testosterone buccal system, mucoadhesive

testosterone buccal system, mucoadhesive

(tess-toss-te-rone buhk-uhl) testosteronebuccalsystem,

Striant

(trade name)

Classification

Therapeutic: hormones
Pharmacologic: androgens
Pregnancy Category: X

Indications

Hypogonadism in androgen-deficient men.

Action

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.

Pharmacokinetics

Absorption: Well absorbed through buccal mucosa.Distribution: Crosses the placenta.Protein Binding: 98%.Metabolism and Excretion: Metabolized by the liver. Absorption from buccal mucosa bypasses initial liver metabolism. 90% eliminated in urine as metabolites.Half-life: 10–100 min.

Time/action profile (androgenic effects†)

ROUTEONSETPEAKDURATION
Buccalunknown10–12 hr12 hr
†Response is highly variable among individuals; may take months

Contraindications/Precautions

Contraindicated in: Hypersensitivity; Obstetric: 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; Geriatric patients (↑ risk of prostatic hyperplasia/carcinoma); Males <18 yr (safety and effectiveness not established).

Adverse Reactions/Side Effects

Central nervous system

  • anxiety
  • fatigue
  • headache

Cardiovascular

  • edema

Gastrointestinal

  • abdominal cramps
  • bitter taste
  • gingivitis
  • gum edema
  • gum tenderness
  • liver function test elevation
  • nausea
  • taste perversion
  • vomiting

Genitourinary

  • priapism
  • prostatic enlargement

Endocrinologic

  • acne
  • gynecomastia
  • hypercholesterolemia

Interactions

Drug-Drug interaction

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

Route/Dosage

Buccal (Adults) Replacement therapy—30 mg (one system) applied to gum region twice daily (in morning and evening, spaced 12 hr apart).

Availability

Buccal system, mucoadhesive: 30 mg/system in blister packs of 10 systems/pack

Nursing implications

Nursing 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.
  • Lab Test Considerations: 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 4–12 wk after starting therapy.

Potential Nursing Diagnoses

Sexual dysfunction (Indications, Side Effects)

Implementation

  • Buccal: Apply to gum region twice daily (about 12 hr apart), rotating sides with each dose.

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.
    • 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 and lab tests to monitor progress.
  • Buccal: Instruct patient to place the rounded side surface of the buccal system in a comfortable position against the gum just above incisor tooth. Hold the system firmly in place with a finger over the lip and against the product for 30 seconds to ensure adhesion. Buccal system is designed to stay in position until removed. If it fails to adhere to the gum or falls off within the first 8 hr after application, remove original system and apply a new one (this counts as replacing the first dose; apply the next system ~12 hr after the original system was applied). If the buccal system falls off after 8 hr but before 12 hr, replace the original system (this replacement can serve as the second dose for that day).
    • Advise patient to avoid dislodging buccal system and to check on placement after toothbrushing, use of mouthwash, eating or drinking. Do not chew or swallow buccal system. To remove, slide system downwards from gum toward tooth to avoid scratching the gum.

Evaluation/Desired Outcomes

  • Resolution of the signs of androgen deficiency without side effects.