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Klina (OTHER DERMATOLOGICAL_ANTIBACTERIAL)

Components:
Benzoyl Peroxide, Clindamycin Phosphate
Method of action:
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Medically reviewed by Fedorchenko Olga Valeryevna, Pharmacy-Provisor. Last updated on 2019.12.06

Name of the medicinal product

Klina (OTHER DERMATOLOGICAL_ANTIBACTERIAL)

Qualitative and quantitative composition

Benzoyl Peroxide; Clindamycin Phosphate

Therapeutic indications

The information provided in Therapeutic indications of Klina (OTHER DERMATOLOGICAL_ANTIBACTERIAL) is based on data of another medicine with exactly the same composition as the Klina (OTHER DERMATOLOGICAL_ANTIBACTERIAL) of the medicine (Benzoyl Peroxide, Clindamycin Phosphate). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Klina (OTHER DERMATOLOGICAL_ANTIBACTERIAL) directly from the package or from the pharmacist at the pharmacy.
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Duac Once Daily Gel is indicated for the topical treatment of mild to moderate acne vulgaris, particularly inflammatory lesions, in adults and adolescents aged 12 years and above.

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

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of Klina (OTHER DERMATOLOGICAL_ANTIBACTERIAL) is based on data of another medicine with exactly the same composition as the Klina (OTHER DERMATOLOGICAL_ANTIBACTERIAL) of the medicine (Benzoyl Peroxide, Clindamycin Phosphate). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug Klina (OTHER DERMATOLOGICAL_ANTIBACTERIAL) directly from the package or from the pharmacist at the pharmacy.
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For cutaneous use only.

Posology

Adults and Adolescents (aged 12 years and above)

Duac Once Daily Gel should be applied once daily in the evening, to the entire affected area.

Patients should be advised that excessive application will not improve efficacy, but may increase the risk of skin irritation. If excessive dryness or peeling occurs, frequency of application should be reduced or application temporarily interrupted.

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

The safety and efficacy of Duac Once Daily Gel has not been studied beyond 12 weeks in acne vulgaris clinical trials. Treatment with Duac Once Daily Gel should not exceed more than 12 weeks of continuous use.

Paediatric population

The safety and efficacy of Duac Once Daily Gel has not been established in children under 12 years of age, therefore Duac Once Daily Gel is not recommended for use in this population.

Elderly patients

No specific recommendations.

Method of administration

Duac Once Daily Gel 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.

Contraindications

The information provided in Contraindications of Klina (OTHER DERMATOLOGICAL_ANTIBACTERIAL) is based on data of another medicine with exactly the same composition as the Klina (OTHER DERMATOLOGICAL_ANTIBACTERIAL) of the medicine (Benzoyl Peroxide, Clindamycin Phosphate). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Klina (OTHER DERMATOLOGICAL_ANTIBACTERIAL) directly from the package or from the pharmacist at the pharmacy.
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Special warnings and precautions for use

The information provided in Special warnings and precautions for use of Klina (OTHER DERMATOLOGICAL_ANTIBACTERIAL) is based on data of another medicine with exactly the same composition as the Klina (OTHER DERMATOLOGICAL_ANTIBACTERIAL) of the medicine (Benzoyl Peroxide, Clindamycin Phosphate). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Klina (OTHER DERMATOLOGICAL_ANTIBACTERIAL) directly from the package or from the pharmacist at the pharmacy.
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Contact with the mouth, eyes, lips, other mucous membranes or areas of irritated or broken skin should be avoided. Application to sensitive areas of skin should be made with caution. In case of accidental contact, rinse well with water.

Duac Once Daily Gel should be used with caution in patients with a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.

Duac Once Daily Gel should be used with caution in atopic patients, in whom further skin drying may occur.

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 of Duac Once Daily Gel or temporarily discontinue use; however, efficacy has not been established for less than once daily dosing frequencies.

Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy may occur, which sometimes may be severe, especially with the use of peeling, desquamating, or abrasive agents.

If severe local irritancy (e.g. severe erythema, severe dryness and itching, severe stinging/burning) occurs, Duac Once Daily Gel should be discontinued.

As benzoyl peroxide may cause increased sensitivity to sunlight, sunlamps should not be used and deliberate or prolonged exposure to sun should be avoided or minimised. When exposure to strong sunlight cannot be avoided, patients should be advised to use a sunscreen product and wear protective clothing.

If a patient has sunburn, this should be resolved before using Duac Once Daily Gel.

If prolonged or significant diarrhoea occurs or the patient suffers from abdominal cramps, treatment with Duac Once Daily Gel should be discontinued immediately, as the symptoms may indicate antibiotic-associated colitis. Suitable diagnostic methods, such as the determination of Clostridium difficile and toxin and, if necessary, colonoscopy should be employed and treatment options for colitis considered.

The product may bleach hair or coloured fabrics. Avoid contact with hair, fabrics, furniture or carpeting.

Resistance to clindamycin

Patients with a recent history of systemic or topical clindamycin or erythromycin use are more likely to have pre-existing anti-microbial resistant Propionibacterium acnes and commensal flora.

Cross-resistance

Cross-resistance may occur with other antibiotics such as lincomycin and erythromycin when using antibiotic monotherapy.

Effects on ability to drive and use machines

The information provided in Effects on ability to drive and use machines of Klina (OTHER DERMATOLOGICAL_ANTIBACTERIAL) is based on data of another medicine with exactly the same composition as the Klina (OTHER DERMATOLOGICAL_ANTIBACTERIAL) of the medicine (Benzoyl Peroxide, Clindamycin Phosphate). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug Klina (OTHER DERMATOLOGICAL_ANTIBACTERIAL) directly from the package or from the pharmacist at the pharmacy.
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Not relevant

Undesirable effects

The information provided in Undesirable effects of Klina (OTHER DERMATOLOGICAL_ANTIBACTERIAL) is based on data of another medicine with exactly the same composition as the Klina (OTHER DERMATOLOGICAL_ANTIBACTERIAL) of the medicine (Benzoyl Peroxide, Clindamycin Phosphate). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Klina (OTHER DERMATOLOGICAL_ANTIBACTERIAL) directly from the package or from the pharmacist at the pharmacy.
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Adverse drug reactions (ADRs) are summarised below for Duac Once Daily Gel as a combination including any additional ADRs that have been reported for the single topical active ingredients, benzoyl peroxide or clindamycin. Adverse drug reactions are listed by MedDRA system organ class and by frequency. Frequencies are defined as: very common (>1/10); common (>1/100 and <1/10); uncommon (>1/1,000 and <1/100); rare (>1/10,000 and <1/1,000) and not known (cannot be estimated from the available data).

MedDRA SOC

Very Common

Common

Uncommon

Not known**

Immune system disorders

Allergic reactions including hypersensitivity and anaphylaxis

Nervous system disorders*

Paraesthesia

Gastrointestinal disorders

Colitis (including pseudomembranous colitis), haemorrhagic diarrhoea, diarrhoea, abdominal pain

Skin and subcutaneous tissue disorders*

Erythema, peeling, dryness

(Generally reported as 'mild' in severity)

Burning sensation

Dermatitis, pruritus, erythematous rash, worsening of acne

Urticaria

General disorders and Administration site conditions

Application site reactions including skin discoloration

*At site of application. **Based on post-marketing reports. Since these reports are from a population of uncertain size and are subject to confounding factors, it is not possible to reliably estimate their frequency however, systemic reactions are rarely seen.

In addition to the ADRs reported in the table above, in the pivotal trial conducted with topical clindamycin 1%/benzoyl peroxide 3% gel, application site photosensitivity reaction was also reported commonly.

Also in addition to the ADRs reported above, in studies conducted with topical clindamycin alone, headache and application site pain were reported commonly.

Local Tolerability

During the five clinical trials with Duac Once Daily Gel, all patients were graded for facial erythema, peeling, burning, and dryness on the following scale: 0 = absent, 1 = mild, 2 = moderate and 3 = severe. The percentage of patients that had symptoms present before treatment (at baseline) and during treatment were as follows:

Local Tolerability Assessments for Subjects (N=397) in the Duac Once Daily Gel Group during the Phase 3 Studies

Before Treatment (Baseline)

During Treatment

Mild

Moderate

Severe

Mild

Moderate

Severe

Erythema

28%

3%

0

26%

5%

0

Peeling

6%

<1%

0

17%

2%

0

Burning

3%

<1%

0

5%

<1%

0

Dryness

6%

<1%

0

15%

1%

0

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Overdose

The information provided in Overdose of Klina (OTHER DERMATOLOGICAL_ANTIBACTERIAL) is based on data of another medicine with exactly the same composition as the Klina (OTHER DERMATOLOGICAL_ANTIBACTERIAL) of the medicine (Benzoyl Peroxide, Clindamycin Phosphate). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Klina (OTHER DERMATOLOGICAL_ANTIBACTERIAL) directly from the package or from the pharmacist at the pharmacy.
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Excessive application of Duac Once Daily Gel may result in severe irritation. In this event, discontinue use and wait until the skin has recovered.

Topically applied benzoyl peroxide is not generally absorbed in sufficient amounts to produce systemic effects.

Excessive application of topically applied clindamycin may result in absorption of sufficient amounts to produce systemic effects.

In the event of accidental ingestion of Duac Once Daily Gel, gastrointestinal adverse reactions similar to those seen with systemically administered clindamycin may be seen.

Appropriate symptomatic measures should be taken to provide relief from irritation due to excessive application.

Accidental ingestion should be managed clinically or as recommended by the National Poisons Centre, where available.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of Klina (OTHER DERMATOLOGICAL_ANTIBACTERIAL) is based on data of another medicine with exactly the same composition as the Klina (OTHER DERMATOLOGICAL_ANTIBACTERIAL) of the medicine (Benzoyl Peroxide, Clindamycin Phosphate). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Klina (OTHER DERMATOLOGICAL_ANTIBACTERIAL) directly from the package or from the pharmacist at the pharmacy.
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Pharmacotherapeutic group: Clindamycin, combinations

ATC Code: D10AF51

Clindamycin is a lincosamide antibiotic with bacteriostatic action against Gram-positive aerobes and a wide range of anaerobic bacteria. Lincosamides such as clindamycin bind to the 23S subunit of the bacterial ribosome and inhibit the early stages of protein synthesis. The action of clindamycin is predominantly bacteriostatic although high concentrations may be slowly bactericidal against sensitive strains.

Although clindamycin phosphate is inactive in-vitro, rapid in-vivo hydrolysis converts this compound to the antibacterial active clindamycin. Clindamycin activity has been demonstrated clinically in comedones from acne patients at sufficient levels to be active against most strains of Propionibacterium acnes. Clindamycin in-vitro inhibits all Propionibacterium acnes cultures tested (MIC 0.4mcg/ml). Free fatty acids on the skin surface have been decreased from approximately 14% to 2% following application of clindamycin.

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.

Duac Once Daily Gel has a combination of mild keratolytic and antibacterial properties providing activity particularly against inflamed lesions of mild to moderate acne vulgaris.

The prevalence of acquired resistance may vary geographically and with time for selected species. Local information of resistance is desirable, particularly when treating severe infections.

The inclusion of benzoyl peroxide reduces the potential for the emergence of organisms resistant to clindamycin.

The presentation of both active ingredients in one product is more convenient and ensures patient compliance.

Clinical efficacy and safety

In five randomised double-blind clinical studies of 1318 patients with facial acne vulgaris with both inflammatory and non-inflammatory lesions, 396 used Duac, 396 used benzoyl peroxide, 349 used clindamycin and 177 used vehicle. Treatment was applied once daily for 11 weeks and patients were evaluated and lesions counted at 2, 5, 8 and 11 weeks.

The mean percentage reduction in the number of lesions after 11 weeks is shown in the table. Mean percent reduction in number of lesions from baseline after 11 weeks

Study 150

(n = 120)

Study 151

(n = 273)

Study 152

(n = 280)

Study 156

(n = 287)

Study 158

* (n = 358)

Inflammatory lesions

Duac Once Daily Gel

65

56

42

57

52

Benzoyl peroxide

36

37

32

57

41

Clindamycin

34

30

38

49

33

Vehicle

19

-0.4

29

-

29

Non-inflammatory lesions

Duac Once Daily Gel

27

37

24

39

25

Benzoyl peroxide

12

30

16

29

23

Clindamycin

-4

13

11

18

17

Vehicle

-9

-5

17

-

-7

Total lesions (inflammatory plus non-inflammatory lesions)

Duac Once Daily Gel

41

45

31

50

41

Benzoyl peroxide

20

35

23

43

34

Clindamycin

11

22

22

33

26

Vehicle

1

-1

22

-

16

* Pivotal study. Statistically significant differences highlighted in bold.

The reduction in total lesions was significantly greater with Duac Once Daily Gel than clindamycin or vehicle in all five studies. The improvement was consistently greater with Duac Once Daily Gel than benzoyl peroxide, but the difference did not achieve statistical significance in individual studies.

Against inflammatory lesions, Duac Once Daily Gel was significantly superior to clindamycin alone in four of five studies and to benzoyl peroxide alone in three of five studies. Against non-inflammatory lesions, Duac Once Daily Gel was significantly better than clindamycin in four of five studies, and tended to be better than benzoyl peroxide alone.

Overall improvement in acne was assessed by the physician and was significantly better with Duac Once Daily Gel than with either benzoyl peroxide or clindamycin alone in three of five studies.

An effect on inflammatory lesions was apparent from week 2 of treatment. The effect on non-inflammatory lesions was more variable, with efficacy generally apparent after 2-5 weeks of treatment.

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of Klina (OTHER DERMATOLOGICAL_ANTIBACTERIAL) is based on data of another medicine with exactly the same composition as the Klina (OTHER DERMATOLOGICAL_ANTIBACTERIAL) of the medicine (Benzoyl Peroxide, Clindamycin Phosphate). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Klina (OTHER DERMATOLOGICAL_ANTIBACTERIAL) directly from the package or from the pharmacist at the pharmacy.
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In a maximised percutaneous absorption study the mean plasma clindamycin levels during a four-week dosing period for Duac Once Daily Gel were negligible (0.043% of applied dose).

The presence of benzoyl peroxide in the formulation did not have an effect on the percutaneous absorption of clindamycin.

Radio-label studies have shown that absorption of benzoyl peroxide through the skin can only occur following its conversion to benzoic acid. Benzoic acid is mostly conjugated to form hippuric acid, which is excreted via the kidneys.

Pharmacotherapeutic group

The information provided in Pharmacotherapeutic group of Klina (OTHER DERMATOLOGICAL_ANTIBACTERIAL) is based on data of another medicine with exactly the same composition as the Klina (OTHER DERMATOLOGICAL_ANTIBACTERIAL) of the medicine (Benzoyl Peroxide, Clindamycin Phosphate). Be careful and be sure to specify the information on the section Pharmacotherapeutic group in the instructions to the drug Klina (OTHER DERMATOLOGICAL_ANTIBACTERIAL) directly from the package or from the pharmacist at the pharmacy.
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Clindamycin, combinations

Preclinical safety data

The information provided in Preclinical safety data of Klina (OTHER DERMATOLOGICAL_ANTIBACTERIAL) is based on data of another medicine with exactly the same composition as the Klina (OTHER DERMATOLOGICAL_ANTIBACTERIAL) of the medicine (Benzoyl Peroxide, Clindamycin Phosphate). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Klina (OTHER DERMATOLOGICAL_ANTIBACTERIAL) directly from the package or from the pharmacist at the pharmacy.
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Duac Once Daily Gel

In a two year carcinogenicity study in mice, topical administration of Duac Once Daily Gel showed no evidence of increased carcinogenic risk, compared with controls.

In a photococarcinogenicity study in mice, a slight reduction in the median time to tumour formation was observed relative to controls following concurrent exposure to Duac Once Daily Gel and simulated sunlight. The clinical relevance of the findings in this study is unknown.

Repeat-dose dermal toxicity studies conducted on Duac Once Daily Gel, in two species, for up to 90 days, revealed no toxic effects, apart from minor local irritation.

An ocular irritation study found Duac Once Daily Gel to be only very slightly irritant.

Benzoyl peroxide

In animal toxicity studies, benzoyl peroxide was well tolerated when applied topically.

Although high doses of benzoyl peroxide have been shown to induce DNA strand breaks, the available data from other mutagenicity studies, carcinogenicity studies and a photo co-carcinogenicity study indicate that benzoyl peroxide is not a carcinogen or a photocarcinogen.

No reproductive toxicity data are available.

Clindamycin

In-vitro and in-vivo studies did not reveal any mutagenic potential of clindamycin. No long-term animal studies investigating the tumorigenic potential of clindamycin have been conducted. Otherwise, preclinical data reveal no special hazard for humans based on conventional studies of single and repeat-dose toxicity and toxicity to reproduction.

Special precautions for disposal and other handling

The information provided in Special precautions for disposal and other handling of Klina (OTHER DERMATOLOGICAL_ANTIBACTERIAL) is based on data of another medicine with exactly the same composition as the Klina (OTHER DERMATOLOGICAL_ANTIBACTERIAL) of the medicine (Benzoyl Peroxide, Clindamycin Phosphate). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Klina (OTHER DERMATOLOGICAL_ANTIBACTERIAL) directly from the package or from the pharmacist at the pharmacy.
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