CEFDINIR powder, for suspension

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

CEFDINIR MONOHYDRATE (UNII: 6E7SN358SE) (CEFDINIR - UNII:CI0FAO63WC)

Dostupné s:

NuCare Pharmaceuticals,Inc.

INN (Mezinárodní Name):

CEFDINIR MONOHYDRATE

Složení:

CEFDINIR 250 mg in 5 mL

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir for oral suspension USP and other antibacterial drugs, cefdinir for oral suspension USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cefdinir for oral suspension USP 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. Caused by Haemophilus influenzae (including β-lactamase producing strains), Haemophilus parainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptibl

Přehled produktů:

Cefdinir for oral suspension USP is a white to off-white powder formulation that, when reconstituted as directed, contains either 125 mg cefdinir/5 mL or 250 mg cefdinir/5 mL. The reconstituted suspension has a white to off-white color and cherry flavor. The powder is available as follows: NDC 68071-3295-1 bottles of 100mL Store the unsuspended powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Once reconstituted, the oral suspension can be stored at controlled room temperature for 10 days.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

CEFDINIR- CEFDINIR POWDER, FOR SUSPENSION
NUCARE PHARMACEUTICALS,INC.
----------
CEFDINIR FOR ORAL SUSPENSION USP
4136
4137
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of cefdinir for oral
suspension USP and other antibacterial drugs, cefdinir for oral
suspension USP should be used only to
treat or prevent infections that are proven or strongly suspected to
be caused by bacteria.
DESCRIPTION
Cefdinir for oral suspension USP contains the active ingredient
cefdinir monohydrate, USP, an
extended-spectrum, semisynthetic cephalosporin, for oral
administration. Chemically, cefdinir
monohydrate, USP is (6 _R_,7
_R_)-7-[[(2Z)-(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-
oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate.
Cefdinir monohydrate, USP is
a white to light yellow crystalline powder. Its solubility is 19.56
mg/mL in 0.1 M pH 7 phosphate
buffer. Cefdinir monohydrate, USP has the structural formula shown
below:
C
H
N
O
S
•H
O M.W. 413.44
Cefdinir for oral suspension USP, after reconstitution, contains 125
mg or 250 mg cefdinir per 5 mL and
the following inactive ingredients: artificial cherry-mixed fruit
flavor, anhydrous citric acid, colloidal
silicon dioxide, guar gum, magnesium stearate, sodium benzoate, sodium
citrate (anhydrous), sucrose,
and xanthan gum.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS AND DRUG METABOLISM
Absorption
_Oral Bioavailability_
Maximal plasma cefdinir concentrations occur 2 to 4 hours postdose
following capsule or suspension
14
13
5
5
2
2
administration. Plasma cefdinir concentrations increase with dose, but
the increases are less than dose-
proportional from 300 mg (7 mg/kg) to 600 mg (14 mg/kg). Following
administration of suspension to
healthy adults, cefdinir bioavailability is 120% relative to capsules.
Estimated bioavailability of
cefdinir suspension is 25%. Cefdinir oral suspension of 250 mg/5 mL
strength was shown to be
bioequivalent to the 125 mg/5 mL strength in healthy adults under
fasting condi