testosterone 30 mg/1.5mL Solution
Other active recalls for Testosterone (different manufacturers) — 4 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Androgen class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Testosterone replacement is specifically for men whose bodies aren't making enough testosterone because of a medical condition — like a problem with the testes themselves (primary...
- What exactly is testosterone replacement therapy for — do I really need it?
- Yes, this is a serious concern. Children who accidentally touch the gel on your skin or clothing can absorb testosterone and develop early puberty signs — things like pubic hair gr...
- I use the gel — do I really need to worry about my kids or partner being exposed to it?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Testosterone — tap one for details:
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Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
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UNII ND2M416302
Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
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UNII 4X49Y0596W
Ethylhexyl salicylate is a synthetic organic compound used as a UV filter and penetration enhancer in topical formulations. It helps protect the product and skin from ultraviolet light damage.
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UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
4 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.562 | $61.86 / 110 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.8705 | $95.76 / 110 ml |
| Medicare drug plans payPart D · Q2 2026 | $2.04 | $224.29 / 110 ml |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Testosterone 30 mg/1.5mL 00591-2114-81 | Actavis | 1 bottle | $0.562 | AT | Availability likely | — |
| testosterone 30 mg/1.5mLthis 45802-0610-01 | Padagis | 1 bottle | $0.562 | AT | Availability likely | — |
| Testosterone 30 mg/1.5mL 68180-0943-11 | Lupin | 1 bottle | $0.562 | AT | Availability likely | — |
| Testosterone 30 mg/1.5mL 69097-0363-44 | Cipla | 1 bottle | $0.562 | AT | Availability likely | — |
| Testosterone 30 mg/1.5mL 62332-0488-11 | Alembic | 1 bottle | — | — | FDA listed | — |
| testosterone 30 mg/1.5mL 63629-9310-01 | Bryant | 1 bottle | — | AT | FDA listed | — |
| testosterone 30 mg/1.5mL 72162-1421-02 | Bryant | 1 bottle | — | AT | FDA listed | — |
| Testosterone 30 mg/1.5mL 21922-0109-16 | Encube | 1 bottle | — | AT | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 45802-0610-01 You're viewing this | 1 BOTTLE, PUMP in 1 CARTON (45802-610-01) / 110 mL in 1 BOTTLE, PUMP | 2017-06-28 | Active |
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: SECONDARY EXPOSURE TO TESTOSTERONE • Virilization has been reported in children who were secondarily exposed to topical testosterone products [see Warnings and Precautions ( 5.2 )] . • Children should avoid contact with unwashed or unclothed application sites in men using Testosterone Topical Solution [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.2 )] . • Healthcare providers should advise patients to strictly adhere to recommended instructions for use [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.2 ) and Patient Counseling Information ( 17 )] . • Children should avoid contact with unwashed or unclothed application sites in men using Testosterone Topical Solution [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.2 )] . • Healthcare providers should advise patients to strictly adhere to recommended instructions for use [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.2 ) and Patient Counseling Information ( 17 )] .
WARNING: SECONDARY EXPOSURE TO TESTOSTERONE See full prescribing information for complete boxed warning. • Virilization has been reported in children who were secondarily exposed to topical testosterone products ( 5.2 ) • Children should avoid contact with unwashed or unclothed application sites in men using Testosterone Topical Solution, 30 mg/1.5 mL ( 2.2 , 5.2 ) • Healthcare providers should advise patients to strictly adhere to recommended instructions for use ( 2.2 , 5.2 , 17 ) • Children should avoid contact with unwashed or unclothed application sites in men using Testosterone Topical Solution, 30 mg/1.5 mL ( 2.2 , 5.2 ) • Healthcare providers should advise patients to strictly adhere to recommended instructions for use ( 2.2 , 5.2 , 17 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Testosterone Topical Solution is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. • Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (FSH, LH) above the normal range. • Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation.
These men have low testosterone serum concentrations but have gonadotropins in the normal or low range. Limitations of use: • Safety and efficacy of Testosterone Topical Solution in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established. • Safety and efficacy of Testosterone Topical Solution in males <18 years old have not been established [ see Use in Specific Populations ( 8.4 ) ]. Testosterone Topical Solution, 30 mg/1.5 mL is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: • Primary hypogonadism (congenital or acquired) ( 1 ) • Hypogonadotropic hypogonadism (congenital or acquired) ( 1 ) Limitations of use: • Safety and efficacy of Testosterone Topical Solution, 30 mg/1.5 mL in men with “age-related hypogonadism” have not been established.
( 1 ) • Safety and efficacy of Testosterone Topical Solution, 30 mg/1.5 mL in males <18 years old have not been established. ( 8.4 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Prior to initiating Testosterone Topical Solution, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range. Prior to initiating Testosterone Topical Solution, 30 mg/1.5 mL, confirm the diagnosis of hypogonadism by ensuring that serum testosterone has been measured in the morning on at least two separate days and that these concentrations are below the normal range ( 2 ). • Starting Testosterone Topical Solution, 30 mg/1.5 mL dose is 60 mg of testosterone (1 pump actuation of 30 mg of testosterone to each axilla), applied once daily, at the same time each morning.
( 2.1 ) • Apply to clean, dry intact skin of the axilla, not to any other parts of the body including the abdomen or genitals. ( 2.2 ) • Dose adjustment: The dose of testosterone may be decreased from 60 mg (2 pump actuations) to 30 mg (1 pump actuation) or increased from 60 mg to 90 mg (3 pump actuations) or from 90 mg to 120 mg (4 pump actuations) based on the serum testosterone concentration from a single blood draw 2 to 8 hours after applying Testosterone Topical Solution, 30 mg/1.5 mL and at least 14 days after starting treatment or following dose adjustment.
( 2.2 ) • Patients should wash hands immediately with soap and water after applying Testosterone Topical Solution, 30 mg/1.5 mL and cover the application site with clothing after the solution has dried. Wash the application site thoroughly with soap and water prior to any situation where skin-to-skin contact of the application site with another person is anticipated. ( 2.2 ) • The application site and dose of Testosterone Topical Solution, 30 mg/1.5 mL are not interchangeable with other topical testosterone products.
( 2.1 )
2.1Dosing and Dose Adjustment The recommended starting dose of Testosterone Topical Solution is 60 mg of testosterone (2 pump actuations) applied once daily. To ensure proper dosing, serum testosterone concentrations should be measured after initiation of therapy to ensure that the desired concentrations (300 ng/dL to 1050 ng/dL) are achieved. The Testosterone Topical Solution dose can be adjusted based on the serum testosterone concentration from a single blood draw 2 to 8 hours after applying Testosterone Topical Solution and at least 14 days after starting treatment or following dose adjustment.
If the measured serum testosterone concentration is below 300 ng/dL, the daily testosterone dose may be increased from 60 mg (2 pump actuations) to 90 mg (3 pump actuations) or from 90 mg to 120 mg (4 pump actuations). If the serum testosterone concentration exceeds 1050 ng/dL, the daily testosterone dose should be decreased from 60 mg (2 pump actuations) to 30 mg (1 pump actuation) as instructed by a physician. If the serum testosterone concentration consistently exceeds 1050 ng/dL at the lowest daily dose of 30 mg (1 pump actuation), Testosterone Topical Solution therapy should be discontinued.
The application site and dose of Testosterone Topical Solution are not interchangeable with other topical testosterone products.
2.2Administration Instructions Testosterone Topical Solution is applied to the axilla, preferably at the same time each morning, to clean, dry, intact skin. Do not apply Testosterone Topical Solution to other parts of the body including to the scrotum, penis, abdomen, shoulders or upper arms. After applying the solution, the application site should be allowed to dry completely prior to dressing.
Avoid fire, flames or smoking until the solution has dried since alcohol based products, including Testosterone Topical Solution, are flammable. When deodorants or antiperspirants are used as part of a regular program for personal hygiene, they should not interfere with the efficacy of Testosterone Topical Solution in treating hypogonadism. If patients use an antiperspirant or deodora…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Testosterone Topical Solution USP is available as a metered-dose pump that delivers 30 mg of testosterone per pump. Each metered-dose pump is supplied with an applicator. Testosterone Topical Solution, 30 mg/1.5 mL is available as a metered-dose pump that delivers 30 mg of testosterone per pump. Each metered-dose pump is supplied with an applicator. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS • Testosterone Topical Solution is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate [ see Warnings and Precaution ( 5.1 ) ]. • Testosterone Topical Solution is contraindicated in women who are, or who may become pregnant, or who are breastfeeding. Testosterone Topical Solution may cause fetal harm when administered to a pregnant woman. Testosterone Topical Solution may cause serious adverse reactions in nursing infants.
If a pregnant woman is exposed to Testosterone Topical Solution, she should be apprised of the potential hazard to the fetus. [ See Use in Specific Populations ( 8.1 , 8.3 ) ]. • Men with carcinoma of the breast or known or suspected carcinoma of the prostate ( 4 , 5.1 ) • Pregnant or breastfeeding women. Testosterone may cause fetal harm ( 4 , 8.1 , 8.3 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH ( 5.1 ) • Avoid unintentional exposure of women or children to Testosterone Topical Solution, 30 mg/1.5 mL. Secondary exposure to testosterone can produce signs of virilization. Testosterone Topical Solution, 30 mg/1.5 mL should be discontinued until the cause of the virilization is identified ( 2.2 , 5.2 ) • Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients using testosterone products.
Evaluate patients with signs or symptoms consistent with DVT or PE. ( 5.4 ) • Some postmarketing studies have shown an increased risk of myocardial infarction and stroke associated with use of testosterone replacement therapy ( 5.5 ) • Exogenous administration of testosterone may lead to azoospermia ( 5.9 ) • Edema with or without congestive heart failure, may be a complication in patients with preexisting cardiac, renal, or hepatic disease ( 5.11 ) • Sleep apnea may occur in those with risk factors ( 5.13 ) • Monitor serum testosterone, prostate specific antigen (PSA), liver function, lipid concentrations, hematocrit and hemoglobin periodically ( 5.1 , 5.3 , 5.10 , 5.14 ) • Testosterone Topical Solution, 30 mg/1.5 mL is flammable until dry ( 5.17 )
5.1Worsening of Benign Prostatic Hyperplasia and Potential Risk of Prostate Cancer • Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH. • Patients treated with Androgens may be at increased risk for prostate cancer. Evaluate patients for prostate cancer prior to initiating treatment. It would be appropriate to reevaluate patients 3 to 6 months after initiation of treatment, and then in accordance with prostate cancer screening practices. [ See Contraindications ( 4 ) ].
5.2Potential for Secondary Exposure to Testosterone Cases of secondary exposure to testosterone in children and women have been reported with topical testosterone products applied to the abdomen or upper arms, including cases of secondary exposure resulting in virilization of children. Signs and symptoms have included enlargement of the penis or clitoris, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age. In most cases, these signs and symptoms regressed with removal of the exposure to testosterone.
In a few cases, however, enlarged genitalia did not fully return to age-appropriate normal size, and bone age remained modestly greater than chronological age. The risk of transfer was increased in some of these cases by not adhering to precautions for the appropriate use of the topical testosterone product. Children and women should avoid contact with unwashed or unclothed application sites in men using Testosterone Topical Solution [ see Dosage and Administration ( 2.2 ), Use in Specific Populations ( 8.1 ) and Clinical Pharmacology ( 12.3 ) ].
Inappropriate changes in genital size or development of pubic hair or libido in children, or changes in body hair distribution, significant increase in acne, or other signs of virilization in adult women should be brought to the attention of a physician and the possibility of secondary exposure to testosterone should also be brought to the attention of a physician. Testosterone therapy should be promptly discontinued at least until the cause of virilization has been identified. [ See Dosage and Administration ( 2.2 ) ].
5.3Polycythemia Increases in hematocrit, reflective of increases in red blood cell mass, may require lowering or discontinuation of testosterone. Check hematocrit prior to initiating testosterone treatment. It would be appropriate to re-evaluate the hematocrit 3 to 6 months after starting testosterone treatment, and then annually.
If hematocrit becomes elevated, stop therapy until hematocrit decreases to an acceptable level. An increase in red blood cell mass may increase the…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Most common adverse reactions (incidence > 4%) are skin application site reactions, increased hematocrit, headache, diarrhea, vomiting, and increased serum PSA ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trials in Hypogonadal Men Table 2 shows the treatment emergent adverse reactions that were reported by either >4% of 155 patients in a 120 day, Phase 3 study or by >4% of 71 patients who continued to use testosterone topical solution for up to 180 days.
These data reflect the experience primarily with a testosterone dose of 60 mg, which was taken by all patients at the start of the study, and was the maintenance dose for 97 patients. However, the doses used varied from 30 mg to 120 mg. Table 2: Adverse Reactions Seen With the Use of Testosterone Topical Solution in either the 120 Day Clinical Trial or in the Extension to 180 Days (>4%) Event 120 Days (155 Patients) 180 Days (71 Patients) Application Site Irritation 11 (7%) 6 (8%) Application Site Erythema 8 (5%) 5 (7%) Headache 8 (5%) 4 (6%) Hematocrit Increased 6 (4%) 5 (7%) Diarrhea 4 (3%) 3 (4%) Vomiting 4 (3%) 3 (4%) PSA Increased 2 (1%) 3 (4%) Other less common adverse reactions reported by at least 2 patients in the 120 day trial included: application site edema, application site warmth, increased hemoglobin, hypertension, erythema (general), increased blood glucose, acne, nasopharyngitis, anger and anxiety.
Other less common adverse reactions reported in fewer than 1% of patients in the 120 day trial included: asthenia, affect lability, folliculitis, increased lacrimation, breast tenderness, increased blood pressure, increased blood testosterone, neoplasm prostate and elevated red blood cell count. During the 120 day trial one patient discontinued treatment because of affect lability/anger which was considered possibly related to testosterone topical solution administration. During the 120 day clinical trial there was an increase in mean PSA values of 0.13 ± 0.68 ng/mL from baseline.
At the end of the 180 day extension clinical trial, there was an overall increase in mean PSA values of 0.1 ± 0.54 ng/mL. Following the 120 day study, seventy-one (71) patients entered a two-month extension study with testosterone topical solution. Two patients (3%) had adverse reactions that led to discontinuation of treatment during the period from Day 120 to Day 180.
These reactions were: one patient with application site irritation (considered possibly related to testosterone topical solution application) and one patient with dry skin and erythema, but not at the application site (considered not related to testosterone topical solution administration) and application site erythema (considered possibly related to testosterone topical solution administration). No serious adverse reactions to testosterone topical solution were reported during either the 120 day trial, or the extension to 180 days.
6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of testosterone topical solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular Disorders: myocardial infarction, stroke [ see Warnings and Precautions ( 5.5 ) ].
Vascular Disorders: Venous thromboembolism [ see Warnings and Precautions ( 5.4 ) ].
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS • Androgens may decrease blood glucose and insulin requirement in diabetic patients ( 7.1 ). • Changes in anticoagulant activity may be seen with androgens. More frequent monitoring of International Normalized Ratio (INR) and prothrombin time is recommended ( 7.2 ). • Use of testosterone with Adrenocorticotropic Hormone (ACTH) or corticosteroids may result in increased fluid retention. Use with caution, particularly in patients with cardiac, renal, or hepatic disease ( 7.3 ).
7.1Insulin 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, insulin requirement.
7.2Oral Anticoagulants Changes in anticoagulant activity may be seen with androgens. More frequent monitoring of INR and prothrombin time is recommended in patients taking anticoagulants, especially at the initiation and termination of androgen therapy.
7.3Corticosteroids The concurrent use of testosterone with ACTH or corticosteroids may result in increased fluid retention and should be monitored cautiously, particularly in patients with cardiac, renal or hepatic disease.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS • There are insufficient long-term safety data in geriatric patients using Testosterone Topical Solution, 30 mg/1.5 mL to assess the potential risks of cardiovascular disease and prostate cancer. ( 8.5 ).
8.1Pregnancy Pregnancy Category X [ see Contraindications ( 4 ) ] — Testosterone Topical Solution is contraindicated during pregnancy or in women who may become pregnant. Testosterone is teratogenic and may cause fetal harm. Exposure of a female fetus to androgens may result in varying degrees of virilization.
If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.
8.3Nursing Mothers Although it is not known how much testosterone transfers into human milk, Testosterone Topical Solution is contraindicated in nursing women because of the potential for serious adverse reactions in nursing infants. Testosterone and other androgens may adversely affect lactation. [ See Contraindications ( 4 ) ].
8.4Pediatric Use Safety and efficacy of Testosterone Topical Solution has not been established in males <18 years of age. Improper use may result in acceleration of bone age and premature closure of epiphyses.
8.5Geriatric Use There have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing testosterone topical solution to determine whether efficacy in those over 65 years of age differs from younger patients. Of the 155 patients enrolled in the pivotal clinical study utilizing testosterone topical solution, 21 were over 65 years of age. Additionally, there were insufficient long-term safety data in these patients utilizing testosterone topical solution to assess a potential incremental risk of cardiovascular disease and prostate cancer.
8.6Renal Impairment No formal studies were conducted involving patients with renal impairment.
8.7Hepatic Impairment No formal studies were conducted involving patients with hepatic impairment.
8.8Use in Men with Body Mass Index (BMI) >35 kg/m 2 Safety and efficacy of Testosterone Topical Solution in males with BMI >35 kg/m 2 has not been established.
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Category X [ see Contraindications ( 4 ) ] — Testosterone Topical Solution is contraindicated during pregnancy or in women who may become pregnant. Testosterone is teratogenic and may cause fetal harm. Exposure of a female fetus to androgens may result in varying degrees of virilization.
If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and efficacy of Testosterone Topical Solution has not been established in males <18 years of age. Improper use may result in acceleration of bone age and premature closure of epiphyses.
🧓 Geriatric Use ▾
8.5Geriatric Use There have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing testosterone topical solution to determine whether efficacy in those over 65 years of age differs from younger patients. Of the 155 patients enrolled in the pivotal clinical study utilizing testosterone topical solution, 21 were over 65 years of age. Additionally, there were insufficient long-term safety data in these patients utilizing testosterone topical solution to assess a potential incremental risk of cardiovascular disease and prostate cancer.
🆘 Overdosage ▾
10 OVERDOSAGE No cases of overdose with testosterone topical solution have been reported in clinical trials. There is one report of acute overdosage by injection of testosterone enanthate: testosterone concentrations of up to 11,400 ng/dL were implicated in a cerebrovascular accident. Treatment of overdosage would consist of discontinuation of Testosterone Topical Solution together with appropriate symptomatic and supportive care.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis and scrotum; the development of male hair distribution, such as facial, pubic, chest and axillary hair; laryngeal enlargement, vocal cord thickening, alterations in body musculature and fat distribution. Testosterone and DHT are necessary for the normal development of secondary sex characteristics.
Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter's syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH).
12.2Pharmacodynamics No specific pharmacodynamic studies were conducted using Testosterone Topical Solution.
12.3Pharmacokinetics Absorption — Testosterone Topical Solution delivers physiologic circulating testosterone that approximate normal concentration range (i.e., 300 to 1050 ng/dL) seen in healthy men following application to the axilla. On the skin, the ethanol and isopropyl alcohol evaporate leaving testosterone and octisalate. The skin acts as a reservoir from which testosterone is released into the systemic circulation over time (see Figure 1).
In general, steady-state serum concentrations are achieved by approximately 14 days of daily dosing. Figure 1: Mean (±SD) Serum Testosterone Concentrations on Day 7 in Patients Following Testosterone Topical Solution Once-Daily Application of 30 mg, 60 mg, or 90 mg of Testosterone When testosterone topical solution treatment is discontinued after achieving steady-state, serum testosterone concentrations returned to their pretreatment concentrations by 7 to 10 days after the last application. Distribution — Circulating testosterone is primarily bound in the serum to sex hormone-binding globulin (SHBG) and albumin.
Approximately 40% of testosterone in plasma is bound to SHBG, 2% remains unbound (free) and the rest is bound to albumin and other proteins. Metabolism —Testosterone is metabolized to various 17-keto steroids through two different pathways. The major active metabolites of testosterone are estradiol and dihydrotestosterone (DHT).
DHT concentration increased in parallel with testosterone concentration during testosterone topical solution treatment. The mean steady-state DHT/T ratio remained within normal limits and ranged from 0.17 to 0.26 across all doses on Days 15, 60, and 120. Excretion — There is considerable variation in the half-life of testosterone as reported in the literature, ranging from 10 to 100 minutes.
About 90% of a dose of testosterone given intramuscularly is excreted in the urine as glucuronic and sulfuric acid conjugates of testosterone and its metabolites; about 6% of a dose is excreted in the feces, mostly in the unconjugated form. Inactivation of testosterone occurs primarily in the liver. Potential for testosterone transfer: The potential for testosterone transfer from males dosed with testosterone topical solution to healthy females was evaluated in a clinical study conducted with a 2% testosterone formulation.
10 males were treated with 60 mg of testosterone in each axilla (the maximum testosterone dose of 120 mg). At 2 hours after the application of testosterone topical solution to the males, the females rubbed their outer forearms for 15 minutes on the axilla of the males. The males had covered the application area with a T-shirt.
Serum concentrations of testosterone were monitored in the female subjects for 72 hours after the transfer procedure. Study results show a 13% and 17% increase in testosterone exposure (AUC [0-24] ) and maximum testosterone concent…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis and scrotum; the development of male hair distribution, such as facial, pubic, chest and axillary hair; laryngeal enlargement, vocal cord thickening, alterations in body musculature and fat distribution. Testosterone and DHT are necessary for the normal development of secondary sex characteristics.
Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter's syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH).
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied Testosterone Topical Solution USP, 30 mg/1.5 mL is available as a metered-dose pump containing 110 mL of solution. The pump is capable of dispensing 90 mL of solution in 60 metered pump actuations. One actuation delivers 30 mg of testosterone in 1.5 mL of solution. Each metered-dose pump is supplied with an applicator. The bottle and the applicator cup are not made with natural rubber latex. NDC 45802- 610 -01
16.2Storage and Handling Keep Testosterone Topical Solution out of reach of children. Store upright at 25°C (77°F). Excursions are permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Used Testosterone Topical Solution bottles and applicators should be discarded in household trash in a manner that prevents accidental exposure of children or pets.
📋 Description ▾
11 DESCRIPTION Testosterone Topical Solution USP, 30 mg/1.5 mL is a clear, colorless, single phase solution containing 30 mg of testosterone in 1.5 mL of Testosterone Topical Solution for topical administration through the axilla. The active pharmacologic ingredient in Testosterone Topical Solution is testosterone. Testosterone USP is a white to practically white crystalline powder chemically described as 17-beta hydroxyandrost-4-en-3-one.
The structural formula is: The inactive ingredients are ethanol, isopropyl alcohol, octisalate, and povidone. chemical-structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION See FDA-Approved Medication Guide. Patients should be informed of the following information:
17.1Use in Men with Known or Suspected Prostate or Breast Cancer Men with known or suspected prostate or breast cancer should not use Testosterone Topical Solution. [ See Contraindications ( 4 ) and Warnings and Precautions ( 5.1 ) ].
17.2Potential for Secondary Exposure to Testosterone and Steps to Prevent Secondary Exposure Cases of secondary exposure to testosterone in children and women have been reported with topical testosterone products applied to the abdomen, shoulders or upper arms, including cases of secondary exposure resulting in virilization of children, with signs and symptoms including enlargement of the penis or clitoris, premature development of pubic hair, increased erections, aggressive behavior and advanced bone age. Inappropriate changes in genital size or premature development of pubic hair or libido in children, or changes in hair distribution, increase in acne, or other signs of testosterone effects in adult women should be brought to the attention of a physician and the possibility of secondary exposure to Testosterone Topical Solution also should be brought to the attention of a physician.
Testosterone Topical Solution should be promptly discontinued at least until the cause of virilization is identified. Strict adherence to the following precautions is advised in order to minimize the potential for secondary exposure to testosterone from Testosterone Topical Solution treated skin: • Testosterone Topical Solution should only be applied to the axilla, not to any other part of the body. • Children and women should avoid contact with the unwashed skin of the axilla or unclothed application sites of men where Testosterone Topical Solution has been applied. • Patients should wash their hands immediately with soap and water after application of Testosterone Topical Solution. • Patients should cover the axilla application site(s) with clothing (e.g., a shirt) after waiting 3 minutes for the solution to dry. • Prior to any situation in which direct skin-to-skin contact of the axilla is anticipated, patients should wash the axilla to which Testosterone Topical Solution has been applied thoroughly with soap and water to remove any testosterone residue. • In the event that unwashed or unclothed skin to which Testosterone Topical Solution has been applied comes in direct contact with the skin of another person, the general area of contact on the other person should be washed with soap and water as soon as possible. [ See Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.2 ) and Clinical Pharmacology ( 12.3 ) ].
17.3Potential Adverse Reactions with Androgens Patients should be informed that treatment with Androgens may lead to adverse reactions which include: • Changes in urinary habits such as increased urination at night, trouble starting your urine stream, passing urine many times during the day, having an urge that you have to go to the bathroom right away, having urine accident, being unable to pass urine and having a weak urine flow. • Breathing disturbances, including those associated with sleep, or excessive daytime sleepiness. • Too frequent or persistent erections of the penis. • Nausea, vomiting, changes in skin color, or ankle swelling.
17.4Patients Should be Advised of these Application Instructions • Ensure that the patient understands how to administer the correct dose. • The pump should be primed by depressing it 3 times prior to its first use. No priming is needed with subsequent uses of that pump. • Testosterone Topical Solution should NOT be applied to the scrotum, penis, abdomen, shoulders or upper arms. • With testosterone doses greater than 60 mg, which require two applications of Testosterone Topical Solution to the same axilla, the product should be allowed to dry after the first application before the second is applied. • Testosterone Topical Solu…
💬 Medication Guide ▾
MEDICATION GUIDE TESTOSTERONE (tes-TOS-te-rone) topical solution USP, for topical use CIII What is the most important information I should know about Testosterone Topical Solution? 1. Testosterone Topical Solution can transfer from your body to others including, children and women.
Children and women should avoid contact with the unwashed or not covered (unclothed) areas where Testosterone Topical Solution has been applied to your skin. Early signs and symptoms of puberty have occurred in young children who have come in direct contact with testosterone by touching areas where men have used Testosterone Topical Solution. Children Signs and symptoms of early puberty in a child when they come in direct contact with Testosterone Topical Solution may include: Abnormal sexual changes: • enlarged penis or clitoris. • early growth of hair near the vagina or around the penis (pubic hair). • erections or acting out sexual urges (sex drive).
Behavior problems : • acting aggressively, behaving in an angry or violent way. Women Signs and symptoms in women when they come in direct contact with Testosterone Topical Solution may include: • changes in body hair. • an abnormal increase in pimples (acne). Stop using Testosterone Topical Solution and call your healthcare provider right away if you see any signs and symptoms in a child or a woman that may have happened through accidental touching of the area where you have applied Testosterone Topical Solution: 2.
To lower the risk of transfer of Testosterone Topical Solution from your body to others, follow these important instructions: • Apply Testosterone Topical Solution only to your armpits. • Wash your hands right away with soap and water after applying Testosterone Topical Solution. • After the solution has dried, cover the application area with clothing. Keep the area covered until you have washed the application area well or have showered. • If you expect to have skin-to-skin contact with another person, first wash the application area well with soap and water. • If a child or woman touches the area where you have applied Testosterone Topical Solution, that area on the child or woman should be washed well with soap and water right away.
What is Testosterone Topical Solution? • Testosterone Topical Solution is a prescription medicine that contains testosterone. Testosterone Topical Solution is used to treat adult males who have low or no testosterone due to certain medical conditions. o Your healthcare provider will test your blood before you start and while you are using Testosterone Topical Solution. o It is not known if Testosterone Topical Solution is safe or effective to treat men who have low testosterone due to aging. o It is not known if Testosterone Topical Solution is safe and effective in children younger than 18 years old.
Improper use of Testosterone Topical Solution may affect bone growth in children. • Testosterone Topical Solution is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your Testosterone Topical Solution in a safe place to protect it. Never give Testosterone Topical Solution to anyone else, even if they have the same symptoms you have.
Selling or giving away this medicine may harm others and it is against the law. • Testosterone Topical Solution is not meant for use in women. Do not use Testosterone Topical Solution if you: • have breast cancer. • have or might have prostate cancer. • are pregnant or may become pregnant or are breastfeeding. Testosterone Topical Solution may harm your unborn or breastfeeding baby.
Women who are pregnant or who may become pregnant should avoid contact with the area of the skin where Testosterone Topical Solution has been applied. Before using Testosterone Topical Solution, tell your healthcare provider about all of your medical conditions, including if you: • have breast cancer. • have or might have prostate cancer. • have urinary problems due to…