testosterone pellets

Responsible for the normal growth and development of male sex organs.
Maintenance of male secondary sex characteristics:
- Growth and maturation of the prostate, seminal vesicles, penis, scrotum,
- Development of male hair distribution,
- Vocal cord thickening,
- Alterations in body musculature and fat distribution.

Therapeutic effects:

Correction of hormone deficiency in male hypogonadism:
- Initiation of male puberty.

Pharmacokinetics ⬆ ⬇

Absorption: Pellets slowly release testosterone.

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
SC	unknown	unknown	3–6 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;
Geriatric patients (↑ risk of prostatic hyperplasia/carcinoma);
Benign prostatic hypertrophy;
Hypercalcemia;
Prepubertal males.

Adv. Reactions/Side Effects ⬆ ⬇

EENT: deepening of voice

CV: MI, STROKE, VENOUS THROMBOEMBOLISM, edema

GI: cholestatic jaundice, drug-induced hepatitis, liver function test elevation, nausea, vomiting

GU: change in libido, erectile dysfunction, priapism, prostatic enlargement

Endo: gynecomastia, hirsutism, oligospermia, hypercholesterolemia

F and E: hypercalcemia, hyperkalemia, hyperphosphatemia

Derm: male pattern baldness

Local: pain at implantation site

Interactions ⬆ ⬇

Drug-drug:

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

Route/Dosage ⬆ ⬇

Male Hypogonadism (replacement therapy)

Delayed Male Puberty

SC
(for subcutaneous implantation)
(Adults ): 150–450 mg every 3–6 mo.
SC
(for subcutaneous implantation)
(Children ): 150–450 mg every 3–6 mo for up to 6 mo.

Availability ⬆ ⬇

Assessment ⬆ ⬇

Monitor intake and output ratios, weigh patient twice weekly, and assess patient for edema. Report significant changes indicative of fluid retention.
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.
Men: Monitor for precocious puberty in boys (acne, darkening of skin, development of male secondary sex characteristics—increase in penis size, frequent erections, growth of body hair). Bone age determinations should be measured every 6 mo to determine rate of bone maturation and effects on epiphyseal closure.
- 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.

Lab Test Considerations:

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). Monitor serum testosterone concentrations 4–12 wk after starting therapy. Discontinue therapy is concentrations are consistently outside of normal range.
- Monitor hemoglobin and hematocrit periodically during therapy; may cause polycythemia.
- Monitor hepatic function tests 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 sodium, chloride, potassium, and phosphate concentrations (may be ↑).

Implementation ⬆ ⬇

Range-of-motion exercises should be done with all bedridden patients to prevent mobilization of calcium from the bone.
Pellets are to be implanted subcutaneously by a health care professional.

Patient/Family Teaching ⬆ ⬇

Advise patient to report the following signs and symptoms promptly: priapism (sustained and often painful erections), difficulty urinating, 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 diabetic patients to monitor blood closely for alterations in blood glucose concentrations.
- Emphasize the importance of regular follow-up physical exams, lab tests, and x-ray exams to monitor progress.
- Radiologic bone age determinations should be evaluated every 6 mo in prepubertal children to determine rate of bone maturation and effects on epiphyseal centers.

Evaluation/Desired Outcomes ⬆ ⬇

Resolution of the signs of androgen deficiency without side effects. Therapy is usually limited to 3–6 mo followed by bone growth or maturation determinations.

US Brand Names ⬆ ⬇

Contr. Subst. Schedule ⬆ ⬇

Schedule III (C-III)

Pot. Nursing Diagnoses ⬆ ⬇

Sexual dysfunction(Indications)(Side Effects)

Code ⬆

NDC Code

66887- Endo Pharmaceuticals Inc.
- 66887-004- Testopel
  - 66887-004-10- 10 AMPULE in 1 BOX (66887-004-10) > 1 PELLET in 1 AMPULE (66887-004-01)

66887- Endo Pharmaceuticals Inc.
- 66887-004- Testopel
  - 66887-004-20- 100 AMPULE in 1 BOX (66887-004-20) > 1 PELLET in 1 AMPULE (66887-004-01)

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇