Consumer medicine information

Otocomb Otic

Gramicidin; Neomycin; Nystatin; Triamcinolone acetonide

BRAND INFORMATION

Brand name

Otocomb Otic

Active ingredient

Gramicidin; Neomycin; Nystatin; Triamcinolone acetonide

Schedule

SUMMARY CMI

OTOCOMB OTIC ear drops and ointment

Consumer Medicine Information (CMI) summary

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

1. Why am I using OTOCOMB OTIC?

OTOCOMB OTIC contains the active ingredients triamcinolone acetonide, neomycin (as sulfate), gramicidin and nystatin. OTOCOMB OTIC 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.

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

2. What should I know before I use OTOCOMB OTIC?

Do not use if you have ever had an allergic reaction to OTOCOMB OTIC or any of the ingredients listed at the end of the CMI.

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

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

3. What if I am taking other medicines?

Some medicines may interfere with OTOCOMB OTIC and affect how it works.

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

4. How do I use OTOCOMB OTIC?

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.

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

5. What should I know while using OTOCOMB OTIC?

Things you should do	Remind any doctor or pharmacist you visit that you are using OTOCOMB OTIC. Tell your doctor if your symptoms do not improve or they get worse. Tell your doctor if you become pregnant while using OTOCOMB OTIC.
Things you should not do	Do not use this medicine to treat any other complaints unless your doctor tell you to. Do not give this medicine to anyone else, even if they have the same conditions as you. Do not use it in your eyes. Do not swallow it. Do not use OTOCOMB OTIC on damaged skin.
Looking after your medicine	Ear drops: Store at 2-8°C in a refrigerator. Do not freeze. Ointment: Store below 25°C.

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

6. Are there any side effects?

Common side effects include mild itching, burning, dryness, skin rash and slow wound healing. Tell your doctor if you notice any ringing in the ears, balance problems, severe fluid retention or eye problems. Stop using this medicine if you notice any allergic reactions which can include shortness of breath, swelling or severe hives.

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

FULL CMI

OTOCOMB OTIC ear drops and ointment

Active ingredients: triamcinolone acetonide, neomycin (as sulfate), gramicidin & nystatin

Consumer Medicine Information (CMI)

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

Where to find information in this leaflet:

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

1. Why am I using OTOCOMB OTIC?

OTOCOMB 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.

OTOCOMB OTIC is only available on prescription from your doctor.

Use in Children

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

2. What should I know before I use OTOCOMB OTIC?

Warnings

Do not use OTOCOMB 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 OTOCOMB 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 OTOCOMB 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 and 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.

Tell your doctor if you or your family members have a mitochondrial mutation disease or loss of hearing due to antibiotic medicines.

Certain mitochondrial mutations may increase your risk of hearing loss with this product.

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

3. What if I am taking other medicines?

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

Some medicines and OTOCOMB 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 OTOCOMB OTIC.

4. How do I use OTOCOMB OTIC?

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

It is important that you always follow your doctor's instructions about how much OTOCOMB 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 OTOCOMB OTIC.

Even if symptoms improve within the first few days of treatment, you should not interrupt or stop OTOCOMB OTIC until the prescribed course of treatment has been completed.

If you forget to use OTOCOMB OTIC

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 OTOCOMB OTIC exactly as prescribed.

If you use too much OTOCOMB OTIC

If you think that you have used too much OTOCOMB OTIC, you may need urgent medical attention.

You should immediately:

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

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

5. What should I know while using OTOCOMB OTIC?

Things you should do

Tell all doctors and pharmacists who are treating you that you are using OTOCOMB 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 OTOCOMB OTIC.

Things you should not do

Do not use OTOCOMB 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 OTOCOMB OTIC on damaged skin.

Looking after your medicine

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

Ointment:
Store below 25°C.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

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

Do not use this medicine after the expiry date.

6. Are there any side effects?

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

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

Less serious side effects

Less serious side effects	What to do
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 or pharmacist if you notice any of the following and they worry you.
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.	Speak to your doctor if you have any of these less serious side effects.

Serious side effects

Serious side effects	What to do
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 OTOCOMB OTIC and may need urgent medical attention.	Stop using OTOCOMB 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.

When used in children

Some of the side effects that may occur include:

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

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

Other side effects not listed here may occur in some people. Some side effects of OTOCOMB OTIC can only be found when your doctor does tests from time to time to check your progress.

Reporting side effects

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

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

7. Product details

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

What OTOCOMB OTIC contains

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

Ear drops

Active ingredients (main ingredients)	triamcinolone acetonide 0.9 mg/mL neomycin sulfate 2.25 mg/mL gramicidin 0.225 mg/mL nystatin 90,000 IU/mL.
Other ingredients (inactive ingredients)	plastibase 5W plastibase 50W.

Ointment

Active ingredients (main ingredients)	triamcinolone acetonide 1 mg/g neomycin sulfate 2.5 mg/g gramicidin 0.25 mg/g nystatin 100,000 IU/g.
Other ingredient (inactive ingredient)	plastibase 50W.

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

What OTOCOMB OTIC looks like

Ear drops: An oily yellow liquid in a plastic 7.5 mL bottle with a dropper nozzle (AUST R 56477)

Ointment: A yellow to amber coloured ointment in a 5 g tube with a tapered nozzle (AUST R 56460).

Who distributes OTOCOMB OTIC

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

This leaflet was revised in April 2024.

Published by MIMS June 2024

BRAND INFORMATION

Brand name

Otocomb Otic

Active ingredient

Gramicidin; Neomycin; Nystatin; Triamcinolone acetonide

Schedule

1 Name of Medicine

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

2 Qualitative and Quantitative Composition

Ointment.

Each gram of Otocomb Otic ointment provides triamcinolone acetonide 1 mg, neomycin (as sulfate) 2.5 mg, gramicidin 0.25 mg and nystatin 100,000 IU.

Ear drops.

Each mL of Otocomb 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.

4 Clinical Particulars

4.1 Therapeutic Indications

Otocomb 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.
Otocomb Otic is only recommended for short-term use.

4.2 Dose and Method of Administration

Prior to administration of any Otocomb 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.

4.3 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 perforate 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.
Patients with mitochondrial DNA mutations, particularly the nucleotide 1555 A to G substitution in the 12S rRNA gene may be at higher risk for ototoxicity, even if the patient's aminoglycoside serum levels were within the recommended range. In case of family history of aminoglycoside-induced deafness or known mitochondrial DNA mutations in the 12S rRNA gene, alternative treatments other than aminoglycosides may need to be considered.
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), 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. 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 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.
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.

4.7 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.

4.8 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.
Otocomb 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.

4.9 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).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Otocomb 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 combating 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.

6 Pharmaceutical Particulars

6.1 List of Excipients

Ointment.

Plastibase 50W.

Ear drops.

Plastibase 50W and Plastibase 5W.

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.

5 g aluminium tube with a tapered nozzle.

Ear drops.

7.5 mL plastic bottle with a dropper nozzle.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

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

Chemical structure.

Triamcinolone acetonide.

Nystatin.

Neomycin (as sulfate).

Gramicidin.

See Table 1.

CAS number.

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

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

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Consumer medicine information

Otocomb Otic

Gramicidin; Neomycin; Nystatin; Triamcinolone acetonide

Keep track of your medicines

BRAND INFORMATION