NUTRESTORE glutamine powder for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

glutamine (UNII: 0RH81L854J) (glutamine - UNII:0RH81L854J)

Available from:

Emmaus Medical, Inc.

INN (International Name):

glutamine

Composition:

glutamine 5 g

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

NUTRESTORE- GLUTAMINE POWDER, FOR SOLUTION
EMMAUS MEDICAL, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NUTRESTORE® SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR NUTRESTORE®.
NUTRESTORE® [L-GLUTAMINE POWDER FOR ORAL SOLUTION]
INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
NutreStore® is an amino acid indicated for:
the treatment of Short Bowel Syndrome in patients receiving
specialized nutritional support when used in conjunction
with a recombinant human growth hormone that is approved for this
indication (1)
DOSAGE AND ADMINISTRATION
30 g daily in divided doses (5 g taken 6 times each day orally) for up
to 16 weeks (2)
Each dose should be reconstituted in 8 oz (250 mL) of water prior to
consumption (2)
Should be taken with meals or snacks at 2- to 3-hour interval while
awake (2)
DOSAGE FORMS AND STRENGTHS
Pre-printed paper-foil-plastic laminate packets: 5 g powder (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Routine monitoring of renal and hepatic function is recommended in
patients receiving lPN, particularly in those with
renal or hepatic impairment (5.1)
ADVERSE REACTIONS
Most common adverse reactions are (6.1):
In initial four (4) weeks (incidence >10%): flatulence, abdominal
pain, nausea, tenesmus, vomiting, hemorrhoids, mouth
dry.
In weeks 5-18 (incidence >10%): nausea, vomiting, tenesmus,
pancreatitis, constipation, Crohn's disease aggravated,
gastric ulcer, gastrointestinal fistula.
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT EMMAUS MEDICAL, INC. AT
1-877-420-6493 OR FDA AT 1-
800-FDA-1088 OR_ WWW.FDA.GOV/MEDWATCH._
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 7/2014
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATION AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Increased Serum Ammonia and Glutamate
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
8 USE IN SPEC