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|MF:||C32H36ClNO8||Storage:||Shading, Confined Preservation|
|Usage:||Selective Estrogen Receptor Modulator||Appearance:||White Or Milky White Crystalline Powder|
sex hormones drugs,
natural anti estrogen
Clomifene / Clomid Non-Steroidal Fertility Medicine Contraindicated in Pregnancy
What is clomiphene?
Clomiphene is a non-steroidal fertility medicine. It causes the pituitary gland to release hormones needed to stimulate ovulation (the release of an egg from the ovary).
Clomiphene is used to cause ovulation in women with certain medical conditions (such as polycystic ovary syndrome) that prevent naturally occurring ovulation.
Clomifene (INN) or clomiphene (USAN) (originally marketed as Clomid and subsequently under many brand names) is a selective estrogen receptor modulator (SERM) of the triphenylethylene group. It revolutionized the treatment of female infertility and marked the beginning of the modern era of assisted reproductive technology. It became the most widely prescribed drug for ovulation induction to reverse anovulation or oligoovulation.
It is on the WHO Model List of Essential Medicines, the most important medications needed in a basic health system.
Before taking this medicine
You should not use clomiphene if you are allergic to it, or if you have:
abnormal vaginal bleeding;
an ovarian cyst that is not related to polycystic ovary syndrome;
past or present liver disease;
a tumor of your pituitary gland;
an untreated or uncontrolled problem with your thyroid or adrenal gland; or
if you are pregnant.
To make sure clomiphene is safe for you, tell your doctor if you have:
endometriosis or uterine fibroids.
Do not use clomiphene if you are already pregnant. Talk to your doctor if you have concerns about the possible effects of this medicine on a new pregnancy.
Clomiphene can pass into breast milk and may 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 clomiphene 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.
Clomifene is useful in those who are infertile due to anovulation or oligoovulation.Evidence is lacking for the use of clomifene in those who are infertile without a known reason.In such cases, studies have observed a clinical pregnancy rate 5.6% per cycle with clomifene treatment vs. 1.3%–4.2% per cycle without treatment.
Clomifene has also been used with other assisted reproductive technology to increase success rates of these other modalities.
Proper timing of the drug is important; it should be taken starting on about the fifth day of the cycle, and there should be frequent intercourse.
The following procedures may be used to monitor induced cycles:
1. Follicular monitoring with vaginal ultrasound, starting 4–6 days after last pill. Serial transvaginal ultrasound can reveal the size and number of developing follicles. It can also provide presumptive evidence of ovulation such as sudden collapse of the preovulatory follicle, and an increase in fluid volume in the rectouterine pouch. After ovulation, it may reveal signs of luteinization such as loss of clearly defined follicular margins and appearance of internal echoes.
2. Serum estradiol levels, starting 4–6 days after last pill.
3. Post-coital test 1–3 days before ovulation to check whether there are at least 5 progressive sperm per HPF
4. Adequacy of LH surge by urine LH surge tests 3 to 4 days after last clomifene pill.
5. Mid-luteal progesterone, with at least 10 ng/ml 7–9 days after ovulation being regarded as adequate.
Repeat dosing: This 5-day treatment course can be repeated every 30 days. The dosage may be increased by 50-mg increments in subsequent cycles until ovulation is achieved. It is not recommended by the manufacturer to use clomifene for more than 6 cycles.
It is no longer recommended to perform an ultrasound examination to exclude any significant residual ovarian enlargement before each new treatment cycle.
Clomifene is sometimes used in the treatment of male hypogonadism as an alternative to testosterone replacement therapy. It has been found to increase testosterone levels by 2- to 2.5-fold in hypogonadal men.
|Characteristics||White or off-white crystalline powder||Complies|
|Organic nitrogenous bases||Conforms||Complies|
|Water||Not more than 1.0%||0.41%|
|Heavy Metals||Not more than 0.002%||Complies|
|Related substances||Related compound A: Not more than
Individual: Not more than 0.5%
|Organic volatile impurities||Conforms||Complies|
|conclusion||Conform with USP 28|
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