"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
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.)
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.
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.
Last reviewed on RxList: 3/5/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Nutropin Depot Information
- Nutropin Depot Drug Interactions Center: somatropin subq
- Nutropin Depot Side Effects Center
- Nutropin Depot Overview including Precautions
- Nutropin Depot FDA Approved Prescribing Information including Dosage
Report Problems to the Food and Drug Administration
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