testosterone topical gel

Absorption: Skin serves as reservoir for sustained release of testosterone into systemic circulation; 10% absorbed into systemic circulation during 24–hr period. Well absorbed through nasal mucosa.

Distribution: Crosses the placenta.

Protein Binding: 98%.

Metabolism/Excretion: Metabolized by the liver; 90% eliminated in urine as metabolites.

Half-Life: 10–100 min.

Time/Action Profile ⬆ ⬇

(androgenic effects‡)

ROUTE	ONSET	PEAK	DURATION
Transdermal (gel)	30 min	unknown	24 hr
Nasal gel	unknown	unknown	3 mo

‡Response is highly variable among individuals; may take mo.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
OB: Pregnancy and lactation;
Male patients with breast or prostate cancer;
Women.

Use Cautiously in:

Pre-existing cardiac, renal, or liver disease;
Sleep apnea;
Obesity;
Chronic lung disease;
Polycythemia
Nasal disorders, nasal/sinus surgery, nasal fracture in previous 6 mo, nasal fracture that caused deviated anterior nasal septum, mucosal inflammatory disorders (e.g. Sjogren's syndrome), or sinus disorders (nasal gel)
Geri: risk of prostatic hyperplasia/carcinoma;
Pedi: Males 18 yr (safety and effectiveness not established).

Adv. Reactions/Side Effects ⬆ ⬇

CV: MI, STROKE, VENOUS THROMBOEMBOLISM, edema, hot flashes, hypertension

EENT: deepening of voice,

nasal gel

epistaxis, nasal scabbing, nasopharyngitis, rhinorrhea

GI: ↑liver enzymes, nausea, vomiting

GU: ↓fertility, nocturia, priapism, prostatic enlargement, urinary hesitancy, urinary incontinence

Endo: acne, breast pain, change in libido, gynecomastia, hypercholesterolemia

Derm: alopecia, dry skin, pruritis

Hemat: anemia, polycythemia

Local: chronic skin irritation

Interactions ⬆ ⬇

Drug-drug:

May ↑ action of oral hypoglycemic agents andinsulin.
Concurrent use with corticosteroids may ↑ risk of edema formation.

Route/Dosage ⬆ ⬇

Topical testosterone products are not interchangeable

Transdermal (Adults ): Androgel 1% or Testim—5 g (contains 50 mg of testosterone; 5 mg systemically absorbed) applied once daily (morning preferable), if needed may be ↑ to maximum of 10 g (contains 100 mg of testosterone; 10 mg systemically absorbed); Androgel 1.62%—40.5 mg of testosterone (2 pump actuations) applied once daily (morning preferable); dose may be adjusted down to a minimum of 20.25 mg or up to a maximum of 81 mg of testosterone, if needed (dose based on serum testosterone levels)Fortesta—40 mg of testosterone (4 pump actuations) applied once daily (morning preferable); dose may be adjusted down to a minimum of 10 mg or up to a maximum of 70 mg of testosterone, if needed (dose based on serum testosterone levels); Vogelxo—50 mg of testosterone (1 tube, 1 packet, or 4 pump actuations) applied once daily; dose may be adjusted up to a maximum of 100 mg of testosterone, if needed (dose based on serum testosterone levels).
(Adults ): 1 actuation (5.5 mg) in each nostril 3 times daily.

Availability ⬆ ⬇

(Generic available)

1% topical gel (Androgel): 25 mg/packet; 50 mg/packet
1% topical gel (Testim): 50 mg/unit–dose tube
1% topical gel (Vogelxo): 50 mg/unit–dose tube; 50 mg/packet; 12.5 mg/actuation in 75–g metered dose pump (each pump dispenses 60 metered doses)
1.62% topical gel (Androgel): 20.25 mg/packet; 40.5 mg/packet; 20.25 mg/actuation in 88–g metered dose pump (each pump dispenses 60 metered doses)
2% topical gel (Fortesta): 10 mg/actuation in 60–g metered dose pump (each pump dispenses 120 metered doses)
Nasal gel (Natesto): 5.5 mg/actuation in 11–g metered dose pump (each pump delivers 60 metered doses)

Assessment ⬆ ⬇

Monitor intake and output ratios, weigh patient twice weekly, and assess patient for edema. Report significant changes indicative of fluid retention.
Monitor for breast enlargement, persistent erections, and increased urge to urinate in men. Monitor for difficulty urinating in elderly men, because prostate enlargement may occur.
Assess for abuse using higher doses than prescribed and usually in conjunction with other anabolic androgenic steroids. May result in heart attack, heart failure, stroke, depression, hostility, aggression, liver toxicity, and infertility. Measure serum testosterone if abuse is suspected.

Lab Test Considerations:

Transdermal gel:Prior to therapy, confirm diagnosis of hypogonadism by measuring serum testosterone in the morning on at least two separate days and these serum testosterone concentrations are below the normal range (300 to 1050 ng/dL). Measure morning, predose serum testosterone concentrations 14 days after starting therapy to ensure proper serum testosterone concentrations are achieved. If concentrations are below normal, dose may be increased. Discontinue therapy is concentrations are consistently outside of normal range.
- Monitor hemoglobin and hematocrit periodically during therapy; may cause polycythemia.
- Monitor hepatic function tests, prostate specific antigen, and serum cholesterol levels periodically during therapy. May ↑ serum AST, ALT, and bilirubin, ↑ cholesterol levels, and suppress clotting factors II, V, VII, and X.
- Monitor blood glucose closely in patients with diabetes who are receiving oral hypoglycemic agents or insulin.
- Monitor serum testosterone concentrations 14 days after starting therapy.
- Nasal gel:Monitor serum testosterone concentrations after 1 mo and periodically during therapy. If total testosterone concentrations consistently exceed 1050 ng/dL, discontinue therapy. If total testosterone concentrations are consistently below 300 ng/dL, consider alternative therapy.

Implementation ⬆ ⬇

Gel: Apply gel once daily, preferably in the morning, to clean dry intact skin of shoulders and upper arms (Androgel, Testim,and Vogelxo) or abdomen (Androgel only) or front or inner thighs (Fortesta). Gel should not be applied to scrotum (5–30x more permeable than other sites). Refer to the chart on the pump label to determine how many full pump depressions are required for the daily prescribed dose.
- The dose of Fortesta should be titrated based on the serum testosterone concentration from a single blood draw 2 hours after applying Fortesta and at approximately 14 days and 35 days after starting treatment or following dose adjustment.
Prime pump by inverting, depressing pump 10 times, and discarding any amount dispensed directly into a sink and washing gel away thoroughly with warm water. Wipe tip with a clean, dry tissue. If gel gets on hands, wash hands with warm water and soap. Priming should be done only prior to first use of each dispenser. Blow nose. Place right index finger on pump of actuator and while in front of a mirror, slowly advance tip of actuator into left nostril upwards until 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. Remove the actuator from the nose while wiping the tip along the inside of the lateral nostril wall to fully transfer the gel. Repeat with right nostril. Press on the nostrils at a point just below bridge of the nose and lightly massage. Refrain from blowing nose or sniffing for 1 hour after administration.

Patient/Family Teaching ⬆ ⬇

Advise patient to report the following signs and symptoms promptly: priapism (sustained and often painful erections), difficulty urinating, breathing problems, gynecomastia, edema (unexpected weight gain, swelling of feet), hepatitis (yellowing of skin or eyes and abdominal pain), or unusual bleeding or bruising.
Instruct patient to use testosterone as directed. Do not use higher than prescribed doses. Explain rationale for prohibiting use of testosterone for increasing athletic performance. Testosterone is neither safe nor effective for this use and has a potential risk of serious side effects.
Advise patient to notify health care professional if their female sexual partner develops signs/symptoms of virilization (e.g. change in body hair distribution, significant increase in acne, deepening of voice, menstrual irregularities).
Advise diabetic patients to monitor blood closely for alterations in blood glucose concentrations.
Emphasize the importance of regular follow-up physical exams and lab tests to monitor progress.
Gel:Instruct patient to apply gel to clean, dry, intact skin. Gel should not be applied to the genital area.
- Advise patient to avoid showering or swimming for at least 5–6 hr (2 hr Vogelxo) after applying the gel.
- Instruct patient using Androgel or Vogelxo multi-dose pump or Fortesta to prime pump before using it for first time by completely depressing the pump three times (Androgel or Vogelxo) or 8 times (Fortesta) and then discarding the dispensed gel. Each depression of the multi-dose pump delivers 1.25 g of product.
- Advise patient to wash their hands immediately after applying the gel. Instruct patient to wear clothing over the application site once the gel has dried to minimize the transfer of testosterone to other people, especially children. If somebody else's skin comes into contact with gel, advise them to wash the affected skin surface thoroughly with soap and water.
- Advise patient to avoid fire, flame, or smoking until gel has dried since gel contains alcohol and is flammable.
Advise patient to notify health care professional if nasal signs or symptoms (nasopharyngitis, rhinorrhea, epistaxis, nasal discomfort, nasal scabbing) occur.

Evaluation/Desired Outcomes ⬆ ⬇

Resolution of the signs of androgen deficiency without side effects.

US Brand Names ⬆ ⬇

Androgel, Fortesta, Natesto, Testim, Vogelxo

Contr. Subst. Schedule ⬆ ⬇

Schedule III (C-III)

Pot. Nursing Diagnoses ⬆ ⬇

Sexual dysfunction(Indications)(Side Effects)

Code ⬆

NDC Code

0051- AbbVie Inc.
- 0051-8425- Androgel
  - 0051-8425-30- 30 PACKET in 1 CARTON (0051-8425-30) > 2.5 g in 1 PACKET (0051-8425-01)

0051- AbbVie Inc.
- 0051-8450- Androgel
  - 0051-8450-30- 30 PACKET in 1 CARTON (0051-8450-30) > 5 g in 1 PACKET (0051-8450-01)

0051- AbbVie Inc.
- 0051-8462- Androgel
  - 0051-8462-30- 30 PACKET in 1 CARTON (0051-8462-30) > 2.5 g in 1 PACKET (0051-8462-01)

0051- AbbVie Inc.
- 0051-8462- Androgel
  - 0051-8462-31- 30 PACKET in 1 CARTON (0051-8462-31) > 1.25 g in 1 PACKET (0051-8462-12)

0051- AbbVie Inc.
- 0051-8462- Androgel
  - 0051-8462-33- 1 BOTTLE, PUMP in 1 CARTON (0051-8462-33) > 88 g in 1 BOTTLE, PUMP

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇