Treating female infertility in certain women. It may also be used for other conditions as determined by your doctor.
Klomen is an ovulatory stimulant. It works by increasing certain hormones, which causes your ovaries to release mature eggs.
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
Klomen® (Klomen tablets USP) is indicated for the treatment of ovulatory dysfunction in women desiring pregnancy. Impediments to achieving pregnancy must be excluded or adequately treated before beginning Klomen 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.
Properly timed coitus in relationship to ovulation is important. A basal body temperature graph or other appropriate tests may help the patient and her physician determine if ovulation occurred. Once ovulation has been established, each course of Klomen therapy should be started on or about the 5th day of the cycle. Long-term cyclic therapy is not recommended beyond a total of about six cycles (including three ovulatory cycles).
Klomen® (Klomen tablets USP) is indicated only in patients with demonstrated ovulatory dysfunction who meet the conditions described below :
1. Patients who are not pregnant.
2. Patients without ovarian cysts. Klomen should not be used in patients with ovarian enlargement except in those with polycystic ovary syndrome. Pelvic examination is necessary prior to the first and each subsequent course of Klomen treatment.
3. Patients without abnormal vaginal bleeding. If abnormal vaginal bleeding is present, the patient should be carefully evaluated to ensure that neoplastic lesions are not present.
4. Patients with normal liver function.
In addition, patients selected for Klomen therapy should be evaluated in regard to the following:
1. Estrogen Levels. Patients should have adequate levels of endogenous estrogen (as estimated from vaginal smears, endometrial biopsy, assay of urinary estrogen, or from bleeding in response to progesterone). Reduced estrogen levels, while less favorable, do not preclude successful therapy.
2. Primary Pituitary or Ovarian Failure. Klomen therapy cannot be expected to substitute for specific treatment of other causes of ovulatory failure.
3. Endometriosis and Endometrial Carcinoma. The incidence of endometriosis and endometrial carcinoma increases with age as does the incidence of ovulatory disorders. Endometrial biopsy should always be performed prior to Klomen therapy in this population.
4. Other Impediments to Pregnancy. Impediments to pregnancy can include thyroid disorders, adrenal disorders, hyperprolactinemia, and male factor infertility.
5. Uterine Fibroids. Caution should be exercised when using Klomen in patients with uterine fibroids due to the potential for further enlargement of the fibroids.
There are no adequate and well-controlled studies that demonstrate the effectiveness of Klomen 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 Klomen is not known.
Although the medical literature suggests various methods, there is no universally accepted standard regimen for combined therapy (i.e., Klomen in conjunction with other ovulation-inducing drugs). Similarly, there is no standard Klomen regimen for ovulation induction in in vitro fertilization programs to produce ova for fertilization and reintroduction. Therefore, Klomen® is not recommended for these uses.
How should I use Klomen?
Use Klomen as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Take Klomen by mouth with or without food.
Properly timed sexual intercourse is important for good results. Ovulation usually occurs 5 to 10 days after a course of Klomen.
If you do not ovulate or become pregnant after 3 courses of treatment, further treatment is not recommended. Long-term use of Klomen is not recommended.
If you miss a dose of Klomen, contact your doctor right away.
Ask your health care provider any questions you may have about how to use Klomen.
Uses of Klomen in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
Klomen is used to treat infertility in women caused by failure or improper release of eggs from ovary (ovulation).It is also used to treat infertility in males due to decreased production of sperms (oligozoospermia).
Klomen is 2-[ρ-(2-chloro-1,2-diphenylvinyl)phenoxy] triethylamine dihydrogen citrate.
Klomen is a chemical analog of other triarylethylene compounds eg, chlorotrianisene and the cholesterol inhibitor, triparanol.
General Considerations: Physicians experienced in managing gynecologic or endocrine disorders should supervise the work-up and treatment of candidate patients for Klomen therapy. Patients should be chosen for Klomen therapy only after careful diagnostic evaluation. The plan of therapy should be outlined in advance. Impediments to achieving the goal of therapy must be excluded or adequately treated before beginning Klomen.
In determining a starting dose schedule, efficacy must be balanced against potential side effects. For example, the available data so far suggests that ovulation and pregnancy are slightly more attainable with 100 mg/day for 5 days than with 50 mg/day for 5 days. As the dosage is increased, however, ovarian overstimulation and other side effects may be expected to increase. Although the data do not yet establish a relationship between dose level and multiple births, it is reasonable that such a correlation exists on pharmacologic grounds.
For these reasons, treatment of the usual patient should initiate with a 50-mg daily dose for 5 days. The dose may be increased only in those patients who do not respond to the 1st course. Special treatment with lower dosage over shorter duration is particularly recommended if unusual sensitivity to pituitary gonadotropin is suspected, including patients with polycystic ovarian syndrome.
Dosage: First Course of Klomen: 50 mg (1 tablet) daily for 5 days. Therapy may be started at any time if the patient has had no recent uterine bleeding. If progestin-induced bleeding is intended, or if spontaneous uterine bleeding occurs prior to therapy, the regimen of 50 mg daily for 5 days should be started on or about the 5th day of the cycle. When ovulation occurs at this dosage, there is no advantage to increasing the dose in subsequent cycles of treatment.
If ovulation does not appear to have occurred after the 1st course of therapy, a 2nd course of 100 mg daily (two 50-mg tablets given as a single daily dose) for 5 days may be started. This course may begin as early as 30 days after the previous one. Increasing the dosage or duration of therapy beyond 100 mg/day for 5 days should not be undertaken.
The majority of patients who respond do so during the 1st course of therapy and 3 courses constitute an adequate therapeutic trial. If ovulatory menses do not occur, the diagnosis should be re-evaluated. Treatment beyond this is not recommended in the patient who does not exhibit evidence of ovulation.
Pregnancy: Properly timed coitus is very important for good results. For regularity of cyclic ovulatory response, it is also important that each course of Klomen be started on or about the 5th day of the cycle, once ovulation has been established. As with other therapeutic modalities, Klomen therapy follows the rule of diminishing returns, such that the likelihood of conception diminishes with each succeeding course of therapy. If pregnancy has not been achieved after 3 ovulatory responses to Klomen, further treatment is not generally recommended.
* If you think you might be pregnant, stop taking this medicine and tell your doctor. Talk to your doctor before taking this medicine if you have thyroid problems. Multiple births (such as twins or triplets) are possible when taking clomiphene. This medicine may cause changes in vision such as blurring or trouble focusing.
In addition to its needed effects, some unwanted effects may be caused by clomiphene (the active ingredient contained in Klomen). In the event that any of these side effects do occur, they may require medical attention.
Major Side Effects
You should check with your doctor immediately if any of these side effects occur when taking clomiphene:
stomach or pelvic pain
If any of the following side effects occur while taking clomiphene, check with your doctor or nurse as soon as possible:
Less common or rare:
decreased or double vision or other vision problems
seeing flashes of light
sensitivity of eyes to light
yellow eyes or skin
Minor Side Effects
Some of the side effects that can occur with clomiphene may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:
Less common or rare:
dizziness or lightheadedness
heavy menstrual periods or bleeding between periods
Klomen® is contraindicated in patients with a known hypersensitivity or allergy to Klomen or to any of its ingredients.
Klomen® should not be administered during pregnancy. Klomen may cause fetal harm in animals. Although no causative evidence of a deleterious effect of Klomen therapy on the human fetus has been established, there have been reports of birth anomalies which, during clinical studies, occurred at an incidence within the range reported for the general population.
To avoid inadvertent Klomen administration during early pregnancy, appropriate tests should be utilized during each treatment cycle to determine whether ovulation occurs. The patient should be evaluated carefully to exclude pregnancy, ovarian enlargement, or ovarian cyst formation between each treatment cycle. The next course of Klomen therapy should be delayed until these conditions have been excluded.
Fetal/Neonatal Anomalies and Mortality. The following fetal abnormalities have been reported subsequent to pregnancies following ovulation induction therapy with Klomen during clinical trials. Each of the following fetal abnormalities were reported at a rate of <1% (experiences are listed in order of decreasing frequency): Congenital heart lesions, Down syndrome, club foot, congenital gut lesions, hypospadias, microcephaly, harelip and cleft palate, congenital hip, hemangioma, undescended testicles, polydactyly, conjoined twins and teratomatous malformation, patent ductus arteriosus, amaurosis, arteriovenous fistula, inguinal hernia, umbilical hernia, syndactyly, pectus excavatum, myopathy, dermoid cyst of scalp, omphalocele, spina bifida occulta, ichthyosis, and persistent lingual frenulum. Neonatal death and fetal death/stillbirth in infants with birth defects have also been reported at a rate of <1%. The overall incidence of reported birth anomalies from pregnancies associated with maternal Klomen ingestion during clinical studies was within the range of that reported for the general population.
In addition, reports of birth anomalies have been received during postmarketing surveillance of Klomen..
Oral administration of Klomen to pregnant rats during organogenesis at doses of 1 to 2 mg/kg/day resulted in hydramnion and weak, edematous fetuses with wavy ribs and other temporary bone changes. Doses of 8 mg/kg/day or more also caused increased resorptions and dead fetuses, dystocia, and delayed parturition, and 40 mg/kg/day resulted in increased maternal mortality. Single doses of 50 mg/kg caused fetal cataracts, while 200 mg/kg caused cleft palate.
Following injection of Klomen 2 mg/kg to mice and rats during pregnancy, the offspring exhibited metaplastic changes of the reproductive tract. Newborn mice and rats injected during the first few days of life also developed metaplastic changes in uterine and vaginal mucosa, as well as premature vaginal opening and anovulatory ovaries. These findings are similar to the abnormal reproductive behavior and sterility described with other estrogens and antiestrogens.
In rabbits, some temporary bone alterations were seen in fetuses from dams given oral doses of 20 or 40 mg/kg/day during pregnancy, but not following 8 mg/kg/day. No permanent malformations were observed in those studies. Also, rhesus monkeys given oral doses of 1.5 to 4.5 mg/kg/day for various periods during pregnancy did not have any abnormal offspring.
Liver Disease. Klomen therapy is contraindicated in patients with liver disease or a history of liver dysfunction.
Abnormal Uterine Bleeding. Klomen is contraindicated in patients with abnormal uterine bleeding of undetermined origin.
Ovarian Cysts. Klomen is contraindicated in patients with ovarian cysts or enlargement not due to polycystic ovarian syndrome.
Other. Klomen is contraindicated in patients with uncontrolled thyroid or adrenal dysfunction or in the presence of an organic intracranial lesion such as pituitary tumor.
The results of a survey conducted on ndrugs.com for Klomen are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Klomen. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
4 consumers reported useful
Was the Klomen drug useful in terms of decreasing the symptom or the disease? According to the reports released by ndrugs.com website users, the below mentioned percentages of users say the drug is useful / not useful to them in decreasing their symptoms/disease. The usefulness of the drug depends on many factors, like severity of the disease, perception of symptom, or disease by the patient, brand name used [matters only to a certain extent], other associated conditions of the patient. If the drug is not effective or useful in your case, you need to meet the doctor to get re-evaluated about your symptoms/disease, and he will prescribe an alternative drug.
4 consumers reported price estimates
Was the price you paid to purchase the drug reasonable? Did you feel it was expensive? The below mentioned numbers have been reported by ndrugs.com website users about whether the Klomen drug is expensive or inexpensive. There is a mixed opinion among users. The rating about the cost of the drug depends on factors like which brand drug the patient purchased, how effective it was for the price paid, the country or place the drug is marketed, and the economic condition of the patient. The users who feel the drug is expensive can look for an alternative brand drug or a generic drug to save the cost.
14 consumers reported time for results
To what extent do I have to use Klomen before I begin to see changes in my health conditions? As part of the reports released by ndrugs.com website users, it takes 5 days and a few days before you notice an improvement in your health conditions. Please note, it doesn't mean you will start to notice such health improvement in the same time frame as other users. There are many factors to consider, and we implore you to visit your doctor to know how long before you can see improvements in your health while taking Klomen. To get the time effectiveness of using Klomen drug by other patients, please click here.
11 consumers reported age
There are no reviews yet. Be the first to write one!