Light orange, round, flat scored tablet with Remedica's logo on one side.
Each Ova-Mit tablet contains: Clomifene Citrate EP 50 mg.
Pharmacotherapeutic group: ovulation stimulants synthetic. ATC code: G03BG02.
Pharmacology: Pharmacodynamics: Mechanism of Action: The ovulatory response to cyclic Ova-Mit tablets therapy is mediated through increased output of pituitary gonadotrophins, which in turn stimulates the maturation and endocrine activity of the ovarian follicle.
Pharmacodynamic effects: Ova-Mit is a triarylethylene compound (related to Chlorotrianisene and Triparanol). It is a non-steroidal agent which stimulates ovulation in a high percentage of appropriately selected anovulatory women. Clomifene Citrate has mainly antiestrogenic effects and some estrogenic effects.
Pharmacokinetics: Orally administered 14C labelled Clomifene Citrate in humans was readily adsorbed. Cumulative excretion of the 14C label by way of urine and faeces averaged about 50% of the oral dose after 5 days in 6 subjects, with mean urinary excretion of 7.8% and mean faecal excretion of 42.4%. A mean rate of excretion of 0.73% per day of the 14C dose after 31 days to 35 days and 0.45% per day of the 14C dose after 42 days to 45 days was seen in faecal and urine samples collected from 6 subjects for 14 to 53 days after Clomifene Citrate 14C administration. The remaining drug/metabolites may be slowly excreted from a sequestered enterohepatic recirculation pool.
Clomifene Citrate (Ova-Mit) is indicated for the treatment of ovulatory failure in women desiring pregnancy. Therapy with Clomifene Citrate (Ova-Mit) will not be successful unless the woman though anovulatory is capable of ovulation and her partner is fertile.
Clomifene Citrate (Ova-Mit) is ineffective in patients with primary pituitary or primary ovarian failure and is indicated only for patients in whom ovulatory dysfunction has been demonstrated. Clomifene Citrate (Ova-Mit) is not a substitute for appropriate therapy of other conditions which may cause ovulatory dysfunctions (e.g. thyroid or adrenal disease).
The usual dose of Clomifene Citrate (Ova-Mit) by mouth is 50 mg daily for five days, starting on or about the 5th day of the menstrual cycle or at any time if there is amenorrhea. If ovulation does not occur a course of 100 mg daily for five days may be given or as prescribed by the physician.
Route of Administration: Oral.
There is no experience of acute overdosage with Clomifene Citrate (Ova-Mit).
Liver disease: Clomifene Citrate (Ova-Mit) therapy is contraindicated in patients with liver disease or a history of liver dysfunction.
Abnormal uterine bleeding: Clomifene Citrate (Ova-Mit) is contraindicated in patients with hormone-dependent tumours or in patient with abnormal uterine bleeding of undetermined origin.
Ovarian cyst: Clomifene Citarte (Ova-Mit) tablets should not be given in the presence of an ovarian cyst, except polycystic ovary, since further enlargement of the cyst may occur. Patients should be evaluated for the presence of the ovarian cyst prior to each course of treatment.
General: 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 favourable prognosis for ovulatory response induced by Ova-Mit. A low level of oestrogen, although clinically less favourable, does not preclude successful outcome of therapy. Ova-Mit therapy is ineffective in patients with primary pituitary or primary ovarian failure. Ova-Mit therapy 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. Ova-Mit is not first line treatment for low weight related amenorrhea, with infertility and has no value if a high FSH blood level is observed following an early menopause.
Before starting treatment with Clomifene Citrate (Ova-Mit), the patient should be thoroughly examined to exclude liver disease, pituitary or ovarian failure and neoplasms of the endometrium. The cause of infertility and any abnormal bleeding should be investigated. The patients should be warned by the possibility of multiple births. Prolonged courses of treatment are not recommended. Patients should be warned that visual symptoms may occasionally occur during treatment.
Clomifene Citrate (Ova-Mit) is contra-indicated during pregnancy. To avoid inadvertent Clomifene Citrate (Ova-Mit) administration during early pregnancy, the patient should be carefully observed to determine if ovulation occurs. The basal body temperature should be recorded throughout all treatment cycles, and Clomifene Citrate (Ova-Mit) therapy should be discontinued if pregnancy is suspected.
None reported.
Drug/Laboratory Test Interferences: Greater than 5% retention of Bromsulphalein (BSP) has been reported in approximately 10 to 20% of patients in whom it was measured. Other liver function tests were usually normal.
Store at temperatures not exceeding 30°C.
G03GB02 - clomifene ; Belongs to the class of synthetic agents used as ovulation stimulants.
Sign Out
Continue with Google
Sign up with email
Already a member?
Sign in
