Sex Rx + Hair Health

Sex Rx + Hair Health (Tadalafil / Finasteride / Minoxidil)

What is this?

This Important Safety Information summarizes the most important warnings and precautions for Sex Rx + Hair Health (Tadalafil + Minoxidil + Finasteride + Supplement Blend), a compounded prescription medication that your provider has prescribed to treat for erectile dysfunction and male pattern hair loss, if deemed clinically appropriate. It does not contain all possible information. You will also receive a medication guide or patient drug information sheet with your medication when it arrives from the pharmacy which contains full information about Sex Rx + Hair Health (Tadalafil + Minoxidil + Finasteride + Supplement Blend). You should read all of the information that comes with your prescription before taking your medication and at each refill. It’s important to take your medication as directed by your provider and to always read your prescription label and follow your healthcare provider's instructions.

Sex Rx + Hair Health (Tadalafil + Minoxidil + Finasteride + Supplement Blend) is compounded by licensed pharmacists and includes the active pharmaceutical ingredients, tadalafil, minoxidil, finasteride, biotin, Vitamin B12, Vitamin D3, and l-theanine. Unless otherwise indicated, the safety information below is based on the known safety profiles of these active ingredients as used in the compounded medication.

Like all compounded medications, Sex Rx + Hair Health (Tadalafil + Minoxidil + Finasteride + Supplement Blend) is not FDA approved. This means that the safety, effectiveness, and quality of this medication has not been verified by the FDA, as the FDA does not verify the safety, effectiveness, and quality of any compounded drugs.

Do not take Sex Rx + Hair Health if you

• Take any medicines called nitrates, often prescribed for chest pain, or guanylate cyclase stimulators like Adempas (riociguat) for pulmonary hypertension. Your blood pressure could drop to an unsafe level

• Are pregnant or may become pregnant. Finasteride may harm your unborn baby.

• If a pregnant woman comes in contact with finasteride & minoxidil compounded tablets, wash the contact area right away with soap and water. If a woman who is pregnant comes into contact with finasteride, a healthcare provider should be consulted. If a woman who is pregnant with a male baby swallows or comes in contact with finasteride, the baby may be born with sex organs that are not normal.

• Use recreational drugs called “poppers” like amyl nitrate or butyl nitrate

• Patients with certain types of heart, kidney or liver disease. Be sure to completely share details of any heart, kidney or liver conditions with your provider so they can determine if treatment is safe for you.

• Have pheochromocytoma

• Have prostate cancer diagnosed within the last 5 years

• Have estrogen sensitive cancer diagnosed within the last 5 years

• Have recently received chemotherapy

• Are using another product containing minoxidil or finasteride.

• Are using finasteride (topical or oral) for hair loss or for treatment of an enlarged prostate (Propecia®, Proscar®). Finasteride and Sex Rx + Hair Health with finasteride cannot be used at the same time.

• Anyone currently taking other medications in the same class as finasteride (5-alpha reductase inhibitors: dutasteride, Avodart®, Jalyn®)

• Are allergic to tadalafil, minoxidil, finasteride, biotin, vitamin B12, vitamin D3, l-theanine or any of the inactive ingredients in Sex Rx + Hair Health. Inactive ingredients include: corn starch, dextrose, maltodextrin, magnesium stearate, microcrystalline cellulose, silicon dioxide, silica, sucralose, FD&C Red #40/Allura Red AC, FD&C Blue #1/Brilliant Blue and FD&C Yellow #6/Sunset Yellow FCF.

• Are younger than 18 years of age

Sexual dysfunction can sometimes be the sign of an underlying health condition such as cardiovascular disease or high cholesterol. Discuss your health with your doctor to ensure that you are healthy enough for sex. If you experience chest pain, dizziness, or nausea during sexual intercourse, seek immediate medical help..

Sex Rx + Hair Health can cause serious side effects. Rarely reported side effects include:

• An erection that will not go away (priapism). If you have an erection that lasts more than 4 hours, get medical help right away. If it is not treated right away, priapism can permanently damage your penis

• Sudden vision loss in one or both eyes. Sudden vision loss in one or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). Stop taking Sex Rx + Hair Health and call your healthcare provider right away if you have any sudden vision loss

• Sudden hearing decrease or hearing loss. Some people may also have ringing in their ears (tinnitus) or dizziness. If you have these symptoms, stop taking Sex Rx + Hair Health and contact a doctor right away

• New or worsening chest pain

• Shortness of breath

• Sudden changes to your vision or hearing

• Very severe heartburn

Before you take Sex Rx + Hair Health, tell your healthcare provider if you:

• Have or have had heart problems such as a heart attack, irregular heartbeat, angina, chest pain, narrowing of the aortic valve, or heart failure

• Have had heart surgery within the last 6 months

• Have pulmonary hypertension

• Have had a stroke

• Have low blood pressure, or high blood pressure that is not controlled

• Have a deformed penis shape

• Have had an erection that lasted for more than 4 hours

• Have problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemia

• Have retinitis pigmentosa, a rare genetic (runs in families) eye disease

• Have ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy NAION

• Have bleeding problems

• Have or have had stomach ulcers

• Have liver problems

• Have kidney problems or are having kidney dialysis

• Have any other medical conditions

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Sex Rx + Hair Health may affect the way other medicines work, and other medicines may affect the way Sex Rx + Hair Health works, causing side effects. Especially tell your healthcare provider if you take any of the following:

• Medicines called nitrates like nitroglycerin or isosorbide

• Medicines called guanylate cyclase stimulators such as Adempas© (riociguat)

• Medicines called alpha-blockers such as Hytrin© (terazosin HCl), Flomax© (tamsulosin HCl), Cardura© (doxazosin mesylate), Minipress© (prazosin HCl), Uroxatral© (alfuzosin HCl), Jalyn© (dutasteride and tamsulosin HCl), or Rapaflo© (silodosin). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients, the use of tadalafil with alpha-blockers can lead to a drop in blood pressure or to fainting

• Medicines called HIV protease inhibitors, such as ritonavir (Norvir©), indinavir sulfate (Crixivan©), saquinavir (Fortovase© or Invirase©), or atazanavir sulfate (Reyataz©)

• Some types of oral antifungal medicines, such as ketoconazole (Nizoral©) and itraconazole (Sporanox©)

• Some types of antibiotics, such as clarithromycin (Biaxin©), telithromycin (Ketek©), or erythromycin

• Other medicine that treat hair loss

• Other medicines or treatments for sexual dysfunction

Tadalafil, which is the same medicine found in another drug called Adcirca©. Adcirca© is used to treat a rare disease called pulmonary arterial hypertension (PAH). Tadalafil should not be used with Adcirca or with other PAH treatments containing tadalafil or any other PDE5 inhibitors (such as Revatio© (sildenafil)).

Sex Rx + Hair Health does not protect against sexually transmitted diseases, including HIV.

The most common side effects of tadalafil include: headache; flushing; upset stomach; abnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred vision; stuffy or runny nose; back pain; muscle pain; nausea; dizziness; rash.

Uncommon adverse events of tadalafil for once daily use or use as needed. A causal relationship of these events to tadalafil use is uncertain. Body as a whole — asthenia, face edema, fatigue, pain. Cardiovascular — angina pectoris, chest pain, hypotension, myocardial infarction, postural hypotension, palpitations, syncope, tachycardia. Digestive — abnormal liver function tests, dry mouth, dysphagia, esophagitis, gastritis, GGTP increased, loose stools, nausea, upper abdominal pain, vomiting. Musculoskeletal — arthralgia, neck pain. Nervous — dizziness, hypesthesia, insomnia, paresthesia, somnolence, vertigo. Respiratory — dyspnea, epistaxis, pharyngitis. Skin and Appendages — pruritus, rash, sweating. Ophthalmologic — blurred vision, changes in color vision, conjunctivitis (including conjunctival hyperemia), eye pain, lacrimation increase, swelling of eyelids. Otologic — sudden decrease or loss of hearing, tinnitus. Urogenital — erection increased, spontaneous penile erection.

The most common side effects of minoxidil and finasteride include: hypertrichosis (increased hair growth on the face or body), lightheadedness, palpitations or tachycardia, headaches, leg swelling or fluid retention (edema), swelling around the eyes, insomnia, nausea or vomiting, rash.

Sexual side effects of finasteride: In clinical trials of finasteride 1 mg daily, the following sexual side effects were experienced by patients. These side effects may or may not occur with Sex Rx + Hair Health. In rare cases patients have reported persistence of these side effects after medication cessation. 

• Decreased libido or lower sex drive (reported in 1.8% of patients taking finasteride vs. 1.3% taking placebo)

• Erectile dysfunction (reported in 1.3% of patients taking finasteride vs. 0.7% taking placebo)

• Ejaculation disorder (reported in 1.2% of patients taking finasteride vs. 0.7% taking placebo)

• Decreased volume of ejaculate (reported in 0.8% of patients taking finasteride vs. 0.4% taking placebo)

The following have been reported as less common side effects with finasteride use:

• Allergic reactions including: rash, itching, hives and swelling of the lips, tongue, throat, and face

• Testicular pain

• Male infertility and/or poor quality of semen

• In rare cases, male breast cancer

• Breast tenderness or enlargement (reported in less than 1% of patients)

These are not all the side effects of Sex Rx + Hair Health.  For more information, read the drug information that comes with your compounded medication, ask your healthcare provider, or ask your pharmacist.Tell your healthcare provider if you have any side effect that bothers you or that does not go away. You may report side effects to the FDA by calling 1-800-FDA-1088 or visiting http://www.fda.gov/MedWatch.

Does finasteride cause depression?

A literature review shows there may be evidence of increased depressive symptoms in individuals younger than age 45 while taking finasteride for hair loss. Patients with new or worsening depression should stop this medication and follow up with their health care provider or a mental health therapist. SOURCE: MEDPAGETODAY.ORG

Sex Rx + Hair Health is a prescription medicine used for the treatment of sexual dysfunction. Sex Rx + Hair Health is not for females or children.

If you experience signs or symptoms of an allergic reaction, stop taking Sex Rx + Hair Health and seek medical attention immediately.