Serophene

Name: Serophene

Warnings

Contraindications

Pregnancy

Liver disease

Undiagnosed abnormal uterine bleeding

Uncontrolled thyroid or adrenal dysfunction

Endometrial cancer

Ovarian cysts not due to PCOS

Cautions

Uterine fibroids, pituitary or ovarian failure

Risk of ovarian enlargement & ovarian hyperstimulation syndrome

Potential for multiple births, especially at 100 mg dosage

Risk of visual disturbance (like scotoma & photopsia)

Pregnancy

Information about this clomiphene-oral-route
Pregnancy Category Explanation
All Trimesters X Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Unusually large ovary or
  • Cyst on ovary—Clomiphene may cause the cyst to increase in size
  • Endometriosis—Inducing ovulation (including using clomiphene) may worsen endometriosis because the body estrogen level is increased; estrogen can cause growth of endometriosis implants
  • Fibroid tumors of the uterus—Clomiphene may cause fibroid tumors to increase in size
  • Inflamed veins due to blood clots—Clomiphene may make condition worse
  • Liver disease (or history of)—Clomiphene may make any liver disease worse
  • Mental depression—Existing depression may become worse because of hormone changes caused by clomiphene
  • Unusual vaginal bleeding—Some irregular vaginal bleeding is a sign that the lining of the uterus is growing too much or is a sign of cancer of the uterus lining; these problems must be ruled out before clomiphene is used because clomiphene can make these conditions worse

What other drugs will affect Serophene (clomiphene)?

Other drugs may interact with clomiphene, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Serophene Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Bloating
  • stomach or pelvic pain

Check with your doctor as soon as possible if any of the following side effects occur:

Less common or rare
  • Blurred vision
  • decreased or double vision or other vision problems
  • seeing flashes of light
  • sensitivity of eyes to light
  • yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Hot flashes
Less common or rare
  • Breast discomfort
  • dizziness or lightheadedness
  • headache
  • heavy menstrual periods or bleeding between periods
  • mental depression
  • nausea or vomiting
  • nervousness
  • restlessness
  • tiredness
  • trouble in sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What are some things I need to know or do while I take Serophene?

  • Tell all of your health care providers that you take Serophene. This includes your doctors, nurses, pharmacists, and dentists.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Follow up with the doctor as you have been told.
  • Long-term use may raise the chance of ovarian cancer.
  • A pregnancy test will be done to show that you are NOT pregnant before starting this medicine. If you get pregnant while taking Serophene, call your doctor right away.
  • To raise the chance of getting pregnant, talk with your doctor about the best time to have sex while taking this medicine.
  • This medicine may raise the chance of getting pregnant with more than one baby.
  • This medicine may raise the chance of tubal pregnancy. Sometimes this may be deadly. Talk with your doctor.
  • If you do not ovulate or get pregnant after 3 courses of Serophene, do not take any more. Talk with your doctor.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Serophene) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Follow how to take Serophene as you have been told by your doctor. Do not use more than you were told to use.

What do I do if I miss a dose?

  • Call your doctor to find out what to do.

Precautions

General

Careful attention should be given to the selection of candidates for clomiPHENE citrate therapy.  Pelvic examination is necessary prior to clomiPHENE citrate treatment and before each subsequent course (see CONTRAINDICATIONS and WARNINGS).

Information for Patients

The purpose and risks of clomiPHENE citrate therapy should be presented to the patient before starting treatment.  It should be emphasized that the goal of clomiPHENE citrate therapy is ovulation for subsequent pregnancy.  The physician should counsel the patient with special regard to the following potential risks:

Visual Symptoms:  Advise that blurring or other visual symptoms occasionally may occur during or shortly after clomiPHENE citrate therapy. It should be made clear that, in some instances, visual disturbances may be prolonged and, possibly, irreversible. Warn that visual symptoms may render such activities as driving a car or operating machinery more hazardous than usual, particularly under conditions of variable lighting (see WARNINGS).

The patient should be instructed to inform the physician whenever any unusual visual symptoms occur.  If the patient has any visual symptoms, treatment should be discontinued and complete ophthalmologic evaluation performed.

Abdominal/Pelvic Pain or Distention:  Ovarian enlargement may occur during or shortly after therapy with clomiPHENE citrate.  To minimize the risks associated with ovarian enlargement, the patient should be instructed to inform the physician of any abdominal or pelvic pain, weight gain, discomfort, or distention after taking clomiPHENE citrate (see WARNINGS).

Multiple Pregnancy:  Inform the patient that there is an increased chance of multiple pregnancy, including bilateral tubal pregnancy and coexisting tubal and intrauterine pregnancy, when conception occurs in relation to clomiPHENE citrate therapy.  The potential complications and hazards of multiple pregnancy should be explained.

Pregnancy Wastage and Birth Anomalies:  The physician should explain the assumed risk of any pregnancy, whether ovulation is induced with the aid of clomiPHENE citrate or occurs naturally.  The patient should be informed of the greater risks associated with certain characteristics or conditions of any pregnant woman, eg, age of female and male partner, history of spontaneous abortions, Rh genotype, abnormal menstrual history, infertility history, organic heart disease, diabetes, exposure to infectious agents such as rubella, familial history of birth anomaly, that may be pertinent to the patient for whom clomiPHENE citrate is being considered.  Based upon the evaluation of the patient, genetic counseling may be indicated.

The overall incidence of reported birth anomalies from pregnancies associated with maternal clomiPHENE citrate ingestion during the investigational studies was within the range of that reported in published references for the general population.  (See CONTRAINDICATIONS: Pregnancy.)

During clinical investigation, the experience from patients with known pregnancy outcome (Table 1) show a spontaneous abortion rate of 20.4% and stillbirth rate of 1.0%.  (See CLINICAL PHARMACOLOGY)

Drug Interactions

Drug interactions with clomiPHENE citrate have not been documented.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term toxicity studies in animals have not been performed to evaluate the carcinogenic or mutagenic potential of clomiPHENE citrate.

Oral administration of clomiPHENE citrate to male rats at doses of 0.3 or 1 mg/kg/day caused decreased fertility, while higher doses caused temporary infertility.  Oral doses of 0.1 mg/kg/day in female rats temporarily interrupted the normal cyclic vaginal smear pattern and prevented conception.  Doses of 0.3 mg/kg/day slightly reduced the number of ovulated ova and corpora lutea, while 3 mg/kg/day inhibited ovulation.

Pregnancy

Pregnancy Category X. (See CONTRAINDICATIONS.)

Nursing Mothers

It is not known whether clomiPHENE citrate is excreted in human milk.  Because many drugs are excreted in human milk, caution should be exercised if clomiPHENE citrate is administered to a nursing woman.  In some patients, clomiPHENE citrate may reduce lactation.

Ovarian Cancer

Prolonged use of clomiPHENE citrate tablets USP may increase the risk of a borderline or invasive ovarian tumor (see ADVERSE REACTIONS).

For the Consumer

Applies to clomiphene: oral tablet

Along with its needed effects, clomiphene (the active ingredient contained in Serophene) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking clomiphene:

More common
  • Bloating
  • stomach or pelvic pain

Check with your doctor as soon as possible if any of the following side effects occur while taking clomiphene:

Less common or rare
  • Blurred vision
  • decreased or double vision or other vision problems
  • seeing flashes of light
  • sensitivity of eyes to light
  • yellow eyes or skin

Some side effects of clomiphene may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Hot flashes
Less common or rare
  • Breast discomfort
  • dizziness or lightheadedness
  • headache
  • heavy menstrual periods or bleeding between periods
  • mental depression
  • nausea or vomiting
  • nervousness
  • restlessness
  • tiredness
  • trouble in sleeping

For Healthcare Professionals

Applies to clomiphene: compounding powder, oral tablet

General

At recommended dosages, clomiphene (the active ingredient contained in Serophene) is generally well tolerated. Adverse reactions usually are mild, transient, and resolve when clomiphene is discontinued.[Ref]

Genitourinary

Male sterility after high dose therapy may be due to hyalinization of the tubular membranes and damage to the spermatids. In general, clomiphene (the active ingredient contained in Serophene) enhances spermatozoal motility and does not change the sperm to abnormal or immature forms.[Ref]

Very common (10% or more): Ovarian enlargement, ovarian hyperstimulation syndrome
Common (1% to 10%): Abnormal uterine bleeding (intermenstrual spotting, menorrhagia), multiple pregnancies, spontaneous abortions (ectopic pregnancies, hydatiform moles, fetus papyraceous)
Uncommon (0.1% to 1%): Stillbirths, increased urinary frequency/volume, vaginal dryness, priapism
Frequency not reported: Temporary sterility in males
Postmarketing reports: Endometriosis, ovarian cyst, ovarian hemorrhage, tubal pregnancy, uterine hemorrhage[Ref]

Ocular

Common (1% to 10%): Blurred vision, lights, floaters, waves, unspecified visual complaints, photophobia, diplopia, scotomata, phosphenes
Frequency not reported: Scintillations, heat waves, irreversible palinopsia (prolonged afterimages), shimmering of the peripheral field
Postmarketing reports: Abnormal accommodation, cataract, eye pain, macular edema, optic neuritis, photopsia, posterior vitreous detachment, retinal hemorrhage, retinal thrombosis, retinal vascular spasm, temporary or prolonged loss of vision, possibly irreversible[Ref]

Cardiovascular

Very common (10% or more): Vasomotor flushes
Postmarketing reports: Arrhythmias, chest pain, edema, hypertension, palpitations, phlebitis, pulmonary embolism, shortness of breath, tachycardia, thrombophlebitis.[Ref]

Endocrine

Frequency not reported: Gynecomastia, thyroid disorders
Postmarketing reports: Thyroid disorders[Ref]

Oncologic

Uncommon (0.1% to 1%): Leydig cell tumor of testis (in male treated for oligospermia)
Frequency not reported: Ovarian cancer, increased risk of borderline or invasive ovarian tumor
Postmarketing reports: Hepatic hemangiosarcoma, liver cell adenoma, hepatocellular carcinoma, fibrocystic disease, breast carcinoma, endometrial carcinoma, astrocytoma, pituitary tumor, prolactinoma, neurofibromatosis, glioblastoma multiforme, brain abscess, luteoma of pregnancy, dermoid cyst of the ovary, ovarian carcinoma, hydatiform mole, choriocarcinoma, melanoma, myeloma, perianal cysts, renal cell carcinoma, Hodgkin's lymphoma, tongue carcinoma, bladder carcinoma[Ref]

Nervous system

Common (1% to 10%): Headache
Uncommon (0.1% to 1%): Dizziness, insomnia, light-headedness, nervous tension, vertigo
Postmarketing reports: Migraine headache, paresthesia, seizure, stroke, syncope[Ref]

Dermatologic

Uncommon (0.1% to 1%): Dermatitis, rash, hair loss, dry hair
Frequency not reported: Reversible alopecia, urticaria, acne, erythema nodosum, erythema multiforme
Postmarketing reports: Acne, allergic reaction, erythema, erythema multiforme, erythema nodosum, hypertrichosis, pruritis, urticaria[Ref]

Gastrointestinal

Common (1% to 10%): Abdominal-pelvic discomfort/distention/bloating, nausea, vomiting
Uncommon (0.1% to 1%): Acute abdomen, constipation, diarrhea[Ref]

Hematologic

Uncommon (0.1% to 1%): Deep vein thrombosis
Frequency not reported: Pituitary hemorrhage (with undiagnosed pituitary tumor)
Postmarketing reports: Leukocytosis[Ref]

A 32-year-old woman receiving clomiphene citrate treatment for ovulation induction was admitted for complaints of swelling and pain in her right calf. Her medical history was unremarkable except for complications following an appendectomy three years prior which resulted in a deep vein thrombosis (DVT) and subsequent pulmonary embolism. The patient had been taking clomiphene two days prior to the development of the first DVT. Six months later, the treatment with clomiphene was renewed. The patient developed recurrent DVT following repeated standard clomiphene treatment.[Ref]

Hepatic

Postmarketing reports: Increased transaminases, hepatitis[Ref]

Metabolic

Uncommon (0.1% to 1%): Increased appetite, weight gain/loss

Musculoskeletal

Postmarketing reports: Arthralgia, back pain, myalgia[Ref]

Other

Common (1% to 10%): Breast discomfort
Uncommon (0.1% to 1%): Fatigue
Frequency not reported: Elevated levels of desmosterol (for prolonged therapy)
Postmarketing reports: Fever, tinnitus, weakness

Fetal/Neonatal Anomalies and Mortality:
Uncommon (0.1% to 1%): Congenital heart lesions, down syndrome, club foot, congenital gut lesions, hypospadias, microcephaly, harelip and cleft palate, congenital hip, hemangioma, undescended testicles, polydactyly, conjoined twins and teratomatous malformation, patent ductus arteriosus, amaurosis, arteriovenous fistula, inguinal hernia, umbilical hernia, syndactyly, pectus excavatum, myopathy, dermoid cyst of scalp, omphalocele, spina bifida occulta, ichthyosis, and persistent lingual frenulum, neonatal death, fetal death/stillbirth
Postmarketing reports: Skeletal malformations of the skull, face, nasal passages, jaw, hand, limb (ectromelia including amelia, hemimelia, and phocomelia), foot (clubfoot), spine, joints; septal heart defects, muscular ventricular septal defect, patent ductus arteriosus, tetralogy of Fallot, coarctation of the aorta; down syndrome; ear abnormalities and deafness; cleft lip and palate, imperforate anus, tracheoesophageal fistula, diaphragmatic hernia, omphalocele; hypospadias, cloacal exstrophy, lung tissue malformations; malformations of the eye and lens (cataract); neuroectodermal tumor, thyroid tumor, hepatoblastoma, lymphocytic leukemia; neural tube defects (anencephaly, meningomyelocele), microcephaly, hydrocephalus; renal agenesis and renal dysgenesis; dwarfism, mental retardation

Psychiatric

Uncommon (0.1% to 1%): Depression
Postmarketing reports: Anxiety, irritability, mood changes, psychosis[Ref]

Respiratory

Uncommon (0.1% to 1%): Pulmonary embolism (in male treated for infertility)[Ref]

Some side effects of Serophene may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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