Prescription Drug Information: DAPTOMYCIN (Page 8 of 8)

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 a sterile, pale yellow to light brown, lyophilized powder or cake, and is supplied as follows:

NDC Daptomycin for Injection Package Factor
71288-016 -15 500 mg of daptomycin in a 15 mL Single-Dose Vial 1 vial per carton

Store original packages refrigerated between 2° and 8°C (36° and 46°F); avoid excessive heat. Storage conditions for the reconstituted and diluted solutions are described in another section of the prescribing information [see Dosage and Administration (2.7)].

Discard unused portion.

Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

17 PATIENT COUNSELING INFORMATION

Allergic Reactions

Advise patients that allergic reactions, including serious skin, kidney, lung, or other organ reactions, could occur and that these serious reactions require immediate treatment. Patients should report any previous allergic reactions to daptomycin [see Warnings and Precautions (5.1, 5.4, 5.5)].

Muscle Pain or Weakness (Myopathy and Rhabdomyolysis, Peripheral Neuropathy)

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, 5.6)].

Cough, Breathlessness, or Fever (Eosinophilic Pneumonia)

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

C. difficile -Associated Diarrhea (CDAD)

Advise patients that diarrhea is a common problem caused by antibacterials including daptomycin, that usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterials, including daptomycin, 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 (5.8)].

Antibacterial Resistance

Patients should be counseled 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.

Brands listed are the trademarks of their respective owners.

meitheal®
Mfd. for Meitheal Pharmaceuticals
8700 W Bryn Mawr Ave., Ste 600S
Chicago, IL 60631 (USA)
©2023 Meitheal Pharmaceuticals Inc.

Mfd. by Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.
No. 16 Xuefu Road
Nanjing High & New Technology Development ZoneNanjing, China 210061

Revised: April 2023

8F7AAU9-03

PRINCIPAL DISPLAY PANEL – Daptomycin for Injection, 500 mg Container Label

NDC 71288-016 -15

Daptomycin for Injection

500 mg per vial

MUST BE REFRIGERATED

For Intravenous Infusion.

Single-Dose Vial –

Discard unused portion

Rx Only

PRINCIPAL DISPLAY PANEL – Daptomycin for Injection, 500 mg Container Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – Daptomycin for Injection, 500 mg Carton

NDC 71288-016 -15

Daptomycin for Injection

500 mg per vial

MUST BE REFRIGERATED

For Intravenous Infusion.

Use 0.9% Sodium Chloride Injection for reconstitution only.

1 Single-Dose Vial –

Discard unused portion

Rx Only

PRINCIPAL DISPLAY PANEL – Daptomycin for Injection, 500 mg 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:71288-016
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DAPTOMYCIN (DAPTOMYCIN) DAPTOMYCIN 500 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71288-016-15 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
1 10 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (71288-016-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213623 06/29/2021
Labeler — Meitheal Pharmaceuticals Inc. (080548348)
Establishment
Name Address ID/FEI Operations
Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. 421297554 MANUFACTURE (71288-016)

Revised: 06/2023 Meitheal Pharmaceuticals Inc.

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