RODINIR (capsules)

COMPOSITION:

Hard gelatıne capsules, size # 1. One capsule contains cefdinir 300 mg.

PHARMACOLOGICAL PROPERTIES

PHARMACODYNAMICS.

Cefdinir is a semisynthetic β-lactam antibiotic. It has bactericidal properties as it inhibits synthesis of the bacterial cell wall. The medication affects various β-lactam producing microorganisms and microorganisms resistant towards penicillins and other cephalosporins; however, it can be hydrolyzed by certain extended-spectrum plasmid-mediated β-lactamases.

Cefdinir is active towards most strains of the following microorganisms (both in vitro and in clinical practice):

•         aerobic gram-positive microorganisms: Staphylococcus aureus (including β-lactam producing strains), Streptococcus pneumoniae (only the strains responsive to penicillin), Streptococcus pyogenes:

-        aerobic gram-negative microorganisms: Haemophilus influenzae (including β-lactam producing strains), Haemophilus parainfluenzae (including β-lactam producing strains), Moraxella catarrhalis (including β-lactam producing strains).

Cefdinir is inactive towards Pseudomonas aeruginosa, Enterobacter spp., Enterococcus spp. and methicillin resistant Staphylococcus spp.

PHARMACOKINETICS

Absorption: maximum plasma concentration of cefdinir is achieved 2-4 hours after enteral administration. Bioavailability of single dose of 300 mg is 21%, 600 mg – 16 %. Maximum plasma concentration (C_max) and AUC decrease by 16% and 10% respectively with fatty foods intake.

Average values of pharmacological parameters in plasma after cefdinir suspension is administered to children between 6 months and 12 years-old are presented in the table:

Dose	Cmax (mcg/ml)	tmax (hours)	AUC (mcg·h/ml)
300 mg	1.60 (0.55)	2.9 (0.89)	7.05 (2.17)
600 mg	2.87 (1.01)	3.0 (0.68)	11.1 (3.87)

 

Distribution: mean cefdinir solvation capacity in adults is 0.35 l/kg, in children (6 months to 12 yearsold) – 0.67 l/kg. The medication dissolves in skin blister fluid, middle ear fluid, tonsils, sinus cavities, bronchial mucus membrane and lung tissue in concentration of 15-48% of plasma level. Cefdinir binds with plasma proteins in 60-70%, binding does not depend on medication concentration.

Metabolism and excretion: cefdinir is not significantly subjected to metabolism, it is excreted mainly via kidneys. The average plasma half-life is 1.7 (± 0.6) hours. The renal clearance is 2.0 ml/min/kg. clearance following oral intake  of the doses of 300 mg and 600 mg is 11.6 ml/min and 15.5 ml/min/kg respectively; 18.4 and 11.6 %, respectively excreted intact with urine.

THERAPEUTIC INDICATIONS 

Mild to moderate infectious inflammatory diseases caused by microorganisms responsive to the medication:

•         infections of ears, throat or nose: acute sinusitis, acute otitis media, pharyngitis and tonsillitis;

-        uncomplicated skin and soft tissue infections.

 

CONTRADICTIONS

-        hypersensitivity to any components of the medication as well as other cefalosphorin antibiotics.

ADVERSE REACTIONS

•         Gastrointestinal tract side effects: nausea, diarrhea; seldom – dyspepsia, gastritis, vomiting, stomach ache, increased activity of AST, ALT and LDH.  
•         Central nervous system side effects: headache; seldom – dizziness; very seldom - spasms.
•         Allergic reactions: anaphylaxis, bronchospasm, dyspnea, rash, urticaria, hypersensitivity, itch, angioedema, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis.
•         Haematopoiesis reactions: aplastic anemia, pancytopenia, leukopenia, neutropenia and agranulocytosis.  
•         Blood coagulation system reactions: increase of prothrombin time and international normalized ratio, haemolytic anemia and internal bleeding, initial positive Coombs test.
•         Urinary system reactions: kidney dysfunction, toxic neuropathy, glycosuria, ketonuria.

-        Other: superinfection.

 

DOSAGE AND ADMINISTRATION

Rodinir capsules should be administered once or twice daily with no regard to food intake.

The dose is adjusted individually depending on character and the severity of the infection, as well as the susceptibility of the causative agent.

Dosage regimen for adults and children over 13 years old:

 

 

•         Recurrent acute chronic bronchitis, pharyngitis and tonsillitis: 300 mg every 12 hours during 5-10 days or 600 mg once daily during 10 days;
•         acute sinusitis: 300 mg every 12 hours during 5-10 days or 600 mg once daily during 10 days;
•         community-acquired pneumonia: uncomplicated skin and soft tissues infections: 300 mg every 12 hours during 10 days. 

Recommended dosage for children aged 6 months-12 years:

•         acute otitis media, pharyngitis and tonsillitis: 7 mg/kg of body weight every 12 hours for 5-10 days or 14 mg/kg  of body weight once daily for 10 days;
•         acute sinusitis: 7 mg/kg of body weight every 12 hours or 14 mg/kg  of body weight once daily for 10 days;
•         uncomplicated skin and soft tissue infections: 7 mg/kg of body weight every 12 hours for 10 days.

It is advisable to administer the medication to children in the form of suspension.

Patients with kidney disorders: with creatinine clearance of less than 30 ml/min:

Adults: 300 mg once daily.

 Children aged 6 months-12 years old: the dose is 7 mg/kg of body weight once daily (up to 300 mg/daily).

Haemodialysis patients: recommended initial dose is 300 mg (or 7 mg/kg of body weight for children aged 6 months-12 years old) every 48 hours. On the completion of every haemodialysis session a dose of 300 mg (7 mg/kg of body weight for children aged 6 months-12 years old) should be administered. The subsequent doses of 300 mg (7 mg/kg of body weight for children aged 6 months12 years old) are administered every 48 hours.

 

PACKAGING

Hard gelatine capsules.

10 capsules in a blister.

1 or 2 blisters with enclosed leaflet in a carton box.