Clomid 50 mg
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10 tabs for $46.15 ($4.62 per tab)
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Clomid 50 mg is available from our online pharmacy for less money than you'd spend locally. If you like the convenience of ordering from your home, you can order your prescription online, or speak with one of our customer service representatives on the phone. Call us, The Drug Company, toll free at 1-888-254-3038. Prior to taking Clomid 50 mg, please consult with your doctor or health professional to see if this medication is right for you. Many customers have saved even more money by speaking with their doctor about a generic substitute.
Pharmacology
Clomiphene is an orally-administered, nonsteroidal agent which may induce ovulation in anovulatory women in appropriately selected cases. The ovulatory response to cyclic clomiphene therapy appears to be mediated through increased output of pituitary gonadotropins, which in turn stimulate the maturation and endocrine activity of the ovarian follicle and the subsequent development and function of the corpus luteum. The role of the pituitary is indicated by increased urinary excretion of gonadotropins and by the response of the ovary, as manifested by increased urinary estrogen excretion. Antagonism of competitive inhibition of endogenous estrogen may play a role in the action of clomiphene on the pituitary.
Clomiphene is a drug of considerable pharmacologic potency. Its administration should be preceded by careful evaluation and selection of the patient, and must be accompanied by close attention to the timing of the dose. With conservative selection and management of the patient, clomiphene has been demonstrated to be a useful therapy for the anovulatory patient.
Based on studies with 14C-labeled clomiphene, the drug is readily absorbed orally in humans, and is excreted principally in the feces. Cumulative excretion of the 14C-label averaged 51% of the oral dose after 5 days in 6 subjects, with mean urinary excretion of 8% and mean fecal excretion of 42%; less than 1% per day was excreted in fecal and urine samples collected from 31 to 53 days after 14C-labeled clomiphene administration. Since C-14 appeared in the feces 6 weeks after administration, available data suggested that the remaining drug/metabolites were being slowly excreted from a sequestered enterohepatic recirculation pool. After i.v. administration, 37% was excreted in 5 days.
Indications
For induction of ovulation in patients with persistent ovulatory dysfunction who desire pregnancy. The work-up and treatment of candidates for clomiphene therapy should be supervised by physicians experienced in management of gynecologic or endocrine disorders. Patients should be chosen for therapy with clomiphene only after careful diagnostic evaluation. The work-up of the patient must begin with a careful and detailed history of menstrual and reproductive function, and a complete physical examination. It should be followed by a selective and careful laboratory investigation based on historical and physical findings.
Clomiphene is indicated only in patients who meet the criteria or have been assessed as described below:
Exclusion of pregnancy: If any doubt exists as to the presence of early pregnancy, clomiphene therapy should be withheld until a diagnosis of pregnancy has been excluded.
Assessment of abnormal or excessive bleeding: Patients with abnormal or excessive bleeding should have particularly careful evaluation prior to clomiphene therapy. It is most important to ensure that neoplastic lesions are not overlooked (see also Contraindications).
Exclusion of presence or history of liver dysfunction: Clinical evaluation of liver function should always precede clomiphene therapy (see also Contraindications).
Exclusion of presence of ovarian cyst: Clomiphene should not be used in patients with ovarian enlargement except those with polycystic ovary syndrome. Pelvic examination is necessary prior to the first and each subsequent course of clomiphene treatment in order to rule out the presence of an ovarian cyst (see also Contraindications).
Confirmed ovulatory dysfunction: The diagnosis of ovulatory dysfunction should be established by such standard techniques as basal body temperature curves, serial vaginal smears, cervical mucus, endometrial biopsy, and pregnanediol determination.
Exclusion of primary pituitary or ovarian failure: Appropriate diagnostic measures should be undertaken to exclude primary pituitary failure or primary ovarian failure. Intact pituitary and ovaries are required for successful therapy. Ovulatory dysfunction in the presence of abnormally high levels of pituitary gonadotropins is indicative of ovarian failure, and patients in this category cannot be expected to respond to clomiphene.
Assessment of estrogen levels: Adequacy of endogenous estrogen, as estimated by vaginal smears, cervical mucus, endometrial biopsy, or urinary estrogen determination, furnishes a measure of ovarian function and indirectly of pituitary function. Bleeding after progesterone administration (progesterone alone, not combined with estrogen) furnishes evidence of an adequate level of endogenous estrogen. A good level of endogenous estrogen provides a favorable prognosis for treatment with clomiphene. A reduced estrogen level, although less favorable, does not always preclude successful therapy.
Exclusion of mechanical impediments to conception: Mechanical impediments to conception, such as tubal obstruction, should be excluded or adequately treated, before undertaking clomiphene therapy.
Exclusion of medical impediments to pregnancy: When disorders such as diabetes, adrenal disease, or thyroid disease are identified during the investigation, specific treatment should be undertaken and subfertility therapy reconsidered only after the underlying disorder has been adequately treated. Clomiphene cannot be expected to substitute for specific therapy of these conditions.
Exclusion of male factor infertility: The husband's potential fertility should be ascertained by semen analysis and other indicated examination. There are no adequate or well-controlled studies that demonstrate the effectiveness of clomiphene in the treatment of male infertility. In addition, testicular tumors and gynecomastia have been reported in males using clomiphene. The cause and effect relationship between reports of testicular tumors and the administration of clomiphene is not known.
Precautions
Lactation
It is not known whether clomiphene is excreted in human milk. Clomiphene may reduce lactation.
Carcinogenicity: Prolonged use of clomiphene may increase the risk of developing a borderline or invasive ovarian tumor.
Mutagenicity: Mutagenic potential of clomiphene has not been evaluated.
Pregnancy
(See also Contraindications and Adverse Effects, Birth Defects).
Teratogenic/Nonteratogenic Effects: The overall incidence of reported birth anomalies from pregnancies associated with maternal clomiphene ingestion during clinical studies was within the range of that reported for the general population.
Pregnancy Wastage: The experience from patients of all diagnoses during clinical investigation of clomiphene shows a pregnancy (single and multiple) wastage or fetal loss rate of 21.4% (abortion rate of 19.0%), ectopic pregnancies 1.18%, hydatidiform mole 0.17%, fetal papyraceous 0.04%, and pregnancies with one or more stillbirths 1.01%.
Multiple Pregnancy: The incidence of multiple pregnancy (including triplets, quadruplets and quintuplets) has been increased up to tenfold when conception takes place during a cycle in which clomiphene therapy is given. During the clinical investigation studies, the incidence of multiple pregnancy was 7.9% (186 of 2369 clomiphene associated pregnancies on which outcome was reported). Among these 2369 pregnancies, 165 (6.9%) were twin, 11 (0.5%) triplet, 7 (0.3%) quadruplet, and 3 (0.13%) quintuplet. Of the 165 twin pregnancies for which sufficient information was available, the ratio of monozygotic to dizygotic twins was 1:5. The patient and her husband should be advised of the frequency and potential hazards of multiple pregnancy before starting treatment.
Ectopic Pregnancy: There is an increased chance of ectopic pregnancy (including tubal and ovarian sites) in women who conceive following clomiphene therapy.
Supplied
Each white, rounded, flat-faced, beveled-edged, compressed tablet, scored on one side with “Clomid” debossed above score and “50” debossed below score, other side plain, contains: clomiphene citrate USP 50 mg. Nonmedicinal ingredients: cornstarch, lactose monohydrate, magnesium stearate, pregelatinized starch and sucrose. Energy: 4.5 kJ (1.1 kcal)/tablet. Unit pack boxes of 50 (5×10 blister packed). Protect from light and moisture.
Contraindications
Pregnancy
Clomiphene should not be administered during pregnancy. Although no causative evidence of a deleterious effect of clomiphene therapy on the human fetus has been established, such evidence in regard to the rat and the rabbit has been presented (see Precautions). To avoid inadvertent clomiphene administration during early pregnancy, careful pelvic examination must be done prior to each course of therapy, the basal body temperature must be recorded throughout all treatment cycles, and the patient should be carefully observed to determine whether ovulation occurs. If the basal body temperature following clomiphene is biphasic and is not followed by menses, the patient should be examined carefully for the presence of an ovarian cyst and should have a pregnancy test. The next course of therapy should be delayed until the possibility of pregnancy has been excluded.
Liver Disease: Clomiphene therapy is contraindicated in patients with liver disease or a history of liver dysfunction.
Hormone-dependent Tumors or Abnormal Uterine Bleeding: Clomiphene is contraindicated in patients with hormone-dependent tumors and in patients with abnormal uterine bleeding of undetermined origin. Clomiphene is not indicated for the management of menstrual disorders.
Ovarian Cyst: Clomiphene 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 ovarian cyst prior to each course of treatment.
Hypersensitivity: Clomiphene is contraindicated in patients with a known hypersensitivity or allergy to clomiphene or any of its ingredients.
Warnings
Occupational Hazards
Visual Symptoms: Patients should be advised that blurring or other visual symptoms such as spots or flashes (scintillating scotomata) may occasionally occur during therapy or shortly after therapy with clomiphene. Patients should be warned that 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 disturbances are usually reversible; however, cases of prolonged visual disturbance have been reported even after clomiphene discontinuation. The visual disturbances may be irreversible, especially with increased dosage or duration of therapy. The significance of these visual symptoms is not yet understood (see Adverse Effects). If the patient has any visual symptoms, treatment should be discontinued and complete ophthalmologic evaluation carried out.
Adverse Effects
Laboratory
Clomiphene has not been reported to cause significant abnormality in the hematologic or renal systems, in protein bound iodine, or in serum cholesterol. Analysis by gas liquid chromatography (GLC) of serum sterols from patients on prolonged, continuous administration of clomiphene yields a peak compatible with an elevated level of desmosterol. This peak is indicative of an interference with cholesterol synthesis. However, the serum sterol GLC pattern from patients receiving recommended doses of clomiphene is not significantly altered.
Postmarketing Surveillance
Other than the adverse events reported above, the following adverse events were reported in postmarketing surveillance data.
Special Senses
Abnormal accomodation, eye pain, macular edema, photopsia, posterior vitreous detachment, retinal hemorrhage, retinal thrombosis, retinal vascular spasm, and temporary loss of vision.
Other
Leukocytosis and thyroid disorder have also been reported.
Tumors/Neoplasms
Liver (hepatic hemangiosarcoma, liver cell adenoma, hepatocellular carcinoma); breast (fibrocystic disease, breast carcinoma); endometrium (endometrial carcinoma); nervous system (astrocytoma, pituitary tumor, prolactinoma, neurofibromatosis, glioblastoma multiforme, brain abscess); trophoblastic (hydatidiform mole, choriocarcinoma); miscellaneous (melanoma, myeloma, perianal cysts, renal cell carcinoma, Hodgkin's lymphoma, tongue carcinoma, bladder carcinoma); and neoplasms of offspring (neuroectodermal tumor, thyroid tumor, hepatoblastoma, lymphocytic leukemia).
Isolated reports have been received on the occurrence of endocrine-related or dependent tumors/neoplasms or their aggravation.
Birth Defects
The following fetal abnormalities have also been reported: delayed development; abnormal bone development including skeletal malformations of the skull, face, nasal passages, jaw, hand, limb (ectromelia including amelia, hemimelia, and phocomelia), foot and joints; tissue malformations including imperforate anus, tracheosophageal fistula, diaphragmatic hernia, renal agenesis and dysgenesis, and malformations of the eye and lens (cataract), ear, lung, heart (ventricular septal defect and tetralogy of Fallot), and genitalia; as well as dwarfism, deafness, mental retardation, chromosomal disorders, and neural tube defects (including anencephaly).
Body as a Whole
fever, tinnitus and weakness have also been reported.
Psychiatric
Anxiety, irritability, mood changes, and psychosis have also been reported.
Genitourinary
There are reports of new cases of endometriosis and exacerbation of pre-existing endometriosis during clomiphene therapy.
Musculoskeletal
arthralgia, back pain, myalgia.
Gastrointestinal System
Sulfobromophthalein (BSP) retention of greater than 5% has been reported in 32 of 141 patients in whom it was measured, including 5 of 43 patients who received approximately the dose of clomiphene now recommended. Retention was usually minimal unless associated with prolonged continuous clomiphene administration or with apparently unrelated liver disease. In some patients, pre-existing BSP retention decreased even though clomiphene therapy was continued. Other liver function tests were usually normal. In a later study in which patients were given 6 consecutive monthly courses of clomiphene (100 mg daily for 3 days) or matching placebo, BSP tests were done on 94 patients. Values in excess of 5% retention were recorded in 11 patients, 6 of whom had received drug and 5 placebo. One patient developed jaundice on the 19th day of treatment (50 mg/day); liver biopsy revealed bile stasis without evidence of hepatitis. A male prison subject who received 200 mg daily for 77 days developed the clinical picture of infectious hepatitis; his cellmate was discovered to have had infectious hepatitis 4 months earlier.
Central Nervous System
Migraine headache, paresthesia, stroke and syncope have been reported. Seizures have been observed rarely with clomiphene therapy.
Genitourinary System
At recommended dosage, abnormal ovarian enlargement (see also Warnings) is infrequent, although the usual cyclic variation in ovarian size may be exaggerated. Similarly, cyclic ovarian pain (mittelschmerz) may be accentuated. With higher or prolonged dosage, more frequent ovarian enlargement and cyst formation (usually luteal) may occur, and the luteal phase of the cycle may be prolonged. Rare instances of massive ovarian enlargement are on record. Southam and Janovski described such an instance in a patient with polycystic ovary syndrome whose clomiphene therapy consisted of 100 mg daily for 14 days. Abnormal ovarian enlargement usually regresses spontaneously, and while laparotomy was performed on several such patients, investigators believe most of these patients should have been treated conservatively.
Multiple pregnancies, (see also Precautions), including simultaneous intrauterine and extrauterine pregnancies, ovarian hemorrhage, tubal pregnancy, uterine hemorrhage have been reported.
Dermatologic
rash, urticaria, acne, allergic reaction, erythema, erythema multiforme, erythema nodosum, hypertrichosis, pruritus.
Cardiovascular
arrhythmia, chest pain, edema, hypertension, palpitation, phlebitis, pulmonary embolism, shortness of breath, tachycardia, thrombophlebitis.
Hepatic
transaminases increased, hepatitis.
Overdose
Treatment
There is no known antidote but gastric lavage and other appropriate supportive measures should be performed.
Dosage
Pregnancy
The importance of properly timed coitus cannot be over-emphasized. In most patients, ovulation appears to occur from 6 to 12 days after completion of therapy. For regularity of cyclic ovulatory response it is also important that each course of clomiphene be started on or about the 5th cycle day, once ovulation has been established. In common with other therapeutic modalities, clomiphene therapy follows the rule of diminishing returns, such that likelihood of conception diminishes with each succeeding course of therapy. If pregnancy has not been achieved after 3 ovulatory responses to clomiphene, further treatment is not recommended. Patients should be advised of the possibility of multiple pregnancy and its potential hazards if conception occurs during a cycle in which clomiphene is given.
Long-term Cyclic Therapy Not Recommended: Since the relative safety of long-term cyclic therapy has not yet been conclusively demonstrated, and since the majority of patients will ovulate following 3 courses, long-term cyclic therapy is not recommended, i.e., beyond a total of about 6 cycles (including 3 ovulatory cycles).
