HALOCAL-S Ointment
Halobetasol Propionate & Salicylic Acid Ointment
Composition:
Each gram of ointment contains:Halobetasol Propionate USP 0.05% w/w
Salicylic Acid IP 3% w/w
In a ointment base q.s.
Description:
Halobetasol and salicylic acid ointment is a combination medication used to treat skin conditions
like psoriasis and eczema. Halobetasol, a corticosteroid, reduces inflammation, redness, and
itching. Salicylic acid, a keratolytic, helps shed dead skin cells, softens the skin, and enhances
Halobetasol absorption.
Indication:
Halobetasol propionate is a super-high potency corticosteroid indicated for the relief of the
inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment
beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50
g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal
(HPA) axis.
Salicylic Acid used for the treatment of hyperkeratotic and scaling conditions such as psoriasis.
Dosage & Administration:
For redness, itching, and swelling of the skin:
Adults and children 12 years of age and older—Apply to the affected area of the skin 1 or 2
times a day.
Children younger than 12 years of age- Use is not recommended.
For plaque psoriasis:
Adults and children 12 years of age and older- Apply to the affected area of the skin 2 times a
day for up to 2 weeks.
Children younger than 12 years of age- Use is not recommended.
Method of administration:
Apply a thin layer of ointment to the affected skin once or twice daily, as directed by your
physician, and rub in gently and completely.
Contraindication:
Contraindicated in those patients with a history of hypersensitivity.
Warning & Precaution:
Halobetasol: Systemic absorption of topical corticosteroids can produce reversible
hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid
insufficiency after withdrawal of treatment. Manifestations of Cushing’s syndrome,
hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of
topical corticosteroids while on treatment.
Patients applying a topical steroid to a large surface area or to areas under occlusion should be
evaluated periodically for evidence of HPA axis suppression. Patients receiving super potent
corticosteroids should not be treated for more than 2 weeks at a time and only small areas should
be treated at any one time due to the increased risk of HPA suppression.
Halobetasol Propionate produced HPA axis suppression when used in divided doses at 7 grams
per day for one week in patients with psoriasis. These effects were reversible upon
discontinuation of treatment.
Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to
their larger skin surface to body mass ratios. If irritation develops, Halobetasol Propionate should
be discontinued and appropriate therapy instituted.
If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial
agent should be used. If a favorable response does not occur promptly, use of Halobetasol
Propionate should be discontinued until the infection has been adequately controlled.
Halobetasol Propionate should not be used in the treatment of rosacea or perioral dermatitis, and
it should not be used on the face, groin, or in the axillae.
Salicylic Acid: Salicylic acid should be avoided in contact with broken or inflamed skin.
Salicylate toxicity may occur if applied to large areas of skin or to the skin of neonates.
Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing,
bedding, dressings etc.) that has been in contact with this product burns more easily and is a
serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally
remove it.
Drug Interaction:
No interaction studies have been performed. Interactions with systemically administered
medicinal products are considered minimal. However, topical salicylic acid may increase the
absorption of other topically applied medicines. Concomitant use of Salicylic Acid Ointment and
other topical medicines on the same area of skin should therefore be avoided.
Use in Specific Population:
Pregnancy:
Teratogenic effects: 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 of the teratogenic potential of halobetasol
propionate in pregnant women. Halobetasol Propionate should be used during pregnancy only if
the potential benefit justifies the potential risk to the fetus.
Breast-Feeding:
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 human milk. Because many drugs are excreted in
human milk, caution should be exercised when Halobetasol Propionate is administered to a
nursing woman.
Salicylic Acid
Whilst there are no known contra-indications to the use of Salicylic Acid Ointment BP during
pregnancy and lactation, the safety has not been established. Salicylic Acid Ointment BP should
therefore be used with caution or following professional advice.
There are no or limited amount of data from the use of Salicylic Acid Ointment during
pregnancy.
Salicylic Acid Ointment should not be used during pregnancy, except for short-term treatment of
a small single area of the skin.
It is not known if the systemic Salicylic Acid Ointment exposure reached after topical
administration can be harmful to an embryo/foetus.
During the third trimester of pregnancy, systemic use of prostaglandin synthetase inhibitors may
induce cardiopulmonary and renal toxicity in the foetus. At the end of the pregnancy prolonged
bleeding time in both mother and child may occur, and labour can be delayed.
Adverse effect:
Halobetasol
The most frequent adverse events reported for Halobetasol Propionate included stinging or
burning in 1.6% of the patients. Less frequently reported adverse reactions were pustulation,
erythema, skin atrophy, leukoderma, acne, itching, secondary infection, telangiectasia, urticaria,
dry skin, miliaria, paresthesia, and rash.
The following additional local adverse reactions are reported infrequently with topical
corticosteroids, and they may occur more frequently with high potency corticosteroids, such as
Halobetasol Propionate. These reactions are listed in an approximate decreasing order of
occurrence: folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral
dermatitis, allergic contact dermatitis, secondary infection, striae and miliaria.
Salicylic Acid: Possible sensitivity reactions, drying and irritation. estimation of the frequency
of adverse reactions is based on a pooled analysis of data from clinical studies and spontaneous
reporting.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization 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.
Overdosage:
Halobetasol: Topically applied Halobetasol Propionate can be absorbed in sufficient amounts to
produce systemic effects.
Salicylic Acid: Symptoms of systemic salicylate poisoning (tinnitus, dizziness and deafness)
have been reported after the application of salicylic acid to large areas of skin and for prolonged
periods. Salicylism may also occur in the unlikely event of large quantities being ingested.
Salicylism is unlikely to occur if Salicylic Acid Ointment BP is used as indicated.
Salicylate poisoning is usually associated with plasma concentrations >350mg/L (2.5mmol/L).
Most adult deaths occur in patients whose concentrations exceed 700mg/L (5.1mmol/L). Single
doses less than 100mg/kg are unlikely to cause serious poisoning.
Symptoms
Common features include vomiting, dehydration, tinnitus, vertigo, deafness, sweating, warm
extremities with bounding pulses, increased respiratory rate and hyperventilation. Some degree
of acid-base disturbance is present in most cases.
Uncommon features include haematemesis, hyperpyrexia, hypoglycaemia, hypokalaemia,
thrombocytopaenia, increased INR/PTR, intravascular coagulation, renal failure and non-cardiac
pulmonary oedema.
Central nervous system features including confusion, disorientation, coma and convulsions are
less common in adults than in children.
Management
Give activated charcoal if an adult presents within one hour of ingestion of more than 250
mg/kg. The plasma salicylate concentration should be measured, although the severity of
poisoning cannot be determined from this alone and the clinical and biochemical features must
be taken into account. Elimination is increased by urinary alkalinisation, which is achieved by
the administration of 1.26% sodium bicarbonate. The urine pH should be monitored.
Pharmacodynamics:
Pharmacotherapeutic group: Corticoids, potent (group I)
ATC code: D07AC21
Like other topical corticosteroids, halobetasol propionate has anti-inflammatory, antipruritic and
vasoconstrictive actions.
The mechanism of the anti-inflammatory activity of the topical corticosteroids, in general, is
unclear. However, corticosteroids are thought to act by the 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.
Salicylic Acid
Salicylic acid has a keratolytic action.
Pharmacokinetics:
Halobetasol: The extent of percutaneous absorption of topical corticosteroids is determined by
many factors including the vehicle and the integrity of the epidermal barrier. Occlusive dressings
with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration;
however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical
corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease
processes in the skin may increase percutaneous absorption.
Human and animal studies indicate that less than 6% of the applied dose of Halobetasol
propionate enters the circulation within 96 hours following topical administration of Halobetasol
Propionate.
Studies performed with Halobetasol Propionate indicate that it is in the super-high range of
potency as compared with other topical corticosteroids.
Salicylic Acid: Salicylic acid may be percutaneously absorbed. However, there is no evidence of
any systemic absorption from the use of Salicylic Acid Ointment BP.
Presentation:
HALOCAL-S is available in 30g of pack filled in laminated tube & packed in carton.
