Consumer medicine information

Cortival

Betamethasone valerate

BRAND INFORMATION

Brand name

Cortival

Active ingredient

Betamethasone valerate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Cortival.

What is in this leaflet

This leaflet answers some common questions about CORTIVAL. It does not contain all the available information about this medicine.

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 CORTIVAL against the benefits this medicine is expected to have for you.

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

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

What is CORTIVAL used for

CORTIVAL contains the active ingredient betamethasone valerate (a type of cortisone) and belongs to the group of medicines called corticosteroids.

CORTIVAL is available as a cream and an ointment.

It is a topical corticosteroid, which is applied to the body surface (skin).

It is used to help relieve the redness, swelling, itching and discomfort of various skin problems such as:

  • eczema
  • other types of dermatitis.

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

Your doctor knows which skin conditions CORTIVAL is helpful for.

The cream and ointment are only available with a doctor's prescription.

Before you use it

When you must not use it

Do not use CORTIVAL if you have ever had an allergic reaction to:

  • betamethasone valerate or any other corticosteroid
  • any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction to CORTIVAL may include red, itchy skin rashes or a lumpy rash (“hives”).

It may also include some or all of the following: wheezing, swelling of the lips/mouth, difficulty in breathing, hay fever or fainting.

Do not use this medicine if you are pregnant or intend to become pregnant or breast feed.

Your doctor will discuss the risks and benefits of using CORTIVAL during pregnancy and breast feeding

Do not use CORTIVAL if you suffer from the following medical conditions:

  • acne rosacea or vulgaris
  • inflammation around the mouth
  • a viral skin infection (e.g. chickenpox, cold sores, shingles, warts)
  • a bacterial skin infection (e.g. impetigo, boils, cellulitus)
  • a fungal skin infection (e.g. tinea, ringworm, thrush)
  • skin conditions with ulcers e.g. leg ulcers
  • tuberculosis of the skin
  • anal or genital itching.

If you are not sure whether you suffer from any of the above medical conditions, ask your doctor before you start using this medicine.

CORTIVAL should not be used if you suffer from poor circulation of blood in the skin region, as it may result in skin ulcers.

Occlusive dressings should not be used if you have a skin infection.

CORTIVAL should not be used in children under the age of 1 year, unless advised by your doctor.

Do not use this medicine after the expiry date (EXP.) printed on the pack.

Do not use your medicine if the packaging shows signs of tampering or if the seal on the tube is broken, or if the product does not look quite right.

If it has expired or is damaged, return it to your pharmacist for disposal.

Before you start to use it

You must tell your doctor if:

  • you are allergic to any other medicines, foods, dyes or preservatives
  • you have any other health problems, especially if you have an infection
  • you are pregnant or intend to become pregnant
  • you are breast-feeding or intend to breastfeed.

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

Use in children

CORTIVAL is not recommended for use in children, unless your doctor tells you to do so.

Using other medicines

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

Some medicines may interfere with CORTIVAL if they are used excessively or for prolonged periods.

Your doctor or pharmacist has a list of medicines that may interfere with CORTIVAL.

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

How to use it

Follow your doctor’s instructions carefully, as they may differ from the information contained in this leaflet.

How to use it

Before you start using CORTIVAL, wash and dry your hands thoroughly.

Gently rub a small amount of cream or ointment on the affected area as directed by your doctor.

After applying the ointment or cream, wash and dry your hands thoroughly, unless it is being used for treating your hands.

Occlusive dressings are NOT recommended, unless advised by your doctor.

It is important to use CORTIVAL exactly as your doctor or pharmacist has told you to.

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

Do not apply CORTIVAL to your face unless specifically advised by your doctor.

If your doctor has told you to use it on your face, do not let the cream or ointment get into your eyes. If you accidently get some in your eyes, wash them thoroughly with running water for at least ten minutes.

If you use CORTIVAL less than you should, it may not work as well and your skin problem may not improve.

However, if you use CORTIVAL more often than you should, it may not improve your skin problem any faster and may cause or increase side effects.

How long to use it

Your doctor will tell you how long to use CORTIVAL.

Your doctor may tell you to reduce the number of applications as the skin disorder subsides.

If you use CORTIVAL for a long time, the chance of side effects occurring is increased.

If you forget to use it

If you forget to use CORTIVAL, use it as soon as you remember and then go back to your normal times for applying CORTIVAL.

Do not try to make up for the amount that you missed by using more than you would normally use.

If you swallow it

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to the accident and emergency centre at your nearest hospital, if anyone swallows CORTIVAL. Do this even if there are no signs of discomfort or poisoning. Urgent medical attention may be needed.

While you are using it

Things you must do

Immediately discontinue using CORTIVAL if an irritation or sensitisation occurs.

Tell any doctors and pharmacists who are treating you that you are using this medicine.

Tell your doctor if you become pregnant while using it.

Tell your doctor if you feel it is not helping your condition or if your skin condition worsens or seems infected.

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

Things you must not do

Do not use CORTIVAL under occlusive dressings (airtight covering) or on large areas of skin unless your doctor tells you to.

Do not use it in or near the eyes.

Do not stop using it or change the amount, area or method of application, without first checking with your doctor.

Do not give this medicine to anyone else even if his or her symptoms seem similar to yours.

Do not use plastic pants or tight-fitting nappies if CORTIVAL is to be used on the nappy area of young children.

Do not use it to treat any other conditions unless your doctor tells you to do so. Your doctor has prescribed CORTIVAL especially for you and your condition. If you use it for another condition, it may not work at all or make the condition worse.

Things to be careful of

Do not use large amounts of CORTIVAL for a long period of time. If you use large amounts for a long time, the chance of systemic absorption through the skin and the chance of side effects may increase.

Only use the cream or ointment on skin areas that rub together such as under the arm or in the groin area if your doctor tells you to.

Only use it on the face if your doctor tells you to. If improvement does not occur within one week, tell your doctor immediately.

Children and adolescents should be followed closely by the doctor, since this medicine is absorbed through the skin and can affect growth or cause other unwanted side effects.

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

Side effects

Tell your doctor or pharmacist if you do not feel well while you are using CORTIVAL.

It helps most people with skin problems but it may have some unwanted side effects in some people.

If side effects occur, they are most likely to be minor and temporary. However, some may be serious and need medical attention.

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

The most commonly reported side effect is local irritation which includes:

  • itching
  • burning
  • dryness
  • redness.

Tell your doctor or pharmacist immediately if you notice any of the following at the application site:

  • thinning of the skin with easy bruising
  • rash around the mouth area
  • stretch marks or streaks on the skin
  • infection of the hair roots
  • change in skin colour
  • increased hair growth
  • heat rash
  • acne.

Side effects are more frequent if CORTIVAL is used under dressings that are close-fitting and keep out the air.

Long periods of treatment under close-fitting dressings may cause thinning of the skin.

If large areas of the skin are treated, especially for a long time and under tight dressings, some steroid may be absorbed into the body. This may cause various effects including:

  • stomach ulcers
  • high blood pressure
  • delayed wound healing
  • increased chance of infection
  • excessive growth of facial and body hair
  • acne
  • increased body fluid
  • muscle weakness
  • eye problems e.g. cataracts, glaucoma and blurred vision.

If you have any questions about any of these effects, you should speak to your doctor immediately.

If you think you are having an allergic reaction to your medicine, tell your doctor immediately or go to the accident and emergency centre at your nearest hospital.

Symptoms may include:

  • wheezing
  • swelling of the eyelids, face, lips and mouth
  • lumpy rash (“hives”)
  • tightness in the chest
  • fainting.

This is not a complete list of all possible side effects. This medicine may cause other side effects.

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

After using it

Storage

Keep your CORTIVAL in its pack, until it is time to use it.

Keep your medicine 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.

Keep CORTIVAL cream and ointment in a cool dry place, protected from light, where the temperature stays below 25°C.

Do not leave it in the car or on windowsills. Heat and dampness can destroy some medicines.

Disposal

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

Product description

What it looks like

CORTIVAL cream is a soft, white cream with a faint odour of chlorocresol. It is available in the following strengths:

  • CORTIVAL 1/2 cream (0.05 %): 15 g aluminium tube
  • CORTIVAL 1/5 cream (0.02%): 100 g aluminium tube

CORTIVAL ointment is a greyish-white, smooth ointment. It is available in the following strengths:

  • CORTIVAL 1/2 ointment (0.05 %): 15 g aluminium tube

Ingredients

Betamethasone valerate is the active ingredient in CORTIVAL cream and ointment.

Inactive ingredients

CORTIVAL cream

  • white soft paraffin
  • liquid paraffin
  • chlorocresol
  • cetostearyl alcohol
  • cetomacrogol 1000
  • monobasic sodium phosphate
  • purified water.

CORTIVAL cream contains chlorocresol as a preservative.

CORTIVAL ointment

  • white soft paraffin
  • liquid paraffin.

CORTIVAL ointment is preservative free.

CORTIVAL cream and ointment do not contain any colouring agents, lanolin or parabens.

Australian Product Registration numbers:

CORTIVAL 1/2 cream:
AUST R 91054

CORTIVAL 1/5 cream:
AUST R 91053

CORTIVAL 1/2 ointment:
AUST R 91055.

Sponsor details

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

This information was revised in August 2019.

Published by MIMS November 2019

BRAND INFORMATION

Brand name

Cortival

Active ingredient

Betamethasone valerate

Schedule

S4

 

1 Name of Medicine

Betamethasone valerate.

6.7 Physicochemical Properties

Betamethasone valerate occurs as a white to almost-white, odourless crystalline powder. Betamethasone valerate 1.2 mg is approximately equivalent to 1.0 mg of betamethasone. Practically insoluble in water. Soluble in alcohol (1 in 16), chloroform (1 in < 10) and ether (1 in 400). It is freely soluble in acetone and in dichloromethane.
Betamethasone valerate is a synthetic, fluorinated corticosteroid ester. It is also chemically known as betamethasone-17α-valerate. The molecular formula is C27H37FO6 with a molecular weight of 476.6.

Chemical structure.


CAS number.

2152-44-5.

2 Qualitative and Quantitative Composition

Cortival 1/2 cream and ointment contain 0.5 mg/g of betamethasone, present as 0.61 mg/g of betamethasone 17α-valerate.
Cortival 1/5 cream contains 0.2 mg/g of betamethasone, present as 0.24 mg/g of betamethasone 17α-valerate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Cortival cream: A soft white cream with an odour faintly of chlorocresol. Free from visible contamination.
Cortival ointment: A smooth greyish-white translucent mass. Free from undispersed particles and visible foreign contamination.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Topical corticosteroids have anti-inflammatory, antipruritic and vasoconstrictive actions. The activity of the drugs is thought to result at least in part from binding with a steroid receptor. Corticosteroids decrease inflammation by stabilising leukocyte lysosomal membranes, preventing release of destructive acid hydrolyses from leukocytes; inhibiting macrophage accumulation in inflamed areas; reducing leukocyte adhesion to capillary endothelium; reducing capillary wall permeability and oedema formation; decreasing complement components; antagonising histamine activity and release of kinin from substrates; reducing fibroblast proliferation, collagen deposition and subsequent scar tissue formation; and possibly by other mechanisms as yet unknown. Vasoconstrictor assays can be used to predict potential potencies and/or clinical efficacies of the topical corticosteroids. There is evidence that the active betamethasone 17-valerate degrades to betamethasone 21-valerate and free betamethasone alcohol after manufacture. These showed less than one-tenth vasoconstrictor response in studies utilising skin blanching effect. At the end of shelf-life Cortival may contain up to 10% of these related substances.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Sufficient corticosteroids may be absorbed to give systemic effects when administered topically. The extent of absorption is determined by many factors including the vehicle, the presence of broken skin and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Absorption is, however, markedly increased when the skin has lost its keratin layer and can also be increased by inflammation and/or diseases of the epidermal barrier (e.g. psoriasis, eczema).
Once absorbed, the pharmacokinetics are similar to systemic steroids.

Distribution.

Corticosteroids in the circulation are bound to plasma proteins in varying degrees, mainly to globulin and less so to albumin.

Metabolism.

Only unbound corticosteroid has pharmacological effects or is metabolised. The synthetic corticosteroids are less extensively protein bound than hydrocortisone. They also tend to have longer half-lives.

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.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

The carcinogenic or mutagenic potential of topical corticosteroids have not been investigated in animal studies.

4 Clinical Particulars

4.1 Therapeutic Indications

Eczema, including: atopic infantile, stasis and discoid eczemas. Besnier's (flexural) prurigo. Otitis externa. Neurodermatoses including lichen simplex, lichen planus. Seborrheic dermatitis, contact sensitivity reactions and allergies.

4.3 Contraindications

Hypersensitivity to the preparations.
Rosacea and acne vulgaris.
Perioral dermatitis, perianal and genital pruritus.
Viral infections of the skin (e.g. herpes simplex, chickenpox).
Gravitational ulcers.
Tuberculosis of the skin.
The use of Cortival skin preparations is not indicated in the treatment of primarily infected skin lesions caused by infections with fungi or bacteria or dermatoses in children under one year of age, including dermatitis and napkin eruptions.

4.4 Special Warnings and Precautions for Use

Long-term continuous topical therapy should be avoided where possible, particularly in children, as adrenal suppression can occur even without occlusion.
As with other topical corticosteroids, when extensive areas are treated, sufficient systemic absorption may occur to produce the features of hypercorticism. This effect is more likely to result if occlusive dressings are used, or if treatment is prolonged.
Rarely, local atrophy or striae may occur after prolonged treatment.
The face, more than other areas of the body, may exhibit atrophic changes after prolonged treatment with potent topical corticosteroids. This must be borne in mind when treating conditions such as severe eczema and seborrheic dermatitis.
If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as glaucoma might result.
Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions which have become infected.
Any spread of infection requires withdrawal of topical corticosteroid therapy and systemic administration of antimicrobial agents.
Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressings, and so the skin should be cleansed before a fresh dressing is applied.
The least potent corticosteroid which will control the disease should be selected.
Patients in whom there is a risk of increased systemic absorption should be regularly evaluated for evidence of hypothalamic pituitary adrenal (HPA) axis suppression by using urinary free cortisol (hydrocortisone) tests and monitoring morning plasma cortisol levels. If there is evidence of suppression, attempts should be made to withdraw the drug, use a less potent steroid, or reduce the frequency of application.
Topical corticosteroids should be used with caution in patients with impaired T cell function or in those patients receiving other immunosuppressive therapy. The immunosuppressive effects of corticosteroids may be associated with impairment of the normal function of T cells and macrophages. The result of this impairment may be the activation of latent infection or exacerbation of intercurrent infections, including those caused by Candida, Mycobacterium, Toxoplasma, Strongyloides, Pneumocystis, Cryptococcus, Nocardia and amoeba.
Topical corticosteroids should be used with caution in the management of psoriasis, as exacerbation of the disease or pustular psoriasis may occur during or on withdrawal of topical corticosteroid therapy.
Topical corticosteroids should not be used in patients with markedly impaired circulation since skin ulceration has occurred in these patients following the use of corticosteroids.
Cortival preparations are usually well tolerated, but if signs of hypersensitivity appear, application should be stopped and appropriate therapy instituted.

Visual disturbance.

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

Information for patients.

Patients using topical corticosteroids should receive the following information and instructions.
i) Cortival should only be used as recommended by a physician. The patient should not use it for any other indication, other than that for which it was prescribed.
ii) Avoid contact with the eyes. If accidentally applied to the eyes they must be washed thoroughly with large volumes of water.
iii) Report to your physician any sign of local adverse reactions, especially under occlusive dressing.
iv) The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician. Similarly, parents of paediatric patients should be advised not to use tight fitting napkins or plastic pants on a child being treated in the napkin area.

Use in the elderly.

No data available.

Paediatric use.

The risk of systemic absorption, and hence systemic toxicity, is greater in children due to a larger skin surface area to bodyweight ratio than adults. Chronic topical corticosteroid therapy may interfere with growth and development of children. HPA suppression, Cushing's syndrome and intracranial hypertension have been reported in children using topical corticosteroids. Manifestations of adrenal suppression in children include delayed weight gain, retardation of linear growth, low plasma cortisol concentrations and lack of response to corticotrophin stimulation. Manifestations of intracranial hypertension include headaches, bulging fontanelles and bilateral papilloedema. Topical corticosteroid therapy in children should be limited to the minimum amount necessary for therapeutic efficacy.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

There are no known interactions of topically applied betamethasone valerate with other drugs.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

There is no information available on the possible effects of topical corticosteroids on human fertility.
(Category B3)
In pregnant animals, the administration of corticosteroids can cause abnormalities of foetal development (commonly cleft palate/ lip). The relevance of this finding to human beings has not been established. Therefore, topical corticosteroids should be used in pregnancy only when the potential benefits justify the possible risks to the fetus. Topical steroids should not be used extensively in pregnancy, i.e. in large amounts or for long periods.
It is not known whether topical corticosteroids are absorbed sufficiently to be excreted in breast milk. The potential benefit should be weighed against possible hazards to the nursing infant.

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.
Topical corticosteroids may cause adverse dermatological effects. Adverse dermatological effects are most likely to occur in intertriginous and facial areas. Local adverse corticosteroid effects occur most frequently with occlusive dressings, especially with prolonged therapy, and may require discontinuation of the dressings.
The following local adverse reactions have been reported with the use of topical corticosteroids: dryness, itching, burning, redness of skin, skin thinning, local irritation, features of hypercorticism, telangiectasia, striae, skin atrophy, hypertrichosis, change in pigmentation, secondary infection, perioral dermatitis, allergic contact dermatitis, maceration of the skin, acneiform eruptions, exacerbation of symptoms. These reactions are more frequent with occlusive dressings.
Rarely reported adverse effects include: folliculitis, furunculosis, pustules or vesiculation, hyperaesthesia, purpura, erythema, pruritus, tightening or cracking of skin, hypopigmentation, miliaria rubra, laceration of the skin.
Adverse dermatological effects usually improve when the drug is discontinued but may persist for long periods; atrophic striae may be permanent.
Topically applied corticosteroids are generally nonsensitising, but allergic contact dermatitis may occur rarely.
Topical corticosteroids should be used with caution in the management of psoriasis (see Section 4.4 Special Warnings and Precautions for Use).
Topical corticosteroids should also be used with caution in patients with impaired T cell function or in those patients receiving other immunosuppressive therapy. The result of this impairment may be the activation of latent infection or exacerbation of intercurrent infections (see Section 4.4 Special Warnings and Precautions for Use).

Post marketing adverse effects.

Eye disorders.

Vision blurred.

4.2 Dose and Method of Administration

A small quantity should be applied to the affected area once or twice daily until improvement occurs. If necessary, cover the area with a dry dressing.
Cortival 1/5 may be applied up to four times daily.
Different presentations of topical corticosteroids may demonstrate variable activity as measured by skin blanching tests, and treatment should be monitored for efficacy and safety in individual patients.

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

Symptoms.

Percutaneous absorption of corticosteroids can occur when large amounts of corticosteroids are applied or when occlusive dressings are used. Toxic effects may include ecchymosis, peptic ulceration, hypertension, delayed wound healing, decreased resistance to infection, hirsutism, acne, oedema and muscle weakness.

Treatment.

No specific antidote is available. Treatment should be symptomatic and supportive. Treatment should involve the withdrawal of the drug carefully, bearing in mind the possibility of adrenal suppression.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

Cortival 1/2 and 1/5 creams contain the following excipients: white soft paraffin, liquid paraffin, chlorocresol 1 mg/g as the preservative, cetostearyl alcohol, cetomacrogol 1000, monobasic sodium phosphate and purified water.
Cortival 1/2 ointment contains the following excipients: liquid paraffin and white soft paraffin.

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

Cortival 1/2 cream (0.5 mg/g): Store below 25°C. Protect from light.
Cortival 1/5 cream (0.2 mg/g): Store below 25°C. Protect from light.
Cortival 1/2 ointment (0.5 mg/g): Store below 25°C. Protect from light.

6.5 Nature and Contents of Container

Cortival 1/2 cream (0.5 mg/g): 15 g and 30 g Al tubes. [AUST R 91054].
Cortival 1/5 cream (0.2 mg/g): 100 g Al tubes. [AUST R 91053].
Cortival 1/2 ointment (0.5 mg/g): 15 g and 30 g Al tubes. [AUST R 91055].
(Note: Not all strengths or pack sizes may be marketed.)

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