Drugs List

Therapeutic Indications

Uses

Antibiotic sensitive infections
Staphylococcal lung infection in cystic fibrosis - treatment

Treatment of serious infections caused by:
Susceptible Gram positive organisms
Staphylococci (both penicillinase- and non-penicillinase producing), including staphylococcal bone and joint infections, peritonitis and staphylococcal lung infection in cystic fibrosis
Streptococci (except Streptococcus faecalis)
Pneumococci
Susceptible anaerobic pathogens

Clindamycin does not penetrate the blood/brain barrier in therapeutically effective quantities.

Unlicensed Uses

Mild to moderate pneumocystis pneumonia
Treatment of falciparum malaria

Treatment of mild to moderate pneumocystis infection (in combination with primaquine).

Treatment of falciparum malaria (with or following quinine).

Contraindications

Diarrhoea
Within 3 days of oral typhoid vaccine
Galactosaemia

Precautions and Warnings

Atopy
Infants
Neonates
Acute porphyria
Breastfeeding
Glucose-galactose malabsorption syndrome
History of colitis
History of gastrointestinal disorder
Lactose intolerance
Moderate hepatic impairment
Pregnancy
Severe renal impairment

Consult national/regional policy on the use of anti-infectives
Contains lactose
Some products may contain soya or soya derivative
Monitor hepatic function on long term therapy
Monitor renal and hepatic function in infants
Monitor renal function on long term therapy
Advise patient to inform physician if/when (delayed) diarrhoea occurs
Consider pseudomembranous colitis if patient presents with diarrhoea
Prolonged use may result in superinfection with non-susceptible organisms
Discontinue if hypersensitivity reactions occur
Discontinue if severe skin reaction occurs
Discontinue immediately if diarrhoea occurs

Clindamycin hydrochloride should only be used in the treatment of serious infections. In considering the use of the product, the practitioner should bear in mind the type of infection and the potential hazard of the diarrhoea (including Clostridium difficile associated diarrhoea) and colitis which may develop. Cases of colitis have been reported during, or even 2 or 3 weeks following, the administration of clindamycin.

Avoid in Acute porphyrias; middle-aged and elderly women, especially after an operation.

Pregnancy and Lactation

Pregnancy

Use clindamycin with caution during pregnancy.

The manufacturers suggest clindamycin should only be administered during pregnancy if the potential benefit outweighs the possible risk to the foetus. Clindamycin is only indicated during pregnancy when penicillins, cephalosporins, erythromycin or the other macrolides are not effective (Schaefer 2015).

At the time of writing there have been no reports linking the use of clindamycin with congenital defects. Clindamycin crosses the placenta, reaching maximum cord serum levels of approximately 50% of the maternal serum. After multiple dosing the foetal tissue levels of clindamycin increase, with the drug concentrating in the foetal liver. Clindamycin may cause antibiotic associated colitis.

Reproduction studies in mice and rats with oral doses up to about 1.1 and 2.1 times the maximum recommended human adult dose based on BSA revealed no evidence of teratogenicity.

There is evidence of foetal harm in animal studies at doses high enough to cause maternal toxicity.

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 clindamycin with caution in breastfeeding.

One manufacturer suggests, if possible, mothers should stop breastfeeding during therapy with clindamycin. The Drugs and Lactation Database (LactMed) suggests if oral clindamycin is required by a breastfeeding mother it is not a reason to discontinue breastfeeding, but an alternative drug may be preferable.

Clindamycin is excreted into human milk. It is unlikely that a nursing infant can absorb a significant amount of clindamycin from its gastro-intestinal tract. However, monitoring of the infant for possible effects on the gastrointestinal flora, such as diarrhoea, candidiasis, or blood in the stool is advisable. Bloody diarrhoea has been reported in one breastfed infant which, possibly, was caused by concurrent maternal use of intravenous clindamycin and gentamicin.

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
Abnormal liver function tests
Acute generalised exanthematous pustulosis
Agranulocytosis
Anaphylactoid reaction
Anaphylaxis
Angioedema
Antibiotic-associated colitis
Diarrhoea
Drug rash with eosinophilia and systemic symptoms (DRESS)
Dysgeusia
Eosinophilia
Erythema multiforme
Exfoliative dermatitis
Hypersensitivity reactions
Jaundice
Leucopenia
Maculopapular rash
Morbilliform-like skin rashes
Nausea
Neutropenia
Oesophageal ulceration
Oesophagitis
Polyarthritis
Pruritus
Pseudomembranous colitis
Stevens-Johnson syndrome
Thrombocytopenia
Toxic epidermal necrolysis
Urticaria
Vaginitis
Vesiculo-bullous reactions
Vomiting

Presentation

Oral formulations containing clindamycin (as clindamycin hydrochloride).

Drugs List

Therapeutic Indications

Uses

Antibiotic sensitive infections
Staphylococcal lung infection in cystic fibrosis - treatment

Treatment of serious infections caused by:
Susceptible Gram positive organisms
Staphylococci (both penicillinase- and non-penicillinase producing), including staphylococcal bone and joint infections, peritonitis and staphylococcal lung infection in cystic fibrosis
Streptococci (except Streptococcus faecalis)
Pneumococci
Susceptible anaerobic pathogens

Clindamycin does not penetrate the blood/brain barrier in therapeutically effective quantities.

Unlicensed Uses

Mild to moderate pneumocystis pneumonia
Treatment of falciparum malaria

Treatment of mild to moderate pneumocystis infection (in combination with primaquine).

Treatment of falciparum malaria (with or following quinine).

Dosage

Treatment for infections caused by beta-haemolytic streptococci should be continued for at least 10 days to guard against subsequent rheumatic fever or glomerulonephritis.

Adults

Children

Neonates

Contraindications

Diarrhoea
Within 3 days of oral typhoid vaccine
Galactosaemia

Precautions and Warnings

Atopy
Infants
Neonates
Acute porphyria
Breastfeeding
Glucose-galactose malabsorption syndrome
History of colitis
History of gastrointestinal disorder
Lactose intolerance
Moderate hepatic impairment
Pregnancy
Severe renal impairment

Consult national/regional policy on the use of anti-infectives
Contains lactose
Some products may contain soya or soya derivative
Monitor hepatic function on long term therapy
Monitor renal and hepatic function in infants
Monitor renal function on long term therapy
Advise patient to inform physician if/when (delayed) diarrhoea occurs
Consider pseudomembranous colitis if patient presents with diarrhoea
Prolonged use may result in superinfection with non-susceptible organisms
Discontinue if hypersensitivity reactions occur
Discontinue if severe skin reaction occurs
Discontinue immediately if diarrhoea occurs

Clindamycin hydrochloride should only be used in the treatment of serious infections. In considering the use of the product, the practitioner should bear in mind the type of infection and the potential hazard of the diarrhoea (including Clostridium difficile associated diarrhoea) and colitis which may develop. Cases of colitis have been reported during, or even 2 or 3 weeks following, the administration of clindamycin.

Avoid in Acute porphyrias; middle-aged and elderly women, especially after an operation.

Pregnancy and Lactation

Pregnancy

Use clindamycin with caution during pregnancy.

The manufacturers suggest clindamycin should only be administered during pregnancy if the potential benefit outweighs the possible risk to the foetus. Clindamycin is only indicated during pregnancy when penicillins, cephalosporins, erythromycin or the other macrolides are not effective (Schaefer 2015).

At the time of writing there have been no reports linking the use of clindamycin with congenital defects. Clindamycin crosses the placenta, reaching maximum cord serum levels of approximately 50% of the maternal serum. After multiple dosing the foetal tissue levels of clindamycin increase, with the drug concentrating in the foetal liver. Clindamycin may cause antibiotic associated colitis.

Reproduction studies in mice and rats with oral doses up to about 1.1 and 2.1 times the maximum recommended human adult dose based on BSA revealed no evidence of teratogenicity.

There is evidence of foetal harm in animal studies at doses high enough to cause maternal toxicity.

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 clindamycin with caution in breastfeeding.

One manufacturer suggests, if possible, mothers should stop breastfeeding during therapy with clindamycin. The Drugs and Lactation Database (LactMed) suggests if oral clindamycin is required by a breastfeeding mother it is not a reason to discontinue breastfeeding, but an alternative drug may be preferable.

Clindamycin is excreted into human milk. It is unlikely that a nursing infant can absorb a significant amount of clindamycin from its gastro-intestinal tract. However, monitoring of the infant for possible effects on the gastrointestinal flora, such as diarrhoea, candidiasis, or blood in the stool is advisable. Bloody diarrhoea has been reported in one breastfed infant which, possibly, was caused by concurrent maternal use of intravenous clindamycin and gentamicin.

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
Abnormal liver function tests
Acute generalised exanthematous pustulosis
Agranulocytosis
Anaphylactoid reaction
Anaphylaxis
Angioedema
Antibiotic-associated colitis
Diarrhoea
Drug rash with eosinophilia and systemic symptoms (DRESS)
Dysgeusia
Eosinophilia
Erythema multiforme
Exfoliative dermatitis
Hypersensitivity reactions
Jaundice
Leucopenia
Maculopapular rash
Morbilliform-like skin rashes
Nausea
Neutropenia
Oesophageal ulceration
Oesophagitis
Polyarthritis
Pruritus
Pseudomembranous colitis
Stevens-Johnson syndrome
Thrombocytopenia
Toxic epidermal necrolysis
Urticaria
Vaginitis
Vesiculo-bullous reactions
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 ).

Further Information

Last Full Review Date: February 2018

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Medications and Mothers' Milk, 16th Edition (2014) Hale, T. Hale Publishing, Amarillo, Texas.

Summary of Product Characteristics: Clindamycin 150 mg Capsules. Sandoz Ltd. Revised September 2017.
Summary of Product Characteristics: Clindamycin 300 mg Capsules. Actavis UK Ltd. Revised February 2016.
Summary of Product Characteristics: Dalacin C Capsules 75 mg and 150 mg. Pharmacia Limited. Revised October 2017.

NICE - Evidence Services
Available at: www.nice.org.uk
Last accessed: 26 January 2018

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
Clindamycin. Last revised: 10 January 2017
Last accessed: 26 January 2018.

The Norwegian Porphyria Centre (NAPOS).
Available at: https://www.drugs-porphyria.org
Last revised: 24 March 2017
Last accessed: 14 February 2018