Goodova

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

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

Melatonin (Goodova) is a biogenic amine that is found in animals, plants and microbes. Aaron B. Lerner of Yale University is credited for naming the hormone and for defining its chemical structure in 1958. In mammals, Melatonin (Goodova) is produced by the pineal gland. The pineal gland is small endocrine gland, about the size of a rice grain and shaped like a pine cone (hence the name), that is located in the center of the brain (rostro-dorsal to the superior colliculus) but outside the blood-brain barrier. The secretion of Melatonin (Goodova) increases in darkness and decreases during exposure to light, thereby regulating the circadian rhythms of several biological functions, including the sleep-wake cycle. In particular, Melatonin (Goodova) regulates the sleep-wake cycle by chemically causing drowsiness and lowering the body temperature. Melatonin (Goodova) is also implicated in the regulation of mood, learning and memory, immune activity, dreaming, fertility and reproduction. Melatonin (Goodova) is also an effective antioxidant. Most of the actions of Melatonin (Goodova) are mediated through the binding and activation of Melatonin (Goodova) receptors. Individuals with autism spectrum disorders (ASD) may have lower than normal levels of Melatonin (Goodova). A 2008 study found that unaffected parents of individuals with ASD also have lower Melatonin (Goodova) levels, and that the deficits were associated with low activity of the ASMT gene, which encodes the last enzyme of Melatonin (Goodova) synthesis. Reduced Melatonin (Goodova) production has also been proposed as a likely factor in the significantly higher cancer rates in night workers.

Clomifene (Goodova)® (clomiPHENE citrate 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 clomiPHENE citrate 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 clomiPHENE citrate 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).

Clomifene (Goodova)® (clomiPHENE citrate tablets USP) is indicated only in patients with demonstrated ovulatory dysfunction who meet the conditions described below :

In addition, patients selected for clomiPHENE citrate therapy should be evaluated in regard to the following:

There are no adequate and well-controlled studies that demonstrate the effectiveness of clomiPHENE citrate 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 citrate is not known.

Although the medical literature suggests various methods, there is no universally accepted standard regimen for combined therapy (i.e., clomiPHENE citrate in conjunction with other ovulation-inducing drugs). Similarly, there is no standard clomiPHENE citrate regimen for ovulation induction in in vitro fertilization programs to produce ova for fertilization and reintroduction. Therefore, Clomifene (Goodova)® is not recommended for these uses.

Used orally for jet lag, insomnia, shift-work disorder, circadian rhythm disorders in the blind (evidence for efficacy), and benzodiazepine and nicotine withdrawal. Evidence indicates that Melatonin (Goodova) is likely effective for treating circadian rhythm sleep disorders in blind children and adults. It has received FDA orphan drug status as an oral medication for this use. A number of studies have shown that Melatonin (Goodova) may be effective for treating sleep-wake cycle disturbances in children and adolescents with mental retardation, autism, and other central nervous system disorders. It appears to decrease the time to fall asleep in children with developmental disabilities, such as cerebral palsy, autism, and mental retardation. It may also improve secondary insomnia associated with various sleep-wake cycle disturbances. Other possible uses for which there is some evidence for include: benzodiazepine withdrawal, cluster headache, delayed sleep phase syndrome (DSPS), primary insomnia, jet lag, nicotine withdrawal, preoperative anxiety and sedation, prostate cancer, solid tumors (when combined with IL-2 therapy in certain cancers), sunburn prevention (topical use), tardive dyskinesia, thrombocytopenia associated with cancer, chemotherapy and other disorders.

Treating female infertility in certain women. It may also be used for other conditions as determined by your doctor.

Clomifene (Goodova) is an ovulatory stimulant. It works by increasing certain hormones, which causes your ovaries to release mature eggs.

Melatonin (Goodova) is a manmade form of a hormone produced in the brain that helps regulate your sleep and wake cycle.

Melatonin (Goodova) has been used in alternative medicine as a likely effective aid in treating insomnia (trouble falling asleep or staying asleep). Melatonin (Goodova) is also likely effective in treating sleep disorders in people who are blind.

Melatonin (Goodova) is also possibly effective in treating jet lag, high blood pressure, tumors, low blood platelets (blood cells that help your blood to clot), insomnia caused by withdrawal from drug addiction, or anxiety caused by surgery. A topical form of Melatonin (Goodova) applied to the skin is possibly effective in preventing sunburn.

Melatonin (Goodova) has also been used to treat infertility, to improve sleep problems caused by shift work, or to enhance athletic performance. However, research has shown that Melatonin (Goodova) may not be effective in treating these conditions.

Other uses not proven with research have included treating depression, bipolar disorder, dementia, macular degeneration, attention deficit hyperactivity disorder, enlarged prostate, chronic fatigue syndrome, fibromyalgia, restless leg syndrome, stomach ulcers, irritable bowel syndrome, nicotine withdrawal, and many other conditions.

It is not certain whether Melatonin (Goodova) is effective in treating any medical condition. Medicinal use of this product has not been approved by the FDA. Melatonin (Goodova) should not be used in place of medication prescribed for you by your doctor.

Melatonin (Goodova) is often sold as an herbal supplement. There are no regulated manufacturing standards in place for many herbal compounds and some marketed supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.

Melatonin (Goodova) may also be used for purposes not listed in this product guide.

General Considerations: Physicians experienced in managing gynecologic or endocrine disorders should supervise the work-up and treatment of candidate patients for clomiphene citrate therapy. Patients should be chosen for clomiphene citrate 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 clomiphene citrate.

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.

Recommended

Dosage: First Course of Clomiphene Citrate: 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 clomiphene citrate be started on or about the 5th day of the cycle, once ovulation has been established. As with other therapeutic modalities, Clomifene (Goodova) 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 Clomifene (Goodova), further treatment is not generally recommended.

Oral

Disturbed biorhythms; Sleep disorders

Adult: Usual dose 3-6 mg at bedtime.

Child: 2-3 mg at bedtime, increased after 1-2 wk to 4-6 mg if needed. Max dose 10 mg.

See also:
What is the most important information I should know about Clomifene (Goodova)?

Hypersensitivity

Clomifene (Goodova)® is contraindicated in patients with a known hypersensitivity or allergy to clomiPHENE citrate or to any of its ingredients.

Pregnancy

Clomifene (Goodova)® should not be administered during pregnancy. ClomiPHENE citrate may cause fetal harm in animals. Although no causative evidence of a deleterious effect of clomiPHENE citrate 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 clomiPHENE citrate 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 clomiPHENE citrate 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 clomiPHENE citrate 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 clomiPHENE citrate 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 clomiPHENE citrate..

Animal Fetotoxicity.

Oral administration of clomiPHENE citrate 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 clomiPHENE citrate 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. ClomiPHENE citrate therapy is contraindicated in patients with liver disease or a history of liver dysfunction.

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

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

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

See also:
What is the most important information I should know about Melatonin (Goodova)?

contraindicated in patients with:

• known hypersensivity to benzodiazepines

• severe respiratory insufficiency, including chronic obstructive airways disease with incipient

respiratory failure

• severe hepatic insufficiency as it may cause encephalopathy

• sleep apnoea syndrome

• myasthenia gravis.

may precipitate suicide or aggressive behavior, not used alone to treat depression or anxiety associated with depression

Use Clomifene (Goodova) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Clomifene (Goodova) 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 Clomifene (Goodova).
• If you do not ovulate or become pregnant after 3 courses of treatment, further treatment is not recommended. Long-term use of Clomifene (Goodova) is not recommended.
• If you miss a dose of Clomifene (Goodova), contact your doctor right away.

Ask your health care provider any questions you may have about how to use Clomifene (Goodova).

Use Melatonin (Goodova) controlled-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Dosing depends on the use and the source of the product.
• Use as directed on the package, unless instructed otherwise by your doctor.
• Swallow whole. Do not break, crush, or chew before swallowing.
• Melatonin (Goodova) is usually taken 2 hours before bedtime for insomnia. Results may be seen within 30 minutes, but it may take 1 to 3 days for the effects to be noticed.
• If you miss taking a dose of Melatonin (Goodova) controlled-release tablets for 1 or more days, there is no cause for concern. If your doctor recommended that you take it, try to remember your dose every day.

Ask your health care provider any questions you may have about how to use Melatonin (Goodova) controlled-release tablets.

Clomifene (Goodova) 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).

To treat primary sleep disturbances (persistent difficulty in falling asleep or staying asleep or poor quality of sleep, that has no apparent cause) for a short time.

See also:
What other drugs will affect Clomifene (Goodova)?

* 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.

* If this becomes severe, tell your doctor.

* Be careful driving or operating machinery.

See also:
What other drugs will affect Melatonin (Goodova)?

Melatonin (Goodova) may interact with the following drugs: aspirin and other NSAIDs (may lower Melatonin (Goodova) levels), fluvoxamine (bioavailability of oral Melatonin (Goodova) is increased with coadministration), beta blockers (may decrease Melatonin (Goodova) levels), fluoxetine (reports of psychotic episodes when coadministered), progestin (coadministration of Melatonin (Goodova) with progestin can inhibit ovarian function in women), benzodiazepenes and other sedating drugs (may result in additive sedation and an increased incidence of adverse effects), and corticosteroids (coadministration of Melatonin (Goodova) and corticosteroids may interfere with the efficacy of the corticosteroids).

See also:
What are the possible side effects of Clomifene (Goodova)?

Applies to clomiphene: oral tablet

In addition to its needed effects, some unwanted effects may be caused by clomiphene (the active ingredient contained in Clomifene (Goodova)). 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:

More common:

• Bloating
• stomach or pelvic pain

Severity: Moderate

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:

• Blurred vision
• 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:

More common:

• Hot flashes

• Breast discomfort
• dizziness or lightheadedness
• headache
• heavy menstrual periods or bleeding between periods
• mental depression
• nausea or vomiting
• nervousness
• restlessness
• tiredness
• trouble in sleeping

See also:
What are the possible side effects of Melatonin (Goodova)?

Psychiatric Disorders: Confusional state, emotional disturbances, libido disorders, nervousness and

depression have been reported.

Paradoxical reactions such as restlessness, agitation, irritability, aggression, delusion, anger, nightmares,

sleep disorders, hallucinations, psychosis, inappropriate behaviour and other adverse behavioural effects

are known to occur with benzodiazepines or benzodiazepine-like agents. Should this occur, the use of

LEXOTAN should be discontinued. Such reactions are more likely to occur in children and elderly

patients than in other patients.

Dependence: Chronic use (even at therapeutic doses) may lead to the development of physical and

psychic drug dependence: discontinuation of therapy may result in withdrawal or rebound phenomena.

Abuse of benzodiazepines has been reported.

Nervous System Disorders: Drowsiness and ataxia become less common with repeated

administration. Headache, dizziness, decreased alertness, seizures, tremor, speech disorders and

incontinence have been reported.

Anterograde amnesia may occur using therapeutic dosages with the risk increasing at higher dosages.

Amnestic effects may be associated with inappropriate behaviour.

Eye Disorders: Diplopia and blurred vision have been reported.

Gastrointestinal Disorders: Gastrointestinal disorders, dry mouth, nausea and vomiting have been

reported.

Metabolic and Nutritional Disorders: Anorexia has been reported.

Skin and Subcutaneous Tissue Disorders: Skin reactions including pruritis and rash have been

reported.

Musculoskeletal and Connective Tissue Disorders: Muscle weakness and muscle spasm have been

reported.

General Disorders and Administration Site Conditions: Fatigue.

Injury, Poisoning and Procedural Complications: An increased risk for falls and fractures has been

reported in elderly benzodiazepine users.

Respiratory Disorders: Respiratory depression has been reported.

Cardiac Disorders: Cardiac failure including cardiac arrest, hypotension, tachycardia and

palpitations have been reported.

Investigations: Instances of decreased haemoglobin and increased white cell counts have been

reported.