What happens if I overdose Fertyl Super?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include flushing; nausea; stomach pain; vision changes (eg, blurred vision, flashes or spots); vomiting.
Proper storage of Fertyl Super:
Store Fertyl Super at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Fertyl Super out of the reach of children and away from pets.
Overdose of Fertyl Super in details
Signs and Symptoms
Toxic effects accompanying acute overdosage of Fertyl Super tablets USP have not been reported. Signs and symptoms of overdosage as a result of the use of more than the recommended dose during Fertyl Super tablets USP therapy include nausea, vomiting, vasomotor flushes, visual blurring, spots or flashes, scotomata, ovarian enlargement with pelvic or abdominal pain.
Oral LD50. The acute oral LD50 of Fertyl Super tablets USP is 1700 mg/kg in mice and 5750 mg/kg in rats. The toxic dose in humans is not known.
Dialysis. It is not known if Fertyl Super tablets USP is dialyzable.
Treatment
In the event of overdose, appropriate supportive measures should be employed in addition to gastrointestinal decontamination.
What should I avoid while taking Fertyl Super?
This medication may cause blurred vision. Be careful if you drive or do anything that requires you to be alert and able to see clearly.
Fertyl Super warnings
Visual Symptoms
Patients should be advised that blurring or other visual symptoms such as spots or flashes (scintillating scotomata) may occasionally occur during therapy with Fertyl Super tablets USP. These visual symptoms increase in incidence with increasing total dose or therapy duration. These visual disturbances are usually reversible; however, cases of prolonged visual disturbance have been reported with some occurring after Fertyl Super tablets USP discontinuation. The visual disturbances may be irreversible, especially with increased dosage or duration of therapy. Patients should be warned that these visual symptoms may render such activities as driving a car or operating machinery more hazardous than usual, particularly under conditions of variable lighting.
These visual symptoms appear to be due to intensification and prolongation of afterimages. Symptoms often first appear or are accentuated with exposure to a brightly lit environment. While measured visual acuity usually has not been affected, a study patient taking 200 mg Fertyl Super tablets USP daily developed visual blurring on the 7th day of treatment, which progressed to severe diminution of visual acuity by the 10th day. No other abnormality was found, and the visual acuity returned to normal on the 3rd day after treatment was stopped.
Ophthalmologically definable scotomata and retinal cell function (electroretinographic) changes have also been reported. A patient treated during clinical studies developed phosphenes and scotomata during prolonged Fertyl Super tablets USP administration, which disappeared by the 32nd day after stopping therapy.
Postmarketing surveillance of adverse events has also revealed other visual signs and symptoms during Fertyl Super tablets USP therapy.
While the etiology of these visual symptoms is not yet understood, patients with any visual symptoms should discontinue treatment and have a complete ophthalmological evaluation carried out promptly.
Ovarian Hyperstimulation Syndrome
The ovarian hyperstimulation syndrome (OHSS) has been reported to occur in patients receiving Fertyl Super therapy for ovulation induction. OHSS may progress rapidly (within 24 hours to several days) and become a serious medical disorder. In some cases, OHSS occurred following cyclic use of Fertyl Super therapy or when Fertyl Super was used in combination with gonadotropins. Transient liver function test abnormalities suggestive of hepatic dysfunction, which may be accompanied by morphologic changes on liver biopsy, have been reported in association with OHSS.
OHSS is a medical event distinct from uncomplicated ovarian enlargement. The clinical signs of this syndrome in severe cases can include gross ovarian enlargement, gastrointestinal symptoms, ascites, dyspnea, oliguria, and pleural effusion. In addition, the following symptoms have been reported in association with this syndrome: pericardial effusion, anasarca, hydrothorax, acute abdomen, hypotension, renal failure, pulmonary edema, intraperitoneal and ovarian hemorrhage, deep venous thrombosis, torsion of the ovary, and acute respiratory distress. The early warning signs of OHSS are abdominal pain and distention, nausea, vomiting, diarrhea, and weight gain. Elevated urinary steroid levels, varying degrees of electrolyte imbalance, hypovolemia, hemoconcentration, and hypoproteinemia may occur. Death due to hypovolemic shock, hemoconcentration, or thromboembolism has occurred. Due to fragility of enlarged ovaries in severe cases, abdominal and pelvic examination should be performed very cautiously. If conception results, rapid progression to the severe form of the syndrome may occur.
To minimize the hazard associated with occasional abnormal ovarian enlargement associated with Fertyl Super tablets USP therapy, the lowest dose consistent with expected clinical results should be used. Maximal enlargement of the ovary, whether physiologic or abnormal, may not occur until several days after discontinuation of the recommended dose of Fertyl Super tablets USP. Some patients with polycystic ovary syndrome who are unusually sensitive to gonadotropin may have an exaggerated response to usual doses of Fertyl Super tablets USP. Therefore, patients with polycystic ovary syndrome should be started on the lowest recommended dose and shortest treatment duration for the first course of therapy.
If enlargement of the ovary occurs, additional Fertyl Super tablets USP therapy should not be given until the ovaries have returned to pretreatment size, and the dosage or duration of the next course should be reduced. Ovarian enlargement and cyst formation associated with Fertyl Super tablets USP therapy usually regress spontaneously within a few days or weeks after discontinuing treatment. The potential benefit of subsequent Fertyl Super tablets USP therapy in these cases should exceed the risk. Unless surgical indication for laparotomy exists, such cystic enlargement should always be managed conservatively.
A causal relationship between ovarian hyperstimulation and ovarian cancer has not been determined. However, because a correlation between ovarian cancer and nulliparity, infertility, and age has been suggested, if ovarian cysts do not regress spontaneously, a thorough evaluation should be performed to rule out the presence of ovarian neoplasia.
What should I discuss with my healthcare provider before taking Fertyl Super?
You should not use Fertyl Super if you are allergic to it, or if you have:
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abnormal vaginal bleeding;
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an ovarian cyst that is not related to polycystic ovary syndrome;
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past or present liver disease;
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a tumor of your pituitary gland;
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an untreated or uncontrolled problem with your thyroid or adrenal gland; or
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if you are pregnant.
To make sure Fertyl Super is safe for you, tell your doctor if you have:
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endometriosis or uterine fibroids.
FDA pregnancy category X. Do not use Fertyl Super if you are already pregnant. Talk to your doctor if you have concerns about the possible effects of Fertyl Super on a new pregnancy.
It is not known whether Fertyl Super passes into breast milk or if it could harm a nursing baby. This medication may slow breast milk production in some women. Tell your doctor if you are breast-feeding a baby.
Using Fertyl Super for longer than 3 treatment cycles may increase your risk of developing an ovarian tumor. Ask your doctor about your specific risk.
Fertility treatment may increase your chance of having multiple births (twins, triplets). These are high-risk pregnancies both for the mother and the babies. Talk to your doctor if you have concerns about this risk.
Fertyl Super precautions
General
Careful attention should be given to the selection of candidates for Fertyl Super tablets USP therapy. Pelvic examination is necessary prior to Fertyl Super tablets USP treatment and before each subsequent course.
Information for Patients
The purpose and risks of Fertyl Super tablets USP therapy should be presented to the patient before starting treatment. It should be emphasized that the goal of Fertyl Super 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 Fertyl Super tablets USP 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.
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 Fertyl Super tablets USP. 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 Fertyl Super tablets USP.
Metabolism Disorders: Cases of hypertriglyceridemia have been reported. Preexisting or family history of hyperlipidemia and use of higher than recommended dose and/or longer duration of treatment with Fertyl Super are associated with a risk of hypertriglyceridemia. Periodic monitoring of plasma triglycerides is recommended in patients with preexisting or family history of hyperlipidemia. Please refer to the DOSAGE AND ADMINISTRATION section for recommended dosage and treatment duration.
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 Fertyl Super tablets USP therapy. The potential complications and hazards of multiple pregnancy should be explained.
Spontaneous Abortion and Congenital Anomalies: Inform the patient that the available data suggest no increase in the rates of spontaneous abortion (miscarriage) or congenital anomalies with maternal Fertyl Super tablets USP use compared to rates in 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%.. Among the birth anomalies spontaneously reported as individual cases since commercial availability of Fertyl Super tablets USP, the proportion of neural tube defects has been high among pregnancies associated with ovulation induced by Fertyl Super tablets USP, but this has not been supported by data from population-based studies.
Drug Interactions
Drug interactions with Fertyl Super tablets USP 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 Fertyl Super.
Oral administration of Fertyl Super tablets USP 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
Fetal Risk Summary
Pregnancy Category X. Fertyl Super use in pregnant women is contraindicated, as Fertyl Super tablets USP treatment does not offer benefit in this population.
Available human data do not suggest an increased risk for congenital anomalies above the background population risk. However, animal reproductive toxicology studies showed increased embryo-fetal loss and structural malformations in offspring. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risks to the fetus.
Clinical Considerations
To avoid inadvertent Fertyl Super tablets USP administration during early pregnancy, appropriate tests should be utilized during each treatment cycle to determine whether ovulation and/or pregnancy occurs. Patients should be evaluated carefully to exclude ovarian enlargement or ovarian cyst formation between each treatment cycle. The next course of Fertyl Super tablets USP therapy should be delayed until these conditions have been excluded.
Human data
The available human data from epidemiologic studies do not show any apparent cause and effect relationship between Fertyl Super periconceptual exposure and an increased risk of overall birth defects, or any specific anomaly. However, due to the small number of cases of congenital anomalies occurring in Fertyl Super treated women, these epidemiologic studies were only able to rule out large differences in risk. The studies did not consider factors associated with female subfertility and were unable to adjust for other important confounders.
In addition, available data do not support an increased rate of spontaneous abortion among subfertile women treated with Fertyl Super for ovulation induction.
Animal data
Oral administration of Fertyl Super to pregnant rats during organogenesis at doses of 1 to 2 mg/kg/day resulted in hydramnion and weak, edematous fetuses with wavy ribs and other temporary bone changes. Doses of 8 mg/kg/day or more also caused increased resorptions and dead fetuses, dystocia, and delayed parturition, and 40 mg/kg/day resulted in increased maternal mortality. Single doses of 50 mg/kg caused fetal cataracts, while 200 mg/kg caused cleft palate. Following injection of Fertyl Super 2 mg/kg to mice and rats during pregnancy, the offspring exhibited metaplastic changes of the reproductive tract. Newborn mice and rats injected during the first few days of life also developed metaplastic changes in uterine and vaginal mucosa, as well as premature vaginal opening and anovulatory ovaries. These findings are similar to the abnormal reproductive behavior and sterility described with other estrogens and antiestrogens.
In rabbits, some temporary bone alterations were seen in fetuses from dams given oral doses of 20 or 40 mg/kg/day during pregnancy, but not following 8 mg/kg/day. No permanent malformations were observed in those studies. Also, rhesus monkeys given oral doses of 1.5 to 4.5 mg/kg/day for various periods during pregnancy did not have any abnormal offspring.
Nursing Mothers
It is not known whether Fertyl Super tablets USP is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised if Fertyl Super tablets USP is administered to a nursing woman. In some patients, Fertyl Super tablets USP may reduce lactation.
Ovarian Cancer
Prolonged use of Fertyl Super tablets USP may increase the risk of a borderline or invasive ovarian tumor.
What happens if I miss a dose of Fertyl Super?
Call your doctor for instructions if you miss a dose of Fertyl Super.
References
- DrugBank. "clomiphene". http://www.drugbank.ca/drugs/DB00882 (accessed September 17, 2018).
- MeSH. "Selective Estrogen Receptor Modulators". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
