BACTERICIDAL ACTIVITY:

• Streptococcus pyogenes: Gram+ve (skin), infections typically begin in the throat or skin, causing bacteremia, pneumonia.

• Haemophilus influenzae: Gram –ve, variety of diseases including meningitis (inflammation of the coverings of the spinal column and brain), otitis media, bacteremia (infection of the blood), and pneumonia (infection of the lungs) commonly unrecognized, cause of bacterial pneumonia

• Haemophilus parainfluenzae: Gram –ve, variety of diseases including bronchitis, otitis media, pneumonia, conjunctivitis, Genital tract infection

• Moraxella catarrhalis : Gram –ve, causes infections of the respiratory system, middle ear, eye, central nervous system, and joints of humans

• S. pneumonia: Gram +ve, causes pneumonia, otitis media, meningitis, spinal fluid infection, bacteremia

MODE OF ACTION:

Cefdinir binds to one or more of the penicillin-binding proteins (PBPs) which inhibits the final transpeptidation step of peptidoglycan synthesis in the bacterial cell wall, thus inhibiting biosynthesis and arresting cell wall assembly resulting in bacterial cell death.

PHARMACOKINETICS:

Absorption:

Oral Bioavailability: Maximal plasma cefdinir concentrations: 2 to 4 hours post-dose administration. Estimated bioavailability: 21%.

Effect of Food: Although the rate (Cmax) and extent (AUC) of cefdinir absorption are reduced by 16% and 10%, respectively, when given with a high-fat meal, the magnitude of these reductions is not likely to be clinically significant. Therefore, cefdinir can be taken before or after food.

Distribution: 

Cefdinir is 60% to 70% bound to plasma proteins in both adult and pediatric subjects; binding is independent of concentration.

Metabolism and Excretion:

Cefdinir is not appreciably metabolized. Activity is primarily due to the parent drug. Cefdinir is eliminated principally via renal excretion with a mean plasma elimination half-life (t½) of 1.7 (±0.6) hours.

ADULT DOSE:

• CAP, uncomplicated SSTI, and acute maxillary rhinosinusitis: 300mg every 12 hours for 10 days
• ABECB and pharyngitis/tonsillitis: 300mg every 12 hours for 5 or 10 days
• ABECB, acute maxillary rhinosinusitis, and pharyngitis/tonsillitis: 600mg every 24 hours for 10 days

Patients with Renal Insufficiency: Dosage adjustment is recommended in patients with markedly compromised renal function.

Hepatic Disease: Because of renal eliminated and not appreciably metabolized, dosage adjustment will not be required in this population with hepatic impairment.

Geriatric Patients: Elderly patients do not require dosage adjustment unless they have markedly compromised renal function.

INDICATIONS:

Respiratory Tract Infections:

• Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB) caused by influenzae, H. parainfluenzae, or M. catarrhalis ( β-lactamase producing strains) & Streptococcus pneumonia (penicillin-susceptible strain only)
• Acute Sinusitis caused by H.influenzae/M. catarrhalis (β-lactamase producing strains) & pneumonia (penicillin-susceptible strain only).
• Community Acquired Pneumonia caused by influenzae, H. parainfluenzae, or M. catarrhalis (β-lactamase producing strains) & S. pneumoniae (penicillin-susceptible strain only).

Acute Otitis Media caused by Haemophilus influenza or Moraxella catarrhalis (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strain only)

Pharyngitis & Tonsillitis caused by Streptococcus pyogenes (Group A β-hemolytic streptococci)

Skin & Skin Structure Infections caused by Staphylococcus aureus (includingβ-lactamase producing strains) or pyogenes.

SIDE EFFECTS:

Diarrhea, nausea, chills, black stools, stomach pain, indigestion, oral thrush, abdominal pain, vaginitis itching, discharge, etc.

DRUG INTERACTION:

Concomitant administration with antacids and iron reduces the rate and extent of absorption. Probenecid reduces renal elimination.

CONTRAINDICATIONS:

Known allergy to the cephalosporin class of antibiotics.

PREGNANCY CATEGORY:

Category: B

PACKAGING:

Strips of 10 ×10 Tablets