Fluocinolone + Hydroquinone + Tretinoin


Generic Medicine Info
Indications and Dosage
Topical/Cutaneous
Moderate to severe melasma of the face
Adult: Available preparation:
Each g of cream contains fluocinolone acetonide 0.1 mg, hydroquinone 40 mg, and tretinoin 0.5 mg

Short-term treatment: Apply thinly once daily at night (at least 30 minutes before bedtime) onto the affected area(s) including approx 1/2 inch of normal appearing skin surrounding each lesion. Continue the therapy until control is achieved. Max treatment duration: 8 weeks.
Special Precautions
Patient receiving hormonal contraceptives may consider changing to non-hormonal contraceptive measures. Not intended for the maintenance treatment of melasma. Use in darker skin types (Fitzpatrick skin types V and VI) has not been evaluated. Pregnancy and lactation.
Adverse Reactions
Significant: Cutaneous hypersensitivity/contact dermatitis, exogenous ochronosis, Kaposi’s sarcoma (prolonged use); systemic effects (e.g. adrenal suppression, manifestations of Cushing’s syndrome, hyperglycaemia, glycosuria); visual disturbances (e.g. blurred vision, cataract, glaucoma, central serous chorioretinopathy).
Gastrointestinal disorders: Dry mouth.
General disorders and administration site conditions: Application site reactions (e.g. local irritation, inflammation, erythema, burning sensation, desquamation, dryness, xeroderma, pruritus).
Nervous system disorders: Paraesthesia, hyperaesthesia.
Skin and subcutaneous tissue disorders: Acne, telangiectasia, pigmentary changes, papules, acne-like rash, rosacea, rash, vesicles.
Patient Counseling Information
Avoid exposure to sunlight and UV light; use sunscreen or wear protective clothing during the day. Do not use occlusive dressings on the affected area. Avoid contact with mucous membranes, eyes, nose, angles of the mouth, and abraded skin.
MonitoringParameters
May consider confirming the pregnancy status prior to treatment initiation in women of reproductive potential. Monitor for signs or symptoms of hypothalamic-pituitary-adrenal (HPA) axis suppression.
Overdosage
Symptoms: Excessive marked peeling, redness, and discomfort at the application site. Management: Symptomatic treatment. Apply less frequently or discontinue use altogether.
Drug Interactions
May cause additive photosensitivity when used concomitantly with known photosensitising agents (e.g. glimepiride, chlorpromazine, hydrochlorothiazide).
Food Interaction
May enhance adverse effects with vitamin A-containing foods (e.g. cod liver oil, halibut fish oil).
Action
Description: Fluocinolone acetonide is a topical corticosteroid. It induces phospholipase A2 inhibitory proteins (lipocortins) and sequential inhibition of arachidonic acid release, thus reducing the formation, release, and activity of endogenous chemical mediators of inflammation (e.g. kinins, liposomal enzymes, histamines, prostaglandins).
Hydroquinone suppresses the metabolic processes of melanocytes, particularly the inhibition of the enzymatic oxidation of tyrosine to 3,4-dihydroxyphenylalanine (DOPA), thereby producing reversible depigmentation of the skin.
Tretinoin, a derivative of vitamin A, modifies epithelial growth and differentiation.
Pharmacokinetics:
Absorption: Minimally absorbed percutaneously.
Metabolism: Metabolised in the liver (for the small amount absorbed).
Excretion: Via urine and faeces.
Chemical Structure

Chemical Structure Image
Fluocinolone acetonide

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 6215, Fluocinolone acetonide. https://pubchem.ncbi.nlm.nih.gov/compound/Fluocinolone-acetonide. Accessed Jan. 25, 2021.


Chemical Structure Image
Hydroquinone

Source: National Center for Biotechnology Information. PubChem Database. Hydroquinone, CID=785, https://pubchem.ncbi.nlm.nih.gov/compound/Hydroquinone (accessed on Jan. 23, 2020)


Chemical Structure Image
Tretinoin

Source: National Center for Biotechnology Information. PubChem Database. Tretinoin, CID=444795, https://pubchem.ncbi.nlm.nih.gov/compound/Tretinoin (accessed on Jan. 23, 2020)

Storage
Store between 2-8°C. Do not freeze.
References
Anon. Fluocinolone (Topical). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 09/10/2020.

Anon. Fluocinolone, Hydroquinone, and Tretinoin. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 09/10/2020.

Anon. Hydroquinone. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 09/10/2020.

Anon. Tretinoin (Topical). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 09/10/2020.

Buckingham R (ed). Hydroquinone. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 09/10/2020.

Fluocinolone; Hydroquinone; Tretinoin. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com/. Accessed 06/11/2020.

Tri-Lucent Cream (HOE Pharmaceuticals Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 09/10/2020.

Tri-Luma Cream (Galderma Laboratories, L.P.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 09/10/2020.

Tri-Luma Cream (Zuellig Pharma Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my/. Accessed 09/10/2020.

Disclaimer: This information is independently developed by MIMS based on Fluocinolone + Hydroquinone + Tretinoin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 MIMS. All rights reserved. Powered by MIMS.com
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