Brand name: Rinicef
International Nonproprietary Name: Cefdinir
Drug form: capsules 300 mg.
Description: hard gelatin capsules, an opaque black color cap and an opaque gray color base.
Composition:
1 capsule contains:
Active substance: Cefdinir – 300.00 mg;
Pharmacotherapeutic group
Antibacterial drugs for systemic use. Third generation cephalosporins
АТC Code: J01DD15
Pharmacological properties
Pharmacodynamics
The active substance Cefdinir is a broad-spectrum semi-synthetic cephalosporin antibiotic of the third generation for oral administration. Similar to other cephalosporin group antibiotics, Cefdinir possesses bactericidal effect against sensitive microorganisms due to the bacterial cell wall peptidoglycan synthesis inhibition by disrupting the final stage of transamination, which is necessary for cross-linking. Cefdinir is resistant to many, but not all, beta-lactamases produced by gram-positive and gram-negative bacteria. Due to this fact, many microorganisms resistant to penicillins and some cephalosporins are sensitive to Cefdinir.
Cefdinir spectrum of action includes:
Aerobic Gram-Positive Microorganisms
Staphylococcus aureus (including beta-lactamase producing strains)
Staphylococcus pneumoniae (penicillin-sensitive strains only)
Staphylococcus 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 data have been obtained in vitro, but their clinical significance is unknown.
Cefdinir minimal inhibitory concentration (MPC) in vitro is 1 μg/ml or less in (≥ 90%) strains of the microorganisms, mentioned below; however, Cefdinir safety and efficacy in treatment of infections caused by these microorganisms has not been demonstrated in clinical studies.
Aerobic Gram-Positive Microorganisms
Staphylococcus epidermidis
Streptococcus agalactiae
Streptococcus viridans
Aerobic gram-negative microorganisms
Citrobacter diversus
Escherichia coli
Klebsiella pneumoniae
Proteus mirabilis
Cefdinir is not effective against Pseudomonas, Enterobacter, Enterococcus and methicillin-resistant strains of Staphylococci.
Dosage and Administration
Recommended dosage and treatment duration to fight infections in adults and adolescents are stated in the table below. The total daily dose for the treatment of all kind of infections is 600 mg. One dose a day for 10 days period is as effective as taking it twice a day. One dose a day has not been studied for pneumonia and skin infections therapy, so in these cases Rinicef should be taken twice a day. Capsules can be taken with or without food.
For administration in children (6 months – 12 years old), Cefdinir should be used in a form of suspension.
Adults and adolescents (aged 13 and above)
|
Infection type |
Dosage |
Duration |
|
Community-acquired pneumoniae |
300 mg every 12 hours |
10 days |
|
Infection type |
Dosage |
Duration |
|
Chronic Bronchitis Exacerbation |
300 mg every 12 hours or 600 mg every 24 hours |
from 5 to 10 days 10 days |
|
Acute maxillary sinusitis |
300 mg every 12 hours or 600 mg every 24 hours |
10 days 10 days |
|
Pharyngitis/tonsillitis |
300 mg every 12 hours or 600 mg every 24 hours |
from 5 to 10 days 10 days |
|
Uncomplicated skin and skin tissue infections
|
300 mg every 12 hours or
|
10 days |
Elderly: no change in dosage regimen is required unless significant renal function impairment is observed (CLCR <30 ml/min). If CLCR <30 ml/min, the drug should be taken at a dose of 300 mg once a day.
Patients with kidney failure
In patients with CLCR <30 ml/min, Cefdinir should be prescribed at a dose of 300 mg once a day.
Hemodialysis patients
Hemodialysis helps to remove Cefdinir from the body. In patients on regular hemodialysis the recommended starting dose is 300 mg or 7 mg/kg every other day (EOD). At the end of each hemodialysis session 300 mg (or 7 mg/kg) of Cefdinir is prescribed. Subsequent doses (300 mg or 7 mg/kg) are then given EOD.
If you missed the next dose, you should take it as soon as you remember. If this dose is missed at the time of the next dose, skip the dose and follow the previous dosing regimen, do not double the dose.
Side effect
Cefdinir is characterized by good tolerability profile; the adverse reactions observed were mild in their manifestation and spontaneously disappeared after withdrawal. Most cases of withdrawal were associated with gastrointestinal tract disorders, mainly manifested by diarrhea or nausea. In rare cases drug withdrawal was required due to rash development during Cefdinir administration.
Adverse reactions are classified by frequency of occurrence: very often (≥ 1/10), often (from ≥ 1/100 to <1/10), infrequently (from ≥ 1/1000 to <1/100), rare (≥1 / 10 000, <1/1000), very rare (<1/10 000), and unknown frequency (the frequency cannot be counted according to the data available).
Very common: diarrhea, rash, nausea.
Often: skin candidiasis, abdominal pain, leukopenia, candidal vaginitis, vaginitis, abnormal stool, dyspepsia, hyperkinesis, maculopapular rash, nausea, increased AST level.
Adverse reactions common for cephalosporin administration
Allergic reactions, anaphylaxis, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, renal dysfunction, toxic nephropathy, liver dysfunction including cholestasis, aplastic anemia, hemolytic anemia, hemorrhagic disturbances, false positive urine glucose test, neutropenia, pancytopenia and agranulocytosis. Pseudomembranous colitis can develop both at the time and after antibiotic therapy completion.
Some cephalosporins administration was accompanied with seizures, especially in patients with impaired renal function, who did not have dose adjustment. When seizures develop during the therapy, the antibiotic should be withdrawn. In case of clinical necessity anticonvulsant therapy may be prescribed.
According to the results of post-registration application, the following adverse reactions have been identified: shock, anaphylaxis (in rare cases with fatality), swelling of ligament space and face edema, suffocation, whey-like syndrome, conjunctivitis, stomatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, erythema multiforme, erythema nodosa, acute hepatitis, cholestatic syndrome, fulminant hepatitis, liver failure, jaundice, increased amylase, acute enterocolitis, hemorrhagic diarrhea, hemorrhagic colitis, melena, pseudomembranous colitis, pancytopenia, granulocytopaenia, leukopenia, thrombocytopenia, idiopathic thrombocytopenic purpura, hemolytic anemia, acute respiratory failure, asthma attack, drug-induced pneumonia, eosinophilic pneumonia, idiopathic interstitial pneumonia, fever, acute renal failure, nephropathy, hemorrhagic tendency, blood-clotting disorder, disseminated intravascular coagulation, bleeding from the upper part of gastrointestinal tract, peptic ulcer, bowel obstruction, loss of consciousness, allergic vasculitis, possible interaction of cefdinir-diclofenac, heart failure, chest pain, myocardial infarction, rhabdomyolysis, sporadic movements, hypertension.
In case of occurrence of the listed adverse reactions, as well as a reaction not specified in the instructions for use, you must consult a doctor.
Contraindications
Rinicef is contraindicated in patients allergic to cephalosporin group antibiotic in anamneses and increased sensitivity to excipients presented in the drug.
Overdose
There are no data regarding Cefdinir overdose in patients.
Acute toxicity studies in rodents have shown that Cefdinir single oral dose of 5600 mg/kg did not lead to the adverse reactions development. The following signs and symptoms of overdose have been observed in concomitant administration with other beta-lactam antibiotics: nausea, vomiting, gastric discomfort, diarrhea and cramps.
During hemodialysis Cefdinir is excreted from the body which can be useful in case of serious toxic reactions caused by overdose, especially in case of impaired renal function in the patient.
Precautions
Before Rinicef therapy it is necessary to check the patient’s history for possible hypersensitivity reactions to penicillins, cephalosporins or other drugs.
In case of suspicion or confirmation of Clostridium difficile-associated diarrhea, the prescribed antibiotic therapy should be discontinued if it is not effective against Clostridium difficile. Based on the patient’s clinical condition, fluid replenishment, electrolytes and amino acid solutions, antibiotic eradication of Clostridium difficile and surgery may be prescribed.
Rinicef, like other broad-spectrum antimicrobial drugs (antibiotics) should be prescribed with caution to patients with a history of colitis.
In patients with short-term or persistent renal failure (CLCR <30 ml/min) Rinicef daily dose should be reduced, as the recommended doses can lead to a significant increase in Cefdinir half-life and plasma concentrations.
Cephalosporins therapy may sometimes demonstrate a positive Coombs test.
Use in pregnancy and lactation.
Pregnancy and childbirth
Experimental reproduction studies haven’t shown any teratogenic effect.
There are no data on the results of cefdinir use in pregnant women. Cefdinir can be prescribed during pregnancy only in a reasonable clinical case.
There are no data on Cefdinir effect on childbirth.
Lactation
In nursing mothers Cefdinir is not detected in breast milk when prescribed in a dose of 600 mg. Cefdinir may be prescribed during lactation only after a careful assessment of the benefit/risk ratio for the mother and child.
Effect on ability to drive and work with mechanisms
Rinicef does not affect the ability to drive and work with mechanisms.
Interactions with other drugs
Concomitant administration of Cefdinir and antacid leads to a decrease in Cefdinir absorption rate (C max) and absorption degree (AUC) by approximately 40%. If it is necessary to take antacids during Rinicef treatment course Rinicef should be taken at least 2 hours before or two hours after antacid.
Similar to other beta-lactam antibiotics, Probenecid disrupts Cefdinir renal excretion when taken together resulting in approximately twofold increase in AUC, an increase in Cefdinir maximal plasma concentration by 54% and an increase in half-life t1/2 by 50%.
Cefdinir concomitant administration with iron-contained drugs contained 60 mg of elemental iron (in a form of FeSO4) or vitamin drugs contained 10 mg of iron reduces Cefdinir absorption by 80% and 31%, respectively. If the patient needs to take iron-contained drugs during Cefdinir therapy, Rinicef should be taken at least 2 hours before or after iron-contained drugs.
There have been reports of reddish stool color in patients on Cefdinir therapy. In many cases, these patients were simultaneously taken iron-fortified food products. Reddish color may be associated with a non-absorbable complex of Cefdinir or its decomposition products and Iron formation in the gastrointestinal tract.
During the therapy with Cefdinir, false positive results on urine ketones may be observed in case of nitroprusside, but not nitroferricyanide used. False positive results can also be noted during urine glucose determination when Benedict solution or Feling Reagent used (glucosuria is recommended to be determined only by the enzymatic method). Cephalosporins can sometimes result in a positive Coombs test.
Shelf-life and storage conditions
At a temperature not above 25°С
Keep out of reach of children!
Shelf-life is 3 years. Not to be used after the expiration date indicated on the package.
Prescription Status
On prescription
Packaging
10 capsules in a blister made of polyvinyl chloride film and flexible packaging based on aluminum foil.
1 or 2 blister strips together with a leaflet placed into a cardboard box.
Manufacturer information
Foreign production and trade unitary enterprise “Reb-Pharma”, 223216, Republic of Belarus, Minsk region, Chervensky district, Smilovichi, Sadovaya Str., 1, tel./fax: (+375) 17 240 26 35,
Comment type is not specified in the component properties.