medroxyprogesterone

(redirected from Depo-Sub Q Provera 104)
Also found in: Dictionary, Thesaurus, Wikipedia.

medroxyprogesterone

 [med-rok″sĭ-pro-jes´tĕ-rōn]
a progestational agent administered orally as the acetate ester for treatment of secondary amenorrhea and dysfunctional uterine bleeding, in the induction of menses, in the prevention and treatment of endometrial hyperplasia, in postmenopause hormone replacement therapy, and as a test for endogenous estrogen production; orally or intramuscularly as an antineoplastic in the treatment of metastatic endometrial, breast, and renal carcinoma, and intramuscularly as a long-acting contraceptive.

medroxyPROGESTERone†

(me-drox-ee-proe-jess-te-rone) ,

Depo-Provera

(trade name),

Depo-Sub Q Provera 104

(trade name),

Medroxy

(trade name),

Provera

(trade name)

Classification

Therapeutic: antineoplastics
Pharmacologic: hormones
Pregnancy Category: X
†For contraceptive use see Contraceptives, Hormonal monograph

Indications

To decrease endometrial hyperplasia in postmenopausal women receiving concurrent estrogen (0.625 mg/day conjugated estrogens).Treatment of secondary amenorrhea and abnormal uterine bleeding caused by hormonal imbalance. Intramuscular: Treatment of advanced unresponsive endometrial or renal carcinoma.†Prevention of pregnancy.Management of endometriosis-associated pain (Depo-Sub Q Provera 104 only).Obesity-hypoventilation (pickwickian) syndrome.Sleep apnea.Hypersomnolence.

Action

A synthetic form of progesterone—actions include secretory changes in the endometrium, increases in basal body temperature, histologic changes in vaginal epithelium, relaxation of uterine smooth muscle, mammary alveolar tissue growth, pituitary inhibition, and withdrawal bleeding in the presence of estrogen.

Therapeutic effects

Decreased endometrial hyperplasia in postmenopausal women receiving concurrent estrogen (combination with estrogen decreases vasomotor symptoms and prevents osteoporosis).
Restoration of hormonal balance with control of uterine bleeding.
Management of endometrial or renal cancer.
Prevention of pregnancy.

Pharmacokinetics

Absorption: 0.6–10% absorbed after oral administration.
Distribution: Enters breast milk.
Metabolism and Excretion: Metabolized by the liver.
Half-life: 1st phase—52 min; 2nd phase—230 min; biological—14.5 hr.

Time/action profile (IM = antineoplastic effects)

ROUTEONSETPEAKDURATION
POunknownunknownunknown
IMwk–mosmounknown†
SCunknown1 wk3 mo
†Contraceptive effect lasts 3 mo

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Hypersensitivity to parabens (IM suspension only);Missed abortion;Thromboembolic disease;Cerebrovascular disease;Severe liver disease;Breast or genital cancer;Porphyria; Obstetric: May ↑ risk of fetal genitourinary malformation.
Use Cautiously in: History of liver disease;Renal disease;Cardiovascular disease;Seizure disorders;Mental depression; Lactation: If used as a contraceptive, wait 6 wk after delivery if breast feeding.

Adverse Reactions/Side Effects

Central nervous system

  • depression

Ear, Eye, Nose, Throat

  • retinal thrombosis

Cardiovascular

  • pulmonary embolism (life-threatening)
  • thromboembolism
  • thrombophlebitis

Gastrointestinal

  • drug-induced hepatitis
  • gingival bleeding

Genitourinary

  • cervical erosions

Dermatologic

  • chloasma
  • melasma
  • rashes

Endocrinologic

  • amenorrhea
  • breakthrough bleeding
  • breast tenderness
  • changes in menstrual flow
  • galactorrhea
  • hyperglycemia
  • spotting

Fluid and Electrolyte

  • edema

Metabolic

  • bone loss

Miscellaneous

  • allergic reactions including anaphylaxis and angioedema (life-threatening)
  • weight gain
  • weight loss

Interactions

Drug-Drug interaction

May ↓ effectiveness of bromocriptine when used concurrently for galactorrhea/amenorrhea.Contraceptive effectiveness may be ↓ by carbamazepine, phenobarbital, phenytoin, rifampin, or rifabutin.

Route/Dosage

Postmenopausal Women Receiving Concurrent Estrogen

Oral (Adults) 2.5–5 mg daily concurrently with 0.625 mg conjugated estrogens (monophasic regimen) or 5 mg daily on days 15–28 of the cycle with 0.625 mg conjugated estrogens taken daily throughout cycle (biphasic regimen).

Secondary Amenorrhea

Oral (Adults) 5–10 mg/day for 5–10 days; start at any time in cycle.

Dysfunctional Uterine Bleeding/Induction of Menses

Oral (Adults) 5–10 mg/day for 5–10 days, starting on day 16 or day 21 of menstrual cycle.

Renal or Endometrial Carcinoma

Intramuscular (Adults) 400–1000 mg, may be repeated weekly; if improvement occurs, attempt to decrease dose to 400 mg monthly.

Endometriosis-Associated Pain

Subcutaneous (Adults) 104 mg every 12–14 wk (3 mo), beginning on day 5 of normal menses (not recommended for more than 2 yr).

Availability (generic available)

Tablets: 2.5 mg, 5 mg, 10 mg, 100 mg
Suspension for depot injection: 50 mg/mL, 150 mg/mL, 400 mg/mL
Suspension for subcutaneous injection (Depo-Sub Q Provera 104): 104 mg/0.65 mL in single-use syringes
In combination with: conjugated estrogens as Prempro (single combination tablet of 0.626 mg conjugated estrogens plus 2.5 or 5 mg medroxyprogesterone) or Premphase (0.625 mg conjugated estrogens tablet for 14 days followed by combination tablet of 0.625 mg conjugated estrogens plus 5 mg medroxyprogesterone for days 15–28) in convenience packages. See combination drugs.

Nursing implications

Nursing assessment

  • Monitor BP periodically during therapy.
    • Assess patient’s usual menstrual history. Administration of drug may begin on any day of cycle in patients with amenorrhea and on day 16 or 21 of cycle in patients with dysfunctional bleeding.
    • Monitor intake and output ratios and weekly weight. Report significant discrepancies or steady weight gain.
  • Lab Test Considerations: Monitor hepatic function before and periodically during therapy.
    • May cause ↑ alkaline phosphatase levels. May ↓ pregnanediol excretion concentrations.
    • May cause ↑ serum LDL concentrations or ↓ HDL concentrations.
    • May alter thyroid hormone assays.

Potential Nursing Diagnoses

Sexual dysfunction (Indications)
Ineffective tissue perfusion (Side Effects)

Implementation

  • Do not confuse Depo-Provera with Depo-subQ Provera 104. Do not confuse Provera (medroxyprogesterone) with Proscar (finasteride) or Prozac (fluoxetine).
    • Only the 150 mg/mL vial should be used for contraception.
    • Injectable medroxyprogesterone may lead to bone loss, especially in women younger than 21 yr. Injectable medroxyprogesterone should be used for >2 yr only if other methods of contraception are inadequate. If used long term, women should use supplemental calcium and vitamin D, and monitor bone mineral density.
  • Subcutaneous: Shake vigorously before use to form a uniform suspension. Inject slowly (over 5–7 seconds) at a 45° angle into fatty area of anterior thigh or abdomen every 12 to 14 wk. If more than 14 wk elapse between injections, rule out pregnancy prior to administration. Do not rub area after injection.
    • When switching from other hormonal contraceptives, administer within dosing period (7 days after taking last active pill, removing patch or ring, or within the dosing period for IM injection).
  • Intramuscular: Shake vial vigorously before preparing IM dose. Administer deep IM into gluteal or deltoid muscle. If period between injections is >14 wk, determine that patient is not pregnant before administering the drug.
    • In patients with cancer, IM dose may initially be required weekly. Once stabilized, IM dose may be required only monthly.

Patient/Family Teaching

  • Explain the dose schedule. Instruct patient to take medication at the same time each day. Take missed doses as soon as remembered, but do not double doses.
    • Advise patients receiving medroxyprogesterone for menstrual dysfunction to anticipate withdrawal bleeding 3–7 days after discontinuing medication.
    • Review patient package insert (PPI) with patient. Emphasize the importance of notifying health care professional if the following side effects occur: visual changes, sudden weakness, incoordination, difficulty with speech, headache, leg or calf pain, shortness of breath, chest pain, changes in vaginal bleeding pattern, yellow skin, swelling of extremities, depression, or rash. Patients receiving medroxyprogesterone for cancer may not receive PPI.
    • Advise patient to keep a 1-mo supply of medroxyprogesterone available at all times.
    • Instruct patient in correct method of monthly breast self-examination. Increased breast tenderness may occur.
    • Advise patient that gingival bleeding may occur. Instruct patient to use good oral hygiene and to receive regular dental care and examinations.
    • Medroxyprogesterone may cause melasma (brown patches of discoloration) on face when patient is exposed to sunlight. Advise patient to avoid sun exposure and to wear sunscreen or protective clothing when outdoors.
    • Instruct patient to notify health care professional if menstrual period is missed or if pregnancy is suspected. Patient should not attempt conception for 3 mo after discontinuing medication in order to decrease risk to fetus.
    • Emphasize the importance of routine follow-up physical exams, including BP; breast, abdomen, and pelvic exams; and Papanicolaou smears every 6–12 mo.
  • Intramuscular: Subcutaneous: Advise patient to maintain adequate amounts of dietary calcium and vitamin D to help prevent bone loss.

Evaluation/Desired Outcomes

  • Regular menstrual periods.
  • Decrease in endometrial hyperplasia in postmenopausal women receiving concurrent estrogen.
  • Control of the spread of endometrial or renal cancer.
  • Prevention of pregnancy.

medroxyprogesterone

/med·roxy·pro·ges·ter·one/ (med-rok″se-pro-jes´ter-ōn) a progestin used as the acetate ester in treatment of menstrual disorders, in postmenopause hormone replacement therapy, as a test for endogenous estrogen production, as an antineoplastic in the treatment of metastatic endometrial, breast, and renal carcinoma, and as a long-acting contraceptive.

medroxyprogesterone

A PROGESTOGEN drug that can be taken by mouth and is used to treat excessive menstrual bleeding (MENORRHAGIA), the premenstrual syndrome, ENDOMETRIOSIS, infertility and oestrogen-dependent cancers. The drug is on the WHO official list. Brand names are Adgyn Medro, Climanor, Provera, Depo-Provera, Farlutal and Premique.

It is also available formulated as an adjunct to oestrogen for menopausal hormone replacement therapy under the brand names Improvera, Premique, Premique Cycle and Tridesta.