Daptomycin (Page 9 of 9)

15 REFERENCES

  1. Liu SL, Howard LC, Van Lier RBL, Markham JK: Teratology studies with daptomycin administered intravenously (iv) to rats and rabbits. Teratology 37(5):475, 1988.
  2. Stroup JS, Wagner J, Badzinski T: Use of daptomycin in a pregnant patient with Staphylococcus aureus endocarditis. Ann Pharmacother 44(4):746-749, 2010.
  3. Buitrago MI, Crompton JA, Bertolami S, North DS, Nathan RA. Extremely low excretion of daptomycin into breast milk of a nursing mother with methicillin-resistant Staphylococcus aureus pelvic inflammatory disease. Pharmacotherapy 2009;29(3):347–351.
  4. Klibanov OM, Vickery S, Nortey C: Successful treatment of infective panniculitis with daptomycin in a pregnant, morbidly obese patient. Ann Pharmacother 48(5):652-655, 2014.
  5. Li JS, Sexton DJ, Mick N, Nettles R, Fowler VG Jr, Ryan T, Bashore T, Corey GR. Proposed modifications to the Duke criteria for the diagnosis of infective endocarditis. Clin Infect Dis 2000;30:633–638.

16 HOW SUPPLIED/STORAGE AND HANDLING

Daptomycin for Injection is supplied as a sterile pale yellow to light brown lyophilized cake in a single-dose 15 mL vial containing 350 mg of daptomycin: Package of 1 (NDC 70594-053-01).

Store original packages at refrigerated temperatures, 2 to 8°C (36 to 46°F); avoid excessive heat [see Dosage and Administration (2.5)].

17 PATIENT COUNSELING INFORMATION

Advise patients that allergic reactions, including serious allergic reactions, could occur and that serious reactions require immediate treatment. Patients should report any previous allergic reactions to daptomycin [see Warnings and Precautions (5.1)] .

Advise patients to report muscle pain or weakness, especially in the forearms and lower legs, as well as tingling or numbness [see Warnings and Precautions (5.2, 5.4)].

Advise patients to report any symptoms of cough, breathlessness, or fever [see Warnings and Precautions (5.3)].

Advise patients that diarrhea is a common problem caused by antibacterials that usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterials, patients can develop watery and bloody stools (with or without stomach cramps and fever), even as late as 2 or more months after having received the last dose of the antibacterial. If this occurs, patients should contact their physician as soon as possible [see Warnings and Precautions (5.6) ].

Counsel patients that antibacterial drugs, including Daptomycin for Injection, should be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Daptomycin for Injection is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be administered exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Daptomycin for Injection or other antibacterial drugs in the future.

Manufactured for:

Xellia Pharmaceuticals USA, LLC
Buffalo Grove, IL 60089

Made in India

LEA-020125-03

Code No: AP/DRUGS/103/97

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL — 350 mg Vial Label

NDC 45932-0039-1 Rx Only

Daptomycin for Injection

350 mg/vial

MUST BE REFRIGERATED

For Intravenous Infusion.

Single-Dose VialDiscard Unused Portion

xellia-label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 350 mg Vial Carton

NDC 45932-0039-1

Daptomycin for Injection

350 mg/vial

MUST BE REFRIGERATED

For Intravenous Infusion.

Use 0.9% Sodium Chloride Injection for reconstitution only.

One Single-Dose Vial

Discard Unused Portion

Rx Only

xellia-carton
(click image for full-size original)
DAPTOMYCIN daptomycin injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45932-0039
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DAPTOMYCIN (DAPTOMYCIN) DAPTOMYCIN 350 mg in 7 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45932-0039-1 1 VIAL in 1 CARTON contains a VIAL
1 7 mL in 1 VIAL This package is contained within the CARTON (45932-0039-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA209949 07/19/2018
Labeler — Xellia Pharmaceuticals USA, LLC (305814345)

Revised: 10/2019 Xellia Pharmaceuticals USA, LLC

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