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Benzyl alcohol as a preservative in Bacteriostatic Water for Injection, USP has been associated with toxicity in newborns. When administering Protropin® (somatrem for injection) to newborns, reconstitute with Sterile Water for Injection, USP. USE ONLY ONE DOSE PER PROTROPIN (somatrem) VIAL AND DISCARD THE UNUSED PORTION.
Protropin® (somatrem for injection) should be prescribed by physicians experienced in the diagnosis and management of patients with growth failure.
Slipped capital femoral epiphysis may occur more frequently in patients with endocrine disorders or in patients undergoing rapid growth. Physicians and parents should be alert to the development of a limp or complaints of hip or knee pain in Protropin (somatrem) -treated patients.
Progression of scoliosis can occur in children who experience rapid growth. Because growth hormone increases growth rate, patients with a history of scoliosis who are treated with growth hormone should be monitored for progression of scoliosis. Growth hormone has not been shown to increase the incidence of scoliosis.
Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea and/or vomiting has been reported in a small number of patients treated with growth hormone products. Symptoms usually occurred within the first eight (8) weeks of the initiation of growth hormone therapy. In all reported cases, IH-associated signs and symptoms resolved after termination of therapy or a reduction of the growth hormone dose. Funduscopic examination of patients is recommended at the initiation and periodically during the course of growth hormone therapy.
See WARNINGS for use of Bacteriostatic Water for Injection, USP (benzyl alcohol preserved) in newborns.
As with any protein, local or systemic allergic reactions may occur. Parents/Patient should be informed that such reactions are possible and that prompt medical attention should be sought if allergic reactions occur.
Serum levels of inorganic phosphorus, alkaline phosphatase, and parathyroid hormone (PTH) may increase with Protropin (somatrem) therapy. Changes in thyroid hormone laboratory measurements may develop during Protropin (somatrem) treatment of children who lack adequate endogenous growth hormone secretion. Untreated hypothyroidism prevents optimal response to Protropin (somatrem) . Therefore, patients should have periodic thyroid function tests and should be treated with thyroid hormone when indicated.
Concomitant glucocorticoid therapy may inhibit the growth promoting effect of Protropin (somatrem) . If glucocorticoid replacement is required, the dose should be carefully adjusted.
Carcinogenicity, mutagenicity and reproduction studies have not been conducted with Protropin (somatrem) .
Pregnancy (Category C). Animal reproduction studies have not been conducted with Protropin (somatrem) . It is also not known whether Protropin (somatrem) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Protropin (somatrem) should be given to a pregnant woman only if clearly needed.
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 Protropin (somatrem) is administered to a nursing mother.
Information for Patients
See PATIENT INFORMATION section.
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
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