CEDIN-300 Capsule

In patients with known allergy to the cephalosporin class of antibiotics.

Diarrhea, Yeast infection, Headache, rashes, Vomiting, and Stomach pain are common adverse effects.

Serious side effects

Blood in stools

Severe or watery diarrhea

Unusual headaches

Blurred vision

Unexplained rash

Itchy skin

Hives

Wheezing

Difficulty breathing

Swelling of the throat

Peeling of the skin

Rare side effects

Serious allergic reaction, indigestion bloody diarrhea, loss of appetite (anorexia), heart failures, gas inflammation of the vagina (vaginitis), chest pain, constipation, high blood pressure (hypertension). Increased rate of red blood cell destruction (hemolytic anemia). Reduced amount of platelets in the blood (thrombocytopenia), liver failure, kidney failure and serious intestinal infection (enterocolitis).

Antacids containing magnesium or aluminum interfere with the absorption of Cefdinir. If this type of antacid is required during Cefdinir therapy, Cefdinir should be taken at least 2 hours before or after the antacid.

Iron supplements, including multivitamins that contain iron, interfere with the absorption of Cefdinir. If iron supplements are required during Cefdinir therapy, Cefdinir should be taken at least 2 hours before or after the supplement.

Pregnancy

This drug should be used during pregnancy only if clearly needed.

Nursing Mothers

Following administration of single 600mg doses, cefdinir was not detected in human breast milk.

General

Prescribing Cefdinir in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. As with other broad-spectrum antibiotics, prolonged treatment may result in the possible emergence and overgrowth of resistant organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate alternative therapy should be administered. Cefdinir, as with other broad-spectrum antimicrobials (antibiotics), should be prescribed with caution in individuals with a history of colitis.

In patients with transient or persistent renal insufficiency (Creatinine Clearance <30mL/min, the total daily dose of Cefdinir should be reduced because high and prolonged plasma concentrations of Cefdinir can result following recommended doses.

Before therapy with cefdinir is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cefdinir, other cephalosporins, penicillins, or other drugs. If cefdinir is to be given to penicillin-sensitive patients, caution should be exercised because cross-hypersensitivity among beta-lactam antibiotics has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction to cefdinir occurs, the drug should be discontinued. Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, pressor amines, and airway management as clinically indicated.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including cefdinir, and may range in severity from mild-to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of “antibiotic-associated colitis”. After the diagnosis of pseudomembranous colitis has been established, appropriate therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile.

Cefdinir is bactericidal and has the same mode of action as other beta-lactam antibiotics (such as penicillins) but is less susceptible to penicillinases. It disrupts the synthesis of the peptidoglycan layer of bacterial cell walls. The peptidoglycan layer is important for cell wall structural integrity. The final transpeptidation step in the synthesis of the peptidoglycan is facilitated by transpeptidases known as penicillin-binding proteins (PBPs). PBPs bind to the D-Ala-D-Ala at the end of mucopeptides (peptidoglycan precursors) to crosslink the peptidoglycan. Beta-lactam antibiotics mimic the D-Ala-D-Ala site, thereby competitively inhibiting PBP crosslinking of peptidoglycan. This leads to the death of the bacteria.

Cefdinir is active against a very wide spectrum of bacteria, including:

Aerobic Gram-Positive Microorganisms

Staphylococcus aureus (including beta-lactamase producing strains)

NOTE: Cefdinir is inactive against methicillin-resistant staphylococci.

Streptococcus pneumoniae (penicillin-susceptible strains only)

Streptococcus pyogenes

Aerobic Gram-Negative Microorganisms

Haemophilus influenzae (including beta-lactamase producing strains)

Haemophilus parainfluenzae (including beta-lactamase producing strains)

Moraxella catarrhalis (including beta-lactamase producing strains)

The following in vitro data are available, but their clinical significance is unknown. (See the package insert.)

Aerobic Gram-Positive Microorganisms

Staphylococcus epidermidis (methicillin-susceptible strains only)

Streptococcus agalactiae

Viridans group streptococci

NOTE: Cefdinir is inactive against Enterococcus and methicillin-resistant Staphylococcus species.

Aerobic Gram-Negative Microorganisms

Citrobacter diversus

Escherichia coli

Klebsiella pneumoniae

Proteus mirabilis

NOTE: Cefdinir is inactive against Pseudomonas and Enterobacter species.