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Chorionic Gonadotropin (Chorionic Gonadotropin (Human)) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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 CALORIE-RESTRICTED DIETS.

  1. 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 between the ages four and nine.
  2. Selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males.
  3. 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.

DOSAGE AND ADMINISTRATION

Intramuscular Use Only

The dosage regimen employed in any particular case will depend upon the indication for use, the age and weight of the patient and the physician’s preference.  The following regimens have been advocated by various authorities.

Prepubertal Cryptochidism Not Due To Anatomical Obstruction

  1. 4,000 USP Units three times weekly for three weeks.
  2. 5,000 USP Units every second day for four injections.
  3. 15 injections of 500 to 1,000 USP Units over a period of six weeks.
  4. 500 USP Units three times weekly for four to six weeks. If this course of treatment is not successful, another is begun one month later giving 1,000 USP Units per injection.

Selected Cases Of Hypogonadotropic Hypogonadism In Males

  1. 500 to 1,000 USP Units three times a week for three weeks, followed by the same dose twice a week for three weeks.
  2. 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 Units is recommended in the labeling for menotropins.)

IMPORTANT: USE COMPLETELY WITHIN 60 DAYS AFTER RECONSTITUTION. REFRIGERATE AFTER RECONSTITUTION.

DIRECTIONS FOR RECONSTITUTION

Two-Vial Package

Withdraw sterile air from lyophilized vial and inject into diluent vial.  Remove 10 mL from diluent vial and add to lyophilized vial; agitate gently until solution is complete.

HOW SUPPLIED

Chorionic Gonadotropin for Injection, USP, lyophilized, is supplied in two-vial packages including Bacteriostatic Water for Injection as diluent as follows:

Product

No.

NDC

No.

25021

63323-025-10            

Chorionic Gonadotropin for Injection, USP, 10,000 USP Units in a 10 mL multiple dose vial with accompanying diluent in packages of 10.

The product is assayed in accord with the USP method and potencies refer to USP Units

(International Units) defined in terms of the USP Chorionic Gonadotropin Reference Standard.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

 

45792G

Revised: April 2011

 


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