Consumer medicine information

Desowen Lotion

Desonide

BRAND INFORMATION

Brand name

Desowen

Active ingredient

Desonide

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Desowen Lotion.

What is in this leaflet

This leaflet answers some common questions about DESOWEN lotion. 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 taking DESOWEN lotion against the benefits this medicine is expected to have for you.

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

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

What DESOWEN lotion is used for

DESOWEN lotion is used for the treatment of the redness, swelling and itching that is associated with a number of skin ailments such as eczema and psoriasis.

It acts by constricting the blood vessels of the skin and affects the release of natural chemicals which cause redness and swelling.

It belongs to a group of medicines called corticosteroids.

Your doctor, however, may have prescribed DESOWEN lotion for another purpose.

Ask your doctor if you have any questions about why DESOWEN lotion has been prescribed for you.

There is no evidence that DESOWEN lotion is addictive. DESOWEN lotion is available only with a doctor's prescription.

Before you use DESOWEN lotion

When you must not use it

Do not use DESOWEN lotion if:

  1. you have ever had an allergic reaction to :
  • medicines containing desonide
  • any of the ingredients listed at the end of this leaflet
  1. you have skin areas affected by viral skin infections (such as cold sores, shingles or chicken pox)
  2. you have skin areas affected by fungal or parasitic skin infections (such as thrush, tinea or ringworm)
  3. you have acne or rosacea unless your doctor tells you to
  4. you have skin areas with ulcerous wounds
  5. you are going to have a bath, shower or are going swimming. If you do you may reduce the effectiveness of this product.

If you are not sure whether you should be using DESOWEN lotion, talk to your doctor.

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

Do not use DESOWEN lotion after the expiry date (EXP) printed on the box or bottle has passed. The expiry date refers to the last day of that month. If you use this medicine after the expiry date it may not work (as well).

Do not use DESOWEN lotion on children under 2 years. Growth retardation may be observed in children in case of systemic penetration of topical corticosteroids on large skin areas.

Before you start to use it

You must tell your doctor if:

  1. you are allergic to any other medicines or other substances such as foods, dyes or preservatives.
  2. you are pregnant or plan to become pregnant
Your doctor will discuss the risks and benefits of using DESOWEN lotion when pregnant.
  1. you are breast-feeding or plan to breast-feed
Your doctor will discuss the risks and benefits of using DESOWEN lotion when breast-feeding.

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

Using other medicines

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

Some medicines may affect the way others work. Your doctor or pharmacist will be able to tell you what to do when using DESOWEN lotion with other medicines.

How to use DESOWEN lotion

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 on the box, ask your doctor or pharmacist for help.

DESOWEN lotion is for topical use only.

How to use

When using DESOWEN lotion, shake well before use.

Apply as a thin film to the affected areas two or three times each day depending on the severity of the skin problem.

DESOWEN lotion is for external use only.

DESOWEN lotion should not come into contact with the eyes, eyelids, lips, or the lining of the mouth or nose.

Do not apply to broken skin.

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

Do not use DESOWEN for more than 8 weeks.

Use in children strictly as directed by your doctor.

As with any topical medication, wash hands carefully after application.

How long to use it

Your doctor will tell you how long to use DESOWEN lotion. It should not be used for more than 8 weeks.

Do not use DESOWEN lotion for longer than your doctor tells you. If you use DESOWEN lotion for longer than your doctor tells you, the chance of side effects may increase. Prolonged and/or intensive treatment with DESOWEN lotion may cause suppression of the immune response, opportunistic infections and other skin conditions.

If you are not sure how long to use DESOWEN lotion, talk to your doctor.

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.

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

If you swallow it

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26), or go to casualty at your nearest hospital, if you think that you or anyone else may have swallowed DESOWEN lotion. 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 DESOWEN lotion

Things you must do

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

If you feel that DESOWEN lotion is not helping your condition, tell your doctor (or pharmacist).

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

If you become pregnant while using DESOWEN lotion, tell your doctor.

If you are or want to start breastfeeding, tell your doctor.

Things you must not do

Do not use DESOWEN lotion in or near the eyes and eyelids.

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

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

Things to be careful of

Do not use large amounts of DESOWEN lotion for a long time.

Avoid contact with the eyes. If the lotion accidentally comes in contact with the eyes, rinse out the eyes with water immediately.

Tell your doctor if experience blurred vision or other visual disturbances after using DESOWEN lotion.

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 if you are concerned about the length of time you have been using DESOWEN lotion.

Side effects

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

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

The more common side effects of DESOWEN lotion (occur in less than 1 in 10 patients) include:

  • skin burning sensation
  • acne
  • inflammation of hair follicles

Tell your doctor if you notice any of these and they worry you.

The uncommon side effects of DESOWEN lotion (occur in less than 1 in 100 patients) include:

  • local signs of skin irritation
  • itching of the skin
  • hives
  • excessive hair growth over what is normally expected
  • skin discolouration
  • eczema
  • skin becoming fragile and prone to tears and ulcerations
  • skin lesions
  • aggravation of rosacea
  • dry skin
  • eye stinging / burning
  • eye irritation
  • headache
  • stretch marks
  • rash including heat rash

Post-marketing adverse event reports have also included

  • erythema (redness)
  • facial swelling
  • application site reaction
  • rash
  • severe itching
  • blurred vision

Some people may get other side effects while using DESOWEN lotion.

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

After using DESOWEN lotion

Storage

Store in the original bottle.

Keep DESOWEN lotion in a cool, dry place where the temperature stays below 25°C. Do not freeze. Do not store it, or any other medicine, in a bathroom or near a sink. Do not leave them in the car or on window sills. Heat and dampness can destroy some medicines.

Keep DESOWEN lotion where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

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

Medicines should not be disposed of via wastewater or household waste.

Product description

What it looks like

DESOWEN lotion is a white to off-white, soft, smooth lotion.

DESOWEN lotion is packaged in high density polyethylene (HDPE) bottles of 10mL, 30mL, 60mL and 125mL. Not all pack sizes may be marketed.

Ingredients

DESOWEN lotion contains the active ingredient desonide 0.5mg/g.

DESOWEN lotion also contains the following excipients:

  • sodium lauryl sulfate
  • light liquid paraffin
  • cetyl alcohol
  • stearyl alcohol
  • propylene glycol
  • methyl hydroxybenzoate
  • propyl hydroxybenzoate
  • sorbitan monostearate
  • self emulsifying glyceryl monostearate
  • edetate sodium
  • purified water
  • citric acid
  • sodium hydroxide

Sponsor/distributor

Galderma Australia Pty Ltd
Suite 4, 13B Narabang Way
Belrose NSW 2085
Ph. 1800 800 765

In New Zealand by:

Healthcare Logistics’
58 Richard Pearce Drive
Airport Oaks
Auckland
Telephone 0800 174 104

Made in France

Australian Registration Number: AUST R 67182

® Registered Trademark

This leaflet was prepared in
August 2018

Published by MIMS October 2018

BRAND INFORMATION

Brand name

Desowen

Active ingredient

Desonide

Schedule

S4

 

1 Name of Medicine

Desonide.

2 Qualitative and Quantitative Composition

Each g of Desowen lotion, ointment and cream contains 0.5 mg of desonide.
For the full list of excipients, see Section 6.1 List of Excipients.

Excipients with known effect.

Desowen lotion.

Contains: hydroxybenzoates.

Desowen cream.

Contains sorbates.

3 Pharmaceutical Form

Desowen lotion is a white to off-white, soft, smooth lotion.
Desowen ointment is a smooth, soft, translucent, grease-like ointment.
Desowen cream is a white, shiny, semi-solid emulsion.

4 Clinical Particulars

4.1 Therapeutic Indications

Desowen Cream 0.05%, Lotion 0.05%, and Ointment 0.05% is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses for adults and children aged 2 years and older.

4.2 Dose and Method of Administration

Desowen Cream 0.05%, Lotion 0.05% or Ointment 0.05% should be applied as a thin film to the affected areas two to three times daily depending on the severity of the condition. Shake lotion well before using.
Occlusive dressing may be used for the management of psoriasis or recalcitrant conditions. If an infection develops the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
Periods of continuous treatment should not exceed 8 weeks in adults or children.
An increase in the number of daily applications may exacerbate the adverse effects without enhancing the therapeutic effects.
Treatment of large skin areas requires monitoring of the number of tubes used.

4.3 Contraindications

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.
Desowen preparations are also contraindicated in most viral infections of the skin (vaccinia, herpes simplex), tuberculosis, acne and rosacea.
Application to ulcerated lesions and to the eyelids is also contraindicated (risk of glaucoma).

4.4 Special Warnings and Precautions for Use

Prolonged use of corticosteroids of medium potency on the face is associated with a risk of occurrence of corticosteroid-related dermatitis that is, paradoxically, corticosteroid-responsive, with a rebound after each treatment discontinuation. Gradual withdrawal by tapering is then required.
The product is not recommended in patients with perioral dermatitis.
The product should not be applied on skin areas affected by bacterial and mycobacterial, viral, fungal, parasitic infections or ulcerous wounds.
Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal axis suppression, manifestations of Cushing syndrome, hyperglycaemia and glucosuria in some patients.
Conditions which augment systemic absorption include the application of more potent steroids, use over a large surface area, prolonged use and the addition of occlusive dressings. Therefore patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted an attempt should be made to reduce the frequency of application or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical steroids. Infrequently signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.
The duration of continuous treatment should not exceed 8 weeks in either adults or children.
Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see Section 4.4 Special Warnings and Precautions for Use, Paediatric use). If signs of skin or subcutaneous atrophy occur discontinue treatment.
If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the event of bacterial or fungal superinfection of a corticosteroid-responsive dermatosis, use specific treatment before the corticosteroid treatment. In case dermatological infections develop during treatment with the corticosteroid, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favourable response does not occur promptly the corticosteroid should be discontinued until the infection has been adequately controlled.
If signs of local intolerance develop, discontinue the treatment and conduct an etiologic investigation.

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.
For external use only.

Use in the elderly.

No data available.

Paediatric use.

Desowen cream, lotion and ointment should not be administered to children under the age of two years. HPA axis suppression has been assessed in a clinical study in which Desowen ointment was administered for 4 weeks. HPA axis suppression has not been assessed during longer periods of administration. Because of a larger skin surface area to body weight ratio, paediatric patients may show a greater susceptibility to topical corticosteroid induced HPA axis suppression and Cushing's syndrome than mature patients. HPA suppression, Cushing's syndrome and intracranial hypertension have been reported in children using topical corticosteroids. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.
Particular attention must be paid to avoid spontaneous occlusive phenomena, which occur in skin folds or under diapers.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The concomitant use of other corticosteroids in the form of tablets, drops or injections may intensify the side effects.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

The effect of desonide on fertility has not been investigated in animals or humans.
(Category B3)
Corticosteroids may be teratogenic in laboratory animals when administered systemically or topically at relatively low dosage levels and a generic 0.05% desonide cream was reported as teratogenic when applied daily at topical maternal doses of 0.6 and 2 g/kg in rats and 2 g/kg in rabbits over appropriate gestational periods. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore drugs of this class should be used during pregnancy only if potential benefit justifies the potential risk to the foetus and should not be used extensively, in large amounts; or for prolonged periods.
 It is not known whether topical corticosteroids are absorbed sufficiently to be excreted 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 exercised when topical steroids are administered to a nursing woman. Do not apply the product to the breasts during lactation, due to the risk of product ingestion by the neonate.

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)

Prolonged use of corticosteroids of medium potency may induce cutaneous atrophy, telangiectasia (particularly on the face), striae atrophicae (at the roots of the limbs in particular and occurring more readily in adolescents), ecchymotic purpura secondary to atrophy, and cutaneous fragility. On the face, corticosteroids may give rise to peri-oral dermatitis or exacerbate rosacea.
Delayed cicatrisation of atonic wounds, decubitus ulcers and leg ulcers may be observed.
Risk of systemic effects (see Section 4.4 Special Warnings and Precautions for Use).
The following local adverse reactions are reported infrequently with Desowen but may occur more frequently with the use of occlusive dressings. These 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. (See Table 1.)

Post-marketing surveillance.

The incidence of adverse drug reactions recorded in global post-marketing surveillance data is less than 1%.
Post marketing data. Very common: ≥ 1/10; common: ≥ 1/100 and < 1/10; uncommon: ≥ 1/1000 and < 1/100; rare: ≥ 1/10,000 and < 1/1,000; very rare: < 1/10,000.

Body as a whole disorders.

Uncommon: Allergic reaction (including facial oedema and application site reaction).
Rare: Reaction aggravated (flare up of original condition).

Skin and appendages disorders.

Uncommon: Rash (irritation including stinging and burning at site of application), pruritus.
Rare: Skin disorder (not otherwise specified).

Eye disorders.

Vision blurred.

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.

4.9 Overdose

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

Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity is unclear. There is evidence to suggest a correlation between vasoconstriction and therapeutic efficacy in man. The McKenzie-Stoughton vasoconstrictor assay yields a ranking on a seven-point scale in which the first rank is the most potent. This assay method has been used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. Desonide 0.05% is a group VI corticosteroid when assessed in this way. The Desowen preparations are classified as mild topical corticosteroids in the USA where this method of assessment of potency is used. In Europe a four-point measure of potency is used, with one designated the most potent. Desonide 0.05% is ranked 3, a mid-potent topical corticosteroid under this system.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Sufficient corticosteroid may be absorbed to give a systemic effect following topical application. The extent of percutaneous 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. Inflammation or other disease processes can increase percutaneous absorption. Occlusive dressings substantially increase percutaneous absorption of topical corticosteroids. Thus occlusive dressings may be a valuable therapeutic adjunct for the treatment of resistant dermatoses.

Distribution.

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees.

Metabolism.

Corticosteroids are metabolised primarily in the liver.

Excretion.

Corticosteroids are excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

5.3 Preclinical Safety Data

Genotoxicity.

There is no information on the genotoxicity of desonide. No mutagenic or clastogenic effects were found following genotoxicity testing of related drugs budesonide and prednisolone.

Carcinogenicity.

Desonide has not been investigated in long term carcinogenicity studies in animals. However, budesonide, which has a close structural resemblance to desonide, caused an increased incidence of primary hepatocellular tumours in male rats dosed orally at 25 and 50 microgram/kg/day. In a repeat study, budesonide, prednisolone and triamcinolone acetonide all had this effect, indicating a class effect of corticosteroids. A related corticosteroid, flunisolide, caused an increased incidence of pulmonary adenomas in mice in a 22 month study, and an increased incidence of mammary adenocarcinomas in rats in a 24 month study.

6 Pharmaceutical Particulars

6.1 List of Excipients

Desowen lotion.

Sodium lauryl sulfate, light liquid paraffin, cetyl alcohol, stearyl alcohol, propylene glycol, methyl hydroxybenzoate, propyl hydroxybenzoate, sorbitan monostearate, self emulsifying glyceryl monostearate, edetate sodium, purified water, citric acid, sodium hydroxide.

Desowen cream.

Propylene glycol, polysorbate 60, emulsifying wax, isopropyl palmitate, stearic acid, synthetic beeswax, propyl gallate, citric acid, sodium hydroxide, purified water, sorbic acid, potassium sorbate.

Desowen ointment.

Plastibase 50W (PI 2377).
See Section 2 Qualitative and Quantitative Composition.

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. Avoid freezing.

6.5 Nature and Contents of Container

Desonide is a nonfluorinated corticosteroid. Desonide is a white powder or crystal. Practically insoluble in water; sparingly soluble in alcohol and in acetone; soluble in chloroform.
Desowen Cream 0.05% and Ointment 0.05% is supplied in tubes (collapsible aluminium tube with white polypropylene cap) containing 25 g, 30 g, 50 g and 60 g.
Desowen Lotion 0.05% is supplied in bottles (HDPE) containing 10 mL, 30 mL, 60 mL and 100 mL.

6.6 Special Precautions for Disposal

In Australia any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.


CAS number.

638-94-8.
Chemical Name: 11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione-cyclic-16, 17- acetonide.
Molecular Formula: C24H32O6.
Molecular weight: 416.52.

7 Medicine Schedule (Poisons Standard)

Prescription Medicine (S4).

Summary Table of Changes