Drugs List

Therapeutic Indications

Uses

Treatment of infections of the urinary and respiratory tracts and of the skin and soft tissues including:

Upper respiratory tract infections - pharyngitis, sinusitis, otitis media, tonsillitis, laryngo-tracheo bronchitis.

Lower respiratory tract infections- acute and chronic bronchitis, lobar and bronchopneumonia.

Urinary tract infections - cystitis, urethritis, pyelonephritis.

Skin and soft tissue infections - abscess, cellulitis, furunculosis, impetigo.

Cefradine has been shown to be effective in reducing the incidence of postoperative infections in patients undergoing surgical procedures associated with a high risk of infection. It is also of value where postoperative infections would be disastrous and where patients have a reduced host resistance to bacterial infection.

Administration

For oral administration. Cefradine may be given without regard to meals.

Contraindications

None known

Precautions and Warnings

There are no specific precautions for use in the elderly except to monitor those patients with impaired renal or hepatic function.

Renal impairment - see Dosage; Renal Impairment

There is evidence of partial cross-allergenicity between the penicillins and the cephalosporins. Cefradine should therefore be used with caution in those patients with known hypersensitivity to penicillins. There have been instances of patients who have had reactions to both drug classes (including anaphylaxis).
Discontinue if drug-related rash or other hypersensitivity reaction occur.

Pregnancy - see Pregnancy section

Breastfeeding - see Lactation section

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 cefradine. 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.

Prolonged use may result in the overgrowth of non-susceptible organisms. The patient should therefore be observed carefully and if superinfection occurs, appropriate measures should be taken.

False positive Coombs' test and false positive urinary glucose tests (if tested for reducing substances) are possible - see Laboratory Tests.

Some formulations may contain lactose and should not be used in patients with galactosaemia, lactose intolerance and glucose-galactose malabsorption syndrome.

Use in Porphyria

Cephalosporins as a group are considered safe however, there is conflicting evidence regarding the safety of cefradine in porphyrias.

Pregnancy and Lactation

Pregnancy

Although animal studies have not demonstrated any teratogenicity, safety in pregnancy has not been established.

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 14-17 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 with caution as cefradine is excreted in breast milk. Limited information indicates that maternal doses of oral cefradine produce low levels in milk that are not expected to cause adverse effects the nursing infant. Disruption of the infants gastrointestinal flora, resulting in diarrhoea or thrush has been reported.

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

Gastrointestinal disturbances
Hypersensitivity reactions. This is more likely to occur in individuals who have previously demonstrated hypersensitivity and those with a history of allergy, asthma, hay fever or urticaria.
Glossitis
Heartburn
Dizziness
Feeling of tightness in chest
Headache
Nausea
Vomiting
Diarrhoea
Abdominal pain
Vaginitis
Candidiasis
Skin reactions
Urticaria
Pruritus
Rash
Fever
Arthralgia
Oedema
Stevens-Johnson syndrome
Anaphylaxis
Toxic epidermal necrolysis
Eosinophilia
Leucopenia
Neutropenia
Thrombocytopenia
Agranulocytosis
Aplastic anaemia
Haemolytic anaemia
Pseudomembranous colitis
Antibiotic-associated colitis
Interstitial nephritis (reversible)
Hepatitis (transient)
Cholestatic jaundice
Serum sickness-like reactions
Hyperactivity
Nervousness
Sleep disturbances
Hallucinations
Confusion
Hypertonia
Alterations in hepatic enzymes

Presentation

Capsules containing 250mg cefradine
Capsules containing 500mg cefradine

Drugs List

Therapeutic Indications

Uses

Treatment of infections of the urinary and respiratory tracts and of the skin and soft tissues including:

Upper respiratory tract infections - pharyngitis, sinusitis, otitis media, tonsillitis, laryngo-tracheo bronchitis.

Lower respiratory tract infections- acute and chronic bronchitis, lobar and bronchopneumonia.

Urinary tract infections - cystitis, urethritis, pyelonephritis.

Skin and soft tissue infections - abscess, cellulitis, furunculosis, impetigo.

Cefradine has been shown to be effective in reducing the incidence of postoperative infections in patients undergoing surgical procedures associated with a high risk of infection. It is also of value where postoperative infections would be disastrous and where patients have a reduced host resistance to bacterial infection.

Dosage

Bacteriology studies to determine the causative organisms and their sensitivity to cefradine should be performed. Therapy may be instituted prior to receiving the results of the sensitivity test.

Consideration should be given to official local guidance on the appropriate use of antibacterial agents.

Adults

Children

Patients with Renal Impairment

Additional Dosage Information

Administration

For oral administration. Cefradine may be given without regard to meals.

Contraindications

None known

Precautions and Warnings

There are no specific precautions for use in the elderly except to monitor those patients with impaired renal or hepatic function.

Renal impairment - see Dosage; Renal Impairment

There is evidence of partial cross-allergenicity between the penicillins and the cephalosporins. Cefradine should therefore be used with caution in those patients with known hypersensitivity to penicillins. There have been instances of patients who have had reactions to both drug classes (including anaphylaxis).
Discontinue if drug-related rash or other hypersensitivity reaction occur.

Pregnancy - see Pregnancy section

Breastfeeding - see Lactation section

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 cefradine. 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.

Prolonged use may result in the overgrowth of non-susceptible organisms. The patient should therefore be observed carefully and if superinfection occurs, appropriate measures should be taken.

False positive Coombs' test and false positive urinary glucose tests (if tested for reducing substances) are possible - see Laboratory Tests.

Some formulations may contain lactose and should not be used in patients with galactosaemia, lactose intolerance and glucose-galactose malabsorption syndrome.

Use in Porphyria

Cephalosporins as a group are considered safe however, there is conflicting evidence regarding the safety of cefradine in porphyrias.

Pregnancy and Lactation

Pregnancy

Although animal studies have not demonstrated any teratogenicity, safety in pregnancy has not been established.

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 14-17 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 with caution as cefradine is excreted in breast milk. Limited information indicates that maternal doses of oral cefradine produce low levels in milk that are not expected to cause adverse effects the nursing infant. Disruption of the infants gastrointestinal flora, resulting in diarrhoea or thrush has been reported.

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

Effects on Ability to Drive and Operate Machinery

Cefradine may cause dizziness. Patients should be aware that this can occur and that their ability to drive and operate machinery may be affected.

Side Effects

Gastrointestinal disturbances
Hypersensitivity reactions. This is more likely to occur in individuals who have previously demonstrated hypersensitivity and those with a history of allergy, asthma, hay fever or urticaria.
Glossitis
Heartburn
Dizziness
Feeling of tightness in chest
Headache
Nausea
Vomiting
Diarrhoea
Abdominal pain
Vaginitis
Candidiasis
Skin reactions
Urticaria
Pruritus
Rash
Fever
Arthralgia
Oedema
Stevens-Johnson syndrome
Anaphylaxis
Toxic epidermal necrolysis
Eosinophilia
Leucopenia
Neutropenia
Thrombocytopenia
Agranulocytosis
Aplastic anaemia
Haemolytic anaemia
Pseudomembranous colitis
Antibiotic-associated colitis
Interstitial nephritis (reversible)
Hepatitis (transient)
Cholestatic jaundice
Serum sickness-like reactions
Hyperactivity
Nervousness
Sleep disturbances
Hallucinations
Confusion
Hypertonia
Alterations in hepatic enzymes

Effects on Laboratory Tests

After treatment with cefradine, a false positive reaction for glucose in the urine may occur with Benedict's or Fehling's solution or with reagent tablets such as Clinitest, but not with the enzyme based tests such as Clinistix or Diastix.

A false positive result for Coombs' test may occur.

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

Store below 25 degrees C

Further Information

Last Full Review Date: November 2011

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, 8th edition (2008) 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: Nicef Capsules 250mg/Cephradine Capsules 250mg. Galen Ltd. Revised September 1998
Summary of Product Characteristics: Nicef Capsules 500mg/Cephradine Capsules 500mg. Galen Ltd. Revised September 1998

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: 29 August 2017

UK Drugs in Lactation Advisory Service.
Available at: https://www.ukmicentral.nhs.uk/drugpreg/qrg_p1.asp
Last accessed: November 16, 2011

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
Cephradine Last revised: February 12, 2010
Last accessed: November 16, 2011