Drugs List

Therapeutic Indications

Uses

Infections due to Gram-positive organisms incl. penicillin-resistant staph.
Mixed infections involving penicillinase-producing staphylococci

Treatment of severe bacterial infections where the cause is unknown and treatment of infections involving beat-lactamase producing Staphylococcus spp .

Typical indications include:
In primary care: Chest, ENT, skin and soft tissue infections in patients whose underlying pathology places them at risk.

In secondary care: Severe respiratory tract infections, post-operative chest and wound infections, septic abortion, puerperal fever, septicaemia, prophylaxis in major surgery and infections in patients receiving immuno-suppressive therapy.

Contraindications

History of hepatic impairment due to previous use of this drug
History of jaundice due to previous use of this drug

Precautions and Warnings

Allergic disposition
Cytomegalovirus infection
Infectious mononucleosis
Neonates
Breastfeeding
Hepatic impairment
Lymphatic leukaemia
Porphyria
Pregnancy
Severe renal impairment

Before initiating therapy enquire about previous hypersensitivity reactions
Monitor hepatic function on long term therapy
Monitor renal function during prolonged/high dose therapy
Erythematous rash common in glandular fever, CMV inf, lymphocytic leukaemia
Prolonged use may result in superinfection with non-susceptible organisms
May affect non-enzyme methods of urine glucose testing
Discontinue at once if pseudomembranous colitis occurs
Discontinue if hypersensitivity reactions occur

Jaundice and hepatitis have been reported up to 2 weeks after the discontinuation of flucloxacillin.
Administration of flucloxacillin for greater than two weeks and increasing age are risk factors.

The Faculty of Sexual and Reproductive Health has issued revised guidance concerning additional contraceptive cover when antibiotics are prescribed to patients taking combined oral contraceptives in January 2011. With the exception of the enzyme-inducing antibiotics rifampicin and rifabutin, it is no longer necessary to advise the patient to take additional contraceptive precautions while also taking an antibiotic.

Advise the patient that if vomiting occurs, she should follow the guidance for the oral contraceptive in respect of additional doses or contraceptive precautions.

Pregnancy and Lactation

Pregnancy

Use co-fluampicil with caution in pregnancy.

Schaefer (2007) recommends that penicillins are used in the usual doses during pregnancy and are the antibiotics of choice. Briggs (2011) concurs and cites reports indicating that penicillins are not teratogenic

At the time of writing there is no evidence to suggest that co-fluampicil has any adverse effects on a developing foetus. Co-fluampicil has been in clinical use since 1971 and no extra side effects have been reported when used by pregnant women. Additionally animal studies have shown no evidence of teratogenicity. Co-fluampicil is able to pass across the placenta.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use co-fluampicil with caution in breastfeeding.

Penicillins and cephalosporins are antibiotics of choice during breastfeeding (Schaefer, 2007). Briggs (2011) identifies three possible problems for the nursing infant, modification of bowel flora, allergic response or sensitisation and interference with culture results if the infant is febrile, but notes that adverse effects are rare. The amount of either antibiotic in breastmilk is low compared to maternal plasma levels.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Anaphylaxis
Angioedema
Arthralgia
Cholestatic jaundice
Convulsions
Diarrhoea
Eosinophilia
Erythema multiforme
Fever
Haemolytic anaemia
Hepatitis
Hypersensitivity reactions
Increases in serum transaminases (transient)
Interstitial nephritis
Leucopenia
Myalgia
Nausea
Pruritus
Pseudomembranous colitis
Purpura
Rash
Stevens-Johnson syndrome
Thrombocytopenia
Toxic epidermal necrolysis
Urticaria
Vomiting

Presentation

Solid oral formulations of ampicillin with flucloxacillin (as flucloxacillin sodium).

Drugs List

Therapeutic Indications

Uses

Infections due to Gram-positive organisms incl. penicillin-resistant staph.
Mixed infections involving penicillinase-producing staphylococci

Treatment of severe bacterial infections where the cause is unknown and treatment of infections involving beat-lactamase producing Staphylococcus spp .

Typical indications include:
In primary care: Chest, ENT, skin and soft tissue infections in patients whose underlying pathology places them at risk.

In secondary care: Severe respiratory tract infections, post-operative chest and wound infections, septic abortion, puerperal fever, septicaemia, prophylaxis in major surgery and infections in patients receiving immuno-suppressive therapy.

Dosage

Adults

Elderly

Children

Patients with Renal Impairment

Contraindications

History of hepatic impairment due to previous use of this drug
History of jaundice due to previous use of this drug

Precautions and Warnings

Allergic disposition
Cytomegalovirus infection
Infectious mononucleosis
Neonates
Breastfeeding
Hepatic impairment
Lymphatic leukaemia
Porphyria
Pregnancy
Severe renal impairment

Before initiating therapy enquire about previous hypersensitivity reactions
Monitor hepatic function on long term therapy
Monitor renal function during prolonged/high dose therapy
Erythematous rash common in glandular fever, CMV inf, lymphocytic leukaemia
Prolonged use may result in superinfection with non-susceptible organisms
May affect non-enzyme methods of urine glucose testing
Discontinue at once if pseudomembranous colitis occurs
Discontinue if hypersensitivity reactions occur

Jaundice and hepatitis have been reported up to 2 weeks after the discontinuation of flucloxacillin.
Administration of flucloxacillin for greater than two weeks and increasing age are risk factors.

The Faculty of Sexual and Reproductive Health has issued revised guidance concerning additional contraceptive cover when antibiotics are prescribed to patients taking combined oral contraceptives in January 2011. With the exception of the enzyme-inducing antibiotics rifampicin and rifabutin, it is no longer necessary to advise the patient to take additional contraceptive precautions while also taking an antibiotic.

Advise the patient that if vomiting occurs, she should follow the guidance for the oral contraceptive in respect of additional doses or contraceptive precautions.

Pregnancy and Lactation

Pregnancy

Use co-fluampicil with caution in pregnancy.

Schaefer (2007) recommends that penicillins are used in the usual doses during pregnancy and are the antibiotics of choice. Briggs (2011) concurs and cites reports indicating that penicillins are not teratogenic

At the time of writing there is no evidence to suggest that co-fluampicil has any adverse effects on a developing foetus. Co-fluampicil has been in clinical use since 1971 and no extra side effects have been reported when used by pregnant women. Additionally animal studies have shown no evidence of teratogenicity. Co-fluampicil is able to pass across the placenta.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use co-fluampicil with caution in breastfeeding.

Penicillins and cephalosporins are antibiotics of choice during breastfeeding (Schaefer, 2007). Briggs (2011) identifies three possible problems for the nursing infant, modification of bowel flora, allergic response or sensitisation and interference with culture results if the infant is febrile, but notes that adverse effects are rare. The amount of either antibiotic in breastmilk is low compared to maternal plasma levels.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Anaphylaxis
Angioedema
Arthralgia
Cholestatic jaundice
Convulsions
Diarrhoea
Eosinophilia
Erythema multiforme
Fever
Haemolytic anaemia
Hepatitis
Hypersensitivity reactions
Increases in serum transaminases (transient)
Interstitial nephritis
Leucopenia
Myalgia
Nausea
Pruritus
Pseudomembranous colitis
Purpura
Rash
Stevens-Johnson syndrome
Thrombocytopenia
Toxic epidermal necrolysis
Urticaria
Vomiting

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Shelf Life and Storage

Further Information

Last Full Review Date: October 2014

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press Accessed on 23 October, 2014.

Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications Accessed on 23 October, 2014.

Summary of Product Characteristics: Co-fluampicil 250mg/250mg hard capsules. Wockhardt UK Ltd. Revised October 2012.

The Renal Drug Handbook. 3rd edition. (2009) ed. Ashley, C and Currie, Radcliffe Publishing Ltd, Abingdon.

The Norwegian Porphyria Centre (NAPOS).
Available at: https://www.drugs-porphyria.com/languages/UnitedKingdom/s1.php?l=gbr
Flucloxacillin Last revised: 18 December, 2009
Last accessed: 23 October, 2014

Faculty of Sexual and Reproductive Healthcare
Available at: https://www.ffprhc.org.uk/pdfs/CEUGuidanceDrugInteractionsHormonal.pdf
Last revised: January 2012
Last accessed: 23 October 2014