Linezolid 2mg/Ml Solution For Infusion
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LINEZOLID 2mg/ml solution for infusion
Linezolid
Read all of this leaflet carefully before this medicine is given to you.
Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Linezolid is and what it is used for
2. What you should know before you are treated with Linezolid
3. How Linezolid is given
4. Possible side effects
5. How to store Linezolid
6. Further information
1. What Linezolid is and what it is used for
Linezolid is an antibiotic of the oxazolidinones group that works by stopping the growth of certain bacteria (germs) that cause infections. It is used to treat pneumonia and some infections in the skin or under the skin. Your doctor will have decided if Linezolid is suitable to treat your infection.
2. What you should know before you are treated with Linezolid You should not be treated with Linezolid if you are:
• allergic (hypersensitive) to linezolid or any of the other ingredients of this medicine.
• taking or have taken within the last 2 weeks any medicines known as monoamine oxidase inhibitors (MAOIs for example phenelzine, isocarboxazid, selegiline, moclobemide). These may be used to treat depression or Parkinson’s disease.
• you are breast-feeding. This is because it passes into breast milk and could affect the baby.
Linezolid may not be suitable for you if you answer yes to any of the following questions. In this case tell your doctor as he/she will need to check your general health and your blood pressure before and during your treatment or may decide that another treatment is better for you.
Ask your doctor if you are not sure whether these categories apply to you.
• Do you have high blood pressure, whether or not you are taking medicines for this?
• Have you been diagnosed with an overactive thyroid?
• Do you have a tumour of the adrenal glands (phaeochromocytoma) or carcinoid syndrome (caused by tumours of the hormone system with symptoms of diarrhoea, flushing of the skin, wheezing)?
• Do you suffer from manic depression, schizoaffective disorder, mental confusion or other mental problems?
• Are you taking any of the following medicines?
-decongestant, cold or flu remedies containing pseudoephedrine or phenylpropanolamine -medicines used to treat asthma such as salbutamol, terbutaline, fenoterol
-antidepressants known as tricyclics or SSRIs (selective serotonin reuptake inhibitors) for example amitriptyline, cipramil, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, sertraline
-medicines used to treat migraine such as sumatriptan and zolmitriptan
-medicines used to treat sudden, severe allergic reactions such as adrenaline (epinephrine)
-medicines which increase your blood pressure, such as noradrenaline (norepinephrine), dopamine and dobutamine
- used to treat moderate to severe pain, such as pethidine
- medicines used to treat anxiety disorders, such as buspirone
- an antibiotic called rifampicin
Take special care with Linezolid
Tell your doctor before you are treated with this medicine if you
• bruise and bleed easily
• are anaemic
• are prone to getting infections
• have a history of seizures
• have liver problems or kidney problems particularly if you have dialysis
• have diarrhoea
Tell your doctor immediately if during treatment you suffer from
• problems with your vision such as blurred vision, changes in colour vision, difficulty in seeing detail or if your field of vision becomes restricted.
• you may develop diarrhoea while taking or after taking antibiotics, including Linezolid. If this becomes severe or persistent or you notice that your stool contains blood or mucus, you should stop taking Linezolid immediately and consult your doctor. In this situation, you should not take medicines that stop or slow bowel movement.
• recurrent nausea or vomiting, abdominal pain or over breathing.
Taking other medicines
There is a risk that Linezolid may sometimes interact with certain other medicines to cause side effects such as changes in blood pressure, temperature or heart rate.
Tell your doctor if you are taking or have taken within the last 2 weeks the following medicines as Linezolid must not be taken if you are already taking these medicines or have taken them recently. (See also Section 2 above ‘Do not take Linezolid’).
• monoamine oxidase inhibitors (MAOIs for example phenelzine, isocarboxazid, selegiline, moclobemide). These may be used to treat depression or Parkinson’s disease
Also tell your doctor if you are taking the following medicines. Your doctor may still decide to give you Linezolid, but will need to check your general health and your blood pressure before and during your treatment. In other cases, your doctor may decide that another treatment is better for you.
• Decongestant cold or flu remedies containing pseudoephedrine or phenylpropanolamine.
• Some medicines used to treat asthma such as salbutamol, terbutaline, fenoterol.
• Certain antidepressants known as tricyclics or SSRIs (selective serotonin reuptake inhibitors). There are many of these, including amitriptyline, cipramil, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, sertraline.
• Medicines used to treat migraine such as sumatriptan and zolmitriptan.
• Medicines used to treat sudden, severe allergic reactions such as adrenaline (epinephrine).
• Medicines which increase your blood pressure, such as noradrenaline (norepinephrine), dopamine and dobutamine.
• Medicines used to treat moderate to severe pain, such as pethidine.
• Medicines used to treat anxiety disorders, such as buspirone.
• Medicines that stop blood clotting, such as warfarin.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Linezolid with food and drink
• You can take Linezolid either before, during or after a meal.
• Avoid eating large amounts of mature cheese, yeast extracts, or soya bean extracts e.g. soy sauce and drinking alcohol, especially draught beers and wine. This is because this medicine may react with a substance called tyramine which is naturally present in some foods to cause an increase in your blood pressure.
• If you develop a throbbing headache after eating or drinking, tell your doctor or pharmacist immediately. Pregnancy and breast-feeding
The effect of Linezolid in pregnant women is not known. Therefore it should not be taken in pregnancy unless advised by your doctor. Tell your doctor if you are pregnant, think you may be pregnant or are trying to become pregnant.
You should not breast-feed when taking Linezolid because it passes into breast milk and could affect the baby.
Driving and using machines
Linezolid may make you feel dizzy or experience problems with your vision. If this happens, do not drive or operate any machinery. Remember that if you are unwell your ability to drive or operate machinery may be affected.
Important information about some of the ingredients in Linezolid Glucose
Each 1 ml of Linezolid solution contains 45.7 mg glucose (13.7 g glucose in one bag).
Please tell your doctor or nurse if you are diabetic.
Sodium
Each 1 ml of Linezolid solution contains 0.38 mg sodium (114 mg sodium in one bag).
Please tell your doctor or nurse if you are on a low sodium diet.
3. How Linezolid is given Adults
This medicine will be given to you through a drip (by infusion into a vein) by a doctor or healthcare professional. The usual dose for adults (18 years and older) is 300 ml (600 mg linezolid) twice daily which is given directly into the blood stream (intravenously) by a drip over a period of 30 to 120 minutes.
If you are on kidney dialysis, you should be given Linezolid after dialysis.
A course of treatment usually lasts 10 to 14 days, but can last up to 28 days. The safety and effectiveness of this medicine have not been established for treatment periods longer than 28 days. Your doctor will decide how long you should be treated.
While you are taking Linezolid, your doctor should perform regular blood tests to monitor your blood count. Your doctor should monitor your eyesight if you take Linezolid for more than 28 days.
Children
Linezolid is not normally used to treat children and adolescents (under 18 years old).
If you receive more Linezolid than you should
If you are concerned that you may have been given too much Linezolid, tell your doctor or a nurse at once.
If you miss a dose of Linezolid
As you will be given this medicine under close supervision, it is very unlikely that you will miss a dose. If you think that you have missed a dose of treatment, tell a doctor or nurse at once.
4. Possible side effects
Like all medicines Linezolid can cause side effects although not everybody gets them.
Tell your doctor, nurse or pharmacist immediately if you notice any of these side effects during your treatment with Linezolid:
• skin reactions such as red sore skin and flaking (dermatitis), rash, itching, or swelling, particularly around the face and neck. This may be the sign of an allergic reaction and it may be necessary for you to stop taking Linezolid.
• problems with your vision such as blurred vision, changes in colour vision, difficulty in seeing detail or if your field of vision becomes restricted.
• severe diarrhoea containing blood and/or mucus (antibiotic associated colitis including pseudomembranous colitis), which in very rare circumstances may develop into complications that are life-threatening.
• recurrent nausea or vomiting, abdominal pain or over breathing.
• fits or seizures have been reported with Linezolid. You should let your doctor know if you experience agitation, confusion, delirium, rigidity, tremor, incoordination and seizure while also taking antidepressants known as SSRI’s (see section 2).
Numbness, tingling or blurred vision have been reported by patients who have been given Linezolid for more than 28 days. If you experience difficulties with your vision you should consult your doctor as soon as possible.
Other side effects include:
Common side effects (likely to occur in less than 1 in 10 people):
• Fungal infections especially vaginal or oral “thrush”
• Headache
• Metallic taste in the mouth
• Diarrhoea, nausea or vomiting
• Changes in some blood test results including those measuring your kidney or liver function or blood sugar levels
• Unexplained bleeding or bruising, which may be due to changes in the numbers of certain cells in the blood which may affect blood clotting or lead to anaemia
Uncommon side effects (likely to occur in less than 1 in 100 people):
• Inflammation of the vagina or genital area in women
• Changes in numbers of certain cells in the blood which may affect your ability to fight infection
• Difficulty in sleeping
• Dizziness, sensations such as tingling or feeling numb
• Blurred vision
• “Ringing” in the ears (tinnitus)
• Increased blood pressure, inflammation of the veins
• Indigestion, stomach pain, constipation
• Dry or sore mouth, swollen, sore, or discoloured tongue
• Skin rash
• Pain at and around the place where the infusion (drip) was given
• Inflammation of the veins (including where the infusion (drip) was given)
• A need to urinate more often
• Fever or chills, aches and pains
• Feeling tired or thirsty
• Inflammation of the pancreas
• Increased sweating
• Changes in proteins, salts or enzymes in the blood which measure kidney or liver function
• Reduction in the numbers of cells in the blood which fight against infection
Rare side effects (likely to occur in less than 1 in 1000 people):
• Changes in heart rate (e.g. increase rate)
• Transient ischaemic attacks (temporary disturbance of blood flow to the brain causing short term symptoms such as loss of vision, leg and arm weakness, slurring of speech and loss of consciousness)
• Kidney failure
The following side effects have also been reported (frequency not known):
• Serotonin syndrome (symptoms include fast heart rate, confusion, abnormal sweating, hallucinations, involuntary movements chills and shivering)
• Lactic acidosis (symptoms include recurrent nausea and vomiting, abdominal pain, over breathing)
• Severe skin disorders
• Convulsions
• Superficial tooth discolouration, removable with professional dental cleaning (manual descaling)
• Alopecia (hair loss)
• Hyponatraemia (low blood sodium levels)
• Changes in colour vision, difficulty in seeing detail or if your field of vision becomes restricted
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Linezolid
Hospital Staff will make sure that Linezolid Solution is not used after the “Use by” date printed on the bag and that it is given to you as soon as the seal is broken. They will also visually inspect the solution prior to use and only clear solution, without particles will be used. They will also make sure that the solution is kept correctly in its box and foil wrapping in order to protect from light and out of the reach and sight of children until it is needed.
6. Further information
What Linezolid solution for infusion contains
-The active substance is linezolid. Each 1ml of solution contains 2 mg linezolid.
-The other ingredients are glucose monohydrate (a type of sugar), sodium citrate (E331), citric acid anhydrous (E330), hydrochloric acid (E507) or sodium hydroxide (E524) and water for injections.
What Linezolid looks like and contents of the pack
Linezolid is presented as a clear solution in single infusion bags containing 300 ml (600mg linezolid) of solution.
The bags are supplied in boxes of 1, 2, 5, 10, 20 or 25 bags.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is Pharmacia Limited, Sandwich, Kent, CT13 9NJ, UK and the manufacturer is Fresenius Kabi Norge AS, Svinesundveien 80, N-1789 Berg I Ostfold, Halden, Norway.
Company contact address: Medical Information Department, Pfizer Limited, Walton Oaks, Dorking Road, Tadworth, Surrey KT20 7NS. Telephone: 01304 616 161.
This leaflet was last revised in 07/2013.
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The following information is intended for healthcare professionals only:
PHYSICIAN LEAFLET INFORMATION FOR DOCTORS AND PHARMACISTS
Linezolid 2mg/ ml solution for infusion Linezolid
For further information, consult the Summary of Product Characteristics (SPC).
Dosage and Method of Administration
Linezolid should only be initiated in a hospital environment and after consultation with a relevant specialist such as a microbiologist or an infectious diseases specialist.
Patients who commence treatment on the parenteral formulation may be switched to either oral presentation when clinically indicated. In such circumstances, no dose adjustment is required as linezolid has an oral bioavailability of approximately 100 %.
The solution for infusion should be administered over a period of 30 to 120 minutes.
The recommended linezolid dosage should be administered IV or orally twice daily.
Recommended dosage and duration for adults:
The duration of treatment is dependent on the pathogen, the site of infection and its severity, and on the patient’s clinical response.
The following recommendations for duration of therapy reflect those used in the clinical trials. Shorter treatment regimens may be suitable for some types of infection but have not been evaluated in clinical trials.
The maximum treatment duration is 28 days. The safety and effectiveness of linezolid have not yet been established for treatment periods longer than 28 days.
No increase in the recommended dosage or duration of treatment is required for infections associated with concurrent bacteraemia. The dose recommendation for the solution for infusion and the tablets/granules for oral suspension are identical and are as follows:
|
Infections |
Dosage and route for twice daily administration |
Duration of treatment |
|
Nosocomial pneumonia |
600 mg twice daily |
10-14 Consecutive Days |
|
Community acquired pneumonia | ||
|
Complicated skin and soft tissue infections |
600 mg twice daily |
Children: There are insufficient data on the pharmacokinetics, safety and efficacy of linezolid in children and adolescents (< 18 years old) to establish dosage recommendations. Therefore, until further data are available, use of linezolid in this age group is not recommended.
Elderly patients: No dose adjustment is required.
Patients with renal insufficiency: No dose adjustment is required.
Patients with hepatic insufficiency: Patients with mild to moderate hepatic insufficiency (Child-Pugh class A or B): No dose adjustment is required.
Instructions for Use and Handling
For single use only. Remove overwrap only when ready to use, then check for minute leaks by squeezing the bag firmly. If the bag leaks, do not use as sterility may be impaired. The solution should be visually inspected prior to use and only clear solutions, without particles should be used. Do not use these bags in series connections. Any unused solution must be discarded. Do not reconnect partially used bags.
LINEZOLID Solution for Infusion is compatible with the following solutions: 5 % glucose intravenous infusion, 0.9 % sodium chloride intravenous infusion, Ringer-lactate solution for injection (Hartmann’s solution for injection).
Incompatibilities
Additives should not be introduced into this solution. If linezolid is to be given concomitantly with other drugs, each drug should be given separately in accordance with its own directions for use. Similarly, if the same intravenous line is to be used for sequential infusion of several drugs, the line should be flushed prior to and following linezolid administration with a compatible infusion solution.
LINEZOLID Solution for Infusion is known to be physically incompatible with the following compounds: amphotericin B, chlorpromazine hydrochloride, diazepam, pentamidine isethionate, erythromycin lactobionate, phenytoin sodium and sulphamethoxazole / trimethoprim. Additionally, it is chemically incompatible with ceftriaxone sodium.
Shelf Life
After opening: From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
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