July 28, 2016
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Nutropin Depot

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Nutropin Depot




Overdosage
Contraindications

OVERDOSE

The recommended dosage of Nutropin Depot (somatropin (rdna origin) for inj) should not be exceeded. Acute overdosage could lead to fluid retention, headache, nausea, vomiting, and/or hyperglycemia. Long-term overdosage could result in signs and symptoms of gigantism and/or acromegaly, consistent with the known effects of excess GH. (See recommended dosage instructions given below.)

CONTRAINDICATIONS

Growth hormone should not be initiated to treat patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma, or to patients having acute respiratory failure. Two placebo-controlled clinical trials in non-growth hormone-deficient adult patients (n = 522) with these conditions revealed a significant increase in mortality (41.9% vs. 19.3%) among somatropin-treated patients (doses 5.3-8 mg/day) compared to those receiving placebo (see WARNINGS).

Nutropin Depot (somatropin (rdna origin) for inj) should not be used for growth promotion in pediatric patients with closed epiphyses.

Nutropin Depot (somatropin (rdna origin) for inj) should not be used in patients with active neoplasia. GH therapy should be discontinued if evidence of neoplasia develops.

Growth hormone is contraindicated in patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment (see WARNINGS). Unless patients with Prader-Willi syndrome also have a diagnosis of growth hormone deficiency, Nutropin Depot (somatropin (rdna origin) for inj) is not indicated for the long term treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 3/5/2009

Overdosage
Contraindications

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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