Consumer medicine information

Colifoam

Hydrocortisone acetate

BRAND INFORMATION

Brand name

Colifoam

Active ingredient

Hydrocortisone acetate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Colifoam.

What is in this leaflet

This leaflet answers some common questions about COLIFOAM. 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 COLIFOAM against the benefits they expect it will have for you.

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

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

What COLIFOAM is used for

COLIFOAM is a type of cortisone and belongs to the group of medicines called corticosteroids.

COLIFOAM is used to treat inflammation of the lower bowel. These diseases can produce severe diarrhoea and pain.

Your doctor may have prescribed COLIFOAM for another purpose.

Ask your doctor or pharmacist if you have any questions about why COLIFOAM has been prescribed for you.

There is no evidence that COLIFOAM is addictive.

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

Before you use COLIFOAM

When you must not use it

Do not use COLIFOAM if you have:

  1. An allergy to:
  • Hydrocortisone Acetate and/or
  • to any of the ingredients at the end of this leaflet
  1. Viral skin infection (such as cold sores, shingles, chicken pox or anal warts).
  2. Fungal skin infection (such as thrush, tinea or ringworm).
  3. Peritonitis, bowel obstruction, abscess, perforation, fresh intestinal anastomoses, or extensive fistulae

Ask your doctor to be sure you do not have any of these conditions.

Do not breastfeed while you are using COLIFOAM unless your doctor says it is safe.

Do not use COLIFOAM just before having a bath, shower or going swimming. If you do, you may reduce the effectiveness of COLIFOAM.

Do not use COLIFOAM if the expiry date (EXP) printed on the pack has passed. If you use this medicine after the expiry date has passed, it may not work as well.

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

Do not use it to treat any other complaints unless your doctor says it is safe.

Do not give this medicine to anyone else.

If you are not sure whether you should start using COLIFOAM, contact your doctor.

Before you start to use it

See your doctor for a check-up before you start to use COLIFOAM.

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 can discuss with you the risks and benefits of using this medicine during pregnancy.
  1. You are breastfeeding or intend to breastfeed.
Your doctor will discuss the risks and benefits of using COLIFOAM when breastfeeding.
  1. You have or have had any other medical conditions including:
  • Liver problems
  • Infections, fever or inflammation
  • Stress
  • Severe affective disorders including depression, manic depressive, anxiety disorders or steroid psychosis
  • Diabetes
  • Tuberculosis
  • Eye problems such as cataracts or glaucoma
  • Severe ulcerative disease
  • Myasthenia gravis
  • High blood pressure
  • Heart disease
  • Renal failure.

If you have not told your doctor about any of the above, tell them before you start using COLIFOAM.

Using other medicines

Tell your doctor or pharmacist if you are using other creams, ointments or lotions or taking any other medicine. This includes any that you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines may interfere with COLIFOAM. These include:

  • Aspirin
  • Non-steroidal anti-inflammatory drugs (NSAIDs)
  • Cardiac glycosides (e.g. Digoxin)
  • Anticoagulants (blood thinners)
  • Diuretics (fluid pills)
  • Anticonvulsants
  • Macrolide antibiotics
  • Ketoconazole
  • Antiretroviral medicines
  • Antidiabetic medicines.
  • Vaccination with live vaccines or other vaccination procedures

These medicines may be affected by COLIFOAM or may affect how well it works. You may need to use different amounts of your medicine, or you may need to use different medicines. Your doctor will advise you.

Your doctor and pharmacist may have more information on medicines to be careful with or avoid while using COLIFOAM.

How to use COLIFOAM

How much to use

Your doctor will prescribe the amount to be used each day. It is normally one to two Applicators full, one in the morning and one at night. Your dose will be shown clearly on the label that your pharmacist puts on your medicine. If it is not, or you are not sure, ask your doctor or pharmacist.

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

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

How to fill the Applicator and administer COLIFOAM
COLIFOAM is a foam enema supplied in an Aerosol Can, filled with white, odourless and expanding foam. Aerosol Can is fitted with white Nozzle. Plastic Applicator with Plunger is also included in the carton and is used to administer foam into the rectum.

Do not attempt to use COLIFOAM until you have examined the illustrations and have read and understood these instructions.

Follow these simple steps:

  1. Closely examine the Applicator, Aerosol Can and Nozzle.
  2. IMPORTANT: Shake the Aerosol Can vigorously up and down for sixty seconds before each use. DO NOT REMOVE NOZZLE.

  1. Place the Aerosol Can upright on a table or a level surface. KEEP THE AEROSOL CAN UPRIGHT DURING THE ENTIRE FILLING PROCEDURE.
  2. Withdraw the Plunger until it stops at the fill line.

  1. Hold the Plunger upright and insert the Aerosol Can Nozzle into the Applicator Tip. Make sure you hold the Plunger and Applicator FIRMLY with your fingers as shown.

  1. Press down gently on top of Aerosol Can with your fingers, until the foam has filled up approximately one quarter of the Applicators body. Only a short press is needed to do this. KEEP PLUNGER WITHDRAWN DURING THIS PROCEDURE.

  1. Wait for a few seconds until the foam stops expanding. DO NOT fill the Applicator in one go. Always release the Nozzle after a short press.
  2. Repeat steps 6 and 7 above until the foam expands to just reach the fill line. Remove Applicator from Aerosol Can. Allow some foam to remain on the Applicator Tip.

  1. Hold Applicator by barrel as shown on the picture below and gently insert Tip sufficiently into the anus to ensure the foam is fully deposited into the rectum. With Applicator in place, depress the Plunger in order to expel foam, and then withdraw Applicator. Some patients find it easier when standing with one leg raised on a chair, or lying down on their side.

REMEMBER:
Shake the Aerosol Can vigorously up and down for 60 seconds prior to each use. Wash the Applicator thoroughly after use. Store the container below 25°C.
Do not refrigerate.

How to use COLIFOAM

Follow cleaning instructions carefully.

Make sure that the Applicator is washed thoroughly in warm soapy water and allowed to dry before the next application.

Do not leave the Applicator with the previous dose in it, clean it up immediately.

The product must never be used for any other purpose than rectal insertion via the Applicator.

It is important to use COLIFOAM exactly as your doctor or pharmacist has told you. If you use it less often than you should, it may not work as well and your problem may not improve. Using it more often than you should may not improve your problem any faster and may cause or increase side effects.

Use COLIFOAM at the same time every day.

It is best to have a routine of waking up in the morning and going to the toilet to move the bowels then using this medication. Remember if you have moved your bowels just after applying the medication you have lost all the benefit. Apply the evening dose before you go to bed.

How long to use it

Your doctor or pharmacist will tell you how long to use COLIFOAM.

This medicine is usually used for 2-3 weeks but your doctor may want you to use it for a longer period of time. Please discuss this with your doctor to make sure that you are using it for the correct amount of time.

If you need to stop using COLIFOAM for any reason, seek advice from your doctor first. If you have been using COLIFOAM for a long time, COLIFOAM needs to be discontinued gradually with your doctor's advice. Stopping COLIFOAM treatment suddenly could cause severe illness.

Do not use COLIFOAM for longer than your doctor tells you. If you use COLIFOAM for longer than your doctor or pharmacist tells you, the chance of side effects may increase.

If you are not sure how long to use COLIFOAM, talk to your doctor or pharmacist.

If you forget to use it

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 your medicine as you would normally.

Do not use a double dose to make up for the dose that you missed. This may increase your chance of getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you use too much (overdose)

If you swallow it

Immediately telephone your doctor or the Poisons Information Centre on 13 11 26 (Australia) or the National Poisons Centre on 0800 764 766 (New Zealand), or go to casualty at your nearest hospital, if you think that you or anyone else may have swallowed COLIFOAM. 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 COLIFOAM

Things you must do

Keep all of your doctors' appointments so that your progress can be checked.

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

If you feel that COLIFOAM is not helping your condition, tell your doctor or pharmacist.

Tell your doctor if, for any reason, you have not used COLIFOAM exactly as prescribed. Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.

If you become pregnant while using COLIFOAM, tell your doctor.

Things you must not do

Do not give COLIFOAM to anyone else, even if they have the same symptoms as yours.

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

Things to be careful of

Do not use large amounts of COLIFOAM for a long time. If you use large amounts for a long time, the chance of absorption through the skin and the chance of side effects increases.

Ask your doctor or pharmacist if you are concerned about the length of time you have been using COLIFOAM.

Side effects

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

Like other medicines, COLIFOAM 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:

  • Water retention
  • Nervousness
  • Sleeplessness
  • Mood swings
  • Feeling depressed
  • Wounds that don't heal well
  • Swollen face
  • Pimples
  • Rash
  • Skin more easily damaged
  • Skin irritation, burning
  • Irregular periods
  • Increase in infections.

These side effects are usually mild.

Tell your doctor immediately if you notice any of the following:

  • Changes in eyesight
  • Irregular heartbeats
  • Fits.

These are serious side effects. You may need urgent medical attention.

If any of the following happen, stop taking COLIFOAM and tell your doctor immediately or go to casualty at your nearest hospital:

  • Sudden signs of allergy, such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath or difficulty breathing or wheezing
  • Severe chest pains
  • Broken bones.

These are very serious side effects. You may need urgent medical attention or hospitalisation.

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.

Ask your doctor or pharmacist if you don't understand anything in this list.

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

More information concerning your condition

Is there anything I can do to avoid an attack?

It is not possible to prevent attacks happening altogether. There are some things though that you can do that will reduce the chances of an attack occurring.

Some people with ulcerative colitis can work out what triggers an attack. The trigger in one person may not produce symptoms in another.

Is there anything I can do to reduce the severity of an attack?

The earlier an attack is treated the less severe it is likely to be. So if you have an attack, contact your doctor as soon as possible. Some people keep a can of steroid foam or steroid liquid enema at home for use as soon as they get symptoms. You may wish to discuss this with your doctor.

Does alcohol affect ulcerative colitis?

Alcohol, particularly wine, may cause diarrhoea in some people with ulcerative colitis. It is best to avoid alcohol if it has this effect on you.

Do I need a special diet?

Most people with ulcerative colitis can eat a normal diet. However, some people find that milk causes diarrhoea and gives them wind. If you discover that particular foods give you diarrhoea you should avoid eating them.

Can I play sport?

Yes, if you feel well enough you can continue to play sport or even take up new sports.

What can I do if I need to use a toilet urgently when I am out?

Large shops, pubs and restaurants usually have public toilets. Even smaller shops will let you use staff toilets if you explain you have a problem. You do not need to explain in detail. A useful aid, in this situation is the "Can't Wait" card provided by the Australian Crohn's and Colitis Association for their members.

Most people worry about having an accident when they are away from home. An emergency kit of pants and moist wipes can be reassuring.

Can I travel abroad?

Check with your doctor if you are unsure whether you are fit to travel. It is probably best to avoid travelling abroad during an attack.

Can I pass the diarrhoea on to my family and friends?

The diarrhoea caused by ulcerative colitis is not infectious and so cannot be passed on to your family or friends.

Will ulcerative colitis affect my sex life?

As with any sort of recurring illness, sympathy and understanding from your partner and family will lessen the strains caused by ulcerative colitis. You and your partner may find it embarrassing to discuss your symptoms. However, talking about them will help your partner understand your problems and help you to understand your partner's concerns.

People with ulcerative colitis often worry about sex. They may find that treatments, such as liquid enemas used last thing at night disrupt a spontaneous sex life. Also they may not feel like having sex because they feel dirty or tired or worry about having an accident in bed. Partners of people with ulcerative colitis often have similar worries and may worry in particular about causing pain.

Discussing these worries with each other and explaining, for example, that you need to lie on your side after an enema will help to prevent misunderstandings and help you enjoy a normal sex life.

What about pregnancy?

Women who have ulcerative colitis are less likely to become pregnant during an attack. However, the fact that a mother has ulcerative colitis does not put the health of her unborn child at risk. Some doctors prefer to avoid giving steroids during pregnancy.

Is it safe to take the pill?

Yes it is safe to take the contraceptive pill. However, you must remember that the diarrhoea associated with an attack of ulcerative colitis can reduce the pill's effectiveness. So, it is advisable to use an extra form of contraception, eg condoms, until the menstrual period after the diarrhoea has stopped.

After using COLIFOAM

Storage

Keep your medicine in the packaging until it is time to use it.

Keep COLIFOAM in a cool dry place where the temperature stays below 25°C. Do not refrigerate, incinerate or puncture Aerosol Can.

Do not store COLIFOAM or any other medicine in the bathroom or near a sink. Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.

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

Product description

What it looks like

COLIFOAM is a foam enema supplied in an Aerosol Can, filled with white, odourless and expanding foam. Aerosol Can is fitted with white Nozzle. Plastic Applicator with Plunger is also included in the carton and is used to administer foam into the rectum.

Ingredients

Your COLIFOAM contains:

Active Ingredient:
Hydrocortisone acetate 10% w/w (Each gram of COLIFOAM contains 100 mg hydrocortisone acetate).

Inactive Ingredients:

  • Propane
  • Isobutane
  • Trolamine
  • Propylene Glycol
  • Emulsifying Wax
  • Cetyl Alcohol
  • Steareth-10
  • Methyl Hydroxybenzoate
  • Propyl Hydroxybenzoate

COLIFOAM contains hydroxybenzoates.

Sponsor

Australia:

Mylan Health Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
AUSTRALIA
www.mylan.com.au
Telephone: 1800 314 527

New Zealand:

Mylan New Zealand Ltd
PO Box 11183
Ellerslie, Auckland
NEW ZEALAND
Telephone: 0800 168 169

The Australian Registration Number is AUST R 43026.

This leaflet was revised in July 2020.

Colifoam_cmi\Jul20/00

Published by MIMS September 2020

BRAND INFORMATION

Brand name

Colifoam

Active ingredient

Hydrocortisone acetate

Schedule

S4

 

1 Name of Medicine

Hydrocortisone acetate.

2 Qualitative and Quantitative Composition

Colifoam contains hydrocortisone acetate 10% w/w.

Excipients with known effect.

Colifoam also contains methyl hydroxybenzoate and propyl hydroxybenzoate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Colifoam is an enema, formulated as a lump free viscous, muco-adherent foam for rectal administration.

4 Clinical Particulars

4.1 Therapeutic Indications

Topical treatment of inflammation occurring in the rectal mucosa, e.g. ulcerative colitis, proctosigmoiditis and granular proctitis.

4.2 Dose and Method of Administration

The dosage is one applicator full containing approximately 90 to 100 mg hydrocortisone acetate, as directed by the doctor. The usual dosage rate is one applicator full once or twice daily for two to three weeks, and every second day thereafter, applied as directed above into the rectum.

Directions for use.

Shake aerosol can vigorously for 60 seconds before each use. Hold aerosol can upright and insert its nozzle into the tip of the applicator. As a result the applicator will be on top of the aerosol can. Be sure the plunger is drawn all the way out. The aerosol can must be held upright to obtain proper flow of medication.
To fill the applicator, hold it by the barrel and press down gently on top of aerosol can until the foam has filled up approximately one-quarter of the applicator's body. Keep the plunger withdrawn during this procedure. Only a short press is needed to do this. Wait for few seconds until the foam has stopped expanding. These steps may be repeated until the foam has reached the fill line. When foam reaches fill line of the applicator, it is ready for use.

Caution.

The aerosol can nozzle should never be inserted directly into the anus.
Remove applicator from aerosol can. Allow some foam to remain on the applicator tip. Hold applicator by barrel and gently insert tip sufficiently into the anus to ensure the foam is fully deposited into the rectum. With applicator in place, push plunger in order to expel foam, and then withdraw applicator. Some patients find the administration easier when standing with one leg raised or lying down on their side. Applicator parts should be pulled apart for thorough cleaning with warm water.

4.3 Contraindications

Hypersensitivity to the active substance and/or to any of the excipients.
Anal warts.
Fungal, viral, tuberculous or bacterial infections.
Obstruction.
Abscess.
Perforation.
Peritonitis.
Fresh intestinal anastomoses.
Extensive fistulae.

4.4 Special Warnings and Precautions for Use

Do not insert any part of the aerosol can into the anus. The contents of the aerosol can are under pressure. Do not burn or puncture the aerosol can. Store below 25°C.
Treatment should be administered with caution in patients with severe ulcerative disease because of their predisposition to perforation of the bowel wall.
Caution should be used in patients with diabetes mellitus, it should be taken into consideration that they may need more insulin or oral anti-diabetics (see Section 4.8 Adverse Effects (Undesirable Effects)).
Stabilisation to corticoids should be done in a hospital when treating patients with myasthenia gravis.
Corticosteroids can cause elevation of blood pressure, salt and water retention in the blood, and increased urinary excretion of potassium. Therefore, patients with severe cardiac and/or renal insufficiency will require careful monitoring, and in patients with hypertension, regular blood pressure control is necessary.
Potentially severe psychiatric adverse reactions may occur with systemic steroids.
Particular care has to be taken in patients with existing or a previous history of severe affective disorders, e.g. depressive or manic-depressive illness and previous steroid psychosis.
Patients should not be vaccinated with live vaccines while on corticosteroid therapy. Other immunisation procedures should not be undertaken in patients on corticosteroid therapy, especially on high doses, because of possible hazards of neurological complications and lack of antibody response. Immunisation procedures may be undertaken in patients receiving corticosteroids as replacement therapy.

Stress and intercurrent illness.

In patients on long-term corticosteroid therapy subject to stress from trauma or infection, steroid dosage should generally be increased to cover the stressful period. For mild infections without fever no increase is necessary. For more serious infections the dose of glucocorticoid should be doubled normal dose.

Infection.

Corticosteroids may mask some signs of infection (e.g. fever and inflammation), and new infections may appear during their use. There may be decreased resistance and inability to localise infection when corticosteroids are used. Susceptibility to infection is not specific for any particular bacterial or fungal pathogen.

Ophthalmological complications.

Visual disturbance may be reported with systemic and topical corticosteroid use. Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses (see Section 4.8 Adverse Effects (Undesirable Effects)). Colifoam should not be used in patients with narrow- or wide-angle glaucoma.
Corticosteroid therapy has been associated with central serous chorioretinopathy (CSCR), which may lead to retinal detachment.
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.

Prolonged corticosteroid therapy.

During prolonged corticosteroid therapy adrenal suppression and atrophy may occur and secretion of corticotrophin may be suppressed. Abrupt withdrawal of corticosteroid therapy may precipitate acute adrenal insufficiency and muscle weakness, hypotension, hypoglycaemia, headache, nausea, vomiting, restlessness and muscle and joint pain. Muscle weakness and stiff joints may persist for three to six months after discontinuation of treatment. In some cases, withdrawal symptoms may stimulate a clinical relapse of the disease for which the patient has been under treatment. Abrupt cessation of therapy should be avoided.
Duration of treatment and dosage appear to be important factors in determining suppression of the hypothalamic-pituitary-adrenal (HPA) axis response to stress on cessation of steroid treatment. The patient's liability to depression is also variable. Some patients may recover normal function rapidly. In others, the production of hydrocortisone in response to the stress of infections, surgical operations or accidents may be insufficient and death results. Therefore, withdrawal of corticosteroids should always be gradual to avoid a drug induced secondary adrenocortical insufficiency. This type of relative insufficiency may persist for months after discontinuation of therapy, therefore in any situation of stress occurring during that period, hormone therapy should be reinstituted. If the patient is receiving steroids already, dosage may have to be increased. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. If sudden withdrawal is necessary, corticotrophin (20 units) given daily by intravenous infusion during eight hours for three to five successive days is usually sufficient to prevent withdrawal symptoms. During long courses of treatment, laboratory and metabolic studies should be done. Fluid retention should be watched for, via a fluid balance chart and daily weighing. Sodium intake may need to be reduced to less than 1 g daily and potassium supplements may be necessary. The possibility of development of osteoporosis should be an important consideration in initiating and managing corticosteroid therapy, especially in postmenopausal women (see Section 4.8 Adverse Effects (Undesirable Effects)).
Close observation is necessary in patients with latent tuberculosis or tuberculin reactivity as reactivation of the disease may occur. Chemoprophylaxis is indicated during prolonged corticosteroid therapy.

Use in hepatic impairment.

Use with caution in patients with impaired hepatic function. A reduction of dosage may be necessary in treating chronic active liver disease with the drug. Major adverse reactions such as vertebral collapse, diabetes, hypertension, cataracts and Cushing's syndrome occur in about 30% of patients.

Use in the elderly.

Caution is recommended for elderly patients, as they are more susceptible to adverse reactions.

Paediatric use.

Children on long-term steroids must be carefully observed for potential serious reactions such as obesity, growth retardation, osteoporosis and adrenal suppression.

Effects on laboratory tests.

Corticosteroids may affect the nitroblue tetrazolium test for bacterial infection and produce false negative results.
Glucocorticoids can lead to positive results in doping tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

For systemic hydrocortisone, interactions with the following medicines are known:
The effects of cardiac glycosides may be potentiated caused by potassium depletion.
When corticosteroids are administered concomitantly with other potassium depleting agents such as diuretic agents and amphotericin B (amphotericin), patients should be observed closely for development of hypokalaemia.
Macrolide antibiotics and ketoconazole may decrease corticosteroid clearance.
Anti-diabetic agents due to reduction of the blood-sugar lowering effect.
Salicylates and other NSAIDs which may increase the risk of gastrointestinal bleeding.
Antiretroviral agents due to the risk of adrenal suppression.
The prothrombin time should be checked frequently in patients who are receiving corticosteroids and coumarin anticoagulants at the same time because of reports that corticosteroids have altered the response to these anticoagulants. Studies have shown that the usual effect produced by adding corticosteroids is inhibition of response to coumarins, although there have been conflicting reports of potentiation not substantiated by studies.
Phenytoin, phenobarbital (phenobarbitone), ephedrine and rifampicin may enhance the metabolic clearance of corticosteroids, resulting in decreased blood levels and lessened physiological activity, thus requiring adjustment in corticosteroid dosage. These interactions may interfere with dexamethasone suppression tests which should be interpreted with caution during administration of these drugs. False negative results in the dexamethasone suppression test in patients being treated with indometacin have been reported.
Co-treatment with CYP3A4 inhibitors is expected to increase the risk of systemic side effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side effects, in which case patients should be monitored for systemic corticosteroid side effects.
Substances which are mainly metabolized by CYP3A4, CYP3A5, CYP3A7.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category A)
In animal experiments, systemic corticosteroids have been found to cause malformations of various kinds (cleft palate, skeletal malformations) and abortion. These findings do not seem to be relevant to humans. Reduced placental weight and birth weight have been recorded in animals and humans after long-term treatment. Since the possibility of suppression of the adrenal cortex in the newborn baby after long-term treatment must be considered, the needs of the mother must be carefully weighed against the risk to the fetus when prescribing these drugs. The short-term use of corticosteroids antepartum for the prevention of respiratory distress syndrome does not seem to pose a risk to the fetus or the newborn infant. Maternal pulmonary oedema has been reported with tocolysis and fluid overload.
Hydrocortisone should not be used extensively in pregnancy, this is in large amounts or for prolonged periods. This medicine should only be used in pregnancy if absolute necessary. The benefit of treatment for the mother must be carefully weighed against the potential risks for the fetus.
 The drug is excreted in breast milk, therefore administration to breastfeeding mothers is not recommended. Otherwise, breast-feeding should be discontinued.

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)

Adverse reactions from corticosteroids are those resulting from withdrawal or from prolonged use of high doses.

More common reactions.

Cardiovascular.

The mineralocorticoid activity of a steroid may lead to salt and water retention which can also result in hypertension. Hypokalaemia can lead to arrhythmias and cardiac arrest.

Central nervous system.

Large doses can cause behavioural personality changes ranging from nervousness, insomnia, euphoria or mood swings to psychotic episodes, which can include both manic and depressive states, paranoid states and acute toxic psychosis.
It is no longer believed that previous psychiatric problems predispose to behavioural disturbances during therapy with glucocorticoids. Conversely, the absence of a history of psychiatric illness is no guarantee against the occurrence of psychosis during hormonal therapy.

Dermatological.

Impaired wound healing; facial plethora. An acneiform eruption on the face, chest and back; red striae on the thighs, buttocks and shoulders. Several months of high dose therapy often results in thinning of skin. Corticosteroid induced purpura resembles senile purpura. This purpura usually occurs on exterior surfaces, dorsum of the hand and radial aspect of the forearm.

Endocrine.

Menstrual irregularities. Cushing's syndrome may result from prolonged elevation of plasma glucocorticoid levels. The endocrine effects of the glucocorticoids involve the hypothalamic-pituitary-adrenal (HPA) axis, the genitals, the parathyroid and the thyroid. There are also metabolic effects, primarily involving carbohydrates. Suppression of growth may occur in children.
Antagonism occurs between the parathyroids and hypercorticism. Latent hyperparathyroidism may be unmasked by the administration of corticosteroids. Hypoparathyroidism may be manifested by phosphate retention occurring in renal failure caused by adrenal insufficiency.

Biochemical.

All glucocorticoids increase gluconeogenesis. Glucose tolerance and sensitivity to insulin are decreased, but provided pancreatic islet function is normal, carbohydrate metabolism will not be noticeably deranged. Steroid diabetes has been reported to develop in one-fifth of patients treated with high glucocorticosteroid dosage.
High dose corticosteroid therapy may induce marked hypertriglyceridaemia with milky plasma.

General.

Retardation of growth by long-term corticosteroid treatment in children.

Haematological.

Corticosteroids will increase the total white blood cell (WBC) count, with an increase in neutrophils and a decrease in monocytes, lymphocytes and eosinophils.

Immunological.

The frequency and severity of clinical infections increase during glucocorticoid therapy.

Musculoskeletal.

Osteoporosis and vertebral compression fractures in patients of all ages. Osteoporosis is an indication for withdrawal of therapy.
Myopathy, characterised by weakness of the proximal musculature of the arms and legs or their associated shoulder and pelvic muscles, is occasionally reported in patients taking large doses of corticosteroids. It may occur soon after treatment is begun and be sufficiently severe to prevent ambulation. It is an indication for withdrawal of therapy. Avascular aseptic necrosis of bone has often been described and preferentially involves the femoral and humeral head.

Ocular.

Increased intraocular pressure and glaucoma occur with corticosteroid treatment. The rise in intraocular pressure may lead to blindness. The incidence of posterior subcapsular cataract in patients undergoing long-term therapy with corticosteroids is approximately 10%. A correlation with the duration of treatment and the total dose is clear.

Less common reactions.

Gastrointestinal, pancreatic.

Peptic ulceration is an occasional complication. The high incidence of haemorrhage and perforation in these ulcers and the insidious nature of their development make them severe therapeutic problems. Some investigators believe the available evidence does not support the conclusion that steroids cause ulcers. Others feel that only patients with rheumatoid arthritis have an increased incidence of ulcers. It has been proposed that the glucocorticoids alter the mucosal defence mechanism.

Neurological.

Latent epilepsy can be rendered manifest by corticosteroid treatment. Long-term treatment may result in benign intracranial hypertension.

Severe or life threatening reactions.

Suppression of the hypothalamic pituitary adrenal (HPA) axis is one of the consequences of repeated administration of glucocorticoids; after termination of treatment a withdrawal syndrome may be experienced (see Section 4.4 Special Warnings and Precautions for Use).
In some cases acute adrenal insufficiency after a period of glucocorticoid treatment has proved fatal.

Frequency not known reactions.

Infections and infestations.

Decreased resistance to infections*.

Immunological.

Hypersensitivity reactions including anaphylactic reaction, angioedema.

Gastrointestinal.

Proctalgia, anorectal discomfort.

Dermatological.

Dermatitis allergic, urticaria, skin reactions (local, generalised) like blister, pruritus, rash.

General.

Application site reactions like erythema, irritation, burning, dryness.

Post marketing.

Eye disorders.

Vision blurred.
Drugs of this class may cause systemic side effects (such as Cushing's Syndrome, decreased resistance to infections*), especially in long-term use, and if the medicine is not used as directed. The risk of systemic side effects when used at the correct dose by the local administration route is much lower than under systemic application.

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

4.9 Overdose

A single overdose of a corticosteroid would not be expected to produce acute symptoms. Hypercorticoid effects are not anticipated unless there has been repeated administration of high doses.

Symptoms.

Systemic effects of chronic overdosage with steroids include effects on sodium and water retention, increased appetite, mobilisation of calcium and phosphorus with osteoporosis, nitrogen depletion, hyperglycaemia, effects on tissue repair, increased susceptibility to infection, adrenal insufficiency, adrenal cortex hyperactivity, mental and neurological disturbances and muscular weakness.

Treatment.

In case of an acute overdose, maintain adequate fluid intake and monitor electrolytes in serum and urine, with particular attention to sodium and potassium balance. In case of chronic toxicity, slowly withdraw drug. Treat electrolyte imbalance if necessary.
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.

Colifoam is administered into the rectum where the hydrocortisone exerts an anti-inflammatory effect on the mucosa. The medication is kept in contact with the inflamed mucosa due to the muco-adherent base. Thus a patient can resume normal duties directly after use.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Limited data available on Colifoam indicate that the amount of hydrocortisone absorbed is comparable to that secreted endogenously. Up to 50% of the administered dose may be absorbed from some rectal preparations of hydrocortisone acetate used in patients with proctitis.

Distribution.

Corticosteroids in the circulation are extensively bound to plasma proteins.

Metabolism.

Corticosteroids are metabolised in the liver and kidney. Hydrocortisone is metabolised by reduction at both hepatic and extrahepatic sites with the formation of tetrahydrocortisol and tetrahydrocortisone being formed in the liver. Further metabolism by conjugation reactions to form sulfate esters or glucuronides occur in the liver and to some extent in the kidney.

Excretion.

Corticosteroids are excreted in the urine.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Propane, isobutane, trolamine, propylene glycol, emulsifying wax, cetyl alcohol, steareth-10, methyl hydroxybenzoate, propyl hydroxybenzoate.

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. Do not refrigerate.

6.5 Nature and Contents of Container

Colifoam is a foam enema supplied in an aerosol can filled with white, odourless, muco-adherent, expanding foam. Aerosol can is fitted with gold ferrule and white nozzle. Plastic applicator with plunger is also included in the carton and is used to administer Colifoam into the rectum.
One aerosol can contains 21.1 g of foam which is equivalent to approximately 14 applications. Each applicator full of Colifoam contains approximately 90 mg hydrocortisone acetate. One gram of foam contains 100 mg hydrocortisone acetate.

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

Hydrocortisone acetate occurs as white or almost white, crystalline powder. It is practically insoluble in water, slightly soluble in anhydrous ethanol and in methylene chloride.
The chemical name for hydrocortisone acetate is 11β,17-Dihydroxy-3,20-dioxopregn-4-en-21-yl acetate.

Chemical structure.


Chemical formula: C23H32O6. Molecular weight: 404.5 g mol-1.

CAS number.

50-03-3.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes