CHORIONIC GONADOTROPHIN FOR INJECTION (HCG) 1000 IU
$35
Human Chorionic Gonadotrophin for Injection
[Product Name]Human Chorionic Gonadotrophin for Injection
[Composition]
A preparation of Chorionic Gonadotrophin, which is a sterile lyophilized form after adding appropriate excipient. The titer is 80%-125% of the labelled amount.
[Indication]
A. The diagnosis and treatment of puberty cryptorchidism.
B. Male infertility induced by pituitary dysfunction. It can be combined with HMG. Long-term gonadotropin dysfunction should be supplemented with testosterone.
C. Female anovulatory infertility induced by pituitary gonadotropin deficiency. It is often treated after clomiphene treatment is ineffective. The combined use with menotropin and post-menopausal gonadotropin could promote ovulation.
D. It is used for obtaining multiple oocytes in vitro fertilization and should combine with postmenopausal gonadotropin.
E. Female luteal phase defect.
F. Dysfunctional uterine bleeding, threatened abortion during early pregnancy, habitual abortion.
[Dosage and Administration]
For adult:
A. For gonadal dysfunction caused by male gonadotropin dysfunction, inject intramuscularly 1000-4000 units, twice or 3 times per week lasting for weeks or months. To promote sperm production, treatment should be continued for 6 months or more. If the sperm count is less than 5,000,000 / ml, the application should be combined with HMG for 12 months.
B. Ovulation promotion. For anovulatory female infertility or in vitro fertilization, inject intramuscularly 5000-10000 IU one day after the last treatment of gonadotropin of post-menopause or 5 to 7 days after treatment of Clomiphene for consistent 3-6 treatment cycles. If no effect is shown, the drug should be withdrawal.
C. For luteal function defect, inject 1500 IU at 15 to 17 days after ovulation once every other day, for 5 times. The dose can be adjusted according to patients’ response. After pregnancy, the original dose should maintain for 7 to 10 gestational weeks.
D. For functional uterine bleeding. Inject intramuscularly 1000-3000 IU. For habitual abortion and pregnancy threatened abortion, inject 1000-5000 IU intramuscularly.
For children:
A. For determination of slow development of testicular function, inject intramuscularly 2000 IU, once a day, for 3 days.
B. For puberty cryptorchidism, inject intramuscularly 1000-5000 IU, 2-3 times per week. The drug withdraws once beneficial effects show. The total number of injections is not more than 10 times.
[How Supplied]
Packing material: injection vial + Medicinal halogenating butyl rubber plug; ampoule;
Pack: (1)1000 IU, 10 vials/box;
[Storage Condition]
Protect from light and keep tightly sealed in a cool place (store below 20).
[Shelf Life]
24 months
Chorionic gonadotropin for injection, USP is a highly purified pyrogen-free preparation obtained from the urine of pregnant females.
It is standardized by a biological assay procedure. It is available for intramuscular injection in multiple dose vials containing 10,000 USP Units of sterile dried powder with 5 mg monobasic sodium phosphate and 4.4 mg dibasic sodium phosphate. If required, pH is adjusted with sodium hydroxide and/or phosphoric acid.
Each package also contains a 10 mL vial of solvent containing: water for injection with 0.56% sodium chloride and 0.9% BENZYL ALCOHOL, WHICH IS NOT FOR USE IN NEWBORNS. If required, pH is adjusted with sodium hydroxide and/or hydrochloric acid.
It is standardized by a biological assay procedure. It is available for intramuscular injection in multiple dose vials containing 10,000 USP Units of sterile dried powder with 5 mg monobasic sodium phosphate and 4.4 mg dibasic sodium phosphate. If required, pH is adjusted with sodium hydroxide and/or phosphoric acid.
Each package also contains a 10 mL vial of solvent containing: water for injection with 0.56% sodium chloride and 0.9% BENZYL ALCOHOL, WHICH IS NOT FOR USE IN NEWBORNS. If required, pH is adjusted with sodium hydroxide and/or hydrochloric acid.
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. HCG HAS NO KNOWN EFFECT ON FAT MOBILIZATION, APPETITE OR SENSE OF HUNGER, OR BODY FAT DISTRIBUTION.
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. HCG HAS NO KNOWN EFFECT ON FAT MOBILIZATION, APPETITE OR SENSE OF HUNGER, OR BODY FAT DISTRIBUTION.
HCG HAS NOT BEEN DEMONSTRATED TO BE EFFECTIVE ADJUNCTIVE THERAPY IN THE TREATMENT OF OBESITY. THERE IS NO SUBSTANTIAL EVIDENCE THAT IT INCREASES WEIGHT LOSS BEYOND THAT RESULTING FROM CALORIC RESTRICTION, THAT IT CAUSES A MORE ATTRACTIVE OR “NORMAL” DISTRIBUTION OF FAT, OR THAT IT DECREASES THE HUNGER AND DISCOMFORT ASSOCIATED WITH CALORIERESTRICTED
DIETS.
DIETS.
- 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.
Precocious puberty, prostatic carcinoma or other androgen-dependent neoplasm, prior allergic reaction to HCG.
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:
(1) Ovarian hyperstimulation, a syndrome of sudden ovarian enlargement, ascites with or without pain, and/or pleural effusion, (2) Rupture of ovarian cysts with resultant hemoperitoneum, (3) Multiple births, and (4) Arterial thromboembolism.
Anaphylaxis has been reported with urinary-derived HCG products.
The principal serious adverse reactions during this use are:
(1) Ovarian hyperstimulation, a syndrome of sudden ovarian enlargement, ascites with or without pain, and/or pleural effusion, (2) Rupture of ovarian cysts with resultant hemoperitoneum, (3) Multiple births, and (4) Arterial thromboembolism.
General
Since androgens may cause fluid retention, HCG should be used with caution in patients with cardiac or renal disease, epilepsy, migraine, or asthma.
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.
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, USP did not include subjects aged 65 and over.
Clinical studies of chorionic gonadotropin for injection, USP did not include subjects aged 65 and over.
Headache, irritability, restlessness, depression, fatigue, edema, precocious puberty, gynecomastia, pain at the site of injection.
Hypersensitivity reactions, both localized and systemic in nature, have been reported.
Hypersensitivity reactions, both localized and systemic in nature, have been reported.
For intramuscular 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 USP Units three times weekly for three weeks.
- 5,000 USP Units every second day for four injections.
- 15 injections for 500 to 1,000 USP Units over a period of six weeks.
- 500 USP 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 USP Units per injection.
Selected cases of hypogonadotropic hypogonadism 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.
(See prescribing information for menotropins for dosage and
administration for that drug product.)
5,000 to 10,000 USP Units one day following the last dose of menotropins. (A dosage of 10,000 USP
Units is recommended in the labeling for menotropins.)
- 500 to 1,000 USP Units three times a week for three weeks, followed by the same dose twice a week for three weeks.
- 4,000 USP Units three times weekly for six to nine months, following which the dosage may be reduced to 2,000 USP 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.
(See prescribing information for menotropins for dosage and
administration for that drug product.)
5,000 to 10,000 USP Units one day following the last dose of menotropins. (A dosage of 10,000 USP
Units is recommended in the labeling for menotropins.)
Directions for Reconstitution
Two-vial package: Withdraw sterile air from lyophilized vial and inject into diluent vial. Remove 1–10 mL from diluent and add to lyophilized vial; agitate gently until powder is completely dissolved in solution.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
IMPORTANT: USE COMPLETELY AFTER RECONSTITUTION. RECONSTITUTED SOLUTION IS STABLE FOR 60 DAYS WHEN REFRIGERATED.
Two-vial package: Withdraw sterile air from lyophilized vial and inject into diluent vial. Remove 1–10 mL from diluent and add to lyophilized vial; agitate gently until powder is completely dissolved in solution.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
IMPORTANT: USE COMPLETELY AFTER RECONSTITUTION. RECONSTITUTED SOLUTION IS STABLE FOR 60 DAYS WHEN REFRIGERATED.
Two-vial package containing:
1-10 mL lyophilized multiple dose vial containing: 10,000 USP Units chorionic gonadotropin per vial,
NDC 0052-0315-10.
1-10 mL vial of solvent containing: water for injection with sodium chloride 0.56% and benzyl alcohol
0.9%, NDC 0052-0325-10.
1-10 mL lyophilized multiple dose vial containing: 10,000 USP Units chorionic gonadotropin per vial,
NDC 0052-0315-10.
1-10 mL vial of solvent containing: water for injection with sodium chloride 0.56% and benzyl alcohol
0.9%, NDC 0052-0325-10.
When reconstituted, each 10 mL vial contains:
If required pH adjusted with sodium hydroxide and/or phosphoric acid.
Storage: Store at controlled room temperature 15–30°C (59–86°F). Reconstituted solution is stable for 60 days when refrigerated.
- Chorionic gonadotropin 10,000 USP Units
- Monobasic sodium phosphate 5 mg
- Dibasic sodium phosphate 4.4 mg
- Sodium chloride 0.56%
- Benzyl alcohol 0.9%
If required pH adjusted with sodium hydroxide and/or phosphoric acid.
Storage: Store at controlled room temperature 15–30°C (59–86°F). Reconstituted solution is stable for 60 days when refrigerated.
