HGH 191AA
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Product Usage
This PRODUCT IS INTENDED AS A RESEARCH CHEMICAL ONLY. This designation allows the use of research chemicals strictly for in vitro testing and laboratory experimentation only. All product information available on this website is for educational purposes only. Bodily introduction of any kind into humans or animals is strictly forbidden by law. This product should only be handled by licensed, qualified professionals. This product is not a drug, food, or cosmetic and may not be misbranded, misused or mislabled as a drug, food or cosmetic.
DESCRIPTION
HGH is a sterile, non-pyrogenic, white lyophilized powder intended for subcutaneous or intramuscular injection, after reconstitution with bacteriostatic water for injection.
U.S.P. PHARMACOLOGY:
In vitro, preclinical, and clinical tests have demonstrated that somatropins are therapeutically equivalent to human growth hormone of pituitary origin and achieve similar pharmacokinetic profiles in normal adults. In pediatric patients who have growth hormone deficiency (GHD), treatment with somatropin stimulates linear growthand normalizes concentrations of Insulin-like Growth Factor -I (IGF-I).In adults with GHD, treatment with somatropin results in reduced fat mass, increased lean body mass, metabolic alterations that include beneficial changes in lipid metabolism, and normalization of IGF-I concentrations.
PHARMACOKINETICS
Absorption : Following a subcutaneous injection of single dose of 4 mg Somatotropin in healthy male and female adults, the extent of absorption (AUC) was 291 hr.μg/L and the peak concentration (Cmax) was 37 μg/L. There are no pharmacokinetic data from patients with GHD.
Distribution: The mean volume of distribution of Somatotropin following administration to healthy adults was estimated to be 1.4 L/kg.
Metabolism: The metabolic fate of Somatotropin was not studied. However, it is presumed that the metabolic fate of Somatotropin involves classical protein catabolism in both the liver and kidneys.
Excretion: The mean clearance subcutaneously administered Somatotropin in healthy adults was 0.23 (± 0.04) L/hrkg. The mean terminal half-life of Somatotropin after a single subcutaneous injection in healthy adults is 2.4 hours
INDICATIONS AND USAGE:
HGH is indicated for:
- Long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone.
- Long-term replacement therapy in adults with growth hormone deficiency (GHD) of either childhood- or adult- onset etiology. GHD should be confirmed by an appropriate growth hormone stimulation test.
INDICATIONS AND USAGE:
The dosage of HGH must be adjusted for the individual patient. The weekly dose should be divided into daily subcutaneous injections (administered preferably in the evening). HGH may be given in the thigh, buttocks, or abdomen; the site of SC injections should be rotated daily to help prevent lipoatrophy. Pediatric GHD Patients: Generally, a dose of 0.16 to 0.24 mg/kg body weight/week is recommended. Adult GHD Patients: The recommended dosage at the start of therapy is not more than 0.04 mg/kg/week. The dose may be increased at 4- to 8-week intervals according to individual patient requirements to a maximum of 0.08 mg/kg/week, depending upon patient tolerance of treatment. Clinical response, side effects, and determination of age-adjusted serum IGF-I may be used as guidance in dose titration. This approach will tend to result in weight-adjusted doses that are larger for women compared with men and smaller for older and obese patients.
CONTRAINDICATIONS:
HGH should not be used when there is any evidence of neoplastic activity. Intracranial lesions must be inactive and antitumor therapy complete prior to the institution of therapy. HGH should be discontinued if there is evidence of tumor growth.
WARNINGS:
The HGH 3.33 mg presentation contains benzyl alcohol as a preservative. It should not be used in newborns increased mortality in patients with acute critical illnesses in intensive care units due to complications following open heart or abdominal surgery, multiple accidental traumas, or with acute respiratory failure. The safety of continuing growth hormone treatment in patients receiving replacement doses for approved indications who concurrently develop these illnesses has not been established. Therefore, the potential benefit of treatment continuation with growth hormone in patients having acute critical illnesses should be weighed against the potential risk.
DRUG INTERACTIONS:
Concomitant glucocorticoid treatment may inhibit the growth-promoting effect of growth hormone. Pediatric GHD patients with coexisting ACTH deficiency should have their glucocorticoid replacement dose carefully adjusted to avoid an inhibitory effect on growth. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CP450) mediated antipyrine clearance in man. These data suggest that growth hormone administration may alter the clearance of compounds known to be metabolized by CP450 liver enzymes (e.g. corticosteroids, sex steroids, anticonvulsants, cyclosporine). Careful monitoring is advisable when growth hormone is administered in combination with other drugs known to be metabolized by CP450 liver enzymes.
PREGNANCY:
Pregnancy Category B Reproduction studies carried out with recombinant human growth hormone. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers:
There have been no studies conducted with somatropin in nursing mothers. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when somatropin is administered to a nursing woman.
Geriatric Use
The safety and effectiveness of HGH in patients age 65 and over has not been evaluated in clinical studies. Elderly patients may be more sensitive to the action of HGH and may be more prone to develop adverse reactions.
ADVERSE REACTIONS:
As with all protein drugs, a small number of patients may develop antibodies to the protein. Growth hormone antibody with binding capacity lower than 2 mg/L has not been associated with growth attenuation. In some cases when binding capacity is > 2mg/L, interference with growth response has been observed. In clinical trials with somatropin in GHD adults, the majority of the adverse events consisted of mild to moderate symptoms of fluid retention, including peripheral swelling, arthralgia, pain and stiffness of the extremities, peripheral edema, myalgia, paresthesia, and hypoesthesia. These events were reported early during therapy, and tended to be transient and/or responsive to dosage reduction. The following events were observed in patientsusing somatropins. Short-term local injection site reactions, suchas pain, numbness, redness and swelling. The subcutaneous administration of growth hormone at the same injection site over a long period may result in local lipoatrophy. Disturbances in fluid balance (swelling), joint pain, muscle pain, stiffness of the hands and feet, numbness. In general, these undesirable effects occur at the beginning of therapy with growth hormones and also depend on the dose. They are common in adult patients, but uncommon in children. Carpal tunnel syndrome in adults. Benign intracranial hypertension, diabetes mellitus. Leukemia has been reported in small number of pediatric patients who have been treated with growth hormone, including growth hormone of pituitary origin and recombinant GH. The relationship, if any, between leukemia and growth hormone therapy is uncertain
