Spiroxidil™

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 Spiroxidil™:

• Spiroxidil™ is a compounded medication combining topical Spironolactone and topical Minoxidil, as well as cetirizine, caffeine and melatonin.
• Spironolactone is primarily a medication used to treat conditions like high blood pressure and fluid retention (edema) due to its diuretic effects. Topical Spironolactone is sometimes used off-label for its  anti-androgenic effects in the treatment of hair loss, particularly in women who have a condition called androgenetic alopecia (female pattern hair loss) or other hair loss conditions with an androgenic component. 
• Topical Minoxidil is FDA-approved for the treatment of hair loss, including androgenetic alopecia. 
• Cetirizine, Caffeine and Melatonin are compounded together to be used off-label as supportive topicals aiding in promoting blood flow, a better scalp environment, slowing further hair loss, and improving hair growth.

Absolute Contraindications – DO NOT use Spiroxidil™ 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 problems, kidney problems or liver problems
• Have high/low blood pressure or orthostatic hypotension
• Have any present or past issues with hyperkalemia, Addison's disease (chronic adrenal insufficiency), or other conditions associated with hyperkalemia and or are receiving other potassium-sparing agents. 

Drug Interactions – DO NOT use Spiroxidil™ if you take: 

• ACE inhibitors
• angiotensin receptor blockers
• Potassium channel blockers or medications for hyperkalemia
• Non-steroidal anti-inflammatory drugs (NSAIDs)
• Diuretics
• Trimethoprim
• Lithium
• Cholestyramine
• Abiraterone
• Digoxin
• Eplerenone
• Alfentanil
• Alprazolam
• Buprenorphine
• Opioids
• Trimethoprim
• Lithium
• Guanethidine
• Certain blood pressure medications and certain hepatic/ liver medications or medications for Addison’s disease (see a doctor in-person about seeking treatment with Spiroxidil™)  

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  
• Hypotension (low blood pressure) 
• Sudden, unexplained weight gain (edema)
• Swelling in the hands, legs, feet or ankles
• Worsening of renal (kidney) or hepatic (liver) function
• Digestive abnormalities including bleeding and vomiting 
• Electrolyte and metabolic abnormalities
• Severe scalp irritation 
• Increase in potassium (hyperkalemia)
• Gynecomastia/breast tenderness/increase in breast size
• Impaired neurological function 
• Stevens-Johnson Syndrome (SJS)

It’s important to closely and regularly monitor for these side effects while taking Spiroxidil™, especially when starting or changing your dose, as they can indicate a severe reaction. If you notice any side effects, stop using Spiroxidil™ and seek immediate medical attention, or call 911. 

Common Side Effects  – Talk to your provider about changing your dose/treatment if you experience: 

• Unwanted hair growth on the face or body
• Headache   
• Scalp irritation, including redness and itching
• Insomnia, nausea, dry mouth
• Hair shedding: It's common to experience increased hair shedding initially. This is typically a temporary phase as hair follicles regenerate. 
• Some may also experience changes in hair texture and color. 

These are not all the possible side effects of Spiroxidil™. For more information, ask your healthcare provider or pharmacist and refer to the complete prescribing information: Spironolactone, Topical Minoxidil, Cetirizine, Topical Melatonin, Caffeine

SERIOUS WARNINGS:

• PREGNANCY RISK: Spironolactone, one of the active ingredients in Spiroxidil™ may cause birth defects based on its mechanism and animal studies. Pregnant women and women who plan to become pregnant in the near future, should not take spironolactone under any circumstances.

Do not let children, pregnant or breastfeeding women, or women who may become pregnant handle this medication. Do not let them touch the area where the medication is applied (scalp). If contact occurs, they should immediately wash the affected skin area with soap and water.

• POSSIBLE INFERTILITY RISK: Spironolactone, one of the active ingredients in Spiroxidil™ may cause an increased risk of  infertility, breast tenderness/increase in breast size, irregular periods, or lack of menstrual periods. If you notice these symptoms, seek immediate emergency medical care. 
• POSSIBLE CANCER RISK: Spironolactone, one of the active ingredients in Spiroxidil™, may cause an increased risk of certain types of cancer.  During animal testing, orally administered spironolactone caused tumor growth in specific rats. Although animal findings don't always reflect human responses, Tangl dermatologists adhere to a principle of caution when prescribing. Due to its potential carcinogenic implications, you should not use Spiroxidil™ if you have a history or risk of cancer. If you notice any unusual symptoms, seek immediate emergency medical care. 
• POSSIBLE CARDIAC RISK: In rare cases topical minoxidil, one of the active ingredients in Spiroxidil™, can lead to cardiovascular side effects. Pericardial effusions, which is the excessive buildup of fluid in the sac surrounding the heart (pericardium), have been reported in patients taking minoxidil. This can progress to cardiac tamponade, which is a life-threatening condition where the fluid pressure compresses the heart, preventing it from effectively pumping blood. Symptoms encompass sharp chest pain and breathing difficulties. If you notice these symptoms, seek immediate emergency medical care.

Always use Spiroxidil™ under the supervision of a healthcare professional and undergo regular medical assessments during treatment.

WARNING: TOXIC TO ANIMALS

• Minoxidil, one of the active ingredients in Spiroxidil™, is highly toxic to animals, especially cats; even trace amounts can be life-threatening. 
• Do not apply minoxidil if pets are in close proximity
• Do not approach your pets until the treated area has thoroughly dried
• Wash hands and surfaces thoroughly after application
• Do not let pets near the application site (i.e. do not hold pets near your face/hair)
• Beware of pillowcases: minoxidil can transfer to pillow cases during sleep. To prevent any risk to your pets, especially cats, consider removing or replacing pillow cases after use. Alternatively, ensure that your pets do not have access to areas where pillows might be.
• Always store Spiroxidil™ in a secure location out of reach of pets. 
• Always store Spiroxidil™ in a secure location out of reach of pets. 
• If you suspect your pet has come into contact with minoxidil or displays symptoms such as lethargy, rapid breathing, vomiting, or collapse, seek emergency veterinary care immediately.

Always Inform Medical Professionals: Always consult a healthcare provider immediately about any unusual side effects, concerns or changes noticed during treatment. You can message your Tangl dermatologist through your Tangl account (trytangl.com/account) if you have any questions or concerns about your treatment.  

Always Provide Accurate Health Information: Failing to provide accurate information about your health and medical history can lead to severe consequences, including harm or, in some instances, death.

Report Side Effects to the FDA: Negative side effects should be reported to the FDA at www.fda.gov/medwatch  or call 1-800-FDA-1088.

Instructions For Use:

• Follow your healthcare provider's specific instructions when using this medication
• Do not apply this medication more than the recommended dose; doing so won't enhance results and may raise the likelihood of side effects.
• Wash your hands with soap after application
• This product is meant solely for your scalp, repeated contact with other skin areas can potentially result in unwanted hair growth. If the medication accidentally gets on your face, wash it off with soap and water immediately.
• Do not apply on other parts of the body
• Avoid contact with the eyes. In case of accidental contact, rinse eyes with copious amounts of cool tap water. 
• Do not use this medication for a condition for which it was not prescribed.
• Never share this medication with others, even if their symptoms are similar to yours. It may be harmful to them. 

Storage Information

• Keep this medication at a room temperature 
• Dispose of the medication if you are no longer using it. 
• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Disclaimer: The FDA has not evaluated all the claims made here. This medication is not guaranteed to diagnose, treat, cure, or prevent any disease. Individual results may vary. This information is not comprehensive. Please see the full prescribing link below for complete safety information: Spironolactone, Topical Minoxidil, Cetirizine, Topical Melatonin, Caffein