RODINIR (Powder for oral suspension)

COMPOSITION:

Powder for oral suspension. 5 ml of the suspension contain cefdinir 125 mg or 250 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. Plasma concentrations of cefdinir increase when the dose is increased; however, starting from 7 mg/kg of body weight until 14 mg/kg of body weight the concentration is less proportional to the dose increase. Absolute bioavailability of cefdinir is 25%. Maximum plasma concentration (C_max) and AUC decrease by 44% and 33% 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)
7 mg/kg	2.30 (0.65)	2.2 (0.60)	8.31 (2.50)
14 mg/kg	3.86 (0.62)	1.8 (0.40)	13.4 (2.64)

 

Solvation: average 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 by 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.

 

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 suspension should be administered enterally.

The dose is adjusted individually depending on age, body weight, kidney function and the severity of the infection.

The suspension should be prepared immediately before first administration. Shake the bottle to loosen the powder, add 38 ml or 63 ml of boiled water cooled down to room temperature in two portions (up to the mark) and each time shake intensively. Next, leave it for approximately 5 minutes until the powder fully dissolves. Shake the bottle well before every administration. 

A measuring 5 ml spoon is provided for accurate dosage, which should be washed thoroughly with water after every use. 

Prepared suspension should be stored at room temperature for no more than 10 days.

For convenient administration to children under 2 years-old it can be diluted in double the amount of water.

Adults and children over 12 years-old: the suspension is usually not administered in this age group due to active ingredients content.

For the treatment of children between 6 months and 12 years-old the following doses are recommended:

•         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.

Recommended dosage for children is included in the table:

Weight	125 mg/5 ml	250 mg/5 ml
9 kg	2.5 ml every 12 hours or  5 ml once daily	Rodinir suspension  125 mg/5 ml
18 kg	5 ml every 12 hours or  10 ml once daily	2.5 ml every 12 hours or  5 ml once daily
27 kg	7.5 ml every 12 hours or  15 ml once daily	3.75 ml every 12 hours or  7.5 ml once daily
36 kg	10 ml every 12 hours or  20 ml once daily	5 ml every 12 hours or  10 ml once daily
≥43* kg	12 ml every 12 hours or 24 ml once daily	6 ml every 12 hours or 12 ml once daily

*To children with body weight ≥43 kg the medication should be administered in maximum daily dose of 600 mg.

Patients with kidney disorders: with creatinine clearance of less than 30 ml/min the dose is 7 mg/kg of body weight once daily (up to 300 mg/daily).

Haemodialysis patients: recommended initial dose is 7 mg/kg of body weight every 48 hours. On the completion of every haemodialysis session a dose of 7 mg/kg of body weight should be administered. The following doses of 7 mg/kg of body weight are administered every 48 hours.

 

PACKAGING

Powder for oral suspension.

125 mg/5 ml or 250 mg/5ml is in 60 ml or 100 ml yellow glass bottle with child-resistant cap. 

1 bottle together with a leaflet and 1 measuring spoon are in a carton box.