Consumer medicine information

Dalacin T Lotion

Clindamycin

BRAND INFORMATION

Brand name

Dalacin T Topical Lotion

Active ingredient

Clindamycin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Dalacin T Lotion.

What is in this leaflet

This leaflet answers some common questions about DALACIN T. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using DALACIN T against the benefits they expect it will have for you.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What DALACIN T is used for

DALACIN T is an antibiotic lotion used on the skin to help treat acne.

DALACIN T works by decreasing acne lesions and/or stopping the growth of skin bacteria that cause acne.

DALACIN T is not addictive.

This medicine is available only with a doctor's prescription.

Before using DALACIN T

When you must not use it

Do not use DALACIN T:

  1. if you have an allergy to:
  • clindamycin or lincomycin
  • any of the ingredients listed at the end of this leaflet
  • Symptoms of an allergic reaction may include skin rash and itching.
  1. if the packaging shows signs of tampering.
  2. if the expiry date (EXP) printed on the pack has passed.

If you are not sure whether you should start using DALACIN T, contact your doctor.

Before you start to use it

You must tell your doctor if:

  1. you have any allergies to:
  • any other medicines
  • any other substances, such as foods, preservatives or dyes
  1. you are pregnant or intend to become pregnant
  2. you are breast-feeding or plan to breast-feed.
  3. you have or have had any other medical conditions, including:
  • other allergies

If you have not told your doctor about any of the above, tell them before you use DALACIN T.

Taking other medicines

  • Tell your doctor if you are taking any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines may interfere with DALACIN T. These include:

  • the antibiotic erythromycin
  • neuromuscular blocking medicines (certain agents used for muscle relaxation in anaesthesia)
  • These medicines may be affected by DALACIN T or may affect how well it works. You may need different amounts of your medicine or you may need to take different medicines. Your doctor will advise you.
  • Your doctor or pharmacist may have more information on medicines to be careful with or avoid while using DALACIN T.

How to use DALACIN T

How much to use and how to use it

Shake the bottle immediately before use. Apply a thin layer twice a day to the affected areas of the skin.

Avoid contact with eyes, lips and mucous membranes.

Follow all directions given to you by your doctor and pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the label, ask your doctor or pharmacist for help.

How long to use it

Continue using DALACIN T for as long as your doctor recommends.

If you are not sure how long you should be using DALACIN T, check with your doctor.

If your acne does not improve within 6 weeks, or if it becomes worse, contact your doctor. However, treatment of acne may take up to 8 to 12 weeks before full improvement is seen.

If you forget to use it

Apply DALACIN T Lotion when you remember, unless it is almost time for your next application, in which case wait and apply at the next application time.

If you use too much

If you use too much DALACIN T, you may experience some of the side effects listed below under side effects.

If Dalacin T is swallowed

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have swallowed DALACIN T. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are using DALACIN T

Things you must do

If you become pregnant while you are using DALACIN T, tell your doctor.

If you are about to start taking any new medicines, tell your doctor and pharmacist that you are using DALACIN T.

Things you must not do

Do not give DALACIN T to anyone else, even if they have the same condition as you.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using DALACIN T.

Check with your doctor as soon as possible if you have any problems while using DALACIN T, even if you do not think they are connected with the medicine or are not listed in this leaflet.

Like other medicines, DALACIN T can cause some side effects. If they occur, most are likely to be minor and temporary. However, some may be serious and need medical attention.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

  • skin irritation (burning, redness, peeling)
  • itchy skin
  • dry skin
  • hives
  • skin oiliness
  • stomach upset (diarrhoea, nausea, vomiting)
  • stomach pain
  • These side effects are usually mild.

Tell your doctor immediately if you notice any of the following side effects during use, or several weeks after stopping treatment with DALACIN T:

  • severe stomach cramps
  • watery and severe diarrhoea, which may also be bloody
  • fever, in combination with one or both of the above

These are rare but serious side effects. DALACIN T can change bacteria, which are normally present in the bowel and harmless, to multiply and therefore cause the above symptoms. You may need urgent medical attention. This side effect is rare.

Do not take any diarrhoea medicine without first checking with your doctor.

Ask your doctor or pharmacist if you don't understand anything in this list.

Other side effects not listed above may also occur in some patients.

Tell your doctor if you notice anything else that is making you feel unwell.

After using DALACIN T

Storage

Keep DALACIN T in a cool, dry place where the temperature stays below 25°C. Do not store it, or any other medicine, in a bathroom or near a sink. Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.

Keep DALACIN T where 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 DALACIN T or the expiry date has passed, ask your pharmacist what to do with any lotion left over.

Product description

What it looks like

DALACIN T is a white to off-white lotion. It is available in a 60 mL bottle.

Ingredients

  • DALACIN T lotion contains clindamycin phosphate equivalent to clindamycin 10 mg/mL as the active ingredient.

It also contains:

  • glycerol
  • sodium lauroyl sarcosinate
  • stearic acid
  • glyceryl monostearate
  • mono- and di-glycerides
  • purified water
  • potassium hydroxide
  • cetostearyl alcohol
  • isostearyl alcohol
  • methyl hydroxybenzoate

Supplier

DALACIN T is supplied in Australia by:

Pfizer Australia Pty Ltd
Sydney NSW
Toll Free number: 1800 675 229
www.pfizer.com.au

Australian Registration Number:

DALACIN T, AUSTR 67060.

This leaflet was prepared in April 2020.

®Registered trademark

© Pfizer Australia Pty Ltd

Published by MIMS July 2020

BRAND INFORMATION

Brand name

Dalacin T Topical Lotion

Active ingredient

Clindamycin

Schedule

S4

 

1 Name of Medicine

Clindamycin phosphate.

6.7 Physicochemical Properties

Chemical structure.


The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside-2-0- dihydrogen phosphate. It has a molecular weight of 504.96, and the molecular formula is C18H34ClN2O8PS.
Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. It is a white to off-white, odourless, hygroscopic, crystalline powder, found to be soluble in water, slightly soluble in dehydrated alcohol, sparingly soluble in dehydrated alcohol, sparingly soluble in acetone, and practically insoluble in chloroform and ether.

CAS number.

CAS Registry Number: 24729-96-2.

2 Qualitative and Quantitative Composition

Dalacin T lotion contains clindamycin phosphate equivalent to clindamycin 10 mg/mL, in an aqueous base.

Excipient of known effect.

Methyl hydroxybenzoates.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Lotion.
White to off-white emulsion.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

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 non spore forming bacilli, including: Propionibacterium acnes.

Pharmacodynamic effects.

Efficacy is related to the time period that the agent level is above the minimum inhibitory concentration (MIC) of the pathogen (%T/MIC).

Resistance.

Resistance to clindamycin in Propionibacterium acnes can be caused by mutations at the rRNA antibiotic binding site or by methylation of specific nucleotides in the 23S RNA of the 50S ribosomal subunit. These alterations can determine cross resistance to macrolides and streptogramins B (MLSB phenotype). Macrolide-resistant isolates should be tested for inducible resistance to clindamycin using the D-zone test. Cross resistance has been demonstrated between clindamycin and lincomycin.
The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable. Particularly in severe infections or therapy failure microbiological diagnosis with verification of the pathogen and its susceptibility to clindamycin is recommended.
Resistance is usually defined by susceptibility interpretive criteria (breakpoints) established by regulatory agencies, CLSI or EUCAST for systemically administered antibiotics. These breakpoints may be less relevant for topically administered clindamycin. Although clindamycin is not specifically cited, EUCAST has suggested that, for topically applied antimicrobials, resistance might be better defined by epidemiological cut-off values (ECOFFS) rather than the clinical breakpoints determined for systemic administration. However, MIC distributions and ECOFFS have not been published by EUCAST for P. acnes. Based on correlations between clinical results in acne patients and the clindamycin MICs for their P. acnes isolates, values as high as 256 mg/L are considered susceptible for topically administered clindamycin.
CLSI has published MIC ranges for a limited number (58) of unique clinical isolates of P. acnes collected in 2010-2012 in US hospitals; 91% of these isolates were susceptible to clindamycin (MIC ≤ 8 mg/L). A recent Belgian surveillance study (2011-2012) of anaerobic bacteria included 22 P. acnes isolates; 95.5% were susceptible to clindamycin. An earlier European surveillance study, which included 304 isolates of P. acnes, had reported a resistance rate of 15% to clindamycin. However, this study used a breakpoint of 0.12 mg/L; using the current breakpoint of 4 mg/L, there were no resistant isolates.

Breakpoints.

CLSI and EUCAST breakpoints for Gram-positive anaerobes are listed in Tables 3 and 4. Although the two institutions report the values differently, the resistance breakpoint is the same, because CLSI recognized a category of intermediate susceptibility (4 mg/L). As indicated above, these breakpoints are based on use in systemic infections.

Clinical trials.

Five randomised, controlled clinical trials have been performed to evaluate the efficacy and safety of clindamycin phosphate topical lotion in patients with moderate to severe acne vulgaris (defined in the studies as 12 to 70 inflammatory pustules and no more than 6 cystic lesions on the face). All studies were either double blind or investigator blind studies. Four studies compared the lotion with placebo and two of these studies also included clindamycin phosphate solution (an alcohol based formulation) as a comparator. Efficacy was based upon the reduction in numbers of acne lesions (including papules, pustules and open and closed comedones).
A total of 362 patients were enrolled in these comparative studies, and 276 patients were evaluable for efficacy. Patients were evaluated at 3, 6, 9 and 12 weeks.
A statistically significant change (p < 0.05) in mean acne lesion scores from baseline favouring Dalacin T lotion (n = 47) over placebo (n = 48) was seen in one study. There was a trend for Dalacin T (n = 56) to produce a superior response to placebo (n = 55) in three other studies in the observation period. The adverse events recorded during treatment with the lotion in these studies were minor and unrelated to therapy.

5.2 Pharmacokinetic Properties

Following multiple topical applications of clindamycin phosphate lotion 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 serum (Cmax 2.7 nanogram/mL) and about 0.23% of the dose is recovered in urine as clindamycin.
Clindamycin in the serum is extensively metabolised. Approximately 10% of an oral dose is excreted as biologically active clindamycin in urine. Inactive metabolites are also excreted in urine.
Clindamycin activity has been demonstrated in comedones from acne patients. The mean concentration of antibiotic activity in extracted comedones after application of clindamycin phosphate topical solution for 4 weeks was 597 microgram eq/g of comedonal material (range 0-1490). Clindamycin in vitro inhibits all Propionibacterium acnes cultures tested (MICs 0.4 microgram/mL). Free fatty acids on the skin surface have been decreased from approximately 14% to 2% following application of a 1% clindamycin solution containing alcohol.

5.3 Preclinical Safety Data

Carcinogenicity.

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

Genotoxicity.

Clindamycin phosphate was negative in assays evaluating the potential to cause gene mutations and chromosomal damage.

4 Clinical Particulars

4.1 Therapeutic Indications

Dalacin T topical lotion is indicated in the treatment of acne vulgaris, particularly forms in which comedones, papules and pustules predominate.

4.3 Contraindications

Dalacin T topical lotion is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.
Dalacin T topical lotion is also contraindicated in individuals with a history of inflammatory bowel disease or a history of antibiotic associated colitis.

4.4 Special Warnings and Precautions for Use

Oral and parenteral clindamycin have been associated with severe diarrhoea and pseudomembranous colitis which may result in patient death. Use of the clindamycin phosphate topical lotion (Dalacin T) results in absorption of the antibiotic from the skin surface. Diarrhoea, bloody diarrhoea and pseudomembranous colitis have been reported with the use of topical and systemic clindamycin.
It is important to consider the diagnosis of antibiotic associated colitis in patients who develop diarrhoea or colitis associated with antibiotic use. Antibiotic associated colitis (whether pseudomembranous or not) appears to result from a toxin produced by Clostridium difficile in the alimentary tract. The severity of the colitis may range from mild watery diarrhoea to severe, persistent, life threatening bloody diarrhoea. The diagnosis is usually made by recognition of the clinical symptoms. The symptoms may occur during therapy or up to several weeks after cessation of therapy. Additional confirmatory signs of antibiotic associated colitis include pseudomembrane formation seen with colonoscopy, C. difficile culture from the stool, or assay of the stool for C. difficile toxin.
Mild cases usually respond to drug discontinuation alone. However, in moderate to severe cases appropriate therapy with a suitable oral antibacterial agent effective against C. difficile should be considered. Fluids, electrolytes and protein replacement should be provided when indicated.
Drugs which delay peristalsis, e.g. opiates and diphenoxylate with atropine (Lomotil), may prolong and/or worsen the condition and should not be used.
Dalacin T should be prescribed with caution in atopic individuals.
For external use only. Avoid contact with sensitive surfaces such as the eyes, lips and mucous membranes.
Dalacin T is not generally effective in severe (nodulocystic) acne.
Use of topical clindamycin (Dalacin T) has been associated with the development of strains of Propionibacterium acnes resistant to clindamycin in some patients. If there is evidence of the development of clinical resistance during treatment, consideration should be given to discontinuation of treatment with topical antibiotics.

Use in the elderly.

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

Paediatric use.

No data available.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Clindamycin has been shown to have neuromuscular blocking properties that may enhance the actions of other neuromuscular blocking agents. Therefore it should be used with caution in patients receiving such agents.
Antagonism has been demonstrated in between clindamycin and erythromycin in vitro. Because of possible clinical significance, these two drugs should not be administered concurrently.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Fertility was not impaired in rats given 300 mg/kg/day in the diet.
(Category A)
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 fetus due to clindamycin. There are however, no adequate and well controlled studies in pregnant women.
It is not known if clindamycin is excreted in human breast milk following the use of topically administered clindamycin phosphate. Clindamycin has been reported to appear in human breast milk in ranges from < 0.5 to 3.8 micrograms/mL following systemic use. Clindamycin has the potential to cause adverse effects on the breastfed infant's gastrointestinal flora such as diarrhoea or blood in the stool, or rash. Therefore, clindamycin is not recommended for nursing mothers.
If oral or intravenous clindamycin is required by a nursing mother, it is not a reason to discontinue breastfeeding, but an alternate drug may be preferred. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clindamycin and any potential adverse effects on the breastfed child from clindamycin or from the underlying maternal condition.

4.8 Adverse Effects (Undesirable Effects)

Tables 1 and 2 list the adverse effects identified through clinical study experience and post-marketing surveillance. The most common adverse reactions are abdominal pain, gastrointestinal disorders, skin irritation, urticaria, dry skin and seborrhoea.

Clinical trial data.

See Table 1.

Post-marketing experience.

See Table 2.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration 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 at https://www.tga.gov.au/reporting-problems.

4.2 Dose and Method of Administration

Apply a thin film of Dalacin T topical lotion twice daily to the affected area.
Dalacin T topical lotion should be shaken immediately before using.
The efficacy of Dalacin T lotion has not been demonstrated beyond 12 week's duration.
See Section 5.1 Pharmacodynamic Properties, Clinical trials.

4.7 Effects on Ability to Drive and Use Machines

The effect of clindamycin on the ability to drive or operate machinery has not been systematically evaluated.

4.9 Overdose

Topically applied Dalacin T can be absorbed in sufficient amounts to produce systemic effects. In the event of overdosage, general symptomatic and supportive measures are indicated as required.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

7 Medicine Schedule (Poisons Standard)

Schedule 4 (Prescription Only Medicine).

6 Pharmaceutical Particulars

6.1 List of Excipients

Glycerol, sodium lauroyl sarcosinate, stearic acid, glyceryl monostearate, mono- and di-glycerides, purified water, potassium hydroxide, cetostearyl alcohol, isostearyl alcohol, methyl hydroxybenzoate.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Dalacin T topical lotion is available in 60 mL bottles.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

Summary Table of Changes