Duac Once Daily Gel

New Zealand - English - Medsafe (Medicines Safety Authority)

Buy It Now

Active ingredient:
Benzoyl peroxide 66.7 mg/g; Clindamycin phosphate 12.8 mg/g
Available from:
GlaxoSmithKline (NZ) Ltd
INN (International Name):
Benzoyl peroxide 66.7 mg/g
Dosage:
1%w/w, 5%w/w
Pharmaceutical form:
Topical gel
Composition:
Active: Benzoyl peroxide 66.7 mg/g Clindamycin phosphate 12.8 mg/g Excipient: Carbomer 940 Colloidal silicon dioxide Dimeticone Disodium edetate dihydrate Disodium lauryl sulfosuccinate Glycerol Poloxamer Purified water Sodium hydroxide
Units in package:
Tube, aluminium, 5 g
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Arkema Inc
Therapeutic indications:
For the topical treatment of comedo, papular and pustular acne vulgaris.
Product summary:
Package - Contents - Shelf Life: Tube, aluminium, - 5 g - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 2 months opened stored at 2° to 8°C (Refrigerate, do not freeze) - Tube, aluminium, - 6 g - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 2 months opened stored at 2° to 8°C (Refrigerate, do not freeze) - Tube, aluminium, Physican's samples 10 x 6g - 10 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 2 months opened stored at 2° to 8°C (Refrigerate, do not freeze) - Tube, aluminium, - 25 g - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 2 months opened stored at 2° to 8°C (Refrigerate, do not freeze) - Tube, aluminium, - 30 g - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 2 months opened stored at 2° to 8°C (Refrigerate, do not freeze) - Tube, aluminium, - 45 g - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 2 months opened stored at 2° to 8°C (Refrigerate, do not freeze) - Tube, aluminium, - 50 g - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 2 months opened stored at 2° to 8°C (Refrigerate, do not freeze) - Tube, aluminium, - 55 g - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 2 months opened stored at 2° to 8°C (Refrigerate, do not freeze) - Tube, aluminium, - 60 g - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 2 months opened stored at 2° to 8°C (Refrigerate, do not freeze) - Tube, aluminium, - 70 g - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 2 months opened stored at 2° to 8°C (Refrigerate, do not freeze)
Authorization number:
TT50-7216
Authorization date:
2004-03-25

DUAC

Duac

®

Once Daily Gel

Active ingredients: clindamycin 1% w/w (as phosphate) and benzoyl peroxide 5% w/w

CONSUMER MEDICINE INFORMATION

What is in this leaflet?

This leaflet answers some common

questions about Duac Once Daily

Gel. It does not contain all the

available information.

It does not take the place of talking to

your doctor or pharmacist.

All medicines have benefits and

risks. Your doctor has weighed the

benefits of you using Duac Once

Daily Gel against the risks he expects

it may have for you.

If you have any concerns about this

medicine, ask your doctor or

pharmacist.

Keep this leaflet with your

medicine. You may need to read it

again.

What is Duac Once

Daily Gel and what is

it used for?

Duac Once Daily Gel contains

clindamycin and benzoyl peroxide.

Clindamycin is an antibiotic, which

prevents the growth of bacteria

which are involved in acne. Benzoyl

peroxide acts to reduce comedones

(blackheads and whiteheads). It is

also effective at killing the bacteria,

which are involved in acne, and

makes the skin less oily.

Duac Once Daily Gel is used on the

skin to treat acne. It helps to:

reduce the bacteria or germs,

which are implicated in acne;

reduce the number of acne spots;

reduce the likelihood of new

blackheads and whiteheads from

forming; and

make your skin less oily.

Your doctor may have prescribed

Duac Once Daily Gel for another

purpose. Ask your doctor if you have

any questions about why Duac Once

Daily Gel has been prescribed for

you.

Duac Once Daily Gel is for use by

adults and adolescents (aged 12 and

above) with acne.

Duac Once Daily Gel is not

addictive.

Duac Once Daily Gel is only

available with a doctor's prescription.

Before you use Duac

Once Daily Gel

When you must not use it

Do not use Duac Once Daily Gel:

if you have an allergy to Duac

Once Daily Gel or any of the

ingredients in Duac Once Daily

Gel listed at the end of this

leaflet.

if you have a known sensitivity

to benzoyl peroxide,

clindamycin or lincomycin.

you have or have ever had:

regional enteritis (inflammation

of the small intestine)

colitis (inflammation of the

large intestine)

ulcerative colitis (inflammation

which may be due to the

presence of ulcers)

antibiotic associated colitis

(inflammation which may be

associated with the past use of

antibiotics)if the packaging is

torn or shows signs of

tampering.

for more than 2 months (kept in

the refrigerator at 2°C to 8°C)

after the date the pharmacist

has dispensed it to you.

If you use this medicine for more

than 2 months after the date the

pharmacist has dispensed it to

you, it may not work as well.

if the expiry date (EXP) printed

on the pack has passed.

If you use this medicine after the

expiry date has passed, it may not

work as well.

If you are not sure whether you

should start taking Duac Once

Daily Gel, contact your doctor.

Before you start to use it

Tell your doctor if:

you are pregnant or intend to

become pregnant.

Your doctor will discuss the risks

and benefits of using Duac Once

Daily Gel when pregnant.

you are breast-feeding or

intend to breast-feed.

Your doctor will discuss the risks

and benefits of using Duac Once

Daily Gel when breast-feeding.

Do not apply Duac Once Daily Gel

to the breasts before breast-feeding.

DUAC

Tell your doctor or pharmacist if

you have used or taken any other

clindamycin or erythromycin

containing medicines recently.

If you have not told your doctor

about any of the above, tell him

before you use Duac Once Daily

Gel.

Using other medicines

Tell your doctor if you are using

other creams, ointments or lotions

or taking any other medicine. This

includes any that you buy without

a prescription from a pharmacy,

supermarket or health food shop.

These include:

medicated or abrasive soaps

and cleansers;

chemical peels; and

cosmetic products that have a

strong drying effect.

These also include products

containing:

erythromycin;

clindamycin;

lincomycin;

benzoyl peroxide;

tretinoin, isotretinoin or

tazarotene;

salicylic acid; and

alcohol.

These medicines may have a

cumulative irritant effect or affect

how well Duac Once Daily Gel

works. You may need to use

different amounts of your medicine

or you may need to use different

medicines. Your doctor will advise

you.

Your doctor and pharmacist may

have more information on medicines

to be careful with, or avoid while

using Duac Once Daily Gel.

How to use Duac

Once Daily Gel

It is important to use Duac Once

Daily Gel exactly as your doctor

has told you.

Directions given to you by your

doctor may differ from the

information contained in this leaflet.

If you do not understand the

instructions on the box, tube or this

leaflet, ask your doctor or pharmacist

for help.

Wash the affected area thoroughly

and rinse with warm water. Lightly

pat dry the skin.

Remove make-up thoroughly before

applying the gel. After it has dried,

you can use a non-greasy make-up.

How to apply Duac Once

Daily Gel

Duac Once Daily Gel is for

application to the skin only.

A thin film of gel should be applied

to all of the area of the skin which

has acne, not just the individual

spots. As a guide, one fingertip (the

amount of gel squeezed from the tube

which reaches from the tip of your

finger to the first joint) is enough to

cover the face, two and one-half

fingertips of gel will cover your face

and back. If the gel does not rub into

your skin easily, you are using too

much.

Wash your hands after applying the

gel.

The usual dose for Duac Once Daily

Gel is apply once daily in the

evening.

How long should you use it

for

It may take 4-6 weeks before you

see the full effects of Duac Once

Daily Gel on your acne.

Use Duac Once Daily Gel for as

long as your doctor tells you to.

Do not use Duac Once Daily Gel

for more than 11 weeks unlessyour

doctor tells you to.

If you use Duac Once Daily Gel less

often than you should, it may not

work as well and your skin problem

may not improve. Using it more

often than you should may not

improve your skin problem any faster

and may cause or increase side

effects.

If you are not sure of how long you

need to use Duac Once Daily Gel,

talk to your doctor.

If you forget to use it

If it is almost time for your next

application of Duac Once Daily

Gel, skip the application you

missed and apply the gel when you

are next meant to. Otherwise, use it

as soon as you remember, and then

go back to using your gel as you

would normally.

Do not apply a double dose to

make up for the dose that you

missed.

If you have trouble remembering to

use your medicine, ask your

pharmacist for some hints.

If you swallow it

Immediately telephone your doctor

or Poisons Information Centre (In

Australia 13 11 26; In New

Zealand 0800 POISON or 0800 764

766), or go to casualty at your

nearest hospital if you think that

you or anyone else may have

swallowed Duac Once Daily Gel.

Do this even if there are no signs of

discomfort or poisoning. You may

need urgent medical attention.

Keep this telephone number

handy.

While you are using

Duac Once Daily Gel

Things you must do

Tell your doctor(s) who is treating

you that you are using Duac Once

Daily Gel.

DUAC

If you feel that Duac Once Daily

Gel is not helping your condition,

tell your doctor.

Tell your doctor if for any reason,

you have not used Duac Once Daily

Gel exactly as prescribed.

Otherwise, your doctor may think

that it was not effective and change

your treatment unnecessarily.

If you become pregnant while

using Duac Once Daily Gel, tell

your doctor.

If you are breastfeeding while

using Duac Once Daily Gel, tell

your doctor.

Things you must not do

Do not give Duac Once Daily Gel

to anyone else, even if they have

the same symptoms as yours.

Things to be careful of

Keep Duac Once Daily Gel away

from your lips, eyes, mouth and

other mucous membranes. Do not

apply to any irritated areas of your

skin; for example if you have cuts,

grazes, sunburn or eczema.

Be careful not to use too much on

your neck or other sensitive areas

of the skin.

Avoid excessive exposure to

sunlight. Sunlamps should not be

used. Avoid using at high altitudes

or where the ground is snow-

covered. When exposure to

sunlight cannot be avoided, use a

sunscreen product and wear

protective clothing.

Duac Once Daily Gel may bleach

hair and coloured fabrics, such as

clothing, towels and bed linen. Be

careful to avoid contact of Duac

Once Daily Gel with hair and

coloured fabrics.

Do not use occlusive (air or water

tight) dressings on areas treated

with Duac Once Daily Gel unless

necessary. Using occlusive

dressing may increase irritation.

Antibiotics may cause a condition

that results in severe diarrhoea

and stomach cramps. Although

this is unlikely to happen with

antibiotics applied to the skin, if

you develop stomach cramps or

diarrhoea that does not improve or

is severe, stop using Duac Once

Daily Gel and contact your doctor

immediately.

Side effects

Tell your doctor if you do not feel

well while you are using Duac

Once Daily Gel.

Duac Once Daily Gel helps most

people with acne but it may have

unwanted side effects in a few

people.

All medicines can have side effects.

Sometimes they are serious, most

of the time they are not. You may

need medical treatment if you get

some of these side effects.

Very common side effects:

At site of application:

Dry skin

Skin peeling

Redness of your skin, especially

during the first few weeks of use

These side effects are generally mild.

Common side effects:

Headache

At the site of application:

Skin burning sensation

Itching

Skin pain

Sensitivity to sunlight

Uncommon side effects:

At the site of application:

Tingling (paraesthesia)

Red, itchy skin, rash (dermatitis,

erythematous rash)

Worsening of acne

Rare side effects:

Allergic reactions

nausea, vomiting, diarrhoea,

including bloody diarrhoea,

stomach pain

At the site of application:

Skin reactions, discoloration of

the skin

Raised itchy rash (hives)

If you suffer severe burning,

peeling or itching, or other effects

not mentioned in this leaflet, you

should stop using Duac Once Daily

Gel and go back to your doctor for

advice.

After using Duac Once

Daily Gel

Storage

Duac Once Daily Gel should be

stored in the refrigerator at 2°C to

8°C for up to 2 months. Do not

freeze.

Do not leave it in the car, especially

the glovebox, or on windowsills.

Do not store Duac Once Daily Gel

or any other medicine in the

bathroom or near a sink.

Heat and dampness can destroy some

medicines.

Keep Duac Once Daily Gel where

young children cannot reach it.

A locked cupboard at least one and a

half metres above the ground is a

good place to store medicines.

Disposal

If your doctor tells you to stop

using Duac Once Daily Gel or it

has passed its expiry date, ask your

pharmacist what to do with any

that is left over.

Product Description

What it looks like

Duac Once Daily Gel is a white to

slightly yellow gel that is available

DUAC

in a 25 gram or 30 gram tube. A 5

gram sample tube is also available

from your physician only.

Not all pack sizes may be available.

Ingredients

The active ingredients in Duac Once

Daily Gel are clindamycin 1% w/w

(as phosphate) and benzoyl peroxide

5% w/w.

Duac Once Daily Gel also contains

the following inactive ingredients:

carbomer 980

dimeticone 100

disodium lauryl sulfosuccinate

disodium edetate

glycerol

silicon dioxide

poloxamer

purified water

sodium hydroxide

Supplier

Duac Once Daily Gel is supplied in

Australia by:

GlaxoSmithKline Australia Pty Ltd

Level 4

436 Johnston Street

Abbotsford

Victoria 3067

Australia

Duac Once Daily Gel is supplied in

New Zealand by:

GlaxoSmithKline NZ Limited

Private Bag 106600

Downtown

Auckland 1143

New Zealand

Australian Registration Number:

AUST R 100707

Date of preparation of this leaflet:

18 October 2016

Duac® is a registered trade mark of

Stiefel Laboratories, Inc.

Version 5.0

NEW ZEALAND DATA SHEET

1.

PRODUCT NAME

Duac Once Daily Gel contains 1% w/w clindamycin (as phosphate) and 5% w/w benzoyl

peroxide

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Duac Once Daily Gel contains 1% w/w clindamycin (as phosphate) and 5% w/w benzoyl

peroxide.

For the full list of excipients, see section 6.1 List of excipients.

3.

PHARMACEUTICAL FORM

Duac Once Daily Gel is a white to slightly yellow homogenous gel for topical use.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

For the topical treatment of comedo, papular and pustular acne vulgaris, in adults and

adolescents aged 12 years and above.

4.2

Dosage and method of administration

Dose

Duac Once Daily Gel is for topical use only.

Duac Once Daily Gel is recommended for a maximum duration of 11 weeks.

Australian Therapeutic Guidelines, Antibiotics, Version 12 recommend addition of topical

antibiotics (topical clindamycin) if there is insufficient response to topical keratolytics alone in

the treatment of acne vulgaris of moderate severity.

Adults and Adolescents (aged 12 years and above)

Duac Once Daily Gel should be applied once daily as a thin film in the evening, to affected

areas after the skin has been thoroughly washed, rinsed with warm water, and gently patted

dry.

If excessive dryness or peeling occurs, frequency of application should be reduced or

application temporarily interrupted.

Patients should be advised that excessive application will not improve efficacy, but may

increase the risk of skin irritation.

Paediatric population

The safety and efficacy of Duac Once Daily Gel has not been established in prepubescent

children (under 12 years of age), since acne vulgaris rarely presents in this age group

4.3

Contraindications

Duac Once Daily Gel is contraindicated in:

patients who have demonstrated hypersensitivity to lincomycin, clindamycin, benzoyl

peroxide or any components of the formulation.

Patients with, or with a history of regional enteritis, ulcerative colitis, or antibiotic-

associated colitis (including pseudomembranous colitis).

4.4 Special warnings and precautions for use

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.

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 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 may sometimes 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.

The irritation potential of the agent may be increased if applied under occlusion.

If the patient experiences a reaction that indicates contact hypersensitivity or severe

irritation, treatment with Duac Once Daily Gel should be discontinued immediately.

As benzoyl peroxide may cause increased sensitivity to sunlight, sunlamps should not be

used and deliberate or prolonged exposure to sunlight 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.

The product may bleach hair and coloured or dyed fabrics. Avoid contact with hair, fabrics,

furniture or carpeting.

Patients should be advised that, in some cases, 4-6 weeks of treatment may be required

before the full therapeutic effect is observed.

Pseudomembranous colitis

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including

clindamycin, and may range in severity from mild to life-threatening, with an onset of up to

several weeks following cessation of therapy.

Although this is unlikely to occur with topically applied clindamycin/benzoyl peroxide, if

prolonged or significant diarrhoea occurs or the patient experiences abdominal cramps,

treatment should be discontinued immediately and the patient investigated further, 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.

Resistance

Prolonged use of clindamycin may lead to selection of resistant micro-organisms and their

overgrowth. Duac Once Daily Gel was associated with reduced potential for emergence of

resistance to clindamycin in Propionibacterium acnes compared to topical clindamycin alone

in a clinical study of short duration. Duac Once Daily Gel is recommended for a maximum

duration of 11 weeks. If acne recurs, and a product containing a topical antibiotic or

antiseptic is considered appropriate, the patient should be retreated with Duac Once Daily

Gel to reduce the risk of development of cross-resistance to other topical antibiotics.

Australian Guidelines* recommend addition of topical antibiotics (topical clindamycin) if there

is insufficient response to topical keratolytics, such as benzoyl peroxide, alone in the

treatment of acne vulgaris of moderate severity. The Australian Therapeutic Guidelines,

Antibiotics Version 12 also recommend re-treating with the same drug if relapse occurs.

Local recommendations about antibiotic use and prevalence of clindamycin resistance

should be taken into consideration.

Clindamycin and erythromycin should not be used in combination.

Benzoyl peroxide reduces the potential for emergence of organisms resistant to clindamycin.

However, 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 has been demonstrated between clindamycin and lincomycin.

Resistance to clindamycin is often associated with inducible resistance to erythromycin (see

Interactions with other medicines and other forms of interaction).

Duac Once Daily Gel may not be adequate for severe nodulocystic acne.

4.5

Interaction with other medicines and other forms of interaction

Concomitant topical antibiotics, medicated or abrasive soaps and cleansers, soaps and

cosmetics that have a strong drying effect, and products with high concentrations of alcohol

and/or astringents, should be used with caution as a cumulative irritant effect may occur.

DUAC Once Daily Gel should not be used in combination with erythromycin-containing

products due to possible antagonism to the clindamycin component.

Clindamycin has been shown to have neuromuscular blocking properties that may enhance

the action of other neuromuscular blocking agents. Therefore DUAC Once Daily Gel should

be used with caution in patients receiving such agents.

Concomitant application of DUAC Once Daily Gel with tretinoin, isotretinoin and tazarotene

should be avoided since benzoyl peroxide may reduce their efficacy and increase irritation. If

combination treatment is required, the products should be applied at different times of the

day (e.g. one in the morning and the other in the evening).

Using topical benzoyl peroxide-containing preparations at the same time as topical

sulphonamide-containing products may cause skin and facial hair to temporarily change

colour (yellow/orange).

No clinical studies have been conducted to assess interactions between Duac Once Daily

Gel and other topical medications.

4.6

Fertility, pregnancy and lactation

Pregnancy

Category A.

Animal embryofoetal development studies have not been conducted with Duac Once Daily

Gel or benzoyl peroxide. Reproductive studies have been performed in rats and mice using

oral and parenteral doses of clindamycin phosphate up to 300 mg/kg/day and have revealed

no evidence of harm to the foetus due to clindamycin. There are no well-controlled studies in

pregnant women treated with DUAC Once Daily Gel.

There are limited data on the use of topical clindamycin or benzoyl peroxide alone in

pregnant women. Animal studies do not indicate direct or indirect harmful effects with

respect to reproductive toxicity. No effects during pregnancy are anticipated since systemic

exposure to clindamycin and benzoyl peroxide is low.

It is not known whether Duac Once Daily Gel can cause foetal harm when administered to a

pregnant woman or can affect reproductive capacity. Duac Once Daily Gel should be used

during pregnancy only if the expected benefit justifies the potential risk to the foetus.

Women of Child-Bearing Potential

There are no contraindications in women of child-bearing potential who are practising

adequate contraception. However, due to the lack of clinical studies in pregnant women,

Duac Once Daily Gel should be used with caution when adequate contraception is not being

practised.

Breast-feeding

DUAC Once Daily Gel has not been studied during breast-feeding.

Percutaneous absorption of clindamycin and benzoyl peroxide is low however; it is not

known whether clindamycin or benzoyl peroxide is excreted in human milk after topical

application. Oral and parenteral administration of clindamycin has been reported to result in

the appearance of clindamycin in breast milk.

DUAC Once Daily Gel should be used during lactation only if the expected benefit justifies

the potential risk to the infant.

To avoid accidental ingestion by the infant if used during lactation, DUAC Once Daily Gel

should not be applied to the breast area.

Fertility

There are no data on the effect of topical clindamycin or benzoyl peroxide on fertility in

humans.

Fertility was not impaired in rats given clindamycin phosphate 300 mg/kg/day in the diet.

4.7

Effects on ability to drive and use machines

There have been no studies to investigate the effect of clindamycin/benzoyl peroxide on

driving performance or the ability to operate machinery. A detrimental effect on such

activities would not be anticipated from the adverse reaction profile of clindamycin/benzoyl

peroxide.

4.8

Undesirable effects

Tabulated list of adverse reactions

Adverse drug reactions (ADRs) are summarised below for topical clindamycin/benzoyl

peroxide 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) very rare (<1/10,000).

Clinical Trials

Very common (≥1/10)

Erythema

Peeling

Dryness

Common (≥1/100, <1/10)

Burning sensation

Uncommon (≥1/1000, <1/100)

Dermatitis

Paraesthesia

Pruritus

Erythematous rash

Worsening of acne

In addition to the ADRs reported above for DUAC Once Daily Gel, in a clinical trial

conducted with a topical clindamycin and /benzoyl peroxide (1%/3%) gel product, application

site photosensitivity reaction was reported commonly.

In addition to the ADRs reported above for DUAC Once Daily Gel, in a clinical trial

conducted with a topical clindamycin product headache and application site pain were

reported commonly.

Adverse events reported in five comparator clinical trials (studies 150, 151, 152, 156 and

158) are presented in the following table.

Number of patients that experienced a treatment emergent sign or symptom

Duac

Once Daily Gel

(n = 397)

Number (%)

Benzoyl

Peroxide

(n = 396)

Number (%)

Clindamycin

Gel

(n = 349)

Number (%)

Vehicle Gel

Control

(n = 177)

Number (%)

Skin

Erythema

38 (10)

46 (12)

17 (5)

20 (12)

Peeling

62 (16)

61 (16)

19 (6)

13 (8)

Burning

16 (4)

17 (4)

9 (3)

4 (2)

Dryness

52 (14)

47 (12)

30 (9)

14 (8)

Pruritus

11 (3)

7 (2)

5 (1)

4 (2)

Seven cases of diarrhoea were reported: Duac Once Daily Gel (n=3), Clindamycin Gel (n=1)

and Benzoyl Peroxide Gel (n=3). Of the three cases in the Duac Once Daily Gel group, one

case was attributed to E. coli food poisoning, which was successfully treated with antibiotics.

The other two patients experienced short episodes of mild diarrhoea with no treatment or

change in usage of study medication.

Contact sensitivity was reported in a patch test study (study 157) conducted on healthy

volunteers. A total of 218 subjects were tested of whom 18 (8.7%) developed allergic contact

dermatitis after 3 weeks exposure to Duac Once Daily Gel. This incidence is similar to that

observed historically (approximately 10%) at the investigative site for products containing

benzoyl peroxide. It is anticipated that the incidence of sensitisation in clinical use will be

much less than that reported in this study since semi-occlusive patching exaggerates any

intrinsic effect of topically applied substances to cause contact sensitisation.

Post-marketing data

In the post marketing environment there have been instances of allergic reactions which can

be sudden and severe.

Immune system disorders

Rare: Allergic reactions including hypersensitivity and anaphylaxis

Gastrointestinal disorders

Rare: Colitis (including pseudomembranous colitis), haemorrhagic diarrhoea, diarrhoea,

abdominal pain

Skin and subcutaneous tissue disorders (at site of application)

Rare: Urticaria

General disorders and Administration site conditions

Rare: Application site reactions including discoloration

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It

allows continued monitoring of the benefit/risk balance of the medicine. Healthcare

professionals are asked to report any suspected adverse reactions via:

https://nzphvc.otago.ac.nz/reporting

4.9

Overdose

Symptoms and signs

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.

Treatment

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

excessive topical application.

For advice on the management of overdose please contact the National Poisons Centre on

0800 POISON (0800 764766).

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Clindamycin, combinations, ATC Code: D10AF51

Mechanism of action

Clindamycin

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 have

been decreased from approximately 14% to 2% following application of clindamycin.

Cross resistance may occur between clindamycin and other antibiotics such as lincomycin

and erythromycin.

The prevalence of clindamycin resistance may vary geographically and with time for selected

species. Local information of resistance is desirable, particularly when treating severe

infections.

Benzoyl Peroxide

Benzoyl peroxide is keratolytic acting against comedones at all stages of their development.

It is an oxidizing 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 keratolytic and antibacterial properties providing

activity against all the inflamed and non-inflamed lesions of mild to moderate acne vulgaris.

Duac Once Daily Gel was associated with reduced potential for emergence of resistance to

clindamycin in Propionibacterium acnes compared to topical clindamycin alone in a clinical

study of short duration.

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 Once Daily Gel, 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.

Against inflammatory lesions, Duac Once Daily Gel was significantly more effective than

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. Against non-inflammatory lesions, Duac Once Daily Gel

was significantly better than benzoyl peroxide in only one of five studies.

Overall improvement 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.

The following table reports results from the pivotal clinical study.

Results from the pivotal clinical study (Study 158)

(Intention To Treat Population)

Table 1

DUAC

Benzoyl

Peroxide

Clindamycin

Vehicle

LS* mean % reduction in

inflammatory lesions

(0.005)

(<0.001)

(<0.001)

LS* mean % reduction in non-

inflammatory lesions

(0.521)

(0.204)

10 (increase)

(0.002)

Global improvement

(good to excellent)

(0.059)

(<0.001)

(<0.001)

*LS mean = least square mean (from analysis of variance with effects for site, treatment and

interaction)

Values in brackets are raw p values.

Chemical Structure

Clindamycin phosphate

Benzoyl peroxide

5.2

Pharmacokinetic properties

Clindamycin

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.

Benzoyl Peroxide

Radio-labelled 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. Benzoic acid has a wide margin of safety

and is an approved food additive.

5.3

Preclinical safety data

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.

Carcinogenicity

Benzoyl peroxide has been shown to be a tumour promoter and progression agent in a

number of animal studies. Studies in mice have shown that benzoyl peroxide does not

increase the growth of tumours initiated by UV light. The clinical significance of this is

unknown.

Long-term studies in animals to evaluate the carcinogenic potential of Duac Once Daily Gel

and clindamycin phosphate have not been performed.

A photocarcinogenicity study, in which hairless mice were exposed to a cumulative

tumourigenic dose of stimulated sunlight, showed that derma application of Duac Once Daily

Gel, for 5 days per week for 40 weeks, caused a statistically significant reduction in the

median time to skin tumour onset. A slight reduction was also observed with the gel vehicle

only. It is unclear whether these results have any clinical significance. Clinical use of Duac

is likely to be much less extensive than that tested in mice.

Genotoxicity

Clindamycin phosphate was negative in assays evaluating the potential to cause gene

mutations and chromosomal damage.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Carbomer 980

Dimeticone 100

Disodium lauryl sulfosuccinate

Disodium edetate

Glycerol

Silicon dioxide

Poloxamer

Purified water

Sodium hydroxide

6.2

Incompatibilities

None.

6.3

Shelf Life

2 years.

Shelf life of medicinal product after dispensing: 2 months.

6.4

Special precautions for storage

Store at 2°C to 8°C. (Refrigerate. Do not freeze).

6.5

Nature and contents of container

Duac Once Daily Gel is presented in internally, lacquered membrane-sealed aluminium

tubes fitted with a polyethylene screw-cap, packed into a carton.

Pack sizes: 5, 6, 25, 30, 45, 50, 55, 60 and 70 grams.

Not all pack sizes may be marketed.

6.6

Special precautions for disposal

No special requirements for disposal.

7.

MEDICINE SCHEDULE

Prescription Medicine

8.

SPONSOR

GlaxoSmithKline NZ Limited

Private Bag 106600

Downtown

Auckland

New Zealand

Phone:

(09) 367 2900

Facsimile:

(09) 367 2910

9.

DATE OF FIRST APPROVAL

Date of publication in the New Zealand Gazette of consent to distribute the medicine:

2 March 2006

10.

DATE OF REVISION OF THE TEXT

20 March 2018

Summary table of changes:

Section changed

Summary of new information

Data Sheet re-format

Added adverse reaction contact information

Revised information for advice on the management of

overdose

Added Pharmacotherapeutic group and ATC code

Added information regarding disposal

Added date of first approval

Version 9.0

Duac

is a registered trade mark of Stiefel Laboratories, Inc.

© 2018 GSK group of companies or its licensor.

Similar products

Search alerts related to this product

Share this information