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
Delatestryl Indications, Dosage, Storage, Stability - Testosterone Enanthate
Delatestryl Indications, Dosage, Storage, Stability - Testosterone Enanthate
INDICATIONS
Males
DELATESTRYL (Testosterone Enanthate Injection) is indicated for
replacement therapy in conditions associated with a deficiency
or absence of endogenous
testosterone.
Primary hypogonadism
(congenital or acquired): Testicular failure due to cryptorchidism,
bilateral torsion,
orchitis, vanishing testis syndrome, or orchidectomy.
Hypogonadotropic hypogonadism
(congenital or acquired): Idiopathic gonadotropin
or leuteinizing hormone-releasing hormone
(LHRH) deficiency, or pituitary-hypothalamic injury
from tumors, trauma, or radiation. (Appropriate adrenal
cortical and thyroid
hormone replacement
therapy are still necessary,
however, and are actually of primary
importance.)
If the above conditions occur prior to puberty, androgen
replacement therapy will
be needed during the adolescent
years for development
of secondary sexual characteristics. Prolonged androgen
treatment will
be required to maintain sexual
characteristics in these and other males who develop testosterone
deficiency after puberty.
Delayed puberty: DELATESTRYL (Testosterone Enanthate
Injection) may be used to stimulate
puberty in carefully
selected males with clearly delayed puberty. These patients usually
have a familial pattern
of delayed puberty that is not secondary
to a pathological disorder; puberty
is expected to occur spontaneously at a relatively late date. Brief
treatment with conservative
doses may occasionally be justified in these patients if they do
not respond to psychological
support. The potential
adverse effect on bone
maturation should
be discussed with the patient
and parents prior to androgen
administration. An X-ray
of the hand and wrist
to determine bone age should
be obtained every six months to assess the effect
of treatment on the epiphyseal centers (see WARNINGS).
Females
Metastatic mammary
cancer: DELATESTRYL (Testosterone Enanthate Injection) may
be used secondarily in women with advancing inoperable
metastatic (skeletal) mammary
cancer who are one to
five years postmenopausal. Primary goals of therapy
in these women include ablation
of the ovaries. Other methods of counteracting estrogen
activity are adrenalectomy,
hypophysectomy, and/or antiestrogen
therapy. This treatment
has also been used in premenopausal women with breast
cancer who have benefited
from oophorectomy
and are considered to have a hormone-responsive tumor. Judgment
concerning androgen
therapy should be made by an oncologist
with expertise in this field.
DOSAGE AND ADMINISTRATION
Dosage and duration
of therapy with DELATESTRYL
(Testosterone Enanthate Injection) will
depend on age, sex, diagnosis,
patient’s response
to treatment, and appearance
of adverse effects. When properly given, injections of DELATESTRYL
are well tolerated. Care should be taken to inject
the preparation
deeply into the gluteal
muscle following the
usual precautions for intramuscular administration. In
general, total doses above 400 mg
per month are not required
because of the prolonged action
of the preparation. Injections more frequently than every two weeks
are rarely indicated. NOTE: Use of a wet
needle or wet
syringe may cause
the solution to become
cloudy; however this does not affect
the potency of the material.
Parenteral drug products
should be inspected visually for particulate
matter and discoloration
prior to administration, whenever solution
and container permit.
DELATESTRYL is a clear, colorless to pale yellow
solution.
Male hypogonadism: As
replacement therapy,
i.e., for eunuchism, the suggested dosage
is 50 to 400 mg every 2 to
4 weeks.
In males with delayed puberty: Various dosage
regimens have been used; some call for lower dosages initially with
gradual increases as puberty
progresses, with or without a decrease to maintenance levels. Other
regimens call for higher dosage
to induce pubertal
changes and lower dosage for maintenance after puberty. The chronological
and skeletal ages must
be taken into consideration, both in determining the initial
dose and in adjusting the dose. Dosage is within the range
of 50 to 200 mg every 2 to
4 weeks for a limited duration, for example, 4 to 6 months. X-rays
should be taken at appropriate
intervals to determine the amount of bone maturation and skeletal
development (see
INDICATIONS
AND USAGE and WARNINGS).
Palliation of inoperable
mammary cancer
in women: A dosage of 200 to 400 mg
every 2 to 4 weeks is recommended. Women with metastatic breast
carcinoma must be
followed closely because androgen
therapy occasionally
appears to accelerate the disease.
HOW SUPPLIED
DELATESTRYL (Testosterone Enanthate Injection USP) is available
in 1 mL (200 mg/mL) Unimatic single dose
syringes (NDC 54396-328-16). Each syringe is supplied with a sterile
disposable 20-gauge, 1 ½-inch needle. DELATESTRYL is also
available in 5 mL (200 mg/mL) multiple
dose vials (NDC 54396-328-40).
Storage
DELATESTRYL (Testosterone Enanthate Injection USP) should be stored
at room temperature. Warming
and rotating the syringe
unit or vial
between the palms of the hands will
redissolve any crystals that may have formed during storage at low
temperatures.
Directions for Use of UNIMATIC® single dose
syringe
1) Screw the threaded tip
of the plunger rod clockwise
into the cartridge plunger and push forward a few millimeters to
break any friction
between the cartridge plunger and syringe
barrel.
2) Holding syringe
erect, aseptically remove the rubber cap
from the tip of the syringe
and attach the sterile,
disposable needle using
a push-twist action.
3) Remove the needle
guard, hold the syringe
erect, and push plunger forward until a drop
appears at tip of needle
and all of the air is evacuated.
Following the usual aspiration
procedure, complete the injection.
4) Destroy the needle
and syringe immediately
after use.
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