COTROPIN 5000 - Human Chorionic Gonadotropin, HCG

Category:- Hormones | Type:- Injection

Each vial contains: Chorionic Gonadotrophin BP 5000 IU (HCG) Excipients q. s.

Pharmacological Properties

Mechanism of action
The action of HCG is virtually identical to that of pituitary LH, although HCG appears to have a small degree of FSH activity as well. It stimulates production of gonadal steroid hormones by stimulating the interstitial cells (Leydig cells) of the testis to produce androgens and the corpus luteum of the ovary to produce progesterone. Androgen stimulation in the male leads to the development of secondary sex characteristics and may stimulate testicular descent when no anatomical impediment to descent is present. This descent is usually reversible when HCG is discontinued. During the normal menstrual cycle, LH participates with FSH in the development and maturation of the normal ovarian follicle, and the mid-cycle LH surge triggers ovulation. HCG can substitute for LH in this function. During a normal pregnancy, HCG secreted by the placenta maintains the corpus luteum after LH secretion decreases, supporting continued secretion of estrogen and progesterone and preventing menstruation.

Indications:

Prepubertal cryptorchidism not due to anatomical obstruction. In general, HCG is thought to induce testicular descent in situations when descent would have occurred at puberty. HCG thus may help predict whether or not orchiopexy will be needed in the future. Although, in some cases, descent following HCG administration is permanent, in most cases, the response is temporary. Therapy is usually instituted in children between the ages of 4 and 9. Selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males. Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure, and who has been appropriately pretreated with human menotropins.

Human chorionic gonadotropin injection is extensively used for final maturation induction in lieu of luteinizing hormone. In the presence of one or more mature ovarian follicles, ovulation can be triggered by the administration of HCG. As ovulation will happen between 38 and 40 hours after a single HCG injection, procedures can be scheduled to take advantage of this time sequence, such as intrauterine insemination or sexual intercourse. Also, patients that undergo IVF, in general, receive HCG to trigger the ovulation process, but have an oocyte retrieval performed at about 34 to 36 hours after injection, a few hours before the eggs actually would be released from the ovary. As HCG supports the corpus luteum, administration of HCG is used in certain circumstances to enhance the production of progesterone. In the male, HCG injections are used to stimulate the Leydig cells to synthesize testosterone. The intratesticular testosterone is necessary for spermatogenesis from the sertoli cells. Typical uses for HCG in men include hypogonadism and fertility treatment, including during testosterone replacement therapy to restore or maintain fertility and prevent testicular atrophy

Dosage and Administration:

For intramuscular and subcutaneous use only.

The dosage regimen employed in any particular case will depend upon the indication for the use, the age and weight of the patient, and the physician's preference. The following regimens have been advocated by various authorities: Prepubertal cryptorchidism not due to anatomical obstruction. Therapy is usually instituted in children between the ages of 4 and 9. 4,000 Units three times weekly for three weeks. 5,000 Units every second day for four injections. 15 injections for 500 to 1,000 Units over a period of six weeks. 500 Units three times weekly for four to six weeks. If this course of treatment is not successful, another series is begun one month later, giving 1,000 Units per injection. Selected cases of hypogonadotropic hypogonadism in males. 500 to 1,000 Units three times a week for three weeks, followed by the same dose twice a week for three weeks. 4,000 Units three times weekly for six to nine months, following which the dosage may be reduced to 2,000 Units three times weekly for an additional three months. Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure and who has been appropriately pretreated with human menotropins.

Contraindications:

Precocious puberty, prostatic carcinoma or other androgen-dependent neoplasm, prior allergic reaction to HCG.
Special Warning and Precautions

WARNING

HCG should be used in conjunction with human menopausal gonadotropins only by physicians experienced with infertility problems who are familiar with the criteria for patient selection, contraindications, warnings, precautions, and adverse reactions described in the package insert for menotropins. Anaphylaxis has been reported with urinary-derived

HCG products.
The principal serious adverse reactions during this use are:
-Ovarian hyperstimulation, a syndrome of sudden ovarian enlargement, ascites with or without pain, and/or pleural effusion
-Rupture of ovarian cysts with resultant hemoperitoneum
-Multiple births
-Arterial thromboembolism

PRECAUTIONS

General
Since androgens may cause fluid retention, HCG should be used with caution in patients with cardiac or renal disease, epilepsy, migraine, or asthma.
Pediatric Use Induction of androgen secretion by HCG may induce precocious puberty in pediatric patients treated for cryptorchidism. Therapy should be discontinued if signs of precocious puberty occur.
Geriatric Use Clinical studies of chorionic gonadotropin for injection did not include subjects aged 65 and over.

Pregnancy

Teratogenic Effects: Pregnancy category C- Chorionic Gonadotrophin may cause fetal harm when administered to a pregnant women. Defect of forelimbs and central nervous system and alteration in sex ration have been reported in mice receiving combined gonadotropin and chorionic gonadotrophin therapy in dosages to induce super ovulation. Multiple Ovulation with resulting plural gestation (mostly twins) have been reported to occur in approximately 20% of pregnancies when conception has followed chorionic gonadotropin therapy.

Undesirable effects:

The following adverse reactions have been associated with the administration of Chorionic Gonadotrophin Injection: headache, irritability, restlessness, depression, fatigue, edema, precocious puberty, gynecomastia, pain at the site of injection

Interactions:

No clinically significant drug interactions have been reported during u-hCG therapy. Interactions of Chorionic Gonadotropin for Injection with other medicines have not been investigated; interactions with commonly used medicinal products can therefore not be excluded. Chorionic gonadotropin may interfere with radioimmunoassay for gonadotropin, particularly luteinizing hormone. Following administration, Chorionic Gonadotropin for Injection may interfere for up to ten days with the immunological determination of serum/urinary hCG, leading to a false positive pregnancy test.

Overdose: NA.

Storage:

Store below 20°C, Do not freeze, Protect from light & Moisture. After reconstitution solution should be used immediately.

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