Consumer medicine information

Clobex Shampoo

Clobetasol propionate

BRAND INFORMATION

Brand name

Clobex

Active ingredient

Clobetasol propionate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Clobex Shampoo.

What is in this leaflet

This leaflet answers some common questions about CLOBEX SHAMPOO. 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 CLOBEX SHAMPOO 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 CLOBEX SHAMPOO is used for

CLOBEX SHAMPOO is used as a topical treatment for moderate to severe scalp psoriasis in adults.

It belongs to a group of medicines called corticosteroids.

CLOBEX SHAMPOO is used on the scalp to relieve the redness, swelling, itching and discomfort of scalp psoriasis.

Your doctor, however, may have prescribed CLOBEX SHAMPOO for another purpose.

Ask your doctor if you have any questions about why CLOBEX SHAMPOO has been prescribed for you.

There is no evidence that CLOBEX SHAMPOO is addictive.

CLOBEX SHAMPOO is available only with a doctor's prescription.

Before you use CLOBEX SHAMPOO

When you must not use it

Do not use CLOBEX SHAMPOO if:

  1. you have ever had an allergic reaction to :
  • medicines containing clobetasol propionate
  • any of the ingredients listed at the end of this leaflet
  1. you have skin areas affected by bacterial, mycobacterial or 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 skin areas affected by specific skin diseases (such as skin tuberculosis or skin disease caused by lues)
  4. you have skin areas with ulcerous wounds

If you are not sure whether you should be using CLOBEX SHAMPOO, talk to your doctor.

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

Do not use CLOBEX SHAMPOO 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 CLOBEX SHAMPOO on children under 2 years. You should not use CLOBEX SHAMPOO on children aged 2 to 18 years unless directed by the child’s doctor. Growth retardation may be observed in children in case of systemic absorption of topical corticosteroids.

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 CLOBEX SHAMPOO when pregnant.
  1. you are breast-feeding or plan to breast-feed
Your doctor will discuss the risks and benefits of using CLOBEX SHAMPOO when breast-feeding.

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

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 taking/using CLOBEX SHAMPOO with other medicines.

How to use CLOBEX SHAMPOO

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.

CLOBEX SHAMPOO is for topical use on the scalp only.

How to use

CLOBEX SHAMPOO should be applied directly to a dry scalp once daily taking care to cover and massage into all lesions.

Using the measuring cup included, measure out 7.5mL which is sufficient to cover the scalp. This is the maximum amount to be used per day.

CLOBEX SHAMPOO should be left without covering for 15 minutes before rinsing.

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

After 15 minutes, the product must be rinsed with water and / or can be washed by using an additional amount of regular shampoo if needed to facilitate washing. Then, hair can be dried as usual.

In order to avoid hair colour changes in hair that has been dyed, CLOBEX SHAMPOO should be thoroughly rinsed.

Avoid contact with the eyes. If you accidentally get CLOBEX SHAMPOO in your eyes, rinse out the eyes with water immediately.

It is important to use CLOBEX SHAMPOO 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.

Use CLOBEX SHAMPOO at the same time every day.

How long to use it

Your doctor will tell you how long to use CLOBEX SHAMPOO. It should not be used continuously for more than 4 weeks.

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

If you are not sure how long to use CLOBEX SHAMPOO, 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 CLOBEX SHAMPOO. 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 CLOBEX SHAMPOO

Things you must do

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

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

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

Tell your doctor if you use other oral/topical medication containing corticosteroids or medication intended to control your immune system (e.g. for autoimmune disease or after a transplantation). Combining Clobex 500 micrograms/g shampoo with these medicines may result in serious infections.

If you become pregnant while using CLOBEX SHAMPOO, tell your doctor.

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

Things you must not do

Do not use CLOBEX SHAMPOO in or near the eyes and eyelids.

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

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

Things to be careful of

Do not use large amounts of CLOBEX SHAMPOO for a long time.

Avoid contact with the eyes. If the shampoo 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 CLOBEX SHAMPOO.

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 CLOBEX SHAMPOO.

Talk to your doctor or pharmacist if you experience newly developed bone pain or worsening of previous bone symptoms during a treatment with Clobex 500 micrograms/g shampoo, especially if you have been using Clobex 500 micrograms/g shampoo for a prolonged time or repeatedly.

Side effects

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

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 CLOBEX SHAMPOO (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 CLOBEX SHAMPOO (occur in less than 1 in 100 patients) include:

  • local signs of skin irritation
  • itching of the skin
  • hives
  • small red or purple clusters on the skin
  • skin becoming fragile and prone to tears and ulcerations
  • skin discomfort
  • pain of skin
  • fluid retention under the skin (oedema)
  • aggravation of psoriasis
  • hair loss causing spot baldness
  • dry skin
  • eye stinging / burning
  • eye irritation
  • ocular tight sensation
  • ocular discomfort
  • headache
  • stretch marks
  • rash

Post-marketing adverse event reports have also included

  • erythema (redness)
  • rash
  • allergic contact dermatitis
  • glaucoma
  • hypersensitivity
  • hypercortisolism (Cushing’s syndrome)
  • adrenal suppression
  • blurred vision

Some people may get other side effects while using CLOBEX SHAMPOO.

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

After using CLOBEX SHAMPOO

Storage

Store in the original bottle.

Keep CLOBEX SHAMPOO in a cool, dry place where the temperature stays below 25°C. 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 CLOBEX SHAMPOO 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

Discard 4 weeks after first opening.

If your doctor tells you to stop using CLOBEX SHAMPOO, 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

CLOBEX SHAMPOO is a viscous, translucent colourless to pale yellow liquid shampoo with alcoholic odour.

CLOBEX SHAMPOO is packaged in high density polyethylene (HDPE) bottles of 60mL or 125mL fitted with polypropylene snap closures which contain 8 or 16 days’ worth of treatment, respectively. The HDPE bottle of 30mL is fitted with polypropylene screw closure which contains 4 days’ worth of treatment. Not all pack sizes may be marketed.

Ingredients

CLOBEX SHAMPOO contains the active ingredient clobetasol propionate 500mcg/mL.

1 millilitre of CLOBEX SHAMPOO contains 500micrograms of clobetasol propionate.

CLOBEX SHAMPOO also contains the following excipients: ethanol, coco-betaine, sodium laureth sulfate, polyquaternium-10, sodium citrate, citric acid, purified water.

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 188346

® Registered Trademark

This leaflet was prepared on
September 2021

Published by MIMS November 2021

BRAND INFORMATION

Brand name

Clobex

Active ingredient

Clobetasol propionate

Schedule

S4

 

1 Name of Medicine

Clobetasol propionate.

2 Qualitative and Quantitative Composition

One millilitre of Clobex Shampoo contains 500 micrograms of clobetasol propionate.

Excipients with known effect.

Contains alcohol as 10% v/v ethanol. For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

A shampoo for topical application. Viscous, translucent, colourless to pale yellow liquid shampoo with alcoholic odour.

4 Clinical Particulars

4.1 Therapeutic Indications

Topical treatment of moderate to severe scalp psoriasis in adults.

4.2 Dose and Method of Administration

For topical use on the scalp only.

Instructions for use/ handling.

Clobex Shampoo should be applied directly on dry scalp once daily taking care to cover and massage the lesions well. Using the measuring cup included, measure out 7.5 mL which is sufficient to cover all the scalp and is the maximum daily dosage. Clobex Shampoo should be then left in place without covering for 15 minutes before rinsing. As with any topical medication, patients should wash their hands carefully after application. After 15 minutes, the product must be rinsed with water and/or hair can be washed by using an additional amount of regular shampoo if needed to facilitate washing. In order to avoid interaction with hair colour dying product, such as hair colour changes, Clobex Shampoo should be thoroughly rinsed. Then, hair can be dried as usual.
Avoid contact with the eyes. If the shampoo accidentally comes in contact with the eyes, rinse out the eyes with water immediately.
The treatment duration should be limited to a maximum of 4 weeks. As soon as clinical results are observed, applications should be spaced out or replaced, if needed, by an alternative treatment. If no improvement is seen within four weeks, reassessment of the diagnosis may be necessary.
Chronic overdosage may occur in the case of continuous use of large quantities for long periods of time.
Clobetasol propionate belongs to the most potent class of topical corticosteroids (class IV) and prolonged use may result in serious undesirable effects (see Section 4.4 Special Warnings and Precautions for Use).

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.
Skin areas affected by bacterial and mycobacterial, viral (varicella, herpes simplex, herpes zoster), fungal or parasitic infections and specific skin diseases (skin tuberculosis, skin diseases caused by lues) or to ulcerous wounds.
Clobex Shampoo must not be applied to the eyes and eyelids (risk of glaucoma, risk of cataract).
Children under 2 years of age.

4.4 Special Warnings and Precautions for Use

General precautions.

Topical corticosteroids should be used with caution for a number of reasons including post-treatment rebound, relapses, development of tolerance (tachyphylaxis) and development of local or systemic toxicity such as skin atrophy, infection (including isolated cases of systemic infections), telangiectasia of the skin or hypothalamic-pituitary-adrenal (HPA) axis suppression. There is a risk of HPA suppression with prolonged use and also with the use of large volumes. Clobex Shampoo should not be used for more than 4 consecutive weeks; nor should a dose greater than 7.5 mL daily be used. In rare instances, treatment of psoriasis with corticosteroids (or its withdrawal) is thought to have provoked generalised pustular psoriasis in case of intensive and prolonged topical use. In very rare cases, hypersensitivity to corticosteroids can be observed. Clobetasol propionate is not recommended in patients who are hypersensitive to other corticosteroids.
In general, treatment of large surface areas, long-term continuous therapy with corticosteroids, use of occlusive dressings can enhance absorption and lead to a higher risk of systemic effects. In such cases, medical supervision should be increased and patients may be evaluated periodically for evidence of HPA axis suppression. Patients applying doses of Clobex Shampoo in excess of 50 mL per week should be carefully monitored. Systemic absorption of topical corticosteroids has caused reversible adrenal suppression with the potential for glucocorticosteroid insufficiency, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Such systemic effects disappear when treatment is stopped. However, abrupt discontinuation can lead to acute adrenal insufficiency, especially in children.
Clobex Shampoo is only intended for the treatment of scalp psoriasis and should not be used to treat other skin areas. In particular, Clobex Shampoo must not be applied on the face, on intertriginous areas (axillae and genitoanal regions) and on other erosive skin surfaces as this could increase the risk of topical adverse events such as atrophic changes, telangiectasia or cortico-induced dermatitis.
Clobex shampoo is not recommended in patients with acne vulgaris, rosacea or perioral dermatitis.
If Clobex Shampoo does enter the eye, the affected eye should be rinsed with copious amounts of water.
Patients should be instructed to use clobetasol propionate for the minimum amount of time necessary to achieve the desired results.
Cases of osteonecrosis, serious infections (including necrotizing fasciitis), and systemic immunosuppression (sometimes resulting in Kaposi's sarcoma lesions) have been reported with long-term use of clobetasol propionate beyond the recommended doses (see Section 4.2 Dose and Method of Administration). In some cases, patients used other potent oral/topical corticosteroids or immunosuppressors concomitantly (e.g. methotrexate, mycophenolate mofetil).

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.

Use in hepatic impairment.

No specific studies have been performed. Patients with severe liver dysfunction should be treated with special caution and closely monitored for side effects.

Use in renal impairment.

No specific studies have been performed. Patients with severe diabetes mellitus should be treated with special caution and closely monitored for side effects.

Use in the elderly.

No specific studies have been performed.

Paediatric use.

The experience in the paediatric population is limited. Clobex Shampoo is not recommended for use in children and adolescents below 18 years of age and is contraindicated in children below 2 years of age. Growth retardation may be observed in case of systemic absorption of topical corticosteroids. Because of a higher ratio of skin surface area to body mass, children are at a greater risk than adults of HPA axis suppression when they are treated with topical corticosteroids. They are also at greater risk of adrenal insufficiency after withdrawal of treatment, and of Cushing's syndrome while on treatment.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No interaction studies have been performed.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

When administered subcutaneously to rats, clobetasol propionate reduced the viability of embryos and reduced maternal reproduction capacities.
Animal studies of the effect of Clobex Shampoo on fertility have not been conducted. However, clobetasol propionate had no effect on male or female mating performance in rats when administered subcutaneously (SC) at doses up to 50 microgram/kg/day. Reductions in both the number of estrous cycles and embryo viability were observed at SC doses from 25-50 microgram/kg/day.
(Category B3)
Animal studies of the effect of Clobex Shampoo on embryofetal development have not been conducted. However, clobetasol propionate was shown to be teratogenic when administered topically or subcutaneously during organogenesis in mice, rats and rabbits. Fetotoxicity and fetal malformations (including skeletal abnormalities, cleft palate, cranioschisis or umbilical cord hernia) were observed in mice (30 microgram/kg/day SC), rats (50 microgram/kg/day topical) and rabbits (3 microgram/kg/day SC) at doses (on a mg/m2 basis) less than the maximum human topical dose.
There are no adequate or well-controlled studies of clobetasol propionate in pregnant women. Studies in animals have shown reproductive toxicity. The clinical relevance of the effects of clobetasol and other corticosteroids in developmental animal studies is unknown. Clobex Shampoo should be avoided during pregnancy, unless clearly necessary.
 Systemically administered corticosteroids pass into breast milk. There are no adequate data on the possible milk transfer of topical clobetasol propionate. However, studies in rats (see below) have shown postnatal pup effects following subcutaneous maternal dosing during weaning. Thus, Clobex Shampoo should be avoided in breastfeeding women, unless clearly necessary.

4.7 Effects on Ability to Drive and Use Machines

As a topical corticosteroid, Clobex Shampoo has no or negligible influence on the ability to drive and use machines.

4.8 Adverse Effects (Undesirable Effects)

During clinical development, in a total of 558 patients receiving Clobex Shampoo, the most commonly reported adverse drug reaction was skin burning sensation with an incidence of approximately 5%. Most adverse events were rated as mild to moderate and they were not affected by race or gender. Clinical signs of skin irritation were uncommon (0.5%). No serious drug-related adverse events were reported during any of the clinical trials.
If signs of local intolerance appear, application should be suspended until they disappear. If signs of hypersensitivity appear, application should be stopped immediately. This can be suspected in case of resistance to treatment.
Table 1 reports the adverse reactions related to treatment by body system and by absolute frequency according to the following classification: Very common ≥ 10%; Common ≥ 1% to < 10%; Uncommon ≥ 0.1% to < 1%.
As a class attribution, prolonged use of topical corticosteroids, treatment of extensive areas or use of large amounts can result in sufficient systemic absorption to produce the features of hypercortisolism (Cushing syndrome) or of Hypothalamus-Pituitary-Adrenal (HPA) axis suppression. Should HPA axis suppression occur, it is likely to be transient with a rapid return to normal values. However, as Clobex Shampoo is to be kept in place for only 15 minutes before rinsing, systemic absorption is seldom observed (see Section 5.2 Pharmacokinetic Properties), and therefore, the risk of appearance of HPA axis suppression is very low compared to non-rinsed potent corticosteroids products. No HPA axis suppression has been observed during clinical trials with Clobex Shampoo.
Prolonged and/or intensive treatment with potent corticosteroid preparations may cause immunosuppression, opportunistic infections, local atrophic changes, such as local skin atrophy, striae, telangiectasia, erythema, purpura, generalised pustular psoriasis and contact dermatitis.
Growth retardation may be observed in children in case of systemic absorption of topical corticosteroids.
When applied to the face, very potent corticosteroids can induce perioral dermatitis, skin atrophy or worsen rosacea. During development of Clobex Shampoo, skin atrophy was assessed using ultrasound measurement of skin thickness in a specific clinical trial involving 13 patients. After 4 weeks of treatment with Clobex Shampoo, no skin thinning was observed.
There are reports of pigmentation changes, acne, pustular eruptions and hypertrichosis with topical corticosteroids.
Cataract has been reported when corticosteroids were applied to the eyes or eyelids.
Rebound effects may occur upon discontinuation of treatment.

Post-marketing safety experience.

Manifestations of Cushing's syndrome have been described in post market reports following long term duration of use of clobetasol propionate. In addition, a report of adrenal suppression has been reported following long-term use in an off label indication (lichen planus).
Glaucoma, hypersensitivity, erythema, rash and allergic contact dermatitis have been described in post-market reports.

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

Acute overdose is very unlikely to occur, however, in the case of chronic overdose or misuse, the features of hypercortisolism may appear and in this situation, treatment should be discontinued gradually. However, because of the risk of acute adrenal suppression, this should be done under medical supervision. For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Corticosteroids, Very Potent (Group IV). ATC code: D07AD01.

Mechanism of action.

Like other topical corticosteroids, clobetasol propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of topical corticosteroids in general is unclear. However, corticosteroids are thought to act by induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Clinical trials.

Five, randomised, controlled Phase III clinical trials were conducted to establish the efficacy and safety of Clobex Shampoo. In all studies, treatment with Clobex Shampoo was for 4 weeks with a daily application for 15 minutes before rinsing. Two studies were vehicle-controlled and three were comparative against an active control [scalp solution of calcipotriol 50 microgram/mL (Daivonex); coal tar solution at 1% w/w (Polytar Liquid); clobetasol propionate 0.05% gel].
The two vehicle-controlled clinical trials involved 290 patients with moderate to severe scalp psoriasis treated with either Clobex Shampoo or the corresponding vehicle applied once daily for 15 minutes before lathering rinsing for a period of 4 weeks. Efficacy results are presented in Table 2.
In all three studies in which comparison was made, Clobex Shampoo has shown a superior efficacy compared to the vehicle.
The efficacy of Clobex Shampoo applied for 15 minutes, once a day was compared over 4 weeks to that of calcipotriol solution 50 microgram/mL applied twice a day (Daivonex) and to that of a coal tar solution at 1% w/w (Polytar Liquid) applied twice a week. Both trials enrolled subjects with moderate to severe scalp psoriasis. After 4 weeks of treatment (Day 28) Clobex Shampoo was shown to be superior to Daivonex Solution (Table 3) and Polytar Liquid (Table 4) on the two co-primary endpoints: Total Sum Score (TSS) and Global Severity Scale (GSS).
Clobex Shampoo (applied daily for 15 minutes and then rinsed) has finally been found non inferior to a clobetasol propionate 0.05% gel applied once a day to the dry scalp without rinsing.
Efficacy and safety of Clobex Shampoo were not investigated beyond 4 weeks of treatment.

5.2 Pharmacokinetic Properties

In vitro liberation-penetration studies on human skin showed that only a small percentage (0.1%) of the applied dose of Clobex Shampoo can be found in the epidermis (including the stratum corneum) when applied for 15 minutes and then rinsed. The very low topical absorption of clobetasol propionate from Clobex Shampoo when applied according to the recommended clinical use (15 minutes before rinse off) resulted in negligible systemic exposure in animal studies and in clinical trials. Available clinical data revealed that only 1 of 126 subjects had a quantifiable clobetasol propionate plasma concentration (0.43 nanogram/mL).
The present pharmacokinetic data indicate that systemic effects following clinical treatment with Clobex Shampoo are highly unlikely due to the low systemic bioavailability of clobetasol propionate.

5.3 Preclinical Safety Data

Genotoxicity.

Clobetasol propionate did not demonstrate any genotoxic potential in vitro (Ames, fluctuation and gene conversion tests and chromosome aberration assay) or in vivo (mouse micronucleus test).

Carcinogenicity.

Long term rodent carcinogenicity studies have not been conducted with Clobex Shampoo. However, a clobetasol propionate lotion formulation had no carcinogenic potential when applied topically to rats for 2 years at doses (on a mg/m2 basis) corresponding to less than one thirtieth of the maximum human topical dose.

6 Pharmaceutical Particulars

6.1 List of Excipients

Ethanol, coco-betaine, sodium laureth sulfate, polyquaternium-10, sodium citrate, citric acid, purified water.

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.
Shelf-life after first opening: 4 weeks.

6.4 Special Precautions for Storage

Store below 25°C. Store in the original container.

6.5 Nature and Contents of Container

The product is packaged in high density polyethylene (HDPE) bottles of 60 mL or 125 mL fitted with polypropylene snap closures. The HDPE bottle of 30 mL is fitted with a polypropylene screw closure.
Bottles contain 30 mL, 60 mL or 125 mL of Shampoo which contain 4, 8 and 16 days treatment, respectively.
Not all pack sizes may be marketed.
AUST R 188346.

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

Common Name: clobetasol propionate.
Chemical Name: 21-chloro-9-fluoro-11β, 17-dihydroxy-16β-methylpregna-1, 4-diene-3, 20-dione 17-propionate.
Molecular Formula: C25H32ClFO5.
Molecular Weight: 467.0.

Chemical structure.


CAS number.

25122-46-7.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Medicine.

Summary Table of Changes