Fertyl M Uses

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What is Fertyl M?

Fertyl M 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).

Fertyl M is used to cause ovulation in women with certain medical conditions (such as polycystic ovary syndrome) that prevent naturally occurring ovulation.

Fertyl M may also be used for purposes not listed in this medication guide.

Fertyl M indications

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.
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Fertyl M 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 Fertyl M tablets USP therapy. Those patients most likely to achieve success with Fertyl M 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 Fertyl M tablets USP 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).

Fertyl M 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. Fertyl M tablets USP 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 Fertyl M tablets USP 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 Fertyl M tablets USP 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. Fertyl M tablets USP 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 Fertyl M tablets USP 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 Fertyl M tablets USP in patients with uterine fibroids due to the potential for further enlargement of the fibroids.

There are no adequate or well-controlled studies that demonstrate the effectiveness of Fertyl M tablets USP in the treatment of male infertility. In addition, testicular tumors and gynecomastia have been reported in males using Fertyl M. The cause and effect relationship between reports of testicular tumors and the administration of Fertyl M tablets USP is not known.

Although the medical literature suggests various methods, there is no universally accepted standard regimen for combined therapy (ie, Fertyl M tablets USP in conjunction with other ovulation-inducing drugs). Similarly, there is no standard Fertyl M tablets USP regimen for ovulation induction in in vitro fertilization programs to produce ova for fertilization and reintroduction. Therefore, Fertyl M tablets USP is not recommended for these uses.

How should I use Fertyl M?

Use Fertyl M as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Fertyl M.

Uses of Fertyl M 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.
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Use: Labeled Indications

Treatment of ovulatory dysfunction: Treatment of ovulatory dysfunction in women desiring pregnancy

Fertyl M description

Fertyl M is 2-[ρ-(2-chloro-1,2-diphenylvinyl)phenoxy] triethylamine dihydrogen citrate.

Fertyl M is a chemical analog of other triarylethylene compounds eg, chlorotrianisene and the cholesterol inhibitor, triparanol.

Fertyl M dosage

General Considerations

The workup and treatment of candidates for Fertyl M tablets USP therapy should be supervised by physicians experienced in management of gynecologic or endocrine disorders. Patients should be chosen for therapy with Fertyl M tablets USP 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 Fertyl M tablets USP. The therapeutic objective should be balanced with potential risks and discussed with the patient and others involved in the achievement of a pregnancy.

Ovulation most often occurs from 5 to 10 days after a course of Fertyl M tablets USP. Coitus should be timed to coincide with the expected time of ovulation. Appropriate tests to determine ovulation may be useful during this time.

Recommended Dosage

Treatment of the selected patient should begin with a low dose, 50 mg daily (1 tablet) for 5 days. The dose should be increased only in those patients who do not ovulate in response to cyclic 50 mg Fertyl M tablets USP. A low dosage or duration of treatment course is particularly recommended if unusual sensitivity to pituitary gonadotropin is suspected, such as in patients with polycystic ovary syndrome.

The patient should be evaluated carefully to exclude pregnancy, ovarian enlargement, or ovarian cyst formation between each treatment cycle.

If progestin-induced bleeding is planned, 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. Therapy may be started at any time in the patient who has had no recent uterine bleeding. 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 occur after the first course of therapy, a second course of 100 mg daily (two 50 mg tablets given as a single daily dose) for 5 days should be given. This course may be started as early as 30 days after the previous one after precautions are taken to exclude the presence of pregnancy. Increasing the dosage or duration of therapy beyond 100 mg/day for 5 days is not recommended.

The majority of patients who are going to ovulate will do so after the first course of therapy. If ovulation does not occur after three courses of therapy, further treatment with Fertyl M tablets USP is not recommended and the patient should be reevaluated. If three ovulatory responses occur, but pregnancy has not been achieved, further treatment is not recommended. If menses does not occur after an ovulatory response, the patient should be reevaluated. Long-term cyclic therapy is not recommended beyond a total of about 6 cycles.

Fertyl M interactions

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What other drugs will affect Fertyl M?

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* 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 Fertyl M. This medicine may cause changes in vision such as blurring or trouble focusing.

* If this becomes severe, tell your doctor.

* Be careful driving or operating machinery.

Fertyl M side effects

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What are the possible side effects of Fertyl M?

Clinical Trial Adverse Events. Fertyl M tablets USP, at recommended dosages, is generally well tolerated. Adverse reactions usually have been mild and transient and most have disappeared promptly after treatment has been discontinued. Adverse experiences reported in patients treated with Fertyl M during clinical studies are shown in Table 2.

Table 2. Incidence of Adverse Events in Clinical Studies (Events Greater than 1%) (n = 8029*)
Adverse Event %
Ovarian Enlargement 13.6
Vasomotor Flushes 10.4
Abdominal-Pelvic Discomfort/Distention/Bloating 5.5
Nausea and Vomiting 2.2
Breast Discomfort 2.1
Visual Symptoms 1.5
Blurred vision, lights, floaters, waves, unspecified visual complaints, photophobia, diplopia, scotomata, phosphenes
Headache 1.3
Abnormal Uterine Bleeding 1.3
Intermenstrual spotting, menorrhagia

* Includes 498 patients whose reports may have been duplicated in the event totals and could not be distinguished as such. Also, excludes 47 patients who did not report symptom data.

The following adverse events have been reported in fewer than 1% of patients in clinical trails: Acute abdomen, appetite increase, constipation, dermatitis or rash, depression, diarrhea, dizziness, fatigue, hair loss/dry hair, increased urinary frequency/volume, insomnia, light-headedness, nervous tension, vaginal dryness, vertigo, weight gain/loss.

Patients on prolonged Fertyl M tablets USP therapy may show elevated serum levels of desmosterol. This is most likely due to a direct interference with cholesterol synthesis. However, the serum sterols in patients receiving the recommended dose of Fertyl M tablets USP are not significantly altered. Ovarian cancer has been infrequently reported in patients who have received fertility drugs. Infertility is a primary risk factor for ovarian cancer; however, epidemiology data suggest that prolonged use of Fertyl M may increase the risk of a borderline or invasive ovarian tumor.

Postmarketing Adverse Events

The following adverse reactions have been identified during post approval use of Fertyl M. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Body as a Whole: Fever, tinnitus, weakness

Cardiovascular: Arrhythmia, chest pain, edema, hypertension, palpitation, phlebitis, pulmonary embolism, shortness of breath, tachycardia, thrombophlebitis

Central Nervous System: Migraine headache, paresthesia, seizure, stroke, syncope

Dermatologic: Acne, allergic reaction, erythema, erythema multiforme, erythema nodosum, hypertrichosis, pruritus, urticaria

Fetal/Neonatal Anomalies:

• Abnormal bone development: skeletal malformations of the skull, face, nasal passages, jaw, hand, limb (ectromelia including amelia, hemimelia, and phocomelia), foot (clubfoot), spine, and joints

• Cardiac abnormalities: septal heart defects, muscular ventricular septal defect, patent ductus arteriosus, tetralogy of Fallot, and coarctation of the aorta

• Chromosomal disorders: Downs syndrome

• Ear abnormalities and deafness

• Gastrointestinal tract abnormalities: cleft lip and palate, imperforate anus, tracheoesophageal fistula, diaphragmatic hernia, omphalocele

• Genitalia abnormalities: hypospadias, cloacal exstrophy

• Lung tissue malformations

• Malformations of the eye and lens (cataract)

• Neoplasms: neuroectodermal tumor, thyroid tumor, hepatoblastoma, lymphocytic leukemia

• Nervous system abnormalities: neural tube defects (anencephaly, meningomyelocele), microcephaly, and hydrocephalus

• Renal abnormalities: renal agenesis and renal dysgenesis

• Others: dwarfism, mental retardation

Gastrointestinal: Pancreatitis

Genitourinary: Endometriosis, ovarian cyst (ovarian enlargement or cysts could, as such, be complicated by adnexal torsion), ovarian hemorrhage, tubal pregnancy, uterine hemorrhage, reduced endometrial thickness

Hepatic: Transaminases increased, hepatitis

Metabolism Disorders: Hypertriglyceridemia, in some cases with pancreatitis

Musculoskeletal: Arthralgia, back pain, myalgia

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 abcess); ovary (luteoma of pregnancy, dermoid cyst of the ovary, ovarian carcinoma); trophoblastic (hydatiform mole, choriocarcinoma); miscellaneous (melanoma, myeloma, perianal cysts, renal cell carcinoma, Hodgkin's lymphoma, tongue carcinoma, bladder carcinoma)

Psychiatric: Anxiety, irritability, mood changes, psychosis -

Visual Disorders: Abnormal accommodation, cataract, eye pain, macular edema, optic neuritis, photopsia, posterior vitreous detachment, retinal hemorrhage, retinal thrombosis, retinal vascular spasm, temporary or prolonged loss of vision, possibly irreversible

Other: Leukocytosis, thyroid disorder

Fertyl M contraindications

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What is the most important information I should know about Fertyl M?

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Hypersensitivity

Fertyl M tablets USP is contraindicated in patients with a known hypersensitivity or allergy to Fertyl M or to any of its ingredients.

Pregnancy

Pregnancy Category X. Fertyl M tablets USP use in pregnant women is contraindicated, as Fertyl M 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. Fertyl M tablets USP therapy is contraindicated in patients with liver disease or a history of liver dysfunction.

Abnormal Uterine Bleeding. Fertyl M tablets USP is contraindicated in patients with abnormal uterine bleeding of undetermined origin.

Ovarian Cysts. Fertyl M tablets USP is contraindicated in patients with ovarian cysts or enlargement not due to polycystic ovarian syndrome.

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



Active ingredient matches for Fertyl M:

Clomiphene Citrate

Clomifene


Unit description / dosage (Manufacturer)Price, USD
Fertyl M 25 mg Tablet$ 0.07
FERTYL M 25 MG TABLET 1 strip / 30 tablets each (Ar-Ex Laboratories Pvt Ltd)$ 2.02
Fertyl M 25mg Tablet (Ar-Ex Laboratories Pvt Ltd)$ 0.09

List of Fertyl M substitutes (brand and generic names):

Fertyl Super 100 mg Tablet (Ar-Ex Laboratories Pvt.Ltd.)$ 0.21
Fetrop Clomifene Citrate 25mg TAB / 100 (Radix (Solitaire Pharmacia Pvt Ltd))
Fetrop Clomifene Citrate 50mg TAB / 100 (Radix (Solitaire Pharmacia Pvt Ltd))$ 9.21
Fetrop Clomifene Citrate 100mg TAB / 100 (Radix (Solitaire Pharmacia Pvt Ltd))$ 15.08
25 mg x 100's (Radix (Solitaire Pharmacia Pvt Ltd))
50 mg x 100's (Radix (Solitaire Pharmacia Pvt Ltd))$ 9.21
100 mg x 100's (Radix (Solitaire Pharmacia Pvt Ltd))$ 15.08
Fetrop 100 mg Tablet (Radix (Solitaire Pharmacia Pvt Ltd))$ 0.15
Fetrop 50 mg Tablet (Radix (Solitaire Pharmacia Pvt Ltd))$ 0.09
Fetrop 25mg TAB / 100 (Radix (Solitaire Pharmacia Pvt Ltd))
Fetrop 50mg TAB / 100 (Radix (Solitaire Pharmacia Pvt Ltd))$ 9.21
Fetrop 100mg TAB / 100 (Radix (Solitaire Pharmacia Pvt Ltd))$ 15.08
FETROP tab 25 mg x 10's (Radix (Solitaire Pharmacia Pvt Ltd))
FETROP tab 50 mg x 10's (Radix (Solitaire Pharmacia Pvt Ltd))$ 0.92
FETROP tab 100 mg x 10's (Radix (Solitaire Pharmacia Pvt Ltd))$ 1.51
Fission 50mg TAB / 10x10 (Biocin Genetics & Pharma)$ 11.90
Fission 50 mg Tablet (Biocin Genetics & Pharma)$ 0.08
Fission 25 mg Tablet (Biocin Genetics & Pharma)$ 0.04
FISSION tab 50 mg x 10's (Biocin Genetics & Pharma)$ 1.19
Focel 50 mg
FOLISTIM Capsule/ Tablet / 100mg / 10 units (Zydus Biogen (Zydus Cadila Healthcare Ltd))$ 1.85
FOLISTIM Capsule/ Tablet / 50mg / 10 units (Zydus Biogen (Zydus Cadila Healthcare Ltd))$ 0.94
Folistim 50mg TAB / 10 (Zydus Biogen (Zydus Cadila Healthcare Ltd))$ 0.87
Folistim 100mg TAB / 10 (Zydus Biogen (Zydus Cadila Healthcare Ltd))$ 1.71
50 mg x 10's (Zydus Biogen (Zydus Cadila Healthcare Ltd))$ 0.87
100 mg x 10's (Zydus Biogen (Zydus Cadila Healthcare Ltd))$ 1.71
Folistim 100 mg Tablet (Zydus Biogen (Zydus Cadila Healthcare Ltd))$ 0.17
Folistim 50 mg Tablet (Zydus Biogen (Zydus Cadila Healthcare Ltd))$ 0.09
FOLISTIM 50MG TABLET 1 strip / 10 tablets each (Zydus Biogen (Zydus Cadila Healthcare Ltd))$ 0.93
FOLISTIM tab 50 mg x 10's (Zydus Biogen (Zydus Cadila Healthcare Ltd))$ 0.87
FOLISTIM tab 100 mg x 10's (Zydus Biogen (Zydus Cadila Healthcare Ltd))$ 1.71
Folistim 50mg TAB / 10 (Zydus Biogen (Zydus Cadila Healthcare Ltd))$ 0.87
Folistim 100mg TAB / 10 (Zydus Biogen (Zydus Cadila Healthcare Ltd))$ 1.71
Folistim 50mg Tablet (Zydus Biogen (Zydus Cadila Healthcare Ltd))$ 0.09
Fulfyl 50 mg Tablet (Micro Nova Pharmaceuticals Ltd.)$ 0.08
Fulfyl 25 mg Tablet (Micro Nova Pharmaceuticals Ltd.)$ 0.04
FULFYL 25 MG TABLET 1 strip / 10 tablets each (Micro Nova Pharmaceuticals Ltd.)$ 0.23
Fulfyl 25mg Tablet (Micro Nova Pharmaceuticals Ltd.)$ 0.02
Fulfyn 25mg TAB / 10 (Micro Labs Ltd)$ 0.44
Fulfyn 50mg TAB / 10 (Micro Labs Ltd)$ 0.80
25 mg x 10's (Micro Labs Ltd)$ 0.44
50 mg x 10's (Micro Labs Ltd)$ 0.80
Fulfyn 25 mg Tablet (Micro Labs Ltd)$ 0.04
Fulfyn 50 mg Tablet (Micro Labs Ltd)$ 0.08
FULFYN tab 25 mg x 10's (Micro Labs Ltd)$ 0.44
FULFYN tab 50 mg x 10's (Micro Labs Ltd)$ 0.80
Gamet 50mg Tablet (Eskag Pharma Pvt Ltd)$ 0.13
GAMET 50 MG TABLET 1 strip / 5 tablets each (Eskag Pharma Pvt Ltd)$ 0.63

References

  1. PubChem. "clomiphene". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  2. DrugBank. "clomiphene". http://www.drugbank.ca/drugs/DB00882 (accessed September 17, 2018).
  3. MeSH. "Selective Estrogen Receptor Modulators". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Fertyl M 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 Fertyl M. 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.

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To what extent do I have to use Fertyl M before I begin to see changes in my health conditions?
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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 Fertyl M. To get the time effectiveness of using Fertyl M drug by other patients, please click here.
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