DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Novarel (Chorionic Gonadotropin) - 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 anatomic obstruction. In general, HCG is thought to induce testicular descent in situations when descent would have occurred at puberty. HCG thus may help to 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 of 4 and 9.

  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 cryptorchidism 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 pre-treated 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).

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HOW SUPPLIED

Chorionic Gonadotropin for Injection, USP, is available as individually packaged vials containing 10,000 USP Units per vial (NDC 55566-1501-0).

Store dry product at controlled room temperature 15° - 30° C (59° - 86° F).

AFTER RECONSTITUTION WITH BACTERIOSTATIC WATER FOR INJECTION PRESERVED WITH BENZYL ALCOHOL 0.9%, REFRIGERATE THE PRODUCT AT 2° - 8° C (36° - 46° F) AND USE WITHIN 30 DAYS.

Product No.: 0126-10

Mfd. for:
Ferring Pharmaceuticals Inc.
Suffern, NY 10901

Mfd. by:
Steris Laboratories, Inc.
Phoenix, AZ 85043 USA

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017