A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Pregnyl Indications, Dosage, Storage, Stability - Chorionic Gonadotropin
Pregnyl Indications, Dosage, Storage, Stability - Chorionic Gonadotropin
INDICATIONS
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 in children 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
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.
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 for 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 series
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 anovulatoiy, infertile woman in whom the cause
of anovulation is secondary and not due to primaiy 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.
HOW SUPPLIED
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.
When reconstituted, each 10 mL vial
contains:
| 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 15°- 30° C( 59°- 86° F).
Reconstituted solution is stable
for 60 days when refrigerated.
top
