Bula do remedy Clomid

the package insert of the medicine Clomid. Therapeutic class of the Induction Ovulation. Active principles Clomiphene and Clomiphene Citrate.

what For?

Treatment of female infertility due to anovulation.

Clomid is only indicated for patients with anovulation demonstrated, in the conditions described in this label and to patients where clomiphene citrate is not contra-indicated.

Other causes of infertility must be excluded or adequately treated before the treatment.

Good levels of estrogen endogenous (estimated by vaginal secretion, biopsy, endometrial, determination of estrogen urinary bleeding or endometrial response to progesterone) constitute favorable prognosis for the response ovulatory induced by clomiphene citrate.

However, a low level of estrogen does not prevent the success of the treatment.

The treatment is ineffective in patients with failed pituitary or ovarian primary and cannot be replaced by the specific treatment of other causes of ovulatory failure, such as dysfunction tiroidianas or adrenal.

Before the treatment, one should perform a careful evaluation, particularly in patients with metrorragia abnormal, it is very important to rule out the presence of neoplastic lesions.

oral – adult Use

Pharmacokinetics

How it works?

Clomid (clomiphene citrate) is an agent non-steroid with estrogenic properties and antiestrogênicas, which can induce ovulation in certain women who do not ovulate.

it Competes with the estrogen endogenous in the receivers estrogenic hipotalâmicos, producing an increase of the secretion of GnRH (releasing hormone gonadotropin) and the levels of LH (luteinizing hormone) and FSH (follicle stimulating hormone), which results in ovarian stimulation, with consequent maturation of the ovarian follicle and development of corpus luteum.

Dosage

How to use?

The treatment consists of 3 cycles, which can be continuous or alternating, at the physician’s discretion.

After the treatment, the patient should attempt pregnancy.

However, if the patient becomes pregnant during treatment, you should stop the medication (see contraindications).

the recommended dose for the first cycle of treatment is 50 mg (1 tablet) daily for 5 days.

In patients amenorréicas the treatment can be started at any period of the menstrual cycle.

If it is programmed induction of metrorragia by progestínico or if spontaneous menstruation, Clomid should be administered from the 5th day of the cycle.

If ovulation occur with this dose, there is no advantage in increasing the dose in the 2 following cycles.

If ovulation does not occur after the first treatment cycle, there should be a second cycle with 100 mg daily for 5 days, after 30 days of the previous treatment.

The increase of the dosage should not exceed the dose and duration 100 mg/day for 5 days.

The majority of patients responsive to the Clomid, ovulate after the first treatment cycle and 3 cycles are sufficient for an evaluation of therapy.

If it does not occur menstruation ovulatory in this time period, the diagnosis should be revised.

continuity of treatment after 3 cycles is not recommended in patients who do not exhibit evidence of ovulation.

Given that it has not been demonstrated the safety relative to the treatment of cyclical extended, it is not recommended to continue the treatment after 6 cycles (including 3 ovulation cycles).

Side Effects

What are the evils that can cause me?

side Effects appear to be dose-dependent, occurring more often in high doses and in treatment extended.

The adverse reactions most frequently reported are (in descending order of incidence):

Increased volume of the ovary: in the recommended dose, an abnormal increase is uncommon (incidence of 13.6%).

it Can occur abdominal pain at the time of ovulation.

Were recorded, however, rare cases of increase in mass of the ovaries, for example, a patient with syndrome of polycystic ovary whose therapy with clomiphene citrate consisted of 100 mg/day/14 days.

The increase in ovarian usually regress spontaneously, and most patients in these conditions should be treated cautiously.

Flushes, vasomotor or hot flashes: (incidence 10.4%) similar to those of menopause, rarely serious and disappear quickly with treatment interruption.

Discomfort in the pelvic – abdominal: increase of abdominal volume, fullness (5,5%), usually related to the increase in ovarian or phenomena ovulation or pre-menstrual.

Also are described:

visual Symptoms: described as visual perturbation, stains or fosfenas (escotomas sparkling) are reported with an incidence related to increased dose and usually subside in days or weeks after stopping treatment.

There are rare reports of cataracts.

skin Changes: there have been reports of dermatitis and rashes associated with conditions, allergic reaction, erythema multiforme, bruising, and edema angioneurótico.

Alopecia has been reported rarely.

neurological Symptoms: dizziness, vertigo, nervousness, insomnia, depression and asthenia have been reported infrequently.

There are reports of other conditions such as syncope/fainting, cerebrovascular accident, cerebral thrombosis, psychotic reactions including psychosis, neurological disorders, disorientation and speech disorders.

liver Dysfunction: the retention of bromosulfaleína was more than 5% in 32 of 141 patients evaluated, including 5 of 43 who took approximately the dose of Clomid currently recommended.

The retention was in general minimal, except when associated with the continuous administration or prolonged with liver disease apparently not related to the drug.

Other tests of liver function were generally normal.

In a later study, in which if administered Clomid for 6 cycles in a row (50 or 100 mg/day for 3 days) or placebo, were tests of retention bromosulfaleína in 94 patients.

of These, 11 had retention high at 5%, 6 of whom had taken drug and 5 placebo.

Neoplasms: isolated reports of the occurrence of neoplasms endocrine-dependent or aggravation (uterine fibroids, pituitary tumors, and breast).

Other symptoms, also described, although the incidence below 3.5%, are: nausea, malaise, gastric, polyuria, metrorragia functional, weight gain, hypersensitivity and breast dysuria.

Contraindications

When should I not use?

Hypersensitivity: Clomid is contraindicated in cases of allergy to clomiphene citrate.

hepatic Insufficiency: Clomid should not be administered to patients with liver disease or history of liver dysfunction.

Metrorragia: Clomid is contraindicated in patients with metrorragia of undetermined origin.

ovarian Cyst: See Precautions.

Warnings and Precautions

what should I know before using?

it Is necessary to perform a pelvic exam before you start each cycle of treatment.

The incidence of carcinoma endometrial dysfunctions ovulatórias increase with age, therefore, biopsy endometrial should always exclude the presence of carcinoma in these patients.

ovarian Cyst: The exception of patients with syndrome of polycystic ovary, Clomid should not be administered in the presence of ovarian cysts (including endometriosis ovarian), since it may produce an additional increase of the size of the same.

During the treatment with Clomid, or even several days after completion, you can occur the increase of ovarian, which usually disappears spontaneously a few days or weeks after discontinuation of treatment.

it Is recommended to use the lowest dose consistent with the prediction of good results, to minimize the possibility of an increase in the ovarian abnormal associated with the therapy with Clomid.

The patient noted abdominal pain or pelvic, weight gain, discomfort and/or increase of abdominal volume during or after the treatment with Clomid should be examined for the possibility of ovarian cyst or other anomaly.

In the event of abnormal increase of the size of the ovary, Clomid should be discontinued until the total regression of the size of pre-treatment.

The dosage and duration of subsequent treatment should be reduced.

multiple Pregnancy: There is an increase in the probability of occurrence of multiple pregnancy, related to treatment with Clomid.

Potential complications and risks arising from the chances of a multiple pregnancy should be discussed with the patient prior to treatment with Clomid.

Clomid in pregnancy and lactation: there are No controlled studies with clomiphene in humans, have been reported congenital malformations and stillbirth associated with its administration, although a direct causal relationship has not been established.

there have Been reported anomalies, made in rodents (rabbits and rats) when Clomid was administered in high doses during the period of pregnancy.

To avoid the administration inadvertent Clomid during early pregnancy, you should determine the body temperature basal in all treatment cycles and the patient should be carefully observed to determine whether or not there are signs of ovulation.

If the basal temperature is biphasic and is not followed by menses, the patient should be re-examined to verificar if there is pregnancy (using a test of selective quantitative) and/or the presence of ovarian cyst.

In some patients, clomiphene citrate may reduce the engurgitamento the breast after childbirth and lactation.

Drug Interactions

there are No reports specific interaction with other drugs, however the doctor should be informed by the patient about other drugs in concurrent use, especially medicines that act in the synthesis of cholesterol.

Overdose

what to do if someone use a larger amount than is recommended?

there are No reports of acute intoxication with Clomid.

Signs and symptoms of a superdose can be nausea and vomiting, flushes, vasomotor, clouding of vision, escotomas shimmering, rising from the ovary with pelvic pain or abdominal.

the Intense overstimulation of the ovary may be accompanied by weight gain, and ascites.

Women of childbearing age who have taken an overdose of Clomid should be observed during 2 or 3 weeks in relation to the possibility of a hypertrophy ovarian.