CEFDINIR powder, for suspension

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Physicians Total Care, Inc.

INN (Tarptautinis Pavadinimas):

CEFDINIR

Sudėtis:

CEFDINIR 125 mg in 5 mL

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

CEFDINIR - CEFDINIR POWDER, FOR SUSPENSION
PHYSICIANS TOTAL CARE, INC.
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CEFDINIR FOR ORAL SUSPENSION
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of cefdinir and
other antibacterial drugs, cefdinir 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 contains 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 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: sucrose, sodium
benzoate, colloidal silicone dioxide,
xanthan gum, guar gum, citric acid (anhydrous), sodium citrate
(dihydrate), strawberry flavour, fresh
cream flavour and magnesium stearate.
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%. Cefdinir oral suspension of 250 mg