Each individual actuation may be pumped into the palm of the hand and then applied to the skin site or pumped directly onto the application site. Regardless of method, apply the gel from one pump actuation to one shoulder and upper arm area, then apply each additional actuation to the alternate shoulder and upper arm area, repeating the application site as needed for dosage increases.
Testim packet: Open packets needed for proper dosing. Do not apply to the genitals or abdomen. Fortesta gel: Apply gel to clean, dry, intact skin of the front and inner thighs. Do not apply to the genitals or other parts of the body. Using one finger, gently rub gel evenly onto the front and inner area of each thigh as directed.
Avoid the area adjacent to the scrotum, and limit the application site to the area that will be covered by shorts or pants. Allow the gel to dry completely and cover with clothing. The pump must be primed before the first use by fully depressing the pump mechanism 8 times and discarding any gel that is released during the priming. Once primed, each actuation of the metered dose pump delivers 10 mg of testosterone. Androderm Transdermal System: Apply patch to a dry, clean area of skin on the upper arms, thighs, back or abdomen immediately after opening the pouch and removing the protective release liner.
If the liner is difficult to pull off or if you see adhesive sticking to the liner, DO NOT use the patch, throw it away and get a new one. Press the system firmly in place, making sure there is good contact with the skin, especially around the edges. Do not apply to the scrotum or bony areas of the body. Do not apply to an area that is oily, damaged, or irritated. Also, avoid applying on a part of the body that may be subject to prolonged pressure during sleep or sitting e.
Washing, showering, and swimming should be avoided for a minimum of 3 hours after application. Rotate sites daily and do not reuse a site for 7 days. Removal of the Androderm patch before undergoing magnetic resonance imaging MRI is recommended because the patch contains aluminum. Mild skin irritation may be ameliorated by treatment of the affected skin with over-the-counter topical hydrocortisone cream applied after system removal.
Additionally, applying a small amount of 0. The administration of 0. Ointment formulations should not be used for pretreatment as they may significantly reduce testosterone absorption. Axiron topical solution: Using the provided applicator, apply the solution to clean, dry, intact skin of the axilla, preferably at the same time each morning.
Do not apply to any other part of the body including the scrotum, penis, abdomen, shoulders, or upper arms. Allow the solution to dry completely before dressing. If an antiperspirant or deodorant is used for personal hygiene, apply these products at least 2 minutes before applying the topical solution.
The pump must be primed before the first use by fully depressing the pump mechanism 3 times, and discarding any solution that is released during the priming. To dispense the solution, position the nozzle over the applicator cup and carefully depress the pump once fully; the cup should be filled with no more than 1 pump actuation 30 mg testosterone.
With the applicator upright, place it up into the axilla and wipe steadily down and up into the axilla. Do not use fingers or hand to rub the solution. If multiple applications are necessary for the required dose, alternate application between the left and right axilla.
When repeat application to the same axilla is necessary, allow the solution to dry completely before the next application. After use, rinse the applicator under running water and pat dry with tissue. Following application, allow the site to dry a few minutes before putting on clothing.
Direct contact of the medicated skin with the skin of another person can result in the transfer of residual testosterone and absorption by the other person. To reduce accidental transfer, the patient should cover the application site s with clothing e.
The application site should be washed with soap and water prior to any skin-to-skin contact regardless of the length of time since application. In the case of direct contact, the other person should wash the area of contact with soap and water as soon as possible. Patients should be advised that the topical solution is flammable; therefore, fire, flame, and smoking should be avoided during use. Advise patients to avoid swimming or washing the application site until 2 hours following application of solution.
Cream: Several commercial compounding kits are available. Follow the directions supplied with each kit for preparation instructions. For intranasal use only; do not administer to other parts of the body. For first time use of the Natesto nasal gel, prime the pump by depressing the pump 10 times over the sink and discarding any dispensed product. Wipe the tip of the dispenser clean with a dry tissue.
Before administration, instruct patient to blow their nose and remove dispenser cap. Place the right index finger on the pump of the actuator and while in front of a mirror, slowly advance the tip of the actuator into the left nostril upwards until the finger on the pump reaches the base of the nose.
Tilt the actuator so that the opening on the tip of the actuator is in contact with the lateral wall of the nostril to ensure that the gel is applied to the nasal wall. Slowly depress the pump until it stops; depress pump completely to administer a full actuation. Each actuation of the metered dose pump dispenses 5.
Remove the actuator from the nose while wiping the tip along the inside of the lateral nostril wall to fully transfer the gel. Using the left index finger, repeat steps for administration of the next actuation, this time to the lateral wall of the right nostril. Wipe the tip of the actuator with a dry tissue, replace dispenser cap. Two actuations total 1 actuation in each nostril will deliver 11 mg of testosterone. Press on the nostrils at a point just below the bridge of the nose and lightly massage.
Do not blow the nose or sniff for 1 hour after administration of the intranasal gel. If any gel gets on the hands, it is recommended to wash hands with warm water and soap.
Replace the nasal gel dispenser when the top of the piston inside the dispenser reaches the arrow at the top of the inside label. The inside label may be found by unwrapping the outer flap from around the container. Androderm: - Do not store outside the pouch provided - Store between 68 to 77 degrees F AndroGel: - Flammable, keep away from heat and flame - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F Andro-L.
Do not store for later use. Androgens may decrease concentrations of thyroxin-binding globulins, resulting in decreased total T4 serum concentrations and increased resin uptake of T3 and T4. Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.
There is a risk of serious hypersensitivity reactions or anaphylaxis with the use of testosterone undecanoate Aveed oil for injection. These allergic reactions can occur after any injection of testosterone undecanoate during the course of therapy, including after the first dose. Observe patients in the healthcare setting for 30 minutes after an Aveed injection in order to provide appropriate medical treatment in the event of serious hypersensitivity reactions or anaphylaxis.
The Aveed injection contains benzyl benzoate, the ester of benzyl alcohol and benzoic acid, and refined castor oil. Therefore, testosterone undecanoate use is contraindicated in patients with polyoxyethylated castor oil hypersensitivity, benzoic acid hypersensitivity, or benzyl alcohol hypersensitivity.
Patients with suspected hypersensitivity reactions should not be re-treated with testosterone undecanoate injection. The testosterone enanthate injections are contraindicated in patients with sesame oil hypersensitivity.
The manufacturers of certain testosterone products i. Do not inject any testosterone products via intravenous administration. Respiratory adverse events have been reported immediately after injection of testosterone enanthate and testosterone undecanoate.
Care should be taken to ensure proper administration of the selected testosterone product. Testosterone can stimulate the growth of cancerous tissue and is contraindicated in male patients with prostate cancer or breast cancer.
Men with prostatic hypertrophy should be treated with caution because androgen therapy may cause a worsening of the signs and symptoms of benign prostatic hypertrophy and may increase the risk for development of malignancy. Patients with clinical or demographic characteristics that are recognized to be associated with an increased risk of prostate cancer should be evaluated for the presence of prostate cancer prior to initiation of testosterone replacement therapy.
In patients receiving testosterone therapy, surveillance for prostate cancer should be consistent with current practices for eugonadal men. The treatment of hypogonadal men with testosterone esters may potentiate sleep apnea, especially in patients that have risk factors for apnea such as obesity or chronic pulmonary disease.
In patients receiving testosterone, check that hematocrit is not elevated prior to initiating therapy. Patients receiving high doses of testosterone are at risk for polycythemia. Periodically, patients receiving testosterone should have their hemoglobin and hematocrit concentrations measured to detect polycythemia.
Evaluate hematocrit approximately every 3 to 6 months during therapy. If hematocrit becomes elevated, interrupt therapy until the hematocrit decreases to an acceptable level. A dose decrease may be warranted. If therapy is restarted and again causes hematocrit to become elevated, discontinue therapy permanently.
Any increase in red blood cell mass may increase the risk of thromboembolic events. Androgens may promote retention of sodium and water. Edema may be a serious complication in patients with preexisting renal disease or hepatic disease.
Testosterone should generally be avoided in patients with severe hepatic disease. Prolonged use of high doses of orally active alpha-alkyl androgens e.
Peliosis hepatis can be a life-threatening or fatal complication. Long-term therapy with intramuscular testosterone enanthate has produced multiple hepatic adenomas. These events have not been reported with the use of oral, topical, nasal, or transdermal testosterone products. Androgen therapy, such as testosterone, can result in changes in insulin sensitivity or glycemic control and should be used with caution in patients with diabetes mellitus.
The metabolic effects of androgens may decrease blood glucose and may decrease antidiabetic agent dosage requirements. Close monitoring of blood glucose is recommended. Testosterone has induced osteolysis and should be used with caution in patients with hypercalcemia, which can be exacerbated in patients with metastatic breast cancer.
Use testosterone with caution in patients with a history of depression. Depression and suicidal ideation and behavior have occurred during clinical trials in patients treated with testosterone enanthate subcutaneous injection and testosterone undecanoate oral capsules.
Testosterone is subject to substance abuse. Physical and psychological dependence i. Testosterone abuse is typically observed at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids.
Abuse and misuse of testosterone are seen in male and female adults and adolescents. Testosterone, often in combination with other anabolic androgenic steroids AAS , and not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders.
There have been reports of misuse by men taking higher doses of legally obtained testosterone than prescribed and continuing testosterone despite adverse events or against medical advice. Testosterone abuse can lead to serious cardiovascular and psychiatric adverse reactions. Drug dependence in individuals using approved doses of testosterone for approved indications has not been documented.
If testosterone abuse is suspected, monitor serum testosterone concentrations to ensure they are within therapeutic range. However, testosterone concentrations may be in the normal or subnormal range in men abusing synthetic testosterone derivatives.
Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. Consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events. Because some testosterone transdermal systems e. Metal components contained in the backing of some transdermal systems can overheat during an MRI scan and cause skin burns in the area where the patch is adhered.
Intranasal formulations of testosterone e. In addition, the safety and efficacy of intranasal testosterone has not been evaluated in individuals with mucosal inflammatory disorders such as Sjogren's syndrome. Patients with rhinorrhea rhinitis who are receiving intranasal formulations of testosterone may experience decreased medication absorption secondary to nasal discharge.
These patients may experience a blunted or impeded response to the intranasal medication. Treatment with intranasal testosterone should be delayed until symptoms resolve in patients with nasal congestion, allergic rhinitis, or upper respiratory infection.
If severe rhinitis symptoms persist, an alternative testosterone replacement therapy is advised. Testosterone replacement therapy may reduce spermatogenesis in men, possibly causing irreversible infertility. Testicular atrophy, subfertility, and infertility have also been reported in men who abuse anabolic androgenic steroids. Testosterone is contraindicated during human pregnancy. Testosterone should not be administered during human pregnancy due to the possibility of virilization of the external genitalia of the female fetus.
This virilization includes clitoromegaly, abnormal vaginal development, and fusion of genital folds to form a scrotal-like structure.
The degree of masculinization is related to the amount of drug given and the age of the fetus and is most likely to occur in the female fetus when the drugs are given in the first trimester. Most products containing testosterone are for use in men only.
Testosterone topical solution, transdermal patches, and gels are contraindicated in lactating women who are breast-feeding. It is recommended that other testosterone formulations be avoided during breast-feeding.
Significant exposure to testosterone via breast-feeding may have adverse androgenic effects on the infant and the drug may also interfere with proper establishment of lactation in the mother.
According to the Beers Criteria, testosterone is considered a potentially inappropriate medication PIM for use in geriatric patients and should be avoided due to the potential for cardiac problems and its contraindication in men with prostate cancer.
The Beers expert panel considers the use of testosterone for confirmed hypogonadism with clinical symptoms as acceptable in geriatric patients. Generally, the use of testosterone in prepubertal children should be undertaken with caution.
The safety and efficacy of Depo-Testosterone injection have not been established in children less than 12 years. If testosterone is administered to prepubertal males, radiographic examinations of the hand and wrist should be performed every 6 months to assess the rate of bone maturation and the effect of the drug on epiphyseal centers.
Once the epiphyses have closed, growth is terminated. Even after discontinuation of treatment, epiphyseal closure can be enhanced for several months. Accidental exposure to topical testosterone gel has also occurred in pediatric patients after skin to skin contact between the child and the application site in treated individuals. The adverse events reported include genitalia enlargement, development of pubic hair, advanced bone age, increased libido, and aggressive behavior. The FDA recommends taking precautions to minimize the potential for accidental exposure by washing hands with soap and warm water after each application, covering application site with clothing, and removing medication with soap and water when contact with another person is anticipated.
Abarelix: Major Concomitant use of androgens or estrogens with abarelix is relatively contraindicated, as both could counteract the therapeutic effect of abarelix. Acarbose: Moderate Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens.
In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease antidiabetic agent dosage requirements. Moniitor blood glucose and HbA1C when these drugs are used together. Alogliptin: Moderate Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens.
Alogliptin; Metformin: Moderate Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. Alogliptin; Pioglitazone: Moderate Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. Alpha-glucosidase Inhibitors: Moderate Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens.
Ambrisentan: Moderate Ambrisentan is a substrate for P-glycoprotein P-gp. The inhibition of P-gp, by drugs such as testosterone, may lead to a decrease in the intestinal metabolism and an increase in the oral absorption of ambrisentan. If ambrisentan is coadministered with a P-gp inhibitor, patients should be monitored closely for adverse effects. Aprepitant, Fosaprepitant: Moderate Use caution if systemic testosterone and aprepitant, fosaprepitant are used concurrently and monitor for an increase in testosterone-related adverse effects for several days after administration of a multi-day aprepitant regimen.
Topical preparations of testosterone are not expected to have this interaction. Testosterone is a CYP3A4 substrate. As a single mg or 40 mg oral dose, the inhibitory effect of aprepitant on CYP3A4 is weak, with the AUC of midazolam increased by 1. After administration, fosaprepitant is rapidly converted to aprepitant and shares many of the same drug interactions. However, as a single mg intravenous dose, fosaprepitant only weakly inhibits CYP3A4 for a duration of 2 days; there is no evidence of CYP3A4 induction.
Fosaprepitant mg IV as a single dose increased the AUC of midazolam given on days 1 and 4 by approximately 1. Less than a 2-fold increase in the midazolam AUC is not considered clinically important. Atazanavir: Minor The plasma concentrations of testosterone may be significantly elevated when administered concurrently with atazanavir.
Clinical monitoring for adverse effects, such as libido changes and other hormone-induced effects, is recommended during coadministration. Atazanavir is an inhibitor of CYP3A4. Atazanavir; Cobicistat: Minor Plasma concentrations of testosterone may be significantly elevated when administered with cobicistat. Minor The plasma concentrations of testosterone may be significantly elevated when administered concurrently with atazanavir.
Boceprevir: Moderate Close clinical monitoring is advised when administering testosterone with boceprevir due to an increased potential for testosterone-related adverse events. If testosterone dose adjustments are made, re-adjust the dose upon completion of boceprevir treatment.
Although this interaction has not been studied, predictions about the interaction can be made based on the metabolic pathway of testosterone. Testosterone is a substrate of the drug efflux transporter P-glycoprotein PGP and of the hepatic isoenzyme CYP3A4; boceprevir is an inhibitor of both the efflux protein and the isoenzyme. Coadministration may result in elevated testosterone plasma concentrations. Cabozantinib: Minor Monitor for an increase in testosterone-related adverse reactions if coadministration of a systemic testosterone preparation with cabozantinib is necessary.
Testosterone is a P-glycoprotein P-gp substrate. Cabozantinib is a P-gp inhibitor and has the potential to increase plasma concentrations of P-gp substrates; however, the clinical relevance of this finding is unknown.
Interactions are not expected with topical testosterone preparations. Canagliflozin: Moderate Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. Canagliflozin; Metformin: Moderate Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens.
Carvedilol and testosterone are both substrates and inhibitors of P-glycoprotein P-gp. Use caution if concomitant use is necessary and monitor for increased side effects. Cobicistat: Minor Plasma concentrations of testosterone may be significantly elevated when administered with cobicistat. Cobimetinib: Minor If concurrent use of cobimetinib and testosterone is necessary, use caution and monitor for a possible increase in cobimetinib-related adverse effects. Cobimetinib is a P-glycoprotein P-gp substrate, and testosterone is a P-gp inhibitor; coadministration may result in increased cobimetinib exposure.
However, coadministration of cobimetinib with another P-gp inhibitor, vemurafenib mg twice daily , did not result in clinically relevant pharmacokinetic drug interactions. Concurrent use may result in elevated testosterone serum concentrations. According to the manufacturer, concomitant use of conivaptan, a strong CYP3A4 inhibitor, and CYP3A substrates, such as testosterone, should be avoided. Theoretically, similar pharmacokinetic effects could be seen with testosterone.
Treatment with testosterone may be initiated no sooner than 1 week after completion of conivaptan therapy. Corticosteroids: Moderate Coadministration of corticosteroids and testosterone may increase the risk of edema, especially in patients with underlying cardiac or hepatic disease. Corticosteroids with greater mineralocorticoid activity, such as fludrocortisone, may be more likely to cause edema. Administer these drugs in combination with caution. Cyclosporine: Moderate Androgens may increase concentrations of cyclosporine, potentially increasing the risk of nephrotoxicity.
Until further data are available, close monitoring of cyclosporine serum concentrations is prudent during coadministration with androgens. Dabigatran: Moderate Increased serum concentrations of dabigatran are possible when dabigatran, a P-glycoprotein P-gp substrate, is coadministered with testosterone, a P-gp inhibitor.
Patients should be monitored for increased adverse effects of dabigatran. P-gp inhibition and renal impairment are the major independent factors that result in increased exposure to dabigatran. Daclatasvir: Minor Systemic exposure of testosterone, a P-glycoprotein P-gp substrate, may be increased when administered concurrently with daclatasvir, a P-gp inhibitor. Taking these drugs together could increase or prolong the therapeutic effects of testosterone; monitor patients for potential adverse effects.
Dapagliflozin: Moderate Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. Dapagliflozin; Metformin: Moderate Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. Dapagliflozin; Saxagliptin: Moderate Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. Darbepoetin Alfa: Moderate Androgens are known to stimulate erythropoiesis.
Concurrent administration of androgens can increase the patient's response to darbepoetin alfa, reducing the amount required to treat anemia. Darunavir: Minor The plasma concentrations of testosterone may be significantly elevated when administered concurrently with darunavir. Darunavir is an inhibitor of CYP3A4. Darunavir; Cobicistat: Minor Plasma concentrations of testosterone may be significantly elevated when administered with cobicistat.
Minor The plasma concentrations of testosterone may be significantly elevated when administered concurrently with darunavir. Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide: Minor Plasma concentrations of testosterone may be significantly elevated when administered with cobicistat. Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir: Moderate Concurrent administration of testosterone with dasabuvir; ombitasvir; paritaprevir; ritonavir may result in elevated plasma concentrations of testosterone, dasabuvir, ombitasvir, paritaprevir, and ritonavir.
In addition, testosterone inhibits the drug transporter P-glycoprotein P-gp ; dasabuvir, ombitasvir, paritaprevir and ritonavir are all substrates of P-gp.
Caution and close monitoring are advised if these drugs are administered together. Moderate Concurrent administration of testosterone with dasabuvir; ombitasvir; paritaprevir; ritonavir or ombitasvir; paritaprevir; ritonavir may result in elevated plasma concentrations of testosterone, dasabuvir, ombitasvir, paritaprevir, and ritonavir. Paritaprevir also inhibits P-gp. Moderate Concurrent administration of testosterone with ritonavir may result in elevated plasma concentrations of testosterone and ritonavir.
In addition, testosterone inhibits P-gp; ritonavir is a substrate of P-gp. Degarelix: Major Concomitant use of androgens with degarelix is relatively contraindicated, as androgens could counteract the therapeutic effect of degarelix. Dipeptidyl Peptidase-4 Inhibitors: Moderate Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. Doravirine; Lamivudine; Tenofovir disoproxil fumarate: Moderate Caution is advised when administering tenofovir, PMPA, a P-glycoprotein P-gp substrate, concurrently with inhibitors of P-gp, such as testosterone.
Coadministration may result in increased absorption of tenofovir. Monitor for tenofovir-associated adverse reactions. The concomitant administration of dronedarone with CYP3A4 and P-gp substrates may result in increased exposure of the substrate and should, therefore, be undertaken with caution.
Edoxaban: Moderate Coadministration of edoxaban and testosterone may result in increased concentrations of edoxaban. Edoxaban is a P-glycoprotein P-gp substrate and testosterone is a P-gp inhibitor. Increased concentrations of edoxaban may occur during concomitant use of testosterone; monitor for increased adverse effects of edoxaban. Dosage reduction may be considered for patients being treated for deep venous thrombosis DVT or pulmonary embolism. Elbasvir; Grazoprevir: Minor Administering testosterone with grazoprevir may result in elevated testosterone plasma concentrations.
If these drugs are used together, closely monitor for signs of adverse events. Eliglustat: Moderate Coadministration of testosterone and eliglustat may result in increased plasma concentrations of testosterone.
Monitor patients closely for testosterone-related adverse effects. Testosterone is a P-glycoprotein P-gp substrate; eliglustat is a P-gp inhibitor. Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide: Minor Plasma concentrations of testosterone may be significantly elevated when administered with cobicistat. Minor Plasma concentrations of testosterone may be significantly elevated when administered with cobicistat.
Empagliflozin: Moderate Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. Empagliflozin; Linagliptin: Moderate Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens.
Empagliflozin; Metformin: Moderate Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. Emtricitabine; Rilpivirine; Tenofovir disoproxil fumarate: Moderate Caution is advised when administering tenofovir, PMPA, a P-glycoprotein P-gp substrate, concurrently with inhibitors of P-gp, such as testosterone. Emtricitabine; Tenofovir disoproxil fumarate: Moderate Caution is advised when administering tenofovir, PMPA, a P-glycoprotein P-gp substrate, concurrently with inhibitors of P-gp, such as testosterone.
Epoetin Alfa: Moderate Androgens are known to stimulate erythropoiesis. Concurrent administration of androgens can increase the patient's response to epoetin alfa, reducing the amount required to treat anemia. Because adverse reactions have been associated with an abrupt increase in blood viscosity, this drug combination should be avoided, if possible. Further evaluation of this combination needs to be made. Ertugliflozin: Moderate Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens.
Ertugliflozin; Metformin: Moderate Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. Ertugliflozin; Sitagliptin: Moderate Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. Etoposide, VP Major Monitor for an increased incidence of etoposide-related adverse effects if used concomitantly with testosterone. Coadministration may increase etoposide concentrations. Coadministration with inhibitors of Pgp, such as testosterone, is not recommended.
Patients may experience an increase in systemic exposure to everolimus if these drugs are coadministered. In addition, testosterone is a substrate of CYP3A4. The effect of everolimus on testosterone pharmacokinetics has not been established; however, pharmacokinetic studies showed no significant impact of the coadministration of everolimus with the CYP3A4 and Pgp substrate atorvastatin.
Fluconazole: Minor Testosterone concentrations may increase during fluconazole administration. Fluconazole is an inhibitor of CYP3A4, the hepatic microsomal isoenzyme responsible for metabolism of testosterone.
The clinical significance of this interaction is unclear at this time. Fosamprenavir: Moderate Concomitant use of testosterone and fosamprenavir may result in elevated fosamprenavir and altered testosterone plasma concentrations.
Glipizide; Metformin: Moderate Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. Glyburide; Metformin: Moderate Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens.
Goserelin: Major Avoid concurrent use of androgens with gonadotropin releasing hormone GnRH agonists such as goserelin. Goserelin inhibits steroidogenesis; concomitant use with androgens may counteract this therapeutic effect.
Histrelin: Major Avoid concurrent use of androgens with gonadotropin releasing hormone GnRH agonists such as histrelin. Histrelin inhibits steroidogenesis; concomitant use with androgens may counteract this therapeutic effect. Hydrochlorothiazide, HCTZ; Propranolol: Moderate Testosterone cypionate has been shown to increase the clearance of propranolol in one study. Monitor patients taking testosterone and proprantolol together for decreased therapeutic efficacy of propranolol.
Incretin Mimetics: Moderate Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. Insulins: Moderate Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens.
Isavuconazonium: Moderate The plasma concentrations of testosterone may be elevated when administered concurrently with isavuconazonium. Ixabepilone: Minor Testosterone is an inhibitor of and substrate for P-glycoprotein Pgp. Ixabepilone is a mild inhibitor of and substrate for Pgp. Caution is recommended if ixabepilone is coadministered with a Pgp inhibitor.
Leuprolide: Major Leuprolide inhibits steroidogenesis. While no drug interactions have been reported with leuprolide, therapy with androgens would be relatively contraindicated and would counteract the therapeutic effect of leuprolide. Leuprolide; Norethindrone: Major Leuprolide inhibits steroidogenesis.
Linagliptin: Moderate Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. Linagliptin; Metformin: Moderate Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. Loperamide: Moderate The plasma concentration of loperamide, a P-glycoprotein P-gp substrate, may be increased when administered concurrently with testosterone, a P-gp inhibitor.
If these drugs are used together, monitor for loperamide-associated adverse reactions, such as CNS effects and cardiac toxicities i. Loperamide; Simethicone: Moderate The plasma concentration of loperamide, a P-glycoprotein P-gp substrate, may be increased when administered concurrently with testosterone, a P-gp inhibitor.
Lopinavir; Ritonavir: Moderate Concurrent administration of testosterone with lopinavir; ritonavir may result in elevated plasma concentrations of testosterone and ritonavir. Lumacaftor; Ivacaftor: Minor Lumacaftor; ivacaftor may alter the exposure of testosterone.
Although induction of testosterone metabolism through the CYP3A pathway may lead to decreased drug efficacy, the net effect of lumacaftor; ivacaftor on P-gp transport is not clear. Maraviroc: Moderate Use caution and careful monitoring with the coadministration of maraviroc and testosterone as increased maraviroc concentrations may occur.
Maraviroc is a substrate of P-glycoprotein P-gp ; testosterone is an inhibitor of P-gp. The effects of P-gp on the concentrations of maraviroc are unknown, although an increase in concentrations and thus, toxicity, are possible. Meglitinides: Moderate Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. Metformin: Moderate Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens.
Metformin; Pioglitazone: Moderate Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. Metformin; Repaglinide: Moderate Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. Metformin; Rosiglitazone: Moderate Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. Metformin; Saxagliptin: Moderate Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens.
Metformin; Sitagliptin: Moderate Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. Methoxy polyethylene glycol-epoetin beta: Moderate Androgens are known to stimulate erythropoiesis.
Despite the fact that endogenous generation of erythropoietin is depressed in patients with chronic renal failure, other tissues besides the kidney can synthesize erythropoietin, albeit in small amounts. Concurrent administration of androgens can increase the patient's response to MPG-epoetin beta, reducing the amount required to treat anemia. Miglitol: Moderate Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens.
Mitotane: Moderate Use caution if mitotane and testosterone are used concomitantly, and monitor for decreased efficacy of testosterone and a possible change in dosage requirements.
Mitotane is a strong CYP3A4 inducer and testosterone is a CYP3A4 substrate; coadministration may result in decreased plasma concentrations of testosterone.
Avoid concurrent use of androgens with GnRH agonists. Testosterone inhibited the formation of paclitaxel metabolites in vitro. Combining the drugs in clinical practice may require close monitoring to ensure proper therapeutic responses. Ombitasvir; Paritaprevir; Ritonavir: Moderate Concurrent administration of testosterone with dasabuvir; ombitasvir; paritaprevir; ritonavir may result in elevated plasma concentrations of testosterone, dasabuvir, ombitasvir, paritaprevir, and ritonavir.
Plasma concentrations and efficacy of testosterone may be reduced if these drugs are administered concurrently. Oxymetazoline: Moderate The drug interaction potential between intranasal testosterone e. Therefore, concomitant use of intranasal testosterone with intranasal drugs other than sympathomimetic decongestants e.
Eighteen males with seasonal allergic rhinitis were treated with intranasal testosterone and randomized to receive oxymetazoline 30 minutes prior to intranasal testosterone or no treatment. A mean decrease in AUC and Cmax 2. Concomitant use of oxymetazoline does not impact the absorption of testosterone. Use caution when concurrent administration of testosterone and pazopanib is necessary.
Pexidartinib: Moderate Monitor for evidence of hepatotoxicity if pexidartinib is coadministered with testosterone. Avoid concurrent use in patients with increased serum transaminases, total bilirubin, or direct bilirubin more than ULN or active liver or biliary tract disease. Posaconazole: Major Posaconazole and testosterone should be coadministered with caution due to an increased potential for adverse events.
This complex interaction may cause alterations in the plasma concentrations of both posaconazole and testosterone, ultimately resulting in an increased risk of adverse events. Posaconazole is a potent inhibitor of CYP3A4, an isoenzyme partially responsible for the metabolism of testosterone.
Further, both testosterone and posaconazole are inhibitors and substrates of the drug efflux protein, P-glycoprotein, which when administered together may increase the absorption or decrease the clearance of the other drug.
Pramlintide: Moderate Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. Propranolol: Moderate Testosterone cypionate has been shown to increase the clearance of propranolol in one study. Ranolazine: Moderate Testosterone is an inhibitor of P-glycoprotein transport.
Ranolazine is a substrate of P-glycoprotein, and inhibitors of P-glycoprotein may increase the absorption of ranolazine. Rifaximin: Moderate Although the clinical significance of this interaction is unknown, concurrent use of rifaximin, a P-glycoprotein P-gp substrate, and testosterone, a P-gp inhibitor, may substantially increase the systemic exposure to rifaximin; caution is advised if these drugs must be administered together.
During one in vitro study, coadministration with cyclosporine, a potent P-gp inhibitor, resulted in an fold and fold increase in the mean Cmax and AUC of rifaximin, respectively. In patients with hepatic impairment, the effects of reduced metabolism and P-gp inhibition may further increase exposure to rifaximin.
Riluzole: Moderate Monitor for signs and symptoms of hepatic injury during coadministration of riluzole and testosterone. Concomitant use may increase the risk for hepatotoxicity. Discontinue riluzole if clinical signs of liver dysfunction are present. Ritonavir: Moderate Concurrent administration of testosterone with ritonavir may result in elevated plasma concentrations of testosterone and ritonavir.
Rivaroxaban: Minor Coadministration of rivaroxaban and testosterone may result in increases in rivaroxaban exposure and may increase bleeding risk.
Testosterone is an inhibitor of P-gp, and rivaroxaban is a substrate of P-gp. If these drugs are administered concurrently, monitor the patient for signs and symptoms of bleeding. Romidepsin: Moderate Romidepsin is a substrate for P-glycoprotein.
Testosterone is an inhibitor of P-gp. Concurrent administration of romidepsin with an inhibitor of P-gp may cause an increase in systemic romidepsin concentrations. Use caution when concomitant administration of these agents is necessary. Sapropterin: Minor Caution is advised with the concomitant use of sapropterin and testosterone as coadministration may result in increased systemic exposure of testosterone. Testosterone is a substrate for the drug transporter P-glycoprotein P-gp ; in vitro data show that sapropterin may inhibit P-gp.
Do not apply AXIRON to any other parts of your body such as your stomach area abdomen , penis, scrotum, shoulders or upper arms. Avoid splashing in the eyes. In case of contact with eyes, flush thoroughly with water. If irritation persists, seek medical advice.
Wash it down the sink to avoid accidental exposure to others. Apply your dose correctly by following the application instructions in the table below. Figure 2 Remove the cap and the applicator cup from the pump. Then, position the nozzle over the applicator cup and depress the pump gently see Figure 2. Figure 3 To apply the AXIRON solution, keep the applicator upright, place it up into the armpit application site and wipe steadily down and up see Figure 3. Do not rub in the solution with your fingers or hand once it has been applied.
Let the application site dry completely before putting on a shirt. After you have finished applying AXIRON, rinse the applicator cup with room temperature running water, and then pat it dry with a tissue. Carefully replace the applicator cup and cap back onto the bottle and make sure you store the bottle safely. Clean up any spilled solution from surfaces such as the sink or floor to make sure others do not come into contact with it.
Wash your hands with soap and water right away. This can include: increased urination at night trouble starting your urine stream having to pass urine many times during the day having an urge that you have to go to the bathroom right away having a urine accident being unable to pass urine or weak urine flow Possible increased risk of prostate cancer.
Your healthcare provider should check you for prostate cancer or any other prostate problems before you start and while you use AXIRON. Swelling of your ankles, feet, or body. Enlarged or painful breasts. Problems breathing while you sleep sleep apnea. Blood clots in the legs. This can include pain, swelling or redness of your legs. The most common side effects of AXIRON include: skin redness or irritation where AXIRON is applied increased red blood cell count headache diarrhea vomiting increase in blood level of Prostate Specific Antigen a test used to screen for prostate cancer Other side effects include more erections than are normal for you or erections that last a long time.
For more information, go to www. Active ingredient: testosterone. Inactive ingredients: ethanol, isopropyl alcohol, octisalate, and povidone. The bottle or applicator cup does not contain latex. Apply 1 application once to one armpit only left OR right. Apply 2 applications: one to the left armpit and then one to the right armpit.
Apply 3 applications: one to the left and one to the right armpit, wait for the product to dry, and then apply again one to the left OR right armpit. Apply 4 applications: one to the left and one to the right armpit, wait for the product to dry, and then apply again one to the left AND one to the right armpit. Figure 2. Remove the cap and the applicator cup from the pump.
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