Consumer medicine information

Kenacomb Otic

Gramicidin; Neomycin; Nystatin; Triamcinolone acetonide

BRAND INFORMATION

Brand name

Kenacomb Otic

Active ingredient

Gramicidin; Neomycin; Nystatin; Triamcinolone acetonide

Schedule

S4

 

Consumer medicine information (CMI) leaflet

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

What is in this leaflet

This leaflet answers some common questions about KENACOMB OTIC. 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 OTIC.

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 OTIC is used for

KENACOMB OTIC is available in either ear drops or ointment forms and is used to relieve itching, burning, pain or inflammation of the outer ear and ear canal when it is infected or likely to be infected. It contains a combination of 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.

Your doctor will need to look inside your ears, especially at your eardrums and may have to clean your ears before prescribing this medicine.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

KENACOMB OTIC is only available on prescription from your doctor.

Use in Children

KENACOMB OTIC should be used carefully in children. Long term use can cause systemic side effects through absorption of KENACOMB OTIC.

Before you use it

When you must not use it

Do not use KENACOMB OTIC 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 medicine if you have any of the following medical conditions:

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

Do not use KENACOMB OTIC to treat a middle ear infection.

Do not use this medicine if your ear drums are perforated.

Do not use it in the eyes.

Do not use after the expiry date has passed.

Do not use KENACOMB OTIC ear drops if the protective seal on the bottle has been broken.

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 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 OTIC.

Taking other medicines

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

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

How to use it

KENACOMB OTIC should only be used as directed by your doctor.

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

How to apply it

Ear Drops:
Shake well before use.

Squeeze two or three drops into the ear canal, two or three times daily. Alternatively, a gauze wick saturated with the drops may be inserted in the ear canal.

Ointment:
Gently and carefully insert the tapered tip of the tube a short way into the ear canal and squeeze out the ointment, two or three times a day.

The ointment can also be applied to the outer ear if required.

How long to use it

Your doctor will tell you how long you need to use KENACOMB OTIC.

Even if symptoms improve within the first few days of treatment, you should not interrupt or stop KENACOMB OTIC 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 OTIC exactly as prescribed.

If you swallow it or if you apply too much (overdose)

If you apply too much or swallow it accidentally, immediately call your doctor or the Poisons Information Centre (phone 13 11 26) 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 OTIC, especially if you are about to start taking any new medicines.

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

Tell your doctor if you become pregnant while using KENACOMB OTIC.

Things you must not do

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

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

Do not use it in your eyes.

Do not swallow it.

Do not use KENACOMB OTIC on damaged skin.

Side effects

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

All medicines, including KENACOMB OTIC, 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 OTIC are uncommon.

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

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

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 OTIC 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 OTIC 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 OTIC can only be found when your doctor does tests from time to time to check your progress.

After using it

Storage

Ear drops:
Store at 2 - 8°C in a refrigerator. Do not freeze.

Ointment:
Store below 25°C.

Keep all medicines out of reach of children.

Disposal

If your doctor tells you to stop using KENACOMB OTIC, or if it has passed its expiry date, ask your pharmacist what to do with any that is left over.

Product description

KENACOMB OTIC is available either as ear drops or as an ointment.

Ear drops:
A yellow coloured oily liquid in a plastic dropper bottle.

Ointment:
A yellow to amber coloured ointment in a 5 g tube with a cannula tip.

Ingredients

Active ingredients

KENACOMB OTIC ear drops contains:

  • triamcinolone acetonide 0.9 mg/mL
  • neomycin sulfate 2.25 mg/mL
  • gramicidin 0.225 mg/mL
  • nystatin 90,000 IU/mL.

KENACOMB OTIC ointment contains:

  • triamcinolone acetonide 1 mg/g
  • neomycin 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 numbers:

Ear drops: AUST R 19200

Ointment: AUST R 19201.

Date of revision: January 2021

Published by MIMS March 2021

BRAND INFORMATION

Brand name

Kenacomb Otic

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 Otic 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

Each gram of Kenacomb Otic ointment provides triamcinolone acetonide 1 mg, neomycin (as sulfate) 2.5 mg, gramicidin 0.25 mg and nystatin 100,000 IU.
Each mL of Kenacomb Otic ear drops provides triamcinolone acetonide 0.9 mg, neomycin (as sulfate) 2.25 mg, gramicidin 0.225 mg and nystatin 90,000 IU.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Ointment: A yellow to amber coloured ointment.
Ear drops: Oily yellow liquid.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Kenacomb Otic is intended for application to the external auditory canal.
Triamcinolone acetonide, a topical corticosteroid has anti-inflammatory, antipruritic, and vasoconstrictive actions.
Neomycin and gramicidin provide antibacterial activity against microorganisms likely to be responsible for bacterial infections of the external auditory canal.
Neomycin exerts its anti-bacterial 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.
Nystatin, an antifungal antibiotic, is included for the prevention or treatment of Candida albicans infections. 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 of 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.
These ingredients give symptomatic relief of the pain, burning and itching of infected otitis externa, while combatting the relevant bacterial and/or monilial infection.
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.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier and the use of occlusive dressing.
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 Otic is indicated for the treatment of otitis externa (acute and chronic) when a topical corticosteroid is required and active infections with susceptible organisms are either present or likely to supervene.
Kenacomb Otic is only recommended for short-term use.

4.3 Contraindications

Tuberculous lesions and topical or systemic viral infections such as herpes simplex, but particularly in vaccinia and varicella.
In the treatment of otitis media or in the presence of a perforated tympanic membrane.
Known hypersensitivity to triamcinolone, neomycin, nystatin, gramicidin or any other component of the preparation.
Ophthalmic use.

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.
This medication is not for ophthalmic use.
Because of the potential hazard of nephrotoxicity and ototoxicity, this medication should not be used in patients with extensive skin damage where absorption of neomycin is possible. The risk of hypersensitivity to neomycin is increased with prolonged or repeated use.
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 administering these preparations should receive the following information and instructions.
1. This medication is to be used as directed by the physician.
2. Avoid contact with eyes.
3. Patients should be advised not to use this medication for any disorder other than for which it was prescribed.
4. Even if symptomatic relief occurs within the first few days of treatment, the patient should be advised not to interrupt or discontinue the therapy until the prescribed course of treatment is completed.
5. Patients should report any signs of adverse reactions.
6. Exercise special care when introducing the cannula tip into the ear.

Use in the elderly.

No data available.

Paediatric use.

Use of this medication 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.
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), 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. Paediatric 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)
Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after skin application in laboratory animals. 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 report 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.
There are no adequate and well controlled studies in pregnant women on teratogenic effects from topically applied components in this medication.
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 medication 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 a deleterious effect on the infant. Nevertheless, caution should be executed 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 Otic products are 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 an 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.
Corticosteroids may cause damage to collagen which constitutes a middle layer of the tympanic membrane. They may also delay healing, and may exert systemic effects including adrenal suppression if absorbed in appreciable amounts.
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 damaged skin. This antibiotic in itself may cause an allergic otitis externa.
Sensitivity reactions to gramicidin have been reported. While no reports of gramicidin absorption following topical administration have been reported, haemolysis may occur should the drug enter the blood. If gramicidin is allowed to come in close proximity to the subarachnoid space, a chemical arachnoiditis may occur.

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

Prior to administration of any Kenacomb preparation, all wax and epithelial debris should be removed and the tympanic membrane inspected.

Ointment.

Apply to the external auditory meatus (and external ear if required) two or three times daily.

Ear drops.

2 or 3 drops should be instilled into the ear two or three times daily. Alternatively, a gauze wick kept saturated with the drops may be inserted into the external auditory meatus.

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) and Plastibase 5W (PI 2745).

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

Ointment: Store below 25°C.
Ear drops: Store at 2°C to 8°C. (Refrigerate. Do not freeze.)

6.5 Nature and Contents of Container

Ointment: 2.5 g (sample) or 5 g aluminium tube with a cannula tip.
Ear drops: Available in a 7.5 mL plastic dropper bottle.
(Note: Not all pack sizes may be available in Australia.)

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