Consumer medicine information

Kenacomb Ointment

Gramicidin; Neomycin; Nystatin; Triamcinolone acetonide

BRAND INFORMATION

Brand name

Kenacomb

Active ingredient

Gramicidin; Neomycin; Nystatin; Triamcinolone acetonide

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Kenacomb Ointment.

What is in this leaflet

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

Always follow the instructions that your doctor or pharmacist give you about KENACOMB ointment.

Ask your doctor or pharmacist if you have any concerns about using this medicine.

Do not throw this leaflet away. You may need to refer to it again later.

What KENACOMB ointment is used for

KENACOMB ointment is used to relieve the inflammation and itching of skin conditions which are likely to become infected or are already infected.

KENACOMB is an ointment containing a combination of the following medicines:

  • triamcinolone acetonide, belongs to a class of drugs called corticosteroids, which helps to relieve itching, inflammation and redness.
  • neomycin, is an antibacterial medicine
  • gramicidin, is an antibacterial medicine
  • nystatin, is an antifungal drug. It is used to prevent or treat a particular type of fungal infection called Candida albicans.

Ask your doctor if you have any questions about why KENACOMB ointment has been prescribed for you. Your doctor may have prescribed it for another purpose.

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

For external use only.

Use in children:

KENACOMB ointment should be used carefully in children. Using it long term or on large areas of skin can cause systemic side effects through absorption of the ointment.

Before you use it

When you must not use it

Do not use KENACOMB ointment if you have an allergy to:

  • any medicine containing nystatin, neomycin, gramicidin, triamcinolone acetonide
  • any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin.

Do not use this ointment if you have any of the following medical conditions:

  • viral skin infections such as shingles, chicken pox, cold sores
  • tuberculosis.

Do not use KENACOMB ointment in the eyes.

Do not use it after the expiry date printed on the back of the pack. If this medicine is used after the expiry date has passed, it may not work as well.

Do not use it if the packaging is torn or shows signs of tampering.

Before you start to use it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have extensive areas of skin damage or other conditions where absorption of neomycin is possible.

Tell your doctor if you are pregnant or plan to become pregnant.

Tell your doctor if you are breast feeding or plan to breast feed. Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell them before you start to use KENACOMB ointment.

Dressings

It is not recommended that you use dressings on the affected area unless your doctor tells you. Dressings may increase the absorption of KENACOMB ointment through the skin and increase the possibility of side effects.

Taking other medicines

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

Some medicines and KENACOMB ointment may interfere with each other. Your doctor or pharmacist may have more information on medicines to be careful with or to avoid while using this ointment.

How to use it

KENACOMB ointment is for external use only.

It is important that you always follow your doctor's instructions about how much KENACOMB ointment to use, how often you should use it, and for how long.

How to use it

Apply the ointment onto the affected areas, two to three times daily.

Wash your hands before and after rubbing it in.

Be careful not to get any in your eyes when applying the ointment.

How long to use it

Your doctor will tell you how long you need to use KENACOMB ointment. Even if symptoms improve within the first few days of treatment, you should not interrupt or stop KENACOMB ointment until the prescribed course of treatment has been completed.

If you forget to use it

If you forget one or more applications, do not apply more than the usual amount to make up for the missed dose. If you do, this may increase the chance of you getting an unwanted side effect.

At the next application time, apply the normal amount and continue the course of treatment.

Tell your doctor if for any reason you have not used KENACOMB ointment exactly as prescribed.

If you swallow it or apply too much (overdose)

If you apply too much or swallow it accidentally, immediately call your doctor or the Poisons Information Centre (phone 131126) for advice, or go to Accident and Emergency at your nearest hospital. Do this even if there are no signs of discomfort or poisoning.

While you are using it

Things you must do

Tell all doctors and pharmacists who are treating you that you are using KENACOMB ointment, especially if you are about to start taking any new medicines.

Tell your doctor if your symptoms do not improve or they get worse.

Use the ointment sparingly and wear loosely fitted clothing if you are applying the ointment to the groin area.

Tell your doctor if you become pregnant while using it.

Things you must not do

Do not use tight fitting plastic pants/ garments for incontinence (loss of control of your bladder or bowels) as these garments may act in the same way as occlusive dressings.

Do not bandage, cover or wrap the treated skin unless directed by your doctor.

Do not use KENACOMB ointment under dressings or on large areas of skin unless your doctor tells you.

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

Do not use it to treat any other complaints unless your doctor tells you to.

Do not use it in the eyes.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using KENACOMB ointment. All medicines, including KENACOMB ointment, can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following list of side effects. You may not experience any of them.

Other side effects not listed below may also occur in some people.

Side effects with KENACOMB ointment are uncommon.

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

  • itching, burning, dryness
  • skin irritation
  • excessive hair growth
  • spots that look like acne
  • skin rash
  • changes in the colour of the skin
  • stretch marks.

Tell your doctor as soon as possible if you notice any of the following:

  • ringing in the ears
  • hearing difficulties
  • problems with your balance
  • severe fluid retention
  • passing less urine than normal
  • eye problems e.g. cataracts, glaucoma and blurred vision.

Stop using KENACOMB ointment and tell your doctor immediately or go to the Accident and Emergency Centre at your nearest hospital if you notice any of the following:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin

If you have any of these symptoms, you may be experiencing an allergic reaction to KENACOMB ointment and may need urgent medical attention.

When used in children

Some of the side effects that may occur include:

  • delayed weight gain and growth
  • headaches
  • bulging soft spots on skull.

Some side effects of KENACOMB ointment can only be found when your doctor does tests from time to time to check your progress.

After using it

Storage

Keep your ointment in a cool dry place where the temperature stays below 25°C.

Do not store KENACOMB ointment, or any other medicine in the bathroom or near the kitchen sink. Do not leave it in the car or on the window sill. Heat and dampness can destroy some medicines.

Keep it 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 the ointment, or the ointment has passed its expiry date, ask your pharmacist what to do with any that is left over.

Product description

What it looks like

KENACOMB ointment is a yellow coloured ointment. Available in single packs of 15 g and 30 g aluminium tubes.

Ingredients

KENACOMB ointment contains:

Active ingredients:

  • triamcinolone acetonide: 1 mg/g
  • neomycin (as sulfate): 2.5 mg/g
  • gramicidin: 0.25 mg/g
  • nystatin: 100,000 IU/g.

Inactive ingredients:

  • liquid paraffin
  • polyethylene.

Sponsor

Aspen Pharmacare Australia Pty Ltd
34-36 Chandos Street
St Leonards NSW 2065
Australia

Australian Registration Number: AUST R 19197

Date of revision: September 2019

Published by MIMS December 2019

BRAND INFORMATION

Brand name

Kenacomb

Active ingredient

Gramicidin; Neomycin; Nystatin; Triamcinolone acetonide

Schedule

S4

 

1 Name of Medicine

Triamcinolone acetonide; nystatin; neomycin (as sulfate) and gramicidin.

6.7 Physicochemical Properties

Kenacomb contains the synthetic corticosteroid triamcinolone acetonide; the antifungal agent nystatin; and the antibiotic agents neomycin (as sulfate) and gramicidin.

Chemical structure.


See Table 1.

CAS number.

Triamcinolone acetonide: 76-25-5. Nystatin: 1400-61-9. Neomycin (as sulfate): 14058-10-3. Gramicidin: 1405-97-6.

2 Qualitative and Quantitative Composition

Kenacomb ointment for topical use contains triamcinolone acetonide 1 mg (0.1%), neomycin (as sulfate) 2.5 mg, gramicidin 0.25 mg and nystatin 100,000 IU per gram.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Kenacomb Ointment is a yellow to amber coloured ointment.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Triamcinolone acetonide, a topical corticosteroid has anti-inflammatory, antipruritic and vasoconstrictive actions.
Nystatin acts by binding to steroids in the cell membrane of susceptible species resulting in a change in membrane permeability and the subsequent leakage of intracellular components.
On repeated subculturing with increasing levels or nystatin Candida albicans does not develop resistance to nystatin. Generally, resistance to nystatin does not develop during therapy.
Nystatin exhibits no activity against bacteria, protozoa or viruses.
Neomycin and gramicidin provide antibacterial activity against microorganisms likely to be responsible for topical bacterial infections.
Neomycin exerts its antibacterial activity against a number of gram-negative organisms by inhibiting protein synthesis. It is not active against Pseudomonas aeruginosa, and resistant strains of gram-negative bacteria may develop.
Gramicidin exerts its antibacterial activity against many gram-positive organisms by altering cell membrane permeability.
The mechanism of anti-inflammatory activity of topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognisable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.
These ingredients give symptomatic relief of the pain, burning and itching of infected skin, while combating the relevant bacterial and/or monilial infection.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

The extent of percutaneous absorption of topical steroids is determined by many factors including the vehicle, the integrity of the epidermal barrier and the use of occlusive dressings.
Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption (see Section 4.4 Special Warnings and Precautions for Use).
Once absorbed through the skin, topical corticosteroids are handled through the same pharmacokinetic pathways as systemically administered corticosteroids.
Nystatin and gramicidin are not absorbed from intact skin or mucous membranes. Neomycin can be absorbed through inflamed skin.

Distribution.

Corticosteroids are bound to plasma proteins in varying degrees.

Metabolism and excretion.

Corticosteroids are metabolised primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.
Once absorbed neomycin is rapidly excreted unchanged through the kidneys. The half-life is approximately 2 to 3 hours.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

4 Clinical Particulars

4.1 Therapeutic Indications

Kenacomb is indicated for the relief of the inflammatory and pruritic manifestations of dermatoses likely to become or which are already infected.

4.3 Contraindications

Known hypersensitivity to triamcinolone, neomycin, nystatin or gramicidin.
Ophthalmic use.
Tuberculous lesions and most viral lesions of the skin such as Herpes simplex, but particularly in vaccinia and varicella.

4.4 Special Warnings and Precautions for Use

General.

If sensitivity or irritation develops, use of this medication should be discontinued and appropriate therapy instituted. Hypersensitivity reactions to the anti-infective components may be masked by the presence of a corticosteroid.
Because of the potential hazard of nephrotoxicity and ototoxicity, this medication should not be used in patients with extensive skin damage or other conditions where absorption of neomycin is possible.
The use of occlusive dressing should be avoided because of the increased risk of sensitivity reactions and increased percutaneous absorption, particularly of triamcinolone acetonide and neomycin.
As with any antibiotic preparation, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi other than Candida. Corticosteroids, furthermore, can enhance microbial infections. Therefore constant observation of the patient is essential. Should superinfection due to nonsusceptible organisms occur, suitable concomitant antimicrobial therapy must be administered. If a favourable response does not occur promptly, application should be discontinued until the infection is adequately controlled by other anti-infective measures.
Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycaemia and glucosuria in some patients.
Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas and prolonged use. Therefore, patients receiving a large dose of any potent topical steroid under any condition(s) which may enhance systemic absorption should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests, and for impairment of thermal homeostasis. If any of these conditions occur, an attempt should be made to withdraw the drug, to reduce the frequency of application, or substitute a less potent steroid.
Recovery of HPA axis function and thermal homeostasis are generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur requiring supplemental systemic corticosteroids.

Visual disturbance.

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Information for patients.

Patients using this medication should receive the following information and instructions:
1. This medication is to be used as directed by the doctor. It is for skin use only. Avoid contact with your eyes.
2. Patients should be advised not to use this medication for any disorder other than that for which it was prescribed.
3. Even if symptomatic relief occurs within the first few days of treatment, the patient should be advised not to interrupt therapy until the prescribed course of treatment is completed.
4. Patients should report any signs of adverse reactions.
5. The treated skin should not be bandaged, covered or wrapped unless directed by the doctor. Do not use tight fitting plastic pants/incontinence garments as these may constitute an occlusive dressing.
6. When using this medication in the inguinal area, patients should be advised to apply the preparation sparingly and to wear loosely fitting clothing.
7. Patients should be advised on preventive measures to avoid reinfection.

Use in the elderly.

No data available.

Paediatric use.

Use of this medication over large surface areas or for prolonged periods in paediatric patients could result in sufficient systemic absorption to produce systemic effects. Paediatric patients may demonstrate greater susceptibility to HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.
HPA axis suppression, Cushing's syndrome and intracranial hypertension have been reported in children receiving topical corticosteroids (see Section 4.8 Adverse Effects (Undesirable Effects), Adverse effects - paediatric patients).
When applied to paediatric patients, this medication should be limited to the least amount for the shortest duration compatible with an effective therapeutic regimen. These patients should be closely monitored for signs and symptoms of systemic effects.

Effects on laboratory tests.

If there is a lack of therapeutic response, KOH smears, cultures or other diagnostic methods should be repeated.
A urinary free cortisol test and ACTH stimulation test may be helpful in evaluating hypothalamic pituitary-adrenal (HPA) axis suppression due to corticosteroid.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Long-term animal studies have not been performed to evaluate carcinogenic or mutagenic potential, or possible impairment of fertility in males or females.
(Category D)
Gentamicin and other aminoglycosides cross the placenta. There is evidence of selective uptake of gentamicin by the foetal kidney resulting in damage (probably reversible) to immature nephrons. Eighth cranial nerve damage has also been reported following in-utero exposure to some of the aminoglycosides. Because of their chemical similarity, all aminoglycosides must be considered potentially nephrotoxic and ototoxic to the foetus. It should also be noted that therapeutic blood levels in the mother do not equate with safety for the foetus.
It is not known whether topical administration of this medicine could result in sufficient systemic absorption of the components to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have deleterious effect on the infant. Nevertheless, caution should be exercised when this medication is administered to a nursing woman.

4.8 Adverse Effects (Undesirable Effects)

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.
Kenacomb is usually well tolerated. The reactions listed, while uncommon, may occur.
The following local adverse reactions are reported infrequently with topical corticosteroids (reactions are listed in approximate decreasing order of occurrence): burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.
Nystatin is well tolerated even with prolonged therapy. Irritation and cases of contact dermatitis have been reported.
Delayed type hypersensitivity reactions have been reported during use of neomycin; sensitisation has been reported following prolonged use. Ototoxicity and nephrotoxicity have been reported when applied to large surfaces or damaged skin.
Sensitivity reactions to gramicidin have been reported.

Adverse effects - paediatric patients.

Manifestations of adrenal suppression in paediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches and bilateral papilloedema.

Post marketing adverse effects.

Eye disorders.

Blurred vision.

4.2 Dose and Method of Administration

Apply to the affected area 2 to 3 times daily.

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

Topically applied corticosteroids and neomycin can be absorbed in sufficient amounts to produce systemic effects (see Section 4.4 Special Warnings and Precautions for Use).

Treatment.

No specific antidote is available, and treatment should be symptomatic.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

Plastibase 50W (PI 2377).

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

Available in single packs of 15 g and 30 g aluminium tubes.

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