Ogen


Ogen

 [o´jen] trademark for preparations of estropipate, an estrone used in the treatment of estrogen deficiency.

estropipate

(ess-troe-pi-pate) estropipate,

Ogen

(trade name),

Ortho-Est

(trade name)

Classification

Therapeutic: hormones
Pharmacologic: estrogens
Pregnancy Category: X

Indications

Oral: As part of HRT in the treatment of vasomotor symptoms of menopause.Treatment of various estrogen deficiency states, including:
  • Female hypogonadism,
  • Ovariectomy,
  • Primary ovarian failure.
Adjunctive therapy of postmenopausal osteoporosis.Concurrent use of progestin is recommended during cyclical therapy to decrease the risk of endometrial carcinoma in patients with an intact uterus.

Action

Estrogens promote the growth and development of female sex organs and the maintenance of secondary sex characteristics in women.Metabolic effects include reduced blood cholesterol, protein synthesis, and sodium and water retention.

Therapeutic effects

Restoration of hormonal balance in various deficiency states.

Pharmacokinetics

Absorption: Well absorbed after oral administration.Distribution: Widely distributed. Crosses the placenta and enters breast milk.Metabolism and Excretion: Mostly metabolized by the liver and other tissues. Enterohepatic recirculation occurs, and more absorption may occur from the GI tract.Half-life: Unknown.

Time/action profile (estrogenic effects)

ROUTEONSETPEAKDURATION
POunknown unknown24 hr

Contraindications/Precautions

Contraindicated in: Thromboembolic disease; Undiagnosed vaginal bleeding; Obstetric: Known to cause fetal harm; Lactation: ↓ quantity and quality of breast milk.Use Cautiously in: Underlying cardiovascular disease; Severe hepatic or renal disease; May ↑ risk of endometrial carcinoma.

Adverse Reactions/Side Effects

(systemic use)

Central nervous system

  • headache (most frequent)
  • dizziness
  • lethargy
  • mental depression

Ear, Eye, Nose, Throat

  • intolerance to contact lenses (most frequent)
  • worsening of myopia or astigmatism

Cardiovascular

  • MI (life-threatening)
  • thromboembolism (life-threatening)
  • edema (most frequent)
  • hypertension (most frequent)

Gastrointestinal

  • nausea (most frequent)
  • weight changes (most frequent)
  • anorexia
  • ↑ appetite
  • jaundice
  • vomiting

Genitourinary

    women:
  • amenorrhea (most frequent)
  • breakthrough bleeding (most frequent)
  • dysmenorrhea (most frequent)
  • cervical erosion
  • loss of libido
  • vaginal candidiasis
  • men:
  • erectile dysfunction (most frequent)
  • testicular atrophy (most frequent)

Dermatologic

  • acne (most frequent)
  • oily skin (most frequent)
  • pigmentation
  • urticaria

Endocrinologic

  • gynecomastia (men) (most frequent)
  • hyperglycemia

Fluid and Electrolyte

  • hypercalcemia
  • sodium and water retention

Musculoskeletal

  • leg cramps

Miscellaneous

  • breast tenderness (most frequent)

Interactions

Drug-Drug interaction

May alter requirement for warfarin, oral hypoglycemic agents, or insulins.Barbiturates or rifampin may ↓ effectiveness.Smoking ↑ the risk of adverse cardiovascular reactions.

Route/Dosage

Vasomotor Symptoms of Menopause/Atrophic Vaginitis/Osteoporosis Oral (Adults) 0.75–6 mg daily or in a cycle.Female Hypogonadism/Ovarian FailureOral (Adults) 1.5–9 mg daily or in a cycle.

Availability (generic available)

Tablets: 0.75 mg, 1.5 mg, 3 mg, 6 mg

Nursing implications

Nursing assessment

  • Assess BP before and periodically throughout therapy.
    • Monitor intake and output ratios and weekly weight. Report significant discrepancies or steady weight gain.
  • Menopause: Assess frequency and severity of vasomotor symptoms.
  • Lab Test Considerations: May cause increased HDL, phospholipids, and triglycerides, and decreased serum LDL and total cholesterol concentrations.
    • May cause increased serum glucose, sodium, cortisol, prolactin, prothrombin, and factor VII, VIII, IX, and X levels. May decrease serum folate, pyridoxine, antithrombin III, and urine pregnanediol concentrations.
    • Monitor hepatic function before and periodically throughout therapy.
    • May cause false interpretations of thyroid function tests, false increases in norepinephrine platelet-induced aggregability, and false decreases in metyrapone tests.

Potential Nursing Diagnoses

Sexual dysfunction (Indications)

Implementation

  • Oral: Administer PO doses with or immediately after food to reduce nausea.
  • Vaginal: Manufacturer provides applicator with cream. Dose is marked on the applicator. Wash applicator with mild soap and warm water after each use.

Patient/Family Teaching

  • Instruct patient to take oral medication as directed. If a dose is missed, take as soon as remembered as long as it is not just before next dose. Do not double doses.
    • Explain medication schedule to women on 21-day cycle followed by 7 days of not taking medication. Encourage patient to take medication at the same time each day.
    • If nausea becomes a problem, advise patient that eating solid food often provides relief.
    • Advise patient to report signs and symptoms of fluid retention (swelling of ankles and feet, weight gain), thromboembolic disorders (pain, swelling, or tenderness in extremities; headache; chest pain; blurred vision), mental depression, hepatic dysfunction (yellowed skin or eyes, pruritus, dark urine, light-colored stools), or abnormal vaginal bleeding to health care professional.
    • Instruct patient to stop taking medication and notify health care professional if pregnancy is suspected.
    • Caution patient that cigarette smoking during estrogen therapy may increase risk of serious side effects, especially for women over age 35.
    • Caution patient to use sunscreen and protective clothing to prevent increased pigmentation.
    • Advise patient to notify health care professional of medication regimen before treatment or surgery.
    • Advise patient treated for osteoporosis that exercise has been found to arrest and reverse bone loss. The patient should discuss any exercise limitations with health care professional before beginning program.
    • Emphasize the importance of routine follow-up physical exams, including BP; breast, abdomen, and pelvic examinations; Papanicolaou smears every 6–12 mo; and mammogram every 12 mo or as directed. Health care professional will evaluate possibility of discontinuing medication every 3–6 mo. If on continuous (not cyclical) therapy or without concurrent progestins, endometrial biopsy may be recommended, if uterus is intact.
  • Vaginal: Instruct patient in the correct use of applicator. Patient should remain recumbent for at least 30 min after administration. May use sanitary napkin to protect clothing, but do not use tampon. If a dose is missed, do not use the missed dose, but return to regular dosing schedule.

Evaluation/Desired Outcomes

  • Resolution of menopausal vasomotor symptoms.
    • Decreased vaginal and vulvar itching, inflammation, or dryness associated with menopause.
  • Normalization of estrogen levels in patients with ovariectomy or hypogonadism.
  • Prevention of osteoporosis.

Ogen

(ō′jən) A trademark for a drug containing estropipate.