Rx Safety Information - Dutoxidil
Drug Safety Information
You must always read this safety information before starting this medication and with every refill. There may be new information. This information is not a substitute for discussing your medical condition or treatment with your healthcare provider.
This compounded product has not been approved by the FDA. It is only available if prescribed by a dermatologist through Tangl who will determine if treatment is suitable.
What I need to know about topical Dutoxidil™:
Dutoxidil™ is a compounded medication combining topical Dutasteride (0.05%), Minoxidil (7%), Tretinoin (0.025%), Melatonin (0.01%), Caffeine (0.5%), and Cetirizine (1%).
- Topical Dutasteride is a potent 5-alpha reductase inhibitor used off-label for androgenetic alopecia (pattern hair loss) due to its ability to reduce scalp DHT levels.
- Topical Minoxidil is FDA-approved for treating hair loss, including androgenetic alopecia, promoting hair regrowth by enhancing blood circulation to hair follicles.
- Tretinoin, Cetirizine, Caffeine, and Melatonin are compounded to provide supportive topical effects, improving scalp health, enhancing absorption, promoting blood flow, and potentially aiding in hair regrowth and thickness.
Absolute Contraindications – DO NOT use Dutoxidil™ if you:
- Are allergic to any of the active ingredients
- Are under 18 or are pregnant, breastfeeding, or planning to become pregnant
- Have any present or past cancer, heart, kidney, or liver problems
- Have high/low blood pressure or orthostatic hypotension
- Have conditions like hyperkalemia, Addison’s disease, or other endocrine or hormonal disorders
Drug Interactions – DO NOT use Dutoxidil™ if you take:
- 5-alpha reductase inhibitors (oral Dutasteride, Finasteride)
- ACE inhibitors
- Angiotensin receptor blockers
- Non-steroidal anti-inflammatory drugs (NSAIDs)
- Diuretics
- Potassium-sparing medications
- Retinoids (oral or topical)
- Medications affecting blood pressure or heart rate
- Certain hepatic/liver medications (consult a doctor)
Serious Side Effects – STOP treatment and seek emergency medical care or call 911 if you experience:
- Chest pain, rapid heartbeat, faintness, dizziness, shortness of breath, or difficulty breathing
- Severe hypotension (low blood pressure)
- Sudden, unexplained weight gain (edema)
- Swelling in hands, legs, feet, or ankles
- Worsening of renal (kidney) or hepatic (liver) function
- Severe scalp irritation or blistering
- Digestive abnormalities including severe nausea or vomiting
- Impaired neurological function
- Stevens-Johnson Syndrome (SJS)
It’s important to closely and regularly monitor for these side effects while taking Dutoxidil™, especially when starting or changing your dose. If you notice any side effects, stop using Dutoxidil™ and seek immediate medical attention or call 911.
Common Side Effects – Talk to your provider about changing your dose/treatment if you experience:
- Scalp irritation, redness, dryness, itching, or peeling
- Temporary hair shedding (common in the initial stages)
- Increased facial or body hair growth
- Changes in hair texture or color
- Mild headache
- Mild nausea or dry mouth
SERIOUS WARNINGS:
PREGNANCY RISK: Dutasteride and Tretinoin are known to cause birth defects and serious fetal harm. Pregnant women and women planning pregnancy should NEVER use this medication. Do not allow women who are pregnant, breastfeeding, or who may become pregnant to touch the medication or the treated scalp area. If contact occurs, wash immediately with soap and water.
POSSIBLE INFERTILITY RISK: Dutasteride may negatively impact male fertility or cause sexual dysfunction, including decreased libido, ejaculation disorders, and impotence. If these symptoms occur, consult your healthcare provider immediately.
POSSIBLE CARDIAC RISK: Topical minoxidil can rarely cause cardiovascular side effects, such as pericardial effusion, potentially progressing to cardiac tamponade, a life-threatening condition. Symptoms include sharp chest pain and breathing difficulties. Seek immediate medical care if symptoms appear.
WARNING: TOXIC TO ANIMALS
Minoxidil is highly toxic to animals, especially cats. Even trace amounts can be life-threatening.
Always Inform Medical Professionals, Provide Accurate Health Information, and Report Side Effects to the FDA.
Instructions For Use:
- Follow healthcare provider’s specific instructions.
- Do not exceed recommended dose.
- Wash hands thoroughly after application.
- Apply solely to the scalp. Avoid contact with other body areas.
- Avoid contact with eyes.
- Do not use for conditions other than prescribed.
- Never share your medication.
Storage Information:
- Store at room temperature.
- Dispose safely if no longer using.
- Keep out of reach of children.
Disclaimer: The FDA has not evaluated all claims made here. This medication is not guaranteed to diagnose, treat, cure, or prevent any disease.