Clomiphene Citrate Tablet, USP
DIN 01008574
50 mg
50 tablets, Square container
DESCRIPTION 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 provoke ovulation in women with certain medical conditions (such as polycystic ovary syndrome) that prevent naturally occurring ovulation.In bodybuilding, Clomiphene is used mainly off-cycle to restore normal testosterone levels.
COMPOSITION Each tablet contains: Medicinal ingredients. Clomiphene citrate, 50 mg. Non-medicinal ingredients: Microcrystalline cellulose, calcium carbonate, steric acid, magnesium stearate.
CLINICAL PHARMACOLOGY Clomiphene inhibits estrogen receptors in the hypothalamus, which restrain negative feedback of estrogen on gonadotropin release, leading to up-regulation of the hypothalamic–pituitary–gonadal axis. Zuclomifene, a more active isomer, stays bound for longer periods of time.
INDICATIONS Clomiphene is useful in those who are infertile due to anovulation or oligoovulation. It has also been used with other assisted reproductive technology to increase success rates of these other modalities.
CONTRAINDICATIONS Clomiphene is contraindicated in patients with a known hypersensitivity or allergy to clomiphene citrate or to any of its ingredients. Clomiphene is also contraindicated for
pregnant women and patients with history of liver problems.
ADVERSE REACTIONS The most common side effects of clomiphene are stomach discomfort, breast discomfort, blurred vision, nausea, and vomiting. Other side effects include abnormal heart beats, acne, allergic reactions, headaches, uterine bleeding, back pain, and muscle pain. The most common adverse drug reaction associated with the use of clomiphene (>10% of people) is reversible ovarian enlargement. Less common effects (1-10% of people) include
visual symptoms (blurred vision, double vision, floaters, eye sensitivity to light, scotomata), headaches, vasomotor flushes (or hot flashes), abnormal uterine bleeding and/or abdominal discomfort. Rare adverse events (<1% of people) include: high blood level of triglycerides, liver inflammation, reversible baldness and/or ovarian hyperstimulation syndrome.
KNOWN SYMPTOMS OF OVERDOSAGE AND TREATMENT Overdosage symptoms include nausea, vomiting, vasomotor flushes, visual blurring, spots or flashes, scotomata, ovarian enlargement with pelvic or abdominal pain. In the event of overdose, appropriate supportive measures should be employed in addition to gastrointestinal decontamination.
STORAGE INSTRUCTIONS Store clomiphene at room temperature, between 15-30 degrees Celsius (59° to 86° F),in a tightly closed, light-resistant container. Keep out of reach of children.