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Pronunciation |
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(HYU
man grothe HOR
mone) |
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U.S. Brand
Names |
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Genotropin® Injection; Humatrope®
Injection; Norditropin® Injection; Nutropin® AQ Injection;
Nutropin® Injection; Protropin® Injection; Saizen®
Injection; Serostim®
Injection |
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Generic
Available |
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No |
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Synonyms |
|
Growth Hormone; Somatrem; Somatropin |
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Pharmacological Index |
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Growth Hormone |
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|
Use |
|
Long-term treatment of growth failure from lack of adequate endogenous growth
hormone secretion
Nutropin®: Treatment of children who have growth
failure associated with chronic renal insufficiency up until the time of renal
transplantation |
|
|
Pregnancy Risk
Factor |
|
C |
|
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Contraindications |
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Closed epiphyses, known hypersensitivity to drug, benzyl alcohol (somatrem),
or m-Cresol or glycerin (somatropin); progression of any underlying intracranial
lesion or actively growing intracranial tumor |
|
|
Warnings/Precautions |
|
Use with caution in patients with diabetes; when administering to newborns,
reconstitute with sterile water for injection |
|
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Adverse
Reactions |
|
S.C. administration can cause local lipoatrophy or lipodystrophy and may
enhance the development of neutralizing antibodies
<1%: Rash, itching, hypoglycemia, pain at injection site, small risk for
developing leukemia, pain in hip/knee |
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Overdosage/Toxicology |
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Symptoms include hypoglycemia, hyperglycemia, acromegaly |
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Drug
Interactions |
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Decreased effect: Glucocorticoid therapy may inhibit growth-promoting
effects. |
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Stability |
|
Somatrem (Protropin®): Store vials at
2°C to
8°C/36°F to
46°F; reconstitute each 5 mg vial with 1-5 mL of
bacteriostatic water for injection; use reconstituted vials within 7 days; avoid
freezing
Somatropin
(Humatrope®/Nutropin®): Store vials
at 2°C to
8°C/36°C to
46°F; avoid freezing; reconstitute each 5 mg vial with 1-5
mL of bacteriostatic water for injection; use reconstituted vials within 14
days; avoid freezing |
|
|
Mechanism of
Action |
|
Somatropin and somatrem are purified polypeptide hormones of recombinant DNA
origin; somatropin contains the identical sequence of amino acids found in human
growth hormone while somatrem's amino acid sequence is identical plus an
additional amino acid, methionine; human growth hormone stimulates growth of
linear bone, skeletal muscle, and organs; stimulates erythropoietin which
increases red blood cell mass; exerts both insulin-like and diabetogenic
effects |
|
|
Pharmacodynamics/Kinetics |
|
Somatrem and somatropin have equivalent pharmacokinetic properties
Absorption: I.M.: Well absorbed
Metabolism: ~90% in the liver
Half-life: 15-50 minutes
Elimination: 0.1% excreted in urine unchanged |
|
|
Usual Dosage |
|
Children (individualize dose):
Somatropin (Genotropin®): S.C.: Weekly dosage of
0.16-0.24 mg/kg divided into 6-7 doses
Somatropin (Humatrope®): I.M., S.C.: Up to 0.06 mg
(0.16 units)/kg/dose 3 times/week
Somatropin (Nutropin®): S.C.:
Growth hormone inadequacy: Weekly dosage of 0.3 mg/kg (0.78 units/kg)
administered daily
Chronic renal insufficiency: Weekly dosage of 0.35 mg/kg (0.91 units/kg)
administered daily
Therapy should be discontinued when patient has reached satisfactory adult
height, when epiphyses have fused, or when the patient ceases to respond
Growth of 5 cm/year or more is expected, if growth rate does not exceed 2.5
cm in a 6-month period, double the dose for the next 6 months, if there is still
no satisfactory response, discontinue therapy |
|
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Administration |
|
Do not shake; administer S.C. or I.M.; refer to product labeling; when
administering to newborns, reconstitute with sterile water for
injection |
|
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Monitoring
Parameters |
|
Growth curve, periodic thyroid function tests, bone age (annually),
periodical urine testing for glucose, somatomedin C levels |
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Mental Health: Effects
on Mental Status |
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None reported |
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Mental Health:
Effects on Psychiatric
Treatment |
|
None reported |
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Dental Health: Local
Anesthetic/Vasoconstrictor
Precautions |
|
No information available to require special precautions |
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Dental Health:
Effects on Dental Treatment |
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No effects or complications reported |
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Patient
Information |
|
Reconstitute each 5 mg vial with 1-5 mL bacteriostatic water for injection
(benzyl alcohol preserved) only; do not shake; do not inject if solution
is cloudy; use a small enough syringe so that the prescribed dose can be drawn
from the vial with reasonable accuracy; use a needle of sufficient length (
greater than or equal to 1") to ensure that the injection reaches the muscle
layer |
|
|
Nursing
Implications |
|
Watch for glucose intolerance |
|
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Dosage Forms |
|
Powder for injection (lyophilized):
Genotropin®: 1.5 mg ~4.5 units (5 mL); 5.8 mg ~17.4
units (5 mL)
Humatrope®: 5 mg ~15 units
Norditropin®: 4 mg ~12 units; 8 mg ~24 units
Nutropin®: 5 mg ~15 units (10 mL); 10 mg ~30 units (10
mL)
Nutropin® AQ: 10 mg ~30 units (2 mL)
Nutropin® Depot™: 13.5 mg (3
mL); 18 mg (3 mL); 22.5 mg (3 mL)
Saizen® (rDNA origin): 5 mg ~15 units
Serostim®: 5 mg ~15 units (5 mL); 6 mg ~18 units (5 mL)
Somatrem, Protropin®: 5 mg ~15 units (10 mL); 10 mg ~30
units (10 mL) |
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References |
|
Howrie DL,
"Growth Hormone for the Treatment of Growth Failure in Children," Clin
Pharm, 1987, 6(4):283-91. |
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