Consumer medicine information

ClindaTech

Clindamycin

BRAND INFORMATION

Brand name

ClindaTech Topical solution

Active ingredient

Clindamycin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using ClindaTech.

What is in this leaflet

ClindaTech is the brand name of a skin preparation containing clindamycin hydrochloride and a moisturiser. ClindaTech Topical Solution is a clear solution packed in a bottle with an outer carton.

It contains clindamycin hydrochloride 1% (active ingredient), ethanol, dioctyl malate and purified water.

It is available in two pack types, i.e. 50mL and 100mL.

What ClindaTech is used for

Clindamycin belongs to a group of medicines called antibiotics. It is available only with a doctor's prescription. Topical clindamycin is used on the skin to treat certain forms of acne. It works by decreasing acne lesions and/or stopping the growth of skin bacteria which cause acne. It is usually used by itself, but your doctor may prescribe one or more other medicines that are applied on the skin or taken by mouth. Your doctor may also prescribe ClindaTech for another purpose. Therefore, ask your doctor if you have any questions why ClindaTech has been prescribed for your conditions.

Before you use ClindaTech

Ask your doctor or pharmacist about this medicine.

Do not use Clindatech if:

  1. you are allergic to medicines that contain clindamycin including those clindamycins taken by mouth or by injection (e.g. Dalacin) or lincomycin (e.g. Lincocin).
  2. you are allergic to any other ingredients in this formulation.
  3. you have a history of inflammatory diseases of the intestines or the large bowel (colitis, including ulcerative colitis, colitis caused by antibiotics, pseudomembranous colitis, or enteritis).
  4. you are breastfeeding or plan to breastfeed.
  5. the expiry date printed on the pack is passed.

Before you start using it

You must tell your doctor if:

  1. you have a history of stomach or intestinal diseases.
  2. you have any medical problems especially affecting the liver or kidney.
  3. you are pregnant or plan on becoming pregnant during treatment.
  4. you have very sensitive skin.
  5. you have any skin disorders.
  6. you are taking any medicines, especially
  • acne preparations;
  • antibiotic preparations;
  • preparations containing clindamycin;
  • erythromycins or tetracycline;
  • preparations containing an abrasive agent (e.g. resorcinol, sulphur, benzoyl peroxide, tretinoin or salicylic acid);
  • skin preparations containing high concentrations of alcohol (e.g. astringents, after-shave lotion).

Tell your doctor or pharmacist if you are taking any other medicines or specific skin products. Your doctor or pharmacist can help you avoid products that may cause problems.

How to use ClindaTech

Follow exactly the instructions of your doctor about when and how to use ClindaTech treatment.

The usual treatment consists of applying a thin film no more than twice daily, once in the morning and once at bedtime. It should be applied to the skin areas being affected as well as those likely to be affected by acne, not just the pimples themselves.

Your doctor would decide the best treatment according to your skin conditions and response. Following carefully the instructions of your doctor and keep using this medicine for the entire course even if the pimples clear up after a few days. However, do not apply more often, or for a longer time than what your doctor has told you.

If your acne does not improve after a few weeks, or if it becomes worse, check with your doctor or pharmacist. The treatment may take up to 8 to 12 weeks before a clear improvement takes place.

How to apply ClindaTech

Before applying this medicine, wash the affected areas thoroughly with warm water and a neutral or pH balanced mild soap, rinse well and pat dry. Shave if needed. Remove any make-up or cosmetics.

Since the medicine contains alcohol, it may irritate freshly washed or shaved skin in some patients. After washing or shaving, allow 15 to 30 minutes before applying the solution.

ClindaTech comes in a bottle with an applicator, which should be used to apply the medicine directly to the skin.

Tilt the bottle and press the tip firmly against your skin. Using a dabbing motion instead of a rolling motion allow the solution to flow through the applicator tip onto the skin.

If the flow is too slow, increase the pressure slightly until the solution flows more freely. If the applicator tip becomes dry, turn the bottle upside down and press the tip several times to moisten it.

Spread the medicine to the affected areas over the entire face. Avoid applying to open wounds, inflamed skin, eyes or any mucous membranes.

If you forget to apply ClindaTech

Apply the medicine as soon as you remember. However, if it is almost time for your next application, skip the dose that you missed and go on to the next application. Do not apply a double dose.

It is important that you do not miss any doses of your topical antibiotic treatment. Ask your pharmacist for some guidance if you have trouble remembering when to apply your treatment.

Using too much solution

Let your doctor know even if you have not had any signs of skin discomfort.

While you are using ClindaTech

Things you must not do

  1. Do not swallow this medicine. Do not take this medicine by mouth. If you or someone else accidentally swallow some solution, contact a doctor or go to the casualty department at your nearest hospital immediately.
  2. Do not use on open wounds.
  3. Do not apply to the eyes, around eyelid areas, mouth, lips, mucosa or angles of the nose.
  4. If the medicine does get in the eyes, wash them out immediately but carefully with large amounts of cool, clean water. If the eyes still burn or become painful, contact your doctor immediately.
  5. Do not apply more often than or longer time than what your doctor told you because it may cause your skin to become too dry.

Things to be careful of

Dry Skin
If your skin becomes unnaturally dry or irritated even under normal use, check with your doctor or pharmacist about adjusting the doses or temporarily discontinue application.

Skin Medications
Do not use any skin preparations of medicated dressings on the same affected areas unless your doctor advised you to do so. If your doctor has prescribed other medicines for applying to the skin, check with your doctor or pharmacist when and how you should apply these medicines.

Abrasive/Alcoholic Products
Avoid using any peeling agents (e.g. resorcinol, salicylic acid, benzoyl peroxide) or preparations that contain high concentrations of alcohol (astringents, medicated cosmetics).

Cosmetics
Check with your doctor or pharmacist which cosmetics and perfumed toiletries you can use. Use a mild bland soap, or any suitable soap-free cleansers as advised by your pharmacist. It is best not to use cosmetics too heavily or too often because this may make your acne worse. Wash off any cosmetics every time before you apply ClindaTech.

Side effects

Like other medicines, ClindaTech may cause some unwanted effects along with its beneficial effects. Most of these side effects are mild and usually temporary. Check with your doctor or pharmacist as soon as possible if you have any problems while you are applying the topical solution. Do this even if you do not think these problems are related to the medicine or are not listed in this leaflet.

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

  • dry skin
  • peeling
  • redness
  • skin rashes
  • oiliness
  • skin irritation
  • stinging or burning feeling
  • mild stomach upset

Stop applying ClindaTech and tell your doctor immediately if you have any of the following as you may need urgent medical care:

  • watery diarrhoea
  • bloody diarrhoea
  • abdominal or stomach cramps
  • nausea or vomiting

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

Other side effects not listed above may occur in some patients. If you notice any other side effects, tell your doctor or pharmacist.

Storage

  • Keep ClindaTech in a cool place below 30°C. Do not freeze or expose it to excessive heat and direct light
  • Do not leave it in the car on a hot day.
  • Keep it where children or pets cannot reach it.
  • Discard the product three months after opening. Do not keep outdated medicine or medicine no longer in use. Ask your pharmacist what to do with any unused medicine.

Further Information

Contact your doctor, pharmacist or the sponsor for any further information.

Sponsor

Made in Australia

iNova Pharmaceuticals (Australia) Pty Limited
ABN: 13 617 871 539
Level 10, 12 Help Street
Chatswood NSW 2067
AUSTRALIA
Australia toll free: 1800 630 056
New Zealand toll free:
0508 375 394

ClindaTech 10mg/mL solution bottle AUST R 66687

® ClindaTech is a Registered Trade Mark

This leaflet was prepared in November 2017.

BRAND INFORMATION

Brand name

ClindaTech Topical solution

Active ingredient

Clindamycin

Schedule

S4

 

1 Name of Medicine

Clindamycin hydrochloride.

6.7 Physicochemical Properties

Chemical name: methyl 6-amino-7-chloro- 6,7,8-trideoxy- N-[(2S,4R)-1-methyl- 4-propylprolyl] -1-thio-L-threo-α-D-galacto-octopyranoside hydrochloride.
Molecular formula is C18H33ClN2O5S.HCl (molecular weight 461.5).

Chemical structure.


CAS number.

21462-39-5.
1.086 g of clindamycin hydrochloride (anhydrous form) is approximately equivalent to 1 g of clindamycin.

2 Qualitative and Quantitative Composition

ClindaTech is a clear hydroalcoholic solution containing clindamycin hydrochloride 1%. Dioctyl malate, a noncomedogenic humectant, is incorporated to prevent skin dryness.
ClindaTech contains alcohol 69% v/v. For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

ClindaTech clindamycin hydrochloride 10 mg/mL solution bottle. A clear, colourless solution.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clindamycin is a lincosamide antibiotic obtained as a semisynthetic derivative from cultures of Streptomyces lincolnensis. It is active in vitro and in vivo against most aerobic Gram positive cocci and several anaerobic and microaerophilic Gram negative and Gram positive organisms including Propionibacterium acnes, a resident anaerobe found in acne susceptible follicles.
Cross resistance has been demonstrated between clindamycin and lincomycin. Antagonism has been demonstrated between clindamycin and erythromycin.
Clindamycin may be bacteriostatic or bactericidal in action, depending on the concentration of the drug attained at the site of infection and the susceptibility of the infecting organism. In vitro studies showed that the minimum inhibitory concentration of clindamycin against most wild strains of P. acnes (46 strains at the concentration of 108/mL) ranged from 0.05 to 0.1 microgram/mL or below. The antibacterial action appears to relate to its ability in inhibiting ribosomal protein synthesis in susceptible organisms by binding to 50S ribosomal subunits.
The precise mechanism by which clindamycin reduces acne lesions has not been fully elucidated. Its therapeutic efficacy appears to act through its ability to decrease acne lesions, suppress or eliminate P. acnes in the sebaceous follicles, inhibit lipase activity, and reduce the levels of free fatty acids in skin surface lipids. Applied to the skin, clindamycin markedly reduces the follicular population of P. acnes and the concentration of skin surface free fatty acids.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Pharmacokinetic studies have not been undertaken with ClindaTech. Published results of studies which involved other clindamycin formulations are described below.
In an in vitro model using human skin, approximately 10% of the dose was absorbed into the stratum corneum following topical application of a 1% hydroalcoholic solution of radiolabelled clindamycin as the hydrochloride.
Absorption of clindamycin into comedones was assessed in an in vivo study in which comedones were removed from acne patients who had applied 1% clindamycin hydrochloride twice daily for 2 weeks or longer. The whole comedonal concentration of clindamycin ranged from 0 to 5 microgram/mg of comedonal material with a mean concentration of 0.824 microgram/mg. It was stated that these antibiotic concentrations are above the minimum inhibitory concentration of clindamycin for most wild strains of P. acnes in vitro at 0.05 to 0.1 microgram/mL or below.
Systemic absorption of clindamycin was assessed by measurement of serum clindamycin in another open study of 18 acne patients. No clindamycin was detected in serum from any of the subjects obtained one to nine hours after application of a 1% clindamycin hydrochloride solution. The patients had been instructed to apply the solution with their fingertips to the affected areas 2 to 3 times daily. The duration of use ranged from 6 to 150 days with mean duration at 43.4 days, but the total volume of solution and surface area of application was not stated. The lower limit of quantification was 1 microgram/mL.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

4 Clinical Particulars

4.1 Therapeutic Indications

ClindaTech is indicated for the topical treatment of acne vulgaris, particularly forms in which comedones, papules and pustules predominate.

4.3 Contraindications

ClindaTech is contraindicated in patients with known history of hypersensitivity reactions to preparations containing clindamycin, lincomycin or other ingredients in the formulation.

4.4 Special Warnings and Precautions for Use

For external use only.
ClindaTech has an unpleasant taste. Caution should be exercised when applying the solution around the mouth to avoid any possible ingestion.
Avoid any contact with eyes, eyelids, abraded skin, nasal folds, lips or mucous membranes because of the irritating dryness caused by the alcoholic solvent. In the event of any accidental contact, bathe with copious amount of cool water.

Use with caution in the following circumstances.

ClindaTech contains alcohol and may cause a burning sensation especially in those patients with sensitive skins. Sensitivity reactions including contact dermatitis and rash are rare but may occur in individuals who are hypersensitive to clindamycin, lincomycin or any ingredient of the formulation.
ClindaTech should be prescribed with caution in atopic individuals or patients with impaired hepatic or renal functions. Safety has not been established when applied to areas affected concurrently with other dermatoses or to severely inflamed skin.
The use of clindamycin may cause overgrowth of nonsusceptible organisms. Although rare, Gram negative folliculitis has been reported following topical application of clindamycin. If superinfection occurs, discontinue treatment.
Use of topical clindamycin has been associated with the development of strains of P. 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 clindamycin (ClindaTech).

Check the following before use.

ClindaTech is not indicated in severe and deep nodulocystic acne.
The drug should not be used for patients with a history of ulcerative colitis, regional enteritis or antibiotic associated colitis.
Oral and parenteral clindamycin have been associated with severe diarrhoea and pseudomembranous colitis which may result in patient death. Use of clindamycin hydrochloride topical solution 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) appear 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 colonscopy, 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. Fluid, 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.

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Concurrent use of topical preparations containing alcohol (e.g. astringents, aftershave lotion, medicated cosmetics) should be avoided because they potentiate the drying action on the skin. The solvent vehicles in some abrasive cleansers, medicated soaps or cosmetics are alcoholic. They may cause a cumulative irritant effect in patients undergoing treatment.
Topical acne preparations containing desquamative or abrasive agents (e.g. benzoyl peroxide, salicylic acid, resorcinol or tretinoin) may sensitise the skin to various local reactions. Concurrent use of these agents and topical clindamycin should be treated with caution in combination therapy. Concomitant use of other anti-acne or comedogenic cosmetic products should be avoided.
Both clindamycin and erythromycin appear to compete for the same ribosomal binding site in exerting their antibacterial action. Antagonism between the two anti-infective agents has been demonstrated. Concomitant use of either antibiotic in the topical treatment of acne is not recommended.
Clindamycin has been shown to have neuromuscular blocking properties that may enhance the actions of other neuromuscular blocking agents.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category A)
Reproductive studies have been performed in rats and mice using oral and parenteral doses up to 300 mg/kg/day and have revealed no evidence of harm to the fetus due to clindamycin. There exist, however, no adequate and well controlled studies to demonstrate safety of use in pregnant women.
It is not known if clindamycin is excreted in human milk following use of topically administered clindamycin. However, after oral or parenteral administration clindamycin has been detected in human milk. In the absence of any adequate and well controlled studies, topical clindamycin should not be used in lactating women.

4.8 Adverse Effects (Undesirable Effects)

The most frequent adverse effect associated with the use of topical clindamycin solution is dryness of skin. Other local reactions including erythema, peeling, oiliness, contact dermatitis, irritation, itching and burning have been reported. While the exact proportion of patients reporting skin reactions was not available in controlled clinical studies, these effects were generally mild and most skin intolerance did not cause discontinuation of treatment.
Patients very frequently (> 10%) experience a sensation of warmth, irritating dryness and/ or burning experience following application of topical clindamycin, especially during the early phase of treatment. Many of these reactions can be attributed to the dehydrating effect of the hydroalcoholic vehicle.
Diarrhoea is commonly reported (> 1%, < 10%), and infrequently, abdominal pain, bloody diarrhoea (including pseudomembranous colitis) have also been reported following topical use of clindamycin hydrochloride. In one multicentre, double blind and placebo controlled study comparing two formulations of 1% topical clindamycin in acne patients, it was noted that 6 of the 120 patients (≈ 5%) in the clindamycin hydrochloride group, 6 of the 124 patients (≈ 5%) in the clindamycin phosphate group and 2 of the 113 patients (≈ 2%) in the placebo group reported diarrhoea during the 8 week study. The diarrhoea episode in one clindamycin treated patient was considered by the investigator to be related to treatment. Sigmoidoscopy was performed and there was no evidence of pseudomembranous colitis. The other patients with diarrhoea continued the study and diarrhoea settled. No cause and effect relationship was established.

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 www.tga.gov.au/reporting-problems.

4.2 Dose and Method of Administration

ClindaTech is for external use only and is applied directly on the skin.
Wash the entire face with mild, non-alkaline soap and warm water prior to any application. Using the Dab-O-Matic applicator provided, apply a thin film directly to each acne lesion or to areas having potential of eruption.
ClindaTech is usually applied to affected areas twice daily, once every morning and once at bedtime. The frequency of treatment will depend on the severity of acne condition as well as skin tolerance, but should not be more than twice daily.
Treatment of acne vulgaris needs to be individualised according to the type of lesion predominating and the response of therapy. Application to the entire face of an average adult is equivalent to approximately 2 mL of solution or clindamycin 20 mg.
Generally, a decrease in the number of inflammatory lesions should be noticed after two or six weeks, but more than eight weeks of therapy may be required before any definite beneficial effects are observed. Therapy is usually continued until a satisfactory response is obtained. If condition does not seem to improve or worsens, modification of treatment or alternative therapy should be considered.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
No information is available concerning overdosage of topical clindamycin in humans.

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

Dioctyl malate, ethanol, purified water.

6.2 Incompatibilities

Information on the physical or chemical compatibility of topical clindamycin with other topical preparations is not available. ClindaTech should only be constituted using the base solution provided.

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 30°C. Do not freeze or expose to excessive heat and direct light.

6.5 Nature and Contents of Container

ClindaTech is packaged in a ready to use pack.
The ready to use pack, in either 6 mL*, 10 mL*, 30 mL*, 50 mL or 100 mL, consists of a white HDPE bottle fitted with a screw neck top and a Dab-O-Matic applicator and a polypropylene closure.
* Not marketed.
A package insert is included with the product in the carton.

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