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Hemobest Tablets(Iron (III) Polymaltose 100mg + Folic Acid 0.35mJits-20 (Esomeprazole pellets (enteric coated) 20mg)

Jax-50 Tablets(Clomiphene Citrate 50mg)

Jax-50 Tablets(Clomiphene Citrate 50mg)

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COMPOSITION:

Each Tablet Contains Clomiphene Citrate USP... 50mg
ACTIONS: JAX-50 an orally administered non-steroidal agent, may induce ovulation in selected women. It is a drug of considerable pharmacological potency. Careful evaluation and selection of the patient and close attention to the timing of the dose is mandatory prior to treatment with Clomiphene Citrate. Conservative selection and management of the patient contribute to successful therapy of anovulation. Clomiphene citrate induces ovulation in most selected anovulatory patients. The various criteria for ovulation induce an ovulation peak of estrogen excretion followed by a biphasic basal body temperature curve, urinary excretion of pregnanediol at post-ovulatory levels and endometrial histological findings characteristic of the luteal phase. Clomiphene Citrate therapy appears to mediate ovulation through increased out put of pituitary gonadotropin. These stimulate the maturation and endocrine activity of the ovarian follicle which is followed by the development and function of the corpus luteum, increased urinary excretion of gonadotropin and estrogen suggest involvement of pituitary.
ABSORPTION AND FATE: JAX-50 is absorbed from the gastro- intestinal tract and slowly excreted through the liver into the bile. The biological half life is reported to be 5 days and entero-hepatic recirculation takes place.
Studies with 14C labelled Clomiphene Citrate have shown that it is readily absorbed orally in humans, and is excreted principally in the feces. An average of 51% at the administered dose was excreted after 5 days. After intravenous administration 37% was excreted In 5 days The appearance of 14C in the feces six weeks after administration suggests that the remaining drug and/or metabolites are slowly excreted from a sequestered entero-hepatic recirculation pool.

INDICATIONS:

JAX-50 is indicated for the treatment of infertility due to impaired hypothalamic pituitary function. JAX-50 (Clomiphene Citrate) stimulates the secretion of pituitary gonadotropic hormones probably by blocking the effect of estrogens at receptor sites in the hypothalamus and pituitary. Clomiphene citrate is indicated for the treatment of anovulatory infertility in patients desiring pregnancy. Therapy with Clomiphene Citrate will not be successful unless the woman, though anovulatory, is capable of ovulation and the partner is fertile. It is effective in primary pituitary or primary ovarian failure Administration of JAX-50 is indicated only in patients with demonstrated ovulatory dysfunction and in whom the following conditions apply:

  • Normal liver function.
  • Physiological indications of normal endogenous estrogen (as estimated from vaginal smears, endometrial biopsy, assay of urine or from bleeding in response to progesterone) Reduced estrogen levels while less favorable, do not prevent successful therapy.
  • Clomiphene Citrate therapy is not effective for those patients with primary pituitary or ovarian failure. It can not substitute for appropriate therapy of other disturbances leading to ovulatory dysfunction, e.g. diseases of the thyroid or adrenals.
  • A careful evaluation prior to Clomiphene citrate therapy should be done in patients with abnormal uterine bleeding. It is most important that neoplastic lesions are detected.

DOSAGE AND ADMINISTRATION:

General Considerations: Physicians experienced in managing gynecological or endocrine disorders should supervise the work up and treatment of candidate patients for Clomiphene Citrate therapy. Patients should be chosen for JAX-50 therapy only after diagnostic evaluation . (see INDICATIONS). The plan of therapy should be outlined in advance. Impediments to achieving the goal of therapy must be excluded or adequately treated before putting the patient on JAX-50 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 100mg/day for 5 days. As the dosage is increased, however ovarian overstimulation and other side-effects may be expected to increase.
For these reasons, treatment of the usual patients should initiate with a 50mg daily dose for 5 days. The dose may be increased only in those patients who do not respond to the first course (see Recommended Dosage). Special treatment with lower dosage over shorter duration is particularly recommended if unusual sensitivity to pituitary gonadotropin is suspected including patients with polycystic ovary syndrome (See Precautions).

RECOMMENDED DOSAGE:

The recommended dosage for the first course of JAX-50 (Clomiphene Citrate) is 50mg (1tab) 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 50mg daily 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 first course of therapy, a second course of 100mg daily (two 50mg tablets given as a single daily dose) for 5 days may be started The course may begin as early as 30 days after the previous one, increasing the dose or duration of therapy beyond 100mg/day for 5 days should not be undertaken.
The majority of patients who respond do so during the first 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 JAX-50 to be started on or about 5th day of the cycle, once ovulation has been established. As with other therapeutic modalities, JAX-50 therapy follows the rate of diminishing returns, such likelihood of conception diminishes with each succeeding course of therapy. If pregnancy has not been achieved after 3 ovulatory responses to JAX-50. Further treatment is not generally recommended.

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.

ADVERSE REACTIONS:

Symptoms: Side effects are not prominent at the recommended dosage of Clomiphene Citrate and infrequently interfere with treatment. Side effects tend to occur more frequently at higher doses after in the longer treatment courses. The more common side effects include vasomotor flushes, abdominal discomfort, abnormal uterine bleeding, ovarian enlargement, breast tenderness and visual symptoms. The vasomotor symptoms resemble menopausal 'hot flushes' and are not usually severe. They promptly disappear after treatment is discontinued. Abdominal discomfort may resemble ovulatory or premenstrual phenomenon or that due to ovarian enlargement. In addition, nausea and vomiting, nervousness and insomnia, dizziness and light headedness, increased urination, depression and fatigue. urticaria and allergic dermatitis, weight gain and reversible hair loss.

The incidence of visual symptoms usually described as 'blurring' or spots or flashes (scintillating scotomata), correlates with increasing total dose. The symptoms disappear within a few days or weeks after Clomiphene Citrate is discontinued. This may be due to intensification and/or prolongation of after images. Symptoms often appear first or are accentuated upon exposure to a more brightly lit environment.

CONTRAINDICATIONS:

Pregnancy: Although no direct effect of Clomiphene Citrate therapy on the human foetus has been seen, Clomiphene Citrate should not be administered in cases of suspected pregnancy as such effects have been reported in animals. To prevent inadvertant reactions, Clomiphene Citrate administration during early pregnancy, the basal body temperature (BBT) should be recorded throughout all treatment cycles and therapy should be discontinued it pregnancy is suspected. If the basal body temperature following Clompihene Citrate is biphasic and is not followed by menses, the possibility of an ovarian cyst and/'or pregnancy should be excluded .Until the correct diagnosis has been determined, the next course of therapy should be delayed.

LIVER DISEASE:

Patients with liver disease or a history of liver dysfunction should not receive Clomiphene Citrate therapy.

ABNORMAL UTERINE BLEEDING:

Clomiphene Citrate is contra-indicated in patients with abnormal uterine bleeding.
WARNINGS: Visual Symptoms: Blurring and/or other visual symptoms may occur occasionally with Clomiphene Citrate therapy. In such a case patient should discontinue treatment and have a complete ophthalmological evaluation.

PRECAUTIONS:

Diagnosis prior to JAX-50 therapy: Careful evaluation should be given to candidate for Clomiphene Citrarate therapy. A complete pelvic examination should be performed prior to treatment and repeated before each subsequent course. JAX-50 should not be given to patients with an ovarian cyst, as further ovarian enlargement may result. Since the incidence of endometrial carcinoma and of ovulatory disorders increases with age, endometrial biopsy should always exclude the former as causative in such patients. If abnormal uterine bleeding is present full diagnostic measures are necessary.

OVARIAN OVERSTIMULATION DURING TREATMENT WITH JAX-50:

To minimize the hazard associated with the occasional abnormal ovarian enlargement, during Clomiphene citrate therapy, the lowest dose producing good results should be chosen. Some patients with polycystic ovary syndrome are unusually sensitive to gonadotropin and may have an exaggerated response to the usual doses of Clomiphene Citrate .Maximal enlargement of the ovary, whether abnormal or physiological doses does not occur until several days after discontinuation of Clomiphene Citrate. The patient complaining of pelvic pains after receiving Clomiphene Citrate should be examined carefully. If enlargement of the ovary occurs, Clomiphene Citrate therapy should be withheld until the ovaries have returned to pretreatment size and the dosage or duration of the net course should be reduced. The ovarian enlargement of the cyst formation following Clomiphene Citrate therapy regress spontaneously within a few days or weeks after discontinuing treatment. Therefore, unless a strong indication for laparotomy exists, such cystic enlargement always should be managed conservatively.

INSTRUCTIONS:

Protect from heat, light & moisture. Medicine should be kept out of the reach of children. To be sold on the prescription of a registered medical practitioner only.

PRESENTATION:

JAX-50 Tablets are available in blister pack of 10 tablets.