NUTRESTORE- glutamine powder, for solution
Emmaus Medical, Inc.
1 INDICATION AND USAGE
NutreStore� [L-glutamine powder for oral solution] is indicated for the treatment of Short Bowel Syndrome (SBS) in patients receiving specialized nutritional support when used in conjunction with a recombinant human growth hormone that is approved for this indication [see Dosage and Administration (2) ].
NutreStore and recombinant human growth hormone (rhGH) therapy should be used in conjunction with optimal management of SBS. Optimal management of SBS may include a specialized oral diet, enteral feedings, parenteral nutrition, fluid and micronutrient supplements. A specialized oral diet may consist of a high carbohydrate, low-fat diet, adjusted for individual patient requirements and preferences.
Routine monitoring of renal and hepatic function is recommended in patients receiving NutreStore and intravenous parenteral nutrition (IPN), particularly in those with renal or hepatic impairment. Glutamine is metabolized to glutamate and ammonia, which may increase in patients with hepatic dysfunction.
The safety and efficacy of NutreStore have not been studied beyond 16 weeks of treatment.
2 DOSAGE AND ADMINISTRATION
NutreStore should be administered as a cotherapy with rhGH (see prescribing information for somatropin [rDNA origin)] for injection) followed by continued NutreStore for up to 16 weeks.
The recommended dosage of NutreStore is 30 g daily in divided doses (5 g taken 6 times each day orally) for up to 16 weeks. Each dose of NutreStore (5 g) should be reconstituted in 8-oz (250-mL) of water prior to consumption.
NutreStore should be taken with meals or snacks at 2- to 3-hour intervals while awake. The volume of water may be varied according to the patient�s preference. In the event of a patient�s transient intolerance to oral intake, a dose may be delayed for up to 2 hours.
3 DOSAGE FORMS AND STRENGTHS
NutreStore is supplied in preprinted paper-foil-plastic laminate packets containing 5 g of L-glutamine powder.