CASE STUDY

Case Courtesy Credit

Dr. Akanksha Sharma
3rd year PG, Dermatology, IGMC Shimla
Acknowledgment: Dept. Dermatology IGMC Shimla
  Sex – F

 Age – 52 years

 Farmer by occupation

Patient Chief complaints:

Particulars
▪ Multiple, itchy, fluid filled lesions on
scalp, mouth, chest, back, both legs &
arms from past 3 months

▪ Burning sensation and discomfort

during food intake from past 3 months
 Apparently well, 3 months back; when patient noticed multiple
fluid filled mildly itchy lesions on the scalp

 Burning sensation and discomfort while taking food due to some

lesions on the insides of the mouth since 3 months

 The patient had visited the civil hospital 1.5 months ago for the
similar complaints and the oral cavity examination was
documented but was referred for further investigations

 The lesions gradually progressed to involve other body sites

History of Present Illness

Case For Discussion Purpose only
Images copyrighted
  Lesions gradually progressed to involve the chest, back, both
arms and legs, followed by mouth over a period of 6 to 7 days

 H/O spontaneous rupture of lesions/rupture on trivial scratching

within 1 to 2 days, with discharge of clear fluid

 H/o spontaneous healing of lesions within a week

 Lesions of the mouth also progressed with increased discomfort

while solid food intake

History of Present Illness

Case For Discussion Purpose only Images copyrighted
 No history of -----

 urticated plaques prior to the onset of lesions

 difficulty in swallowing food

Negative  any other complaints suggestive of systemic involvement

History  exposure to pesticides/insecticides or application of irritants to skin

 drug intake

 excessive sun exposure

 excessive weight loss, loss of appetite

Case For Discussion Purpose only

  No H/O similar lesions in the past
 No H/O DM/HTN/ATT intake

Past
 No H/O previous medical/ surgical intervention

History
 Past treatment details not available

Case For Discussion Purpose only

  No H/O any food or drug allergy
Personal  No H/O addictions (non-smoker, non-alcoholic)

History  Vegetarian
 Bowel, bladder habits: Normal
 Post-menopausal, LCB – 20 years back

Family  Married, Family completed with 3 children

 No family history of similar complaints/illness or
History other significant medical illnesses

Case For Discussion Purpose only

  Calm, Conscious, Co-operative
 Well Oriented in time, place and person; Sitting
comfortably

General  Temperature – Afebrile

 Pulse – 76/min, Regular ; Respiratory rate – 14/ min

Examination  BP- 140/90mmHg (left supine position); JVP: not raised

 Pallor – + ;
 Icterus, Cyanosis, Edema, Clubbing, LAP- absent
 Lymph nodes – cervical, axillary, inguinal lymph node
not enlarged

Case For Discussion Purpose only

  CNS – WNL
 CVS – S1, S2 + , no murmur
 Respiratory System – bilateral vesicular BS, no
Systemic added sounds; chest expansion WNL
 Per abdomen – soft, non-tender, no
Examination organomegaly, Bowel sounds +
 Musculoskeletal system – Power normal across
all joints; No joint swelling, tenderness, crepitus
or deformity; range of motion of joints WNL

Case For Discussion Purpose only

 Cutaneous Sites involved:

Examination  Scalp
 Face, neck
 Chest (lower > upper)
 Abdomen
 Back (upper> lower)
 Bilateral arms, thighs and legs

For Discussion Purpose only Images copyrighted

 Cutaneous Examination
For Discussion Purpose only Images copyrighted
  Few, well defined, discrete clear fluid filled vesicles
and flaccid bullae of size ranging from 0.5 x 0.5 cms
to 3 x 2 cms with no peri-lesional erythema
 Multiple, well defined, discrete, erythematous

Cutaneous
erosions of size 1x1 cm to 1.5 x1.5 cms with
evidence of yellowish-brown crusting at places

Examination On Palpation: Non tender, Non-indurated lesions

 Multiple, well to ill defined, discrete,
hyperpigmented macules and patches of size
0.4 x 0.3 cms to 5 x 3 cms

For Discussion Purpose only

  Oral cavity Examination:

Oral & buccal mucosa, angle of mouth and palate :

Muco- multiple, well defined, erythematous erosions of size

Cutaneous 0.3 x 0.3cms to 2 x 2cms with overhanging margins and

Examination slough at base. With reference to the previous oral cavity

examination progression in terms of erosion is evident

 Ocular Examination: Conjunctival congestion +

 Genital, Nasal and Perianal mucosa: WNL

For Discussion Purpose only

Oral lesions 1.5 months ago Progression of Oral lesions

Muco-cutaneous Examination
Images copyrighted
  Nail examination:
On finger and toenails--- Increased longitudinal ridging

Cutaneous  Nikolsky sign:

Examination • Direct: negative

• Indirect: positive

 Bulla spread sign: Negative

For Discussion Purpose only

 ? Pemphigus vulgaris
co-existent with Oral Lichen
Clinical Planus

Impression ? Lichen Planus

pemphigoids
  Tzanck smear:

• Multiple acantholytic cells seen with no inflammatory

cells
Investigations  Histopathological Examination:
Findings Supra-basal cleft with Tombstone appearance

 Direct immunofluorescence (DIF):

IgG 2 +, supra-basal fishnet pattern

Case For Discussion Purpose only

 ▪ 52 years old female, farmer by occupation came with the chief complaints
of Multiple, itchy, fluid filled lesions that were first started on scalp and
gradually progressed to mouth, chest, back, both legs & arms over the
period 3 months. This was associated with burning sensation and
discomfort during food intake due to presence and gradual progression of
oral lesions. The lesions were associated with spontaneous rupture on
trivial trauma and underwent spontaneous healing as well.
Summary ▪ The cutaneous examination demonstrated the vesicular, bullous lesions as
well as erythematous erosions with crusting. The mucocutaneous
examination of oral mucosa initially gave the clinical impression of oral
lichen planus like lesion, but gradually progressed to give clear clinical
picture of oral pemphigus vulgaris lesion over the period of 1 month.

▪ The investigations like Tzanck smear, HPE and DIF were confirmatory for
the diagnosis of Pemphigus vulgaris
Case For Discussion Purpose only
Pemphigus Vulgaris

Final Diagnosis
 Approach to such patient….
Approach after the investigations for the confirmation of diagnosis

❑ Workup: before starting the immunosuppressants [Complete Hemogram, LFT, RFT, FBS, Hep B, C and HIV];
Chest X ray and Montoux

❑ General Measures and counselling of the patient (Treating associated symptoms like pain; prevention of
secondary infections)

❑ Rituximab

❑ Systemic Corticosteroids (CS) [DCP pulse]

❑ CS + Immunosuppressants Combination

❑ CS sparing agents: Azathioprine, Mycophenolate moftil (MMF) and Cyclophosphamide

 For Cutaneous lesions

 Bullous pemphigoid

 Linear IgA bullous dermatosis

Some  Bullous erythema multiforme

Differential  Dermatitis herpetiformis

For Oral mucosal lesions

Diagnoses  Lichen planus

 Systemic lupus erythematosus

 Paraneoplastic pemphigus

 Mucous membrane pemphigoid

Porro, A. M., Seque, C. A., Ferreira, M., & Enokihara, M. (2019). Pemphigus vulgaris. Anais
brasileiros de dermatologia, 94(3), 264–278. https://doi.org/10.1590/abd1806-4841.20199011
 Role of Topical Steroids
❑ Corticosteroid creams and/or antibiotic creams

❑ Potent gel corticosteroids may be used in the oral mucosa

❑ Triamcinolone acetonide (10 mg/mL) may be used in the form of intralesional

injection for refractory skin lesions (e.g., pemphigus vegetans)

Porro, A. M., Seque, C. A., Ferreira, M., & Enokihara, M. (2019). Pemphigus vulgaris. Anais brasileiros de dermatologia, 94(3), 264–278. https://doi.org/10.1590/abd1806-4841.20199011
Reference
Questions
QUESTION 1 :

The following conditions may be associated with pemphigus vulgaris, except:

A. Cardiovascular diseases, systemic lupus erythematosus, multiple myeloma, and
depression
B. Rheumatoid arthritis, myasthenia gravis, non-Hodgkin’s lymphoma, and type 1
diabetes mellitus
C. Esophageal neoplasia, laryngeal neoplasia, chronic leukemias, and polycythemia
vera
D. Hydradenitis, smoking, insomnia, and Parkinson’s disease
 QUESTION 2:
The most sensitive and specific test to confirm the diagnosis of pemphigus vulgaris is:
A. Tzanck smear
B. Biopsy and histopathological examination
C. Immunohistochemical examination
D. Direct immunofluorescence
 QUESTION 3:
Check the correct alternative regarding the use of rituximab in the treatment of PV:
A. It is an anti-TNF-α drug, contraindicated in patients with history of tuberculosis
B. The most used scheme is the lymphoma protocol, which uses 1,000 mg/m2, once
a week for four to eight weeks
C. It may be administered in combination with corticosteroids and
immunosuppressants
D. It should always be used in combination with intravenous immunoglobulin to
avoid a rebound effect
 QUESTION 4:
Regarding the use of corticosteroids in the treatment of PV, check the correct alternative:
A. They are indicated only for mucocutaneous cases, but not in exclusively mucosal
forms
B. The dose should be promptly increased until complete control of the condition is
achieved, and then reduced slowly
C. They can be used in doses of up to 4 mg/kg/day, until control of the condition is
achieved
D. They are the basis for the treatment of PV, and the most used drug is deflazacort
 QUESTION 5:
Mark the incorrect alternative regarding the evolution of the PV:
A. The mortality rate fell from 50% to 10% with the use of systemic corticosteroids
B. The main cause of death is infection; therefore, it is always necessary to introduce
prophylactic antibiotic therapy together with immunosuppressants
C. Mucosal lesions usually appear before cutaneous lesions, and respond more
slowly to treatment
D. It is rarely possible to stop treatment in less than one year
 TOPICAL
CORTIOSTEROID
POTENCY
CLASSIFICATION

Ference et al. Am Fam Physician. 2009;79(2):135-140.

FLUTIVATE KEY SAFETY INFORMATION:
▪ Fluticasone propionate is contraindicated in Dermatoses in
infants under 3 months of age.
▪ Avoid long-term continuous topical corticosteroid therapy in
infants and children under 12 years
▪ of age and on face.
▪ Local skin burning can occur uncommonly.
▪ Increased risk of systemic effects due to application on a
larger surface area
TENOVATE KEY SAFETY INFORMATION:
▪ Hypercortisolism and reversible hypothalamic-pituitary-adrenal
axis suppression can occur as a result of increased systemic
absorption of topical corticosteroids. The following conditions
should not be treated with Tenovate: Untreated cutaneous
infections, Rosacea, acne vulgaris, pruritus without
inflammation, perianal and genital pruritus, perioral dermatitis.
Tenovate is contra-indicated in dermatoses in infants less than
one year of age, including dermatitis. Caution is advised when
applied over a large body surface area
Abbreviated Prescribing Information of TENOVATE
(Clobetasol Cream IP/ Clobetasol Ointment IP)
ACTIVE INGREDIENTS: Clobetasol propionate IP 0.05% w/w. THERAPEUTIC INDICATIONS: For adults, elderly and children over 1 year for relief of inflammatory and pruritic manifestations of steroid responsive dermatoses:
psoriasis (excluding widespread plaque psoriasis), recalcitrant dermatoses, lichen planus, discoid lupus erythematosus, other skin conditions which do not respond satisfactorily to less potent steroids. POSOLOGY AND METHOD
OF ADMINISTRATION: Ointment - appropriate for dry lichenified or scaly lesions. Creams - appropriate for moist or weeping surfaces. Adults, Elderly and Children over 1year: Apply thinly and gently rub in using only enough to
cover entire affected area once or twice daily for up to 4 weeks until improvement occurs, then reduce frequency of application or change treatment to a less potent preparation. Allow adequate time for absorption after each
application before applying an emollient. Repeated short courses may be used to control exacerbations. In more resistant lesions, especially in hyperkeratotic lesions, effect can be enhanced, by occluding treatment area with
polythene film. Overnight occlusion only is adequate to bring about a satisfactory response; thereafter, improvement can usually be maintained by application without occlusion. If condition worsens or does not improve within 2-4
weeks, treatment and diagnosis to be re-evaluated. Treatment should not be continued for more than 4 weeks. If continuous treatment is necessary, a less potent preparation to be used. Maximum weekly dose not to exceed
50gms/week. Atopic dermatitis (eczema): Therapy should be gradually discontinued once control is achieved and an emollient continued as maintenance therapy. Rebound of pre-existing dermatoses can occur with abrupt
discontinuation. Recalcitrant dermatoses: Patients who frequently relapse- Once an acute episode has been treated effectively with a continuous course of topical corticosteroid, intermittent dosing (once daily, twice weekly,
without occlusion) may be considered, as it been shown to be helpful in reducing frequency of relapse. Application should be continued to all previously affected sites or to known sites of potential relapse; this should be combined
with routine daily use of emollients. The condition and benefits and risks of continued treatment must be re-evaluated on a regular basis. Children (over 1 year)- More likely to develop local and systemic side effects of topical
corticosteroids and, in general, require shorter courses and less potent agents than adults. Care to be taken to ensure the amount applied is minimum that provides therapeutic benefit. Elderly/ Renal / Hepatic Impairment: Use
minimum quantity for shortest duration to achieve desired clinical benefit. CONTRAINDICATIONS: Untreated cutaneous infections, rosacea, acne vulgaris, pruritus without inflammation, perianal and genital pruritus, perioral
dermatitis, dermatoses in children under one year of age (including dermatitis). SPECIAL WARNINGS AND PRECAUTIONS FOR USE: To be used with caution in patients with history of local hypersensitivity to corticosteroids or
to any of the excipients in the preparation, these may resemble symptoms of the condition under treatment. Manifestations of hypercortisolism (Cushing’s syndrome) and reversible hypothalamic-pituitary-adrenal (HPA) axis
suppression, leading to glucocorticosteroid insufficiency, can occur in some individuals as a result of increased systemic absorption of topical steroids. If either of the above are observed, withdraw drug gradually by reducing
frequency of application, or by substituting a less potent corticosteroid. Abrupt withdrawal of treatment may result in glucocorticosteroid insufficiency. Risk factors for increased systemic effects are: Potency and formulation of
topical steroid, duration of exposure, application to a large surface area, use on occluded areas of skin e.g. on intertriginous areas or under occlusive dressings (in infants nappy may act as occlusive dressing), increasing hydration
of the stratum corneum, use on thin skin areas such as the face, use on broken skin or other conditions where skin barrier may be impaired. In comparison with adults, children may absorb proportionally larger amounts of topical
corticosteroids and thus be more susceptible to systemic adverse effects as children have an immature skin barrier and a greater surface area to body weight ratio compared with adults. If a patient using systemic and/or topical
corticosteroids has blurred vision or other visual disturbances, consider evaluation of possible causes which may include cataract, glaucoma or central serous chorioretinopathy. Children: In infants and children <12 years of age,
long-term continuous topical corticosteroid therapy should be avoided where possible, as adrenal suppression can occur. Children are more susceptible to develop atrophic changes with use of topical corticosteroids. If TENOVATE
is required for use in children, treatment should be limited to only a few days and reviewed weekly. Infection risk with occlusion: Bacterial infection is encouraged by warm, moist conditions within skin folds or caused by occlusive
dressings; if occlusive dressings are used, skin should be cleansed before a fresh dressing is applied. Use in psoriasis: Should be used with caution in psoriasis as rebound relapses, development of tolerances, risk of generalised
pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of skin have been reported in some cases. If used, careful patient supervision is important. Concomitant infection: 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 administration of appropriate antimicrobial
therapy. Chronic leg ulcers: Use may be associated with higher occurrence of local hypersensitivity reactions and increased risk of local infection. Application to face: Undesirable, as this area is more susceptible to atrophic
changes; if used, treatment should be limited to only a few days. Application to eyelids: Care is needed to ensure that preparation does not enter the eye, as cataract and glaucoma might result from repeated exposure. As
TENOVATE OINTMENT contains paraffin, instruct patients not to smoke or go near naked flames due to risk of severe burns. Fabric that have been in contact with this product burn more easily and is a serious fire hazard.
Washing clothing and bedding may reduce product build-up but not totally remove it UNDESIRABLE EFFECTS: Common (≥1/100 and <1/10): Pruritus, local skin burning /skin pain. Uncommon (≥1/1,000 and <1/100): Skin
atrophy, striae, telangiectasias. Very rare (<1/10,000)- Opportunistic infection, local hypersensitivity, skin thinning, skin wrinkling, skin dryness, pigmentation changes, hypertrichosis, exacerbation of underlying symptoms, allergic
contact dermatitis/dermatitis, pustular psoriasis, erythema, rash, urticaria, acne, application site irritation/pain, HPA axis suppression: cushingoid features (e.g. moon face, central obesity), delayed weight gain/growth retardation in
children, osteoporosis, glaucoma, hyperglycaemia/glucosuria, cataract, glaucoma, central serous chorioretinopathy, hypertension, increased weight/obesity, decreased endogenous cortisol levels, alopecia, trichorrhexis..
TEN/API/IN updated 17 Oct 2020
Abbreviated Prescribing Information of FLUTIVATE SKIN CREAM
ACTIVE INGREDIENTS: Fluticasone Propionate I.P. 0.05% w/w THERAPEUTIC INDICATIONS: In adults, children and
infants ≥3 months for relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses such as atopic
dermatitis (including infantile atopic dermatitis), nummular dermatitis (discoid eczemas), prurigo nodularis, psoriasis (excluding
widespread plaque psoriasis), lichen simplex chronicus (neurodermatitis) and lichen planus, seborrhoeic dermatitis, irritant or
allergic contact dermatitis, discoid lupus erythematosus, adjunct to systemic steroid therapy in generalised erythroderma, insect bite
reactions and miliaria (prickly heat). Reduction of risk of relapse of chronic recurrent atopic dermatitis, once acute episode has been
treated effectively. POSOLOGY AND METHOD OF ADMINISTRATION: Adults, elderly, children and infants ≥ 3 months -
Creams appropriate for moist or weeping surfaces. Inflammatory Dermatoses- Apply thinly to cover entire affected area once or
twice daily for up to 4 weeks until improvement occurs, then reduce frequency or change to less potent steroid. Allow adequate time
for absorption before applying emollient. If condition worsens or does not improve within 2-4 weeks, re-evaluate treatment and
diagnosis. Atopic dermatitis- Gradually discontinue once control is achieved and continue emollient. Pre-existing dermatoses can
rebound with abrupt discontinuation especially with potent steroids. Reduction of Risk of Relapse - Reduce frequency to once daily,
twice weekly, without occlusion. Apply to all previously affected sites or sites of potential relapse and re-evaluate on regular basis.
Children ˃3 months - More likely to develop side effects, in general require shorter courses and less potent agents. Apply minimum
amount that provides therapeutic benefit. Elderly/Renal/Hepatic Impairment – Use minimum quantity for shortest duration to
achieve desired clinical benefit. CONTRAINDICATIONS: Untreated cutaneous infections, rosacea, acne vulgaris, perioral
dermatitis, perianal and genital pruritus, pruritus without inflammation, dermatoses in infants <3 months, including dermatitis and
nappy rash. SPECIAL WARNINGS AND PRECAUTIONS FOR USE: Use caution in patients with local hypersensitivity to any
ingredients. Increased systemic absorption can result in Cushing’s syndrome and reversible hypothalamic-pituitary-adrenal (HPA)
axis suppression, leading to glucocorticosteroid insufficiency. Gradually reduce frequency of application or substitute by less potent
corticosteroid. Abrupt withdrawal may result in glucocorticosteroid insufficiency. Risk factors for increased systemic effects:
Potency and formulation, duration of exposure, application to large area, increasing hydration of stratum corneum, use on occluded
areas, thin skin like face, broken skin or conditions with impaired skin barrier. Visual disturbances such as cataract, glaucoma or
central serous chorioretinopathy have been reported by patients using corticosteroids. Children and infants may absorb
proportionally larger amounts of steroids. Infants and Children< 12 years - Avoid long-term continuous therapy where possible. Use
caution in psoriasis as rebound relapses, development of tolerance, risk of generalised pustular psoriasis and development of toxicity
due to impaired skin barrier reported and carefully supervise patient. Prolonged application to face is undesirable as this area is more
susceptible to atrophic changes. Ensure that preparation does not enter eye. Use appropriate antimicrobial therapy while treating
infected inflammatory lesions; withdraw steroid if infection spreads and administer appropriate antimicrobial therapy. Bacterial
infection is encouraged by occlusion; cleanse skin before fresh dressing. Use in dermatitis around chronic leg ulcers associated with
high local hypersensitivity reactions and increased risk of local infection. Overt HPA-axis suppression very unlikely unless treating
more than 50% adult’s body surface and applying > 20 g/day. As it contains paraffin, instruct patients not to smoke or go near naked
flames due to risk of severe burns. Fabric that have been in contact with this product burn more easily and is a serious fire hazard.
Washing clothing and bedding may reduce product build-up but not totally remove it. Excipient imidurea releases traces of
formaldehyde as a breakdown product which may cause allergic sensitization or irritation upon contact with skin. DRUG
INTERACTIONS: CYP3A4 inhibitors (e.g. ritonavir, itraconazole) can lead to increased systemic steroid exposure.
UNDESIRABLE EFFECTS: Common (≥1/100 to <1/10): Pruritis. Uncommon (≥1/1,000 to <1/100): Local skin burning. Very
rare (<1/10,000): Skin thinning, atrophy, striae, telangiectasias, pigmentation changes, hypertrichosis, allergic contact dermatitis,
exacerbation of underlying symptoms, pustular psoriasis, erythema, rash, urticaria, opportunistic infection, hypersensitivity, HPA
axis suppression- increased weight/obesity, delayed weight gain/growth retardation in children, cushingoid features (e.g. moon face,
central obesity), decreased endogenous cortisol levels, hyperglycaemia/ glucosuria, hypertension, osteoporosis, cataract, glaucoma.
FTVC/API/IN updated 09 Sep 2020
Abbreviated Prescribing Information of FLUTIVATE SKIN OINTMENT
(Fluticasone Ointment IP)
ACTIVE INGREDIENTS: Fluticasone Propionate IP 0.005 %w/w THERAPEUTC INDICATIONS: In adults, children and infants
≥3 months for relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses such as atopic dermatitis
(including infantile atopic dermatitis), nummular dermatitis (discoid eczemas), prurigo nodularis, psoriasis (excluding widespread
plaque psoriasis), lichen simplex chronicus (neurodermatitis) and lichen planus, seborrhoeic dermatitis, irritant or allergic contact
dermatitis, discoid lupus erythematosus, adjunct to systemic steroid therapy in generalised erythroderma, insect bite reactions
and miliaria (prickly heat). Reduction of risk of relapse of chronic recurrent atopic dermatitis, once acute episode has been
treated effectively. POSOLOGY AND METHOD OF ADMINISTRATION: Adults, elderly, children and infants ≥ 3 months:
Ointment appropriate for dry, lichenified or scaly lesions. Inflammatory Dermatoses- Apply thinly to cover entire affected area
once or twice daily for up to 4 weeks until improvement occurs, then reduce frequency or change to less potent steroid. Allow
adequate time for absorption before applying emollient. If condition worsens or does not improve within 2-4 weeks, re-evaluate
treatment and diagnosis. Atopic dermatitis- Gradually discontinue once control is achieved and continue emollient. Pre-existing
dermatoses can rebound with abrupt discontinuation especially with potent steroids. Reduction of Risk of Relapse - Reduce
frequency to once daily, twice weekly, without occlusion. Apply to all previously affected sites or sites of potential relapse and re-
evaluate on regular basis. Children ˃3 months - More likely to develop side effects, in general require shorter courses and less
potent agents. Apply minimum amount that provides therapeutic benefit. Elderly/Renal/Hepatic Impairment – Use minimum
quantity for shortest duration to achieve desired clinical benefit. CONTRAINDICATIONS: Untreated cutaneous infections,
rosacea, acne vulgaris, perioral dermatitis, perianal and genital pruritus, pruritus without inflammation, dermatoses in infants <3
months, including dermatitis and nappy rash. SPECIAL WARNINGS AND PRECAUTIONS FOR USE: Use caution in patients
with local hypersensitivity to any ingredients. Increased systemic absorption can result in Cushing’s syndrome and reversible
hypothalamic-pituitary-adrenal (HPA) axis suppression, leading to glucocorticosteroid insufficiency. Gradually reduce frequency
of application or substitute by less potent steroid. Abrupt withdrawal may result in glucocorticosteroid insufficiency. Risk factors
for increased systemic effects: Potency and formulation, duration of exposure, application to large area, increasing hydration of
stratum corneum, use on occluded areas, thin skin like face, broken skin or conditions with impaired skin barrier. Visual
disturbances such as cataract, glaucoma or central serous chorioretinopathy have been reported by patients using steroids.
Children and infants may absorb proportionally larger amounts of steroids. Infants and Children< 12 years - Avoid long-term
continuous therapy where possible. Use caution in psoriasis as rebound relapses, development of tolerance, risk of generalised
pustular psoriasis and development of toxicity due to impaired skin barrier reported and carefully supervise patient. Prolonged
application to face is undesirable as this area is more susceptible to atrophic changes. Ensure that preparation does not enter
eye. Use appropriate antimicrobial therapy while treating infected inflammatory lesions; withdraw steroid if infection spreads and
administer appropriate antimicrobial therapy. Bacterial infection is encouraged by occlusion; cleanse skin before fresh dressing.
Use in dermatitis around chronic leg ulcers associated with high local hypersensitivity reactions and increased risk of local
infection. Overt HPA-axis suppression very unlikely unless treating more than 50% adult’s body surface and applying > 20 g/day.
As it contains paraffin, instruct patients not to smoke or go near naked flames due to risk of severe burns. Fabric that have been
in contact with this product burn more easily and is a serious fire hazard. Washing clothing and bedding may reduce product
build-up but not totally remove it. UNDESIRABLE EFFECTS: Common (≥1/100 to <1/10): Pruritis. Uncommon (≥1/1,000 to
<1/100): Local skin burning. Very rare (<1/10,000): Skin thinning, atrophy, striae, telangiectasias, pigmentation changes,
hypertrichosis, allergic contact dermatitis, exacerbation of underlying symptoms, pustular psoriasis, erythema, rash, urticaria,
opportunistic infection, hypersensitivity, HPA axis suppression- increased weight/obesity, delayed weight gain/growth retardation
in children, cushingoid features (e.g. moon face, central obesity), decreased endogenous cortisol levels, hyperglycaemia/
glucosuria, hypertension, osteoporosis, cataract, glaucoma.
FTVO/API/IN updated 21 Sep 2020
Document Code: PM-IN-COP-PPTX-220003 Date of Preparation: May 2022
For the Use of Registered Medical Practitioner or Hospital or Laboratory Only.
“Registered medical practitioners can refer company website
http://india-pharma.gsk.com/en-in/products/prescribing-information/ for full Product Information.

Please report adverse events with any GSK product to the company at india.pharmacovigilance@gsk.com
GlaxoSmithKline Pharmaceuticals Ltd, Dr Annie Besant Road, Worli, Mumbai-30