testosterone enanthate

(redirected from Apo-Tetra)

testosterone enanthate

Delatestryl, PMS-Testosterone EnthanateApo-Tetra, Novotetra, Nu-Tetra, Topicycline

Pharmacologic class: Hormone

Therapeutic class: Androgenic and anabolic steroid, antineoplastic

Controlled substance schedule III

Pregnancy risk category X

Pharmacologic class: Tetracycline

Therapeutic class: Anti-infective

Pregnancy risk category B (topical form), D (oral form)

Pregnancy risk category B (topical form), D (oral form)

FDA Box Warning

Virilization has occurred in children secondarily exposed to testosterone gel.

Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel.

Health care providers should advise patients to strictly adhere to recommended instructions for use.

Action

Responsible for normal growth and development of male sex organs and maintenance and maturation of secondary sex characteristics. Also decreases estrogen activity, which aids treatment of some breast cancers.

Availability

testosterone

Buccal system: 30 mg

Gel: 1% (25 mg, 50 mg), 1.62% (metered-dose pump delivers 20.25 mg/actuation), 2% (10 mg/one metered-dose pump actuation)

Injection (aqueous suspension): 100 mg/ml

Pellets (subcutaneous implant): 75 mg

Solution (topical): 30 mg/metered-dose pump actuation

Transdermal system: 2 mg/day, 4 mg/day

testosterone cypionate

Injection: 100 mg/ml, 200 mg/ml

testosterone enanthate

Injection (in oil): 200 mg/ml

Indications and dosages

Male hypogonadism

Adult males: 10 to 25 mg (testosterone) I.M. two to three times weekly or 50 to 400 mg (enanthate) I.M. q 2 to 4 weeks for 3 to 4 years. Or 150 to 450 mg (pellet) implanted subcutaneously q 3 to 6 months. Or, 4 mg (transdermal system) daily, adjusted to 2 mg or 6 mg based on serum testosterone level. Or, 60 mg (one 30-mg actuation of Axiron topical solution applied to each axilla) daily at same time each morning, adjusted to 30 mg (one pump actuation) or increased from 60 to 90 mg (three pump actuations) or from 90 to 120 mg (four pump actuations) based on serum testosterone concentration from single blood draw 2 to 8 hours after applying solution and at least 14 days after starting treatment or following dosage adjustment. Or, 40 mg (four actuations of Fortesta topical gel) applied to clean, intact skin of thighs once daily in morning, adjusted to 10 mg (one pump actuation) or up to 70 mg (seven pump actuations) based on total serum testosterone level 2 hours after applying gel at approximately 14 days after starting treatment or following dosage adjustment. Or, 50 mg testosterone gel (AndroGel 1%) daily applied topically, adjusted up to 75 mg daily within 14 days, with subsequent dosages up to 100 mg daily. Or, 30 mg (buccal system) to gum region b.i.d. Or, 50 to 400 mg I.M. (cypionate) q 2 to 4 weeks.

Delayed puberty

Adult males: 50 to 200 mg I.M. (enanthate only) q 2 to 4 weeks for limited duration (4 to 6 months); or 150 to 450 mg subcutaneously (pellets) q 3 to 6 months

Inoperable breast cancer in women 1 to 5 years after menopause

Adults: 200 to 400 mg I.M. (enanthate) q 2 to 4 weeks

Contraindications

• Hypersensitivity to drug, its components, or tartrazine
• Males with breast cancer or suspected prostate cancer
• Females (buccal or transdermal systems or gel)
• Pregnancy or breastfeeding

Precautions

Use cautiously in:
• diabetes mellitus; edema associated with serious cardiac, hepatic, or renal disease; sleep apnea; hypercalcemia
• children younger than age 18 (safety and efficacy not established).

Administration

• Evaluate elderly patients and patients at increased risk for prostate cancer for presence of prostate cancer before starting testosterone replacement therapy.
• Inspect aqueous solution for injection. If crystals are visible, warm bottle and shake contents to dissolve crystals.
• Rotate I.M. injection sites within upper outer quadrant of gluteus maximus. Inject deeply into muscle.
• Apply gel once daily to clean, dry, intact skin on shoulder, upper arm, or abdomen.
• Place buccal system just above incisor tooth. Have patient hold it in place for 30 seconds to ensure adhesion. Rotate to other side of mouth with each application.

Adverse reactions

CNS: headache, depression, emotional lability, nervousness, anxiety, asthenia, memory loss, dizziness, vertigo, cerebrovascular accident

CV: edema, peripheral edema, deepvein phlebitis, heart failure

GI: bleeding

GU: hematuria, urinary tract infection, impaired urination, scrotal cellulitis, benign prostatic hyperplasia, scrotal papilloma (with transdermal use), prostatitis, libido changes, breast pain or tenderness, gynecomastia, virilization in females, excessive hormonal effects in males

Hematologic: polycythemia, leukopenia, suppressed clotting factors

Hepatic: hepatic adenoma (with long-term enanthate use)

Metabolic: hyperphosphatemia, hypernatremia, hypercalcemia, hypoglycemia, hyperkalemia

Musculoskeletal: myalgia

Respiratory: sleep apnea

Skin: acne; rash, itching, burning, discomfort, irritation, burn-like blister, erythema (with transdermal use); pain, local edema, and induration at injection site (with I.M. or subcutaneous use)

Other: accidental injury, flulike symptoms, hypersensitivity reaction

Interactions

Drug-drug. Corticosteroids: increased risk of edema

Hepatotoxic drugs: increased risk of hepatotoxicity

Insulin, oral hypoglycemics: decreased blood glucose level

Oral anticoagulants: increased anticoagulant effect

Oxyphenbutazone: increased oxyphenbutazone blood level

Propranolol: increased propranolol clearance

Drug-diagnostic tests. Bilirubin, liver function tests: abnormal results

Calcium, cholesterol, hematocrit, hemoglobin, phosphate, prostate-specific antigen (with topical use), sodium: increased levels

Clotting factors, creatine excretion, glucose, serum creatinine, thyroxine, thyroxine-binding globulin: decreased levels

Urine creatine and creatinine: decreased excretion

Urine 17-ketosteroids: increased excretion

Drug-herbs. Chaparral, comfrey, germander, jin bu huan, kava, pennyroyal: increased risk of hepatotoxicity

Patient monitoring

• Monitor electrolyte levels, liver function tests, blood and urine calcium levels, lipid panels, CBC with white cell differential, and semen studies.
• Assess diabetic patient carefully for hypoglycemia.
• Closely monitor neurologic status. Stay alert for sleep apnea.
• Assess for early signs of excessive hormonal effects in females (virilization). If these occur, drug withdrawal may be indicated.

Patient teaching

Instruct patient to immediately report signs and symptoms of liver problems, including nausea, vomiting, yellowing of skin or eyes, and ankle swelling.
• Teach prepubertal male about signs and symptoms of excessive hormonal effects, such as acne, priapism, increased body and facial hair, and penile enlargement.
• Teach postpubertal male about signs and symptoms of excessive adverse hormonal effects, such as erectile dysfunction, gynecomastia, epididymitis, testicular atrophy, and infertility.

Tell female patient to immediately report signs of masculinization, such as excessive body or facial hair, deepening of voice, clitoral enlargement, and menstrual irregularities.
• Advise female of childbearing age to use barrier contraceptives. Caution her not to breastfeed.
• Tell patient which transdermal patches can be applied to scrotum. Instruct him to apply patch daily to clean, dry skin after removing protective liner to expose drug-containing film. To prevent irritation, instruct him to apply each patch to a different site, waiting at least 1 week before reusing same site.
• Advise patient to apply topical gel once daily to clean, dry skin on shoulder, upper arm, or abdomen. Tell him that after opening packet, he should squeeze entire contents into palm and apply immediately. Instruct him to wait until gel dries before getting dressed.
• Teach patient to place buccal system in comfortable position just above incisor tooth and hold it in place for about 30 seconds to ensure adhesion. Tell him to use opposite side of mouth with each application. Caution him not to dislodge buccal system, especially when eating, drinking, brushing teeth, or using mouthwash. If system doesn't properly adhere or falls out during 12hour dosing interval, tell him to discard it and apply new system. If it falls out within 4 hours of next dose, tell him to apply new system and keep it in place until next regularly scheduled dose.
• Instruct patient to apply topical solution to clean, dry, intact skin of axilla area only and to allow application site to dry completely before dressing. Advise patient to wash axilla with soap and water to remove any testosterone residue if direct skin-to-skin contact with another person is anticipated.
• Tell patient drug shouldn't be used to enhance athletic performance or physique.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and herbs mentioned above.


tetracycline hydrochloride

Apo-Tetra, Novotetra, Nu-Tetra, Topicycline


Pharmacologic class: Tetracycline

Therapeutic class: Anti-infective

Pregnancy risk category B (topical form), D (oral form)

 

Action

Unknown. Thought to inhibit bacterial protein synthesis at level of 30S and 50S bacterial ribosomes and to alter cytoplasmic membrane of susceptible organisms.

Availability

Capsules: 250 mg, 500 mg

Indications and dosages

Mild to moderate infections caused by susceptible organisms

Adults: 500 mg P.O. b.i.d. or 250 mg P.O. q.i.d.

Severe infections caused by susceptible organisms

Adults: 500 mg P.O. q.i.d.

Children older than age 8: 25 to 50 mg/kg P.O. q.i.d.

Syphilis in penicillin-allergic patients

Adults: 500 mg P.O. q.i.d. for 14 days

Late syphilis (except neurosyphilis)

Adults: 500 mg P.O. q.i.d. for 28 days

Leptospirosis when penicillin is contraindicated or ineffective

Adults: 1 to 2 g P.O. daily in two to four divided doses for 5 to 7 days

Yaws

Adults: 1 to 2 g P.O. daily in two to four divided doses for 10 to 14 days

Gonorrhea in penicillin-allergic patients

Adults: Initially, 1.5 g P.O., followed by 500 mg P.O. q 6 hours for 4 days, up to a total of 9 g

Uncomplicated urethral, endocervical, or rectal infections caused by

Chlamydia trachomatis

Adults: 500 mg P.O. q.i.d. for 7 days

Rickettsial and mycoplasmal infections

Adults: 1 to 2 g P.O. daily in two to four divided doses for 7 days

Helicobacter pylori infection

Adults: In patients with active duodenal ulcer, 500 mg P.O. q.i.d. at meals and bedtime for 14 days, given with other drugs (such as metronidazole, bismuth subsalicylate, amoxicillin, or omeprazole)

Brucellosis

Adults: 500 mg P.O. q.i.d. for 3 weeks, given with streptomycin I.M. b.i.d. during week 1 and streptomycin once daily during week 2

Granuloma inguinale; chancroid

Adults: 1 to 2 g P.O. daily in two to four divided doses for 2 to 4 weeks

Cholera

Adults: 500 mg P.O. q 6 hours for 48 to 72 hours

Plague when streptomycin is contraindicated or ineffective

Adults: 2 to 4 g P.O. q.i.d. for 10 days

Children older than age 8: 30 to 40 mg/kg P.O. q.i.d. for 10 to 14 days

Tularemia as an alternative to streptomycin

Adults: 1 to 2 g P.O. daily in two to four divided doses for 1 to 2 weeks

Campylobacter infection

Adults: 1 to 2 g P.O. daily in two to four divided doses for 10 days

Relapsing fever caused by Borrelia recurrentis

Adults: 1 to 2 g P.O. daily in two to four divided doses for 7 days or until patient is afebrile

Adjunctive treatment of inflammatory acne

Adults and adolescents: 500 mg to 1 g P.O. q.i.d. for 1 to 2 weeks, decreased gradually to 125 to 500 mg P.O. daily

Dosage adjustment

• Renal impairment

Off-label uses

• Rosacea
• Anthrax
• Arthritis
• Lyme disease
• Sclerosing agent to control pleural effusions

Contraindications

• Hypersensitivity to drug, other tetracyclines, bisulfites, or alcohol (in some products)

Precautions

Use cautiously in:
• renal disease, hepatic impairment, nephrogenic diabetes insipidus
• cachectic or debilitated patients
• pregnant or breastfeeding patients (except in anthrax treatment)
• children younger than age 8 (except in anthrax treatment).

Administration

• Give with 8 oz of water at least 1 hour before or 2 hours after a meal (especially if it includes milk or other dairy products), antacids, laxatives, or antidiarrheal drugs.

Adverse reactions

CNS: paresthesia, benign intracranial hypertension

CV: pericarditis

EENT: abnormal conjunctival pigmentation, hoarseness, pharyngitis

GI: nausea, vomiting, diarrhea, loose bulky stools, esophageal ulcers, epigastric distress, enterocolitis, oral and anogenital candidiasis, stomatitis, black hairy tongue, glossitis, anorexia, pancreatitis

GU: dark yellow or brown urine, vaginal candidiasis, anogenital lesions

Hematologic: eosinophilia, hemolytic anemia, neutropenia, thrombocytopenia, thrombocytopenia purpura

Hepatic: fatty liver

Musculoskeletal: retarded bone growth, polyarthralgia

Respiratory: pulmonary infiltrates

Skin: photosensitivity, maculopapular or erythematous rash, increased pigmentation, urticaria, onycholysis

Other: permanent tooth discoloration (in children younger than age 8), tooth enamel defects, superinfection, hypersensitivity reactions including anaphylaxis, serum sickness-like reaction, exacerbation of systemic lupus erythematosus

Interactions

Drug-drug. Adsorbent antidiarrheals, antacids, calcium, cholestyramine, cimetidine, colestipol, iron, magnesium, sodium bicarbonate: decreased tetracycline absorption

Digoxin: increased digoxin blood level, greater risk of toxicity

Hormonal contraceptives: decreased contraceptive efficacy

Insulin: reduced insulin requirement

Lithium: increased or decreased lithium blood level

Methoxyflurane: increased risk of nephrotoxicity

Penicillin: decreased penicillin activity

Sucralfate: prevention of tetracycline absorption from GI tract

Warfarin: enhanced warfarin effects

Drug-diagnostic tests. Alanine aminotransferase, alkaline phosphatase, amylase, aspartate aminotransferase, bilirubin, blood urea nitrogen: increased levels

Hemoglobin, neutrophils, platelets, white blood cells: decreased levels

Urinary catecholamines: false elevation

Drug-food. Dairy products, foods containing calcium: decreased drug absorption

Drug-behaviors. Alcohol use: decreased drug efficacy

Sun exposure: increased risk of photosensitivity

Patient monitoring

• Monitor for signs and symptoms of superinfection and hypersensitivity reaction.
• With long-term use, monitor CBC, liver function tests, and (in prepubertal patients) bone growth.
• Assess neurologic status. Stay alert for benign intracranial hypertension (especially in children).

Patient teaching

• Tell patient to take oral form with 8 oz of water at least 1 hour before or 2 hours after eating a meal, consuming dairy products, or taking antacids, laxatives, or antidiarrheal drugs. Advise him to take last daily dose at least 1 hour before bedtime.
• Stress importance of completing entire course of therapy as ordered, even after symptoms improve.

Caution patient not to use outdated tetracycline, because it may cause serious kidney disease.
• Teach patient to recognize and report signs and symptoms of yeast infection and other infections.
• With long-term therapy, tell patient he'll undergo regular blood testing. Advise parents that prepubertal child should have periodic bone X-rays.
• Caution patient to avoid alcohol during therapy.
• Tell parents that tetracycline use during tooth development period (last half of pregnancy, infancy, and childhood to age 8) may cause permanent yellow, gray, or brownish tooth discoloration.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, foods, and behaviors mentioned above.

testosterone enanthate

(tess-toss-te-rone en-an-thate) ,

Delatestryl

(trade name)

Classification

Therapeutic: hormones
Pharmacologic: androgens
Pregnancy Category: X

Indications

Hypogonadism in androgen-deficient men.Delayed puberty in men.Androgen-responsive breast cancer in postmenopausal women (palliative).

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:
  • Initiation of male puberty.
Suppression of tumor growth in some forms of breast cancer.

Pharmacokinetics

Absorption: Well absorbed from IM sites; absorbed slowly.
Distribution: Crosses the placenta.
Protein Binding: 98%.
Metabolism and Excretion: Metabolized by the liver; 90% eliminated in urine as metabolites.
Half-life: 10–100 min.

Time/action profile (androgenic effects†)

ROUTEONSETPEAKDURATION
IMunknownunknown2–4 wk
†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.
Use Cautiously in: Hypercalcemia; Coronary artery disease; Pre-existing cardiac, renal, or liver disease; Geriatric patients (↑ risk of prostatic hyperplasia/carcinoma); Prepubertal males.

Adverse Reactions/Side Effects

Ear, Eye, Nose, Throat

  • deepening of voice (most frequent)

Cardiovascular

  • edema (most frequent)

Gastrointestinal

  • cholestatic jaundice
  • drug-induced hepatitis
  • liver function test elevation
  • nausea
  • vomiting

Genitourinary

    women-:
  • change in libido (most frequent)
  • clitoral enlargement (most frequent)
  • menstrual irregularities
  • men-:
  • erectile dysfunction (most frequent)
  • priapism (most frequent)
  • prostatic enlargement

Endocrinologic

  • hypercholesterolemia
  • women-:
  • hirsutism (most frequent)
  • men-:
  • gynecomastia (most frequent)
  • oligospermia (most frequent)

Fluid and Electrolyte

  • hypercalcemia
  • hyperkalemia
  • hyperphosphatemia

Dermatologic

  • male pattern baldness

Local

  • pain at injection site

Interactions

Drug-Drug interaction

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

Route/Dosage

Male Hypogonadism (replacement therapy)
Intramuscular (Adults) 50–400 mg every 2–4 wk.
Delayed Male Puberty
Intramuscular (Children) 50–200 mg every 2–4 wk for up to 6 mo.
Palliative Management of Breast Cancer (in postmenopausal women)
Intramuscular (Adults) 200–400 mg every 2–4 wk.

Availability (generic available)

Injection (in oil): 200 mg/mL in 5-mL vials and 1-mL prefilled syringes

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.
  • 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.
  • Women: Assess for virilism (deepening of voice, unusual hair growth, clitoral enlargement, acne, menstrual irregularities).
    • In women with metastatic breast cancer, monitor for symptoms of hypercalcemia (nausea, vomiting, constipation, lethargy, loss of muscle tone, thirst, polyuria).
  • Lab Test Considerations: 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 serum and urine calcium levels and serum alkaline phosphatase concentrations in women with metastatic breast cancer.
    • 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 ↑).

Potential Nursing Diagnoses

Sexual dysfunction (Indications,  Side Effects)

Implementation

  • Range-of-motion exercises should be done with all bedridden patients to prevent mobilization of calcium from the bone.
  • Intramuscular: Administer IM deep into gluteal muscle. Crystals may form when vials are stored at low temperatures; warming and rotating the vial between the palms of hands will redissolve crystals. Use of a wet syringe or needle may cause solution to become cloudy but will not affect its potency.

Patient/Family Teaching

  • Advise patient to report the following signs and symptoms promptly: in male patients, priapism (sustained and often painful erections), difficulty urinating, or gynecomastia; in female patients, virilism (which may be reversible if medication is stopped as soon as changes are noticed), or hypercalcemia (nausea, vomiting, constipation, and weakness); in male or female patients, 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.
    • Instruct females to notify health care professional immediately if pregnancy is planned or suspected.
    • 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.
  • Decrease in the size and spread of breast malignancy in postmenopausal women. In antineoplastic therapy, response may require 3 mo of therapy; if signs of disease progression appear, therapy should be discontinued.

testosterone enanthate

a long-acting form of testosterone.
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