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CO-FLUAMPICIL 250MG/250MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance(s): AMPICILLIN / FLUCLOXACILLIN / AMPICILLIN / FLUCLOXACILLIN / AMPICILLIN / FLUCLOXACILLIN

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If any of the above statements apply to you, you should not be given
Magnapen Injection.

1 NAME OF THE MEDICINAL PRODUCT
Magnapen® 250mg/250mg Powder for Solution for Injection or Infusion or
Co-fluampicil 250mg/250mg Powder for Solution for Injection or Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Co-fluampicil 500mg Vials contain 250mg ampicillin as ampicillin sodium with
250mg flucloxacillin as flucloxacillin sodium (co-fluampicil 250/250).
3 PHARMACEUTICAL FORM
Powder for Solution for Injection or Infusion
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Co-fluampicil is indicated for the treatment of severe infections where
the causative organism is unknown, and for mixed infections involving
ß-lactamase-producing staphylococci. Typical indications include:
In general practice: Chest infections, ENT infections, skin and soft tissue
infections, and infections in patients whose underlying pathology places them
at special risk.
In hospital (prior to laboratory results being available): severe respiratory
tract infections, post-operative chest and wound infections, septic abortion,
puerperal fever; septicaemia, prophylaxis in major surgery, infections in patients
receiving immuno-suppressive therapy.
The spectrum of activity of co-fluampicil also makes it suitable for the treatment
of many mixed infections, particularly those where ß-lactamase-producing
staphylococci are suspected or confirmed.
Parenteral usage is indicated where oral dosage is inappropriate.
4.2 Posology and method of administration
Usual adult dosage (including elderly patients and children over ten years):
Intramuscular/Intravenous: 500mg four times a day.
Usual children’s dosage:
Intramuscular/Intravenous: Under 2 years: quarter adult dose, four times a day.
2-10 years: half adult dose, four times a day.
The above dosages for adults and children may be doubled where necessary.
Therapy may be continued for as long as it is indicated by the nature of infection.
Administration:
Intramuscular: Add 1.5ml Water for Injections to vial contents.
Intravenous: Dissolve 500mg in 10ml Water for Injections.
Administer by slow intravenous injection.
Co-fluampicil Injection may be added to infusion fluids or injected, suitably
diluted into the drip tube over a period of 3-4 minutes.
4.3 Contra-indications
Co-fluampicil contains ampicillin and flucloxacillin which are penicillins, and
should not be given to patients with a history of hypersensitivity to ß-lactam
antibiotics (e.g. penicillins, cephalosporins).
Co-fluampicil is contraindicated in patients with a history of flucloxacillinassociated jaundice/hepatic dysfunction.
Ocular administration.
4.4 Special warnings and precautions for use
Before initiating therapy with co-fluampicil careful enquiries should be made
concerning previous hypersensitivity reactions to ß-lactam antibiotics.
Serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have
been reported in patients receiving ß-lactam antibiotics. Although anaphylaxis
is more frequent following parenteral therapy, it has occurred in patients on
oral therapy. These reactions are more likely to occur in individuals with
hypersensitivity to ß-lactam antibiotics.
Co-fluampicil contains ampicillin and should be avoided if infectious
mononucleosis and/or acute or chronic leukaemia of lymphoid origin are
suspected. The occurrence of a skin rash has been associated with these
conditions following the administration of ampicillin.
In case of severe and persistent diarrhoea, the possibility of
pseudomembranous colitis should be considered; flucloxacillin therapy should
be discontinued.
Care is required when treating some patients with spirochaete infections such
as syphilis or leptospirosis because the Jarisch-Herxheimer reaction may occur
shortly after treatment with a penicillin is started.
Co-fluampicil should be used with caution in patients with evidence of hepatic
dysfunction (see Section 4.8).
Special caution is essential in the newborn because of the risk of
hyperbilirubinemia. Studies have shown that, at high dose following parenteral
administration, flucloxacillin can displace bilirubin from plasma protein

Important information about the sodium content of Magnapen Injection
This medicinal product contains 29.9mg (1.3mmol) of sodium per dose.
To be taken into consideration by patients on a controlled sodium diet.
3. HOW MAGNAPEN INJECTION SHOULD BE GIVEN
Your medicine will be made up before use and given to you by injection
into the muscle (intramuscular) or injection into a vein (intravenous) or via
a drip (infusion).
The dose of Magnapen Injection your doctor prescribes and the length of
time for which you will be given it, will depend on your infection.
The usual dose for treating infection is:
The elderly, adults and children over 10 years
Intramuscular- 500mg four times a day
Intravenous- 500mg four times a day

binding sites, and may therefore predispose to kernicterus in a jaundiced baby.
In addition, special caution is essential in the newborn because of the potential
for high serum levels of flucloxacillin due to a reduced rate of renal excretion.
Care is necessary if very high doses of flucloxacillin are given, especially if renal
function is poor, because of the risk of nephrotoxicity and/or neurotoxicity. The
intrathecal route should be avoided. Care is also necessary if large doses of
sodium (salts) are given to patients with impaired renal function or heart failure.
Flucloxacillin should be used with caution in patients with evidence of hepatic
dysfunction (see section 4.8). Renal, hepatic and haematological status should
be monitored during prolonged and high-dose therapy (e.g. osteomyelitis,
endocarditis). Prolonged use may occasionally result in overgrowth of
non-susceptible organisms
Sodium content: Co-fluampicil 500mg vials contains 29.9mg (1.3 mmol)
sodium per vial. This should be included in the daily allowance of patients on
sodium restricted diets.
4.5 Interaction with other medicinal products and other forms of interaction
Other antibacterials: There may be antagonism between penicillins, including
ampicillin and bacteriostatic agents such as chloramphenicol, erythromycins or
tetracyclines. This may reduce the effectiveness of penicillins particularly in the
treatment of infections such as pneumococcal meningitis and scarlet fever.
Cytotoxics: Penicillins reduce the excretion of methotrexate (increased risk of
toxicity).
In common with other oral broad-spectrum antibiotics, co-fluampicil may reduce
the efficacy of oral contraceptives and patients should be warned accordingly.
Probenecid decreases the renal tubular secretion of co-fluampicil. Concurrent
use with co-fluampicil may result in increased and prolonged blood levels of
both ampicillin and flucloxacillin.
Concurrent administration of allopurinol during treatment with ampicillin can
increase the likelihood of allergic skin reactions.
Interference with diagnostic tests: Penicillins may produce false-positive results
with the direct antiglobulin (Coombs’) test, falsely high urinary glucose results
with the copper sulphate test and falsely high urinary protein results, but glucose
enzymatic tests (e.g. Clinistix) and bromophenol blue tests (e.g. Multistix or
Albustix) are not affected
4.6 Fertility, pregnancy and lactation
Pregnancy: Animal studies with co-fluampicil have shown no teratogenic effects.
The product has been in clinical use since 1971 and the limited number of
reported cases of use in human pregnancy have shown no evidence of untoward
effects. The decision to administer any drug during pregnancy should be taken
with the utmost care. Therefore co-fluampicil should only be used in pregnancy
when the potential benefits outweigh the potential risks associated with treatment.
Lactation: Trace quantities of ampicillin and flucloxacillin can be detected in
breast milk. The possibility of hypersensitivity reactions must be considered
in breast-fed infants. Therefore co-fluampicil should only be administered to a
breast-feeding mother when the potential benefit outweigh the potential risks
associated with treatment.
4.7 Effects on ability to drive and use machines
Adverse effects on the ability to drive or operate machinery have not been
observed.
4.8 Undesirable effects
Blood and lymphatic system disorders:
As with other ß-lactam antibiotics haematological effects including reversible
leucopenia, reversible thrombocytopenia and haemolytic anaemia have been
reported rarely.
Immune System Disorders:
Anaphylaxis (see Item 4.4-warnings) has been reported rarely.
If any hypersensitivity reaction occurs, the treatment should be discontinued.
Late sensitivity reactions may include serum sickness-like reactions
(featuring symptoms such as arthralgia, rash, urticaria, fever, angioedema,
lymphadenopathy), haemolytic anaemia and acute interstitial nephritis.
Metabolism and nutrition disorders:
Electrolyte disturbances, such as hypokalaemia, due to administration of large
amounts of sodium
Psychiatric disorders:
There is a potential for hallucinations to occur rarely with flucloxacillin.
Nervous System Disorders
Convulsions may be associated with IV administration of high doses to patients
with underlying renal failure.
Coma may develop with high doses of Flucloxacillin.

Process Black

Colours Used

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Pharma
Code

Artwork No.

610826

17/11/2015

English
Language

Date

UK
Market

3

8.5pt (main body) / 9pt (variables)
Min. Point Size

Proof No.

190 x 470mm
Size

matt.pirie-scott

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Proof By

IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.

Magnapen Injection should not be given if you:
• know that you are allergic to penicillin, cephalosporins, any other
antibiotic or any of the ingredients contained in Magnapen Injection
(see ‘What Magnapen Injection contains’ in section 6)
• have ever had a skin rash or swelling of the face or neck when taking
an antibiotic
• have ever had a serious complaint, such as liver problems, when
taking an antibiotic.

Pregnancy and breast-feeding
You should let your doctor know if you are pregnant, think you might be
pregnant or are breast-feeding before being given this medicine. Your
doctor will decide if this medicine is suitable for you.

Warning! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our clientʼs brief,
the final responsibility must be taken by our client.

2. BEFORE YOU ARE GIVEN MAGNAPEN INJECTION

If you have any doubts about whether you should take this medicine then
discuss matters with your doctor before taking it.

Clearly mark any amendments on one proof and return to MPS

In hospital this medicine may also be used to prevent and treat infections:
• which occur after surgery
• in patients receiving treatment which affects the immune system
• of the blood (septicaemia)
• associated with difficulties in childbirth (septic abortion (abortion
complicated by fever, often leading to sepsis) and puerperal fever
(an infection of the membrane of the uterus following childbirth or
abortion)).

Profile

Magnapen Injection is used to treat a wide range of infections caused by
bacteria. These infections may affect the chest, ear, nose, throat, skin and
soft tissues.

If you are required to have a urine test, please inform your doctor you are
taking Magnapen. False positive results can occur with certain tests for
sugar in the urine (e.g. the Fehling’s test), tests that look for antibodies,
(e.g Coomb’s test) or test for protein in the urine (e.g. Copper Sulphate
test) whilst taking Magnapen.

artwork.leicester@multipkg.com

Magnapen Injection contains two active ingredients, ampicillin and
flucloxacillin which together are known as co-fluampicil. Magnapen
Injection is an antibiotic medicine. It belongs to the penicillin group
of antibiotics and works by killing bacteria that cause infections.

Tell your doctor if you are using the following medicines (or any other
medicines):
• a contraceptive pill as you will need to take extra precautions such as
use of a condom
• probenecid and allopurinol, used in the treatment of gout
• or if you are being treated with any other antibiotic (e.g. penicillinsincluding ampicillin, or bacteriostatic agents like chloramphenicol,
erythromycins or tetracyclines)
• methotrexate, used to treat cancer, autoimmune diseases.

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1. WHAT MAGNAPEN INJECTION IS AND WHAT IT IS USED FOR

Taking other medicines
Taking another medicine while you are receiving treatment with Magnapen
Injection can affect how it or the other medicine works. Please inform your
doctor or pharmacist if you are taking or have recently taken any other
medicines, even those you may have bought yourself without a prescription.

Item Code

In this leaflet:
1. What Magnapen Injection is and what it is used for
2. Before you are given Magnapen Injection
3. How Magnapen Injection should be given
4. Possible side effects
5. How to store Magnapen Injection
6. Further information

If any of the above apply your doctor may decide to change the dose of
Magnapen Injection or prescribe a different medicine.
Co-fluampicil (Magnapen) injection leaflet

The name of your medicine is Magnapen 250mg/250mg Powder for
Solution for Injection or Infusion. In the rest of this leaflet it is called
Magnapen Injection.

Additional monitoring of kidney and liver function is recommended for
patients on prolonged treatment e.g. osteomyelitis (bone infection) or
endocarditis (infection of the muscle around the heart).

Description

- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or nurse.
- This medicine has been prescribed for you personally and you should
not pass it on to others. It may harm them, even if their symptoms are
the same as yours

Wockhardt UK Limited

Read all of this leaflet carefully before you start using this medicine.

Customer

Magnapen 250mg/250mg Powder for Solution
for Injection or Infusion
(Ampicillin and Flucloxacillin)

Speak to your doctor before being given Magnapen Injection if you:
• are being treated for kidney or liver problems
• have glandular fever
• are having blood tests because your medicine sometimes causes
short-term changes in your blood cell counts.
• have syphilis or leptospirosis

Measure bar should be 150mm at 100% scale

PACKAGE LEAFLET INFORMATION FOR THE USER

Children under two years receive quarter of the adult dose.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme www.mhra.gov.uk/
yellowcard

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Please be ready to give the following information:
Product Name

Reference

Magnapen 250mg/250mg powder
for solution for injection or infusion

PL 29831/0054

This is a service provided by the Royal National Institute of Blind People

If you have Syphilis:
Patients who have syphilis have occasionally suffered from a type of
reaction (Jarisch-Herxheimer reaction) shortly after treatment, with fever,
chills, headache and reactions at the site of lesions.

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Respiratory, thoracic and mediastinal disorders:
Bronchospasm may occur as a result of penicillin allergy.
There is a potential for acute, severe dyspnoea to occur with flucloxacillin.

The following drugs are incompatible with Magnapen® 250mg/250mg Powder
for Solution for Injection or Infusion or Co-fluampicil 250mg/250mg Powder for
Solution for Injection or Infusion:

Gastrointestinal disorders:
Minor gastrointestinal disturbances, including occasionally nausea, vomiting
and diarrhoea may occur during treatment. Pseudomembranous colitis has
been reported rarely.

Amikacin sulphate
Amiodarone
Amphotericin B cholesteryl sulphate complex
Atropine Sulphate
Buprenorphine
Calcium gluconate
Chlorpromazine hydrochloride
Ciprofloxacin
Clarithromycin
Diazepam
Dobutamine Hydrochloride
Dopamine hydrochloride
Erythromycin lactobionate
Gentamicin sulphate
Heparin sodium
Hydralazine hydrochloride
Hydrocortisone sodium succinate
Kanamycin sulphate
Lincomycin hydrochloride
Morphine Sulphate
Metoclopramide hydrochloride
Netilmicin Sulphate
Ofloxacin
Papaveretum
Pethidine Hydrochloride
Polymyxin B sulphate
Prochlorperazine edisylate
Prochlorperazine mesylate
Promethazine Hydrochloride
Sodium bicarbonate
Tobramycin
Verapamil Hydrochloride

Hepatobiliary disorders:
Hepatitis and cholestatic jaundice have been reported rarely. These may be
delayed for up to two months after withdrawal of treatment. In some cases the
course of these conditions has been protracted and lasted for several months.
Very rarely deaths have been reported from hepatic effects but are mostly
limited to patients with serious underlying disease.
As with most other antibiotics, a moderate transient increase in transaminases
has been reported.
Skin and subcutaneous tissue disorders:
Skin rash, puritis and urticaria have been reported. The incidence of rash is
higher in patients suffering from infectious mononucleosis and acute or chronic
leukaemia of lymphoid origin. Purpura, fever, eosinophilia and sometimes
angioneurotic oedema have also been reported. Rarely, skin reactions such
as erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal
necrolysis have been reported. Reactions such as fever, arthralgia, and myalgia
can develop more than 48 hours after the start of the treatment.
Erythema nodosum may occur rarely with flucloxacillin.
Potential for pemphigoid reactions to occur rarely with flucloxacillin.
There is potential for non-thrombocytopenic purpura to occur rarely with
flucloxacillin.
Vasculitis may occur rarely with flucloxacillin.
Renal and urinary disorders:
Interstitial nephritis may occur.
Congenital, familial and genetic disorders:
Potential for acute attacks of porphyria to occur with flucloxacillin.
General disorders and administration site conditions:
Some patients with spirochaete infections such as syphilis or leptospirosis may
experience a Jarisch-Herxheimer reaction shortly after treatment with a penicillin
is started. Symptoms include fever, chills, headache and reaction at the site of
lesions. The reaction can be dangerous in cardiovascular syphilis or where there
is a serious risk of increased local damage such as with optic atrophy
4.9 Overdose
Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident
and should be treated symptomatically.
Co-fluampicil contains flucloxacillin. Haemodialysis does not lower the serum
levels of flucloxacillin.
Co-fluampicil contains ampicillin, which may be removed from the circulation
by haemodialysis.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Co-fluampicil is indicated for the treatment of severe infections where
the causative organism is unknown, and for mixed infections involving
ß-lactamase-producing staphylococci.
5.2 Pharmacokinetic properties
Co-fluampicil is excreted via the kidneys with a plasma half life of approximately
one hour.
5.3 Preclinical safety data
Not relevant
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
None
6.2 Incompatibilities
Co-fluampicil should not be mixed with blood products or other proteinaceous
fluids (e.g. protein hydrolysates) or with intravenous lipid emulsions.
If co-fluampicil is prescribed concurrently with an aminoglycoside, the
antibiotics should not be mixed in the syringe, intravenous fluid container or
giving set because of loss of activity of the aminoglycoside can occur under
these conditions.

This leaflet was last revised 10/2015

6.3 Shelf life
Three years.
See also Section 6.6.
6.4 Special precautions for storage
Co-fluampicil Vials for Injection should be stored in a dry place at, or below 25°C.
6.5 Nature and contents of container
5 or 10 ml glass vials fitted with butyl rubber disc and an aluminium seal.
Boxes of 10 vials with instructions for use.
6.6 Special precautions for disposal
Co-fluampicil solutions for injection should be used immediately. Co-fluampicil
may be added to most intravenous fluids (e.g. Water for Injections, sodium
chloride 0.9%, glucose 5%, sodium chloride 0.18% with glucose 4%).
In intravenous solutions containing glucose or other carbohydrates, co-fluampicil
should be infused within two hours of preparation. Intravenous solutions of
co-fluampicil in Water for Injections or sodium chloride 0.9% should be infused
within 24 hours of preparation. Full particulars are given in the package enclosure
leaflet. Preparation of co-fluampicil infusion solutions must be carried out under
appropriate aseptic conditions if these extended storage periods are required.
7 MARKETING AUTHORISATION HOLDER
Wockhardt UK Ltd
Ash Road North
Wrexham
LL13 9UF
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 29831/0054
7. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
08 May 2000 / 18 June 2007
10 DATE OF REVISION OF THE TEXT
10/2015

107018/3

Pharma
Code

Artwork No.

610826

17/11/2015

English
Language

Date

UK
Market

3

8.5pt (main body) / 9pt (variables)
Min. Point Size

Proof No.

190 x 470mm
Size

matt.pirie-scott

n-a

Proof By

IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.

Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio
please call, free of charge:
0800 198 5000 (UK Only)

Warning! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our clientʼs brief,
the final responsibility must be taken by our client.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Wockhardt Ltd, Ash Road North,
Wrexham, LL 13 9UF, UK.
Manufacturer: CP Pharmaceuticals Ltd, Ash Road North, Wrexham,
LL 13 9UF, UK.

Profile

Contents of the pack
The vials are available in packs of 10.

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The vials for injection contain no other ingredients.

Item Code

What Magnapen Injection contains
Magnapen Injection contains two active ingredients, ampicillin and
flucloxacillin which together are known as co-fluampicil.
Magnapen vials each contain 250 mg ampicillin as ampicillin sodium
and 250 mg of flucloxacillin as flucloxacillin sodium (co-fluampicil
250mg/250mg).

Clearly mark any amendments on one proof and return to MPS

Other side effects
• coma (if you are on very high doses)
• difficulty breathing

6. FURTHER INFORMATION

artwork.leicester@multipkg.com

Frequent side effects which are usually mild include:
• nausea (feeling sick)
• vomiting (being sick)
• diarrhoea.

Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.

Co-fluampicil (Magnapen) injection leaflet

Treatment with Magnapen Injection should be stopped and medical
attention sought immediately if you:
• get severe diarrhoea with bleeding or stomach pain
• notice your urine becoming darker or your faeces becoming paler
• notice your skin or whites of your eyes turning yellow
• notice red or purple discolourations on the skin
• notice that your face is swollen and you have breathing problems
• start to itch or get a rash
• notice blistering of the skin, mouth, eyes or genitals
• notice increased bleeding/bruising, pale skin or weakness (due to
changes in the levels of certain blood cells)
• develop nephritis (inflammation ofthe kidneys that can cause swollen
ankles or high blood pressure)
• develop a fever
• have porphyria (rare hereditary disease where the blood pigment
haemoglobin is abnormally metabolised) as there is a potential of
acute attacks
• notice red lumps on both lower legs
• develop pain in your joints
• notice your lymph nodes become enlarged
• notice that you are tired and have shortness of breath
• have blood in your urine
• develop muscle weakness and fatigue
• start to hallucinate

5. HOW TO STORE MAGNAPEN INJECTION
Keep out of the sight and reach of children.
Do not take the medicine after the expiry date printed on the label.
The expiry date refers to the last day of that month.
Do not store above 25°C. Store in a dry place.

Description

4. POSSIBLE SIDE EFFECTS
Like many medicines Magnapen Injection may cause side effects in
some patients, particularly when treatment is first started, although not
everybody gets them.

By reporting side effects you can help provide more information on the
safety of this medicine.

Wockhardt UK Limited

If you think you have missed a dose of Magnapen Injection
If you think you have missed a dose of Magnapen Injection, speak to your
doctor or nurse.

Customer

If you think you have received too much Magnapen lnjection
If you think you have received too much Magnapen Injection contact your
doctor or nurse immediately. Symptoms of an overdose include feeling
sick, being sick and diarrhoea.

Measure bar should be 150mm at 100% scale

If the infection is severe, your doctor may double these doses.

Keyline (does not print)

Some of these reactions can be delayed for several weeks after finishing
the treatment.
Process Black

Children
Children two to 10 years receive half the adult dose.

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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.

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