Find similiar products:
The text only version may be available in large print, Braille or audio CD.
For further information call emc accessibility on
0800 198 5000.
The product code(s) for this leaflet is: PL16853/0109.
Isoniazid Ampoules 50 mg/2 ml
Isoniazid 50 mg/2 ml Solution for Injection
Isoniazid
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
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.
Talk to your doctor or pharmacist before using this medicine if you:
This medicine can be used in children and adolescents of all ages.
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:
Your doctor may wish to monitor you closely if you are using Isoniazid with these medications.
Isoniazid may interact with foods containing histamine or tyramine (e.g. matured cheeses, cured meat, some fish like tuna, salmon and mackerel, wine and beer), causing symptoms including headache, sweating, flushing, fast, uneven or forceful heartbeat (palpitations), dizziness, feel lightheaded or faint (due to low blood pressure). These foods should be avoided if you are receiving isoniazid. Your doctor will be able to advise further.
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.
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.
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.
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.
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.
No dosage adjustments are necessary in the elderly.
Your doctor may wish to change your dose. If you are receiving dialysis, Isoniazid should be given to you after your dialysis treatments.
Your doctor may wish to monitor your liver enzymes closely.
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 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:
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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, contact your doctor as soon as possible:
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.
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. Theexpiry 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 pharmacisthow to throw away medicines you no longer use. These measures will help protect theenvironment.
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.
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:
Manufacturer:
This leaflet was last revised in January 2019.
Alliance and associated devices are registered trademarks of Alliance Pharmaceuticals Limited.
© Alliance Pharmaceuticals Limited 2015.
Isoniazid Ampoules PIL UK 006