Tri-Luma (Fluocinolone/Tretinoin/Hydroquinone)

Fluocinolone/tretinoin/hydroquinone is used for short-term treatment of moderate to severe dark skin discoloration (melasma).

Fluocinolone/Tretinoin/Hydroquinone is available under the following different brand names: Tri-Luma.

Dosages of Fluocinolone/Tretinoin/Hydroquinone:

Dosage Forms and Strengths

Cream

• (0.01%/0.05%/4%)/30g

Dosage Considerations – Should be Given as Follows:

• Melasma
• Indicated for short-term treatment of moderate to severe melasma
• Apply to face at night, at least 30 min before bedtime
• Wash face gently before application; rinse and pat dry
• Apply a thin film of Tri-Luma to the hyperpigmented area and 1/2-inch surrounding skin
• Do not use an occlusive dressing

Safety and efficacy not established in pediatric patients

Common side effects of fluocinolone/tretinoin/hydroquinone include:

• Redness
• Skin peeling
• Burning
• Dryness
• Itching
• Acne
• Spider veins
• Increased skin sensitivity
• Rosacea
• Blisters
• Dry mouth
• Numbness and tingling

Less common side effects of fluocinolone/tretinoin/hydroquinone include:

• HPA axis suppression
• Loss of pigmentation (hypopigmentation)
• Ochronosis
• “Sweat rash” (miliaria)
• Skin atrophy
• Rash around the mouth

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Severe interactions of fluocinolone/tretinoin/hydroquinone include:
  • doxycycline
  • minocycline
  • tetracycline
• Fluocinolone/Tretinoin/Hydroquinone has serious interactions with at least 32 different drugs.
• Moderate interactions of fluocinolone/tretinoin/hydroquinone include:
  • cannabidiol
  • dichlorphenamide
  • ketoconazole
  • methotrexate
  • mifepristone
  • siponimod
  • stiripentol
  • tecovirimat
  • teriflunomide
  • tobramycin inhaled
  • tranexamic acid oral
  • trastuzumab
• Mild interactions of fluocinolone/tretinoin/hydroquinone include:
  • benazepril

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

• This medication contains fluocinolone/tretinoin/hydroquinone. Do not take Tri-Luma if you are allergic to fluocinolone/tretinoin/hydroquinone or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Fluocinolone/Tretinoin/Hydroquinone?”

Long-Term Effects

• See "What Are Side Effects Associated with Using Fluocinolone/Tretinoin/Hydroquinone?”

Cautions

• Not indicated for maintenance treatment of melasma
• Avoid sun exposure
• Safety and efficacy of Tri-Luma in patients of skin types V and VI not studied. Excessive bleaching in patients with darker skin cannot be excluded.
• Safety and efficacy in the treatment of hyperpigmentation conditions other than melasma of face not studied
• Contains sodium metabisulfite which may cause allergic-type reactions in susceptible patients
• Hydroquinone may produce exogenous ochronosis (darkening of the skin)- promptly discontinue if occurs

Pregnancy and Lactation

• Use fluocinolone/tretinoin/hydroquinone with caution during pregnancy if the benefits outweigh the risks. Animal studies show risk and human studies are not available or neither animal nor human studies were done.
• It is not known whether fluocinolone/tretinoin/hydroquinone is excreted in breast milk. Use caution while breastfeeding.