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Indications/Uses
For Female: Sterility due to absence of follicle-ripening or ovulation. In combination with FSH or HMG, promotion of controlled superovulation in medically assisted reproduction programmes.
For Male: Hypogonadotrophic Hypogonadism.
Delayed puberty associated with insufficient gonadotrophic pituitary function. Sterility in selected cases of deficient spermatogenesis.
For Male: Hypogonadotrophic Hypogonadism.
Delayed puberty associated with insufficient gonadotrophic pituitary function. Sterility in selected cases of deficient spermatogenesis.
Dosage/Direction for Use
After addition of the solvent to the freeze-dried substance, the solution should be given immediately by intramuscular injection. Any unused solution should be discarded. Self-administration of PUBERGEN should only be performed by patients who are well-motivated, adequately trained and with access to expert advice.
In Females: The dosage regimen employed in any particular case will depend upon the indication for use, the age and weight of the patients, and the physician's preference. The following regimens have been advocated by various authorities. 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.
5,000 IU to 10,000 IU one injection on 12th day of menstrual cycle or when the Graafian follicle attains a size ≥18 mm.
In Males: Chorionic Gonadotropin (Pubergen) 5,000 IU twice weekly for 12 weeks sand may have to be continued even up to 1 year to improve semen quality.
In Females: The dosage regimen employed in any particular case will depend upon the indication for use, the age and weight of the patients, and the physician's preference. The following regimens have been advocated by various authorities. 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.
5,000 IU to 10,000 IU one injection on 12th day of menstrual cycle or when the Graafian follicle attains a size ≥18 mm.
In Males: Chorionic Gonadotropin (Pubergen) 5,000 IU twice weekly for 12 weeks sand may have to be continued even up to 1 year to improve semen quality.
Overdosage
The toxicity of human chorionic gonadotropic hormone is very low. However, too high a dose may lead to hyperstimulation of the ovaries. (See unwanted Hyperstimulation as follows.)
Unwanted/Hyperstimulation: During treatment of female patients, determinations of oestrogen levels and assessment of ovarian size and if possible, ultrasonography should be performed prior to treatment and at regular intervals during treatment. High dosages may cause oestrogen levels to rise excessively rapidly, e.g. more than doubling on 2-3 consecutive days, and possibly reaching excessively high preovulatory values. The diagnosis of unwanted ovarian hyperstimulation, on may be confirmed by ultrasound examination.
If unwanted hyperstimulation occurs, (i.e. not as port of a treatment preparing for IVF/ET or GIFT or other assisted reproduction techniques), the administration of HMG should be discontinued immediately, hCG must not be given, because the administration of an hLH - active gonadotropin at this stage may induce, in addition to multiple ovulations, the ovarian hyperstimulation. This warming is particularly important with respect to patients with polycystic ovarian disease.
The severe form of ovarian hyperstimulation syndrome may be life threatening and is characterized by large ovarian cyst (prone to rupture), acute abdominal pain. ascites, very often hydrothorax and occasionally thromboembolic phenomena.
In the male: Treatment with hCG leads to increased androgen production.
Therefore: Patients with latent or overt cardiac failure, renal dysfunction, hypertension, epilepsy or migraine (or history of these conditions) should be kept under close medical supervision, since aggravation or recurrence may occasionally be induced as a result increased androgen production.
hCG should be used cautiously in prepubertal boys to avoid premature epiphyseal closure or precocious sexual development. Skeletal maturation should be monitored regularly.
Unwanted/Hyperstimulation: During treatment of female patients, determinations of oestrogen levels and assessment of ovarian size and if possible, ultrasonography should be performed prior to treatment and at regular intervals during treatment. High dosages may cause oestrogen levels to rise excessively rapidly, e.g. more than doubling on 2-3 consecutive days, and possibly reaching excessively high preovulatory values. The diagnosis of unwanted ovarian hyperstimulation, on may be confirmed by ultrasound examination.
If unwanted hyperstimulation occurs, (i.e. not as port of a treatment preparing for IVF/ET or GIFT or other assisted reproduction techniques), the administration of HMG should be discontinued immediately, hCG must not be given, because the administration of an hLH - active gonadotropin at this stage may induce, in addition to multiple ovulations, the ovarian hyperstimulation. This warming is particularly important with respect to patients with polycystic ovarian disease.
The severe form of ovarian hyperstimulation syndrome may be life threatening and is characterized by large ovarian cyst (prone to rupture), acute abdominal pain. ascites, very often hydrothorax and occasionally thromboembolic phenomena.
In the male: Treatment with hCG leads to increased androgen production.
Therefore: Patients with latent or overt cardiac failure, renal dysfunction, hypertension, epilepsy or migraine (or history of these conditions) should be kept under close medical supervision, since aggravation or recurrence may occasionally be induced as a result increased androgen production.
hCG should be used cautiously in prepubertal boys to avoid premature epiphyseal closure or precocious sexual development. Skeletal maturation should be monitored regularly.
Contraindications
Precocious puberty, prostatic carcinoma or other androgen dependent neoplasia, prior allergic reaction to Chorionic Gonadotropin.
Hypersensitivity to human gonadotropin or any of its substances.
Presence of uncontrolled non-gonadal endocrinopathies (e.g. thyroid, adrenal or pituitary disorders).
Breast uterine, ovarian, testicular tumours.
Vaginal bleeding of unknown cause.
Known or suspected androgen-dependent tumours, carcinoma of the prostate or mammary carcinoma in males.
Hypersensitivity to human gonadotropin or any of its substances.
Presence of uncontrolled non-gonadal endocrinopathies (e.g. thyroid, adrenal or pituitary disorders).
Breast uterine, ovarian, testicular tumours.
Vaginal bleeding of unknown cause.
Known or suspected androgen-dependent tumours, carcinoma of the prostate or mammary carcinoma in males.
Warnings
hCG should be used by the physicians experienced with infertility problems. The principal reactions during the use are: Ovarian enlargement, ascites, with or without pain and/or pleural effusion; Rupture of ovarian cysts with resultant haemoperitoneum; Multiple births; Arterial thromboembolism; Ovarian hyperstimulation syndrome.
Special Precautions
Induction of androgen secretion by Chorionic gonadotropin may induce precocious puberty in patients for Cryptorchidism. If signs of precocious puberty occur therapy should be discontinued. Since androgen may cause fluid retention, chorionic gonadotropin should be used with caution in patient with epilepsy, migraine, asthma, cardiac or renal disease.
Adverse Reactions
Headache, irritability, edema, restlessness, depression, tiredness, precocious puberty, gynaecomastia and pain at the site of injection.
Caution For Usage
Directions for reconstitution: To reconstitute, inject 1 mL of 0.9% w/v Sodium Chloride Solution to the vial of hCG and shake well. Use immediately after reconstitution.
Storage
Store at temperature between 2°C to 8°C. Do not freeze.
Action
Pharmacology: Pharmacodynamics: The action of Chorionic Gonadotropin (Pubergen) 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 testes to produce androgens and the corpus luteum of the ovary to produce progesterone. The biologic action of hCG is similar to that of LH. It causes leutinisation of ovarian follicular and interstitial cells. Induction of ovulation of a mature follicle stimulation of Leydig cells. and augmentation of progesterone (ovary) and testosterone (testis) biosynthesis, hCG exerts it biologic effect (increasing steroid biosynthesis by augmenting the conversion of cholesterol to pregnenolone) via activation of adenylate cyclase and increase of adenosine cyclic 3'-5'-monophosphate (cyclic AMP, CAMP). Besides its role of maintain and stimulating steroid production by the corpus luteum, hCG also appears to promote fetoplacental-unit steroidogenesis, hCG has been shown to enhance placental conversion of cholesterol to pregnenolone and progesterone in vitro. Also, hCG has been found to stimulate fetal adrenal dehydroepiandrosterone sulphate (DHEA-S) synthesis. The fetal testis has specific binding sites of hCG, and the hormone stimulates testosterone production in the fetal testis during early pregnancy. Fetal serum testosterone levels and Leydig cell proliferation reach peak around 15 to 17 weeks of gestation; that is after serum hCG concentrations have peaked. The action of CG on the testis can hardly be regarded as physiological, for the hormone gains access to the male only in utero, when it does cause minimal gonadal stimulation; CG stimulates the interstitial cells of the testis to secrete androgen. Activation of somniferous epithelium is minimal and may be mediated entirely by the androgen of Leydig-cell origin.
MedsGo Class
Trophic Hormones & Related Synthetic Drugs
Features
Dosage
5000 IU
Ingredients
- Human Chorionic Gonadotropin
Packaging
Lyophilized Powder for Injection (I.M.) 1's
Generic Name
Human Chorionic Gonadotropin
Registration Number
BR-975
Classification
Prescription Drug (RX)
Product Questions
Questions
