine and some fish (your doctor
will be able to advise).
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a baby, talk to your doctor or
pharmacist before using this medicine. Isoniazid is generally regarded as safe during pregnancy, but during
early pregnancy there may be an increased risk of deformation of the foetus.
If you are breast-feeding, tell your doctor before using this medicine. Isoniazid is excreted in the breast milk,
which can be passed on to your child. If you are breast-feeding, you and your child may also be given another
medicine called pyridoxine to help minimise side effects.
Driving and using machines
Isoniazid can cause fits, mental health problems and optic neuritis (inflammation of the optic nerve that may
cause loss of vision). If affected you should not drive or use machinery.
3. How to use Isoniazid
You will receive your doses of Isoniazid by injections given to you by a doctor or nurse.
Isoniazid can be injected into the muscles, veins, spine or chest.
Use in Adults and Children
The recommended dose for adults, when injected into a vein or the muscles, is 200 to 300 mg (four to six
ampoules) as a single daily dose.
The recommended dose for children, when injected into a vein or the muscles, is 100 to 300 mg (two to six
ampoules) as a single daily dose.
Doses much larger than these can sometimes be given. In particular, a higher dose may be used for the
treatment of meningitis caused by an infection of tuberculosis.
If you receive your injection in the chest, a lower dose of 50 to 250 mg (one to five ampoules) is
recommended.
If you receive your injection in the spine, a much lower dose of 25 to 50 mg for adults and 10 to 20 mg for
children is recommended. You may also be given another medicine called pyridoxine to help reduce the
chance of side effects.
Newborn babies (less than 4 weeks old)
The recommended dose, when injected into a vein or the muscles, for newborn babies is 3 – 5 mg per kg of
body weight, up to a maximum of 10 mg per kg daily.
Elderly
No dosage adjustments are necessary in the elderly.
Patients with kidney problems
Your doctor may wish to change your dose. If you are receiving dialysis, Isoniazid should be given to you after
your dialysis treatments.

Patients with liver problems
Your doctor may wish to monitor your liver enzymes closely.
Regular tests
Your doctor may want you to have a monthly blood test to make sure your liver function is not being affected
by this medicine.
If you use more Isoniazid than you should
If you think you have been given too much of this medicine tell your doctor or nurse straight away. The
common signs of overdose are the side effects as listed in Section 4 of this leaflet together with the following:










Difficulty walking, tremor and altered coordination
Deep, rapid breathing
Feeling or being sick
Faster heart beat
Dizziness
Hallucinations
Slurred speech
Increased visual sensitivity
Overactive reflexes (e.g. twitching).

In severe cases of overdose, fits may occur. If this happens tell your doctor or nurse immediately.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
If you experience any of the following side effects, contact your doctor as soon as possible:
• Difficulty breathing, swelling of the mouth, throat, face or lips. You could be experiencing a severe allergic reaction.
• Inflammation of the pancreas, which causes severe pain in the abdomen and back (pancreatitis, frequency
not known).
• Severe extensive skin damage (separation of the epidermis and superficial mucous membranes) (toxic
epidermal necrolysis, TEN, may affect up to 1 in 1,000 people).
• A drug reaction that causes rash, fever, inflammation of internal organs, haematological abnormalities and
systemic illness (DRESS syndrome, may affect up to 1 in 1,000 people).
• Yellowing of the skin or whites of the eyes, or urine getting darker and stools paler, fatigue, weakness, malaise,
loss of appetite, nausea or vomiting caused by liver problems (hepatitis, may affect up to 1 in 100 people).
• Fits (for further information on when fits may be more likely to occur see section 2 ‘Warnings and Precautions’).






Vision problems such as loss of sight, blurred vision and reduced vision.
Blood disorders which may cause tiredness and flu-like symptoms.
Reduction in blood platelets, which increases risk of bleeding or bruising.
High blood sugar levels, signs of which include increased hunger, increased thirst and going to the toilet more often.
Mental health problems, signs of which may include hallucinations, delusions, confusion, disturbed
thoughts and a lack of self-awareness.

Other side effects (frequency not known)
• Inflammation of the blood vessels
• Fever
• Nerve problems which can cause movement problems, tingling and numbness (this can be prevented with
the use of pyridoxine)
• Hair loss





Skin conditions (including lumpy red rash, red/purple skin discolouration, skin scaling)
Immune system problems with symptoms that include tiredness, joint pain and skin rashes
Vitamin B3 deficiency (Pellagra), symptoms of which include memory problems, diarrhoea, scaly skin rash
Breast growth in males.

Reporting of side effects
If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly via the internet at www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Isoniazid
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and ampoule. The expiry date
refers to the last day of that month.
Do not store above 25°C. Keep away from light sources.
Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What Isoniazid contains
The active substance is Isoniazid. Each ampoule contains 50 mg of Isoniazid in 2 ml of solution.
The other ingredients are Hydrochloric Acid and Water for Injections.
What Isoniazid looks like and contents of the pack
Isoniazid ampoules are colourless glass ampoules with dark red and orange colour rings.
Isoniazid is available in packs containing 10 ampoules. Each ampoule contains 2 ml of solution.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Alliance Pharmaceuticals Limited, Avonbridge House, Bath Road,
Chippenham, Wiltshire, SN15 2BB, UK
Manufacturer: Boots Contract Manufacturing, 1 Thane Road, Nottingham, Nottinghamshire, NG2 3AA,
United Kingdom
This leaflet was last revised in July 2015.
Alliance and associated devices are registered trademarks of Alliance Pharmaceuticals Limited.
© Alliance Pharmaceuticals Limited 2015.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide