
Prescription Drug Name:
Cefdinir for Oral Suspension, USP, Rx only
ID:
ab5a8f5e-fbed-4b20-9e14-0871b5add264
Code:
34391-3
DESCRIPTION
id: 766411ef-ee45-4062-b288-3b4773052e4e
displayName: Description Section
FDA Article Code: 34089-3
INDICATIONS AND USAGE
id: 1c5dc055-9fdf-4fcf-b5e1-cf6bdf214081
displayName: Indications & Usage Section
FDA Article Code: 34067-9
Cefdinir for oral suspension is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
CONTRAINDICATIONS
id: a9d88d97-e793-44c1-abd7-d4b88616759e
displayName: Contraindications Section
FDA Article Code: 34070-3
WARNINGS
id: 17339887-0185-4f63-b3cf-e9a7855e6fbf
displayName: Warnings Section
FDA Article Code: 34071-1
If CDAD is suspected or confirmed, ongoing antibacterial use not directed against
OVERDOSAGE
id: aac1627b-391e-48b2-b2d7-130e7bdc52e1
displayName: Overdosage Section
FDA Article Code: 34088-5
DOSAGE AND ADMINISTRATION
id: a0585344-410a-4d5d-87ab-2872efe05aad
displayName: Dosage & Administration Section
FDA Article Code: 34068-7
The recommended dosage and duration of treatment for infections in pediatric patients are described in the following chart; the total daily dose for all infections is 14 mg/kg, up to a maximum dose of 600 mg per day. Once-daily dosing for 10 days is as effective as BID dosing. Once-daily dosing has not been studied in skin infections; therefore, cefdinir for oral suspension should be administered twice daily in this infection. Cefdinir for oral suspension may be administered without regard to meals.
Pediatric Patients (Age 6 Months Through 12 Years) | ||
---|---|---|
Type of Infection | Dosage | Duration |
Acute Bacterial Otitis Media | 7 mg/kg q12h or 14 mg/kg q24h |
5 to 10 days 10 days |
Acute Maxillary Sinusitis | 7 mg/kg q12h or 14 mg/kg q24h |
10 days 10 days |
Pharyngitis/Tonsillitis | 7 mg/kg q12h or 14 mg/kg q24h |
5 to 10 days 10 days |
Uncomplicated Skin and Skin Structure Infections | 7 mg/kg q12h | 10 days |
CEFDINIR FOR ORAL SUSPENSION PEDIATRIC DOSAGE CHART | ||
---|---|---|
aPediatric patients who weigh ≥ 43 kg should receive the maximum daily dose of 600 mg. | ||
|
|
|
9 kg/20 lbs | 2.5 mL q12h or 5 mL q24h | Use 125 mg/5 mL product |
18 kg/40 lbs | 5 mL q12h or 10 mL q24h | 2.5 mL q12h or 5 mL q24h |
27 kg/60 lbs | 7.5 mL q12h or 15 mL q24h | 3.75 mL q12h or 7.5 mL q24h |
36 kg/80 lbs | 10 mL q12h or 20 mL q24h | 5 mL q12h or 10 mL q24h |
≥ 43 kga/95 lbs | 12 mL q12h or 24 mL q24h | 6 mL q12h or 12 mL q24h |
HOW SUPPLIED
id: 5bf1e9f5-3c14-4d4b-b074-3b1f16fc0eab
displayName: How Supplied Section
FDA Article Code: 34069-5
60 mL Bottle NDC 16714-392-01
100 mL Bottle NDC 16714-392-02
Cefdinir for Oral Suspension, USP 250 mg/5 mL is a off-white to yellowish — white colored granular powder, on constitution with water, forming an off-white to yellowish-white colored suspension with strawberry and cream flavors.
60 mL Bottle NDC 16714-393-01
100 mL Bottle NDC 16714-393-02
Store dry powder at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Once reconstituted, the oral suspension can be stored at controlled room temperature for 10 days.
REFERENCES
id: e71dce0e-747f-4164-bd98-28226e8afbb3
displayName: References Section
FDA Article Code: 34093-5
Clinistix® and Clinitest® are registered trademarks of Miles Diagnostics.
Tes-Tape® is a registered trademark of Eli Lilly and company.
Manufactured for: Northstar Rx LLC
Memphis, TN38141.
Manufactured by: Aurobindo Pharma Limited
Chitkul (V)-502 307, India.
M.L.No.: 78/MD/AP/96/F/B/R
Revised: 09/2017
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL – 125 mg/5 mL (60 mL Bottle)
id: a32ed700-431a-4cc5-9cf7-7e2da5e917ad
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Suspension, USP
Keep bottle tightly closed.
Any unused portion must be
discarded 10 days after mixing.
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL – 125 mg/5 mL (60 mL) Carton Label
id: ec101d56-1cf3-4dc1-81b7-f56e0f5ae1bf
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Suspension, USP
Keep bottle tightly closed.
Any unused portion must be
discarded 10 days after mixing.
38 mL WATER
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL – 250 mg/5 mL (60 mL Bottle)
id: 88b4e582-e0fa-41c5-b590-5962d065026b
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Suspension, USP
Keep bottle tightly closed.
Any unused portion must be
discarded 10 days after mixing.
NORTHSTARTM
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL – 250 mg/5 mL (60 mL) Carton Label
id: a9427de3-b2b2-41a3-8cbd-fbd285e80219
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Suspension, USP
Keep bottle tightly closed.
Any unused portion must be
discarded 10 days after mixing.
38 mL WATER