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  • Ikaclomin
    / Teva


    Active Ingredient

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Tablets

    10 X 50 mg

    full basket chart 1009 9009

    Related information


    Dosage

    50 mg, daily for 5 days. Therapy may be started at any time, if the patient has had no recent uterine bleeding. If progestin-induced bleeding is intended, or spontaneous uterine bleeding occurs prior to therapy, 50 mg daily for 5 days should be started on or about day 5 of the cycle. If ovulation does not appear to have occurred after the first course of therapy, a second course of 100 mg (administered as a single daily dose) for 5 days may be started. This course may begin as early as 30 days after the previous one. Increasing the dosage or duration of therapy beyond 100 mg/day for 5 days should not be undertaken.


    Indications

    Ovulatory failure in women whose partners are fertile and potent.


    Contra-Indications

    Pregnancy, abnormal uterine bleeding, patients with liver disease or a history of liver dysfunction, infertile males or females who have either pituitary tumors or pituitary failure with hypogonadotropic hypogonadism.
    See prescribing information for full details.


    Special Precautions

    NOTES: General: It is important that neoplastic lesions be detected before clomiphene citrate therapy is instituted. Good levels of endogenous oestrogen (as estimated from vaginal smears, endometrial biopsy, assay of urinary oestrogen, or endometrial bleeding in response to progesterone) provide a favorable prognosis for ovulatory response induced by clomiphene citrate. A low level of oestrogen, although clinically less favourable, does not preclude successful outcome of therapy. Ikaclomin therapy is ineffective in patients with primary pituitary or primary ovarian failure. Therefore Ikaclomin cannot be expected to substitute for specific treatment of other causes of ovulatory failure, such as thyroid or adrenal disorders. For hyperprolactinaemia there is other preferred specific treatment. Ikaclomin is not first line treatment for low weight related amenorrhoea, with infertility, and has no value if a high FSH blood level is observed following an early menopause. Although no direct effect of clomiphene citrate therapy on the human fetus has been seen, clomiphene citrate should not be administered in cases of suspected pregnancy, as effects on the fetus have been reported in animals. To prevent inadvertent clomiphene citrate administration during early pregnancy, the basal body temperature should be recorded throughout all treatment cycles, and therapy should be discontinued if pregnancy is suspected. If the basal body temperature following clomiphene citrate is biphasic and not followed by menses, the possibility of an ovarian cyst and/or pregnancy should be excluded. The next course of therapy should be delayed until the correct diagnosis has been determined.
    Ovarian Hyperstimulation Syndrome: Ovarian Hyperstimulation Syndrome (OHSS) has been reported in patients receiving clomiphene citrate therapy for ovulation induction. In some cases, OHSS occurred following the cyclic use of clomiphene citrate therapy or when clomiphene citrate was used in combination with gonadotropins. The following symptoms have been reported in association with this syndrome during clomiphene citrate therapy: pericardial effusion, anasarca, hydrothorax, acute abdomen, renal failure, pulmonary oedema, ovarian haemorrhage, deep venous thrombosis, torsion of the ovary and acute respiratory distress. If conception results, rapid progression to the severe form of the syndrome may occur. To minimise the hazard of the abnormal ovarian enlargement associated with clomiphene citrate therapy, the lowest dose consistent with expectation of good results should be used. The patient should be instructed to inform the physician of any abdominal or pelvic pain, weight gain, discomfort or distension after taking clomiphene citrate. Maximal enlargement of the ovary may not occur until several days after discontinuation of the course of clomiphene citrate. Some patients with polycystic ovary syndrome who are unusually sensitive to gonadotropin may have an exaggerated response to usual doses of clomiphene citrate. The patient who complains of abdominal or pelvic pain, discomfort, or distension after taking clomiphene citrate should be examined because of the possible presence of an ovarian cyst or other cause. Due to fragility of enlarged ovaries in severe cases, abdominal and pelvic examination should be performed very cautiously. If abnormal enlargement occurs clomiphene citrate should not be given until the ovaries have returned to pre-treatment size. Ovarian enlargement and cyst formation associated with clomiphene citrate therapy usually regress spontaneously within a few days or weeks after discontinuing treatment. Most of these patients should be managed conservatively. The dosage and/or duration of the next course of treatment should be reduced.
    Visual Symptoms: Patients should be warned that blurring and/or other visual symptoms such as spots or flashes (scintillating scotomata) may occur occasionally (during or shortly after) clomiphene citrate therapy. These visual disturbances are usually reversible; however, cases of prolonged visual disturbance have been reported including after clomiphene citrate discontinuation. The visual disturbances may be irreversible especially with increased dosage or duration of therapy. These may make activities such as driving or operating machinery more hazardous than usual, particularly under conditions of poor lighting. The significance of these visual symptoms is not understood. If the patient has any visual symptoms, treatment should be discontinued and ophthalmologic evaluation performed..Patients experiencing any visual symptoms should discontinue treatment and undergo a complete ophthalmological evaluation.


    Side Effects

    Symptoms/Signs/Conditions: Adverse effects appeared to be dose—related, occurring more frequently at the higher dose and with the longer courses of treatment used in investigational studies. At recommended dosage, adverse effects are not prominent and infrequently interfere with treatment. During the investigational studies, the more commonly reported adverse effects included ovarian enlargement (13.6%), vasomotor flushes (10.4%), abdominal-pelvic discomfort (distention, bloating) (5.5%), nausea and vomiting (2.2%), breast discomfort (2.1%), visual symptoms (1.5%), headache (1.3%) and intermenstrual spotting or menorrhagia (1.3%).
    Ovarian enlargement
    :
    At recommended dosage, abnormal ovarian enlargement is infrequent although the usual cyclic variation in ovarian size may be exaggerated. Similarly, cyclic ovarian pain (mittelschmerz) may be accentuated. With higher or prolonged dosage, more frequent ovarian enlargement and cyst formation may occur, and the luteal phase of the cycle may be prolonged. Rare instances of massive ovarian enlargement are recorded. Such an instance has been described in a patient with polycystic ovary syndrome whose clomiphene citrate therapy consisted of 100 mg daily for 14 days. Abnormal ovarian enlargement usually regresses spontaneously; most of the patients with this condition should be treated conservatively.
    Eye/Visual Symptoms:
    Symptoms described usually as “blurring” or spots or flashes (scintillating scotomata) increase in incidence with increasing total dose. These symptoms appear to be due to intensification and prolongation of afterimages. After-images as such have also been reported. Symptoms often first appear or are accentuated with exposure to bright-light environment. Ophthalmologically definable scotomata, phosphenes and reduced visual acuity have been reported. There are rare reports of cataracts and optic neuritis. These visual disturbances are usually reversible. However, cases of prolonged visual disturbance have been reported, including after clomiphene citrate have been discontinued. The visual disturbances may be irreversible, especially with increased dosage or duration of therapy.
    Genitourinary: There are reports of new cases of endometriosis and exacerbation of pre-existing endometriosis during clomiphene citrate therapy. Multiple pregnancies, including simultaneous intrauterine and extrauterine pregnancies, have been reported. There is an increased chance of ectopic pregnancy in women who conceive following clomiphene citrate therapy.
    Tumours/neoplasms: Isolated reports have been received on the occurrence of endocrine-related or dependent neoplasms or their aggravation.
    For full details see prescribing information.


    Drug interactions

    Interactions with other drugs have not been documented.


    Pregnancy and Lactation

    Pregnancy: Clomiphene citrate is not indicated during pregnancy. Although there is no evidence that clomiphene citrate has a harmful effect on the human foetus, there is evidence that clomiphene citrate has a deleterious effect on rat and rabbit foetuses when given in high doses to the pregnant animal. To avoid inadvertent clomiphene citrate administration during early pregnancy, appropriate tests should be utilised during each treatment cycle to determine whether ovulation occurs. The patient should have a pregnancy test before the next course of clomiphene citrate therapy.
    Breastfeeding: It is not known whether clomiphene citrate is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised if this drug is administered to a nursing mother. In some patients clomiphene citrate may reduce lactation.


    Overdose

    Toxic effects of acute overdose of clomiphene citrate have not been reported but the number of overdose cases recorded is small. In the event of an overdose, appropriate supportive measures should be employed.


    Manufacturer
    Teva Pharmaceutical Industries Ltd, Israel
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