Consumer medicine information

Dalacin V Cream

Clindamycin

BRAND INFORMATION

Brand name

Dalacin V Cream 2%

Active ingredient

Clindamycin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Dalacin V Cream.

What is in this leaflet

This leaflet answers some common questions about Dalacin V Cream. 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 V Cream against the benefits it is expected to have for you.

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

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

What Dalacin V Cream is used for

Dalacin V Cream is an antibiotic. It is used to treat vaginal infection.

Dalacin V Cream works by stopping the growth of the bacteria causing the vaginal infection.

Your doctor may have prescribed Dalacin V Cream for another purpose. Ask your doctor or pharmacist if you have any questions about why Dalacin V Cream has been prescribed for you.

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

Before you use Dalacin V Cream

When you must not use it

Do not use Dalacin V Cream if you have an allergy to clindamycin or lincomycin or any of the ingredients in Dalacin V Cream listed at the end of this leaflet.

Do not use Dalacin V Cream if the packaging is torn or shows signs of tampering.

Do not use Dalacin V Cream if the expiry date (EXP) printed on the pack has passed.

If you are not sure whether you should start using Dalacin V Cream, contact your doctor.

Before you start to use it

You must tell your doctor if:

  1. you have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes
  2. you are pregnant or intend to become pregnant
    Your doctor will discuss the risks and benefits of using Dalacin V Cream when pregnant.
  3. you are breast-feeding or plan to breast-feed
    Your doctor will discuss the risks and benefits of using Dalacin V Cream when breastfeeding.
  4. you have or have had any other medical conditions, including inflammation of the bowel or severe diarrhoea associated with the use of antibiotics.

If you have not told your doctor about any of the above, tell him/her before you use Dalacin V Cream.

Using other medicines

Tell your doctor if you are using other creams, ointments or lotions or 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 V Cream. These include:-

  • the antibiotic, erythromycin
  • medicines used for muscle relaxation in anaesthesia

These medicines may be affected by Dalacin V Cream or may affect how well Dalacin V Cream 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 V Cream.

How to use Dalacin V Cream

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

If you do not understand the instructions in this leaflet, ask your doctor or pharmacist for help.

How much to use and how long to use Dalacin V Cream

The recommended dose of Dalacin V Cream is one applicator-full (about 5 grams) of cream, once-a-day, at bedtime, for seven days in a row.

How to use Dalacin V Cream

The plastic applicators provided with Dalacin V Cream are designed to allow the correct placement of the cream in the vagina. To load and use the applicator correctly, follow these steps:

  • Wash hands thoroughly with soap and water before and after using the vaginal applicator.
  • Remove the cap from the tube of cream.
  • Screw the open end of the applicator onto the tube. Gently squeeze from the base of the tube, forcing the cream into the applicator.
  • As the cream enters the applicator, the plunger will be pushed back until it reaches the stopping point. At this stage, unscrew the applicator from the tube and replace the cap.
  • Choose a position to apply Dalacin V cream which is comfortable for you, keeping in mind that the applicator must reach as high as is comfortable in the vagina. This may be the position which you usually use for the insertion of a tampon. For example:
    a) squatting;
    b) standing with your legs apart or with one leg raised on a chair;
    c) lying on your back with your legs raised.
  • The lips of the vagina should be parted with the fingers of one hand. Grasp the applicator between the thumb and middle finger of the other hand and insert it (open end first) into the vagina as deeply as it will comfortably reach.
  • Holding the applicator in place, slowly push the plunger until it stops, so depositing the cream in the vagina.
  • Carefully withdraw the applicator from the vagina and dispose of the applicator safely where children cannot find it.

If you forget to use Dalacin V Cream

If it is almost time for your next dose, skip the dose you missed and use your next dose when you are meant to. Otherwise, use it as soon as you remember, and then go back to using Dalacin V Cream as you would normally.

Do not use a double dose to make up for the dose that you missed.

If you use too much

It is important that you do not use more Dalacin V Cream than your doctor has prescribed. If you do use more Dalacin V Cream than you have been prescribed, contact your doctor for advice. Some of the symptoms which you may experience if you use Dalacin V Cream too often include, increased irritation of the vagina, vulva and cervix.

If Dalacin V Cream is swallowed

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

While you are using Dalacin V Cream

Things you must do

Tell all doctors and pharmacists who are treating you that you are using Dalacin V Cream.

If you are about to start taking any new medicines, tell your doctor and pharmacist that you are using Dalacin V Cream.

If you feel that Dalacin V Cream is not helping your condition, tell your doctor.

Tell your doctor if, for any reason, you have not used Dalacin V Cream exactly as prescribed.

Things you must not do

Do not use condoms or vaginal contraceptive diaphragms as methods of contraception while using Dalacin V Cream or within 72 hours after the end of your treatment with Dalacin V Cream. Condoms or diaphragms may not work as mineral oil in Dalacin V Cream may weaken the latex or rubber in these contraceptive devices.

Do not take any medicines for diarrhoea (e.g., Lomotil) without first checking with your doctor.

Do not give Dalacin V Cream to anyone else, even if they have the same condition as you.

Do not use Dalacin V Cream to treat other complaints unless your doctor tells you to.

Things to be careful of

Dalacin V Cream will cause burning and irritation if it gets in your eyes. If by accident you get Dalacin V Cream in your eyes, rinse the eye with lots of cool tap water.

Side effects

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

Like other medicines, Dalacin V Cream 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.

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:

  • vaginal irritation
  • vaginal itching
  • vaginal discharge
  • dizziness
  • headache
  • vertigo
  • heartburn
  • nausea
  • vomiting
  • diarrhoea
  • constipation
  • stomach pain
  • rash
  • hives (itchy rash)
  • redness of the skin (erythema)
  • pain when passing urine.
  • pelvic pain
  • back pain
  • irregular menstruation
  • altered taste
  • bad breath
  • flatulence

Tell your doctor immediately if you notice any of the following side effects while you are using Dalacin V Cream or several weeks after stopping treatment:

  • 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. You may need urgent medical attention.

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.

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

After using Dalacin V Cream

Storage

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

Keep Dalacin V Cream 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 V Cream or it has passed its expiry date, ask your pharmacist what to do with any cream left over.

Product description

What it looks like

Dalacin V is a white cream. It is available in a 40 g collapsible laminate tube. Each 40 g pack also contains 7 disposable applicators intended to be used once only at night for 7 days.

Ingredients

Dalacin V Cream contains clindamycin phosphate, the active ingredient, in a white cream base in a strength of 20 mg clindamycin per gram (2%).

Dalacin V Cream also contains:

  • sorbitan monostearate
  • polysorbate 60
  • propylene glycol
  • stearic acid
  • cetostearyl alcohol
  • cetyl esters wax
  • liquid paraffin
  • purified water
  • benzyl alcohol

Supplier

Dalacin V Cream 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 V Cream, AUSTR 48431.

This leaflet was prepared in April 2020.

® Registered Trademark
© Pfizer Australia Pty Ltd

Published by MIMS July 2020

BRAND INFORMATION

Brand name

Dalacin V Cream 2%

Active ingredient

Clindamycin

Schedule

S4

 

1 Name of Medicine

Clindamycin phosphate.

6.7 Physicochemical Properties

Chemical structure.


Clindamycin is a semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The MW of clindamycin phosphate is 504.96.

CAS number.

CAS Registry Number: 24729-96-2.

2 Qualitative and Quantitative Composition

Dalacin V Cream 2% contains the equivalent of 2% (20 mg/g) free clindamycin as a water soluble ester of clindamycin and phosphoric acid (clindamycin phosphate). Each unit dose of Dalacin V Cream 2% (approximately 5 grams) represents 100 mg of clindamycin.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Intravaginal cream.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clindamycin is a lincosamide antibiotic that inhibits bacterial protein synthesis at the level of the bacterial ribosome. The antibiotic binds preferentially to the 50S ribosomal subunit and affects the translation process. Although clindamycin phosphate is inactive in vitro, rapid in vivo hydrolysis converts this compound to the antibacterially active clindamycin.
Clindamycin, like most protein synthesis inhibitors, is predominantly bacteriostatic and efficacy is associated with the length of time the concentration of active ingredient remains above the MIC of the infecting organism.
Resistance to clindamycin is most often due to modification of the target site on the ribosome, usually by chemical modification of RNA bases or by point mutations in RNA or occasionally in proteins. Cross resistance has been demonstrated in vitro between lincosamides, macrolides and streptogramins B in some organisms. Cross resistance has been demonstrated between clindamycin and lincomycin.
Clindamycin is active in vitro against most strains of the following organisms that have been reported to be associated with bacterial vaginosis.
Bacteroides spp.
Gardnerella vaginalis.
Mobiluncus spp.
Mycoplasma hominis.
Peptostreptococcus spp.
Culture and sensitivity testing of bacteria are not routinely performed to establish the diagnosis of bacterial vaginosis and to guide treatment. Standard methodology for the susceptibility testing of the potential bacterial vaginosis pathogens, Gardnerella vaginalis and Mobiluncus spp. has not been defined. Methods for determining the susceptibility of Bacteroides spp. and Gram-positive anaerobic cocci, as well as Mycoplasma spp. have been described by the Clinical and Laboratory Standards Institute (CLSI) and clindamycin susceptibility breakpoints for Gram-negative and Gram-positive anaerobes have been published by both EUCAST and CLSI. Clinical isolates that test susceptible to clindamycin and resistant to erythromycin should also be tested for inducible clindamycin resistance using the D-test. However, the breakpoints are intended to guide systemic, rather than localised, antibiotic treatment.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Following a once a day (for seven days) dosing of approximately 5 grams of Dalacin V Cream containing the equivalent of 100 mg clindamycin, peak serum clindamycin levels averaged 20 nanogram/mL (range 3 to 93 nanogram/mL) in normal volunteers. Approximately 3% (range 0.1 to 11.3%) of the administered dose was absorbed systemically.
In women with bacterial vaginosis being treated with Dalacin V Cream once daily (5 grams) for seven days, the amount of clindamycin absorbed was 4% (range 0.8 to 8.2%), which approximates results seen in normal volunteers.
The levels of clindamycin absorbed following the intravaginal administration of Dalacin V Cream reached steady state within four days of the seven day regimen.

5.3 Preclinical Safety Data

Carcinogenicity.

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

Genotoxicity.

Genotoxicity tests performed included a rat micronucleus test and an Ames test. Both tests were negative.

4 Clinical Particulars

4.1 Therapeutic Indications

Dalacin V Cream 2% is indicated for the treatment of symptomatic bacterial vaginosis.

Note.

For the purposes of this indication, bacterial vaginosis is usually defined by positive results to at least three of the four following criteria.
1. Vaginal discharge with pH > 4.5.
2. Vaginal discharge demonstrating an amine ("fishy") odour with the addition of 10% potassium hydroxide.
3. Vaginal discharge with "clue cells" on microscopy.
4. A Gram stain consistent with a diagnosis of bacterial vaginosis (Lactobacillus morphotype absent or markedly decreased, Gardnerella morphotype predominant flora, white blood cells absent or few, Mobiluncus morphotype may or may not be present).
Other pathogens which may be associated with genital infection such as Trichomonas vaginalis, Candida albicans, Chlamydia trachomatis and Neisseria gonorrhoeae should be ruled out by appropriate laboratory means.

4.3 Contraindications

Clindamycin phosphate cream is contraindicated in patients with a history of hypersensitivity to clindamycin, lincomycin or other components of the cream (see Section 6.1 List of Excipients). Clindamycin phosphate cream is also contraindicated in individuals with a history of inflammatory bowel disease or history of antibiotic associated colitis.

4.4 Special Warnings and Precautions for Use

For intravaginal use only. Not for ophthalmic, dermal or oral use.
Antibiotic associated pseudomembranous colitis has been reported with many antibiotics, including clindamycin. A toxin produced by Clostridium difficile appears to be the primary cause. The severity of the colitis may range from mild to life threatening. It is important to consider this diagnosis in patients who develop diarrhoea or colitis in association with the use of antibiotics, including vaginally administered clindamycin (approximately 4% of the administered dose is absorbed systemically, see Section 5.2 Pharmacokinetic Properties). Symptoms may occur up to several weeks after cessation of antibiotic therapy.
Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone, however, in moderate to severe cases appropriate therapy with a suitable oral antibacterial agent effective against Clostridium 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 (e.g. Lomotil)) may prolong and/or worsen the condition and should not be used.
Dalacin V Cream 2% should be used with caution in patients with a history of regional enteritis, ulcerative colitis or antibiotic associated colitis.
The use of intravaginal clindamycin phosphate may result in the localised overgrowth of nonsusceptible organisms, particularly yeasts. Clindamycin has shown in vitro activity against Lactobacilli sp., which are the predominant bacteria in normal vaginal flora. In clinical trials approximately 14% of patients treated with Dalacin V Cream 2% developed symptomatic cervicitis/ vaginitis predominantly due to C. albicans (see Section 4.8 Adverse Effects (Undesirable Effects)).
The persistence of symptoms following treatment with Dalacin V Cream 2% should alert the clinician to the possibility of concomitant infection with organisms such as Trichomonas vaginalis, Candida albicans, Chlamydia trachomatis and Neisseria gonorrhoeae. Appropriate microbiological investigations and therapy directed at such organisms should be considered.
The patient should be instructed not to engage in vaginal intercourse or use other vaginal products (such as tampons or douches) during treatment with clindamycin vaginal cream.
This cream contains mineral oil. As mineral oil may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms, the use of these contraceptive devices is not recommended within 72 hours following treatment with Dalacin V Cream 2%.
Dalacin V Cream 2% contains ingredients that will cause burning and irritation of the eyes. In the event of accidental contact with the eyes, rinse the eye with copious quantities of cool tap water.

Use in the elderly.

Clinical studies for clindamycin phosphate vaginal cream 2% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Paediatric use.

The safety and effectiveness of Dalacin V Cream 2% has not been established in children.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Cross resistance has been demonstrated between clindamycin, erythromycin and lincomycin.
No systemic drug interactions are known or anticipated with Dalacin V Cream. Antagonism has been demonstrated between clindamycin and erythromycin in vitro, however, this potential interaction would not appear to be applicable unless erythromycin was also applied intravaginally.
Systemic clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents.
As the studies involving Dalacin V Cream did not allow concurrent intravaginal medication to be administered, there are no data regarding the concomitant use of other intravaginal medications.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Fertility studies in rats treated orally with up to 300 mg/kg/day (31 times the human exposure based on mg/m2) revealed no effects on fertility or mating.
(Category A)
Category A where the fetal membranes are intact.
Studies of Dalacin V Cream 2% have not been conducted in women during the first trimester.
It is not known if clindamycin is excreted in human breast milk following the use of vaginally 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)

Clinical trials.

Non-pregnant women.

In clinical trials involving non-pregnant women, medical events judged to be related, probably related, possibly related or of unknown relationship to Dalacin V Cream 2% were reported in 20.7% of the patients receiving treatment for 3 days and 21.3% of the patients receiving treatment for 7 days. Events occurring in ≥ 1% of patients receiving 3 day or 7 day Dalacin V Cream 2% are shown in Table 1.
The following ADRs were reported in < 1% (uncommon) of the patients receiving clindamycin vaginal cream application during clinical trials.

Infections and infestations.

Fungal infection, bacterial infection, skin candida, urinary tract infection, vaginal infection.

Immune system disorders.

Hypersensitivity.

Endocrine disorders.

Hyperthyroidism.

Nervous system disorders.

Headache, dizziness.

Ear and labyrinth disorders.

Vertigo.

Respiratory, thoracic and mediastinal disorders.

Epistaxis.

Gastrointestinal disorders.

Abdominal pain, constipation, diarrhoea, nausea, vomiting, breath odour, dyspepsia, flatulence, gastrointestinal disorder.

Skin and subcutaneous tissue disorders.

Pruritus (non-application site), rash, maculopapular rash, urticaria, erythema.

Reproductive system and breast disorders.

Menstrual disorder, metrorrhagia, vaginal discharge, vulvovaginal pain, endometriosis.

General disorder and administration site conditions.

Inflammation.

Investigations.

Microbiology test abnormal.

Special senses.

Taste perversion.

Pregnant women.

In clinical trials involving women during the second trimester of pregnancy, medical events judged to be related, probably related, possibly related or of unknown relationship to Dalacin V Cream 2% were reported in 22.8% of pregnant patients. Events occurring in ≥ 1% of patients receiving Dalacin V Cream 2% or placebo are shown in Table 2.
Events occurring in < 1% of the patients receiving Dalacin V Cream 2% with a frequency of uncommon include the following.

Infections and infestations.

Candida infection, upper respiratory tract infection, vulvovaginitis trichomonal.

Gastrointestinal disorders.

Diarrhoea.

Skin and subcutaneous tissue disorders.

Erythema.

Renal and urinary disorders.

Glycosuria, proteinuria, dysuria.

Reproductive system and breast disorders.

Metrorrhagia, vulvovaginal pain.

Postmarketing experience.

Postmarketing experience of the patients receiving Dalacin V Cream 2% with a frequency category of frequency not known include:

Gastrointestinal disorders.

Pseudomembranous colitis, abdominal distension.

Musculoskeletal and connective tissue disorders.

Back pain.

Reproductive system and breast disorders.

Pelvic pain.

General disorder and administration site conditions.

Pain.

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

The recommended dose of Dalacin V Cream 2% is one applicator full (approximately 5 grams) of cream intravaginally at bedtime for seven (7) consecutive days.

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

Clindamycin from Dalacin V Cream 2% may be absorbed in sufficient amounts to produce systemic effects. Acute ingestion of clindamycin has not been associated with significant toxicity. Gastrointestinal decontamination is probably not necessary in most cases.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

6 Pharmaceutical Particulars

6.1 List of Excipients

Sorbitan monostearate, polysorbate 60, propylene glycol, stearic acid, cetostearyl alcohol, cetyl ester wax, liquid paraffin, purified water, benzyl alcohol (each 5 g contains 50 mg benzyl alcohol as preservative).

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 V Cream 2% is supplied in a 40 g collapsible laminate tube. Each 40 gram pack also contains seven (7) single-use disposable applicators, intended to be used once nightly for seven (7) days.

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