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Halcinonide: Drug information

Halcinonide: Drug information
(For additional information see "Halcinonide: Patient drug information" and see "Halcinonide: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Halog
Pharmacologic Category
  • Corticosteroid, Topical
Dosing: Adult
Steroid-responsive dermatoses

Steroid-responsive dermatoses: Topical: Apply to affected area sparingly 2 to 3 times daily. Therapy should be discontinued when control is achieved; if no improvement is seen, reassessment of diagnosis may be necessary.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Halcinonide: Pediatric drug information")

Note: Dosage should be based on severity of disease and patient response; use smallest amount for shortest period of time to avoid hypothalamic-pituitary-adrenal (HPA) axis suppression. Therapy should be discontinued when control is achieved.

Dermatoses

Dermatoses (corticosteroid-responsive, including contact/atopic dermatitis):

Infants, Children, and Adolescents: Cream, ointment, or solution: 0.1% strength: Topical: Apply to affected area 1 to 3 times daily; most experts suggest once or twice daily application; suggested maximum duration of therapy for high potency agents: 14 days (Ref). Note: Halcinonide 0.1% (cream/ointment/solution) is a group/class 2 highly potent topical corticosteroid; use should be reserved for severe cases; it should not be routinely used on the face or neck (Ref).

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined. Adverse reactions reported with topical corticosteroids; may occur more frequently with occlusive dressing.

Central nervous system: Intracranial hypertension (children), localized burning

Dermatologic: Acneiform eruption, allergic contact dermatitis, atrophic striae, folliculitis, hypertrichosis, hypopigmentation, maceration of the skin, miliaria, perioral dermatitis, pruritus, skin atrophy, xeroderma

Endocrine & metabolic: Cushing syndrome, glycosuria, growth suppression (children), HPA-axis suppression, hyperglycemia

Infection: Secondary infection

Local: Local irritation

Contraindications

Hypersensitivity to halcinonide or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis.

• Contact dermatitis: Allergic contact dermatitis can occur, it is usually diagnosed by failure to heal rather than clinical exacerbation.

• Immunosuppression: Prolonged use may result in fungal or bacterial superinfection; discontinue if dermatological infection persists despite appropriate antifungal or antimicrobial therapy.

• Kaposi's sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi's sarcoma (case reports); if noted, discontinuation of therapy should be considered (Goedert 2002).

• Sensitization: Topical use has been associated with local sensitization (redness, irritation); discontinue if sensitization is noted.

• Systemic effects: Topical corticosteroids may be absorbed percutaneously. Absorption of topical corticosteroids may cause manifestations of Cushing's syndrome, hyperglycemia, or glycosuria. Absorption is increased by the use of occlusive dressings, application to denuded skin, or application to large surface areas.

Special populations:

• Older adult: Because of the risk of adverse effects associated with systemic absorption, topical corticosteroids should be used cautiously in older adults in the smallest possible effective dose for the shortest duration.

• Pediatric: Infants and children may absorb proportionally larger amounts after topical application and may be more prone to systemic effects. HPA axis suppression, intracranial hypertension, and Cushing's syndrome have been reported in children receiving topical corticosteroids. Prolonged use may affect growth velocity; growth should be routinely monitored in pediatric patients.

Dosage form specific issues:

• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated hyperosmolality, lactic acidosis, seizures and respiratory depression; use caution (AAP ["Inactive" 1997]; Zar 2007).

Other warnings/precautions:

• Appropriate use: For external use only; not for oral, ophthalmic, or intravaginal use. Avoid use of topical preparations with occlusive dressings or on weeping or exudative lesions.

Warnings: Additional Pediatric Considerations

Topical corticosteroids may be absorbed percutaneously. The extent of absorption is dependent on several factors, including epidermal integrity (intact vs abraded skin), formulation, age of the patient, prolonged duration of use, and the use of occlusive dressings. Percutaneous absorption of topical steroids is increased in neonates (especially preterm neonates), infants, and young children. Hypothalamic-pituitary-adrenal (HPA) axis suppression may occur, particularly in younger children or in patients receiving high doses for prolonged periods; acute adrenal insufficiency (adrenal crisis) may occur with abrupt withdrawal after long-term therapy or with stress. Infants and small children may be more susceptible to HPA axis suppression or other systemic toxicities due to larger skin surface area to body mass ratio; use with caution in pediatric patients.

Some dosage forms may contain propylene glycol; in neonates, large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Cream, External:

Halog: 0.1% (60 g) [contains cetyl alcohol, propylene glycol]

Generic: 0.1% (30 g, 60 g)

Ointment, External:

Halog: 0.1% (60 g)

Solution, External:

Halog: 0.1% (120 mL) [contains edetate (edta) disodium, polyethylene glycol 300 (peg-6)]

Generic Equivalent Available: US

May be product dependent

Pricing: US

Cream (Halcinonide External)

0.1% (per gram): $13.29 - $13.85

Cream (Halog External)

0.1% (per gram): $15.40

Ointment (Halog External)

0.1% (per gram): $15.40

Solution (Halog External)

0.1% (per mL): $7.70

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Topical: For external use only; not for oral, ophthalmic, or intravaginal use. Wash hands before and after use. Avoid use of topical preparations on weeping or exudative lesions.

Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. Gently rub or apply a small amount of cream, ointment, or solution to the affected area. Cover with a pliable nonporous film and seal the edges. If additional moisture is needed on the affected area, it may be moistened with water prior to applying medication; a damp cloth may also be applied to the lesion before the dressing is applied. A 12-hour occlusion regimen may also be used; apply cream, ointment, or solution under occlusive dressing in the evening and remove dressing in the morning (apply additional product without occlusion during the day). Cream, ointment, or solution should be reapplied at each dressing change. Discontinue use of occlusive dressings if an infection develops.

Administration: Pediatric

Topical: For external use only; not for oral, ophthalmic, or intravaginal use. Wash hands before and after use. Apply a thin film to clean, dry skin and rub in gently. Avoid use of topical preparations on weeping or exudative lesions.

Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. Gently rub or apply a small amount of cream, ointment, or solution to the affected area. Cover with a pliable nonporous film and seal the edges. If additional moisture is needed on the affected area, it may be moistened with water prior to applying medication; a damp cloth may also be applied to the lesion before the dressing is applied. Cream, ointment, or solution should be reapplied at each dressing change. Discontinue use of occlusive dressings if an infection develops.

Use: Labeled Indications

Steroid-responsive dermatoses: Relief of inflammatory and pruritic effects of corticosteroid-responsive dermatoses (high potency topical corticosteroid)

Medication Safety Issues
Sound-alike/look-alike issues:

Halcinonide may be confused with Halcion

Halog may be confused with Haldol

Pediatric patients: High-risk medication:

KIDs List: Medium, high, and very high potency topical corticosteroids, when used in neonates and infants <1 year of age for diaper dermatitis, are identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list; use should be avoided due to risk of adrenal suppression; systemic absorption is higher in pediatric patients than adults (strong recommendation; low quality of evidence) (PPA [Meyers 2020]).

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Reproductive Considerations

Topical corticosteroids may be used for the treatment of corticosteroid-responsive dermatosis, such as atopic dermatitis, in patients planning a pregnancy (Vestergaard 2019).

Pregnancy Considerations

Systemic bioavailability of topical corticosteroids is variable (eg, integrity of skin, use of occlusion) and may be further influenced by trimester of pregnancy (Chi 2017). In general, the use of topical corticosteroids is not associated with a significant risk of adverse pregnancy outcomes. However, there may be an increased risk of low-birth-weight infants following maternal use of potent or very potent topical products, especially in high doses, although this risk is likely to be low (Andersson 2021; Chi 2015; Chi 2017).

When first-line treatments, such as emollients, are insufficient, topical corticosteroids may be used for the treatment of atopic dermatitis in pregnant patients (Vestergaard 2019). Topical corticosteroids are classified by potency; the medication and formulation (eg, cream, gel, and/or salt form) contribute to the potency classification (Oakley 2021; Stacey 2021; Tadicherla 2009). In general, use of the least potent product in limited amounts is recommended during pregnancy. Mild to moderate potency corticosteroids are preferred; potent to very potent topical corticosteroids should only be used as alternative therapy in limited amounts under obstetrical care. Pregnant patients should avoid application of topical corticosteroids to areas with high percutaneous absorption (eg, arm pit, skin folds, vulva) (Chi 2017), and caution should be used when applying to areas prone to striae formation (eg, abdomen, breast, thighs) (Vestergaard 2019).

Breastfeeding Considerations

Systemic corticosteroids are excreted in human milk. It is not known if sufficient quantities of halcinonide are absorbed following topical administration to produce detectable amounts in breast milk. However, systemic corticosteroids are present in breast milk.

Although the manufacturer recommends that caution be used, topical corticosteroids are generally considered acceptable for use in patients who are breastfeeding (Butler 2014; WHO 2002).

Avoid application of topical corticosteroids to the nipple and areola area until breastfeeding ceases; hypertension was noted in a breastfed infant when a high-potency topical corticosteroid was applied to the nipple (AAD-NPF [Elmets 2021]; Butler 2014; Leachman 2006). If needed, apply topical corticosteroids immediately after breastfeeding, then clean nipples prior to the next feeding (Vestergaard 2019).

Monitoring Parameters

Evaluate for HPA axis suppression by using the following tests: ACTH stimulation test, urinary free cortisol test; growth (adolescents/children); presence of infection

Mechanism of Action

Topical corticosteroids have anti-inflammatory, antipruritic, and vasoconstrictive properties. May depress the formation, release, and activity of endogenous chemical mediators of inflammation (kinins, histamine, liposomal enzymes, prostaglandins) through the induction of phospholipase A2 inhibitory proteins (lipocortins) and sequential inhibition of the release of arachidonic acid. Halcinonide has high range potency.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Dependent on strength of preparation, amount applied, integrity of skin at application site, vehicle, and use of occlusive dressing; increased in areas of skin damage, inflammation, or occlusion.

Metabolism: Primarily hepatic

Excretion: Urine

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Volog;
  • (BD) Bangladesh: Dermalog;
  • (BR) Brazil: Halog;
  • (CH) Switzerland: Betacorton;
  • (CO) Colombia: Alcinon | Alcinon BC;
  • (CZ) Czech Republic: Betacorton;
  • (DE) Germany: Halcimat | Halog;
  • (DO) Dominican Republic: Baciderm | Halciderm;
  • (ES) Spain: Halog;
  • (FI) Finland: Halocort | Halog;
  • (FR) France: Halog;
  • (GB) United Kingdom: Halciderm | Halcort;
  • (HK) Hong Kong: Halog;
  • (ID) Indonesia: Halog;
  • (IL) Israel: Halciderm;
  • (IN) India: Cortilate;
  • (IT) Italy: Halciderm;
  • (JP) Japan: Adcortin | Mutayain | Sawastin;
  • (KR) Korea, Republic of: Halog | Halosin | Hanold | Velodan;
  • (LT) Lithuania: Betacorton;
  • (LV) Latvia: Betacorton | Halciderm;
  • (MX) Mexico: Dermalog simple;
  • (MY) Malaysia: Halog;
  • (NO) Norway: Halog;
  • (PE) Peru: Halciderm | Halciderm e;
  • (PK) Pakistan: Volog;
  • (PR) Puerto Rico: Halog;
  • (SE) Sweden: Halog;
  • (SK) Slovakia: Betacorton;
  • (TH) Thailand: Halog;
  • (TN) Tunisia: Halog;
  • (TR) Turkey: Betacorton | Volog;
  • (TW) Taiwan: Confumin;
  • (VE) Venezuela, Bolivarian Republic of: Halog
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