CEFDINIR powder, for suspension

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

CEFDINIR (UNII: CI0FAO63WC) (CEFDINIR - UNII:CI0FAO63WC)

Dostupné z:

Lupin Pharmaceuticals, Inc.

INN (Medzinárodný Name):

CEFDINIR

Zloženie:

CEFDINIR 125 mg in 5 mL

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir for oral suspension and other antibacterial drugs, cefdinir for oral suspension 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 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-susceptible strains only), and Moraxella catarrhalis (including β-lacta

Prehľad produktov:

Cefdinir for oral suspension USP, is an off-white to creamish powder formulation that, when reconstituted as directed, contains 125 mg cefdinir/5 mL or 250 mg cefdinir/5 mL. The reconstituted suspension has an off-white to creamish color and strawberry flavor. The powder is available as follows: 125 mg/5 mL: 60 mL bottles                                       NDC 68180-722-04 100 mL bottles                                     NDC 68180-722-05 250 mg/5 mL: 60 mL bottles                                      NDC 68180-723-04 100 mL bottles                                    NDC 68180-723-05 Store dry powder and reconstituted suspension at 20° to 25 °C (68° to 77 °F); [See USP Controlled Room Temperature].

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

CEFDINIR- CEFDINIR POWDER, FOR SUSPENSION
LUPIN PHARMACEUTICALS, INC.
----------
CEFDINIR FOR ORAL SUSPENSION USP
125 MG/5 ML & 250 MG/5 ML
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of cefdinir for oral
suspension and other antibacterial drugs, cefdinir for oral suspension
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 contain the active ingredient cefdinir,
an extended-spectrum, semisynthetic
cephalosporin, for oral administration. Chemically, cefdinir is
[6R-[6α,7β(Z)]]-7-[[(2-amino-4-
thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-
carboxylic acid. Cefdinir is a white to slightly brownish-yellow
solid. It is slightly soluble in dilute
hydrochloric acid and sparingly soluble in 0.1 M pH 7.0 phosphate
buffer. The molecular formula is
C
H N O S and the molecular weight is 395.42. Cefdinir has the
structural formula shown below:
Cefdinir for oral suspension, after reconstitution, contains 125 mg
cefdinir per 5 mL or 250 mg cefdinir
per 5 mL and the following inactive ingredients: anhydrous citric
acid; colloidal silicon dioxide; guar
gum; anhydrous sodium citrate; sodium benzoate; strawberry flavour;
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 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 capsules is 21% following
administration of a 300 mg capsule
dose, and 16% following administration of a 600 mg capsule dose.
Estimated absolute bioavailability of
cefdinir suspension is 25%