Drugs List

Therapeutic Indications

Uses

Antibiotic sensitive infections

Treatment of the following infections due to susceptible Gram-positive and Gram-negative micro-organisms:
Respiratory tract infections, otitis media, skin and soft tissue infections, bone and joint infections and genito-urinary tract infections (including acute prostatitis and dental infections)

Unlicensed Uses

Prophylaxis of recurrent urinary tract infections

Prophylaxis against recurrent urinary tract infections.

Contraindications

None known

Precautions and Warnings

Breastfeeding
Galactosaemia
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
Lactose intolerance
Pregnancy
Severe renal impairment

Reduce dose in patients with severe renal impairment
Before initiating therapy enquire about previous hypersensitivity reactions
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain lactose
Some formulations contain sucrose
Monitor periodically for overgrowth of non-susceptible organisms
Consider pseudomembranous colitis if patient presents with diarrhoea
Prolonged use may result in superinfection with non-susceptible organisms
May cause false positive Coomb's test and glycosuria test
Discontinue at once if pseudomembranous colitis occurs
Discontinue if drug-related rash or other hypersensitivity reactions occur
Advise patient to avoid zinc products 3 hours before or after dose

Before therapy is initiated, it should be determined whether the patient has shown previous hypersensitivity to cephalosporins, penicillins, or other drugs. Cefalexin should be given cautiously to patients who have shown hypersensitivity to penicillins, as there is some evidence of partial cross-allergenicity between the penicillins and cephalosporins.

There is a possibility of development of pseudomembranous colitis and it is therefore important to consider its diagnosis in patients who develop diarrhoea whilst taking cefalexin. The condition may range in severity from mild to life threatening with mild cases usually responding to cessation of therapy. Appropriate measures should be taken in moderate to severe cases.

Pregnancy and Lactation

Pregnancy

Use cefalexin with caution in pregnancy.

Although laboratory and clinical studies have shown no evidence of teratogenicity, caution should be exercised when prescribing for pregnant women.

Cephalosporins can cross the placenta and can reach therapeutic levels in amniotic fluid and foetal tissues. Also the elimination of cephalosporins in pregnancy is faster and therefore may be necessary to adjust the dosage.

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 cefalexin with caution in breastfeeding.

Cefalexin can pass into breast milk after oral dosing. The amount available to the nursing infant is between 0.5 and 1% of the maternal weight adjusted dose which is significantly lower than the recommended infant dosing regimen.

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

Abdominal pain
Agitation
Agranulocytosis
Alterations in hepatic enzymes
Anal pruritus
Anaphylaxis
Angioedema
Antibiotic-associated colitis
Aplastic anaemia
Arthralgia
Arthritis
Cholestatic jaundice
Confusion
Diarrhoea
Dizziness
Dyspepsia
Eosinophilia
Erythema multiforme
Fatigue
Fever
Genital candidiasis
Genital pruritus
Haemolytic anaemia
Hallucinations
Headache
Hepatitis
Hyperactivity
Hypersensitivity reactions
Hypertonia
Increase in serum ALT/AST
Interstitial nephritis (reversible)
Joint disorder
Leucopenia
Nausea
Nervousness
Neutropenia
Overgrowth by non-susceptible organisms
Pruritus
Pseudomembranous colitis
Rash
Serum sickness-like reactions
Sleep disturbances
Stevens-Johnson syndrome
Thrombocytopenia
Toxic epidermal necrolysis
Urticaria
Vaginal discharge
Vaginitis
Vomiting

Presentation

Oral formulations of cefalexin (as cefalexin monohydrate)

Drugs List

Therapeutic Indications

Uses

Antibiotic sensitive infections

Treatment of the following infections due to susceptible Gram-positive and Gram-negative micro-organisms:
Respiratory tract infections, otitis media, skin and soft tissue infections, bone and joint infections and genito-urinary tract infections (including acute prostatitis and dental infections)

Unlicensed Uses

Prophylaxis of recurrent urinary tract infections

Prophylaxis against recurrent urinary tract infections.

Dosage

Adults

Children

Neonates

Patients with Renal Impairment

Additional Dosage Information

Contraindications

None known

Precautions and Warnings

Breastfeeding
Galactosaemia
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
Lactose intolerance
Pregnancy
Severe renal impairment

Reduce dose in patients with severe renal impairment
Before initiating therapy enquire about previous hypersensitivity reactions
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain lactose
Some formulations contain sucrose
Monitor periodically for overgrowth of non-susceptible organisms
Consider pseudomembranous colitis if patient presents with diarrhoea
Prolonged use may result in superinfection with non-susceptible organisms
May cause false positive Coomb's test and glycosuria test
Discontinue at once if pseudomembranous colitis occurs
Discontinue if drug-related rash or other hypersensitivity reactions occur
Advise patient to avoid zinc products 3 hours before or after dose

Before therapy is initiated, it should be determined whether the patient has shown previous hypersensitivity to cephalosporins, penicillins, or other drugs. Cefalexin should be given cautiously to patients who have shown hypersensitivity to penicillins, as there is some evidence of partial cross-allergenicity between the penicillins and cephalosporins.

There is a possibility of development of pseudomembranous colitis and it is therefore important to consider its diagnosis in patients who develop diarrhoea whilst taking cefalexin. The condition may range in severity from mild to life threatening with mild cases usually responding to cessation of therapy. Appropriate measures should be taken in moderate to severe cases.

Pregnancy and Lactation

Pregnancy

Use cefalexin with caution in pregnancy.

Although laboratory and clinical studies have shown no evidence of teratogenicity, caution should be exercised when prescribing for pregnant women.

Cephalosporins can cross the placenta and can reach therapeutic levels in amniotic fluid and foetal tissues. Also the elimination of cephalosporins in pregnancy is faster and therefore may be necessary to adjust the dosage.

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 cefalexin with caution in breastfeeding.

Cefalexin can pass into breast milk after oral dosing. The amount available to the nursing infant is between 0.5 and 1% of the maternal weight adjusted dose which is significantly lower than the recommended infant dosing regimen.

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

Abdominal pain
Agitation
Agranulocytosis
Alterations in hepatic enzymes
Anal pruritus
Anaphylaxis
Angioedema
Antibiotic-associated colitis
Aplastic anaemia
Arthralgia
Arthritis
Cholestatic jaundice
Confusion
Diarrhoea
Dizziness
Dyspepsia
Eosinophilia
Erythema multiforme
Fatigue
Fever
Genital candidiasis
Genital pruritus
Haemolytic anaemia
Hallucinations
Headache
Hepatitis
Hyperactivity
Hypersensitivity reactions
Hypertonia
Increase in serum ALT/AST
Interstitial nephritis (reversible)
Joint disorder
Leucopenia
Nausea
Nervousness
Neutropenia
Overgrowth by non-susceptible organisms
Pruritus
Pseudomembranous colitis
Rash
Serum sickness-like reactions
Sleep disturbances
Stevens-Johnson syndrome
Thrombocytopenia
Toxic epidermal necrolysis
Urticaria
Vaginal discharge
Vaginitis
Vomiting

Effects on Laboratory Tests

Positive direct Coombs' tests have been reported during treatment with cephalosporin antibiotics. In haematological studies, or in transfusion cross-matching procedures when antiglobulin tests are performed on the minor side, or in Coombs' testing of newborns whose mothers have received cephalosporin antibiotics before parturition, it should be recognised that a positive Coombs' test may be due to the drug.

A false positive reaction for glucose in the urine may occur with Benedict's or Fehling's solutions, or with copper sulfate test tablets. Tests based on glucose oxidation reactions may be safely used.

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 ).

Further Information

Last Full Review Date: January 2015

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.

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

Summary of Product Characteristics: Cefalexin 125mg/5mg Oral Suspension. Aurobindo Pharma - Milpharm Ltd. Revised September 2012.
Summary of Product Characteristics: Cefalexin 250mg/5ml Oral Suspension. Aurobindo Pharma - Milpharm Ltd. Revised March 2012.
Summary of Product Characteristics: Cefalexin 250mg Capsules. Aurobindo Pharma - Milpharm Ltd. Revised January 2012.
Summary of Product Characteristics: Cefalexin 500mg Capsules. Aurobindo Pharma - Milpharm Ltd. Revised January 2012.

Summary of Product Characteristics: Cefalexin 250mg Capsules. Kent Pharma Ltd. Revised July 2013.
Summary of Product Characteristics: Cefalexin 500mg Capsules. Kent Pharma Ltd. Revised July 2013.

Summary of Product Characteristics: Cefalexin Oral Suspension BP 125mg/5mg. Sandoz Ltd. Revised July 2014.
Summary of Product Characteristics: Cefalexin Oral Suspension BP 250mg/5ml. Sandoz Ltd. Revised July 2014.
Summary of Product Characteristics: Cefalexin 250mg Tablets. Sandoz Ltd. Revised July 2014.
Summary of Product Characteristics: Cefalexin 500mg Tablets. Sandoz Ltd. Revised July 2014.
Summary of Product Characteristics: Cefalexin 500mg Capsules. Sandoz Ltd. Revised July 2014.

Summary of Product Characteristics: Keflex tablets, Capsules and Granules. Flynn Pharma Ltd. Revised March 2011.

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

NICE - Evidence Services
Available at: www.nice.org.uk
Last accessed: 22 June 2017

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Cefalexin Last revised: 7 September, 2013
Last accessed: 10 January, 2015