LINEZOLID 2 MG/ML SOLUTION FOR INFUSION

Active substance: LINEZOLID

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER
Linezolid 2mg/ml Solution for Infusion

Read all of this leaflet carefully before you start receiving this medicine because it
contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, nurse or pharmacist.
If you get any side effects talk to your doctor, nurse or pharmacist. This includes any
possible side effects not listed in this leaflet.
In this leaflet:
1.
What Linezolid is and what it is used for
2.
What you need to know before you are given Linezolid
3.
How Linezolid is given
4.
Possible side effects
5.
How to store Linezolid
6.
Contents of the pack and other 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 NEED TO KNOW BEFORE YOU ARE GIVEN LINEZOLID

You should NOT be given Linezolid if you are:

allergic to linezolid or any of the other ingredients of this medicine (listed in section 6)

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.

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 any of the following 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, sertaline
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
an antibiotic called rifampicin
medicines used to treat similar medical conditions which can cause monoamine
oxidase inhibition. Please check with your doctor.

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 are having 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
• recurrent nausea or vomiting, abdominal pain or over breathing.
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.
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 “You should not be given Linezolid”):


medicines which can cause monoamine oxidase inhibition (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.

Ask your doctor or pharmacist for advice before taking any medicine.
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 of Linezolid
Glucose
Each 1 ml of Linezolid solution for infusion contains 45.7 mg glucose (13.710 g glucose in
one bag). This should be taken into account in patients with diabetes mellitus.
Sodium
Each 1 ml of Linezolid solution for infusion contains 0.38 mg sodium (0.0165 mmol) (114.0
mg sodium in one bag). To be taken into consideration by patients on a controlled sodium
diet.
Please tell your doctor if you are on a low sodium diet.

3.

HOW LINEZOLID IS GIVEN

Always use this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
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
nurse immediately.
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
immediately.
If you have any further questions on the use of this medicine, ask your doctor, nurse or
pharmacist.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine 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 (may affect up to 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 (may affect up to 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, itching

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 (may affect up to 1 in 1,000 people):

Changes in heart rate (e.g. increased 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):

Serious allergic reaction which causes difficulty in breathing or dizziness

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 including blistering of the skin, mouth, eyes and genitals (StevensJohnson syndrome)

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, nurse or pharmacist.

5.

HOW TO STORE LINEZOLID

Keep this medicine out of the sight and reach of children.
Hospital staff will make sure that Linezolid is not used after the expiry date which is stated on
the bag label after EXP. The expiry date refers to the last day of that month. 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 wrapping in order to
protect from light and out of the sight and reach of children until it is needed.
Storage conditions:
Before opening: Do not store above 30°C. Do not refrigerate or freeze. Store in the original
package (overpouch) until ready to use in order to protect from light.
After opening:
Chemical and physical in-use stability has been demonstrated for 4 hours at room
temperature. From a microbiological point of view, the product should be used immediately.
If not used immediately, in-use storage times and conditions prior to use are the responsibility
of the user.
For single use only. Discard any unused solution.
Medicines should not be disposed of via wastewater or household waste. Your doctor should
dispose of medicines that are no longer required. These measures will help to protect the
environment.

6.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Linezolid contains
-

The active substance is linezolid. 1 ml of solution for infusion contains 2 mg of
linezolid. 300 ml of solution for infusion contains 600 mg of linezolid.
The other ingredients are citric acid anhydrous (E330), sodium citrate dihydrate (E331),
glucose monohydrate (a type of sugar) and water for injections.

What Linezolid looks like and contents of the pack
Linezolid is presented as a clear, colourless solution, in a one or two port plastic infusion bag
fitted with a twist off connector plastic spike port. The infusion bag is contained in a plastic
overpouch.
Pack sizes: 300 ml bags (600 mg linezolid) in packs of 1, 10 or 30 bags.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva UK Limited
Manufacturer
Teva Pharmaceutical Works Private Limited Company
Táncsics Mihály út 82.
H-2100 Gödöllő,
Hungary

This leaflet was last revised in 07/2012.
PL 00289/1638
----------------------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only:
IMPORTANT: Refer to the Summary of Product Characteristics before prescribing
Linezolid is not active against infections caused by Gram negative pathogens. Specific
therapy against Gram negative organisms must be initiated concomitantly if a Gram negative
pathogen is documented or suspected.
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 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.
Recommended dosage and duration of treatment 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 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 is as follows:
Infections
Nosocomial pneumonia
Community acquired pneumonia
Complicated skin and soft tissue infections

Dosage
Duration of treatment
600 mg twice daily 10-14 Consecutive
days
600 mg twice daily 10-14 Consecutive
days
600 mg twice daily 10-14 Consecutive
days

Children: There are insufficient data on the 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 severe renal insufficiency (i.e. creatinine clearance (CLCR) ≤30 ml/min): No
dose adjustment is required. Due to the unknown clinical significance of higher exposure (up
to 10 fold) to the two primary metabolites of linezolid in patients with severe renal
insufficiency, linezolid should be used with special caution in these patients and only when
the anticipated benefit is considered to outweigh the theoretical risk.
As approximately 30% of a linezolid dose is removed during 3 hours of haemodialysis,
linezolid should be given after dialysis in patients receiving such treatment. The primary
metabolites of linezolid are removed to some extent by haemodialysis, but the concentrations
of these metabolites are still very considerably higher following dialysis than those observed
in patients with normal renal function or mild to moderate renal insufficiency. Therefore,
linezolid should be used with special caution in patients with severe renal insufficiency who
are undergoing dialysis and only when the anticipated benefit is considered to outweigh the
theoretical risk.
To date, there is no experience of linezolid administration to patients undergoing continuous
ambulatory peritoneal dialysis (CAPD) or alternative treatments for renal failure (other than
haemodialysis).
Patients with hepatic insufficiency: No dose adjustment is required. However, there are
limited clinical data and it is recommended that linezolid should be used in such patients only
when the anticipated benefit is considered to outweigh the theoretical risk
Method of administration: The recommended linezolid dosage should be administered
intravenously twice daily.

Overdose
No specific antidote is known.
No cases of overdose have been reported. However, the following information may prove
useful:
Supportive care is advised together with maintenance of glomerular filtration. Approximately
30% of a linezolid dose is removed during 3 hours of haemodialysis, but no data are available
for the removal of linezolid by peritoneal dialysis or haemoperfusion.
Instructions for use and handling
For single use only.
Remove overpouch 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:
Glucose 50 mg/ml (5%) solution for infusion,
Sodium chloride 9 mg/ml (0.9%) solution for 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 medicinal products, each medicinal product 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 medicinal products, 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
2 years
After opening:
Chemical and physical in-use stability has been demonstrated for 4 hours at room
temperature. From a microbiological point of view, the product should be used immediately.
If not used immediately, in-use storage times and conditions prior to use are the responsibility
of the user.

Special precautions for Storage
Do not store above 30°C. Do not refrigerate or freeze. Store in the original package
(overpouch) until ready to use in order to protect from light.
Disposal
Any unused solution must be disposed of in accordance with local requirements.

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
(web3)