Serophene
clomiphene citrate (clomifene (UK))
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
See 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) clomiphene,Clomid
(trade name),Serophene
(trade name)Classification
Therapeutic: ovulation inducerIndications
Action
Therapeutic effects
Pharmacokinetics
Time/action profile (ovulation)
| ROUTE | ONSET | PEAK | DURATION |
|---|---|---|---|
| PO | 5–14 days | unknown | unknown |
Contraindications/Precautions
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)Availability
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.