Double Growth Hair Capsules™

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 Double Growth Hair Capsules™:

Double Growth is a compounded oral medication combining spironolactone, oral minoxidil, folic acid, vitamin B12 and vitamin D3. 

• Spironolactone is primarily a medication used to treat conditions like high blood pressure and fluid retention (edema) due to its diuretic effects. Spironolactone is sometimes used off-label for its anti-androgenic effects in the treatment of hair loss in women who have a condition called androgenetic alopecia (female pattern hair loss) or other hair loss conditions with an androgenic component. Spironolactone is primarily a medication used to treat conditions like high blood pressure and fluid retention (edema) due to its anti-androgenic effects.
• Oral minoxidil is FDA-approved for high blood pressure treatment for patients unresponsive to other blood pressure treatments. For hair loss, dermatologists may prescribe it “off-label” in low doses. While it has been observed to promote hair growth, its FDA approval and long term safety data is for blood pressure management. 
• Folic acid, vitamin B12 and vitamin D3 are compounded together to be used off-label as a supportive oral therapy aiding in promoting hair follicle health and improving hair growth.

Absolute Contraindications – DO NOT use Double Growth Hair Caps™if you: 

• Are allergic to any of the active ingredients
• Are under 18 or are pregnant, breastfeeding, or planning to become pregnant 
• Have a history of cancer, heart failure, kidney problems or liver problems
• Have any present or past heart conditions like arrhythmias (abnormal heart rhythms), angina (ongoing chest pain), carditis, cardiomyopathy, heart valve disease, stroke, heart attack, congenital heart disease, aortic aneurysms, peripheral artery disease, EKG abnormalities, or other vascular conditions.
• 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.
• Have any pulmonary, endocrine (thyroid/adrenal), rheumatological (bone/joint) or GI conditions such as pulmonary hypertension, hyperthyroidism, Addison’s disease, pheochromocytoma, lupus, rheumatoid arthritis, osteoarthritis, gastric ulcers, ulcerative colitis, GI bleeding, or other conditions. 

Drug Interactions – DO NOT use Double Growth Hair Caps™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 Double Growth Hair Caps™)  

Serious Side Effects – STOP treatment and seek emergency medical care or call 911 if you experience:  

• Chest pain or tightness 
• Shortness of breath or difficulty breathing 
• Rapid heart rate or heart palpitations (irregular heartbeats)  
• Dizziness, lightheadedness or fainting 
• Swelling in the face, hands, legs, feet or ankles 
• Rapid weight gain or fluid retention (edema) 
• Significant or sudden drop in blood pressure (hypotension)
• Worsening of renal (kidney) or hepatic (liver) function 
• Severe skin rashes 
• Digestive abnormalities including severe heartburn/indigestion, vomiting, pain or bleeding 
• Electrolyte and metabolic abnormalities
• Increase in potassium (hyperkalemia)
• Impaired neurological function
• Gynecomastia/breast tenderness/increase in breast size
• Stevens-Johnson Syndrome (SJS)

It’s important to closely and regularly monitor for these side effects while taking Double Growth Hair Caps™, especially when starting or changing your dose, as they can indicate a severe reaction. If you notice any side effects, stop taking Double Growth Hair Caps™ and get 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 (hypertrichosis) 
• Increased urination
• Headache    
• Insomnia or changes in energy levels  
• Nausea 
• Changes in libido and menstrual cycle (e.g. irregular or absence of periods)   
• 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 Double Growth Hair Caps™. For more information, ask your healthcare provider or pharmacist and refer to the complete prescribing information: Spironolactone, Oral Minoxidil  

WARNING: SERIOUS CARDIAC EFFECTS

Minoxidil, one of the active ingredients in Double Growth Hair Caps™, 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.

Animal testing results: During animal testing, minoxidil was found to cause cardiac lesions and other harmful heart effects. Although animal findings don't always reflect human responses, Tangl dermatologists adhere to a principle of caution when prescribing. Due to its potential cardiac implications you should not use Double Growth Hair Caps™ if you have any heart conditions or a history of cardiac issues. If you notice any cardiac symptoms, seek immediate emergency medical care. 

WARNING: SERIOUS PREGNANCY RISK

Spironolactone, one of the active ingredients in Double Growth™ 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.

WARNING: POSSIBLE INFERTILITY RISK

Spironolactone, one of the active ingredients in Double Growth Hair Caps™ 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.

WARNING: POSSIBLE CANCER RISK

Spironolactone, one of the active ingredients in Double Growth Hair Caps™, may cause an increased risk of certain types of cancer.  During animal testing, 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 Double Growth Hair Caps™ if you have a history or risk of cancer. If you notice any unusual symptoms, seek immediate emergency medical care. 

Always use Double Growth Hair Caps™ under the supervision of a healthcare professional and undergo regular medical assessments during treatment.

WARNING: TOXIC TO ANIMALS  

• Minoxidil is highly toxic to animals, especially cats; even trace amounts can be life-threatening. 
• Always store minoxidil 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.
• Minoxidil may cause changes to your EKG; always inform your doctor that you are taking Double Growth Hair Caps™ before an EKG or before starting any new medication. 
• 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 take more than the recommended dose
• 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. 

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, Oral Minoxidil