Active substance: ISONIAZID

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Patient Information Leaflet
What you should know about Isoniazid Ampoules
This leaflet contains information about Isoniazid Ampoules, which will be given to you
(or your child) by injection. Although you will not be taking this medicine or giving it
to your child yourself, this leaflet contains important information to help you
understand how Isoniazid is used. Keep it until the course of treatment has been
finished, as you may want to read it again.
Always follow your doctor`s advice, and if there is anything you do not understand,
please ask your doctor or nurse to explain it.
What do Isoniazid Ampoules contain?
Each ampoule contains 50mg of Isoniazid (the active ingredient) together with two
other ingredients, which are as follows:
Hydrochloric Acid BP
Water for Injections BP
Isoniazid is supplied in packs of 10 ampoules, each ampoule containing 2 ml.
Isoniazid is known as a `tuberculostatic drug`. This means that it stops the bacteria
that cause tuberculosis from growing and multiplying. The body`s own defences can
cope with the bacteria that are left, once the drug has stopped them reproducing.
The holder of the product licence for this medicine is Alliance Pharmaceuticals Ltd,
Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB, UK. The
ampoules are made by Boots Contract Manufacturing, 1 Thane Road, Nottingham,
NG2 3AA.
What is Isoniazid used for?
Isoniazid Ampoules are used to treat all forms of tuberculosis (TB).
When should Isoniazid not be used?
Isoniazid Ampoules should not be given to patients who have previously had any sort
of unpleasant reaction to the active ingredient (Isoniazid) or to any of the excipients
listed above. Please tell the doctor who is responsible for your treatment, or a nurse,
if you think you have had Isoniazid before and reacted badly to it or if you are allergic
to any other medicines.
You should also tell the doctor if you suffer from epilepsy, any mental illness, liver or
kidney problems, if you are an alcoholic, or if you are taking any other medicines. In
particular, if you are taking phenytoin, primidone or carbamazepine (used for treating
epilepsy), you should mention this to your doctor as the dose of these medicines may
need to be reduced. If you are also taking rifampicin for TB it is likely that your doctor
will want you to have regular blood tests to show that your liver is working properly.

Isoniazid Ampoules PIL UK 002

Naturally if Isoniazid is being used to treat your child, then these warnings apply to
him or her.

WOMEN: Please let the doctor know if you are pregnant of breast-feeding. Although
Isoniazid is generally regarded as safe in pregnancy, the doctor may prefer a
different treatment to be given under these circumstances. Isoniazid passes into the
breast milk but no harm to the baby has been reported as a result. Please do not
hesitate to discuss these matters with the doctor if you are concerned about possible
effects on your baby, whether already born or not.
How Isoniazid is used
Isoniazid is usually given by injection into a vein or muscle, directly into the chest or
into the spine. It may also be given slowly by infusion into a vein, especially if the
patient is already being given treatment in this way. Isoniazid is sometimes given by
other methods and is usually used together with other medicines in order to combat
tuberculosis more effectively. The usual dose of Isoniazid when given into a vein or
muscle is 200 to 300 mg (four to six ampoules) once daily for adults and 100 to 300
mg (two to six ampoules) daily for children. However larger doses may be used in
some conditions (such as tuberculous meningitis) and lower doses are used when
Isoniazid is administered into the chest or spine.
If a regular dose is not given at the normal time, it should be given to you as soon as
possible on the right day but if a daily dose is missed altogether there is no need for
extra Isoniazid to be given the next day.
If you think you have been given too much medicine, tell your doctor. The likely
signs of an overdose are the occurrence of side-effects as listed below. In severe
cases of overdose, convulsions may occur and if this happens you should seek
medical help immediately.
If you would like any other information about the use of Isoniazid, please ask a doctor
or nurse.
The most likely side-effects are numbness and tingling sensations in the hands and
feet, hair loss, fever and skin reactions (such as rashes) whilst blurred vision or
unusual bruising can occur sometimes. There have also been occasional reports of
inflammation of the tongue, changes in the blood (which may cause, fever, sore
throat, bleeding gums, rigors, pallor, fatigue, shortness of breath and easy bruising),
raised sugar in the blood and enlargement of the breast in men due to treatment with
Isoniazid. Please tell your doctor as soon as possible if any of these have occurred.
If you think that Isoniazid has caused any other side-effect, please tell your doctor,
nurse or pharmacist (chemist) about it.
This medicine should be stored out of the light at a maximum temperature of 25ºC
and should not be used after the expiry date that is shown on the carton.
All medicines should be kept out of the reach of children.
This leaflet was last revised:January 2012
Isoniazid Ampoules PIL UK 002

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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.