4.1 Therapeutic indications
Clobetasol Propionate Spray, 0.05% is a super-high potent topical corticosteroid formulation
indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body
surface area (BSA) in patients 18 years of age or older. The total dosage should not exceed 50
grams (59 mL or 2 fl. oz.) per week. Do not use more than 26 sprays per application or 52
sprays per day. Treatment should be limited to 4 consecutive weeks.
Patients should be instructed to use Clobetasol Propionate Spray, 0.05% for the minimum
amount of time necessary to achieve the desired results.
Use in patients under 18 years of age is not recommended because safety has not been
established and because numerically high rates of HPA axis suppression were seen with other
clobetasol propionate topical formulations.

Limitations of Use
Clobetasol Propionate Spray, 0.05% should not be used on the face, axillae, or groin.
Clobetasol Propionate Spray, 0.05% should not be used if there is atrophy at the treatment
site. Clobetasol Propionate Spray, 0.05% should not be used in the treatment of rosacea or
perioral dermatitis.

Clobetasol Propionate Spray, 0.05% is for topical use only, and not for ophthalmic, oral or
intravaginal use.
Clobetasol Propionate Spray, 0.05% should be sprayed directly onto the affected skin areas
twice daily and rubbed in gently and completely.
The total dosage should not exceed 50 grams (59 mL or 2 fluid ounces) per week because of
the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Do not
use more than 26 sprays per application or 52 sprays per day.
Clobetasol Propionate Spray, 0.05% contains a topical corticosteroid; therefore treatment
should be limited to 4 weeks. Therapy should be discontinued when control has been
achieved. Treatment beyond 2 weeks should be limited to localized lesions of moderate to
severe plaque psoriasis that have not sufficiently improved after the initial 2 weeks of
treatment with Clobetasol Propionate Spray, 0.05%. If no improvement is seen within 2
weeks, reassessment of diagnosis may be necessary. Before prescribing for more than 2
weeks, any additional benefits of extending treatment to 4 weeks should be weighed against
the risk of HPA axis suppression.
Use in pediatric patients younger than 18 years is not recommended because of the potential
for HPA axis suppression.

Use in pediatric patients younger than 18 years is not recommended because of the potential
for HPA axis suppression.
Unless directed by physician, Clobetasol Propionate Spray, 0.05% should not be used with
occlusive dressings.
Method of administration
Clobetasol Spray is for Topical Application.

Effects on the Endocrine System
Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress
the HPA axis at the lowest doses tested.
Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitaryadrenal
(HPA) axis suppression with the potential for clinical glucocorticosteroid
insufficiency. This may occur during treatment or upon withdrawal of the topical
corticosteroid.
In studies evaluating the potential for hypothalamic-pituitary-adrenal (HPA) axis suppression,
using the Cosyntropin Stimulation Test, Clobetasol Propionate Spray, 0.05% demonstrated
rates of suppression that were comparable after 2 and 4 weeks of twice-daily use (19% and 15
to 20%, respectively), in adult patients with moderate to severe plaque psoriasis (≥20% BSA).
In these studies, HPA axis suppression was defined as serum cortisol level ≤18 mcg/dL 30
minutes post cosyntropin stimulation.
Because of the potential for systemic absorption, use of topical corticosteroids may require
that patients be periodically evaluated for HPA axis suppression. Factors that predispose a
patient using a topical corticosteroid to HPA axis suppression include the use of more potent
steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on
an altered skin barrier, and use in patients with liver failure.
An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression. If
HPA axis suppression is documented, an attempt should be made to gradually withdraw the
drug, to reduce the frequency of application, or to substitute a less potent steroid.
Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids.
Recovery of HPA axis function is generally prompt and complete upon discontinuation of
topical corticosteroids.
Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result
from systemic absorption of topical corticosteroids.
Use of more than one corticosteroid-containing product at the same time may increase the
total systemic corticosteroid exposure.
Pediatric patients may be more susceptible to systemic toxicity from use of topical
corticosteroids.
Local Adverse Reactions with Topical Corticosteroids
The following additional local adverse reactions have been reported with topical
corticosteroids. They may occur more frequently with the use of occlusive dressings and
higher potency corticosteroids, including clobetasol propionate. These reactions are listed in
an approximate decreasing order of occurrence: folliculitis, acneiform eruptions,
hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae
and miliaria.
Allergic Contact Dermatitis
Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed
by a failure to heal rather than a clinical exacerbation. Clinical diagnosis of allergic contact
dermatitis can be confirmed by patch testing.
Concomitant Skin Infections
In the presence of dermatological infections, the use of an appropriate antifungal or
antibacterial agent should be instituted. If a favorable response does not occur promptly, use
of Clobetasol Propionate Spray, 0.05% should be discontinued until the infection has been
adequately controlled.
Flammable Contents
Clobetasol Propionate Spray, 0.05% is flammable; keep away from heat or flame.
 

Co-administered drugs that can inhibit CYP3A4 (e.g. ritonavir and itraconazole) have been
shown to inhibit the metabolism of corticosteroids leading to increased systemic exposure.
The extent to which this interaction is clinically relevant depends on the dose and route of
administration of the corticosteroids and the potency of the CYP3A4 inhibitor.

Pregnancy
Teratogenic Effects: Pregnancy Category C:
There are no adequate and well-controlled studies in pregnant women. Therefore, Clobetasol
Propionate Spray, 0.05% should be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus.
Corticosteroids have been shown to be teratogenic in laboratory animals when administered
systemically at relatively low dosage levels. Some corticosteroids have been shown to be
teratogenic after dermal application to laboratory animals.
Clobetasol propionate is absorbed percutaneously, and when administered subcutaneously it
was a significant teratogen in both the rabbit and the mouse.
Clobetasol propionate has greater teratogenic potential than steroids that are less potent.
The effect of clobetasol propionate on pregnancy outcome and development of offspring was
studied in the rat. Clobetasol propionate was administered subcutaneously to female rats
twice daily (0, 12.5, 25, and 50 mcg/kg/day) from day 7 of presumed gestation through day
25 of lactation or day 24 presumed gestation for those rats that did not deliver a litter. The
maternal NOEL for clobetasol propionate was less than 12.5 mcg/kg/day due to reduced
body weight gain and feed consumption during the gestation period. The reproductive NOEL
in the dams was 25 mcg/kg/day (ratio of animal dose to proposed human dose of 0.07 on a
mg/m2/day basis) based on prolonged delivery at a higher dose level. The no-observedadverse-
effect-level (NOAEL) for viability and growth in the offspring was 12.5 mcg/kg/day
(ratio of animal dose to proposed human dose of 0.03 on a mg/m2/day basis) based on
incidence of stillbirths, reductions in pup body weights on days 1 and 7 of lactation,
increased pup mortality, increases in the incidence of umbilical hernia, and increases in the
incidence of pups with cysts on the kidney at higher dose levels during the preweaning
period. The weights of the epididymides and testes were significantly reduced at higher
dosages. Despite these changes, there were no effects on the mating and fertility of the
offspring.
Nursing Mothers
Systemically administered corticosteroids appear in human milk and could suppress growth,
interfere with endogenous corticosteroid production, or cause other untoward effects. It is not
known whether topical administration of corticosteroids could result in sufficient systemic
absorption to produce detectable quantities in breast milk. Because many drugs are excreted
in human milk, caution should be exercised when Clobetasol Propionate Spray, 0.05% is
administered to a nursing woman.
 

There have been no studies to investigate the effect of clobetasol on driving performance or
the ability to operate machinery. A detrimental effect on such activities would not be
anticipated from the adverse reaction profile of topical clobetasol.
 

Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates
observed in the clinical trials of a drug cannot be directly compared to rates in the clinical
trials of another drug and may not reflect the rates observed in practice.
In controlled, clinical trials with Clobetasol Propionate Spray, 0.05%, the most common
adverse reaction was burning at the site of application [40% of subjects treated with
Clobetasol Propionate Spray, 0.05% and 47% of subjects treated with Spray Vehicle]. Other
commonly reported adverse reactions for Clobetasol Propionate Spray, 0.05% and Spray
Vehicle, respectively, are noted in Table 1.

Most local adverse reactions were rated as mild to moderate and they are not affected by age,
race or gender.
Systemic absorption of topical corticosteroids has produced hypothalamic-pituitary-adrenal
(HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and
glucosuria in some patients.
Postmarketing Experience
Because these reactions are reported voluntarily from a population of uncertain size, it is not
always possible to reliably estimate their frequency or establish a causal relationship to drug
exposure.
The following adverse reactions have been identified during post-approval use of Clobetasol
Propionate Spray, 0.05%.
Skin: Burning, pruritus, erythema, pain, irritation, rash, peeling, urticaria, and contact
dermatitis.
To report any side effect(s):
- Saudi Arabia:
- The National Pharmacovigilance and Drug Safety Centre (NPC)
Fax: +966-11-205-7662
Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
Toll free phone: 8002490000
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc
Other GCC States: Please contact the relevant competent authority.

Topically applied Clobetasol Propionate Spray, 0.05% can be absorbed in sufficient amount
to produce systemic effects.

Mechanism of Action
Like other topical corticosteroids Clobetasol Propionate Spray, 0.05% has anti-inflammatory,
antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory
activity of the topical steroids 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.
ATC-code: D07AD01.

Vasoconstrictor Assay
Clobetasol Propionate Spray, 0.05% is in the super-high range of potency as demonstrated in
a vasoconstrictor study in healthy subjects when compared with other topical corticosteroids.
However, similar blanching scores do not necessarily imply therapeutic equivalence.
Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression
The effect of Clobetasol Propionate Spray, 0.05% on hypothalamic-pituitary-adrenal (HPA)
axis function was investigated in adults in two studies. In the first study, patients with plaque
psoriasis covering at least 20% of their body applied Clobetasol Propionate Spray, 0.05%
twice daily for up to 4 weeks. 15% (2 out of 13) of patients displayed adrenal suppression
after 4 weeks of use based on the Cosyntropin Stimulation Test. The laboratory suppression
was transient; all subjects returned to normal after cessation of drug use. In the second study,
patients with plaque psoriasis covering at least 20% of their body applied Clobetasol
Propionate Spray, 0.05% twice daily for either 2 or 4 weeks. 19% (4 out of 21) of patients
treated for 2 weeks and 20% (3 out of 15) of patients treated for 4 weeks displayed adrenal
suppression at the end of treatment based on the Cosyntropin Stimulation Test. The
laboratory suppression was transient; all subjects returned to normal after cessation of drug
use. In these studies, HPA axis suppression was defined as serum cortisol level < 18 mcg/dL
30 minutes post cosyntropin (ACTH 1-24) stimulation.

The extent of percutaneous absorption of topical corticosteroids is determined by many
factors, including the vehicle, the integrity of the epidermal barrier and occlusion.
Topical corticosteroids can be absorbed from normal intact skin. Inflammation and other
disease processes in the skin may increase percutaneous absorption.
There are no human data regarding the distribution of corticosteroids to body organs
following topical application. Nevertheless, once absorbed through the skin, topical
corticosteroids are handled through metabolic pathways similar to systemically administered
corticosteroids. They are metabolized, primarily in the liver, and are then excreted by the
kidneys. In addition, some corticosteroids and their metabolites are also excreted in the bile.

Carcinogenesis, Mutagenesis, Impairment of Fertility
Clobetasol propionate was not carcinogenic to rats when topically applied for 2 years at
concentrations up to 0.005% which corresponded to doses up to 11 mcg/kg/day (ratio of
animal dose to proposed human dose of 0.03 on a mg/m2/day basis).
Clobetasol propionate at concentrations up to 0.001% did not increase the rate of formation
of ultra violet light-induced skin tumors when topically applied to hairless mice 5 days per
week for a period of 40 weeks. Clobetasol propionate was negative in the in vitro mammalian
chromosomal aberration test and in the in vivo mammalian erythrocyte micronucleus test.
The effect of subcutaneously administered clobetasol propionate on fertility and general
reproductive toxicity was studied in rats at doses of 0, 12.5, 25, and 50 mcg/kg/day. Males
were treated beginning 70 days before mating and females beginning 15 days before mating
through day 7 of gestation. A dosage level of less than 12.5 mcg/kg/day clobetasol
propionate was considered to be the no-observed-effect-level (NOEL) for paternal and
maternal general toxicity based on decreased weight gain and for male reproductive toxicity
based on increased weights of the seminal vesicles with fluid. The female reproductive
NOEL was 12.5 mcg/kg/day (ratio of animal dose to proposed human dose of 0.03 on a
mg/m2/day basis) based on reduction in the numbers of estrous cycles during the precohabitation
period and an increase in the number of nonviable embryos at higher doses.

6.1 List of excipients:
Alcohol (Ethanol 96%) NF
Isopropyl Myristate NF
Sodium Lauryl Sulfate NF
Undecylenic acid USP

None Reported

Keep tightly closed. Store below 30ºC. Do not freeze, refrigerate or store above 30ºC. Spray
is flammable; avoid heat, flame or smoking when using this product. Keep out of the reach
of children. For external use only. Not for eye use.

2 fl oz/59ml in Opaque White Round HDPE bottle with screw cap along with spray pump.
4.25 fl oz/125ml in Opaque White Round HDPE bottle with screw cap along with spray
pump.

Check with your pharmacist about how to throw out unused drugs.