Consumer medicine information

Dalacin T 1% Topical 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 1% Topical Lotion.

SUMMARY CMI

DALACIN® T 1% Topical Lotion

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using Dalacin T?

Dalacin T contains the active ingredient clindamycin phosphate. Dalacin T is used on the skin to help treat acne.

For more information, see Section 1. Why am I using Dalacin T? in the full CMI.

2. What should I know before I use Dalacin T?

Do not use if you have ever had an allergic reaction to Dalacin T, clindamycin, lincomycin, methyl hydroxybenzoate, or any of the ingredients listed at the end of the CMI; have or have previously had inflammatory bowel disease or antibiotic-associated colitis.

Talk to your doctor if you have had any bowel problems, atopic dermatitis, or any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use Dalacin T? in the full CMI.

3. What if I am taking/using other medicines?

Some medicines may interfere with Dalacin T and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Dalacin T?

  • Shake the bottle immediately before use. Apply a thin layer twice a day to the affected areas of the skin.
  • Avoid contact with sensitive surfaces such as the eyes, eyelids, ears, lips, inside the mouth, inside the nose, penis, vagina, and anus.

More instructions can be found in Section 4. How do I use Dalacin T? in the full CMI.

5. What should I know while using Dalacin T?

Things you should do
  • Remind any doctor, dentist, or pharmacist you visit that you are using Dalacin T.
  • If you get severe diarrhoea tell your doctor or seek medical treatment immediately. Do this even if it occurs several weeks after you have stopped using Dalacin T.
Things you should not do
  • Do not stop using this medicine without talking to your doctor.
  • Do not give your medicine to anyone else, even if they have the same condition as you.
Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how Dalacin T affects you.
Drinking alcohol
  • No information available.
Looking after your medicine
  • Store it in a cool dry place below 25°C, away from moisture, heat, or sunlight.
  • Keep it where young children cannot reach it.

For more information, see Section 5. What should I know while using Dalacin T? in the full CMI.

6. Are there any side effects?

Nausea; diarrhoea; irritated, dry, oily, or itchy skin; skin rash, redness, burning sensation; stomach pain.

More rarely: cold/flu, cough, sore throat, stuffy nose/congestion; indigestion/heartburn, bloating, excessive wind; constipation; dizziness; headache; eye pain/irritation; nausea, vomiting; skin flaking, discolouration or blisters; weight loss; hair loss; change in taste/voice; numbness of face; nosebleed; coloured tongue; swelling of hands/feet/ankles.

There are rare but serious side effects that may need immediate medical attention: severe diarrhoea which may have blood and mucus; bleeding/bruising more easily than normal; signs of an allergic reaction; discomfort when urinating; rapid heartbeat, chest tightness.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

DALACIN® T 1% Topical Lotion

Active ingredient(s): [Clindamycin phosphate]

Consumer Medicine Information (CMI)

This leaflet provides important information about using Dalacin T. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Dalacin T.

Where to find information in this leaflet:

1. Why am I using Dalacin T?
2. What should I know before I use Dalacin T?
3. What if I am taking/using other medicines?
4. How do I use Dalacin T?
5. What should I know while using Dalacin T?
6. Are there any side effects?
7. Product details

1. Why am I using Dalacin T?

Dalacin T contains the active ingredient clindamycin phosphate. Dalacin T is an antibiotic lotion used on the skin to treat acne.

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

Ask your doctor if you have any questions about why Dalacin T has been prescribed for you. Your doctor may have prescribed Dalacin T for another reason.

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

Dalacin T is not addictive.

2. What should I know before I take use Dalacin T?

Warnings

You must tell your doctor, and should not use Dalacin T if you:

  • have ever had an allergic reaction to clindamycin or lincomycin or methyl hydroxybenzoates or any of the ingredients listed at the end of this leaflet.
  • have, or have previously had inflammatory bowel disease, or antibiotic-associated colitis (severe diarrhoea associated with the use of antibiotics).

You should not be using this medicine if the expiry date printed on the pack has passed or if the packaging is torn or shows signs of tampering.

Check with your doctor if you:

  • have bowel disease or any gastrointestinal (stomach or gut) problems
  • have atopic dermatitis
  • take any medicines for any other conditions.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Talk to your doctor if you are:

  • pregnant or intend to become pregnant.
  • breastfeeding or intend to breastfeed.

Dalacin T may pass into breastmilk and may have effects on your baby. Your doctor can discuss with you the risks and benefits involved.

3. What if I am taking/using other medicines?

Tell your doctor or pharmacist if you are taking/using any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Dalacin T and affect how it works including:

  • erythromycin, a medicine used to treat bacterial infections.
  • opiates, medicines used to treat strong pain.
  • diphenoxylate with atropine used for diarrhoea.
  • some medicines that may be used during surgery.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Dalacin T.

4. How do I 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 sensitive surfaces such as the eyes, eyelids, ears, lips, inside the mouth, inside the nose, penis, vagina and anus. If you are not sure what to do and how to use it, ask your doctor or pharmacist.

How long to use it

Continue using Dalacin T for as long as your doctor recommends. Treatment of acne may take up to 12 weeks before full improvement is seen. However, results from the use of this medicine have not been demonstrated beyond 12 weeks. If you are not sure how long you should be using Dalacin T, check with your doctor.

If you forget to use Dalacin T

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 Dalacin T

If you use too much Dalacin T, you may experience unwanted side effects.

If Dalacin T is Swallowed

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Dalacin T?

Things you should do

  • For external use only. Avoid contact with sensitive surfaces such as the eyes, eyelids, ears, lips, inside the mouth, inside the nose, penis, vagina and anus.
  • Tell your doctor or pharmacist if you do not feel well while using Dalacin T.
  • Tell your doctor immediately if you suffer mild diarrhoea, or seek immediate emergency medical attention if you experience severe diarrhoea which may contain blood. Do this even if it occurs several weeks after stopping Dalacin T.
  • If you are about to be started on any new medicine, remind your doctor and pharmacist that you are using Dalacin T.
  • Tell any other doctors, dentists, and pharmacists who treat you that you are using this medicine.
  • If you become pregnant or plan to breastfeed while using Dalacin T, tell your doctor immediately.
  • Keep all of your doctor's appointments so that your progress can be checked.

Things you should not do

  • Do not stop using this medicine without talking to your doctor.
  • Do not give your medicine to anyone else, even if they have the same condition as you.
  • Do not use Dalacin T to treat any other illnesses unless your doctor tells you to.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Dalacin T affects you.

Drinking alcohol

No information available.

Looking after your medicine

Store it in a cool dry place where the temperature stays below 25°C, away from moisture, heat, or sunlight; for example, do not store it:

  • in the bathroom or near a sink, or
  • in the car or on window-sills.

Keep it where young children cannot reach it.

A locked cupboard at least one-and-a-half meters above the ground is a good place to store medicines.

When to discard your medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Side effects

Side effectsWhat to do
  • Symptoms of cold/flu, cough, sore throat, stuffy nose, congestion
  • dizziness
  • headache
  • eye pain or irritation.
  • nausea, vomiting
  • constipation
  • coloured tongue
  • stomach pain, indigestion, heartburn, bloating, passing excessive wind
  • skin problems such as flaking, itching, burning, dryness, irritation, oiliness, discoloration, blisters
  • weight loss
  • change in taste or voice
  • hair loss or small pimples around hair follicles that may be itchy or sore
  • swelling of the hands, ankles or feet
  • numbness of the face
  • nosebleed
  • broken bones
Speak to your doctor if you have any of these side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
  • severe diarrhoea which may have blood and mucus, stomach pain, fever
  • bleeding or bruising more easily than normal
  • signs of allergy (rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing)
  • discomfort when urinating, change in urinary color/frequency/urgency.
  • rapid heartbeat, chest tightness
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/safety/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

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

What Dalacin T contains

Active ingredient
(main ingredient)		clindamycin phosphate
Other ingredients
(inactive ingredients)		cetostearyl alcohol
glycerol
glyceryl monostearate
isostearyl alcohol
methyl hydroxybenzoate
mono- and di-glycerides
potassium hydroxide
purified water
sodium lauroyl sarcosinate
stearic acid
Potential allergensmethyl hydroxybenzoate

Do not take this medicine if you are allergic to any of these ingredients.

What Dalacin T looks like

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

AUST R 67060 - DALACIN T 1% clindamycin 10mg/mL (as phosphate) lotion bottle

Who distributes Dalacin T

Pfizer Australia Pty Ltd
Level 17, 151 Clarence Street SYDNEY NSW 2000
Toll Free Number: 1800 675 229
www.pfizermedicalinformation.com.au

This leaflet was prepared in December 2024.

®Registered Trademark

© Pfizer

Published by MIMS February 2025

BRAND INFORMATION

Brand name

Dalacin T Topical Lotion

Active ingredient

Clindamycin

Schedule

S4

 

1 Name of Medicine

Clindamycin phosphate.

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.

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.

4.2 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.

4.3 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.

4.7 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.

4.8 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.

4.9 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).

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.

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.

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.

7 Medicine Schedule (Poisons Standard)

Schedule 4 (Prescription Only Medicine).

Summary Table of Changes