Registered Malawi · PMRA

HALOVATE CREAM 0.05% W/W CREAM

HALOBETASOL PROPIONATE

PMPB/PL64/95 CREAM dermatologicals INN generic

What it does

Halobetasol is a strong topical steroid used to reduce inflammation and relieve itching in certain skin conditions.

Commonly used for: psoriasis, eczema, dermatitis

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
PMPB/PL64/95
Registration date
18/01/2013
Expiry date
30/06/2013
Status
Registered
Active ingredient
HALOBETASOL PROPIONATE
Dosage form
CREAM
Strength
-
Pack size
-
Therapeutic class
-
ATC class (WHO)
D07AC - Corticosteroids, potent (group III)
Drug group
DERMATOLOGICALS
RxNorm RxCUI
41208
Manufacturer / MAH
-
Applicant / LTR
-
Country of origin
-

Source: Pharmacy and Medicines Regulatory Authority · fetched 2026-04-21 17:37:46 · updated 2026-09-26 04:30:28

Disclaimer: This information is sourced from Pharmacy and Medicines Regulatory Authority (Malawi). Always consult a qualified healthcare professional before using any medication.

About this medicine

Halobetasol is a strong topical steroid used to reduce inflammation and relieve itching in certain skin conditions.

What it treats

  • psoriasis
  • eczema
  • dermatitis

How it works

Halobetasol works by decreasing inflammation and suppressing the immune response in the skin.

Who it's for

Halobetasol is for adults and children with specific skin conditions that require strong anti-inflammatory treatment.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: halobetasol

BNF-referenced

Halobetasol is a potent topical corticosteroid primarily used to treat inflammatory skin conditions such as psoriasis, eczema, and dermatitis. It is characterized by its strong anti-inflammatory properties and is effective in reducing symptoms like redness, swelling, and itching. Halobetasol is formulated for topical application and is typically used for limited durations to minimize potential side effects associated with prolonged corticosteroid use.

Indications

  • Psoriasis
  • Eczema
  • Dermatitis
  • Inflammatory skin disorders

Dosage

Children: Refer to the BNF for Children for appropriate dosing guidelines.

Adults: Apply a thin layer to the affected area once or twice daily. Do not exceed the recommended duration of treatment.

Mechanism of action

The mechanism of action of halobetasol involves binding to the glucocorticoid receptor, leading to decreased vasodilation and permeability of capillaries as well as reduced leukocyte migration to sites of inflammation. This results in inhibition of pro-inflammatory signals and promotion of anti-inflammatory signals. Halobetasol also inhibits phospholipase 2 and prevents neutrophil apoptosis and demargination, thus decreasing the formation of arachidonic acid derivatives. Additionally, it inhibits NF-Kappa B and other inflammatory transcription factors while promoting anti-inflammatory genes like interleukin-10.

Pharmacodynamics

Halobetasol exhibits a moderate duration of action, allowing for once or twice daily applications. The wide therapeutic window of corticosteroids like halobetasol means that patients may require doses significantly higher than the body's natural production. However, patients should be advised about the risks of hypothalamic-pituitary-adrenal axis suppression and increased susceptibility to infections with corticosteroid use.

Pharmacokinetics

Halobetasol, when applied topically, has localized effects with minimal systemic absorption. Its pharmacokinetics may vary based on factors such as skin condition, area of application, and duration of use. The drug's effects peak within hours of application, although the complete therapeutic effects may take longer to manifest due to the underlying mechanisms of action related to gene expression modulation.

Adverse effects

  • Skin atrophy
  • Striae
  • Telangiectasia
  • Acne
  • Folliculitis
  • Hypopigmentation
  • Burning
  • Itching
  • Irritation at the application site

Precautions

  • Use with caution in patients with a history of systemic fungal infections
  • Consider the potential for adrenal suppression with prolonged use
  • Monitor for signs of local infection

Pregnancy

Halobetasol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution is advised.

Breast-feeding

Caution is recommended when halobetasol is used during breastfeeding. It is not known if halobetasol is excreted in human milk.

Storage

Store at room temperature, away from direct sunlight and moisture. Keep out of reach of children.

Formulations

  • Topical cream
  • Topical ointment

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: halobetasol

PubChem CID 5311167

Molecular formula: C22H27ClF2O4

Mechanism of action

The short term effects of corticosteroids are decreased vasodilation and permeability of capillaries, as well as decreased leukocyte migration to sites of inflammation. Corticosteroids binding to the glucocorticoid receptor mediates changes in gene expression that lead to multiple downstream effects over hours to days. Glucocorticoids inhibit phospholipase 2 and neutrophil apoptosis and demargination, resulting in decreased formation of arachidonic acid derivatives. They also inhibit NF-Kappa B and other inflammatory transcription factors while promoting anti-inflammatory genes like interleukin-10. Lower doses of corticosteroids provide an anti-inflammatory effect, while higher doses are immunosuppressive. High doses of glucocorticoids for an extended period bind to the mineralocorticoid receptor, raising sodium levels and decreasing potassium levels.

Pharmacodynamics

Corticosteroids bind to the glucocorticoid receptor, inhibiting pro-inflammatory signals, and promoting anti-inflammatory signals. Ulobetasol has a moderate duration of action as it is applied once or twice daily. Corticosteroids have a wide therapeutic window as patients may require doses that are multiples of what the body naturally produces. Patients taking corticosteroids should be counselled regarding the risk of hypothalamic-pituitary-adrenal axis suppression and increased susceptibility to infections.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.