Drugs List

Therapeutic Indications

Uses

Treatment of the following infections when caused by susceptible organisms:
Respiratory tract infections - pneumonia, acute and chronic bronchitis, pharyngitis, tonsillitis, sinusitis
Otitis media
Skin and soft tissue infections
Urinary tract infections (acute and chronic) - pyelonephritis, cystitis

Cefaclor is usually effective in eradication streptococci from the nasopharynx. However, it is not known if cefaclor is effective in the subsequent prevention of rheumatic fever or bacterial endocarditis.

Administration

For oral administration.

Suspension
After reconstitution, the suspension should be stored at 2-8 degrees C and used within 14 days.

Contraindications

Children less than 1 month old
Porphyria

Precautions and Warnings

Before therapy is initiated, it should be determined whether the patient has shown previous hypersensitivity to cephalosporins, penicillins, beta-lactams, or other drugs. Cefaclor should be given cautiously to patients who have shown hypersensitivity to penicillins or other drugs.

Discontinue if allergic reaction occurs and treat the patient with the appropriate agents

Use with caution in patients with severe renal impairment. See Dosage; Renal impairment.

Use with caution in patients with a history of gastrointestinal disease, especially colitis.

Consider the possibility of pseudomembranous colitis in patients with diarrhoea in association with the use of antibiotics. Mild cases usually respond to drug discontinuation, but moderate to severe cases should be treated with appropriate measures.

Prolonged use may result in superinfection with non-susceptible organisms. If this occurs, take appropriate measures.

May affect results of some laboratory tests. See Laboratory Tests.

Some suspension formulations contain aspartame - use with caution in patients with phenylketonuria.

Cefaclor may decrease the efficacy of oestrogen containing oral contraceptives.

Pregnancy and Lactation

Pregnancy

Cephalosporins are generally thought to be safe for use during pregnancy.

There are no adequate or well-controlled studies available for the use of cefaclor in human pregnancy.

Animal studies have shown no evidence of impaired fertility or teratogenicity.

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

Cephalosporins are generally thought to be safe for use during breast-feeding.

Small amounts of cefaclor have been detected in breast milk following administration of single 500mg doses. Average levels of 0.2micrograms/ml were detected up to 5 hours after cefaclor administration. Trace amounts were detected after one hour.

Briggs (2011) suggests even though the small amounts of cefaclor are detected in breast milk three potential problems exist for the nursing infant, modification of bowel flora, direct effects on the infant and interference with the interpretation of culture results if a fever workup is required.

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

Diarrhoea
Nausea
Vomiting
Abdominal discomfort
Dyspepsia
Rash
Urticaria
Pruritus
Serum sickness-like reactions
Erythema multiforme
Arthritis
Arthralgia
Fever
Lymphadenopathy
Proteinuria
Eosinophilia
Monilia vaginitis
Vaginitis
Headache
Dizziness
Somnolence
Increase in serum ALT/AST
Increase in alkaline phosphatase
Increase in blood urea nitrogen
Serum creatinine increased
Thrombocytopenia
Leucopenia
Lymphocytosis
Neutropenia
Possible alteration of laboratory tests
Anaphylaxis
Stevens-Johnson syndrome
Positive Coombs test
Genital pruritus
Pseudomembranous colitis
Angioedema
Asthenia
Facial oedema
Oedema of the extremities (arms and legs)
Dyspnoea
Paraesthesia
Syncope
Vasodilatation
Hypersensitivity reactions
Toxic epidermal necrolysis
Interstitial nephritis
Cholestatic jaundice
Hyperactivity
Agitation
Nervousness
Insomnia
Confusion
Hallucinations
Hypertonia
Aplastic anaemia
Agranulocytosis
Haemolytic anaemia
Colitis
Hepatitis

Presentation

Capsules containing 250mg cefaclor (as cefaclor monohydrate)
Capsules containing 500mg cefaclor (as cefaclor monohydrate)

Suspension containing 125mg/5ml cefaclor (as cefaclor monohydrate)
Suspension containing 250mg/5ml cefaclor (as cefaclor monohydrate)

Sugar free suspension containing 125mg/5ml cefaclor (as cefaclor monohydrate)
Sugar free suspension containing 250mg/5ml cefaclor (as cefaclor monohydrate)

Drugs List

Therapeutic Indications

Uses

Treatment of the following infections when caused by susceptible organisms:
Respiratory tract infections - pneumonia, acute and chronic bronchitis, pharyngitis, tonsillitis, sinusitis
Otitis media
Skin and soft tissue infections
Urinary tract infections (acute and chronic) - pyelonephritis, cystitis

Cefaclor is usually effective in eradication streptococci from the nasopharynx. However, it is not known if cefaclor is effective in the subsequent prevention of rheumatic fever or bacterial endocarditis.

Dosage

Adults

Children

Neonates

Patients with Renal Impairment

Administration

For oral administration.

Suspension
After reconstitution, the suspension should be stored at 2-8 degrees C and used within 14 days.

Contraindications

Children less than 1 month old
Porphyria

Precautions and Warnings

Before therapy is initiated, it should be determined whether the patient has shown previous hypersensitivity to cephalosporins, penicillins, beta-lactams, or other drugs. Cefaclor should be given cautiously to patients who have shown hypersensitivity to penicillins or other drugs.

Discontinue if allergic reaction occurs and treat the patient with the appropriate agents

Use with caution in patients with severe renal impairment. See Dosage; Renal impairment.

Use with caution in patients with a history of gastrointestinal disease, especially colitis.

Consider the possibility of pseudomembranous colitis in patients with diarrhoea in association with the use of antibiotics. Mild cases usually respond to drug discontinuation, but moderate to severe cases should be treated with appropriate measures.

Prolonged use may result in superinfection with non-susceptible organisms. If this occurs, take appropriate measures.

May affect results of some laboratory tests. See Laboratory Tests.

Some suspension formulations contain aspartame - use with caution in patients with phenylketonuria.

Cefaclor may decrease the efficacy of oestrogen containing oral contraceptives.

Pregnancy and Lactation

Pregnancy

Cephalosporins are generally thought to be safe for use during pregnancy.

There are no adequate or well-controlled studies available for the use of cefaclor in human pregnancy.

Animal studies have shown no evidence of impaired fertility or teratogenicity.

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

Cephalosporins are generally thought to be safe for use during breast-feeding.

Small amounts of cefaclor have been detected in breast milk following administration of single 500mg doses. Average levels of 0.2micrograms/ml were detected up to 5 hours after cefaclor administration. Trace amounts were detected after one hour.

Briggs (2011) suggests even though the small amounts of cefaclor are detected in breast milk three potential problems exist for the nursing infant, modification of bowel flora, direct effects on the infant and interference with the interpretation of culture results if a fever workup is required.

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

None known

Side Effects

Diarrhoea
Nausea
Vomiting
Abdominal discomfort
Dyspepsia
Rash
Urticaria
Pruritus
Serum sickness-like reactions
Erythema multiforme
Arthritis
Arthralgia
Fever
Lymphadenopathy
Proteinuria
Eosinophilia
Monilia vaginitis
Vaginitis
Headache
Dizziness
Somnolence
Increase in serum ALT/AST
Increase in alkaline phosphatase
Increase in blood urea nitrogen
Serum creatinine increased
Thrombocytopenia
Leucopenia
Lymphocytosis
Neutropenia
Possible alteration of laboratory tests
Anaphylaxis
Stevens-Johnson syndrome
Positive Coombs test
Genital pruritus
Pseudomembranous colitis
Angioedema
Asthenia
Facial oedema
Oedema of the extremities (arms and legs)
Dyspnoea
Paraesthesia
Syncope
Vasodilatation
Hypersensitivity reactions
Toxic epidermal necrolysis
Interstitial nephritis
Cholestatic jaundice
Hyperactivity
Agitation
Nervousness
Insomnia
Confusion
Hallucinations
Hypertonia
Aplastic anaemia
Agranulocytosis
Haemolytic anaemia
Colitis
Hepatitis

Effects on Laboratory Tests

A false-positive reaction for glucose in the urine may occur with Benedict's or Fehling's solutions or with copper sulfate test tablets.

Positive direct Coombs' test have been reported with cephalosporin therapy.

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

Capsules
Store below 25 degrees C
Keep containers tightly closed and protected from light

Suspensions - pre-reconstitution
Store at room temperature (15 to 25 degrees C)
Keep containers tightly closed and protected from light

Further Information

Last Full Review Date: December 2012

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.

Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

Summary of Product Characteristics: Distaclor 500mg capsules, 125mg/5ml and 250mg/5ml suspension. Flynn Pharma Ltd. Revised November 2005.
Summary of Product Characteristics: Cefaclor/Keftid 250mg/ml suspension. Co-pharma Ltd. Revised July 2010.

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