Fertiphen®

Therapeutic Area:

Generic Name:

Clomiphene Citrate

Dosage Form:

50 mg Tablet

Drug Dose

Therapeutic Indications:

Fertiphen® is indicated for the treatment of ovulatory dysfunction in women desiring pregnancy. Impediments to achieving pregnancy must be excluded or adequately treated before beginning Fertiphen® therapy. Those patients most likely to achieve success with clomiphene therapy include patients with polycystic ovary syndrome, amenorrhea-galactorrhea syndrome, psychogenic amenorrhea, post-oral-contraceptive amenorrhea, and certain cases of secondary amenorrhea of undetermined etiology.

Fertiphen® is indicated only in patients with demonstrated ovulatory dysfunction who meet the conditions described below:

1.Patients who are not pregnant.

2.Patients without ovarian cysts.

  1. Patients without abnormal vaginal bleeding.
  2. Patients with normal liver function.

Mechanism of Action:

Clomiphene triggers the brain’s pituitary gland to secrete an increased amount of follicle stimulating hormone (FSH) and LH (luteinizing hormone). This action stimulates the growth of the ovarian follicle and thus initiates ovulation.

Method of Administration:

The workup and treatment of candidates for Fertiphen® therapy should be supervised by physicians experienced in management of gynecologic or endocrine disorders. Patients should be chosen for therapy with Fertiphen® only after careful diagnostic evaluation. The plan of therapy should be outlined in advance. Impediments to achieving the goal of therapy must be excluded or adequately treated before beginning Fertiphen®. The therapeutic objective should be balanced with potential risks and discussed with the patient and others involved in the achievement of a pregnancy.

Ovulation most often occurs from 5 to 10 days after a course of Fertiphen®. Coitus should be timed to coincide with the expected time of ovulation. Appropriate tests to determine ovulation may be useful during this time.

Treatment of the selected patient should begin with a low dose, 50 mg daily (1 tablet) for 5 days. The dose should be increased only in those patients who do not ovulate in response to cyclic 50 mg Fertiphen®. A low dosage or duration of treatment course is particularly recommended if unusual sensitivity to pituitary gonadotropin is suspected, such as in patients with polycystic ovary syndrome.

The patient should be evaluated carefully to exclude pregnancy, ovarian enlargement, or ovarian cyst formation between each treatment cycle.

Notes

Contraindications:

Hypersensitivity

Fertiphen® is contraindicated in patients with a known hypersensitivity or allergy to clomiphene citrate or to any of its ingredients.

Pregnancy

Fertiphen® use in pregnant women is contraindicated.

Liver Disease

Fertiphen® therapy is contraindicated in patients with liver disease or a history of liver dysfunction.

Abnormal Uterine Bleeding

Fertiphen® is contraindicated in patients with abnormal uterine bleeding of undetermined origin. Ovarian Cysts

Fertiphen® is contraindicated in patients with ovarian cysts or enlargement not due to polycystic ovarian syndrome

Other

Fertiphen® is contraindicated in patients with uncontrolled thyroid or adrenal dysfunction or in the presence of an organic intracranial lesion such as pituitary tumor.

Interactions:

There are no known significant drug interactions.

Pregnancy and Lactation:

Pregnancy Category X.

Fertiphen® use in pregnant women is contraindicated, as Fertiphen® treatment does not offer benefit in this population and must not be given during pregnancy.

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.

Warning and Precaution:

Visual Symptoms: Advise that blurring or other visual symptoms occasionally may occur during or shortly after Fertiphen® therapy. It should be made clear to the patient that, in some instances, visual disturbances may be prolonged, and possibly irreversible, especially with increased dosage or duration of therapy. 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.

-Careful attention should be given to the selection of candidates for Fertiphen® therapy. Pelvic examination is necessary prior to Fertiphen® treatment and before each subsequent course.

-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 t Fertiphen® therapy. The potential complications and hazards of multiple pregnancy should be explained.

-Ovarian hyperstimulation syndrome and abnormal ovarian enlargement may occur, lowest dose is suggested to minimize this complication.

-Ovarian cyst: Pelvic examination is necessary prior to start and before each subsequent course of clomiphene citrate treatment. Clomiphene citrate should not be given in the presence of an ovarian cyst (including endometriosis involving the ovary).

Adverse Reactions:

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Fertiphen®, at recommended dosages, is generally well tolerated. Adverse reactions usually have been mild and transient and most have disappeared promptly after treatment has been discontinued.

Insidence >1%

Ovarian enlargement, Vasomotor flushes, Abdominal-pelvic discomfort/distention/bloating, Nausea and vomiting, Breast discomfort, Visual symptoms (Blurred vision, lights, floaters, waves, unspecified visual complaints, photophobia, diplopia, scotomata, phosphenes), Headache, Abnormal uterine bleeding (Intermenstrual spotting, menorrhagia).

Storage:

Store below 30 and protect from light and moisture.