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DRUG SIDE EFFECTS: FULL DISCLOSURE AND NOTICE
Drugs and medications have side effects. This section puts the user on notice about the known side effects of the medications used in the compounding formula. This is not a complete list and there may be side effects in the literature that may not be in this section. The side effects include but are not limited to the following stated below. BY USING FOLLIKLE, USERS AGREE THAT IN NO EVENT Robert Tracy DO, INC, ITS OFFICERS, DIRECTORS, EMPLOYEES, HEALTH COUNSELORS, INDEPENDENT CONTRACTORS OR STAFF PHYSICIANS OR AGENTS, BE LIABLE TO YOU FOR ANY DIRECT (INCLUDING DEATH), PSYCHOLOGICAL, EMOTIONAL, INDIRECT, INCIDENTAL, FINANCIAL, SPECIAL, PUNITIVE, OR CONSEQUENTIAL DAMAGES WHATSOEVER RESULTING FROM 1. THE PURCHASE AND USE OF PRODUCTS SOLD ON OUR WEBSITE, 2. ANY SIDE EFFECTS THAT THESE MEDICATIONS MAY HAVE EITHER ALONE BY THEMSELVES OR COMPOUNDED TOGETHER IN A FORMULA. IF YOU ARE WORRIED ABOUT THE SIDE EFFECTS OF THESE MEDICATIONS, PLEASE DO NOT USE FOLLIKLE. BY AGREEING TO PURCHASE AND USE HAPPY HEAD, YOU HAVE UNDERSTOOD AND AGREED TO THE SIDE EFFECTS STATED BELOW AND UNDERSTAND THAT ANY OF THESE SIDE EFFECTS MAY OCCUR, AND BE EITHER TEMPORARY OR PERMANENT. YOU ALSO AGREE THAT THERE MAY BE SIDE EFFECTS NOT LISTED AND THIS IS NOT A COMPLETE LIST OF SIDE EFFECTS. In conclusion, we do not take any responsibility for the safety or efficacy of any of the products sold through this website, nor for any possible side effects that may result due to the use of these products. It is highly encouraged for consumers to ask their personal physicians about the safety and efficacy of such products before use. None of the products sold on this website is intended to treat, prevent, cure, relieve, resolve, or stop any type of medical condition. This product may burn the skin, temporarily or permanently and may cause permanent scarring alopecia. The information provided by our healthcare counselors does not replace talking with your primary care physician regarding your medical conditions and your treatment with topical finasteride / minoxidil. Please read all this information before you start taking the topical finasteride / minoxidil / RA solution and please reread this every time you get a new refill, as the information may change and there may be updated, new information provided.
FINASTERIDE SIDE EFFECTS: FULL DISCLOSURE AND NOTICE TO USERS
Read this Patient Information before you start taking Finasteride and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment. Finasteride is for use by MEN ONLY and should NOT be used by women or children. For full transparency, side effects of finasteride include but not limited to hypersensitivity reaction (allergic reaction), angioedema, prostate cancer (high-grade), breast cancer, male infertility, impotence, loss in sexual ability, sexual desire, sexual drive, or performance, decrease libido, hypotension, abnormal ejaculation, any form of sexual dysfunction described or not described here, impotence, loss of interest in sex, or trouble having an orgasm, erectile dysfunction, decrease volume of ejaculate, tenderness in genital organs, testicular pain or numbness, infertility, poor seminal quality, poor sperm mobility, penile curviture changes, gynecomastia (enlarge breast tissue), breast tenderness, swelling tingling burning or pain in your face, throat hands or feet, swelling or tenderness in your breasts, lump under the arms or in the breast area, hair loss (temporary or permanent), change in shape of penis, dizziness, weakness, feeling like you might pass out, headache, confusion, brain fog, fogginess of the head, short-term and long-term memory loss, terrible fatigue, trouble concentrating, increasingly moody, depression, mood swings, mood changes, runny nose, sleepiness or unusual drowsiness, slurred speech, sneezing, stuffy nose, abdominal/stomach pain, back pain, decreased amount of semen, diarrhea, hives or welts, itchy skin, rapid weight gain, redness of the skin, skin rash, death, swelling of the lips and face, tingling of the hands or feet, unusual weight gain or loss, breast cancer in males and females, any other cancer in males and females, depression, lower testosterone, complete loss of testosterone, shrinkage of sexual organs, change in sexual orientation and any side effect contributed to what is now called post-finasteride syndrome and listed on the website www.pfsfoundation.org/about-pfs-post-finasteride-syndrome/). All sexual side effects may be long-term (permanent). Patients should not share the medication with any female. Females of childbearing age should not take this medication, as it is a Category X. The above is not a complete list of all side effects or studies conducted. User agrees and understands that there may also be other side effects that may occur that have not been reported, discovered or listed in the literature yet and may have been reported but not listed here. This list is intended to give full transparency about the possibility of most or all of the side effects of finasteride, some of which may be long term and permanent. User understands and agrees that they have been fully informed about the above side effects. Our goal is to empower our patients to make educated decisions about their treatment choices. We are incorporating the following drug PDR in this section as a reference. https://www.pdr.net/drug-summary/Propecia-finasteride-378.609. Also, on 6/9/2011, FDA released a drug safety communication detailing the long term side effects of finasteride and it is referenced here at the following link: https://www.pdr.net/fda-drug-safety-communication/propecia?druglabelid=378&id=8965. In patients taking finasteride, there is an increased risk of the more advanced stage of (high grade) prostate cancer or serious prostate cancer. In rare cases, male breast cancer has also been reported.
Finasteride & PSA (Prostate Specific Antigen): PSA test is a screening blood test performed by your physician to check for prostate cancer. Finasteride has been shown to reduce the PSA level, sometimes as much as 50%. The significance of this is as follows. Reduction in PSA can mask underlying prostate cancer. When you have a PSA test done, it is imperative that you tell your physician that you are taking finasteride in order to better assess the real PSA value of your blood test. Any changes from your baseline PSA can indicate a possible prostate cancer, even if your levels are within normal limits. You should always tell your physician if you are or are not taking finasteride, as this will impact the actual interpretation of your PSA level.
The American Academy of Family Physicians and the Canadian Task Force on Preventive Health Care recommend against PSA-based screening for prostate cancer. The American College of Physicians recommends that clinicians discuss the benefits and harms of screening with men aged 50 to 69 years and only recommends screening for men who prioritize screening and have a life expectancy of more than 10 to 15 years. The American Urological Association recommends that men aged 55 to 69 years with a life expectancy of more than 10 to 15 years be informed of the benefits and harms of screening and engage in shared decision making with their clinicians, taking into account each man’s values and preferences. It notes that to reduce the harms of screening, the screening interval should be 2 or more years. The American Urological Association also notes that decisions about screening, including potentially starting screening before age 55 years, should be individual ones for African American men and men with a family history of prostate cancer. The American Cancer Society adopted detailed screening recommendations in 2016 that highlight the importance of shared decision making and the need for informed discussion of the uncertainties, risks, and potential benefits of screening. It recommends conversations about screening beginning at age 50 years and earlier for African American men and men with a father or brother with a history of prostate cancer before age 65 years.
PREGNANCY WARNING: Females who are pregnant or who may become pregnant should not come in contact with finasteride. Finasteride may harm your unborn baby. If a woman who is pregnant comes in contact with finasteride solution, please wash the area right away with soap and water and contact your healthcare provider. If a pregnant woman with a male baby fetus swallows or comes in contact with finasteride, the male baby may be born with sex organs that are not normal.
DUTASTERIDE SIDE EFFECTS: FULL DISCLOSURE AND NOTICE TO USERS
Read this Patient Information before you start taking dutasteride and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment. Dutasteride is for use by MEN ONLY and should NOT be used by women or children. For full transparency, side effects of dutasteride include but not limited to hypersensitivity reaction (allergic reaction), angioedema, prostate cancer (high-grade), breast cancer, male infertility, Impotence, loss in sexual ability, desire, drive, or performance, decrease libido, hypotension, abnormal ejaculation, depression, anxiety, sexual dysfunction, loss of interest in sex, or trouble having an orgasm, erectile dysfunction, penile fibrosis, penile scarring, decrease volume of ejaculate, tenderness in genital organs, testicular pain, infertility, poor seminal quality, poor sperm mobility, gynecomastia (enlarge breast tissue), swelling in your face, throat hands or feet, swelling or tenderness in your breasts, lump under the arms or in the breast area, hair loss (temporary or permanent), change in shape of penis, dizziness, weakness, feeling like you might pass out, headache, confusion, runny nose, sleepiness or unusual drowsiness, sneezing, stuffy nose, abdominal/stomach pain, back pain, decreased amount of semen, diarrhea, hives or welts, itchy skin, rapid weight gain, redness of the skin, skin rash, swelling of the lips and face, tingling of the hands or feet, unusual weight gain or loss, breast cancer in males and females, depression, lower testosterone, and shrinkage of sexual organs. All sexual side effects may be long-term (permanent). Patients can not share the medication with any female. Females of childbearing age cannot take this medication, as it is a Category X. Impotence, loss in sexual ability, desire, drive, or performance, decrease libido, hypotension, abnormal ejaculation, sexual dysfunction, loss of interest in sex, or trouble having an orgasm, erectile dysfunction, decrease volume of ejaculate, tenderness in genital organs, testicular pain, infertility, poor seminal quality, testicular pain, testicular numbness, poor sperm mobility, gynecomastia (enlarge breast tissue), swelling in your face, throat hands or feet, swelling or tenderness in your breasts, lump under the arms or in the breast area, change in shape of penis, dizziness, weakness, feeling like you might pass out, headache, confusion, brain fog, fogginess of the head, short-term and long-term memory loss, terrible fatigue, trouble concentrating, increasingly moody, depression, runny nose, sleepiness or unusual drowsiness, sneezing, stuffy nose, abdominal/stomach pain, back pain, decreased amount of semen, diarrhea, hives or welts, itchy skin, rapid weight gain, redness of the skin, skin rash, swelling of the lips and face, tingling of the hands or feet, unusual weight gain or loss, , depression, lower testosterone, complete loss of testosterone, breast cancer, heart failure, atrial fibrillation, teratogenesis, visual impairment, exfoliative dermatitis, Stevens-Johnson syndrome, angioedema, erythema multiforme, ejaculation dysfunction, impotence (erectile dysfunction), orthostatic hypotension, priapism, testicular swelling, hypotension, palpitations, dyspnea, chest pain (unspecified), blurred vision, floppy iris syndrome, edema, constipation, depression, libido decrease, dizziness, vertigo, syncope, diarrhea, sinusitis, cough, rhinitis, back pain, asthenia, pharyngitis, insomnia, infection, drowsiness, testicular pain, orgasm dysfunction, decreased ejaculate volume, breast enlargement, gynecomastia, rash, urticaria, pruritus, vomiting, xerostomia, epistaxis, oligospermia, spermatogenesis inhibition. Although dutasteride is not the same as finasteride, possibility of post dutasteride syndrome may still exist and will cite the post finasteride syndrome as a reference as a possibility of side effects. Post-finasteride syndrome (www.pfsfoundation.org/about-pfs-post-finasteride-syndrome/), and shrinkage of sexual organs. All sexual side effects may be long-term (permanent). There may also be other side effects that may occur that have not been listed. This is intended to give full transparency about the possibility of the side effects of dutasteride, some of which may be long term, and that you are fully informed about the above side effects. Our goal is to empower our patients to make educated decisions about their treatment choices. The above is not a complete list of all side effects or studies conducted. With respect to labs, you are responsible for checking your PSA levels with your own primary care physician.
Do not use Dutasteride if you have orthostatic hypotension, vertigo, or syncope. Dutasteride is not intended for use in neonates, infants, children, and adolescents under 18 years of age. Safety and effectiveness have not been established in this age group. Patients receiving or who have previously received treatment with dutasteride or other alpha-1 blockers may be at risk for intraoperative floppy iris syndrome during surgery for cataracts (ocular surgery). Dutasteride is a non-arylamine sulfonamide derivative. In patients with sulfonamide hypersensitivity, allergic reaction to tamsulosin has been rarely reported. If a patient reports a serious or life threatening sulfonamide allergy, the manufacturer advises caution when administering dutasteride. Rarely (probably less than 1 in 50,000) like other alpha adrenergic antagonists, has been associated with priapism (persistent painful penile erection unrelated to sexual activity). Priapism, if not treated promptly, can result in irreversible damage to the erectile tissue. Patients who have an erection lasting greater than 4 hours, whether painful or not, should seek emergency medical attention. Dutasteride should be used with caution in patients with hepatic disease. Pregnant women or women trying to conceive or women who are breastfeeding should not handle dutasteride. Dutasteride is not indicated for use in females, and the use of this product during pregnancy is contraindicated. Infertility, decreased semen production or any fertility issue may be associated with use of dutasteride.
Dutasteride & PSA (Prostate Specific Antigen): PSA test is a screening blood test performed by your physician to check for prostate cancer. Dutasteride has been shown to reduce the PSA level, sometimes as much as 50%. The significance of this is as follows. Reduction in PSA can mask underlying prostate cancer. When you have a PSA test done, it is imperative that you tell your physician that you are taking dutasteride in order to better assess the real PSA value of your blood test. Any changes from your baseline PSA can indicate a possible prostate cancer, even if your levels are within normal limits. You should always tell your physician if you are or are not taking dutasteride, as this will impact the actual interpretation of your PSA level.
The American Academy of Family Physicians and the Canadian Task Force on Preventive Health Care recommend against PSA-based screening for prostate cancer. The American College of Physicians recommends that clinicians discuss the benefits and harms of screening with men aged 50 to 69 years and only recommends screening for men who prioritize screening and have a life expectancy of more than 10 to 15 years. The American Urological Association recommends that men aged 55 to 69 years with a life expectancy of more than 10 to 15 years be informed of the benefits and harms of screening and engage in shared decision making with their clinicians, taking into account each man’s values and preferences. It notes that to reduce the harms of screening, the screening interval should be 2 or more years. The American Urological Association also notes that decisions about screening, including potentially starting screening before age 55 years, should be individual ones for African American men and men with a family history of prostate cancer. The American Cancer Society adopted detailed screening recommendations in 2016 that highlight the importance of shared decision making and the need for informed discussion of the uncertainties, risks, and potential benefits of screening. It recommends conversations about screening beginning at age 50 years and earlier for African American men and men with a father or brother with a history of prostate cancer before age 65 years.
Again, dutasteride can have rare and uncommon side effects that you should be aware of. This includes sexual side effects (such as decrease libido, erectile dysfunction), psychological side effects (such as depression or anxiety) and similar side effects to the post-finasteride syndrome. If these side effects do occur, even if mild, please report them to your doctor immediately and stop taking the medication. There is an increased risk of the more advanced stage of (high grade) prostate cancer or serious prostate cancer. In rare cases, male breast cancer has also been reported.
Oral Dutasteride is an FDA approved medication used to treat enlarged prostate and has been used off-label for treating male pattern hair loss. Compounded medications are not approved by the FDA. Topical version of the dutasteride has not been tested/approved by the FDA. The combination of dutasteride, minoxidil, retinoic acid and hydrocortisone is a compounded prescription medication prescribed by your doctor and not tested/approved by the FDA.
PREGNANCY WARNING: Dutasteride is for use by MEN ONLY and should NOT be used by women or children. Patients should not use dutasteride if your spouse is planning to get pregnant, is pregnant or breastfeeding. Patients should wash their hands with soap and water every time after the application of the topical dutasteride solution. Females who are pregnant or who may become pregnant or planning on becoming pregnant or breastfeeding should not come in contact or handle dutasteride. Dutasteride may harm your unborn baby. If a woman who is pregnant comes in contact with dutasteride solution, please wash the area right away with soap and water and contact your healthcare provider. If a pregnant woman with a male baby fetus swallows or comes in contact with dutasteride, the male baby may be born with sex organs that are not normal.
MINOXIDIL SIDE EFFECTS: FULL DISCLOSURE AND NOTICE TO USERS
Systemic minoxidil is a potent vasodilator with potential to produce hypotension and reflex tachycardia; serious complications may occur. Minoxidil is relatively contraindicated in patients with cardiac disease (including angina, coronary artery disease, recent or acute myocardial infarction), or cerebrovascular disease because a reflex increase in heart rate and decrease in blood pressure can exacerbate these conditions. Pericardial effusion, heart failure, cardiac tamponade, pericarditis, Stevens-Johnson syndrome, allergic reaction, swelling of extremities, edema, peripheral edema , sodium retention, hypotension, angina, sinus tachycardia, leukopenia, thrombocytopenia, bullous rash, contact dermatitis, erythema, mastalgia, headache, hypertrichosis, pruritus, xerosis, vomiting, nausea, irritation, flakiness, itch, tingling and burning. This medication may burn the skin, temporarily or permanently and may cause permanent scarring alopecia.
If applied with fingertips, wash hands thoroughly after applying. If the metered-spray applicator is used, avoid inhalation of the mist. Minoxidil is classified as pregnancy risk category C. Although no adequate human studies have examined the effects of this drug on the fetus, animal reproduction studies have shown adverse effects, including reduced ability to conceive and a reduced survival of offspring. Dysmorphic facial features and hypertrichosis were observed in an infant whose mother took oral minoxidil during pregnancy. According to the manufacturer, minoxidil should not be administered to a nursing mother. Skin abrasion or irritations, such as excoriations, psoriasis, or sunburn, can increase the systemic absorption of topically administered minoxidil. The safety and efficacy of topical minoxidil products have not been established in children and adolescents. Children should not take or come in contact with minoxidil. We are incorporating the following drug PDR in this section by referencing it here: https://www.pdr.net/drug-summary/Minoxidil-minoxidil-774.
TRETINOIN SIDE EFFECTS: FULL DISCLOSURE AND NOTICE TO USERS
GI bleeding, disseminated intravascular coagulation (DIC), arrhythmia exacerbation, pleural effusion, visual impairment, increased intracranial pressure, intracranial bleeding, heart failure, hearing loss, pulmonary edema, laryngeal edema, peptic ulcer, cardiomyopathy, pericarditis, pulmonary hypertension, myocarditis, myocardial infarction, cardiac arrest, stroke, agnosia, seizures, coma, renal failure (unspecified), renal tubular necrosis, erythema nodosum, differentiation syndrome, pericardial effusion, hypervitaminosis A, pancreatitis, thrombosis, papilledema, spontaneous fetal abortion, teratogenesis, bone pain, dyspnea, elevated hepatic, enzymes, hyperlipidemia, bleeding, fluid retention, peripheral edema, stomatitis, constipation, wheezing, hypotension, depression, phlebitis, hypertension, confusion, flank pain, hepatomegaly, splenomegaly, dysuria, edema, hallucinations, ascites, hepatitis, impaired, cognition, ataxia, dysarthria, aphasia, encephalopathy, thrombocytosis, erythema, hypoxia, respiratory depression, pseudotumor cerebri, hypertriglyceridemia, hypercholesterolemia, hypercalcemia, headache, fever, fatigue, malaise, shivering, vomiting, nausea, rash, leukocytosis, abdominal pain,, weight gain, diarrhea, flushing, otalgia, dizziness, diaphoresis, anorexia, weight loss, anxiety, paresthesias, alopecia, myalgia, dyspepsia, insomnia, agitation, pallor, asterixis, weakness, tremor, hyporeflexia, drowsiness, hypothermia, increased urinary, frequency, skin hyperpigmentation, skin hypopigmentation, skin irritation, pruritus, xerosis, photosensitivity, vesicular rash. Tretinoin should not be used during pregnancy and breastfeeding. The safety and efficacy of topical tretinoin products have not been established in children and adolescents. Children should not take or come in contact with tretinoin. We are incorporating the following drug PDR in this section by referencing it here: https://www.pdr.net/drug-summary/Tretinoin-tretinoin-24012.
HYDROCORTISONE SIDE EFFECTS: FULL DISCLOSURE AND NOTICE TO USERS
Exfoliative dermatitis, increased intracranial pressure, papilledema, tendon rupture, bone, fractures, avascular necrosis, esophageal ulceration, GI perforation, pancreatitis, GI bleeding, peptic ulcer, skin atrophy, anaphylactoid reactions, lupus-like symptoms, angioedema, heart, failure, seizures, optic neuritis, retinopathy, visual impairment, ocular hypertension, cardiac, arrest, thrombosis, pulmonary edema, stroke, bradycardia, vasculitis, cardiomyopathy, rosacea, peri-oral dermatitis, myocardial infarction, arrhythmia exacerbation, thromboembolism, erythema, hypothalamic-pituitary-adrenal (HPA) suppression, hypotension, physiological dependence, pseudotumor cerebri, withdrawal, adrenocortical insufficiency, hypothyroidism, Cushing’s, syndrome, hyperthyroidism, postmenopausal bleeding, osteopenia, myopathy, osteoporosis, constipation, gastritis, impaired wound healing, skin ulcer, candidiasis, neutropenia, immunosuppression, hypertension, hypokalemia, hypernatremia, hypocalcemia, metabolic, alkalosis, edema, fluid retention, sodium retention, neuritis, psychosis, memory impairment, peripheral neuropathy, euphoria, mania, delirium, hallucinations, EEG changes, amnesia, depression, impaired cognition, exophthalmos, blurred vision, ocular infection, cataracts, glycosuria, hyperglycemia, diabetes mellitus, phlebitis, hypercholesterolemia, sinus tachycardia, palpitations, angina, tolerance, growth inhibition, hepatomegaly, elevated hepatic enzymes, contact dermatitis, anemia, glossitis, pruritus, maculopapular rash, xerosis, skin irritation, lethargy, fever, dysmenorrhea, amenorrhea, menstrual irregularity, arthralgia, myalgia, arthropathy, weakness, abdominal pain, appetite stimulation, nausea, weight gain, vomiting, hiccups, anorexia, weight loss, diarrhea, petechiae, urticaria, acne vulgaris, telangiectasia, folliculitis, alopecia, skin hyperpigmentation, acneiform rash, hypertrichosis, rash, miliaria, perineal pain, diaphoresis, striae, purpura, ecchymosis, hirsutism, injection site reaction, skin, hypopigmentation, leukocytosis, infection, vertigo, restlessness, malaise, irritability, anxiety, headache, emotional lability, paresthesias, insomnia, syncope, dizziness. Hydrocortisone should not be used during pregnancy and breastfeeding. The safety and efficacy of topical hydrocortisone products have not been established in children and adolescents. Children should not take or come in contact with hydrocortisone. The side effects of long term use of hydrocortisone have not been established in clinical studies. Happy Head formula does contain hydrocortisone 1% and you are placed on notice regarding the long term side effects, which include but not limited to the side effects listed above. If you do not want the hydrocortisone included in the product Happy Head, please notify us and your formula will be customized to remove the hydrocortisone. You are giving consent allowing us to use hydrocortisone in your product, and understand and agree to the side effects. We are incorporating the following drug PDR in this section by referencing it here: https://www.pdr.net/drug-summary/Hydrocortisone-Lotion-2-5–hydrocortisone-3417.4123.
SPIRONOLACTONE SIDE EFFECTS: FULL DISCLOSURE AND NOTICE TO USERS
Most common side effects include dizziness, lightheadedness, increased urination, changes in metabolites like potassium, breast tenderness, irregular periods or lack of menstrual periods, breast enlargement, breast tenderness, chest pain, difficulty breathing, allergic reaction, rash, feeling like faint or passing out. Patients should avoid getting pregnant on this medication and should avoid food high in potassium such as banana, coconut water, avocado etc. Other side effects include but not limited to hyperkalemia, bradycardia, new primary malignancy, renal failure, toxic epidermal necrolysis, anaphylactoid reactions, Stevens-Johnson syndrome, vasculitis, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), agranulocytosis, hepatic failure, gout, hypomagnesemia, hyperuricemia, hypocalcemia, hyponatremia, hyperglycemia, metabolic alkalosis, metabolic acidosis, impotence (erectile dysfunction), infertility, postmenopausal bleeding, tumorigenicity, gastritis, ataxia, confusion, dehydration, hypotension, hypovolemia, erythema, thrombocytopenia, leukopenia, paresthesias, fatigue, weakness, mastalgia, amenorrhea, menstrual irregularity, hirsutism, gynecomastia, libido decrease, abdominal pain, vomiting, nausea, diarrhea, lethargy, headache, drowsiness, dizziness, polyuria, maculopapular rash, urticaria, pruritus, alopecia, fever, muscle cramps. Please note that there might be other side effects that were not mentioned here.
Spironolactone is contraindicated in patients with hyperkalemia, Addison’s disease (chronic adrenal insufficiency), or other conditions associated with hyperkalemia and should not be administered to those who are receiving other potassium-sparing agents. The Endocrine Society guidelines on the diagnosis and treatment of primary adrenal insufficiency state that use of aldosterone antagonists, such as spironolactone, are contraindicated in patients with adrenal insufficiency (Addison’s disease). Hyperkalemia stimulates aldosterone production and aldosterone, in turn, enhances sodium and water reabsorption in exchange for potassium excretion in the distal tubule and collecting duct of the kidney. In Addison’s disease, aldosterone deficiency results in hyponatremia, hypovolemia, hypotension and hyperkalemia. Thus, spironolactone therapy will exacerbate the hyponatremia, hypovolemia, hypotension and hyperkalemia seen in adrenal insufficiency and worsen the signs and symptoms of the disease. Spironolactone-induced hyperkalemia can cause life-threatening cardiac arrhythmias, and it is more likely to occur in patients with impaired renal function or diabetes mellitus. Excessive diuresis may cause symptomatic dehydration, hypotension, and worsening renal function. Spironolactone tablets are contraindicated in patients with anuria or any renal disease associated with severe renal impairment (CrCl less than 10 mL/minute) or acute renal failure. Monitor serum potassium and renal function 3 days and 1 week after initiation or dosage increase, monthly for 3 months, quarterly for a year, and every 6 months thereafter. Monitor volume status periodically. Patients receiving spironolactone should not receive potassium supplementation or increase their dietary intake of potassium unless they have refractory hypokalemia. In adults, the risk of hyperkalemia increases progressively when serum creatinine exceeds 1.6 mg/dL; the threshold for pediatric patients is unknown. In adults, spironolactone should be discontinued if the serum creatinine is greater than 4 mg/dL or serum potassium is greater than 5 mEq/L. Spironolactone may cause a transient elevation of BUN, especially in patients with preexisting renal impairment. The precaution for spironolactone in patients with diabetes mellitus is primarily due to the risk of hyperkalemia and not the risk of inducing hyperglycemia, which may occur with thiazide or loop diuretics. Correct significant acid/base imbalance before spironolactone is initiated, as mild acidosis or hypochloremic metabolic alkalosis may occur with its use. Close monitoring of the acid-base status is required in debilitated patients or severely ill patients in whom respiratory acidosis or metabolic acidosis may occur (e.g., cardiopulmonary disease or uncontrolled diabetes). These patients are at a higher risk for developing sudden metabolic acidosis or respiratory acidosis, with resultant rapid increases in serum potassium concentrations that could be exacerbated by potassium-sparing diuretic therapy.
Spironolactone-induced fluctuations in serum electrolyte concentrations can occur rapidly and precipitate hepatic encephalopathy and hepatic coma in patients with hepatic disease with biliary cirrhosis and ascites. In these patients, initiate spironolactone in the hospital. Clearance of spironolactone and its metabolites is reduced in patients with cirrhosis; start with the lowest initial dose and titrate slowly in these patients. Reversible hyperchloremic metabolic acidosis, usually in association with hyperkalemia, has been reported in patients with decompensated hepatic cirrhosis, even with normal renal function.Spironolactone can cause antiandrogenic and endocrine effects; use with caution in patients with menstrual irregularity or breast enlargement. Spironolactone has been demonstrated to be tumorigenic in chronic toxicity studies in rats. Although human data are not available, the potential for tumorigenicity or development of a new primary malignancy are potential risks to consider during spironolactone therapy. FDA-approved labeling for the tablet product recommends that spironolactone only be used as indicated within the prescribing information; avoid unnecessary use. Somnolence and dizziness have been reported to occur in some patients. Therefore, caution is advised when driving or operating machinery until the response to treatment with spironolactone has been determined.
Avoid spironolactone in pregnancy, breastfeeding or advise pregnant women of the potential risk to a male fetus. Because of its anti-androgenic activity and the requirement of testosterone for male morphogenesis, spironolactone may have the potential for adversely affecting sex differentiation of the male during embryogenesis. Animal studies report feminization of male fetuses and endocrine dysfunction in females exposed to spironolactone in utero. Animal offspring exposed to spironolactone during late pregnancy exhibited changes in the reproductive tract, including dose-dependent decreases in weights of the ventral prostate and seminal vesicle in males, ovaries and uteri that were enlarged in females, and other indications of endocrine dysfunction that persisted into adulthood. Limited data from published case reports and case series did not demonstrate an association between major malformations or other adverse pregnancy outcomes with spironolactone use. In animal studies involving female rats, spironolactone was associated with a reduction in circulating estrogen levels and retarded ovarian follicle development. Inhibition of ovulation and reduction in number of implanted embryos were observed with spironolactone administration to female mice. The potential for infertility in humans is unknown. We are incorporating the following drug PDR in this section by referencing it here: https://www.pdr.net/drug-summary/Aldactone-spironolactone-978.2934.
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