Serophene


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Related to Serophene: Clomid

clomiphene citrate (clomifene (UK))

Clomid, Serophene

Pharmacologic class: Chlorotrianisene derivative

Therapeutic class: Fertility drug, ovulation stimulant

Pregnancy risk category X

Action

Binds with estrogen receptors in cytoplasm, increasing secretion of folliclestimulating hormone, luteinizing hormone, and gonadotropin in hypothalamus and pituitary gland. These actions induce ovulation.

Availability

Tablets: 50 mg

Indications and dosages

Ovarian failure

Adults: 50 mg/day P.O. for 5 days starting any time in patients with no recent uterine bleeding; or 50 mg/day P.O. starting on fifth day of menstrual cycle. If ovulation doesn't occur, increase to 100 mg/day P.O. for 5 days. Start next course of therapy as early as 30 days after previous course. If patient doesn't respond after three courses, no further doses are recommended.

Off-label uses

• Male sterility (controversial)

Contraindications

• Hepatic disease
• Organic intracranial lesions
• Uncontrolled thyroid or adrenal dysfunction
• Ovarian cyst
• Abnormal uterine bleeding or bleeding of undetermined origin
• Pregnancy

Precautions

None

Administration

• Obtain pregnancy test before therapy begins.
• Be aware that patient should undergo pelvic and eye examinations before starting therapy.

Adverse reactions

CNS: nervousness, insomnia, dizziness, light-headedness

CV: vasomotor flushing

EENT: visual disturbances

GI: nausea; vomiting; abdominal discomfort, distention, and bloating

GU: breast tenderness, ovarian enlargement, multiple pregnancies, birth defects in resulting pregnancies, ovarian hyperstimulation syndrome, uterine bleeding

Interactions

None significant

Patient monitoring

• Monitor patient for bleeding and other adverse reactions.

Patient teaching

Instruct patient to immediately report signs and symptoms of ovarian hyperstimulation syndrome, including nausea, vomiting, diarrhea, abdominal or pelvic pain, and swelling in hands or legs.
• Tell patient to report bleeding.
• Advise patient not to take drug if she is or may become pregnant.
• Inform patient that drug increases risk of multiple births, which heightens maternal risk.
• As appropriate, review all other significant and life-threatening adverse reactions.

clomiPHENE

(kloe-mi-feen) ,

Clomid

(trade name),

Serophene

(trade name)

Classification

Therapeutic: ovulation inducer
Pregnancy Category: X

Indications

Induces ovulation in anovulatory women who desire pregnancy. Requires intact anterior pituitary, thyroid, and adrenal function.Male infertility due to oligospermia.

Action

Stimulates release of pituitary gonadotropins, follicle-stimulating hormone, and luteinizing hormone, resulting in ovulation and the development of the corpus luteum.

Therapeutic effects

Induction of ovulation.

Pharmacokinetics

Absorption: Well absorbed following oral administration.
Distribution: Unknown.
Metabolism and Excretion: Metabolized by the liver, with enterohepatic recirculation. Excreted in feces.
Half-life: 5–7 days.

Time/action profile (ovulation)

ROUTEONSETPEAKDURATION
PO5–14 daysunknownunknown

Contraindications/Precautions

Contraindicated in: Liver disease or history of liver dysfunction; Enlargement or development of ovarian cysts (not due to polycystic ovarian syndrome); Pregnancy; Uncontrolled thyroid or adrenal dysfunction; Pituitary tumor; Abnormal uterine bleeding of unknown origin.
Use Cautiously in: Endometriosis; Fibroids; Known sensitivity to pituitary gonadotropins (e.g. polycystic ovary syndrome).

Adverse Reactions/Side Effects

Central nervous system

  • headache

Ear, Eye, Nose, Throat

  • blurred vision
  • floaters
  • photophobia
  • scotomata
  • phosphenes

Cardiovascular

  • hot flashes (most frequent)

Gastrointestinal

  • abdominal pain
  • bloating
  • distention
  • nausea
  • vomiting
  • ↑ liver enzymes

Endocrinologic

  • ovarian cyst formation (most frequent)
  • ovarian enlargement (most frequent)
  • breast discomfort
  • multiple births
  • intermenstrual spotting
  • ovarian hyperstimulation syndrome
  • abnormal menstrual flow

Metabolic

  • weight gain

Interactions

Drug-Drug interaction

None significant.

Route/Dosage

Ovulatory Failure (Females)
Oral (Adults) 50 mg/day for 5 days (begin on or about 5th day of cycle); if ovulation does not occur, a second course of 100 mg/day for 5 days may be given 30 days after the initial course. A maximum of 3 courses may be administered. ↑ dose above 100 mg/day for 5 days is not recommended.
Male Infertility
Oral (Adults) 25 mg/day for 25 days with 5 days rest or 100 mg every Monday, Wednesday, and Friday.

Availability

Tablets: 50 mg

Nursing implications

Nursing assessment

  • Perform a pelvic examination to determine ovarian size and presence of ovarian cysts prior to therapy and before subsequent courses of therapy.
  • An endometrial biopsy is recommended in older patients prior to clomiphene therapy to rule out the presence of endometrial carcinoma.
  • Assess patient for abdominal pain throughout therapy. Occurrence requires immediate pelvic examination to determine ovarian enlargement or cyst formation. If these occur, discontinue therapy until ovaries have returned to pretreatment size, usually within a few days to weeks. Dose and duration of next course should be decreased.
  • If 3 ovulatory responses occur without achievement of pregnancy, further treatment with clomiphene is not recommended.
  • Lab Test Considerations: Estrogen excretion determinations, histologic studies of the luteal phase endometrium, serum progesterone, and urinary excretion of pregnanediol may be used to determine whether ovulation has occurred following a course of clomiphene.
    • Liver function tests should be performed prior to course of therapy.
    • Immunologic assay for human chorionic gonadotropin (HCG) should be used to determine pregnancy if menses do not occur prior each course of treatment with clomiphene.

Potential Nursing Diagnoses

Deficient knowledge, related to medication regimen (Patient/Family Teaching)

Implementation

  • Do not confuse Serophene (clomiphene) with Sarafem (fluoxetine).
    • Clomiphene therapy is usually begun on the 5th day of the menstrual cycle.

Patient/Family Teaching

  • Instruct patient to take clomiphene exactly as directed at the same time each day. Missed doses should be taken as soon as remembered and the dose doubled if not remembered until the time of the next dose. Notify health care professional if more than one dose is missed.
  • Advise patient that conception should be attempted with intercourse every other day starting 48 hr prior to ovulation. Ovulation usually occurs 7 days (range 5–10) after last dose of clomiphene.
  • Instruct patient in the correct method for measuring basal body temperature. A record of the daily basal body temperature should be maintained prior to and throughout course of therapy. Emphasize the importance of compliance with all aspects of therapy.
  • Prior to therapy, patient should be informed of the potential for multiple births.
  • Medication may cause visual disturbances or dizziness. Caution patient to avoid driving until the response to the medication is known.
  • Instruct patient to notify health care professional immediately if pregnancy is suspected; clomiphene should not be taken during pregnancy.
  • Advise patient to notify health care professional if visual changes occur; therapy should be discontinued and an ophthalmologic exam performed. Blurring and potentially irreversible changes may occur.
  • Advise patient to notify health care professional promptly if bloating, stomach or pelvic pain, blurred vision, jaundice, persistent hot flashes, breast discomfort, headache, diarrhea, weight gain, or nausea and vomiting occur.
  • Emphasize the importance of close monitoring by health care professional throughout therapy.

Evaluation/Desired Outcomes

  • Occurrence of ovulation measured by estrogen excretion, biphasic body temperature curve, urinary excretion of pregnan­ediol at postovulatory levels, and endometrial histologic changes. If conception is not achieved after 3 courses of clomiphene, diagnosis should be re-evaluated.

Serophene

A brand name for the drug CLOMIPHENE (clomifene), used in the treatment of infertility.