Clindamycin/ Anhydrous Benzoyl Peroxide

Registered South African indications:

• Acne vulgaris

Contraindications

• Hypersensitivity to the active ingredient(s) or any of the excipients in this combination product
• Hypersensitivity to benzoyl peroxide
• Hypersensitivity to lincomycin

Cautions

• Pregnancy
• Breastfeeding
• Contact with hair, mouth, eyes, lips and mucous membranes
• Irritated or broken skin
• Sensitive skin
• History of regional enteritis
• History of ulcerative colitis
• Recent history of systemic or topical clindamycin, or erythromycin use
• History of antibiotic-associated colitis
• Atopic patients
• Deliberate or prolonged exposure to sun
• Concomitant use of sunlamps

Forms avail. in SA and covered in this monograph: gel 

Acne vulgaris - mild to moderate
- With inflammatory lesions

Clindamycin/ Anhydrous benzoyl peroxide
1/5 (g/100g)

• Topical (gel): Apply small quantity to affected area(s), dly, at night; Max treatment duration: 12 weeks

Excessive topical application will not improve efficacy but may increase the risk of skin irritation

An effect on inflammatory and non-inflammatory lesions may be seen as early as week 2-5 of treatment

See additional prescribing points

Not established for use in children below 12 years

Pregnancy

• Caution
• There are no adequate data from the use of clindamycin/ anhydrous benzoyl peroxide gel in pregnant women. Animal reproductive/ developmental studies have not been conducted with topical clindamycin/ anhydrous benzoyl peroxide or benzoyl peroxide. There are limited data on the use of clindamycin/ anhydrous benzoyl peroxide alone in pregnant women. Data from a limited number of pregnancies exposed in the first trimester to clindamycin indicate no adverse effects of clindamycin on pregnancy or on the health of the foetus/ new-born child
• Reproduction studies in rats and mice, using subcutaneous and oral doses of clindamycin, revealed no evidence of impaired fertility or harm to the foetus due to clindamycin
• The safety of clindamycin anhydrous benzoyl peroxide gel in human pregnancy is not established. Therefore, clindamycin/ anhydrous benzoyl peroxide gel should only be prescribed to pregnant women after careful risk/benefit assessment

Breastfeeding

• Caution
• Use of clindamycin/ anhydrous benzoyl peroxide gel has not been studied during breastfeeding. Percutaneous absorption of topical clindamycin/ anhydrous benzoyl peroxide is low, however, it is not known whether clindamycin or benzoyl peroxide is excreted in human milk following the use of clindamycin/ anhydrous benzoyl peroxide gel. Oral and parenteral administration of clindamycin has been reported to result in the appearance of clindamycin in breast milk
• For this reason, clindamycin/ anhydrous benzoyl peroxide gel should be used during breastfeeding only if the expected benefit justifies the potential risk to the infant. To avoid accidental ingestion by the infant if used during breastfeeding, clindamycin/ anhydrous benzoyl peroxide gel should not be applied to the breast area

Fertility

• There are no data on the effect of clindamycin/ anhydrous benzoyl peroxide on fertility in humans

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended 

Elderly

• No dose adjustment recommended 

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache 
• Paraesthesia

Gastrointestinal Disorders

• Colitis
• Pseudomembranous colitis
• Haemorrhagic diarrhoea
• Diarrhoea
• Abdominal pain

Skin and Subcutaneous Tissue Disorders

• Pruritus
• Burning sensation
• Dryness
• Erythema
• Peeling
• Dermatitis
• Photosensitivity reaction
• Erythematous rash
• Worsening of acne
• Urticaria
• Application site reactions
• Skin discolouration

Immune, Blood and Lymphatic System Disorders

• Allergic reactions
• Hypersensitivity
• Anaphylaxis

• Topical antibiotics
• Other topical acne therapy
• Systemic or topical erythromycin 
• Lincomycin
• Topical sulfonamide-containing products
• Tretinoin
• Isotretinoin
• Tazarotene
• Neuromuscular blockers
• Medicated or abrasive soaps and cleansers 
• Products with high concentrations of alcohol and/or astringents 
• Cosmetics with a strong drying effect 

None routine

Precautions for use

• Clindamycin/ anhydrous benzoyl peroxide should be applied in a thin film after washing gently with a mild cleanser and fully drying. If the gel does not rub into the skin easily, too much is being applied
• Hands should be washed after application

Peeling and reddening of skin

• During the first weeks of treatment, an increase in peeling and reddening will occur in most patients. Depending upon the severity of these side effects, patients can use a non-comedogenic moisturiser, temporarily reduce the frequency of application or temporarily discontinue use

Clindamycin
Clindamycin has a primarily bacteriostatic action. It binds to the 50S subunit of the bacterial ribosome and thus inhibits the early stages of protein synthesis.

Anhydrous benzoyl peroxide
Benzoyl peroxide is mildly keratolytic acting against comedones at all stages of their development. It is an oxidising agent with bactericidal activity against Propionibacterium acnes, the organism implicated in acne vulgaris. Furthermore it is sebostatic, counteracting the excessive sebum production associated with acne.

COMBINATION PREPARATIONS

Clindamycin/ Anhydrous Benzoyl Peroxide

Gel (per 100g) 1g/5g

• Clindoxyl (GSK) originator