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Components:
Clindamycin Phosphate
Method of action:
Antiacne, Antibacterial Local, Bacteriostatic, Gynecological Antiinfectives And Antiseptics
Medically reviewed by Oliinyk Elizabeth Ivanovna, Pharmacy. Last updated on 2020.03.30

Overdose

Topically applied clindamycin can be absorbed in sufficient amounts to produce systemic effects.

In the event of overdosage, general symptomatic and supportive measures are indicated as required.

Pharmacodynamic properties

Pharmacotherapeutic group: Anti-infectives for treatment of acne, ATC Code: DA10AF01.

Microbiology

Clindamycin is a lincosamide antibiotic that inhibits bacterial protein synthesis. It binds to the 50S ribosomal subunit and affects both ribosome assembly and the translation process. Although clindamycin phosphate is inactive in vitro, rapid in vivo hydrolysis converts this compound to the antibacterially active clindamycin.

Clindamycin has been shown to have in vitro activity against isolates of the following organisms:

Anaerobic gram positive nonsporeforming bacilli, including:

- Propionibacterium acnes.

EUCAST has established susceptibility interpretive criteria for gram-negative and gram-positive anaerobes (with the exception of C. difficile): susceptible, ≤4 mg/L; resistant, >4 mg/L.

In a U.S. surveillance study, clindamycin MICs were ≤4 mg/L for 97% of P. acnes isolates tested.

In some bacterial species, cross resistance has been demonstrated in vitro among lincosamides, macrolides, and streptogramins B.

Clinical efficacy and safety

P. acnes produces an extracellular lipase that hydrolyses sebum triglycerides to glycerol, used by the organism as a growth substrate, and free fatty acids, which have pro-inflammatory and comedogenic properties. A double-blind study had been conducted to examine the effect of topical 1% clindamycin hydrochloride hydrate in a hydroalcoholic vehicle as compared to the effect of the vehicle alone. Fourteen patients applied clindamycin or vehicle alone twice daily for eight weeks. Free fatty acid surface lipid percentages, quantitative bacterial counts, and clinical response were assessed every two weeks. A significant reduction (88%) in the percentage of free fatty acids in the surface lipids was seen in the clindamycin-treated group and not in the vehicle-treated group. Free fatty acids on the skin surface have been decreased from approximately 14% to 2% following application of clindamycin solution in a hydroalcoholic base to 9 patients (average age 22.3 years) with acne vulgaris. There was no significant change in the surface microflora. Despite the short duration of treatment, objective clinical improvement was seen in three of nine treated patients, while none was observed in the placebo-treated patients.

Pharmacokinetic properties

Following multiple topical applications of clindamycin phosphate at a concentration equivalent to 10 mg clindamycin per mL in an isopropyl alcohol and water solution, very low levels of clindamycin are present in the serum (0-3 ng/mL) and less than 0.2% of the dose is recovered in urine as clindamycin.

Clindamycin concentrations has been demonstrated in comedones from acne patients. The mean (±SD) concentration of clindamycin in extracted comedones after application of clindamycin topical solution for 4 weeks was 0.60±0.11 mcg.

Older people

Clinical studies for topical clindamycin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Pharmacotherapeutic group

Anti-infectives for treatment of acne, ATC Code: DA10AF01.

Preclinical safety data

Embryo fetal development studies using oral doses in rats and subcutaneous doses in rats and rabbits, revealed no evidence of developmental toxicity except at doses that produced maternal toxicity. In reproductive studies in rats there was no evidence of impaired fertility.

Clindamycin was not genotoxic when evaluated in the in vivo rat micronucleus test and the Ames test.

Long-term studies in animals to evaluate carcinogenic potential have not been performed with clindamycin.

List of excipients

glycerol

sodium lauroyl sarcosinate

stearic acid

tegin

cetostearyl alcohol

isostearyl alcohol

methylparaben

purified water

Incompatibilities

Not applicable.

Shelf life

24 months.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

LDPE bottles and polypropylene dispensing cap containing 30 ml or 60 ml of Dalacin T Topical lotion.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

Marketing authorisation holder

Pfizer Limited

Ramsgate Road

Sandwich Kent

CT13 9NJ

United Kingdom

Marketing authorisation number(s)

PL 00057/0961

Date of first authorisation/renewal of the authorisation

Date of first authorisation: 18th September 1990

Date of latest renewal: 7th August 2009.

Date of revision of the text

04/2017

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