Description

Clomiphene Citrate

Strength: 50 mg
Molecular Formula: C32H36CINO8
Molecular Weight: 598.08314 g/mol
Active Ingredient: Clomiphene citrate
CAS number: 50-41-9
Dosage Form: Tablet
Route: Oral
Market Status: Prescription
Company: Hilma Biocare

DESCRIPTION

Clomiphene citrate 50 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 citrate 50 is used to cause ovulation in women with certain medical conditions
(such as polycystic ovary syndrome) that prevent naturally occurring ovulation. Clomiphene
citrate 50 may also be used for purposes not listed in this medication guide.

CLINICAL PHARMACOLOGY

Clomiphene citrate tablets USP is a drug of considerable pharmacological potency. With
careful selection and proper management of the patient, Clomiphene citrate tablets USP has
been demonstrated to be a useful therapy for the anovulatory patient desiring pregnancy.
Clomiphene citrate is capable of interacting with estrogen-receptor- containing tissues,
including the hypothalamus, pituitary, ovary, endometrium, vagina, and cervix. It may
compete with estrogen for estrogen- receptor-binding sites and may delay medicines you
use now and any medicine you start or stop using.

ADVERSE REACTIONS

Most side effect studies are based on female cancer patients whose primary sex hormone
estrogen is effectively blocked through the use of tamoxifen. Male patients have
demonstrated reduced levels of side effects. Side effects may include nausea, Coughing,
vomiting and hot flashes, difficulty breathing; swelling of your face, lips, tongue, or throat.
Sudden numbness or weakness, especially on one side of the body, sudden headache,
confusion, problems with vision, speech, or balance; chest pain, shortness of breath.
Reduced cognition and memory impairment, vaginal bleeding, amenorrhea, altered menses,
discharge, ovarian cysts or pelvic pain. Corneal changes, reduced color vision, cataract
formation, retinal dvt, and retinopathy. Thromboembolic events, anorexia, pain, depression.
Rarely elevation of liver enzymes and liver disease. Reduced platelet production,
leuko-penia, thrombocytopenia. hypercalcaemia, peripheral oedema, distaste for food
pruritus vulvae, depression, dizziness, light-headedness, headache, hair thinning, hair loss,
and vaginal dryness. Increases in serum triglycerides. Stop using tamoxifen and call your
doctor at once if you experience any of these serious side effects.

DOSAGE AND ADMINISTRATION

Usual Adult Dose for Ovulation Induction: 50 mg orally once a day for 5 days. Therapy
should be initiated on or near the 5th day of the menstrual cycle, take this medicine in larger
or smaller amounts or for longer than recommended. Your doctor will perform medical tests
to make sure you do not have conditions that would prevent you from safely using
clomiphene. Clomiphene is usually taken for 5 days. starting on the 5th day of your
menstrual period. Follow your doctor’s instructions, You will need to have a pelvic
examination before each treatment cycle. You must remain under the care of a doctor while
you are using this medicine. You will most likely ovulate within 5 to 10 days after you take
clomiphene. To improve your chance of becoming pregnant, you should have sexual
intercourse while you are ovulating. Your doctor may have you take your temperature each
morning and record your daily readings on a chart. This will help you determine when you
can expect ovulation to occur. If ovulation occurs but you do not get pregnant after 3
treatment cycles, your doctor may stop treatment and evaluate your infertility further. In most
cases, clomiphene should not be used for more than 3 treatment cycles.

CONTRAINDICATIONS

Do not use clomiphene if you are already pregnant. You should not use clomiphene if you
have: liver disease. abnormal vaginal bleeding, uncontrolled adrenal gland or thyroid
disorder, an ovarian cyst (unrelated to polycystic ovary syndrome), or if you are pregnant.

WARNINGS

To be used only under the care of a physician.

PRECAUTIONS

Get emergency medical help if you have any of these signs of an allergic reaction to
clomiphene citrate : hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Some women using this medicine develop a condition called ovarian hyperstimulation
syndrome (OHS), especially after the first treatment. OHSS can be a life threatening
condition. Call your doctor right away if you have any of the following symptoms of OHSS:
stomach pain, bloating; nausea, vomiting, diarrhea; rapid weight gain, especially in your face
and midsection 3B little or no urinating; pain when you breathe, rapid heart rate, feeling short
of breath (especially when lying down). Stop using clomiphene citrate and call your doctor at
once if you have: pelvic pain or pressure, enlargement in your pelvic area; vision problems;
seeing flashes of light or “floaters” in your vision; increased sensitivity of your eyes to light;
heavy vaginal bleeding. Common clomiphene citrate side effects may include: hot flashes;
headache; breast pain or tenderness; mild stomach discomfort; break-through bleeding or
spotting.

DRUG INTERACTIONS

Other drugs may interact with clomiphene, including prescription and over-the-counter
medicines, vitamins, and herbal products. Tell each of your health care providers about all
medicines you use now and any eyou start or stop using.

ADVERSE REACTIONS

Most side effect studies are based on female cancer patients whose primary sex homone
estrogen is effectively blocked through the use of tamoxifen. Male patients have
demonstrated reduced levels of side effects. Side effects may include nausea, Coughing,
vomiting and hot flashes, difficulty breathing; swelling of your face, lips, tongue, or throat.
Sudden numbness or weakness, especially on one side of the body, sudden headache,
confusion, problems with vision, speech, or balance; chest pain, shortness of breath.
Reduced cognition and memory impairment, vaginal bleeding, amenorrhea, altered menses,
discharge, ovarian cysts or pelvic pain. Corneal changes, reduced color vision, cataract
formation, retinal dvt, and retinopathy. Thromboembolic events, anorexia, pain, depression.
Rarely elevation of liver enzymes and liver disease. Reduced platelet production,
leuko-penia, thrombocytopenia. hypercalcaemia, peripheral oedema, distaste for food
pruritus vulvae, depression, dizziness. light-headedness, headache, hair thinning, hair loss,
and vaginal dryness. Increases in serum triglycerides.Stop using tamoxifen and call your
doctor at once if you experience any of these serious side effects.

DOSAGE AND ADMINISTRATION

Usual Adult Dose for Ovulation Induction: 50 mg orally once a day for 5 days. Therapy
should be initiated on or near the 5th day of the menstrual cycle, and may be started at any
time in patients without recent uterine bleeding. If ovulation occurs and pregnancy is not
achieved, up to 2 additional courses of omi-phene 50 mg orally once a day or 5 days may be
administered. Each subsequent course may be started as early as 30 days after the
previous Course and after pregnancy has been excluded. Most patients ovulate following the
first course of therapy. However, if the patient fails to ovulate, a second course of 100
mg/day for 5 days may be given as early as 30 days following the initial course. A third
course of 100 mg/day for 5 days may be given after 30 days, if necessary. Treatments
beyond three cycles of clomiphene, dosages greater than 100 mg once a day, and/or course
durations beyond 5 days are not recommended by the manufacturer. However, successful
pregnancies and term deliveries have been reported in women receiving up to 200 mg/day
for 5 days, or extended 10-day course of therapy, or consecutive cycles of treatment beyond
the 3 recommended by the manufacturer. Usual Adult Dose for Lactation Suppression: 50 to
100 mg orally once a day for 5 days. Generally, one course of therapy is sufficient. Usual
Adult Dose for Oligospermia: 25 to 100 mg orally once a day. Therapy is generally given
over a period of several months. Clomiphene citrate 50 mg uncoated tablets: 50 tablets in 1
bottle.

STORAGE

Store in a cool dry place between 15- 25°C. Protect from light.

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