Pharmaceutical Name

Trade (marketing or proprietary) name: Clomid®

Generic (nonproprietary or active ingredient) name: Clomiphene citrate tablets USP

Indication and Usage

Reason the product has been approved for sale on the market.

FDA approved this drug for treatments of ovulatory dysfunction in women desiring pregnancy. Impediments to achieving pregnancy must be excluded or adequately treated
before beginning Clomid therapy. Those patients most likely to achieve success with
clomiphene therapy include patients with polycystic ovary syndrome, amenorrhea-galactorrhea syndrome, psychogenic amenorrhea, post-oral-contraceptive amenorrhea, and certain cases of secondary amenorrhea of undetermined etiology.

Manufacturer Insert

Ingredients

Also known as “excipients” for vaccines.

50 mg clomiphene citrate USP, corn starch, lactose, magnesium stearate, pregelatinized cornstarch, and sucrose.

Contraindications

Per the FDA, contraindications are conditions in a recipient that increases the risk for a serious adverse reaction. Product should not be administered when a patient has a listed contraindication.

Hypersensitivity
CLOMID is contraindicated in patients with a known hypersensitivity or allergy to clomiphene citrate or to any of its ingredients.

Pregnancy
Pregnancy Category X. CLOMID use in pregnant women is contraindicated, as CLOMID does not offer benefit in this population. Available human data do not suggest an increased risk for congenital anomalies above the background population risk when used as indicated. However, animal reproductive toxicology studies showed increased embryo-fetal loss and structural malformations in offspring. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risks to the fetus.

Liver Disease. CLOMID therapy is contraindicated in patients with liver disease or a history of liver dysfunction

Abnormal Uterine Bleeding. CLOMID is contraindicated in patients with abnormal uterine bleeding of undetermined origin.

Ovarian Cysts. CLOMID is contraindicated in patients with ovarian cysts or enlargement not due to polycystic ovarian syndrome.

Other. CLOMID is contraindicated in patients with uncontrolled thyroid or adrenal dysfunction or in the presence of an organic intracranial lesion such as pituitary tumor.

Warnings and Precautions

Per the FDA, warnings are clinically significant adverse reactions or risks. According to the CDC, a precaution is a condition in a recipient that might increase the risk for a serious adverse reaction, might cause diagnostic confusion, or might compromise the effectiveness of the product. In general, a product should be deferred when a precaution is present.

Visual Symptoms
Patients should be advised that blurring or other visual symptoms such as spots or flashes
(scintillating scotomata) may occasionally occur during therapy with CLOMID. These
visual symptoms increase in incidence with increasing total dose or therapy duration.
These visual disturbances are usually reversible; however, cases of prolonged visual
disturbance have been reported with some occurring after CLOMID discontinuation. The
visual disturbances may be irreversible, especially with increased dosage or duration of
therapy. Patients should be warned that these visual symptoms may render such activities
as driving a car or operating machinery more hazardous than usual, particularly under
conditions of variable lighting.

These visual symptoms appear to be due to intensification and prolongation of
afterimages. Symptoms often first appear or are accentuated with exposure to a brightly
lit environment. While measured visual acuity usually has not been affected, a study
patient taking 200 mg CLOMID daily developed visual blurring on the 7th day of
treatment, which progressed to severe diminution of visual acuity by the 10th day. No
other abnormality was found, and the visual acuity returned to normal on the 3rd day
after treatment was stopped.

Ophthalmologically definable scotomata and retinal cell function (electroretinographic)
changes have also been reported. A patient treated during clinical studies developed
phosphenes and scotomata during prolonged CLOMID administration, which
disappeared by the 32nd day after stopping therapy.

Postmarketing surveillance of adverse events has also revealed other visual signs and
symptoms during CLOMID therapy.

While the etiology of these visual symptoms is not yet understood, patients with any
visual symptoms should discontinue treatment and have a complete ophthalmological
evaluation carried out promptly.

Ovarian Hyperstimulation Syndrome
The ovarian hyperstimulation syndrome (OHSS) has been reported to occur in patients
receiving clomiphene citrate therapy for ovulation induction. OHSS may progress rapidly
(within 24 hours to several days) and become a serious medical disorder. In some cases,
OHSS occurred following cyclic use of clomiphene citrate therapy or when clomiphene
citrate was used in combination with gonadotropins. Transient liver function test
abnormalities suggestive of hepatic dysfunction, which may be accompanied by
morphologic changes on liver biopsy, have been reported in association with OHSS.

OHSS is a medical event distinct from uncomplicated ovarian enlargement. The clinical
signs of this syndrome in severe cases can include gross ovarian enlargement,
gastrointestinal symptoms, ascites, dyspnea, oliguria, and pleural effusion. In addition,
the following symptoms have been reported in association with this syndrome:
pericardial effusion, anasarca, hydrothorax, acute abdomen, hypotension, renal failure,
pulmonary edema, intraperitoneal and ovarian hemorrhage, deep venous thrombosis,
torsion of the ovary, and acute respiratory distress. The early warning signs of OHSS are
abdominal pain and distention, nausea, vomiting, diarrhea, and weight gain. Elevated
urinary steroid levels, varying degrees of electrolyte imbalance, hypovolemia,
hemoconcentration, and hypoproteinemia may occur. Death due to hypovolemic shock,
hemoconcentration, or thromboembolism has occurred. Due to fragility of enlarged
ovaries in severe cases, abdominal and pelvic examination should be performed very
cautiously. If conception results, rapid progression to the severe form of the syndrome
may occur.

Manufacturer-Listed Adverse Reactions

Per the CDC, adverse reactions are an undesirable medical condition that has been demonstrated to be caused by a vaccine. Evidence for the causal relation is usually obtained through randomized clinical trials, controlled epidemiologic studies, isolation of the vaccine strain from the pathogenic site, or recurrence of the condition with repeated vaccination (i.e., rechallenge); synonyms include side effect and adverse effect.

Ovarian Hyperstimulation Syndrome (OHSS), Erythema (multiforme/nordosum), Phlebitis (vein inflammation), Paresthesia (skin crawling), Tinnitus (ringing ears), Arrhythmia, Chest pain, Hypertension, Palpitation, Pulmonary embolism, Shortness of breath, Tachycardia, Thrombophlebitis, Migraine headache, Seizure, Neoplasm (abnormal/excessive growth) (see following slides), Anxiety, Thyroid disorder, Irritability, Mood changes, Psychosis, Visual disorders (see following slides), Leukocytosis, Fetal/Neonatal Anomalies (see following slides), Multiple pregnancy, Fever, Blurred vision, Seeing spots/flashes, Weakness, Stroke, Syncope (fainting), Acne, Allergic reaction, Edema, Pruritus (itchy skin), Hypertrichosis (werewolf syndrome), Urticaria (hives), Endometriosis, Ovarian cyst, Ovarian hemorrhage, Uterine hemorrhage, Tubal pregnancy (ectopic), Transaminases increased, Hepatitis, Arthralgia (joint pain), Back pain, Myalgia (muscle pain)

Specific Populations

Pregnancy

Pregnancy Category X. CLOMID use in pregnant women is contraindicated, as CLOMID treatment does not offer benefit in this population.

Available human data do not suggest an increased risk for congenital anomalies above the
background population risk. However, animal reproductive toxicology studies showed
increased embryo-fetal loss and structural malformations in offspring. If this drug is used
during pregnancy, or if the patient becomes pregnant while taking this drug, the patient shouldbe apprised of the potential risks to the fetus.

Breastfeeding

It is not known whether CLOMID is excreted in human milk. Because many drugs are
excreted in human milk, caution should be exercised if CLOMID is administered to a
nursing woman. In some patients, CLOMID may reduce lactation.

Fertility

Oral administration of CLOMID to male rats at doses of 0.3 or 1 mg/kg/day caused
decreased fertility, while higher doses caused temporary infertility. Oral doses of 0.1
mg/kg/day in female rats temporarily interrupted the normal cyclic vaginal smear pattern
and prevented conception. Doses of 0.3 mg/kg/day slightly reduced the number of
ovulated ova and corpora lutea, while 3 mg/kg/day inhibited ovulation.

Ovarian Cancer

Prolonged use of clomiphene citrate tablets USP may increase the risk of a borderline or
invasive ovarian tumor.

Mechanism of Action

This is the specific biochemical interaction through which a drug or vaccine substance produces its pharmacological effect. This section also includes the minimum protective level designated for a certain disease.

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 replenishment
of intracellular estrogen receptors. Clomiphene citrate initiates a series of endocrine
events culminating in a preovulatory gonadotropin surge and subsequent follicular
rupture. The first endocrine event in response to a course of clomiphene therapy is an
increase in the release of pituitary gonadotropins. This initiates steroidogenesis and
folliculogenesis, resulting in growth of the ovarian follicle and an increase in the
circulating level of estradiol. Following ovulation, plasma progesterone and estradiol rise
and fall as they would in a normal ovulatory cycle.

Available data suggest that both the estrogenic and antiestrogenic properties of
clomiphene may participate in the initiation of ovulation. The two clomiphene isomers
have been found to have mixed estrogenic and antiestrogenic effects, which may vary from one species to another. Some data suggest that zuclomiphene has greater estrogenic
activity than enclomiphene.

Analytical Deep Dive

What is informed consent?

Alternatives

Looking for Clomid alternatives? Here are some products to research:

Rowe Casa Organics Ovary Health Drops

$17.60 with discount | For your first Rowe Casa Organics order, use discount code “JUSTTHEINSERTS” for 20% off.

This blend was created in response to requests from customers for something to help with their ovarian issues. We formulated this natural blend to help women who experience PCOS and other female reproductive health challenges, to address the root cause and bring comfort to unwanted ovarian pain.

⚠️ Please Note: This blend may interfere with oral contraceptives, use caution, and consider additional birth control if you are not planning to get pregnant but are still able to do so. *Always check with your doctor before using a new product or supplement if you have any questions or concerns about how a product may affect your current health, medications, pregnancy, or breastfeeding. 

Rowe Casa Organics Hormone Kit

$63.20 with discount | For your first Rowe Casa Organics order, use discount code “JUSTTHEINSERTS” for 20% off.

The glands in our endocrine system naturally produce and release different types of hormones into the bloodstream. However when an imbalance occurs – which could be due to one or more of several reasons, there can be too much or little of a hormone.

Hormones such as, estrogen, progesterone, even testosterone (both men and women need testosterone to lead an active life), and others in the right proportion play an essential role in regulating the different vital processes in a woman’s body – be it sleep, appetite, mood, menstrual cycle, sex drive, body temperature, or others.

Supporting your body’s natural balance of hormones is therefore necessary for overall mental and physical health as well as appearance. This is why Hormone Kit was designed to support you in balancing several key hormones in your body. Inside this kit you will find simple yet detailed instructions on how to use 4 of this best-selling blends to help you balance key hormones.

⚠️ Please Note: These hormone blends may interfere with oral contraceptives, use caution if you are not planning to get pregnant but are still able to do so. This kit is not recommended for use during pregnancy.

Dr. Green Life Fertility & Prenatal Nourishment (alcohol free) “JTI” for 10% off

This is a tonic herbal formula for use at all stages of the fertility journey.

• This beautiful formula contains nourishing herbs traditionally used in Western Herbalism to promote a healthy menstrual cycle and fertility
• These nutrient-rich herbs promote glowing good health, vitality, and strength
• Physician Formulated, cGMP, Third Party Tested
• Alcohol Free, Non-GMO, Gluten Free, Soy Free, Dairy Free, Vegan, Kosher