Nausea, vomiting, vasomotor flushes, blurred vision, spots or flashes, scotomata, ovarian enlargement with pelvic or abdominal pain. GI decontamination in addition to supportive measures.
The purpose and risks of Dufine tablets USP therapy should be presented to the patient before starting treatment. It should be emphasized that the goal of Dufine tablets USP 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 Dufine tablets USP 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.
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 Dufine tablets USP. To minimize the risks associated with ovarian enlargement, the patient should be instructed to inform the physician of any abdominal or elvic pain, weight gain, discomfort, or distention after taking Dufine tablets USP.
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 Dufine tablets USP 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 Dufine tablets USP 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 Dufine tablets USP 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 Dufine tablets USP ingestion during the investigational studies was within the range of that reported in published references for the general population.
During clinical investigation, the experience from patients with known pregnancy outcome (Table 1) shows a spontaneous abortion rate of 20.4% and stillbirth rate of 1.0%..
Dufine should be used cautiously in patients with known hypersensitivity to pituitary gonadotropin eg, patients with polycystic ovary syndrome.
Patient with ovarian cyst should not use Dufine, since it may cause enlargement of the ovaries.
Patients should always be monitored for signs of excessive ovarian stimulation (eg, pelvic pain) during Dufine therapy.
If ovulary enlargement or cyst formation has occurred, therapy should be discontinued until the size of the ovary returns to normal, and the dose or duration of the continuing therapy should be reduced.
If any visual disturbances have occurred during Dufine treatment, it should be discontinued and complete ophthalmologic evaluation should be performed.
Effects on the Ability to Drive or Operate Machinery: Caution should be taken if the job of the patients need a high degree of alertness or high level of mental and physical conditions.
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Information checked by Dr. Sachin Kumar, MD Pharmacology