Betnovate-S Skin Ointment

Betnovate–S Skin Ointment (Betamethasone Valerate and Salicylic Acid Ointment) is used for the treatment of subacute and chronic hyperkeratotic and dry skin diseases which respond to external topical steroid therapy. These conditions include: Psoriasis (excluding widespread plaque psoriasis), Keratosis palmaris et plantaris (keratinisation of the palm of the hand and the sole of the foot), Chronic eczema or allergic skin diseases (including industrial eczema), Endogenous eczema/ Atopic dermatitis, Seborrhoeic eczema, Dyshidrosis lemellosa sicca (itching, dry, squamous vesicles on palms of the hand, sides of fingers or foot-soles), Lichen planus and lichen simplex and Ichthyosis.

1. Betnovate-S (Betamethasone Valerate & Salicylic Acid Ointment)
© The Swiss Pharmacy

2. Betnovate-S (Betamethasone Valerate & Salicylic Acid Ointment)
© The Swiss Pharmacy
Betnovate–S Skin Ointment (Betamethasone Valerate and Salicylic
Acid Ointment) is used for the treatment of subacute and chronic
hyperkeratotic and dry skin diseases which respond to external
topical steroid therapy. These conditions include: Psoriasis
(excluding widespread plaque psoriasis), Keratosis palmaris et
plantaris (keratinisation of the palm of the hand and the sole
of the foot), Chronic eczema or allergic skin diseases (including
industrial eczema), Endogenous eczema/ Atopic dermatitis,
Seborrhoeic eczema, Dyshidrosis lemellosa sicca (itching, dry,
squamous vesicles on palms of the hand, sides of fingers or foot-
soles), Lichen planus and lichen simplex and Ichthyosis.

3. Betnovate-S (Betamethasone Valerate & Salicylic Acid Ointment)
© The Swiss Pharmacy
Betnovate-S Cream is manufactured by
GlaxoSmithkline Pharmaceuticals
Limited, India in the strength of
Betamethasone 0.1% w/w and Salicylic
Acid IP 3.0 % w/w.

4. Betnovate-S (Betamethasone Valerate & Salicylic Acid Ointment)
© The Swiss Pharmacy

Chemical Structure - Betamethasone Valerate

5. Betnovate-S (Betamethasone Valerate & Salicylic Acid Ointment)
© The Swiss Pharmacy

Chemical Structure - Salicylic Acid

6. Betnovate-S (Betamethasone Valerate & Salicylic Acid Ointment)
© The Swiss Pharmacy
The active ingredients contained in Betnovate-S topical
ointment are Betamethasone Valerate and Salicylic
Acid (Betamethasone USP, 0.1% and Salicylic Acid IP
3%).
Each gram of Betnovate-S topical Ointment contains
1.2 mg Betamethasone Valerate USP (equivalent to 1.0
mg Betamethasone) and 30 mg Salicylic acid.

7. Betnovate-S (Betamethasone Valerate & Salicylic Acid Ointment)
© The Swiss Pharmacy
Uses of Betnovate-S Ointment (Betamethasone 0.1% and Salicylic Acid
3%) :
Betnovate-S (Betamethasone Valerate and Salicylic Acid Ointment) is
used to treat a variety of skin conditions (e.g., eczema, dermatitis,
allergies, rash). This medication is a medium-strength corticosteroid.
Betnovate is a topical corticosteroid, which is applied to the body
surface (skin). Betamethasone is a synthetic fluorinated corticosteroid.
It is active topically and produces a rapid and sustained response in
those inflammatory dermatoses that are normally responsive to topical
corticosteroid therapy, and it is also effective in the less responsive
conditions, such as psoriasis of the scalp, chronic plaque psoriasis of the
hands and feet, but excluding widespread plaque psoriasis.

8. Betnovate-S (Betamethasone Valerate & Salicylic Acid Ointment)
© The Swiss Pharmacy
Uses of Betnovate-S Ointment (Betamethasone 0.1% and Salicylic Acid
3%) :
Topical Salicylic Acid softens keratin, loosens cornified epithelium and
desquamates the epidermis.
Diprosalic presentations are therefore indicated for the treatment of
hyperkeratotic and dry corticosteroid-responsive dermatoses where the
cornified epithelium may resist penetration of the steroid. The salicylic
acid constituent of Diprosalic preparations, as a result of its descaling
action, allows access of the dermis more rapidly than by applying
steroid alone.

9. Betnovate-S (Betamethasone Valerate & Salicylic Acid Ointment)
© The Swiss Pharmacy
Recommended Dosage
The recommended dose of
Betnovate-S (Betamethasone Valerate and Salicylic Acid Ointment)
for adults, elderly and children over 1 year is given below:
Ointments are especially appropriate for dry, lichenified or scaly lesions.
Apply thinly and gently rub in using only enough to cover the entire
affected area once or twice daily for up to 4 weeks until improvement
occurs, then reduce the frequency of application or change the
treatment to a less potent preparation. Allow adequate time for absorption
after each application before applying an emollient. If the condition
worsens or does not improve within 2 to 4 weeks, treatment and diagnosis
should be re-evaluated.

10. Betnovate-S (Betamethasone Valerate & Salicylic Acid Ointment)
© The Swiss Pharmacy
Recommended Dosage
Atopic Dermatitis (Eczema): Therapy with Betnovate-S Skin Ointment 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 of Betnovate-S Skin Ointment.
Recalcitrant Dermatoses: Patients who frequently relapse once an acute episode
has been treated effectively with a continuous course of topical corticosteroid,
intermittent dosing with a topical corticosteroid (without Salicylic Acid) (once
daily, twice weekly, without occlusion) may be considered. This has been
shown to be helpful in reducing the frequency of relapse. Application of a topical
corticosteroid (without Salicylic Acid) should be continued to all previously
affected sites or to known sites of potential relapse. This regime should be
combined with routine daily use of emollients. The condition and the benefits and
risks of continued treatment must be re-evaluated on a regular basis.

11. Betnovate-S (Betamethasone Valerate & Salicylic Acid Ointment)
© The Swiss Pharmacy
Recommended Dosage
Children: Betnovate-S Ointment (Betamethasone Valerate and
Salicylic Acid Ointment) is contraindicated in children under one
year of age.
Children are 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 should be taken when using BETNOVATE –S to ensure the
amount applied is the minimum that provides therapeutic benefit.

12. Betnovate-S (Betamethasone Valerate & Salicylic Acid Ointment)
© The Swiss Pharmacy
Contraindications
➔Betnovate-S Ointment is contraindicated in patients with a known
hypersensitivity to Betamethasone Valerate, Salicylic Acid or any
component of the ointment.
➔The following conditions should not be treated with Betamethasone
Valerate and Salicylic Acid Ointment (Betnovate-S Ointment): Untreated
cutaneous infections, Rosacea, Acne vulgaris, Pruritus without
inflammation, Perianal and genital pruritus and Perioral dermatitis.
➔Betnovate-S Ointment is contraindicated in dermatoses in infants under
one year of age, including dermatitis.

13. Betnovate-S (Betamethasone Valerate & Salicylic Acid Ointment)
© The Swiss Pharmacy
Storage Instructions
Betnovate-S Ointment (Betamethasone Valerate and
Salicylic Acid Ointment) has to be stored at controlled
room temperature i.e. from 20°C to 25°C (68°F to 77°F)
with excursions permitted between 15° to 30°C (59° to
86°F).
Keep this as well as all other medicines away from
children and pets.

14. Betnovate-S (Betamethasone Valerate & Salicylic Acid Ointment)
© The Swiss Pharmacy
Warnings
Betnovate-S Ointment (Betamethasone Valerate and Salicylic Acid Ointment) should be
used with caution in patients with a history of local hypersensitivity to other
corticosteroids. Local hypersensitivity reactions 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 the drug gradually by reducing the frequency of
application, or by substituting a less potent corticosteroid. Abrupt withdrawal of treatment
may result in glucocorticosteroid insufficiency.
In infants and children under 12 years of age, treatment courses should be limited to five
days and occlusion should not be used; long-term continuous topical corticosteroid therapy
should be avoided where possible, as adrenal suppression can occur.

15. Betnovate-S (Betamethasone Valerate & Salicylic Acid Ointment)
© The Swiss Pharmacy
Warnings
Bacterial infection is encouraged by the warm, moist conditions within skin folds or
caused by occlusive dressings. When using occlusive dressings, the skin should be
cleansed before a fresh dressing is applied.
Topical corticosteroids 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 the skin have been
reported in some cases. If used in psoriasis careful patient supervision is important.
Prolonged application to the face is undesirable as this area is more susceptible to
atrophic changes; therefore, treatment courses should be limited to five days and
occlusion should not be used.
If applied to the eyelids, care is needed to ensure that the preparation does not enter
the eye, as cataract and glaucoma might result from repeated exposure.

16. Betnovate-S (Betamethasone Valerate & Salicylic Acid Ointment)
© The Swiss Pharmacy
Warnings
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.
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.
Topical corticosteroids are sometimes used to treat the dermatitis around chronic leg
ulcers. However, this use may be associated with a higher occurrence of local
hypersensitivity reactions and an increased risk of local infection.

17. Betnovate-S (Betamethasone Valerate & Salicylic Acid Ointment)
© The Swiss Pharmacy
Warnings
Co-administered drugs that can inhibit Cyp3a4 (e.g. Ritonavir, 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.
There have been no studies to investigate the effect of Betnovate-S
Ointment (Betamethasone Valerate and Salicylic Acid Ointment) on driving
performance or the ability to operate machinery. A detrimental effect on such
activities would not be anticipated from the adverse effects profile of topical
Betamethasone Valerate and Salicylic Acid .

18. Betnovate-S (Betamethasone Valerate & Salicylic Acid Ointment)
© The Swiss Pharmacy
Possible Side Effects
Continuous application without interruption may result in local atrophy of
the skin, striae and superficial vascular dilation, particularly on the face.
side effects that have been reported with the use of topical corticosteroids
include: burning, itching, irritation, dryness, folliculitis, hypertrichosis,
acneiform eruptions, hypopigmentation, perioral dermatitis and allergic
contact dermatitis.
The following may occur more frequently with the use of occlusive dressings:
maceration of the skin, secondary infection, skin atrophy, striae and miliaria.
Vision blurred has been reported with corticosteroid use. In addition,
prolonged use of salicylic acid preparations may cause dermatitis.

19. Betnovate-S (Betamethasone Valerate & Salicylic Acid Ointment)
© The Swiss Pharmacy
Possible Side Effects
The following Betnovate-S Ointment (Betamethasone Valerate and Salicylic Acid
Ointment) side effects have been reported post marketing:
Infections and infestations:
Very rare: Opportunistic infection.
Immune system disorders:
Very rare: Local hypersensitivity. If signs of hypersensitivity appear, application
should stop immediately.
Endocrine disorders:
Very rare: Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushingoid
features (e.g. moon face, central obesity), delayed weight gain/growth retardation in
children, osteoporosis, glaucoma, hyperglycaemia/glucosuria, cataract, hypertension,
increased weight/obesity, decreased endogenous cortisol levels, alopecia,
trichorrhexis.

20. Betnovate-S (Betamethasone Valerate & Salicylic Acid Ointment)
© The Swiss Pharmacy
Possible Side Effects
The following Betnovate-S Ointment (Betamethasone Valerate and Salicylic
Acid Ointment) side effects have been reported post marketing:
Skin and subcutaneous tissue disorders
Common: Pruritus, local skin burning / skin pain.
Very rare: Allergic contact dermatitis/dermatitis, erythema, rash, urticaria,
pustular psoriasis, skin thinning / skin atrophy, skin wrinkling, skin
dryness, stria, telangiectasias, pigmentation changes, hypertrichosis,
exacerbation of underlying symptoms.
General disorders and administration site conditions
Very rare: Application site irritation / pain.
In addition, prolonged use of salicylic acid preparations may cause dermatitis.

21. Betnovate-S (Betamethasone Valerate & Salicylic Acid Ointment)
© The Swiss Pharmacy
Betnovate-S Ointment Overdosage
Excessive prolonged use of topical corticosteroids including Betnovate-S Ointment
can suppress pituitary-adrenal functions resulting in secondary adrenal insufficiency,
and produce manifestations of hypercorticism, including Cushing's disease.
Treatment: Appropriate symptomatic treatment is indicated. Acute hypercorticoid
symptoms are usually reversible. Treat electrolyte imbalance, if necessary. In case of
chronic toxicity, slow withdrawal of corticosteroids is advised.
With topical preparations containing Salicylic Acid excessive prolonged use may
result in symptoms of salicyclism. Treatment is symptomatic. Measures should be
taken to rid the body rapidly of Salicylate. Administer oral sodium bicarbonate to
alkalinise the urine and force diuresis.
The steroid content of each tube is so low as to have little or no toxic effect in the
unlikely event of accidental oral ingestion.

22. Betnovate-S (Betamethasone Valerate & Salicylic Acid Ointment)
© The Swiss Pharmacy
Betnovate-S Ointment During Pregnancy
Betamethasone Valerate (Betnovate-S skin ointment) has been classified by
the US FDA as Pregnancy Category C.
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
in laboratory animals.
There are no adequate and well-controlled studies in pregnant women.
Therefore, Betnovate-S skin ointment, should be used during pregnancy
only if the potential benefit justifies the potential risk to the fetus.
Medicines of this class should not be used extensively on pregnant
patients, in large amounts, or for prolonged periods of time.

23. Betnovate-S (Betamethasone Valerate & Salicylic Acid Ointment)
© The Swiss Pharmacy
Betnovate-S Skin Ointment are manufactured by
GlaxoSmithkline Pharmaceuticals Limited, India.
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